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6. Monitoring response to neoadjuvant chemotherapy in triple negative breast cancer using circulating tumor DNA

Author

Chen, Jennifer H., Addanki, Sridevi, Roy, Dhruvajyoti, Bassett, Roland, Kalashnikova, Ekaterina, Spickard, Erik, Kuerer, Henry M., Meas, Salyna, Sarli, Vanessa N., Korkut, Anil, White, Jason B., Rauch, Gaiane M., Tripathy, Debu, Arun, Banu K., Barcenas, Carlos H., Yam, Clinton, Sethi, Himanshu, Rodriguez, Angel A., Liu, Minetta C., Moulder, Stacy L., and Lucci, Anthony

Published
2024
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16. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial

Author

Vicini, Frank A, Cecchini, Reena S, White, Julia R, Arthur, Douglas W, Julian, Thomas B, Rabinovitch, Rachel A, Kuske, Robert R, Ganz, Patricia A, Parda, David S, Scheier, Michael F, Winter, Kathryn A, Paik, Soonmyung, Kuerer, Henry M, Vallow, Laura A, Pierce, Lori J, Mamounas, Eleftherios P, McCormick, Beryl, Costantino, Joseph P, Bear, Harry D, Germain, Isabelle, Gustafson, Gregory, Grossheim, Linda, Petersen, Ivy A, Hudes, Richard S, Curran, Walter J, Bryant, John L, and Wolmark, Norman

Subjects
Breast Cancer, Comparative Effectiveness Research, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Adult, Aged, Brachytherapy, Breast Neoplasms, Combined Modality Therapy, Female, Humans, Lymphatic Metastasis, Mammography, Mastectomy, Segmental, Middle Aged, Neoplasm Grading, Neoplasm Invasiveness, Neoplasm Staging, Prognosis, Radiotherapy Dosage, Survival Rate, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundWhole-breast irradiation after breast-conserving surgery for patients with early-stage breast cancer decreases ipsilateral breast-tumour recurrence (IBTR), yielding comparable results to mastectomy. It is unknown whether accelerated partial breast irradiation (APBI) to only the tumour-bearing quadrant, which shortens treatment duration, is equally effective. In our trial, we investigated whether APBI provides equivalent local tumour control after lumpectomy compared with whole-breast irradiation.MethodsWe did this randomised, phase 3, equivalence trial (NSABP B-39/RTOG 0413) in 154 clinical centres in the USA, Canada, Ireland, and Israel. Adult women (>18 years) with early-stage (0, I, or II; no evidence of distant metastases, but up to three axillary nodes could be positive) breast cancer (tumour size ≤3 cm; including all histologies and multifocal breast cancers), who had had lumpectomy with negative (ie, no detectable cancer cells) surgical margins, were randomly assigned (1:1) using a biased-coin-based minimisation algorithm to receive either whole-breast irradiation (whole-breast irradiation group) or APBI (APBI group). Whole-breast irradiation was delivered in 25 daily fractions of 50 Gy over 5 weeks, with or without a supplemental boost to the tumour bed, and APBI was delivered as 34 Gy of brachytherapy or 38·5 Gy of external bream radiation therapy in 10 fractions, over 5 treatment days within an 8-day period. Randomisation was stratified by disease stage, menopausal status, hormone-receptor status, and intention to receive chemotherapy. Patients, investigators, and statisticians could not be masked to treatment allocation. The primary outcome of invasive and non-invasive IBTR as a first recurrence was analysed in the intention-to-treat population, excluding those patients who were lost to follow-up, with an equivalency test on the basis of a 50% margin increase in the hazard ratio (90% CI for the observed HR between 0·667 and 1·5 for equivalence) and a Cox proportional hazard model. Survival was assessed by intention to treat, and sensitivity analyses were done in the per-protocol population. This trial is registered with ClinicalTrials.gov, NCT00103181.FindingsBetween March 21, 2005, and April 16, 2013, 4216 women were enrolled. 2109 were assigned to the whole-breast irradiation group and 2107 were assigned to the APBI group. 70 patients from the whole-breast irradiation group and 14 from the APBI group withdrew consent or were lost to follow-up at this stage, so 2039 and 2093 patients respectively were available for survival analysis. Further, three and four patients respectively were lost to clinical follow-up (ie, survival status was assessed by phone but no physical examination was done), leaving 2036 patients in the whole-breast irradiation group and 2089 in the APBI group evaluable for the primary outcome. At a median follow-up of 10·2 years (IQR 7·5-11·5), 90 (4%) of 2089 women eligible for the primary outcome in the APBI group and 71 (3%) of 2036 women in the whole-breast irradiation group had an IBTR (HR 1·22, 90% CI 0·94-1·58). The 10-year cumulative incidence of IBTR was 4·6% (95% CI 3·7-5·7) in the APBI group versus 3·9% (3·1-5·0) in the whole-breast irradiation group. 44 (2%) of 2039 patients in the whole-breast irradiation group and 49 (2%) of 2093 patients in the APBI group died from recurring breast cancer. There were no treatment-related deaths. Second cancers and treatment-related toxicities were similar between the two groups. 2020 patients in the whole-breast irradiation group and 2089 in APBI group had available data on adverse events. The highest toxicity grade reported was: grade 1 in 845 (40%), grade 2 in 921 (44%), and grade 3 in 201 (10%) patients in the APBI group, compared with grade 1 in 626 (31%), grade 2 in 1193 (59%), and grade 3 in 143 (7%) in the whole-breast irradiation group.InterpretationAPBI did not meet the criteria for equivalence to whole-breast irradiation in controlling IBTR for breast-conserving therapy. Our trial had broad eligibility criteria, leading to a large, heterogeneous pool of patients and sufficient power to detect treatment equivalence, but was not designed to test equivalence in patient subgroups or outcomes from different APBI techniques. For patients with early-stage breast cancer, our findings support whole-breast irradiation following lumpectomy; however, with an absolute difference of less than 1% in the 10-year cumulative incidence of IBTR, APBI might be an acceptable alternative for some women.FundingNational Cancer Institute, US Department of Health and Human Services.

Published
2019

19. Eliminating breast surgery for invasive breast cancer in exceptional responders to neoadjuvant systemic therapy: a multicentre, single-arm, phase 2 trial

Author

Moseley, Tanya W, van la Parra, Raquel FD, Adrada, Beatriz E, Leung, Jessica WT, Sun, Susie X, Teshome, Mediget, Miggins, Makesha V, Hunt, Kelly K, DeSnyder, Sarah M, Ehlers, Richard A, Hwang, Rosa F, Colen, Jessica S, Arribas, Elsa, Samiian, Laila, Lesnikoski, Beth-Ann, Piotrowski, Mathew, Bedrosian, Isabelle, Chong, Clayton, Refinetti, Ana P, Huang, Monica, Candelaria, Rosalind P, Loveland-Jones, Catherine, Mitchell, Melissa P, Shaitelman, Simona F, Kuerer, Henry M, Smith, Benjamin D, Krishnamurthy, Savitri, Yang, Wei T, Valero, Vicente, Shen, Yu, Lin, Heather, Lucci, Anthony, Boughey, Judy C, White, Richard L, Diego, Emilia J, and Rauch, Gaiane M

Published
2022
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20. Monitoring Response to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Using Circulating Tumor DNA

Author

Chen, Jennifer H., primary, Addanki, Sridevi, additional, Roy, Dhruvajyoti, additional, Bassett, Roland, additional, Kalashnikova, Ekaterina, additional, Spickard, Erik, additional, Kuerer, Henry M., additional, Meas, Salyna, additional, Sarli, Vanessa N., additional, Korkut, Anil, additional, White, Jason B., additional, Rauch, Gaiane M., additional, Tripathy, Debu, additional, Arun, Banu K., additional, Barcenas, Carlos H., additional, Yam, Clinton, additional, Sethi, Himanshu, additional, Rodriguez, Angel A., additional, Liu, Minetta C., additional, Moulder, Stacy L., additional, and Lucci, Anthony, additional

Published
2024
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33. Omission of Axillary Dissection Following Nodal Downstaging With Neoadjuvant Chemotherapy

Author

Montagna, Giacomo, Mrdutt, Mary M., Sun, Susie X., Hlavin, Callie, Diego, Emilia J., Wong, Stephanie M., Barrio, Andrea V., van den Bruele, Astrid Botty, Cabioglu, Neslihan, Sevilimedu, Varadan, Rosenberger, Laura H., Hwang, E. Shelley, Ingham, Abigail, Papassotiropoulos, Bärbel, Nguyen-Sträuli, Bich Doan, Kurzeder, Christian, Aybar, Danilo Díaz, Vorburger, Denise, Matlac, Dieter Michael, Ostapenko, Edvin, Riedel, Fabian, Fitzal, Florian, Meani, Francesco, Fick, Franziska, Sagasser, Jacqueline, Heil, Jörg, Karanlik, Hasan, Dedes, Konstantin J., Romics, Laszlo, Banys-Paluchowski, Maggie, Muslumanoglu, Mahmut, Perez, Maria Del Rosario Cueva, Díaz, Marcelo Chávez, Heidinger, Martin, Fehr, Mathias K., Reinisch, Mattea, Tukenmez, Mustafa, Maggi, Nadia, Rocco, Nicola, Ditsch, Nina, Gentilini, Oreste Davide, Paulinelli, Regis R., Zarhi, Sebastián Solé, Kuemmel, Sherko, Bruzas, Simona, di Lascio, Simona, Parissenti, Tamara K., Hoskin, Tanya L., Güth, Uwe, Ovalle, Valentina, Tausch, Christoph, Kuerer, Henry M., Caudle, Abigail S., Boileau, Jean-Francois, Boughey, Judy C., Kühn, Thorsten, Morrow, Monica, and Weber, Walter P.

Abstract

IMPORTANCE: Data on oncological outcomes after omission of axillary lymph node dissection (ALND) in patients with breast cancer that downstages from node positive to negative with neoadjuvant chemotherapy are sparse. Additionally, the best axillary surgical staging technique in this scenario is unknown. OBJECTIVE: To investigate oncological outcomes after sentinel lymph node biopsy (SLNB) with dual-tracer mapping or targeted axillary dissection (TAD), which combines SLNB with localization and retrieval of the clipped lymph node. DESIGN, SETTING, AND PARTICIPANTS: In this multicenter retrospective cohort study that was conducted at 25 centers in 11 countries, 1144 patients with consecutive stage II to III biopsy-proven node-positive breast cancer were included between April 2013 and December 2020. The cumulative incidence rates of axillary, locoregional, and any invasive (locoregional or distant) recurrence were determined by competing risk analysis. EXPOSURE: Omission of ALND after SLNB or TAD. MAIN OUTCOMES AND MEASURES: The primary end points were the 3-year and 5-year rates of any axillary recurrence. Secondary end points included locoregional recurrence, any invasive (locoregional and distant) recurrence, and the number of lymph nodes removed. RESULTS: A total of 1144 patients (median [IQR] age, 50 [41-59] years; 78 [6.8%] Asian, 105 [9.2%] Black, 102 [8.9%] Hispanic, and 816 [71.0%] White individuals; 666 SLNB [58.2%] and 478 TAD [41.8%]) were included. A total of 1060 patients (93%) had N1 disease, 619 (54%) had ERBB2 (formerly HER2)–positive illness, and 758 (66%) had a breast pathologic complete response. TAD patients were more likely to receive nodal radiation therapy (85% vs 78%; P = .01). The clipped node was successfully retrieved in 97% of TAD cases and 86% of SLNB cases (without localization). The mean (SD) number of sentinel lymph nodes retrieved was 3 (2) vs 4 (2) (P < .001), and the mean (SD) number of total lymph nodes removed was 3.95 (1.97) vs 4.44 (2.04) (P < .001) in the TAD and SLNB groups, respectively. The 5-year rates of any axillary, locoregional, and any invasive recurrence in the entire cohort were 1.0% (95% CI, 0.49%-2.0%), 2.7% (95% CI, 1.6%-4.1%), and 10% (95% CI, 8.3%-13%), respectively. The 3-year cumulative incidence of axillary recurrence did not differ between TAD and SLNB (0.5% vs 0.8%; P = .55). CONCLUSIONS AND RELEVANCE: The results of this cohort study showed that axillary recurrence was rare in this setting and was not significantly lower after TAD vs SLNB. These results support omission of ALND in this population.

Published
2024
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37. Patient Interest in Exploring Nonsurgical Treatment Approaches for Early-Stage Breast Cancer: A Qualitative Study

Author

Guhan, Maya, primary, Crane, Stacey M., additional, Valerius, Lillian S., additional, Cruz, Denise De La, additional, Smith, Benjamin D., additional, Woodward, Wendy A., additional, Mitchell, Melissa P., additional, Valero, Vicente, additional, Rauch, Gaiane M., additional, Krishnamurthy, Savitri, additional, Warnecke, Carla L., additional, Kuerer, Henry M., additional, and Shaitelman, Simona F., additional

Published
2023
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47. Dermatologic Emergencies

Author

Mays, Steven R., Hymes, Sharon R., Cole, Katherine C., Kuerer, Henry M., Buzdar, Aman U., Series editor, Freedman, Ralph S., Series editor, Manzullo, Ellen F., editor, Gonzalez, Carmen Esther, editor, Escalante, Carmen P., editor, and Yeung, Sai-Ching J., editor

Published
2016
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48. NRG Oncology–Radiation Therapy Oncology Group Study 1014: 1-Year Toxicity Report From a Phase 2 Study of Repeat Breast-Preserving Surgery and 3-Dimensional Conformal Partial-Breast Reirradiation for In-Breast Recurrence

Author

Arthur, Douglas W., Winter, Kathryn A., Kuerer, Henry M., Haffty, Bruce G., Cuttino, Laurie W., Todor, Dorin A., Simone, Nicole L., Hayes, Shelly B., Woodward, Wendy A., McCormick, Beryl, Cohen, Randi J., Sahijdak, Walter M., Canaday, Daniel J., Brown, Doris R., Currey, Adam D., Fisher, Christine M., Jagsi, Reshma, and White, Julia

Published
2017
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