Key clinical point: External beam radiation therapy (EBRT) does not show a survival benefit in newly diagnosed elderly patients with metastatic prostate cancer.

Major finding: Patients who received EBRT vs. those who did not showed similar overall survival (hazard ratio [HR], 0.97; P = .6) and cancer-specific survival (HR, 1.04; P = .4).

Study details: A retrospective study of 6,556 patients, aged 75 years and above, with metastatic prostate cancer identified from the Surveillance, Epidemiology and End Results database between 2004 and 2016, of which 1,105 received EBRT.

Disclosures: No study source was identified for this work. The authors declared no conflict of interests.

Source: Wenzel M et al. Prostate. 2021 Oct 11. doi: 10.1002/pros.24249.

Key clinical point: External beam radiation therapy (EBRT) does not show a survival benefit in newly diagnosed elderly patients with metastatic prostate cancer.

Major finding: Patients who received EBRT vs. those who did not showed similar overall survival (hazard ratio [HR], 0.97; P = .6) and cancer-specific survival (HR, 1.04; P = .4).

Study details: A retrospective study of 6,556 patients, aged 75 years and above, with metastatic prostate cancer identified from the Surveillance, Epidemiology and End Results database between 2004 and 2016, of which 1,105 received EBRT.

Disclosures: No study source was identified for this work. The authors declared no conflict of interests.

Source: Wenzel M et al. Prostate. 2021 Oct 11. doi: 10.1002/pros.24249.

Key clinical point: External beam radiation therapy (EBRT) does not show a survival benefit in newly diagnosed elderly patients with metastatic prostate cancer.

Major finding: Patients who received EBRT vs. those who did not showed similar overall survival (hazard ratio [HR], 0.97; P = .6) and cancer-specific survival (HR, 1.04; P = .4).

Study details: A retrospective study of 6,556 patients, aged 75 years and above, with metastatic prostate cancer identified from the Surveillance, Epidemiology and End Results database between 2004 and 2016, of which 1,105 received EBRT.

Disclosures: No study source was identified for this work. The authors declared no conflict of interests.

Source: Wenzel M et al. Prostate. 2021 Oct 11. doi: 10.1002/pros.24249.

Key clinical point: In patients with localized prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy (RRP) has similar prostate cancer-specific mortality (PCSM) and lower risk for erectile dysfunction in the long term.

Major finding: At 8 years, urinary incontinence was not significantly different between RALP and RRP groups. Erectile dysfunction was significantly lower in the RALP group (66% vs 70%; adjusted risk ratio, 0.93; 95% confidence interval [CI], 0.87-0.99). PCSM was significantly lower in the RALP group (adjusted hazard ratio, 0.56; 95% CI, 0.34-0.93).

Study details: A prospective, controlled, nonrandomized trial of 4,003 patients with localized prostate cancer who were randomly assigned to either RALP and RRP between 2008 and 2011.

Disclosures: This work was supported by the Swedish Cancer Society, Swedish Research Council, Region Västra Götaland, Sahlgrenska University Hospital, Mrs. Mary von Sydow Foundation, Anna and Edwin Berger Foundation, Stockholm County Council, and Swedish Medical Association. The authors declared no competing interests.

Source: Lantz A et al. Eur Urol. 2021 Sep 15. doi: 10.1016/j.eururo.2021.07.025.

Key clinical point: In patients with localized prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy (RRP) has similar prostate cancer-specific mortality (PCSM) and lower risk for erectile dysfunction in the long term.

Major finding: At 8 years, urinary incontinence was not significantly different between RALP and RRP groups. Erectile dysfunction was significantly lower in the RALP group (66% vs 70%; adjusted risk ratio, 0.93; 95% confidence interval [CI], 0.87-0.99). PCSM was significantly lower in the RALP group (adjusted hazard ratio, 0.56; 95% CI, 0.34-0.93).

Study details: A prospective, controlled, nonrandomized trial of 4,003 patients with localized prostate cancer who were randomly assigned to either RALP and RRP between 2008 and 2011.

Disclosures: This work was supported by the Swedish Cancer Society, Swedish Research Council, Region Västra Götaland, Sahlgrenska University Hospital, Mrs. Mary von Sydow Foundation, Anna and Edwin Berger Foundation, Stockholm County Council, and Swedish Medical Association. The authors declared no competing interests.

Source: Lantz A et al. Eur Urol. 2021 Sep 15. doi: 10.1016/j.eururo.2021.07.025.

Key clinical point: In patients with localized prostate cancer, robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy (RRP) has similar prostate cancer-specific mortality (PCSM) and lower risk for erectile dysfunction in the long term.

Major finding: At 8 years, urinary incontinence was not significantly different between RALP and RRP groups. Erectile dysfunction was significantly lower in the RALP group (66% vs 70%; adjusted risk ratio, 0.93; 95% confidence interval [CI], 0.87-0.99). PCSM was significantly lower in the RALP group (adjusted hazard ratio, 0.56; 95% CI, 0.34-0.93).

Study details: A prospective, controlled, nonrandomized trial of 4,003 patients with localized prostate cancer who were randomly assigned to either RALP and RRP between 2008 and 2011.

Disclosures: This work was supported by the Swedish Cancer Society, Swedish Research Council, Region Västra Götaland, Sahlgrenska University Hospital, Mrs. Mary von Sydow Foundation, Anna and Edwin Berger Foundation, Stockholm County Council, and Swedish Medical Association. The authors declared no competing interests.

Source: Lantz A et al. Eur Urol. 2021 Sep 15. doi: 10.1016/j.eururo.2021.07.025.

Key clinical point: Adding abiraterone plus prednisone to androgen deprivation therapy (ADT) following definitive treatment in patients with biochemically recurrent castration-naïve prostate cancer prolongs prostate-specific antigen (PSA)-free survival (PSA less than 0.2 ng/mL).

Major finding: Abiraterone and prednisone plus ADT vs ADT alone significantly improved PSA-free survival (27.0 months vs 19.9 months; hazard ratio, 0.64; 95% confidence interval, 0.47-0.87).

Study details: A phase 2, randomized, open-label trial of 200 patients with nonmetastatic biochemically recurrent castration-naïve prostate cancer who were randomly assigned to either abiraterone plus prednisone to ADT or ADT alone following definitive treatment.

Disclosures: This study was funded by the Prostate Cancer Foundation, Janssen Research, Koch Center for Applied Biology, and Alexander & Eckstein Labs. The authors received research grant/funding, honoraria, advisory/consulting fees, and travel expenses. Dr. Subudhi SK declared ownership interest with Apricity Health.

Source: Spetsieri N et al. Eur J Cancer. 2021 Sep 15. doi: 10.1016/j.ejca.2021.06.017.

Key clinical point: Adding abiraterone plus prednisone to androgen deprivation therapy (ADT) following definitive treatment in patients with biochemically recurrent castration-naïve prostate cancer prolongs prostate-specific antigen (PSA)-free survival (PSA less than 0.2 ng/mL).

Major finding: Abiraterone and prednisone plus ADT vs ADT alone significantly improved PSA-free survival (27.0 months vs 19.9 months; hazard ratio, 0.64; 95% confidence interval, 0.47-0.87).

Study details: A phase 2, randomized, open-label trial of 200 patients with nonmetastatic biochemically recurrent castration-naïve prostate cancer who were randomly assigned to either abiraterone plus prednisone to ADT or ADT alone following definitive treatment.

Disclosures: This study was funded by the Prostate Cancer Foundation, Janssen Research, Koch Center for Applied Biology, and Alexander & Eckstein Labs. The authors received research grant/funding, honoraria, advisory/consulting fees, and travel expenses. Dr. Subudhi SK declared ownership interest with Apricity Health.

Source: Spetsieri N et al. Eur J Cancer. 2021 Sep 15. doi: 10.1016/j.ejca.2021.06.017.

Key clinical point: Adding abiraterone plus prednisone to androgen deprivation therapy (ADT) following definitive treatment in patients with biochemically recurrent castration-naïve prostate cancer prolongs prostate-specific antigen (PSA)-free survival (PSA less than 0.2 ng/mL).

Major finding: Abiraterone and prednisone plus ADT vs ADT alone significantly improved PSA-free survival (27.0 months vs 19.9 months; hazard ratio, 0.64; 95% confidence interval, 0.47-0.87).

Study details: A phase 2, randomized, open-label trial of 200 patients with nonmetastatic biochemically recurrent castration-naïve prostate cancer who were randomly assigned to either abiraterone plus prednisone to ADT or ADT alone following definitive treatment.

Disclosures: This study was funded by the Prostate Cancer Foundation, Janssen Research, Koch Center for Applied Biology, and Alexander & Eckstein Labs. The authors received research grant/funding, honoraria, advisory/consulting fees, and travel expenses. Dr. Subudhi SK declared ownership interest with Apricity Health.

Source: Spetsieri N et al. Eur J Cancer. 2021 Sep 15. doi: 10.1016/j.ejca.2021.06.017.

Key clinical point: Addition of apalutamide to abiraterone and prednisone improves radiographic progression-free survival (rPFS) in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC).

Major finding: At a median follow-up of 54.8 months, apalutamide in combination with abiraterone plus prednisone vs. abiraterone plus prednisone significantly improves rPFS (24.0 months vs 16.6 months; hazard ratio, 0.70; P < .0001).

Study details: A randomized, placebo-controlled, double-blind, phase 3 ACIS study of 982 chemotherapy-naïve patients with mCRPC who were randomly assigned to either apalutamide plus abiraterone and prednisone or abiraterone plus prednisone.

Disclosures: The study received funding from Janssen Research & Development. The authors reported leadership roles and receiving financial support, grants/contracts, consulting fees, and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, and/or educational events from various sources, and/or being employed with and holding stocks in pharmaceutical companies.

Source: Saad F et al. Lancet Oncol. 2021 Sep 30. doi: 10.1016/ S1470-2045(21)00402-2.

Key clinical point: Addition of apalutamide to abiraterone and prednisone improves radiographic progression-free survival (rPFS) in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC).

Major finding: At a median follow-up of 54.8 months, apalutamide in combination with abiraterone plus prednisone vs. abiraterone plus prednisone significantly improves rPFS (24.0 months vs 16.6 months; hazard ratio, 0.70; P < .0001).

Study details: A randomized, placebo-controlled, double-blind, phase 3 ACIS study of 982 chemotherapy-naïve patients with mCRPC who were randomly assigned to either apalutamide plus abiraterone and prednisone or abiraterone plus prednisone.

Disclosures: The study received funding from Janssen Research & Development. The authors reported leadership roles and receiving financial support, grants/contracts, consulting fees, and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, and/or educational events from various sources, and/or being employed with and holding stocks in pharmaceutical companies.

Source: Saad F et al. Lancet Oncol. 2021 Sep 30. doi: 10.1016/ S1470-2045(21)00402-2.

Key clinical point: Addition of apalutamide to abiraterone and prednisone improves radiographic progression-free survival (rPFS) in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC).

Major finding: At a median follow-up of 54.8 months, apalutamide in combination with abiraterone plus prednisone vs. abiraterone plus prednisone significantly improves rPFS (24.0 months vs 16.6 months; hazard ratio, 0.70; P < .0001).

Study details: A randomized, placebo-controlled, double-blind, phase 3 ACIS study of 982 chemotherapy-naïve patients with mCRPC who were randomly assigned to either apalutamide plus abiraterone and prednisone or abiraterone plus prednisone.

Disclosures: The study received funding from Janssen Research & Development. The authors reported leadership roles and receiving financial support, grants/contracts, consulting fees, and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, and/or educational events from various sources, and/or being employed with and holding stocks in pharmaceutical companies.

Source: Saad F et al. Lancet Oncol. 2021 Sep 30. doi: 10.1016/ S1470-2045(21)00402-2.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: In patients with intermediate-/high-risk prostate cancer undergoing radical prostatectomy and lymph node dissection, Gallium 68 prostate-specific membrane antigen (⁶⁸Ga-PSMA)-11 positron emission tomographic (PET) imaging shows sensitivity and specificity of 0.40 and 0.95, respectively.

Major finding: Compared with histopathology, ⁶⁸Ga-PSMA-11 PET imaging showed a sensitivity, specificity, positive predictive value, and negative predictive value for pelvic nodal metastases of 0.40, 0.95, 0.75, and 0.81, respectively.

Study details: A single-arm, open-label, phase 3 imaging trial (NCT03368547, NCT02611882, and NCT02919111) of 764 patients with intermediate- to high-risk prostate cancer considered for prostatectomy who underwent ⁶⁸Ga-PSMA-11 PET scan.

Disclosures: This work is supported by grants from the National Cancer Institute, Prostate Cancer Foundation, Society of Nuclear Medicine and Molecular Imaging, Philippe Foundation Inc, ARC Foundation, German Research Foundation, Doctor Robert Pfleger Foundation, and Wiedenfeld Foundation. The authors received grants, personal fees, cooperation projects, and speaker/advisory/consulting fees; held a patent; and/or reported being founder/shareholder outside this work.

Source: Hope TA et al. JAMA Oncol. 2021 Sep 16. doi: 10.1001/jamaoncol.2021.3771.

Key clinical point: The assessment of circulating tumor DNA (ctDNA) performed postoperatively, postadjuvantly, and serially during surveillance could help predict the risk of recurrence and the outcome of adjuvant chemotherapy (ACT) in patients with stage III colorectal cancer (CRC).

Major finding: Presence of ctDNA was associated with shorter recurrence-free survival postoperatively (hazard ratio, [HR], 7.0; P < .001) and after the completion of ACT (HR, 50.76; P < .001). Only patients with complete clearance of ctDNA during ACT did not relapse. Similarly, serial ctDNA assessed after the end of treatment was predictive of recurrence (HR, 50.80; P < .001).

Study details: This prospective study included 160 patients with stage III CRC treated with curative intent.

Disclosures: The study was supported by Novo Nordisk Foundation, Danish Cancer Society, Dansk Kræftforskningsfond, Krista and Viggo Petersen Foundation, and others. S Sharma, D Renner, D Hafez, H HHhSethi, and A Aleshin declared being employees of Natera, Inc.

Source: Henriksen TV et al. Clin Cancer Res. 2021 Oct 8. doi: 10.1158/1078-0432.CCR-21-2404.

Key clinical point: The assessment of circulating tumor DNA (ctDNA) performed postoperatively, postadjuvantly, and serially during surveillance could help predict the risk of recurrence and the outcome of adjuvant chemotherapy (ACT) in patients with stage III colorectal cancer (CRC).

Major finding: Presence of ctDNA was associated with shorter recurrence-free survival postoperatively (hazard ratio, [HR], 7.0; P < .001) and after the completion of ACT (HR, 50.76; P < .001). Only patients with complete clearance of ctDNA during ACT did not relapse. Similarly, serial ctDNA assessed after the end of treatment was predictive of recurrence (HR, 50.80; P < .001).

Study details: This prospective study included 160 patients with stage III CRC treated with curative intent.

Disclosures: The study was supported by Novo Nordisk Foundation, Danish Cancer Society, Dansk Kræftforskningsfond, Krista and Viggo Petersen Foundation, and others. S Sharma, D Renner, D Hafez, H HHhSethi, and A Aleshin declared being employees of Natera, Inc.

Source: Henriksen TV et al. Clin Cancer Res. 2021 Oct 8. doi: 10.1158/1078-0432.CCR-21-2404.

Key clinical point: The assessment of circulating tumor DNA (ctDNA) performed postoperatively, postadjuvantly, and serially during surveillance could help predict the risk of recurrence and the outcome of adjuvant chemotherapy (ACT) in patients with stage III colorectal cancer (CRC).

Major finding: Presence of ctDNA was associated with shorter recurrence-free survival postoperatively (hazard ratio, [HR], 7.0; P < .001) and after the completion of ACT (HR, 50.76; P < .001). Only patients with complete clearance of ctDNA during ACT did not relapse. Similarly, serial ctDNA assessed after the end of treatment was predictive of recurrence (HR, 50.80; P < .001).

Study details: This prospective study included 160 patients with stage III CRC treated with curative intent.

Disclosures: The study was supported by Novo Nordisk Foundation, Danish Cancer Society, Dansk Kræftforskningsfond, Krista and Viggo Petersen Foundation, and others. S Sharma, D Renner, D Hafez, H HHhSethi, and A Aleshin declared being employees of Natera, Inc.

Source: Henriksen TV et al. Clin Cancer Res. 2021 Oct 8. doi: 10.1158/1078-0432.CCR-21-2404.

Key clinical point: Dose-escalated chemoradiation (CRT) for locally advanced rectal cancer (LARC) had transient but considerable impact on quality of life (QoL), which was largely resolved from 12 months onwards.

Major finding: Dose-escalated vs standard CRT resulted in larger decline in global health score, role functioning, physical functioning, and social functioning at 6 months and higher fatigue (89% vs. 76%), pain (67% vs 36%), and diarrhea (45% vs 29%) at 3 months after treatment initiation (all P < .05). All symptoms and QoL were similar between the 2 treatment groups from 12 months onwards.

Study details: Findings are from 2 years of follow-up of RECTAL-BOOST trial including 128 patients with LARC treated with either standard CRT (50 Gy in 25 fractions with concurrent capecitabine) or dose-escalated CRT (radiation boost of 15 Gy in 5 fractions without concurrent chemotherapy in the week prior to CRT initiation).

Disclosures: The study was partially supported by Maag Lever Darm Stichting (MLDS), the Netherlands, Grant. HM Verkooijen declared receiving research funding and MPWI personal fees from Elekta AB (Stockholm, Sweden).

Source: Verweij ME et al. Int J Radiat Oncol Biol Phys. 2021 Oct 8. doi: 10.1016/j.ijrobp.2021.09.052.

Key clinical point: Dose-escalated chemoradiation (CRT) for locally advanced rectal cancer (LARC) had transient but considerable impact on quality of life (QoL), which was largely resolved from 12 months onwards.

Major finding: Dose-escalated vs standard CRT resulted in larger decline in global health score, role functioning, physical functioning, and social functioning at 6 months and higher fatigue (89% vs. 76%), pain (67% vs 36%), and diarrhea (45% vs 29%) at 3 months after treatment initiation (all P < .05). All symptoms and QoL were similar between the 2 treatment groups from 12 months onwards.

Study details: Findings are from 2 years of follow-up of RECTAL-BOOST trial including 128 patients with LARC treated with either standard CRT (50 Gy in 25 fractions with concurrent capecitabine) or dose-escalated CRT (radiation boost of 15 Gy in 5 fractions without concurrent chemotherapy in the week prior to CRT initiation).

Disclosures: The study was partially supported by Maag Lever Darm Stichting (MLDS), the Netherlands, Grant. HM Verkooijen declared receiving research funding and MPWI personal fees from Elekta AB (Stockholm, Sweden).

Source: Verweij ME et al. Int J Radiat Oncol Biol Phys. 2021 Oct 8. doi: 10.1016/j.ijrobp.2021.09.052.

Key clinical point: Dose-escalated chemoradiation (CRT) for locally advanced rectal cancer (LARC) had transient but considerable impact on quality of life (QoL), which was largely resolved from 12 months onwards.

Major finding: Dose-escalated vs standard CRT resulted in larger decline in global health score, role functioning, physical functioning, and social functioning at 6 months and higher fatigue (89% vs. 76%), pain (67% vs 36%), and diarrhea (45% vs 29%) at 3 months after treatment initiation (all P < .05). All symptoms and QoL were similar between the 2 treatment groups from 12 months onwards.

Study details: Findings are from 2 years of follow-up of RECTAL-BOOST trial including 128 patients with LARC treated with either standard CRT (50 Gy in 25 fractions with concurrent capecitabine) or dose-escalated CRT (radiation boost of 15 Gy in 5 fractions without concurrent chemotherapy in the week prior to CRT initiation).

Disclosures: The study was partially supported by Maag Lever Darm Stichting (MLDS), the Netherlands, Grant. HM Verkooijen declared receiving research funding and MPWI personal fees from Elekta AB (Stockholm, Sweden).

Source: Verweij ME et al. Int J Radiat Oncol Biol Phys. 2021 Oct 8. doi: 10.1016/j.ijrobp.2021.09.052.

Side effects from relugolix combination therapy (Myfembree) in premenopausal women treated for uterine fibroids and endometriosis are minimal, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The Food and Drug Administration approved relugolix, a daily oral gonadotropin-releasing hormone antagonist medication, earlier this year to treat heavy menstrual bleeding associated with uterine fibroids. It has not received Food and Drug Administration approval to treat endometriosis yet.

“It was a good kind of vindication about the safety of relugolix combination therapy,” Ayman Al-Hendy, MD, PhD, gynecologist and endoscopic surgeon at the University of Chicago, said in an interview.

Researchers led by Dr. Al-Hendy analyzed the results from two 24-week clinical trials that examined the effects of relugolix on premenopausal women between the ages of 18 and 50 suffering from uterine fibroids and endometriosis, both of which found that the treatment was well tolerated. With 1,344 patients in total, researchers found that the most common side effects of the treatment were headache, which occurred in 24.3% of participants, and hot flush, which affected 10.6%.

However, the prevalence of adverse reactions was similar to that of the placebo group in which 21.4% of participants experienced headaches and 6.4% experienced hot flushes, which, according to Dr. Al-Hendy, means that there is “really no increased risk” of experiencing an adverse event while taking relugolix.

“If we follow a large number of patients [with uterine fibroids or endometriosis], they will have some of these symptoms like headache or hot flushes or fatigue and so on. Either because it just happens in women for no known reason or because maybe the disease itself is causing some of these symptoms. The question is does the treatment in this case increase the frequency of these events?” Dr. Al-Hendy said.

“As long as it’s similar, fairly similar, or close between the [treatment and placebo group], then we know it’s not because of the medication,” Dr. Al-Hendy added.

Other adverse reactions that occurred while taking relugolix were “relatively rare” Dr. Al-Hendy said during his presentation. About 5.5% of those who took relugolix had uterine bleeding, 3.4% had decreased libido, 1.9% suffered from hyperhidrosis, 1.2% experienced night sweats, and 1.3% suffered from vaginal dryness.

The study shows that the risk profile of relugolix combination therapy is favorable and the side effects are relatively mild compared with past treatment options used to treat fibroids or endometriosis, said J. Ricardo Loret de Mola, MD, FACOG, FACS, who was not involved in the study.

However, Dr. Loret de Mola emphasized that this treatment isn’t for women who are seeking fertility or to get pregnant so it’s important for physicians to ask patients about their goals for treatment. Relugolix treatment could be a way for fibroid patients in their reproductive age to buy time and reduce the number of surgeries needed to get them to “the point where they would be ready to become mothers.”

He said surgery could be the right option for endometriosis patients who want to have children in the near future.

“This is an additional tool that we have available now that’s effective,” Dr. Loret de Mola said. “It is not going to cure either one of the two conditions, but could buy enough time for patients to be able to reach their goals, which is not having symptoms of endometriosis and fibroids after menopause or for people who just want to buy time.”

Dr. Al-Hendy said he hopes his findings reassure and encourage health care providers to discuss with patients different options for treating fibroids, and not just counsel them about surgery.

“So more awareness of these nonsurgical options hopefully will offer our patients a wide range of options when they seek help with fibroids and then against endometriosis [if or when] it’s [FDA]-approved,” Dr. Al-Hendy said.

None of the experts interviewed had conflicts of interest.

Side effects from relugolix combination therapy (Myfembree) in premenopausal women treated for uterine fibroids and endometriosis are minimal, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The Food and Drug Administration approved relugolix, a daily oral gonadotropin-releasing hormone antagonist medication, earlier this year to treat heavy menstrual bleeding associated with uterine fibroids. It has not received Food and Drug Administration approval to treat endometriosis yet.

“It was a good kind of vindication about the safety of relugolix combination therapy,” Ayman Al-Hendy, MD, PhD, gynecologist and endoscopic surgeon at the University of Chicago, said in an interview.

Researchers led by Dr. Al-Hendy analyzed the results from two 24-week clinical trials that examined the effects of relugolix on premenopausal women between the ages of 18 and 50 suffering from uterine fibroids and endometriosis, both of which found that the treatment was well tolerated. With 1,344 patients in total, researchers found that the most common side effects of the treatment were headache, which occurred in 24.3% of participants, and hot flush, which affected 10.6%.

However, the prevalence of adverse reactions was similar to that of the placebo group in which 21.4% of participants experienced headaches and 6.4% experienced hot flushes, which, according to Dr. Al-Hendy, means that there is “really no increased risk” of experiencing an adverse event while taking relugolix.

“If we follow a large number of patients [with uterine fibroids or endometriosis], they will have some of these symptoms like headache or hot flushes or fatigue and so on. Either because it just happens in women for no known reason or because maybe the disease itself is causing some of these symptoms. The question is does the treatment in this case increase the frequency of these events?” Dr. Al-Hendy said.

“As long as it’s similar, fairly similar, or close between the [treatment and placebo group], then we know it’s not because of the medication,” Dr. Al-Hendy added.

Other adverse reactions that occurred while taking relugolix were “relatively rare” Dr. Al-Hendy said during his presentation. About 5.5% of those who took relugolix had uterine bleeding, 3.4% had decreased libido, 1.9% suffered from hyperhidrosis, 1.2% experienced night sweats, and 1.3% suffered from vaginal dryness.

The study shows that the risk profile of relugolix combination therapy is favorable and the side effects are relatively mild compared with past treatment options used to treat fibroids or endometriosis, said J. Ricardo Loret de Mola, MD, FACOG, FACS, who was not involved in the study.

However, Dr. Loret de Mola emphasized that this treatment isn’t for women who are seeking fertility or to get pregnant so it’s important for physicians to ask patients about their goals for treatment. Relugolix treatment could be a way for fibroid patients in their reproductive age to buy time and reduce the number of surgeries needed to get them to “the point where they would be ready to become mothers.”

He said surgery could be the right option for endometriosis patients who want to have children in the near future.

“This is an additional tool that we have available now that’s effective,” Dr. Loret de Mola said. “It is not going to cure either one of the two conditions, but could buy enough time for patients to be able to reach their goals, which is not having symptoms of endometriosis and fibroids after menopause or for people who just want to buy time.”

Dr. Al-Hendy said he hopes his findings reassure and encourage health care providers to discuss with patients different options for treating fibroids, and not just counsel them about surgery.

“So more awareness of these nonsurgical options hopefully will offer our patients a wide range of options when they seek help with fibroids and then against endometriosis [if or when] it’s [FDA]-approved,” Dr. Al-Hendy said.

None of the experts interviewed had conflicts of interest.

Side effects from relugolix combination therapy (Myfembree) in premenopausal women treated for uterine fibroids and endometriosis are minimal, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.

The Food and Drug Administration approved relugolix, a daily oral gonadotropin-releasing hormone antagonist medication, earlier this year to treat heavy menstrual bleeding associated with uterine fibroids. It has not received Food and Drug Administration approval to treat endometriosis yet.

“It was a good kind of vindication about the safety of relugolix combination therapy,” Ayman Al-Hendy, MD, PhD, gynecologist and endoscopic surgeon at the University of Chicago, said in an interview.

Researchers led by Dr. Al-Hendy analyzed the results from two 24-week clinical trials that examined the effects of relugolix on premenopausal women between the ages of 18 and 50 suffering from uterine fibroids and endometriosis, both of which found that the treatment was well tolerated. With 1,344 patients in total, researchers found that the most common side effects of the treatment were headache, which occurred in 24.3% of participants, and hot flush, which affected 10.6%.

However, the prevalence of adverse reactions was similar to that of the placebo group in which 21.4% of participants experienced headaches and 6.4% experienced hot flushes, which, according to Dr. Al-Hendy, means that there is “really no increased risk” of experiencing an adverse event while taking relugolix.

“If we follow a large number of patients [with uterine fibroids or endometriosis], they will have some of these symptoms like headache or hot flushes or fatigue and so on. Either because it just happens in women for no known reason or because maybe the disease itself is causing some of these symptoms. The question is does the treatment in this case increase the frequency of these events?” Dr. Al-Hendy said.

“As long as it’s similar, fairly similar, or close between the [treatment and placebo group], then we know it’s not because of the medication,” Dr. Al-Hendy added.

Other adverse reactions that occurred while taking relugolix were “relatively rare” Dr. Al-Hendy said during his presentation. About 5.5% of those who took relugolix had uterine bleeding, 3.4% had decreased libido, 1.9% suffered from hyperhidrosis, 1.2% experienced night sweats, and 1.3% suffered from vaginal dryness.

The study shows that the risk profile of relugolix combination therapy is favorable and the side effects are relatively mild compared with past treatment options used to treat fibroids or endometriosis, said J. Ricardo Loret de Mola, MD, FACOG, FACS, who was not involved in the study.

However, Dr. Loret de Mola emphasized that this treatment isn’t for women who are seeking fertility or to get pregnant so it’s important for physicians to ask patients about their goals for treatment. Relugolix treatment could be a way for fibroid patients in their reproductive age to buy time and reduce the number of surgeries needed to get them to “the point where they would be ready to become mothers.”

He said surgery could be the right option for endometriosis patients who want to have children in the near future.

“This is an additional tool that we have available now that’s effective,” Dr. Loret de Mola said. “It is not going to cure either one of the two conditions, but could buy enough time for patients to be able to reach their goals, which is not having symptoms of endometriosis and fibroids after menopause or for people who just want to buy time.”

Dr. Al-Hendy said he hopes his findings reassure and encourage health care providers to discuss with patients different options for treating fibroids, and not just counsel them about surgery.

“So more awareness of these nonsurgical options hopefully will offer our patients a wide range of options when they seek help with fibroids and then against endometriosis [if or when] it’s [FDA]-approved,” Dr. Al-Hendy said.

None of the experts interviewed had conflicts of interest.

Key clinical point: Fasting blood glucose (FBG) variability was significantly associated with an increased risk of colorectal cancer (CRC) in healthy population without overt diabetes.

Major finding: Overall, CRC incidence during the follow-up period was 116.7 per 100,000 person-years. The highest vs lowest quintile of standard deviation of FBG showed a significantly higher risk of incident CRC (adjusted hazard ratio, 1.19; 95% confidence interval, 1.07-1.32) with each increase in standard deviation quintile being significantly associated with an increased risk of CRC (P for trend = .001).

Study details: Findings are from an analysis of 246,241 healthy subjects without overt diabetes who underwent general health screening at least once between 2002 and 2003.

Disclosures: The study was funded by National Research Foundation of Korea grant funded by the Korea government. The authors declared no conflict of interests.

Source: Jun H et al. Gut Liver. 2021 Oct 1. doi: 10.5009/gnl210048.

Key clinical point: Fasting blood glucose (FBG) variability was significantly associated with an increased risk of colorectal cancer (CRC) in healthy population without overt diabetes.

Major finding: Overall, CRC incidence during the follow-up period was 116.7 per 100,000 person-years. The highest vs lowest quintile of standard deviation of FBG showed a significantly higher risk of incident CRC (adjusted hazard ratio, 1.19; 95% confidence interval, 1.07-1.32) with each increase in standard deviation quintile being significantly associated with an increased risk of CRC (P for trend = .001).

Study details: Findings are from an analysis of 246,241 healthy subjects without overt diabetes who underwent general health screening at least once between 2002 and 2003.

Disclosures: The study was funded by National Research Foundation of Korea grant funded by the Korea government. The authors declared no conflict of interests.

Source: Jun H et al. Gut Liver. 2021 Oct 1. doi: 10.5009/gnl210048.

Key clinical point: Fasting blood glucose (FBG) variability was significantly associated with an increased risk of colorectal cancer (CRC) in healthy population without overt diabetes.

Major finding: Overall, CRC incidence during the follow-up period was 116.7 per 100,000 person-years. The highest vs lowest quintile of standard deviation of FBG showed a significantly higher risk of incident CRC (adjusted hazard ratio, 1.19; 95% confidence interval, 1.07-1.32) with each increase in standard deviation quintile being significantly associated with an increased risk of CRC (P for trend = .001).

Study details: Findings are from an analysis of 246,241 healthy subjects without overt diabetes who underwent general health screening at least once between 2002 and 2003.

Disclosures: The study was funded by National Research Foundation of Korea grant funded by the Korea government. The authors declared no conflict of interests.

Source: Jun H et al. Gut Liver. 2021 Oct 1. doi: 10.5009/gnl210048.