Breast Cancer

Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).

Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).

Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.

Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.

Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w  Source

Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).

Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).

Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.

Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.

Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w  Source

Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).

Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).

Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.

Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.

Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w  Source

Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.

Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).

Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.

Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.

Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source

Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.

Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).

Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.

Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.

Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source

Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.

Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).

Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.

Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.

Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source

Key clinical point: MRI response can be used to identify patients with hormone receptor-negative (HR−), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who may only require three cycles of neoadjuvant chemotherapy to achieve pathological complete response (pCR).

Major finding: After one to three cycles of chemotherapy, nearly one third of patients with HR−/HER2+ BC achieved radiological complete response (36%; 95% CI 30%-43%), of whom the majority of patients achieved pCR (88%; 95% CI 79%-94%). No treatment-related deaths were reported.

Study details: This phase 2 TRAIN-3 trial included 235 and 232 patients with stages II-III HR−/HER2+ and HR+/HER2+ BC, respectively, who received neoadjuvant chemotherapy once every 3 weeks for up to nine cycles and whose response was monitored using breast MRI after every three cycles and lymph node biopsy.

Disclosures: This study received unrestricted financial support from Roche Netherlands. Two authors declared receiving institutional research funding from or having other ties with various sources, including Roche.

Source: van der Voort A, Louis FM, van Ramshorst MS, et al, on behalf of the Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II–III HER2-positive breast cancer (TRAIN-3): A multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 (Apr 5). doi: 10.1016/S1470-2045(24)00104-9 Source

Key clinical point: MRI response can be used to identify patients with hormone receptor-negative (HR−), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who may only require three cycles of neoadjuvant chemotherapy to achieve pathological complete response (pCR).

Major finding: After one to three cycles of chemotherapy, nearly one third of patients with HR−/HER2+ BC achieved radiological complete response (36%; 95% CI 30%-43%), of whom the majority of patients achieved pCR (88%; 95% CI 79%-94%). No treatment-related deaths were reported.

Study details: This phase 2 TRAIN-3 trial included 235 and 232 patients with stages II-III HR−/HER2+ and HR+/HER2+ BC, respectively, who received neoadjuvant chemotherapy once every 3 weeks for up to nine cycles and whose response was monitored using breast MRI after every three cycles and lymph node biopsy.

Disclosures: This study received unrestricted financial support from Roche Netherlands. Two authors declared receiving institutional research funding from or having other ties with various sources, including Roche.

Source: van der Voort A, Louis FM, van Ramshorst MS, et al, on behalf of the Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II–III HER2-positive breast cancer (TRAIN-3): A multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 (Apr 5). doi: 10.1016/S1470-2045(24)00104-9 Source

Key clinical point: MRI response can be used to identify patients with hormone receptor-negative (HR−), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who may only require three cycles of neoadjuvant chemotherapy to achieve pathological complete response (pCR).

Major finding: After one to three cycles of chemotherapy, nearly one third of patients with HR−/HER2+ BC achieved radiological complete response (36%; 95% CI 30%-43%), of whom the majority of patients achieved pCR (88%; 95% CI 79%-94%). No treatment-related deaths were reported.

Study details: This phase 2 TRAIN-3 trial included 235 and 232 patients with stages II-III HR−/HER2+ and HR+/HER2+ BC, respectively, who received neoadjuvant chemotherapy once every 3 weeks for up to nine cycles and whose response was monitored using breast MRI after every three cycles and lymph node biopsy.

Disclosures: This study received unrestricted financial support from Roche Netherlands. Two authors declared receiving institutional research funding from or having other ties with various sources, including Roche.

Source: van der Voort A, Louis FM, van Ramshorst MS, et al, on behalf of the Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II–III HER2-positive breast cancer (TRAIN-3): A multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 (Apr 5). doi: 10.1016/S1470-2045(24)00104-9 Source

Key clinical point: In patients with breast cancer (BC), premastectomy radiotherapy (PreMRT) followed by mastectomy and immediate breast reconstruction (IMBR) is feasible, safe, and shortens the time required for breast reconstruction.

Major finding: At a median follow-up of 29.7 months, there were no complete flap losses, locoregional recurrences, distant metastases, or deaths in the 48 patients who completed mastectomy with IMBR. Patients could undergo mastectomy with IMBR as early as 3 weeks (median 23 days) after completing radiotherapy. No grade 3-4 radiotherapy-related toxic effect or discontinuation of radiotherapy was reported.

Study details: The study enrolled 49 patients with T0-T3, N0-N3b, M0 BC from the phase 2 SAPHIRE trial who received PreMRT and were randomly assigned to receive hypofractionated or conventionally fractionated regional nodal irradiation, followed by mastectomy and IMBR.

Disclosures: This study was supported by the National Cancer Institute of the US National Institutes of Health and others. Five authors declared receiving grants from or having other ties with various sources.

Source: Schaverien MV, Singh P, Smith BD, et al. Premastectomy radiotherapy and immediate breast reconstruction: A randomized clinical trial. JAMA Netw Open. 2024;7(4):e245217 (Apr 5). doi: 10.1001/jamanetworkopen.2024.5217 Source

Key clinical point: In patients with breast cancer (BC), premastectomy radiotherapy (PreMRT) followed by mastectomy and immediate breast reconstruction (IMBR) is feasible, safe, and shortens the time required for breast reconstruction.

Major finding: At a median follow-up of 29.7 months, there were no complete flap losses, locoregional recurrences, distant metastases, or deaths in the 48 patients who completed mastectomy with IMBR. Patients could undergo mastectomy with IMBR as early as 3 weeks (median 23 days) after completing radiotherapy. No grade 3-4 radiotherapy-related toxic effect or discontinuation of radiotherapy was reported.

Study details: The study enrolled 49 patients with T0-T3, N0-N3b, M0 BC from the phase 2 SAPHIRE trial who received PreMRT and were randomly assigned to receive hypofractionated or conventionally fractionated regional nodal irradiation, followed by mastectomy and IMBR.

Disclosures: This study was supported by the National Cancer Institute of the US National Institutes of Health and others. Five authors declared receiving grants from or having other ties with various sources.

Source: Schaverien MV, Singh P, Smith BD, et al. Premastectomy radiotherapy and immediate breast reconstruction: A randomized clinical trial. JAMA Netw Open. 2024;7(4):e245217 (Apr 5). doi: 10.1001/jamanetworkopen.2024.5217 Source

Key clinical point: In patients with breast cancer (BC), premastectomy radiotherapy (PreMRT) followed by mastectomy and immediate breast reconstruction (IMBR) is feasible, safe, and shortens the time required for breast reconstruction.

Major finding: At a median follow-up of 29.7 months, there were no complete flap losses, locoregional recurrences, distant metastases, or deaths in the 48 patients who completed mastectomy with IMBR. Patients could undergo mastectomy with IMBR as early as 3 weeks (median 23 days) after completing radiotherapy. No grade 3-4 radiotherapy-related toxic effect or discontinuation of radiotherapy was reported.

Study details: The study enrolled 49 patients with T0-T3, N0-N3b, M0 BC from the phase 2 SAPHIRE trial who received PreMRT and were randomly assigned to receive hypofractionated or conventionally fractionated regional nodal irradiation, followed by mastectomy and IMBR.

Disclosures: This study was supported by the National Cancer Institute of the US National Institutes of Health and others. Five authors declared receiving grants from or having other ties with various sources.

Source: Schaverien MV, Singh P, Smith BD, et al. Premastectomy radiotherapy and immediate breast reconstruction: A randomized clinical trial. JAMA Netw Open. 2024;7(4):e245217 (Apr 5). doi: 10.1001/jamanetworkopen.2024.5217 Source

Key clinical point: Higher levels of tumor-infiltrating lymphocytes (TIL) in breast cancer tissue was associated with improved survival outcomes in patients with early-stage triple-negative breast cancer (TNBC) who received locoregional therapy but no adjuvant or neoadjuvant chemotherapy.

Major finding: At a median follow-up of 18 years, each 10% increase in TIL levels was associated with significantly improved invasive disease-free survival (adjusted hazard ratio [aHR] 0.92; 95% CI 0.89-0.94), overall survival (aHR 0.88; 95% CI 0.85-0.91), and recurrence-free survival outcomes (aHR 0.90; 95% CI 0.87-0.92).

Study details: This retrospective pooled analysis included 1966 patients with early-stage TNBC (stage I TNBC, 55%) who underwent surgery with or without radiotherapy but no adjuvant or neoadjuvant chemotherapy.

Disclosures: This study was partly supported by grants from the Breast Cancer Research Foundation and others. Several authors declared ties with various sources.

Source: Leon-Ferre RA, Jonas SF, Salgado R, et al, for the International Immuno-Oncology Biomarker Working Group. Tumor-infiltrating lymphocytes in triple-negative breast cancer. JAMA. 2024;331:1135-1144 (Apr 2). doi: 10.1001/jama.2024.3056 Source

Key clinical point: Higher levels of tumor-infiltrating lymphocytes (TIL) in breast cancer tissue was associated with improved survival outcomes in patients with early-stage triple-negative breast cancer (TNBC) who received locoregional therapy but no adjuvant or neoadjuvant chemotherapy.

Major finding: At a median follow-up of 18 years, each 10% increase in TIL levels was associated with significantly improved invasive disease-free survival (adjusted hazard ratio [aHR] 0.92; 95% CI 0.89-0.94), overall survival (aHR 0.88; 95% CI 0.85-0.91), and recurrence-free survival outcomes (aHR 0.90; 95% CI 0.87-0.92).

Study details: This retrospective pooled analysis included 1966 patients with early-stage TNBC (stage I TNBC, 55%) who underwent surgery with or without radiotherapy but no adjuvant or neoadjuvant chemotherapy.

Disclosures: This study was partly supported by grants from the Breast Cancer Research Foundation and others. Several authors declared ties with various sources.

Source: Leon-Ferre RA, Jonas SF, Salgado R, et al, for the International Immuno-Oncology Biomarker Working Group. Tumor-infiltrating lymphocytes in triple-negative breast cancer. JAMA. 2024;331:1135-1144 (Apr 2). doi: 10.1001/jama.2024.3056 Source

Key clinical point: Higher levels of tumor-infiltrating lymphocytes (TIL) in breast cancer tissue was associated with improved survival outcomes in patients with early-stage triple-negative breast cancer (TNBC) who received locoregional therapy but no adjuvant or neoadjuvant chemotherapy.

Major finding: At a median follow-up of 18 years, each 10% increase in TIL levels was associated with significantly improved invasive disease-free survival (adjusted hazard ratio [aHR] 0.92; 95% CI 0.89-0.94), overall survival (aHR 0.88; 95% CI 0.85-0.91), and recurrence-free survival outcomes (aHR 0.90; 95% CI 0.87-0.92).

Study details: This retrospective pooled analysis included 1966 patients with early-stage TNBC (stage I TNBC, 55%) who underwent surgery with or without radiotherapy but no adjuvant or neoadjuvant chemotherapy.

Disclosures: This study was partly supported by grants from the Breast Cancer Research Foundation and others. Several authors declared ties with various sources.

Source: Leon-Ferre RA, Jonas SF, Salgado R, et al, for the International Immuno-Oncology Biomarker Working Group. Tumor-infiltrating lymphocytes in triple-negative breast cancer. JAMA. 2024;331:1135-1144 (Apr 2). doi: 10.1001/jama.2024.3056 Source

Key clinical point: Ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone for 3 years significantly improved invasive disease-free survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC).

Major finding: At 3 years, ribociclib + NSAI vs NSAI alone led to a 25.2% lower risk for invasive disease, recurrence, or death (hazard ratio 0.75; two-sided P = .003), with an absolute invasive disease-free survival benefit of 3.3% (90.4% vs 87.1%). No new safety signals were reported.

Study details: This prespecified interim analysis of the phase 3 NATALEE trial included 5101 patients with HR+/HER2− stage II or III early BC who were randomly assigned to receive ribociclib (dosage 400 mg/day for 21 consecutive days followed by 7 days off; duration 36 months) in combination with an NSAI or NSAI alone.

Disclosures: The trial was funded by Novartis. Six authors declared being employees of or holding stocks in Novartis. Several authors declared ties with various sources, including Novartis.

Source: Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390:1080-1091 (Mar 20). doi: 10.1056/NEJMoa2305488 Source

Key clinical point: Ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone for 3 years significantly improved invasive disease-free survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC).

Major finding: At 3 years, ribociclib + NSAI vs NSAI alone led to a 25.2% lower risk for invasive disease, recurrence, or death (hazard ratio 0.75; two-sided P = .003), with an absolute invasive disease-free survival benefit of 3.3% (90.4% vs 87.1%). No new safety signals were reported.

Study details: This prespecified interim analysis of the phase 3 NATALEE trial included 5101 patients with HR+/HER2− stage II or III early BC who were randomly assigned to receive ribociclib (dosage 400 mg/day for 21 consecutive days followed by 7 days off; duration 36 months) in combination with an NSAI or NSAI alone.

Disclosures: The trial was funded by Novartis. Six authors declared being employees of or holding stocks in Novartis. Several authors declared ties with various sources, including Novartis.

Source: Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390:1080-1091 (Mar 20). doi: 10.1056/NEJMoa2305488 Source

Key clinical point: Ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) vs NSAI alone for 3 years significantly improved invasive disease-free survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer (BC).

Major finding: At 3 years, ribociclib + NSAI vs NSAI alone led to a 25.2% lower risk for invasive disease, recurrence, or death (hazard ratio 0.75; two-sided P = .003), with an absolute invasive disease-free survival benefit of 3.3% (90.4% vs 87.1%). No new safety signals were reported.

Study details: This prespecified interim analysis of the phase 3 NATALEE trial included 5101 patients with HR+/HER2− stage II or III early BC who were randomly assigned to receive ribociclib (dosage 400 mg/day for 21 consecutive days followed by 7 days off; duration 36 months) in combination with an NSAI or NSAI alone.

Disclosures: The trial was funded by Novartis. Six authors declared being employees of or holding stocks in Novartis. Several authors declared ties with various sources, including Novartis.

Source: Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390:1080-1091 (Mar 20). doi: 10.1056/NEJMoa2305488 Source

Key clinical point: Recurrence-free survival after sentinel lymph node biopsy (SLNB) yielded noninferior outcomes compared to complete axillary lymph node dissection (ALND) in patients with clinically node-negative breast cancer (BC) and one or two sentinel-node macrometastases.

Major finding: The estimated 5-year recurrence-free survival was comparable in the SLNB alone vs completion ALND group (89.7% [95% CI 87.5%-91.9%] vs 88.7% [95% CI 86.3%-91.1%]), with the hazard ratio for recurrence or death being significantly below the noninferiority margin (0.89; P < .001 for non-inferiority).

Study details: Findings are from the noninferiority trial, SENOMAC, which included 2540 patients with clinically node-negative primary T1 to T3 BC with one or two sentinel lymph-node macrometastases who were randomly assigned to undergo SLNB alone (n = 1335) or completion ALND (n = 1205).

Disclosures: This study was supported by the Swedish Research Council and others. Oreste D. Gentilini declared serving as a consultant for various sources. The other authors declared no conflicts of interest.

Source: de Boniface J, Tvedskov TF, Rydén L, et al, for the SENOMAC Trialists’ Group. Omitting axillary dissection in breast cancer with sentinel-node metastases. N Engl J Med. 2024;390:1163-1175 (Apr 3). doi: 10.1056/NEJMoa2313487 Source

Key clinical point: Recurrence-free survival after sentinel lymph node biopsy (SLNB) yielded noninferior outcomes compared to complete axillary lymph node dissection (ALND) in patients with clinically node-negative breast cancer (BC) and one or two sentinel-node macrometastases.

Major finding: The estimated 5-year recurrence-free survival was comparable in the SLNB alone vs completion ALND group (89.7% [95% CI 87.5%-91.9%] vs 88.7% [95% CI 86.3%-91.1%]), with the hazard ratio for recurrence or death being significantly below the noninferiority margin (0.89; P < .001 for non-inferiority).

Study details: Findings are from the noninferiority trial, SENOMAC, which included 2540 patients with clinically node-negative primary T1 to T3 BC with one or two sentinel lymph-node macrometastases who were randomly assigned to undergo SLNB alone (n = 1335) or completion ALND (n = 1205).

Disclosures: This study was supported by the Swedish Research Council and others. Oreste D. Gentilini declared serving as a consultant for various sources. The other authors declared no conflicts of interest.

Source: de Boniface J, Tvedskov TF, Rydén L, et al, for the SENOMAC Trialists’ Group. Omitting axillary dissection in breast cancer with sentinel-node metastases. N Engl J Med. 2024;390:1163-1175 (Apr 3). doi: 10.1056/NEJMoa2313487 Source

Key clinical point: Recurrence-free survival after sentinel lymph node biopsy (SLNB) yielded noninferior outcomes compared to complete axillary lymph node dissection (ALND) in patients with clinically node-negative breast cancer (BC) and one or two sentinel-node macrometastases.

Major finding: The estimated 5-year recurrence-free survival was comparable in the SLNB alone vs completion ALND group (89.7% [95% CI 87.5%-91.9%] vs 88.7% [95% CI 86.3%-91.1%]), with the hazard ratio for recurrence or death being significantly below the noninferiority margin (0.89; P < .001 for non-inferiority).

Study details: Findings are from the noninferiority trial, SENOMAC, which included 2540 patients with clinically node-negative primary T1 to T3 BC with one or two sentinel lymph-node macrometastases who were randomly assigned to undergo SLNB alone (n = 1335) or completion ALND (n = 1205).

Disclosures: This study was supported by the Swedish Research Council and others. Oreste D. Gentilini declared serving as a consultant for various sources. The other authors declared no conflicts of interest.

Source: de Boniface J, Tvedskov TF, Rydén L, et al, for the SENOMAC Trialists’ Group. Omitting axillary dissection in breast cancer with sentinel-node metastases. N Engl J Med. 2024;390:1163-1175 (Apr 3). doi: 10.1056/NEJMoa2313487 Source

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.

Medicare reimbursement for common breast cancer surgeries decreased significantly over the past two decades, and the resulting shortage of funds could affect quality of care and access to services, especially for vulnerable patient populations.

These were findings of new research presented by Terry P. Gao, MD, at the American Society of Breast Surgeons annual meeting.

Medicare reimbursements often set a benchmark that is followed by private insurers, and the impact of changes on various breast surgeries have not been examined, Dr. Gao, a research resident at Temple University Hospital, Philadelphia, said during a press briefing in advance of the meeting.

“This study is important because it is the first to analyze trends in Medicare reimbursement for breast cancer surgery over a long period,” Dr. Gao said during an interview. The findings highlight a critical issue that could impact access to quality care, especially for vulnerable populations, she said.
 

How Were the Data Analyzed?

Dr. Gao and colleagues reviewed percent changes in reimbursement procedures over a 20-year period and compared them to changes in the consumer price index (CPI) to show the real-life impact of inflation.

The study examined reimbursements based on the Medicare Physician Fee Schedule Look-Up Tool from 2003 to 2023 for 10 procedures. The procedures were core needle biopsy, open incisional breast biopsy, open excisional breast biopsy, lumpectomy, lumpectomy with axillary lymph node dissection (ALND), simple mastectomy, radical mastectomy, modified radical mastectomy, biopsy/removal of lymph nodes, and sentinel lymph node biopsy.
 

What Does the New Study Show?

“Reimbursements did not keep pace with the price of goods and services,” Dr. Gao said during the press briefing.

After the researchers corrected data for inflation, the overall mean Medicare reimbursement for breast cancer surgeries decreased by approximately 21%, based in part on the 69% increase in the CPI over the study period, Dr. Gao said. The greatest change was in core needle biopsy, for which reimbursement decreased by 36%.

After inflation adjustment, reimbursement increases were seen for only two procedures, lumpectomy and simple mastectomy, of 0.37% and 3.58%, respectively, but these do not represent meaningful gains, Dr. Gao said.

The researchers also used a model to estimate the real-life impact of decreased reimbursement on clinicians. They subtracted the actual 2023 compensation from expected 2023 compensation based on inflation for a breast cancer case incidence of 297,790 patients who underwent axillary surgery, breast lumpectomy, or simple mastectomy. The calculated potential real-world compensation loss for that year was $107,604,444.
 

What are the Clinical Implications? 

The current study is the first to put specific numbers on the trend in declining breast cancer payments, and the findings should encourage physicians to advocate for equitable policies, Dr. Gao noted during the briefing.

The substantial decrease in inflation-adjusted reimbursement rates was significant, she said during the interview. Although the decrease reflects similar trends seen in other specialties, the magnitude is a potential cause for concern, she said.

Declining reimbursements could disproportionately hurt safety-net hospitals serving vulnerable populations by limiting their ability to invest in better care and potentially worsening existing racial disparities, Dr. Gao told this publication. “Additionally, surgeons may opt out of Medicare networks due to low rates, leading to access issues and longer wait times. Finally, these trends could discourage future generations from specializing in breast cancer surgery.”

The study findings should be considered in the context of the complex and rapidly changing clinical landscape in which breast cancer care is evolving, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said during an interview.

“Surgery remains a critically important aspect to curative treatment,” Dr. Teshome said.

Surgical decision-making tailored to each patient’s goals involves coordination from a multidisciplinary team as well as skill and attention from surgeons, she added.

“This degree of specialization and nuance is not always captured in reimbursement models for breast surgery,” Dr. Teshome emphasized. The policy implications of any changes in Medicare reimbursement will be important given the American Cancer Society reports breast cancer as the most commonly diagnosed cancer in women in the United States, and as the second leading cause of cancer death in US women, she noted.
 

What Additional Research Is Needed?

Research is needed to understand how declining reimbursements affect patients’ access to care, treatment choices, and long-term outcomes, Dr. Gao said in the interview. Future studies also are needed to examine provider overhead costs, staffing structures, and profit margins to offer a more comprehensive understanding of financial sustainability.

Dr. Gao and Dr. Teshome had no financial conflicts to disclose.

Medicare reimbursement for common breast cancer surgeries decreased significantly over the past two decades, and the resulting shortage of funds could affect quality of care and access to services, especially for vulnerable patient populations.

These were findings of new research presented by Terry P. Gao, MD, at the American Society of Breast Surgeons annual meeting.

Medicare reimbursements often set a benchmark that is followed by private insurers, and the impact of changes on various breast surgeries have not been examined, Dr. Gao, a research resident at Temple University Hospital, Philadelphia, said during a press briefing in advance of the meeting.

“This study is important because it is the first to analyze trends in Medicare reimbursement for breast cancer surgery over a long period,” Dr. Gao said during an interview. The findings highlight a critical issue that could impact access to quality care, especially for vulnerable populations, she said.
 

How Were the Data Analyzed?

Dr. Gao and colleagues reviewed percent changes in reimbursement procedures over a 20-year period and compared them to changes in the consumer price index (CPI) to show the real-life impact of inflation.

The study examined reimbursements based on the Medicare Physician Fee Schedule Look-Up Tool from 2003 to 2023 for 10 procedures. The procedures were core needle biopsy, open incisional breast biopsy, open excisional breast biopsy, lumpectomy, lumpectomy with axillary lymph node dissection (ALND), simple mastectomy, radical mastectomy, modified radical mastectomy, biopsy/removal of lymph nodes, and sentinel lymph node biopsy.
 

What Does the New Study Show?

“Reimbursements did not keep pace with the price of goods and services,” Dr. Gao said during the press briefing.

After the researchers corrected data for inflation, the overall mean Medicare reimbursement for breast cancer surgeries decreased by approximately 21%, based in part on the 69% increase in the CPI over the study period, Dr. Gao said. The greatest change was in core needle biopsy, for which reimbursement decreased by 36%.

After inflation adjustment, reimbursement increases were seen for only two procedures, lumpectomy and simple mastectomy, of 0.37% and 3.58%, respectively, but these do not represent meaningful gains, Dr. Gao said.

The researchers also used a model to estimate the real-life impact of decreased reimbursement on clinicians. They subtracted the actual 2023 compensation from expected 2023 compensation based on inflation for a breast cancer case incidence of 297,790 patients who underwent axillary surgery, breast lumpectomy, or simple mastectomy. The calculated potential real-world compensation loss for that year was $107,604,444.
 

What are the Clinical Implications? 

The current study is the first to put specific numbers on the trend in declining breast cancer payments, and the findings should encourage physicians to advocate for equitable policies, Dr. Gao noted during the briefing.

The substantial decrease in inflation-adjusted reimbursement rates was significant, she said during the interview. Although the decrease reflects similar trends seen in other specialties, the magnitude is a potential cause for concern, she said.

Declining reimbursements could disproportionately hurt safety-net hospitals serving vulnerable populations by limiting their ability to invest in better care and potentially worsening existing racial disparities, Dr. Gao told this publication. “Additionally, surgeons may opt out of Medicare networks due to low rates, leading to access issues and longer wait times. Finally, these trends could discourage future generations from specializing in breast cancer surgery.”

The study findings should be considered in the context of the complex and rapidly changing clinical landscape in which breast cancer care is evolving, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said during an interview.

“Surgery remains a critically important aspect to curative treatment,” Dr. Teshome said.

Surgical decision-making tailored to each patient’s goals involves coordination from a multidisciplinary team as well as skill and attention from surgeons, she added.

“This degree of specialization and nuance is not always captured in reimbursement models for breast surgery,” Dr. Teshome emphasized. The policy implications of any changes in Medicare reimbursement will be important given the American Cancer Society reports breast cancer as the most commonly diagnosed cancer in women in the United States, and as the second leading cause of cancer death in US women, she noted.
 

What Additional Research Is Needed?

Research is needed to understand how declining reimbursements affect patients’ access to care, treatment choices, and long-term outcomes, Dr. Gao said in the interview. Future studies also are needed to examine provider overhead costs, staffing structures, and profit margins to offer a more comprehensive understanding of financial sustainability.

Dr. Gao and Dr. Teshome had no financial conflicts to disclose.

Medicare reimbursement for common breast cancer surgeries decreased significantly over the past two decades, and the resulting shortage of funds could affect quality of care and access to services, especially for vulnerable patient populations.

These were findings of new research presented by Terry P. Gao, MD, at the American Society of Breast Surgeons annual meeting.

Medicare reimbursements often set a benchmark that is followed by private insurers, and the impact of changes on various breast surgeries have not been examined, Dr. Gao, a research resident at Temple University Hospital, Philadelphia, said during a press briefing in advance of the meeting.

“This study is important because it is the first to analyze trends in Medicare reimbursement for breast cancer surgery over a long period,” Dr. Gao said during an interview. The findings highlight a critical issue that could impact access to quality care, especially for vulnerable populations, she said.
 

How Were the Data Analyzed?

Dr. Gao and colleagues reviewed percent changes in reimbursement procedures over a 20-year period and compared them to changes in the consumer price index (CPI) to show the real-life impact of inflation.

The study examined reimbursements based on the Medicare Physician Fee Schedule Look-Up Tool from 2003 to 2023 for 10 procedures. The procedures were core needle biopsy, open incisional breast biopsy, open excisional breast biopsy, lumpectomy, lumpectomy with axillary lymph node dissection (ALND), simple mastectomy, radical mastectomy, modified radical mastectomy, biopsy/removal of lymph nodes, and sentinel lymph node biopsy.
 

What Does the New Study Show?

“Reimbursements did not keep pace with the price of goods and services,” Dr. Gao said during the press briefing.

After the researchers corrected data for inflation, the overall mean Medicare reimbursement for breast cancer surgeries decreased by approximately 21%, based in part on the 69% increase in the CPI over the study period, Dr. Gao said. The greatest change was in core needle biopsy, for which reimbursement decreased by 36%.

After inflation adjustment, reimbursement increases were seen for only two procedures, lumpectomy and simple mastectomy, of 0.37% and 3.58%, respectively, but these do not represent meaningful gains, Dr. Gao said.

The researchers also used a model to estimate the real-life impact of decreased reimbursement on clinicians. They subtracted the actual 2023 compensation from expected 2023 compensation based on inflation for a breast cancer case incidence of 297,790 patients who underwent axillary surgery, breast lumpectomy, or simple mastectomy. The calculated potential real-world compensation loss for that year was $107,604,444.
 

What are the Clinical Implications? 

The current study is the first to put specific numbers on the trend in declining breast cancer payments, and the findings should encourage physicians to advocate for equitable policies, Dr. Gao noted during the briefing.

The substantial decrease in inflation-adjusted reimbursement rates was significant, she said during the interview. Although the decrease reflects similar trends seen in other specialties, the magnitude is a potential cause for concern, she said.

Declining reimbursements could disproportionately hurt safety-net hospitals serving vulnerable populations by limiting their ability to invest in better care and potentially worsening existing racial disparities, Dr. Gao told this publication. “Additionally, surgeons may opt out of Medicare networks due to low rates, leading to access issues and longer wait times. Finally, these trends could discourage future generations from specializing in breast cancer surgery.”

The study findings should be considered in the context of the complex and rapidly changing clinical landscape in which breast cancer care is evolving, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said during an interview.

“Surgery remains a critically important aspect to curative treatment,” Dr. Teshome said.

Surgical decision-making tailored to each patient’s goals involves coordination from a multidisciplinary team as well as skill and attention from surgeons, she added.

“This degree of specialization and nuance is not always captured in reimbursement models for breast surgery,” Dr. Teshome emphasized. The policy implications of any changes in Medicare reimbursement will be important given the American Cancer Society reports breast cancer as the most commonly diagnosed cancer in women in the United States, and as the second leading cause of cancer death in US women, she noted.
 

What Additional Research Is Needed?

Research is needed to understand how declining reimbursements affect patients’ access to care, treatment choices, and long-term outcomes, Dr. Gao said in the interview. Future studies also are needed to examine provider overhead costs, staffing structures, and profit margins to offer a more comprehensive understanding of financial sustainability.

Dr. Gao and Dr. Teshome had no financial conflicts to disclose.

Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.

Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower-income countries.

The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.

That being said, “the clinical utility of multicancer detection tests has not been established and we’re concerned about issues of overdiagnosis and overtreatment,” she noted.

The Early Data 

One new MCED test called CanScan, developed by Geneseeq Technology, uses plasma cell-free DNA fragment patterns to detect cancer signals as well as identify the tissue of origin across 13 cancer types.

Overall, the CanScan test covers cancer types that contribute to two thirds of new cancer cases and 74% of morality globally, said presenter Shanshan Yang, of Geneseeq Research Institute, in Nanjing, China.

However, only five of these cancer types have screening recommendations issued by the US Preventive Services Task Force (USPSTF), Dr. Yang added.

The interim data comes from an ongoing large-scale prospective study evaluating the MCED test in a cohort of asymptomatic individuals between ages 45 and 75 years with an average risk for cancer and no cancer-related symptoms on enrollment.

Patients at baseline had their blood collected for the CanScan test and subsequently received annual routine physical exams once a year for 3 consecutive years, with an additional 2 years of follow-up. 

The analysis included 3724 participants with analyzable samples at the data cutoff in September 2023. Among the 3724 participants, 29 had confirmed cancer diagnoses. Among these cases, 14 patients had their cancer confirmed through USPSTF recommended screening and 15 were detected through outside of standard USPSTF screening, such as a thyroid ultrasound, Dr. Yang explained.

Almost 90% of the cancers (26 of 29) were detected in the stage I or II, and eight (27.5%) were not one of the test’s 13 targeted cancer types.

The CanScan test had a sensitivity of 55.2%, identifying 16 of 29 of the patients with cancer, including 10 of 21 individuals with stage I (47.6%), and two of three with stage II (66.7%). 

The test had a high specificity of 97.9%, meaning out of 100 people screened, only two had false negative findings.

Among the 15 patients who had their cancer detected outside of USPSTF screening recommendations, eight (53.3%) were found using a CanScan test, including patients with liver and endometrial cancers.

Compared with a positive predictive value of (PPV) of 1.6% with screening or physical exam methods alone, the CanScan test had a PPV of 17.4%, Dr. Yang reported. 

“The MCED test holds significant potential for early cancer screening in asymptomatic populations,” Dr. Yang and colleagues concluded.

Another new MCED test called MERCURY, also developed by Geneseeq Technology and presented during the session, used a similar method to detect cancer signals and predict the tissue of origin across 13 cancer types.

The researchers initially validated the test using 3076 patients with cancer and 3477 healthy controls with a target specificity of 99%. In this group, researchers reported a sensitivity of 0.865 and a specificity of 0.989.

The team then performed an independent validation analysis with 1465 participants, 732 with cancer and 733 with no cancer, and confirmed a high sensitivity and specificity of 0.874 and 0.978, respectively. The sensitivity increased incrementally by cancer stage — 0.768 for stage I, 0.840 for stage II, 0.923 for stage III, and 0.971 for stage IV.

The test identified the tissue of origin with high accuracy, the researchers noted, but cautioned that the test needs “to be further validated in a prospective cohort study.”

MCED in Low-Income Settings

The session also featured findings on a new affordable MCED test called OncoSeek, which could provide greater access to cancer testing in low- and middle-income countries.

The OncoSeek algorithm identifies the presence of cancer using seven protein tumor markers alongside clinical information, such as gender and age. Like other tests, the test also predicts the possible tissue of origin.

The test can be run on clinical protein assay instruments that are already widely available, such as Roche cobas analyzer, Mao Mao, MD, PhD, the founder and CEO of SeekIn, of Shenzhen, China, told this news organization.

This “feature makes the test accessible worldwide, even in low- and middle-income countries,” he said. “These instruments are fully-automated and part of today’s clinical practice. Therefore, the test does not require additional infrastructure building and lab personal training.”

Another notable advantage: the OncoSeek test only costs about $20, compared with other MCED tests, which can cost anywhere from $200 to $1000.

To validate the technology in a large, diverse cohort, Dr. Mao and colleagues enrolled approximately 10,000 participants, including 2003 cancer cases and 7888 non-cancer cases.

Peripheral blood was collected from each participant and analyzed using a panel of the seven protein tumor markers — AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA 21-1.

To reduce the risk for false positive findings, the team designed the OncoSeek algorithm to achieve a specificity of 93%. Dr. Mao and colleagues found a sensitivity of 51.7%, resulting in an overall accuracy of 84.6%.

The performance was consistent in additional validation cohorts in Brazil, China, and the United States, with sensitivities ranging from 39.0% to 77.6% for detecting nine common cancer types, including breast, colorectal, liver, lung, lymphoma, esophagus, ovary, pancreas, and stomach. The sensitivity for pancreatic cancer was at the high end of 77.6%.

The test could predict the tissue of origin in about two thirds of cases. 

Given its low cost, OncoSeek represents an affordable and accessible option for cancer screening, the authors concluded. 

Overall, “I think MCEDs have the potential to enhance cancer screening,” Dr. Wood told this news organization.

Still, questions remain about the optimal use of these tests, such as whether they are best for average-risk or higher risk populations, and how to integrate them into standard screening, she said. 

Dr. Wood also cautioned that the studies presented in the session represent early data, and it is likely that the numbers, such as sensitivity and specificity, will change with further prospective analyses.

And ultimately, these tests should complement, not replace, standard screening. “A negative testing should not be taken as a sign to avoid standard screening,” Dr. Wood said.

Dr. Yang is an employee of Geneseeq Technology, Inc., and Dr. Mao is an employee of SeekIn. Dr. Wood had no disclosures to report.

A version of this article appeared on Medscape.com.

Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.

Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower-income countries.

The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.

That being said, “the clinical utility of multicancer detection tests has not been established and we’re concerned about issues of overdiagnosis and overtreatment,” she noted.

The Early Data 

One new MCED test called CanScan, developed by Geneseeq Technology, uses plasma cell-free DNA fragment patterns to detect cancer signals as well as identify the tissue of origin across 13 cancer types.

Overall, the CanScan test covers cancer types that contribute to two thirds of new cancer cases and 74% of morality globally, said presenter Shanshan Yang, of Geneseeq Research Institute, in Nanjing, China.

However, only five of these cancer types have screening recommendations issued by the US Preventive Services Task Force (USPSTF), Dr. Yang added.

The interim data comes from an ongoing large-scale prospective study evaluating the MCED test in a cohort of asymptomatic individuals between ages 45 and 75 years with an average risk for cancer and no cancer-related symptoms on enrollment.

Patients at baseline had their blood collected for the CanScan test and subsequently received annual routine physical exams once a year for 3 consecutive years, with an additional 2 years of follow-up. 

The analysis included 3724 participants with analyzable samples at the data cutoff in September 2023. Among the 3724 participants, 29 had confirmed cancer diagnoses. Among these cases, 14 patients had their cancer confirmed through USPSTF recommended screening and 15 were detected through outside of standard USPSTF screening, such as a thyroid ultrasound, Dr. Yang explained.

Almost 90% of the cancers (26 of 29) were detected in the stage I or II, and eight (27.5%) were not one of the test’s 13 targeted cancer types.

The CanScan test had a sensitivity of 55.2%, identifying 16 of 29 of the patients with cancer, including 10 of 21 individuals with stage I (47.6%), and two of three with stage II (66.7%). 

The test had a high specificity of 97.9%, meaning out of 100 people screened, only two had false negative findings.

Among the 15 patients who had their cancer detected outside of USPSTF screening recommendations, eight (53.3%) were found using a CanScan test, including patients with liver and endometrial cancers.

Compared with a positive predictive value of (PPV) of 1.6% with screening or physical exam methods alone, the CanScan test had a PPV of 17.4%, Dr. Yang reported. 

“The MCED test holds significant potential for early cancer screening in asymptomatic populations,” Dr. Yang and colleagues concluded.

Another new MCED test called MERCURY, also developed by Geneseeq Technology and presented during the session, used a similar method to detect cancer signals and predict the tissue of origin across 13 cancer types.

The researchers initially validated the test using 3076 patients with cancer and 3477 healthy controls with a target specificity of 99%. In this group, researchers reported a sensitivity of 0.865 and a specificity of 0.989.

The team then performed an independent validation analysis with 1465 participants, 732 with cancer and 733 with no cancer, and confirmed a high sensitivity and specificity of 0.874 and 0.978, respectively. The sensitivity increased incrementally by cancer stage — 0.768 for stage I, 0.840 for stage II, 0.923 for stage III, and 0.971 for stage IV.

The test identified the tissue of origin with high accuracy, the researchers noted, but cautioned that the test needs “to be further validated in a prospective cohort study.”

MCED in Low-Income Settings

The session also featured findings on a new affordable MCED test called OncoSeek, which could provide greater access to cancer testing in low- and middle-income countries.

The OncoSeek algorithm identifies the presence of cancer using seven protein tumor markers alongside clinical information, such as gender and age. Like other tests, the test also predicts the possible tissue of origin.

The test can be run on clinical protein assay instruments that are already widely available, such as Roche cobas analyzer, Mao Mao, MD, PhD, the founder and CEO of SeekIn, of Shenzhen, China, told this news organization.

This “feature makes the test accessible worldwide, even in low- and middle-income countries,” he said. “These instruments are fully-automated and part of today’s clinical practice. Therefore, the test does not require additional infrastructure building and lab personal training.”

Another notable advantage: the OncoSeek test only costs about $20, compared with other MCED tests, which can cost anywhere from $200 to $1000.

To validate the technology in a large, diverse cohort, Dr. Mao and colleagues enrolled approximately 10,000 participants, including 2003 cancer cases and 7888 non-cancer cases.

Peripheral blood was collected from each participant and analyzed using a panel of the seven protein tumor markers — AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA 21-1.

To reduce the risk for false positive findings, the team designed the OncoSeek algorithm to achieve a specificity of 93%. Dr. Mao and colleagues found a sensitivity of 51.7%, resulting in an overall accuracy of 84.6%.

The performance was consistent in additional validation cohorts in Brazil, China, and the United States, with sensitivities ranging from 39.0% to 77.6% for detecting nine common cancer types, including breast, colorectal, liver, lung, lymphoma, esophagus, ovary, pancreas, and stomach. The sensitivity for pancreatic cancer was at the high end of 77.6%.

The test could predict the tissue of origin in about two thirds of cases. 

Given its low cost, OncoSeek represents an affordable and accessible option for cancer screening, the authors concluded. 

Overall, “I think MCEDs have the potential to enhance cancer screening,” Dr. Wood told this news organization.

Still, questions remain about the optimal use of these tests, such as whether they are best for average-risk or higher risk populations, and how to integrate them into standard screening, she said. 

Dr. Wood also cautioned that the studies presented in the session represent early data, and it is likely that the numbers, such as sensitivity and specificity, will change with further prospective analyses.

And ultimately, these tests should complement, not replace, standard screening. “A negative testing should not be taken as a sign to avoid standard screening,” Dr. Wood said.

Dr. Yang is an employee of Geneseeq Technology, Inc., and Dr. Mao is an employee of SeekIn. Dr. Wood had no disclosures to report.

A version of this article appeared on Medscape.com.

Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.

Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower-income countries.

The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.

That being said, “the clinical utility of multicancer detection tests has not been established and we’re concerned about issues of overdiagnosis and overtreatment,” she noted.

The Early Data 

One new MCED test called CanScan, developed by Geneseeq Technology, uses plasma cell-free DNA fragment patterns to detect cancer signals as well as identify the tissue of origin across 13 cancer types.

Overall, the CanScan test covers cancer types that contribute to two thirds of new cancer cases and 74% of morality globally, said presenter Shanshan Yang, of Geneseeq Research Institute, in Nanjing, China.

However, only five of these cancer types have screening recommendations issued by the US Preventive Services Task Force (USPSTF), Dr. Yang added.

The interim data comes from an ongoing large-scale prospective study evaluating the MCED test in a cohort of asymptomatic individuals between ages 45 and 75 years with an average risk for cancer and no cancer-related symptoms on enrollment.

Patients at baseline had their blood collected for the CanScan test and subsequently received annual routine physical exams once a year for 3 consecutive years, with an additional 2 years of follow-up. 

The analysis included 3724 participants with analyzable samples at the data cutoff in September 2023. Among the 3724 participants, 29 had confirmed cancer diagnoses. Among these cases, 14 patients had their cancer confirmed through USPSTF recommended screening and 15 were detected through outside of standard USPSTF screening, such as a thyroid ultrasound, Dr. Yang explained.

Almost 90% of the cancers (26 of 29) were detected in the stage I or II, and eight (27.5%) were not one of the test’s 13 targeted cancer types.

The CanScan test had a sensitivity of 55.2%, identifying 16 of 29 of the patients with cancer, including 10 of 21 individuals with stage I (47.6%), and two of three with stage II (66.7%). 

The test had a high specificity of 97.9%, meaning out of 100 people screened, only two had false negative findings.

Among the 15 patients who had their cancer detected outside of USPSTF screening recommendations, eight (53.3%) were found using a CanScan test, including patients with liver and endometrial cancers.

Compared with a positive predictive value of (PPV) of 1.6% with screening or physical exam methods alone, the CanScan test had a PPV of 17.4%, Dr. Yang reported. 

“The MCED test holds significant potential for early cancer screening in asymptomatic populations,” Dr. Yang and colleagues concluded.

Another new MCED test called MERCURY, also developed by Geneseeq Technology and presented during the session, used a similar method to detect cancer signals and predict the tissue of origin across 13 cancer types.

The researchers initially validated the test using 3076 patients with cancer and 3477 healthy controls with a target specificity of 99%. In this group, researchers reported a sensitivity of 0.865 and a specificity of 0.989.

The team then performed an independent validation analysis with 1465 participants, 732 with cancer and 733 with no cancer, and confirmed a high sensitivity and specificity of 0.874 and 0.978, respectively. The sensitivity increased incrementally by cancer stage — 0.768 for stage I, 0.840 for stage II, 0.923 for stage III, and 0.971 for stage IV.

The test identified the tissue of origin with high accuracy, the researchers noted, but cautioned that the test needs “to be further validated in a prospective cohort study.”

MCED in Low-Income Settings

The session also featured findings on a new affordable MCED test called OncoSeek, which could provide greater access to cancer testing in low- and middle-income countries.

The OncoSeek algorithm identifies the presence of cancer using seven protein tumor markers alongside clinical information, such as gender and age. Like other tests, the test also predicts the possible tissue of origin.

The test can be run on clinical protein assay instruments that are already widely available, such as Roche cobas analyzer, Mao Mao, MD, PhD, the founder and CEO of SeekIn, of Shenzhen, China, told this news organization.

This “feature makes the test accessible worldwide, even in low- and middle-income countries,” he said. “These instruments are fully-automated and part of today’s clinical practice. Therefore, the test does not require additional infrastructure building and lab personal training.”

Another notable advantage: the OncoSeek test only costs about $20, compared with other MCED tests, which can cost anywhere from $200 to $1000.

To validate the technology in a large, diverse cohort, Dr. Mao and colleagues enrolled approximately 10,000 participants, including 2003 cancer cases and 7888 non-cancer cases.

Peripheral blood was collected from each participant and analyzed using a panel of the seven protein tumor markers — AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA 21-1.

To reduce the risk for false positive findings, the team designed the OncoSeek algorithm to achieve a specificity of 93%. Dr. Mao and colleagues found a sensitivity of 51.7%, resulting in an overall accuracy of 84.6%.

The performance was consistent in additional validation cohorts in Brazil, China, and the United States, with sensitivities ranging from 39.0% to 77.6% for detecting nine common cancer types, including breast, colorectal, liver, lung, lymphoma, esophagus, ovary, pancreas, and stomach. The sensitivity for pancreatic cancer was at the high end of 77.6%.

The test could predict the tissue of origin in about two thirds of cases. 

Given its low cost, OncoSeek represents an affordable and accessible option for cancer screening, the authors concluded. 

Overall, “I think MCEDs have the potential to enhance cancer screening,” Dr. Wood told this news organization.

Still, questions remain about the optimal use of these tests, such as whether they are best for average-risk or higher risk populations, and how to integrate them into standard screening, she said. 

Dr. Wood also cautioned that the studies presented in the session represent early data, and it is likely that the numbers, such as sensitivity and specificity, will change with further prospective analyses.

And ultimately, these tests should complement, not replace, standard screening. “A negative testing should not be taken as a sign to avoid standard screening,” Dr. Wood said.

Dr. Yang is an employee of Geneseeq Technology, Inc., and Dr. Mao is an employee of SeekIn. Dr. Wood had no disclosures to report.

A version of this article appeared on Medscape.com.