Deepa Varma

TOPLINE:

Omitting axillary lymph node dissection does not increase the risk for recurrence or compromise 5-year overall survival outcomes in patients with early-stage, node-negative breast cancer with sentinel-node metastases undergoing surgery and radiation therapy.

METHODOLOGY:

• A growing body of evidence has indicated that patients with one or two positive sentinel nodes undergoing breast-conserving surgery and radiation therapy can skip axillary lymph node dissection and achieve similar outcomes compared with patients receiving axillary dissection.
• However, these earlier studies had notable limitations, such as limited statistical power, uncertain nodal radiotherapy target volumes, and minimal data on relevant clinical subgroups.
• To fill the gaps in the literature, the researchers conducted a trial with a large, inclusive cohort of patients with node-negative stage T1-T3 breast cancer who had one or two sentinel-node macrometastases and had undergone a mastectomy or breast-conserving surgery.
• The trial randomized 2540 patients to either completion axillary lymph node dissection (n = 1205) or sentinel-node biopsy only (n = 1335). Nearly 90% of patients received adjuvant radiation therapy, and the majority also received systematic therapy.
• Earlier recurrence-free survival findings and patient-reported outcomes were reported last December. The researchers now reported overall survival findings as well as secondary endpoints of breast cancer-specific survival.

TAKEAWAY:

• The researchers reported 191 recurrences or deaths over a median follow-up of 46.8 months; 62 patients (4.6%) in the sentinel-node biopsy–only group died, and 69 patients (5.7%) in the dissection group died.
• The biopsy-only group had an estimated 5-year overall survival of 92.9% compared with 92.0% in the dissection group and an estimated 5-year breast cancer-specific survival of 97.1% vs 96.6% in the dissection group.
• The estimated 5-year recurrence-free survival was 89.7% in the biopsy-only group vs 88.7% in the dissection group (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19).
• This non-inferior difference held across all prespecified patient subgroups, except in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–positive disease, in which sentinel biopsy alone appeared to be better (HR, 0.26).

IN PRACTICE:

“This trial provides robust evidence that the omission of completion axillary-lymph-node dissection was safe in patients with clinically node-negative T1, T2, or T3 breast cancer and one or two sentinel-node macrometastases who received adjuvant systemic treatment and radiation therapy according to national guidelines,” the authors concluded.

“It is clear that the role of axillary dissection is rapidly disappearing,” Kandace P. McGuire, MD, of Virginia Commonwealth University, Richmond, wrote in an accompanying editorial. “However, axillary staging continues to be vital with regard to decisions about appropriate breast cancer therapy.”

SOURCE:

This work, led by Jana de Boniface, MD, PhD, from Karolinska Institute, Stockholm, was published online in The New England Journal of Medicine, alongside the accompanying editorial by Dr. McGuire.

LIMITATIONS:

The study limitations include unavailable radiation therapy details for comparison, low male recruitment hindering sex-based analysis, short follow-up for luminal subtype breast cancer, unmet enrollment targets, and higher withdrawal rates in the dissection group.

DISCLOSURES:

This study was supported by the Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, and Swedish Breast Cancer Association. One coauthor reported receiving consultancy fees from various pharmaceutical companies outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Omitting axillary lymph node dissection does not increase the risk for recurrence or compromise 5-year overall survival outcomes in patients with early-stage, node-negative breast cancer with sentinel-node metastases undergoing surgery and radiation therapy.

METHODOLOGY:

• A growing body of evidence has indicated that patients with one or two positive sentinel nodes undergoing breast-conserving surgery and radiation therapy can skip axillary lymph node dissection and achieve similar outcomes compared with patients receiving axillary dissection.
• However, these earlier studies had notable limitations, such as limited statistical power, uncertain nodal radiotherapy target volumes, and minimal data on relevant clinical subgroups.
• To fill the gaps in the literature, the researchers conducted a trial with a large, inclusive cohort of patients with node-negative stage T1-T3 breast cancer who had one or two sentinel-node macrometastases and had undergone a mastectomy or breast-conserving surgery.
• The trial randomized 2540 patients to either completion axillary lymph node dissection (n = 1205) or sentinel-node biopsy only (n = 1335). Nearly 90% of patients received adjuvant radiation therapy, and the majority also received systematic therapy.
• Earlier recurrence-free survival findings and patient-reported outcomes were reported last December. The researchers now reported overall survival findings as well as secondary endpoints of breast cancer-specific survival.

TAKEAWAY:

• The researchers reported 191 recurrences or deaths over a median follow-up of 46.8 months; 62 patients (4.6%) in the sentinel-node biopsy–only group died, and 69 patients (5.7%) in the dissection group died.
• The biopsy-only group had an estimated 5-year overall survival of 92.9% compared with 92.0% in the dissection group and an estimated 5-year breast cancer-specific survival of 97.1% vs 96.6% in the dissection group.
• The estimated 5-year recurrence-free survival was 89.7% in the biopsy-only group vs 88.7% in the dissection group (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19).
• This non-inferior difference held across all prespecified patient subgroups, except in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–positive disease, in which sentinel biopsy alone appeared to be better (HR, 0.26).

IN PRACTICE:

“This trial provides robust evidence that the omission of completion axillary-lymph-node dissection was safe in patients with clinically node-negative T1, T2, or T3 breast cancer and one or two sentinel-node macrometastases who received adjuvant systemic treatment and radiation therapy according to national guidelines,” the authors concluded.

“It is clear that the role of axillary dissection is rapidly disappearing,” Kandace P. McGuire, MD, of Virginia Commonwealth University, Richmond, wrote in an accompanying editorial. “However, axillary staging continues to be vital with regard to decisions about appropriate breast cancer therapy.”

SOURCE:

This work, led by Jana de Boniface, MD, PhD, from Karolinska Institute, Stockholm, was published online in The New England Journal of Medicine, alongside the accompanying editorial by Dr. McGuire.

LIMITATIONS:

The study limitations include unavailable radiation therapy details for comparison, low male recruitment hindering sex-based analysis, short follow-up for luminal subtype breast cancer, unmet enrollment targets, and higher withdrawal rates in the dissection group.

DISCLOSURES:

This study was supported by the Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, and Swedish Breast Cancer Association. One coauthor reported receiving consultancy fees from various pharmaceutical companies outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Omitting axillary lymph node dissection does not increase the risk for recurrence or compromise 5-year overall survival outcomes in patients with early-stage, node-negative breast cancer with sentinel-node metastases undergoing surgery and radiation therapy.

METHODOLOGY:

• A growing body of evidence has indicated that patients with one or two positive sentinel nodes undergoing breast-conserving surgery and radiation therapy can skip axillary lymph node dissection and achieve similar outcomes compared with patients receiving axillary dissection.
• However, these earlier studies had notable limitations, such as limited statistical power, uncertain nodal radiotherapy target volumes, and minimal data on relevant clinical subgroups.
• To fill the gaps in the literature, the researchers conducted a trial with a large, inclusive cohort of patients with node-negative stage T1-T3 breast cancer who had one or two sentinel-node macrometastases and had undergone a mastectomy or breast-conserving surgery.
• The trial randomized 2540 patients to either completion axillary lymph node dissection (n = 1205) or sentinel-node biopsy only (n = 1335). Nearly 90% of patients received adjuvant radiation therapy, and the majority also received systematic therapy.
• Earlier recurrence-free survival findings and patient-reported outcomes were reported last December. The researchers now reported overall survival findings as well as secondary endpoints of breast cancer-specific survival.

TAKEAWAY:

• The researchers reported 191 recurrences or deaths over a median follow-up of 46.8 months; 62 patients (4.6%) in the sentinel-node biopsy–only group died, and 69 patients (5.7%) in the dissection group died.
• The biopsy-only group had an estimated 5-year overall survival of 92.9% compared with 92.0% in the dissection group and an estimated 5-year breast cancer-specific survival of 97.1% vs 96.6% in the dissection group.
• The estimated 5-year recurrence-free survival was 89.7% in the biopsy-only group vs 88.7% in the dissection group (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19).
• This non-inferior difference held across all prespecified patient subgroups, except in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–positive disease, in which sentinel biopsy alone appeared to be better (HR, 0.26).

IN PRACTICE:

“This trial provides robust evidence that the omission of completion axillary-lymph-node dissection was safe in patients with clinically node-negative T1, T2, or T3 breast cancer and one or two sentinel-node macrometastases who received adjuvant systemic treatment and radiation therapy according to national guidelines,” the authors concluded.

“It is clear that the role of axillary dissection is rapidly disappearing,” Kandace P. McGuire, MD, of Virginia Commonwealth University, Richmond, wrote in an accompanying editorial. “However, axillary staging continues to be vital with regard to decisions about appropriate breast cancer therapy.”

SOURCE:

This work, led by Jana de Boniface, MD, PhD, from Karolinska Institute, Stockholm, was published online in The New England Journal of Medicine, alongside the accompanying editorial by Dr. McGuire.

LIMITATIONS:

The study limitations include unavailable radiation therapy details for comparison, low male recruitment hindering sex-based analysis, short follow-up for luminal subtype breast cancer, unmet enrollment targets, and higher withdrawal rates in the dissection group.

DISCLOSURES:

This study was supported by the Swedish Research Council, Swedish Cancer Society, Nordic Cancer Union, and Swedish Breast Cancer Association. One coauthor reported receiving consultancy fees from various pharmaceutical companies outside this work.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a common reason for discontinuation.

METHODOLOGY:

• Progestin-only LARC may increase the risk for acne, but this has not been well studied in adolescents and young adults.
• In the study, researchers evaluated the incidence of acne, acne as a reason for removal, and strategies used to manage acne after insertion of a progestin-only intrauterine device (IUD) or contraceptive implant in 1319 adolescents and young adults across four Adolescent Medicine LARC Collaborative study sites from January 2017 to June 2021.The mean age at insertion was 18.6 years.
• Overall, 24% of participants had acne at the time of LARC insertion.
• Worsening acne was defined as new patient reports of concern about acne, observations of acne, or addition of an acne medication after insertion; increased severity noted on an exam during follow-up or at the time of LARC removal; or acne reported as a side effect and/or reason for LARC removal.

TAKEAWAY: 

• During the study period, 376 participants (28.5%) experienced worsening acne after LARC insertion, and 17% reported acne as a new concern, with no differences between those who received an IUD or an implant.
• Only 44 of the 376 participants (11.7%) who reported worsening acne were being treated with an oral agent at follow-up.
• Of the 542 individuals (41% of the total) who had the LARC device removed, 40 (7.4%) cited concerns about acne for removing the device, although just 5 (0.92%) said that acne was the only reason for removal. Of the 40 with concerns about acne when the device was removed, 18 (45%) had documented acne at the time of insertion.

IN PRACTICE:

The authors recommend that clinicians prescribing progestin-only LARC should counsel patients that acne may be a side effect, reassuring them that if they develop acne, “it typically is not problematic enough to warrant discontinuation,” and concluded that “concerns about the development or worsening of acne should not be cause to avoid these forms of contraception.”

SOURCE:

The study, led by Markus D. Boos, MD, PhD, of the division of dermatology in the Department of Pediatrics, University of Washington in Seattle and Seattle Children’s Hospital, was published in Pediatric Dermatology.

LIMITATIONS:

Individuals without documented acne were assumed to be acne-free, creating potential bias. Acne evaluation and treatment were not standardized and were not performed by dermatologists; acne severity was not recorded for many participants, possibly underestimating severity, and excluding LARC insertions without follow-up or with removal within 8 weeks may have underestimated the percentage of participants who developed new or worsening acne.

DISCLOSURES: 

The study was supported by Investigator-Initiated Studies Program of Organon and by the Health Resources and Services Administration of the US Department of Health and Human Services. Many authors received grants for this work. The authors did not disclose any other competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Secondary cancers were flagged in 4.3% of all adverse event reports among patients who received CAR T therapy, with T-cell malignancies comprising only 0.15% of the total reports and 3.54% of all second primary malignancies, according to an analysis of adverse event reports submitted to the US Food and Drug Administration (FDA).

METHODOLOGY:

• In November 2023, the FDA announced its investigation into whether chimeric antigen receptor (CAR) T-cell immunotherapies can cause secondary blood cancers, specifically T-cell malignancies. At the time, the agency said: “Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T-cell malignancy with serious outcomes.”
• In January 2024, the FDA issued boxed warnings on the six approved CART cell therapies, citing the possibility of second primary malignancies, including CAR-positive lymphomas, in patients who had received a CAR T agent.
• To evaluate the extent of these secondary cancers, researchers analyzed the FDA Adverse Event Reporting System database for CAR T-cell reports citing second primary malignancies.

TAKEAWAY:

• Overall, the authors identified 12,394 unique adverse events associated with CAR T therapy; of these, 536 adverse events (4.3%) were second primary malignancies.
• Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tis-cel) accounted for most of the second primary malignancies reports — 51.7% (277 of 536 patients) for axi-cel and 33% (177 of 536 patients) for tis-cel.
• The researchers identified 19 cases of T-cell malignancies, representing only 0.15% of all unique adverse events and 3.54% of all second primary malignancies (19 of 536 patients); 17 of these cases were T-cell non-Hodgkin lymphomas, and two were T-cell large granular lymphocytic leukemia.
• Among the reported 536 second primary malignancies, the most frequent cancers were leukemias (333 reports, or 62%), followed by skin neoplasms (54 reports, or 10.1%), hematopoietic neoplasms excluding leukemias and lymphomas (26 reports, 4.85%), nervous system tumors (21 reports, 3.92%), and respiratory neoplasms (20 reports, 3.73%).

IN PRACTICE:

“We will continue to monitor the data released by the FDA to learn more about CAR T-associated risks. However, it’s crucial to stress that the benefits of CAR T-cell therapies still outweigh the risks for the approved indications,” Magdi Elsallab, MD, the study’s co-lead author, said in a news release.

SOURCE:

This work, led by Dr. Elsallab from Harvard Medical School in Boston, was published online on March 14 in Blood.

LIMITATIONS:

The limitations of the analysis include the presence of duplicate report submissions, incomplete data, difficulty establishing causal relationships, and the potential for both underreporting and overreporting based on the severity of adverse events. Furthermore, without the total number of prescribed products, it was difficult to determine the adverse event frequency.

DISCLOSURES:

The study funding source was not disclosed. Some of the authors reported financial ties with various organizations outside this work, including Bristol Myers Squibb, Janssen Biotech, Johnson & Johnson, Kite Pharma, and Novartis.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Secondary cancers were flagged in 4.3% of all adverse event reports among patients who received CAR T therapy, with T-cell malignancies comprising only 0.15% of the total reports and 3.54% of all second primary malignancies, according to an analysis of adverse event reports submitted to the US Food and Drug Administration (FDA).

METHODOLOGY:

• In November 2023, the FDA announced its investigation into whether chimeric antigen receptor (CAR) T-cell immunotherapies can cause secondary blood cancers, specifically T-cell malignancies. At the time, the agency said: “Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T-cell malignancy with serious outcomes.”
• In January 2024, the FDA issued boxed warnings on the six approved CART cell therapies, citing the possibility of second primary malignancies, including CAR-positive lymphomas, in patients who had received a CAR T agent.
• To evaluate the extent of these secondary cancers, researchers analyzed the FDA Adverse Event Reporting System database for CAR T-cell reports citing second primary malignancies.

TAKEAWAY:

• Overall, the authors identified 12,394 unique adverse events associated with CAR T therapy; of these, 536 adverse events (4.3%) were second primary malignancies.
• Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tis-cel) accounted for most of the second primary malignancies reports — 51.7% (277 of 536 patients) for axi-cel and 33% (177 of 536 patients) for tis-cel.
• The researchers identified 19 cases of T-cell malignancies, representing only 0.15% of all unique adverse events and 3.54% of all second primary malignancies (19 of 536 patients); 17 of these cases were T-cell non-Hodgkin lymphomas, and two were T-cell large granular lymphocytic leukemia.
• Among the reported 536 second primary malignancies, the most frequent cancers were leukemias (333 reports, or 62%), followed by skin neoplasms (54 reports, or 10.1%), hematopoietic neoplasms excluding leukemias and lymphomas (26 reports, 4.85%), nervous system tumors (21 reports, 3.92%), and respiratory neoplasms (20 reports, 3.73%).

IN PRACTICE:

“We will continue to monitor the data released by the FDA to learn more about CAR T-associated risks. However, it’s crucial to stress that the benefits of CAR T-cell therapies still outweigh the risks for the approved indications,” Magdi Elsallab, MD, the study’s co-lead author, said in a news release.

SOURCE:

This work, led by Dr. Elsallab from Harvard Medical School in Boston, was published online on March 14 in Blood.

LIMITATIONS:

The limitations of the analysis include the presence of duplicate report submissions, incomplete data, difficulty establishing causal relationships, and the potential for both underreporting and overreporting based on the severity of adverse events. Furthermore, without the total number of prescribed products, it was difficult to determine the adverse event frequency.

DISCLOSURES:

The study funding source was not disclosed. Some of the authors reported financial ties with various organizations outside this work, including Bristol Myers Squibb, Janssen Biotech, Johnson & Johnson, Kite Pharma, and Novartis.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Secondary cancers were flagged in 4.3% of all adverse event reports among patients who received CAR T therapy, with T-cell malignancies comprising only 0.15% of the total reports and 3.54% of all second primary malignancies, according to an analysis of adverse event reports submitted to the US Food and Drug Administration (FDA).

METHODOLOGY:

• In November 2023, the FDA announced its investigation into whether chimeric antigen receptor (CAR) T-cell immunotherapies can cause secondary blood cancers, specifically T-cell malignancies. At the time, the agency said: “Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T-cell malignancy with serious outcomes.”
• In January 2024, the FDA issued boxed warnings on the six approved CART cell therapies, citing the possibility of second primary malignancies, including CAR-positive lymphomas, in patients who had received a CAR T agent.
• To evaluate the extent of these secondary cancers, researchers analyzed the FDA Adverse Event Reporting System database for CAR T-cell reports citing second primary malignancies.

TAKEAWAY:

• Overall, the authors identified 12,394 unique adverse events associated with CAR T therapy; of these, 536 adverse events (4.3%) were second primary malignancies.
• Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tis-cel) accounted for most of the second primary malignancies reports — 51.7% (277 of 536 patients) for axi-cel and 33% (177 of 536 patients) for tis-cel.
• The researchers identified 19 cases of T-cell malignancies, representing only 0.15% of all unique adverse events and 3.54% of all second primary malignancies (19 of 536 patients); 17 of these cases were T-cell non-Hodgkin lymphomas, and two were T-cell large granular lymphocytic leukemia.
• Among the reported 536 second primary malignancies, the most frequent cancers were leukemias (333 reports, or 62%), followed by skin neoplasms (54 reports, or 10.1%), hematopoietic neoplasms excluding leukemias and lymphomas (26 reports, 4.85%), nervous system tumors (21 reports, 3.92%), and respiratory neoplasms (20 reports, 3.73%).

IN PRACTICE:

“We will continue to monitor the data released by the FDA to learn more about CAR T-associated risks. However, it’s crucial to stress that the benefits of CAR T-cell therapies still outweigh the risks for the approved indications,” Magdi Elsallab, MD, the study’s co-lead author, said in a news release.

SOURCE:

This work, led by Dr. Elsallab from Harvard Medical School in Boston, was published online on March 14 in Blood.

LIMITATIONS:

The limitations of the analysis include the presence of duplicate report submissions, incomplete data, difficulty establishing causal relationships, and the potential for both underreporting and overreporting based on the severity of adverse events. Furthermore, without the total number of prescribed products, it was difficult to determine the adverse event frequency.

DISCLOSURES:

The study funding source was not disclosed. Some of the authors reported financial ties with various organizations outside this work, including Bristol Myers Squibb, Janssen Biotech, Johnson & Johnson, Kite Pharma, and Novartis.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Topical calcineurin inhibitors (TCIs), topical corticosteroids (TCSs), and topical Janus kinase (JAK) inhibitors are supported as mainstay treatments in new expert recommendations on the use of topical therapeutics in children, adolescents, and young adults with vitiligo.

METHODOLOGY:

• While half of all vitiligo cases manifest within the initial two decades of life, no guidelines specifically address the management of vitiligo in children, adolescents, and young adults with vitiligo.
• A protocol was established to formulate consensus recommendations addressing questions related to pediatric vitiligo.
• Overall, 50 articles on topical corticosteroids and/or topical calcineurin inhibitors, five on topical Janus kinase inhibitors, and two each on pseudocatalase and microdermabrasion were included.
• The participants recorded their agreement levels with the formulated statements, using a 5-point Likert scale.

TAKEAWAY:

• TCIs, TCSs, JAK inhibitors, and phototherapy, specifically narrowband ultraviolet (UV)-B light therapy, are mainstay treatments; the combination of UV-B light and topical therapy may enhance initial repigmentation.
• Long-term monitoring for skin cancers is advised, and short outdoor UV exposure is suggested for pediatric patients.
• TCIs, such as tacrolimus and pimecrolimus, are recommended as first-line therapy, particularly on the face, applied twice daily for ≥ 3 months; continued use for 6-12 additional months is recommended if repigmentation is observed.
• The choice of TCS class depends on the site and planned usage duration. Short-term use or overlap with TCIs is recommended because of the risk for atrophy with long-term TCS use. Class 5-6 agents are another option.
• For areas with thin skin, TCSs can be considered second-line treatments.
• Topical JAK inhibitors, specifically topical 1.5% ruxolitinib cream, are recommended for patients aged ≥ 12 years, as first- or second-line therapy. Limitation to 10% body surface area is recommended to minimize systemic absorption. Limited evidence exists for children aged < 12 years.

IN PRACTICE:

“Effective therapy requires a focus on long-term therapeutic interventions to maximize the local gain and retention of pigmentation with a trial period of twice-weekly application. Counseling should include discussion of the chronicity of vitiligo and the need for long-term care,” the authors wrote.

LIMITATIONS:

Some of the recommendations were opinion-based because of the scarcity of evidence-based literature.

SOURCE:

The consensus statement was published on March 13 in JAMA Dermatology.

DISCLOSURES:

This work was supported by grants from Vitiligo Research Foundation and Incyte Pharmaceuticals. The majority of authors disclosed financial relationships outside this work; several reported no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Topical calcineurin inhibitors (TCIs), topical corticosteroids (TCSs), and topical Janus kinase (JAK) inhibitors are supported as mainstay treatments in new expert recommendations on the use of topical therapeutics in children, adolescents, and young adults with vitiligo.

METHODOLOGY:

• While half of all vitiligo cases manifest within the initial two decades of life, no guidelines specifically address the management of vitiligo in children, adolescents, and young adults with vitiligo.
• A protocol was established to formulate consensus recommendations addressing questions related to pediatric vitiligo.
• Overall, 50 articles on topical corticosteroids and/or topical calcineurin inhibitors, five on topical Janus kinase inhibitors, and two each on pseudocatalase and microdermabrasion were included.
• The participants recorded their agreement levels with the formulated statements, using a 5-point Likert scale.

TAKEAWAY:

• TCIs, TCSs, JAK inhibitors, and phototherapy, specifically narrowband ultraviolet (UV)-B light therapy, are mainstay treatments; the combination of UV-B light and topical therapy may enhance initial repigmentation.
• Long-term monitoring for skin cancers is advised, and short outdoor UV exposure is suggested for pediatric patients.
• TCIs, such as tacrolimus and pimecrolimus, are recommended as first-line therapy, particularly on the face, applied twice daily for ≥ 3 months; continued use for 6-12 additional months is recommended if repigmentation is observed.
• The choice of TCS class depends on the site and planned usage duration. Short-term use or overlap with TCIs is recommended because of the risk for atrophy with long-term TCS use. Class 5-6 agents are another option.
• For areas with thin skin, TCSs can be considered second-line treatments.
• Topical JAK inhibitors, specifically topical 1.5% ruxolitinib cream, are recommended for patients aged ≥ 12 years, as first- or second-line therapy. Limitation to 10% body surface area is recommended to minimize systemic absorption. Limited evidence exists for children aged < 12 years.

IN PRACTICE:

“Effective therapy requires a focus on long-term therapeutic interventions to maximize the local gain and retention of pigmentation with a trial period of twice-weekly application. Counseling should include discussion of the chronicity of vitiligo and the need for long-term care,” the authors wrote.

LIMITATIONS:

Some of the recommendations were opinion-based because of the scarcity of evidence-based literature.

SOURCE:

The consensus statement was published on March 13 in JAMA Dermatology.

DISCLOSURES:

This work was supported by grants from Vitiligo Research Foundation and Incyte Pharmaceuticals. The majority of authors disclosed financial relationships outside this work; several reported no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Topical calcineurin inhibitors (TCIs), topical corticosteroids (TCSs), and topical Janus kinase (JAK) inhibitors are supported as mainstay treatments in new expert recommendations on the use of topical therapeutics in children, adolescents, and young adults with vitiligo.

METHODOLOGY:

• While half of all vitiligo cases manifest within the initial two decades of life, no guidelines specifically address the management of vitiligo in children, adolescents, and young adults with vitiligo.
• A protocol was established to formulate consensus recommendations addressing questions related to pediatric vitiligo.
• Overall, 50 articles on topical corticosteroids and/or topical calcineurin inhibitors, five on topical Janus kinase inhibitors, and two each on pseudocatalase and microdermabrasion were included.
• The participants recorded their agreement levels with the formulated statements, using a 5-point Likert scale.

TAKEAWAY:

• TCIs, TCSs, JAK inhibitors, and phototherapy, specifically narrowband ultraviolet (UV)-B light therapy, are mainstay treatments; the combination of UV-B light and topical therapy may enhance initial repigmentation.
• Long-term monitoring for skin cancers is advised, and short outdoor UV exposure is suggested for pediatric patients.
• TCIs, such as tacrolimus and pimecrolimus, are recommended as first-line therapy, particularly on the face, applied twice daily for ≥ 3 months; continued use for 6-12 additional months is recommended if repigmentation is observed.
• The choice of TCS class depends on the site and planned usage duration. Short-term use or overlap with TCIs is recommended because of the risk for atrophy with long-term TCS use. Class 5-6 agents are another option.
• For areas with thin skin, TCSs can be considered second-line treatments.
• Topical JAK inhibitors, specifically topical 1.5% ruxolitinib cream, are recommended for patients aged ≥ 12 years, as first- or second-line therapy. Limitation to 10% body surface area is recommended to minimize systemic absorption. Limited evidence exists for children aged < 12 years.

IN PRACTICE:

“Effective therapy requires a focus on long-term therapeutic interventions to maximize the local gain and retention of pigmentation with a trial period of twice-weekly application. Counseling should include discussion of the chronicity of vitiligo and the need for long-term care,” the authors wrote.

LIMITATIONS:

Some of the recommendations were opinion-based because of the scarcity of evidence-based literature.

SOURCE:

The consensus statement was published on March 13 in JAMA Dermatology.

DISCLOSURES:

This work was supported by grants from Vitiligo Research Foundation and Incyte Pharmaceuticals. The majority of authors disclosed financial relationships outside this work; several reported no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment modifications, such as dose reductions, schedule changes, or use of less toxic regimens, can improve how well older patients with advanced cancer and aging-related conditions tolerate chemotherapy regimens.

METHODOLOGY:

• Older patients are underrepresented in clinical trials, which means the reported risks associated with standard-of-care regimens typically reflect outcomes in younger, healthier patients. This underrepresentation in clinical trials has also led to uncertainties about the safety of standard chemotherapy regimens in older patients who often have other health conditions to manage, alongside cancer.
• In this secondary analysis, researchers evaluated the association between primary treatment modifications to standard-of-care chemotherapy regimens and treatment tolerability.
• The trial included 609 patients aged ≥ 70 years who had advanced cancer alongside at least one age-related condition, such as impaired cognition, and planned to start a new palliative chemotherapy regimen in the community oncology setting. The most common cancer types were gastrointestinal cancer (37.4%) and lung cancer (28.6%).
• The primary outcome was grade 3-5 adverse events within 3 months of chemotherapy initiation.
• Secondary outcomes included patient-reported functional decline and combined adverse outcomes, which incorporated clinician-rated toxic effects, patient-reported functional decline, and 6-month overall survival.

TAKEAWAY: 

• Overall, 281 patients (46.1%) received a primary treatment modification, most often a dose reduction (71.9%) or a scheduling change (11.7%).
• Patients who received primary treatment modifications had a 15% lower risk for grades 3-5 adverse effects (relative risk [RR], 0.85) and a 20% lower risk for patient-reported functional decline (RR, 0.80) than those who received standard treatment.
• Patients receiving treatment modifications had 32% lower risk for a worse combined adverse outcome (odds ratio, 0.68).
• Cancer type may matter as well. When looking at outcomes by cancer type, patients with gastrointestinal cancers who received a primary treatment modification had a lower risk for toxic effects (RR, 0.82), whereas patients with lung cancer did not (RR, 1.03; 95% CI, 0.88-1.20).

IN PRACTICE:

These findings “can help oncologists to choose the optimal drug regimen, select a safe and effective initial dose, and undertake appropriate monitoring strategies to manage the clinical care of older people with advanced cancer,” the authors said. 

SOURCE:

This study, led by Mostafa R. Mohamed from University of Rochester, New York, was published February 15 in JAMA Network Open.

LIMITATIONS: 

Residual confounding may be present. Extremely healthy older patients may have been excluded due to study criteria, limiting generalizability. There may be variation in toxicities due to inclusion of patients with multiple heterogeneous cancer.

DISCLOSURES:

This work was supported by the National Cancer Institute and the University of Rochester, New York. The authors disclosed financial relationships outside this work.

A version of this article first appeared on Medscape.com.

TOPLINE:

Treatment modifications, such as dose reductions, schedule changes, or use of less toxic regimens, can improve how well older patients with advanced cancer and aging-related conditions tolerate chemotherapy regimens.

METHODOLOGY:

• Older patients are underrepresented in clinical trials, which means the reported risks associated with standard-of-care regimens typically reflect outcomes in younger, healthier patients. This underrepresentation in clinical trials has also led to uncertainties about the safety of standard chemotherapy regimens in older patients who often have other health conditions to manage, alongside cancer.
• In this secondary analysis, researchers evaluated the association between primary treatment modifications to standard-of-care chemotherapy regimens and treatment tolerability.
• The trial included 609 patients aged ≥ 70 years who had advanced cancer alongside at least one age-related condition, such as impaired cognition, and planned to start a new palliative chemotherapy regimen in the community oncology setting. The most common cancer types were gastrointestinal cancer (37.4%) and lung cancer (28.6%).
• The primary outcome was grade 3-5 adverse events within 3 months of chemotherapy initiation.
• Secondary outcomes included patient-reported functional decline and combined adverse outcomes, which incorporated clinician-rated toxic effects, patient-reported functional decline, and 6-month overall survival.

TAKEAWAY: 

• Overall, 281 patients (46.1%) received a primary treatment modification, most often a dose reduction (71.9%) or a scheduling change (11.7%).
• Patients who received primary treatment modifications had a 15% lower risk for grades 3-5 adverse effects (relative risk [RR], 0.85) and a 20% lower risk for patient-reported functional decline (RR, 0.80) than those who received standard treatment.
• Patients receiving treatment modifications had 32% lower risk for a worse combined adverse outcome (odds ratio, 0.68).
• Cancer type may matter as well. When looking at outcomes by cancer type, patients with gastrointestinal cancers who received a primary treatment modification had a lower risk for toxic effects (RR, 0.82), whereas patients with lung cancer did not (RR, 1.03; 95% CI, 0.88-1.20).

IN PRACTICE:

These findings “can help oncologists to choose the optimal drug regimen, select a safe and effective initial dose, and undertake appropriate monitoring strategies to manage the clinical care of older people with advanced cancer,” the authors said. 

SOURCE:

This study, led by Mostafa R. Mohamed from University of Rochester, New York, was published February 15 in JAMA Network Open.

LIMITATIONS: 

Residual confounding may be present. Extremely healthy older patients may have been excluded due to study criteria, limiting generalizability. There may be variation in toxicities due to inclusion of patients with multiple heterogeneous cancer.

DISCLOSURES:

This work was supported by the National Cancer Institute and the University of Rochester, New York. The authors disclosed financial relationships outside this work.

A version of this article first appeared on Medscape.com.

TOPLINE:

Treatment modifications, such as dose reductions, schedule changes, or use of less toxic regimens, can improve how well older patients with advanced cancer and aging-related conditions tolerate chemotherapy regimens.

METHODOLOGY:

• Older patients are underrepresented in clinical trials, which means the reported risks associated with standard-of-care regimens typically reflect outcomes in younger, healthier patients. This underrepresentation in clinical trials has also led to uncertainties about the safety of standard chemotherapy regimens in older patients who often have other health conditions to manage, alongside cancer.
• In this secondary analysis, researchers evaluated the association between primary treatment modifications to standard-of-care chemotherapy regimens and treatment tolerability.
• The trial included 609 patients aged ≥ 70 years who had advanced cancer alongside at least one age-related condition, such as impaired cognition, and planned to start a new palliative chemotherapy regimen in the community oncology setting. The most common cancer types were gastrointestinal cancer (37.4%) and lung cancer (28.6%).
• The primary outcome was grade 3-5 adverse events within 3 months of chemotherapy initiation.
• Secondary outcomes included patient-reported functional decline and combined adverse outcomes, which incorporated clinician-rated toxic effects, patient-reported functional decline, and 6-month overall survival.

TAKEAWAY: 

• Overall, 281 patients (46.1%) received a primary treatment modification, most often a dose reduction (71.9%) or a scheduling change (11.7%).
• Patients who received primary treatment modifications had a 15% lower risk for grades 3-5 adverse effects (relative risk [RR], 0.85) and a 20% lower risk for patient-reported functional decline (RR, 0.80) than those who received standard treatment.
• Patients receiving treatment modifications had 32% lower risk for a worse combined adverse outcome (odds ratio, 0.68).
• Cancer type may matter as well. When looking at outcomes by cancer type, patients with gastrointestinal cancers who received a primary treatment modification had a lower risk for toxic effects (RR, 0.82), whereas patients with lung cancer did not (RR, 1.03; 95% CI, 0.88-1.20).

IN PRACTICE:

These findings “can help oncologists to choose the optimal drug regimen, select a safe and effective initial dose, and undertake appropriate monitoring strategies to manage the clinical care of older people with advanced cancer,” the authors said. 

SOURCE:

This study, led by Mostafa R. Mohamed from University of Rochester, New York, was published February 15 in JAMA Network Open.

LIMITATIONS: 

Residual confounding may be present. Extremely healthy older patients may have been excluded due to study criteria, limiting generalizability. There may be variation in toxicities due to inclusion of patients with multiple heterogeneous cancer.

DISCLOSURES:

This work was supported by the National Cancer Institute and the University of Rochester, New York. The authors disclosed financial relationships outside this work.

A version of this article first appeared on Medscape.com.

TOPLINE:

Upon reviewing repeated prostate cancer screenings, researchers observed the absence of suspicious MRI findings in over 86% of men who had prostate-specific antigen (PSA) levels of 3 ng/mL or higher during their second screening.

METHODOLOGY:

• New initiatives are focusing on organizing prostate cancer screening using MRI to reduce overdiagnosis, as current evidence does not support the effectiveness of a single PSA test, with guidelines now recommending repeated testing every 1-4 years.
• In the STHLM3-MRI trial, men, aged 50-74 years, living in Stockholm County, Sweden, were invited to participate in prostate cancer screening and randomly assigned to traditional screening with systematic  or an MRI-based strategy.
• Blood samples were analyzed for PSA levels and Stockholm3 risk score; men with elevated risk underwent targeted MRI and biopsy procedures.
• In this follow-up analysis, 2,078 men with PSA levels of 1.5 ng/mL or higher and a Stockholm3 risk score less than 0.11 were re-invited for screening 2-3 years after their initial screening.
• The primary outcome was clinically significant prostate cancer (Gleason score of 3 + 4 or greater). A Gleason score of 6 was detected in 0.7% of patients, and a score of 4 + 3 or greater was detected in 19 (1.3%) men.

TAKEAWAY:

• Of 1,500 men (median age of 67 years) who underwent a blood test, the median PSA level was 2.8 ng/mL and 26.0% changed risk classification groups (PSA levels < 3 vs 3 ng/mL).
• Out of 667 men with PSA levels of 3 ng/mL or higher, 617 (92.5%) had an MRI. Of the 617, 51 (7.6%) had equivocal lesions (a Prostate Imaging-Reporting and Data System score of 3) and 33 (4.9%) had suspicious lesions.
• Of the 1,500 rescreened men, clinically significant prostate cancer was detected in 48 men (3.2%); this corresponds to 59.2% of the biopsied men.
• Out of 383 men who had previously received a negative MRI result, only 10 (2.6%) exhibited a lesion with a Prostate Imaging-Reporting and Data System score of 4 or higher.

IN PRACTICE:

In an accompanying editorial, Ola Bratt, MD, PhD, noted that the “most important finding was the very high proportion of nonsuspicious repeat MRI scans,” but also emphasizes the necessity of observing a decrease in overall prostate cancer incidence before asserting that the current cancer diagnostics effectively reduce overdiagnosis.

SOURCE:

This study, led by Tobias Nordström, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published on February 7, 2024, in JAMA Network Open.

LIMITATIONS:

Long-term outcomes like prostate cancer mortality were not evaluated. Information on cancer detection in men with a negative MRI result at rescreening was not available. Authors noted that a subset of individuals may still be at risk despite lower PSA levels.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare, Karolinska Institute, Prostatacancerförbundet, Region Stockholm, and Åke Wibergs Stiftelse. The authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Upon reviewing repeated prostate cancer screenings, researchers observed the absence of suspicious MRI findings in over 86% of men who had prostate-specific antigen (PSA) levels of 3 ng/mL or higher during their second screening.

METHODOLOGY:

• New initiatives are focusing on organizing prostate cancer screening using MRI to reduce overdiagnosis, as current evidence does not support the effectiveness of a single PSA test, with guidelines now recommending repeated testing every 1-4 years.
• In the STHLM3-MRI trial, men, aged 50-74 years, living in Stockholm County, Sweden, were invited to participate in prostate cancer screening and randomly assigned to traditional screening with systematic  or an MRI-based strategy.
• Blood samples were analyzed for PSA levels and Stockholm3 risk score; men with elevated risk underwent targeted MRI and biopsy procedures.
• In this follow-up analysis, 2,078 men with PSA levels of 1.5 ng/mL or higher and a Stockholm3 risk score less than 0.11 were re-invited for screening 2-3 years after their initial screening.
• The primary outcome was clinically significant prostate cancer (Gleason score of 3 + 4 or greater). A Gleason score of 6 was detected in 0.7% of patients, and a score of 4 + 3 or greater was detected in 19 (1.3%) men.

TAKEAWAY:

• Of 1,500 men (median age of 67 years) who underwent a blood test, the median PSA level was 2.8 ng/mL and 26.0% changed risk classification groups (PSA levels < 3 vs 3 ng/mL).
• Out of 667 men with PSA levels of 3 ng/mL or higher, 617 (92.5%) had an MRI. Of the 617, 51 (7.6%) had equivocal lesions (a Prostate Imaging-Reporting and Data System score of 3) and 33 (4.9%) had suspicious lesions.
• Of the 1,500 rescreened men, clinically significant prostate cancer was detected in 48 men (3.2%); this corresponds to 59.2% of the biopsied men.
• Out of 383 men who had previously received a negative MRI result, only 10 (2.6%) exhibited a lesion with a Prostate Imaging-Reporting and Data System score of 4 or higher.

IN PRACTICE:

In an accompanying editorial, Ola Bratt, MD, PhD, noted that the “most important finding was the very high proportion of nonsuspicious repeat MRI scans,” but also emphasizes the necessity of observing a decrease in overall prostate cancer incidence before asserting that the current cancer diagnostics effectively reduce overdiagnosis.

SOURCE:

This study, led by Tobias Nordström, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published on February 7, 2024, in JAMA Network Open.

LIMITATIONS:

Long-term outcomes like prostate cancer mortality were not evaluated. Information on cancer detection in men with a negative MRI result at rescreening was not available. Authors noted that a subset of individuals may still be at risk despite lower PSA levels.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare, Karolinska Institute, Prostatacancerförbundet, Region Stockholm, and Åke Wibergs Stiftelse. The authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Upon reviewing repeated prostate cancer screenings, researchers observed the absence of suspicious MRI findings in over 86% of men who had prostate-specific antigen (PSA) levels of 3 ng/mL or higher during their second screening.

METHODOLOGY:

• New initiatives are focusing on organizing prostate cancer screening using MRI to reduce overdiagnosis, as current evidence does not support the effectiveness of a single PSA test, with guidelines now recommending repeated testing every 1-4 years.
• In the STHLM3-MRI trial, men, aged 50-74 years, living in Stockholm County, Sweden, were invited to participate in prostate cancer screening and randomly assigned to traditional screening with systematic  or an MRI-based strategy.
• Blood samples were analyzed for PSA levels and Stockholm3 risk score; men with elevated risk underwent targeted MRI and biopsy procedures.
• In this follow-up analysis, 2,078 men with PSA levels of 1.5 ng/mL or higher and a Stockholm3 risk score less than 0.11 were re-invited for screening 2-3 years after their initial screening.
• The primary outcome was clinically significant prostate cancer (Gleason score of 3 + 4 or greater). A Gleason score of 6 was detected in 0.7% of patients, and a score of 4 + 3 or greater was detected in 19 (1.3%) men.

TAKEAWAY:

• Of 1,500 men (median age of 67 years) who underwent a blood test, the median PSA level was 2.8 ng/mL and 26.0% changed risk classification groups (PSA levels < 3 vs 3 ng/mL).
• Out of 667 men with PSA levels of 3 ng/mL or higher, 617 (92.5%) had an MRI. Of the 617, 51 (7.6%) had equivocal lesions (a Prostate Imaging-Reporting and Data System score of 3) and 33 (4.9%) had suspicious lesions.
• Of the 1,500 rescreened men, clinically significant prostate cancer was detected in 48 men (3.2%); this corresponds to 59.2% of the biopsied men.
• Out of 383 men who had previously received a negative MRI result, only 10 (2.6%) exhibited a lesion with a Prostate Imaging-Reporting and Data System score of 4 or higher.

IN PRACTICE:

In an accompanying editorial, Ola Bratt, MD, PhD, noted that the “most important finding was the very high proportion of nonsuspicious repeat MRI scans,” but also emphasizes the necessity of observing a decrease in overall prostate cancer incidence before asserting that the current cancer diagnostics effectively reduce overdiagnosis.

SOURCE:

This study, led by Tobias Nordström, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published on February 7, 2024, in JAMA Network Open.

LIMITATIONS:

Long-term outcomes like prostate cancer mortality were not evaluated. Information on cancer detection in men with a negative MRI result at rescreening was not available. Authors noted that a subset of individuals may still be at risk despite lower PSA levels.

DISCLOSURES:

This study was funded by the Swedish Research Council for Health, Working Life and Welfare, Karolinska Institute, Prostatacancerförbundet, Region Stockholm, and Åke Wibergs Stiftelse. The authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE: 

In patients with stages I-III colorectal cancer (CRC) who are cancer-free 5 years after surgery, the incidence of late recurrence or metachronous disease after 5 years is low and has decreased over time, new data showed.

METHODOLOGY:

• Recent treatment advances in CRC have reduced the likelihood that patients with nonmetastatic disease will recur or develop a second primary cancer more than 6 months after the first. Although late recurrences and metachronous CRC remain infrequent, it’s not clear if patients might benefit from longer term surveillance.
• To investigate whether extending surveillance beyond the recommended 5 years is beneficial, researchers assessed the incidence of late recurrence, metachronous CRC, and second primary cancers 5 years after surgical resection with curative intent.
• The researchers identified patients with stages I-III CRC, under age 80 years, from Danish healthcare registries who underwent surgical resection between January 2004 and December 2013.
• A total of 8883 patients were followed from 5 years after primary surgery until the date of recurrence, metachronous CRC, or second non-CRC primary cancer.

TAKEAWAY:

• Between 5 and 10 years after surgery, 370 survivors developed late recurrence (4.16%), 270 developed metachronous disease (3.0%), and 635 were diagnosed with a second primary cancer (7.15%).
• During 2009-2013 and 2004-2008, the risk for late recurrence decreased by 48% (5.6% vs 2.9%; subdistribution hazard ratio [sHR], 0.52) and the risk for metachronous disease decreased by 50% (4.1% vs 2.1%; sHR, 0.50).
• During the same timeframe, the risk for second non-CRC primary cancer remained unchanged (7.1% vs 7.1%; sHR, 0.98).
• Compared with patients diagnosed with late recurrences (46%), 5-year overall survival was higher for patients with metachronous CRC (72%; adjusted HR, 0.37) and slightly higher for those with second primary cancers (48%; adjusted HR, 0.78).

IN PRACTICE:

Because the incidences of late recurrence and metachronous CRC are low and decreased between 2004 and 2013, the data do not support extending CRC-specific surveillance beyond 5 years, the authors concluded. “Symptoms or suspicion of a cancer occurring 5-10 years from primary CRC treatment, is more likely to represent a non-CRC cancer (7.1%).”

SOURCE:

This study, led by Jesper Nors from Aarhus University Hospital, Aarhus, Denmark, was published on February 7, 2024, in the International Journal of Cancer.

LIMITATIONS:

Misclassification of a late recurrence or metachronous CRC could have affected the findings.

DISCLOSURES:

This work was funded by Institute of Clinical Medicine, Aarhus University, Denmark, Novo Nordisk Foundation, Innovation Fund Denmark, and the Danish Cancer Society. The authors reported no conflict of interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Cancer surgery poses an elevated risk for venous thromboembolism, which can vary depending on the type of cancer and the timing of surgery, a study suggested.

METHODOLOGY:

• Both major surgery and cancer increase the risk for venous thromboembolism, which can lead to severe illness and death. Research showed that approximately 2% of patients who have cancer surgery experience clinically significant venous thromboembolism, which accounts for about half of the deaths that occur immediately after surgery.
• The American Society of Clinical Oncology and European Association of Urology guidelines recommend an extended 28-day prophylaxis for patients undergoing cancer surgery. These guidelines also provide specific estimates of the excess risk for thromboembolic events for each disease.
• This retrospective study included data on 432,218 patients (median age, 67 years) from Swedish nationwide registers who underwent major surgery for eight types of cancer (bladder, breast, colorectal, gynecologic, lung, prostate, gastroesophageal, and kidney or upper tract urothelial cancer) from 1998 to 2016.
• The researchers matched the patients with 4,009,343 cancer-free individuals from the general population in a 1:10 ratio.
• The primary outcome was the incidence of venous thromboembolic events, including subsegmental pulmonary embolism and deep venous thromboembolism in the calf, within 1 year after the surgery.

TAKEAWAY:

• The researchers found an increased absolute risk for pulmonary embolism at 1 year following cancer surgery, with the highest increase in patients with bladder cancer (a 2.69 percentage point difference), followed by lung (a 2.61 percentage point difference), gastroesophageal (2.13), colorectal (1.57), kidney or upper urinary tract (1.38), gynecologic (1.32), breast (0.59), and prostate cancer (0.57).
• The increased 1-year absolute risk for deep vein thrombosis (in percentage points) was highest for the bladder (a 4.67 percentage point difference), followed by gastroesophageal (2.19), colorectal (2.15), upper urinary tract (2.14), gynecologic (2.02), lung (1.40), breast (1.36), and prostate cancer (0.75).
• The temporal trends showed that the risk for pulmonary embolism and deep vein thrombosis peaked immediately after surgery and plateaued within 120 days for most cancers. At 30 days after surgery, the risk for pulmonary embolism following cancer surgery was 10- to 30-fold times higher than with no surgery for all cancers aside from breast cancer (hazard ratio, 5.18). The researchers observed a similar elevated risk for deep vein thrombosis 30 days following surgery.
• The risk for pulmonary embolism and deep vein thrombosis remained significant at 1 year for all cancer types, except prostate.

IN PRACTICE:

“The marked variation in the occurrence patterns of postoperative venous thromboembolic events indicates a need for a more tailored approach to prophylaxis,” the authors noted, advocating for individualized venous thromboembolism risk evaluation and prophylaxis regimens.

SOURCE:

This study, led by Johan Björklund, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

The information regarding treatments other than surgery that might be linked to an elevated risk for venous thromboembolism was not available. Additionally, changes in clinical practices and diagnostics over time could affect both the occurrence and detection of outcomes. Adoption of minimally invasive surgical techniques, increased use of thromboprophylaxis over time, improved diagnostic capabilities, and a trend toward operating on older patients with more comorbidities over time may have influenced outcomes.

DISCLOSURES: 

The work was funded by the Karolinska Institute and the Swedish Cancer Society. Two study authors reported receiving personal or consulting fees. Other authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Cancer surgery poses an elevated risk for venous thromboembolism, which can vary depending on the type of cancer and the timing of surgery, a study suggested.

METHODOLOGY:

• Both major surgery and cancer increase the risk for venous thromboembolism, which can lead to severe illness and death. Research showed that approximately 2% of patients who have cancer surgery experience clinically significant venous thromboembolism, which accounts for about half of the deaths that occur immediately after surgery.
• The American Society of Clinical Oncology and European Association of Urology guidelines recommend an extended 28-day prophylaxis for patients undergoing cancer surgery. These guidelines also provide specific estimates of the excess risk for thromboembolic events for each disease.
• This retrospective study included data on 432,218 patients (median age, 67 years) from Swedish nationwide registers who underwent major surgery for eight types of cancer (bladder, breast, colorectal, gynecologic, lung, prostate, gastroesophageal, and kidney or upper tract urothelial cancer) from 1998 to 2016.
• The researchers matched the patients with 4,009,343 cancer-free individuals from the general population in a 1:10 ratio.
• The primary outcome was the incidence of venous thromboembolic events, including subsegmental pulmonary embolism and deep venous thromboembolism in the calf, within 1 year after the surgery.

TAKEAWAY:

• The researchers found an increased absolute risk for pulmonary embolism at 1 year following cancer surgery, with the highest increase in patients with bladder cancer (a 2.69 percentage point difference), followed by lung (a 2.61 percentage point difference), gastroesophageal (2.13), colorectal (1.57), kidney or upper urinary tract (1.38), gynecologic (1.32), breast (0.59), and prostate cancer (0.57).
• The increased 1-year absolute risk for deep vein thrombosis (in percentage points) was highest for the bladder (a 4.67 percentage point difference), followed by gastroesophageal (2.19), colorectal (2.15), upper urinary tract (2.14), gynecologic (2.02), lung (1.40), breast (1.36), and prostate cancer (0.75).
• The temporal trends showed that the risk for pulmonary embolism and deep vein thrombosis peaked immediately after surgery and plateaued within 120 days for most cancers. At 30 days after surgery, the risk for pulmonary embolism following cancer surgery was 10- to 30-fold times higher than with no surgery for all cancers aside from breast cancer (hazard ratio, 5.18). The researchers observed a similar elevated risk for deep vein thrombosis 30 days following surgery.
• The risk for pulmonary embolism and deep vein thrombosis remained significant at 1 year for all cancer types, except prostate.

IN PRACTICE:

“The marked variation in the occurrence patterns of postoperative venous thromboembolic events indicates a need for a more tailored approach to prophylaxis,” the authors noted, advocating for individualized venous thromboembolism risk evaluation and prophylaxis regimens.

SOURCE:

This study, led by Johan Björklund, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

The information regarding treatments other than surgery that might be linked to an elevated risk for venous thromboembolism was not available. Additionally, changes in clinical practices and diagnostics over time could affect both the occurrence and detection of outcomes. Adoption of minimally invasive surgical techniques, increased use of thromboprophylaxis over time, improved diagnostic capabilities, and a trend toward operating on older patients with more comorbidities over time may have influenced outcomes.

DISCLOSURES: 

The work was funded by the Karolinska Institute and the Swedish Cancer Society. Two study authors reported receiving personal or consulting fees. Other authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Cancer surgery poses an elevated risk for venous thromboembolism, which can vary depending on the type of cancer and the timing of surgery, a study suggested.

METHODOLOGY:

• Both major surgery and cancer increase the risk for venous thromboembolism, which can lead to severe illness and death. Research showed that approximately 2% of patients who have cancer surgery experience clinically significant venous thromboembolism, which accounts for about half of the deaths that occur immediately after surgery.
• The American Society of Clinical Oncology and European Association of Urology guidelines recommend an extended 28-day prophylaxis for patients undergoing cancer surgery. These guidelines also provide specific estimates of the excess risk for thromboembolic events for each disease.
• This retrospective study included data on 432,218 patients (median age, 67 years) from Swedish nationwide registers who underwent major surgery for eight types of cancer (bladder, breast, colorectal, gynecologic, lung, prostate, gastroesophageal, and kidney or upper tract urothelial cancer) from 1998 to 2016.
• The researchers matched the patients with 4,009,343 cancer-free individuals from the general population in a 1:10 ratio.
• The primary outcome was the incidence of venous thromboembolic events, including subsegmental pulmonary embolism and deep venous thromboembolism in the calf, within 1 year after the surgery.

TAKEAWAY:

• The researchers found an increased absolute risk for pulmonary embolism at 1 year following cancer surgery, with the highest increase in patients with bladder cancer (a 2.69 percentage point difference), followed by lung (a 2.61 percentage point difference), gastroesophageal (2.13), colorectal (1.57), kidney or upper urinary tract (1.38), gynecologic (1.32), breast (0.59), and prostate cancer (0.57).
• The increased 1-year absolute risk for deep vein thrombosis (in percentage points) was highest for the bladder (a 4.67 percentage point difference), followed by gastroesophageal (2.19), colorectal (2.15), upper urinary tract (2.14), gynecologic (2.02), lung (1.40), breast (1.36), and prostate cancer (0.75).
• The temporal trends showed that the risk for pulmonary embolism and deep vein thrombosis peaked immediately after surgery and plateaued within 120 days for most cancers. At 30 days after surgery, the risk for pulmonary embolism following cancer surgery was 10- to 30-fold times higher than with no surgery for all cancers aside from breast cancer (hazard ratio, 5.18). The researchers observed a similar elevated risk for deep vein thrombosis 30 days following surgery.
• The risk for pulmonary embolism and deep vein thrombosis remained significant at 1 year for all cancer types, except prostate.

IN PRACTICE:

“The marked variation in the occurrence patterns of postoperative venous thromboembolic events indicates a need for a more tailored approach to prophylaxis,” the authors noted, advocating for individualized venous thromboembolism risk evaluation and prophylaxis regimens.

SOURCE:

This study, led by Johan Björklund, MD, PhD, from Karolinska Institute, Stockholm, Sweden, was published online in JAMA Network Open.

LIMITATIONS:

The information regarding treatments other than surgery that might be linked to an elevated risk for venous thromboembolism was not available. Additionally, changes in clinical practices and diagnostics over time could affect both the occurrence and detection of outcomes. Adoption of minimally invasive surgical techniques, increased use of thromboprophylaxis over time, improved diagnostic capabilities, and a trend toward operating on older patients with more comorbidities over time may have influenced outcomes.

DISCLOSURES: 

The work was funded by the Karolinska Institute and the Swedish Cancer Society. Two study authors reported receiving personal or consulting fees. Other authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Multivitamin supplements at a moderate dose appear to lower the risk for both all-cause and cancer-related mortality in patients with colorectal cancer (CRC); however, high doses of multivitamin supplements may increase the risk for CRC-specific mortality.

METHODOLOGY:

• Some studies suggest that multivitamin supplements might increase a person’s risk for CRC, and other research indicates that certain components of multivitamins, such as vitamins C and D, may have anti-CRC properties.
• Because as many as half of CRC survivors take a multivitamin, researchers wanted to assess whether multivitamin use affects overall survival among people with CRC.
• In the current prospective cohort study, researchers evaluated the use and dose of multivitamin supplements in 2424 patients with stages I-III CRC, using detailed information from patients in the Nurses’ Health Study and Health Professionals Follow‐Up Study.
• The participants completed a mailed questionnaire every 2 years, which included questions about the current use of multivitamin supplements as well as doses per week (0, 1-2, 3-5, 6-9, and ≥ 10 tablets).
• The researchers assessed the potential association between multivitamin use and CRC-related as well as all‐cause mortality.

TAKEAWAY:

• Over a median follow-up period of 11 years, 1512 deaths and 343 cancer-specific deaths occurred.
• For patients diagnosed with CRC, a moderate dose of multivitamins (three to five tablets per week) vs no multivitamin use was associated with a 45% lower risk for cancer-related mortality (adjusted hazard ratio [aHR], 0.55; P = .005).
• Moderate multivitamin use was also associated with a lower risk for all-cause mortality (aHR, 0.81; P = .04) as was a higher dose of six to nine tablets per week (aHR, 0.79; P < .001).
• However, high doses of 10 or more tablets per week were associated with a 60% higher risk for cancer-related mortality (aHR, 1.60; P = .02).

IN PRACTICE:

The study findings suggested that moderate multivitamin supplement use may come with a survival benefit in patients with CRC, while high doses may not, but “further studies are needed before making clinical recommendations for multivitamin use in patients with CRC,” the authors said.

SOURCE:

This work, led by Ming‐ming He of Sun Yat‐sen University Cancer Center, Guangzhou, China, was published in Cancer.

LIMITATIONS:

Given the study’s observational design, residual confounding may be possible. Reverse causation and recall bias are also possible limitations.

DISCLOSURES:

This study was funded by the National Institutes of Health, American Institute for Cancer Research, Wellesley College, Dana‐Farber Cancer Institute, and the Entertainment Industry Foundation. Three study authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Multivitamin supplements at a moderate dose appear to lower the risk for both all-cause and cancer-related mortality in patients with colorectal cancer (CRC); however, high doses of multivitamin supplements may increase the risk for CRC-specific mortality.

METHODOLOGY:

• Some studies suggest that multivitamin supplements might increase a person’s risk for CRC, and other research indicates that certain components of multivitamins, such as vitamins C and D, may have anti-CRC properties.
• Because as many as half of CRC survivors take a multivitamin, researchers wanted to assess whether multivitamin use affects overall survival among people with CRC.
• In the current prospective cohort study, researchers evaluated the use and dose of multivitamin supplements in 2424 patients with stages I-III CRC, using detailed information from patients in the Nurses’ Health Study and Health Professionals Follow‐Up Study.
• The participants completed a mailed questionnaire every 2 years, which included questions about the current use of multivitamin supplements as well as doses per week (0, 1-2, 3-5, 6-9, and ≥ 10 tablets).
• The researchers assessed the potential association between multivitamin use and CRC-related as well as all‐cause mortality.

TAKEAWAY:

• Over a median follow-up period of 11 years, 1512 deaths and 343 cancer-specific deaths occurred.
• For patients diagnosed with CRC, a moderate dose of multivitamins (three to five tablets per week) vs no multivitamin use was associated with a 45% lower risk for cancer-related mortality (adjusted hazard ratio [aHR], 0.55; P = .005).
• Moderate multivitamin use was also associated with a lower risk for all-cause mortality (aHR, 0.81; P = .04) as was a higher dose of six to nine tablets per week (aHR, 0.79; P < .001).
• However, high doses of 10 or more tablets per week were associated with a 60% higher risk for cancer-related mortality (aHR, 1.60; P = .02).

IN PRACTICE:

The study findings suggested that moderate multivitamin supplement use may come with a survival benefit in patients with CRC, while high doses may not, but “further studies are needed before making clinical recommendations for multivitamin use in patients with CRC,” the authors said.

SOURCE:

This work, led by Ming‐ming He of Sun Yat‐sen University Cancer Center, Guangzhou, China, was published in Cancer.

LIMITATIONS:

Given the study’s observational design, residual confounding may be possible. Reverse causation and recall bias are also possible limitations.

DISCLOSURES:

This study was funded by the National Institutes of Health, American Institute for Cancer Research, Wellesley College, Dana‐Farber Cancer Institute, and the Entertainment Industry Foundation. Three study authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Multivitamin supplements at a moderate dose appear to lower the risk for both all-cause and cancer-related mortality in patients with colorectal cancer (CRC); however, high doses of multivitamin supplements may increase the risk for CRC-specific mortality.

METHODOLOGY:

• Some studies suggest that multivitamin supplements might increase a person’s risk for CRC, and other research indicates that certain components of multivitamins, such as vitamins C and D, may have anti-CRC properties.
• Because as many as half of CRC survivors take a multivitamin, researchers wanted to assess whether multivitamin use affects overall survival among people with CRC.
• In the current prospective cohort study, researchers evaluated the use and dose of multivitamin supplements in 2424 patients with stages I-III CRC, using detailed information from patients in the Nurses’ Health Study and Health Professionals Follow‐Up Study.
• The participants completed a mailed questionnaire every 2 years, which included questions about the current use of multivitamin supplements as well as doses per week (0, 1-2, 3-5, 6-9, and ≥ 10 tablets).
• The researchers assessed the potential association between multivitamin use and CRC-related as well as all‐cause mortality.

TAKEAWAY:

• Over a median follow-up period of 11 years, 1512 deaths and 343 cancer-specific deaths occurred.
• For patients diagnosed with CRC, a moderate dose of multivitamins (three to five tablets per week) vs no multivitamin use was associated with a 45% lower risk for cancer-related mortality (adjusted hazard ratio [aHR], 0.55; P = .005).
• Moderate multivitamin use was also associated with a lower risk for all-cause mortality (aHR, 0.81; P = .04) as was a higher dose of six to nine tablets per week (aHR, 0.79; P < .001).
• However, high doses of 10 or more tablets per week were associated with a 60% higher risk for cancer-related mortality (aHR, 1.60; P = .02).

IN PRACTICE:

The study findings suggested that moderate multivitamin supplement use may come with a survival benefit in patients with CRC, while high doses may not, but “further studies are needed before making clinical recommendations for multivitamin use in patients with CRC,” the authors said.

SOURCE:

This work, led by Ming‐ming He of Sun Yat‐sen University Cancer Center, Guangzhou, China, was published in Cancer.

LIMITATIONS:

Given the study’s observational design, residual confounding may be possible. Reverse causation and recall bias are also possible limitations.

DISCLOSURES:

This study was funded by the National Institutes of Health, American Institute for Cancer Research, Wellesley College, Dana‐Farber Cancer Institute, and the Entertainment Industry Foundation. Three study authors reported financial relationships outside this work.

A version of this article appeared on Medscape.com.

TOPLINE:

Belantamab mafodotin plus a combination of bortezomib and dexamethasone improved median progression-free survival (PFS) by 23 months in patients with relapsed or refractory multiple myeloma, compared with daratumumab alongside the same combination.
 

METHODOLOGY:

• Belantamab mafodotin, a first-in-class anti-BCMA monoclonal antibody conjugate, was approved in the US in 2020 for adult patients with relapsed or refractory multiple myeloma who had received at least 4 prior therapies. However, in February 2023, the FDA withdrew this approval, following disappointing findings from a large confirmatory trial, called DREAMM-3. Although the agent is still being investigated to treat relapsed or refractory multiple myeloma, the current FDA label says the agent is only available in the US through a restricted program.
• Patients with multiple myeloma who relapse often become refractory to frontline triplet or quadruplet regimens and need effective second-line options.
• In the current phase 3 DREAMM-7 study, the researchers evaluated triplet therapy with belantamab mafodotin vs daratumumab as a second-line or later treatment option in patients with relapsed or refractory multiple myeloma.
• In this multicenter, open-label, randomized, phase 3 trial, 494 patients with relapsed/refractory multiple myeloma who previously received at least one prior line of therapy received bortezomib plus dexamethasone with either belantamab mafodotin or daratumumab.
• The primary outcome was PFS; secondary endpoints were overall survival, duration of response, and overall response rate.

TAKEAWAY:

• At a median follow-up of 28.2 months, patients who received belantamab mafodotin demonstrated significantly longer median PFS than those who received daratumumab (36.6 vs 13.4 months; hazard ratio [HR], 0.41). The improvement was evident in all prespecified groups, including patients refractory to lenalidomide (HR, 0.37) and those with a high risk for cytogenetic abnormalities (HR, 0.36).
• The early overall survival trend favored belantamab mafodotin — with 84% of patients alive at 18 months vs 73% in the daratumumab group — but overall survival follow-up is ongoing.
• The overall response rate was 83% in the belantamab mafodotin group vs 71% in the daratumumab group. Complete response rates were also higher in the belantamab mafodotin: 34.6% vs 17.1%. Median duration of response was twice as long in the belantamab mafodotin group (36 vs 18 months).
• Grade 3 or higher non-ocular adverse events in belantamab mafodotin vs daratumumab group included thrombocytopenia (55% vs 35%), infections and infestations (31% vs 20%), neutropenia (12% vs 6%), pneumonia (12% vs 4%), and anemia (8% vs 10%). Grade 3 or higher ocular adverse events were reported in 34% of patients treated with belantamab mafodotin, but ocular toxicities reversed in most patients.

IN PRACTICE:

Based on favorable PFS and manageable safety profile, belantamab mafodotin in combination with bortezomib plus dexamethasone has potential to become a new standard of care in the second line or later among patients with relapsed or refractory multiple myeloma, the author concluded.

SOURCE:

This study, led by Maria-Victoria Mateos, MD, PhD, from University Hospital of Salamanca, Salamanca, Spain, was presented at ASCO Plenary Series: February 2024 Session and published in the Journal of Clinical Oncology.

LIMITATIONS:

Open-label design was a limitation of this study. Follow-up for overall survival was ongoing.

DISCLOSURES:

This study was funded by GSK. Dr. Mateos reported receiving honoraria, consulting/personal fees outside this work.

A version of this article first appeared on Medscape.com.

TOPLINE:

Belantamab mafodotin plus a combination of bortezomib and dexamethasone improved median progression-free survival (PFS) by 23 months in patients with relapsed or refractory multiple myeloma, compared with daratumumab alongside the same combination.
 

METHODOLOGY:

• Belantamab mafodotin, a first-in-class anti-BCMA monoclonal antibody conjugate, was approved in the US in 2020 for adult patients with relapsed or refractory multiple myeloma who had received at least 4 prior therapies. However, in February 2023, the FDA withdrew this approval, following disappointing findings from a large confirmatory trial, called DREAMM-3. Although the agent is still being investigated to treat relapsed or refractory multiple myeloma, the current FDA label says the agent is only available in the US through a restricted program.
• Patients with multiple myeloma who relapse often become refractory to frontline triplet or quadruplet regimens and need effective second-line options.
• In the current phase 3 DREAMM-7 study, the researchers evaluated triplet therapy with belantamab mafodotin vs daratumumab as a second-line or later treatment option in patients with relapsed or refractory multiple myeloma.
• In this multicenter, open-label, randomized, phase 3 trial, 494 patients with relapsed/refractory multiple myeloma who previously received at least one prior line of therapy received bortezomib plus dexamethasone with either belantamab mafodotin or daratumumab.
• The primary outcome was PFS; secondary endpoints were overall survival, duration of response, and overall response rate.

TAKEAWAY:

• At a median follow-up of 28.2 months, patients who received belantamab mafodotin demonstrated significantly longer median PFS than those who received daratumumab (36.6 vs 13.4 months; hazard ratio [HR], 0.41). The improvement was evident in all prespecified groups, including patients refractory to lenalidomide (HR, 0.37) and those with a high risk for cytogenetic abnormalities (HR, 0.36).
• The early overall survival trend favored belantamab mafodotin — with 84% of patients alive at 18 months vs 73% in the daratumumab group — but overall survival follow-up is ongoing.
• The overall response rate was 83% in the belantamab mafodotin group vs 71% in the daratumumab group. Complete response rates were also higher in the belantamab mafodotin: 34.6% vs 17.1%. Median duration of response was twice as long in the belantamab mafodotin group (36 vs 18 months).
• Grade 3 or higher non-ocular adverse events in belantamab mafodotin vs daratumumab group included thrombocytopenia (55% vs 35%), infections and infestations (31% vs 20%), neutropenia (12% vs 6%), pneumonia (12% vs 4%), and anemia (8% vs 10%). Grade 3 or higher ocular adverse events were reported in 34% of patients treated with belantamab mafodotin, but ocular toxicities reversed in most patients.

IN PRACTICE:

Based on favorable PFS and manageable safety profile, belantamab mafodotin in combination with bortezomib plus dexamethasone has potential to become a new standard of care in the second line or later among patients with relapsed or refractory multiple myeloma, the author concluded.

SOURCE:

This study, led by Maria-Victoria Mateos, MD, PhD, from University Hospital of Salamanca, Salamanca, Spain, was presented at ASCO Plenary Series: February 2024 Session and published in the Journal of Clinical Oncology.

LIMITATIONS:

Open-label design was a limitation of this study. Follow-up for overall survival was ongoing.

DISCLOSURES:

This study was funded by GSK. Dr. Mateos reported receiving honoraria, consulting/personal fees outside this work.

A version of this article first appeared on Medscape.com.

TOPLINE:

Belantamab mafodotin plus a combination of bortezomib and dexamethasone improved median progression-free survival (PFS) by 23 months in patients with relapsed or refractory multiple myeloma, compared with daratumumab alongside the same combination.
 

METHODOLOGY:

• Belantamab mafodotin, a first-in-class anti-BCMA monoclonal antibody conjugate, was approved in the US in 2020 for adult patients with relapsed or refractory multiple myeloma who had received at least 4 prior therapies. However, in February 2023, the FDA withdrew this approval, following disappointing findings from a large confirmatory trial, called DREAMM-3. Although the agent is still being investigated to treat relapsed or refractory multiple myeloma, the current FDA label says the agent is only available in the US through a restricted program.
• Patients with multiple myeloma who relapse often become refractory to frontline triplet or quadruplet regimens and need effective second-line options.
• In the current phase 3 DREAMM-7 study, the researchers evaluated triplet therapy with belantamab mafodotin vs daratumumab as a second-line or later treatment option in patients with relapsed or refractory multiple myeloma.
• In this multicenter, open-label, randomized, phase 3 trial, 494 patients with relapsed/refractory multiple myeloma who previously received at least one prior line of therapy received bortezomib plus dexamethasone with either belantamab mafodotin or daratumumab.
• The primary outcome was PFS; secondary endpoints were overall survival, duration of response, and overall response rate.

TAKEAWAY:

• At a median follow-up of 28.2 months, patients who received belantamab mafodotin demonstrated significantly longer median PFS than those who received daratumumab (36.6 vs 13.4 months; hazard ratio [HR], 0.41). The improvement was evident in all prespecified groups, including patients refractory to lenalidomide (HR, 0.37) and those with a high risk for cytogenetic abnormalities (HR, 0.36).
• The early overall survival trend favored belantamab mafodotin — with 84% of patients alive at 18 months vs 73% in the daratumumab group — but overall survival follow-up is ongoing.
• The overall response rate was 83% in the belantamab mafodotin group vs 71% in the daratumumab group. Complete response rates were also higher in the belantamab mafodotin: 34.6% vs 17.1%. Median duration of response was twice as long in the belantamab mafodotin group (36 vs 18 months).
• Grade 3 or higher non-ocular adverse events in belantamab mafodotin vs daratumumab group included thrombocytopenia (55% vs 35%), infections and infestations (31% vs 20%), neutropenia (12% vs 6%), pneumonia (12% vs 4%), and anemia (8% vs 10%). Grade 3 or higher ocular adverse events were reported in 34% of patients treated with belantamab mafodotin, but ocular toxicities reversed in most patients.

IN PRACTICE:

Based on favorable PFS and manageable safety profile, belantamab mafodotin in combination with bortezomib plus dexamethasone has potential to become a new standard of care in the second line or later among patients with relapsed or refractory multiple myeloma, the author concluded.

SOURCE:

This study, led by Maria-Victoria Mateos, MD, PhD, from University Hospital of Salamanca, Salamanca, Spain, was presented at ASCO Plenary Series: February 2024 Session and published in the Journal of Clinical Oncology.

LIMITATIONS:

Open-label design was a limitation of this study. Follow-up for overall survival was ongoing.

DISCLOSURES:

This study was funded by GSK. Dr. Mateos reported receiving honoraria, consulting/personal fees outside this work.

A version of this article first appeared on Medscape.com.