Lifen Cao1,2,3,4, Robert Shenk2,3, Nickolas Stabellini4, Megan E Miller2,3, Christopher W Towe3,5, Alberto J Montero6,7. 1. Division of Hematology and Oncology, Department of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA. 2. Division of Surgical Oncology, Department of Surgery, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA. 3. University Hospitals Research in Surgical Outcomes and Effectiveness (UH-RISES), Cleveland, OH, USA. 4. Case Western Reserve University School of Medicine, Cleveland, OH, USA. 5. Division of Thoracic and Esophageal Surgery, Department of Surgery, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA. 6. Division of Hematology and Oncology, Department of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA. Alberto.Montero@UHhospitals.org. 7. University Hospitals Seidman Cancer Center, Case Western Reserve University School of Medicine, 11100 Euclid Avenue, Lakeside Suite 1200, Cleveland, OH, 44106, USA. Alberto.Montero@UHhospitals.org.
Abstract
PURPOSE: Approximately 20% of all breast cancers (BC) are HER2 amplified. In the APT trial, weekly paclitaxel/trastuzumab in node negative HER2+ BC with tumors < 3 cm was associated with a 7-year invasive disease-free survival of 93%. However, this was in the context of a non-randomized trial, and for pT1N0 HER2+ BC it remains unclear whether HER2 monotherapy would provide similar clinical outcomes to chemo-HER2 therapy. We hypothesized that adjuvant chemo-HER2 therapy would be associated with a modestly improved overall survival compared to HER2 monotherapy in patients with tumors < 2 cm. METHODS: In the National Cancer Database (2004-2017), patients with a primary diagnosis of pT1N0M0 HER2+ BC, were separated into two groups: (i) HER2 monotherapy, i.e., trastuzumab, and (ii) chemo-HER2 therapy. A 3:1 propensity match was performed to balance patient selection bias between the two different cohorts. Long-term overall survival (OS) was compared between both groups. RESULTS: A total of 23,281 patients met the criteria. 22,268 (96.7%) received chemo-HER2 therapy and 1013 (4.4%) received HER2 monotherapy. Propensity match identified 1995 patients who received chemo-HER2 therapy, and 666 who received HER2 monotherapy. After matching, adjuvant chemo-HER2 therapy was associated with a modest survival advantage over HER2 monotherapy (5-year OS 94.1% vs. 90.6%, P = 0.041). CONCLUSIONS: Even though there is a modest OS advantage favoring adjuvant chemo-HER2 therapy in patients with pT1N0 HER2+ BC, HER2 monotherapy was associated with 5-year OS > 90%. Therefore, in select patients who have contraindications for cytotoxic chemotherapy, or decline adjuvant chemotherapy altogether, adjuvant trastuzumab monotherapy appears to be a reasonable alternative.
PURPOSE: Approximately 20% of all breast cancers (BC) are HER2 amplified. In the APT trial, weekly paclitaxel/trastuzumab in node negative HER2+ BC with tumors < 3 cm was associated with a 7-year invasive disease-free survival of 93%. However, this was in the context of a non-randomized trial, and for pT1N0 HER2+ BC it remains unclear whether HER2 monotherapy would provide similar clinical outcomes to chemo-HER2 therapy. We hypothesized that adjuvant chemo-HER2 therapy would be associated with a modestly improved overall survival compared to HER2 monotherapy in patients with tumors < 2 cm. METHODS: In the National Cancer Database (2004-2017), patients with a primary diagnosis of pT1N0M0 HER2+ BC, were separated into two groups: (i) HER2 monotherapy, i.e., trastuzumab, and (ii) chemo-HER2 therapy. A 3:1 propensity match was performed to balance patient selection bias between the two different cohorts. Long-term overall survival (OS) was compared between both groups. RESULTS: A total of 23,281 patients met the criteria. 22,268 (96.7%) received chemo-HER2 therapy and 1013 (4.4%) received HER2 monotherapy. Propensity match identified 1995 patients who received chemo-HER2 therapy, and 666 who received HER2 monotherapy. After matching, adjuvant chemo-HER2 therapy was associated with a modest survival advantage over HER2 monotherapy (5-year OS 94.1% vs. 90.6%, P = 0.041). CONCLUSIONS: Even though there is a modest OS advantage favoring adjuvant chemo-HER2 therapy in patients with pT1N0 HER2+ BC, HER2 monotherapy was associated with 5-year OS > 90%. Therefore, in select patients who have contraindications for cytotoxic chemotherapy, or decline adjuvant chemotherapy altogether, adjuvant trastuzumab monotherapy appears to be a reasonable alternative.
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Authors: Martine Piccart; Marion Procter; Debora Fumagalli; Evandro de Azambuja; Emma Clark; Michael S Ewer; Eleonora Restuccia; Guy Jerusalem; Susan Dent; Linda Reaby; Hervé Bonnefoi; Ian Krop; Tsang-Wu Liu; Tadeusz Pieńkowski; Masakazu Toi; Nicholas Wilcken; Michael Andersson; Young-Hyuck Im; Ling Ming Tseng; Hans-Joachim Lueck; Marco Colleoni; Estefania Monturus; Mihaela Sicoe; Sébastien Guillaume; José Bines; Richard D Gelber; Giuseppe Viale; Christoph Thomssen Journal: J Clin Oncol Date: 2021-02-04 Impact factor: 44.544
Authors: Reshma Mahtani; Frankie-Ann Holmes; Sunil Badve; Humberto Caldera; Robert Coleman; Eleftherios Mamounas; Kevin Kalinsky; Muaiad Kittaneh; Elyse Lower; Mark Pegram; Michael F Press; Hope S Rugo; Lee Schwartzberg; Charles Vogel Journal: Clin Breast Cancer Date: 2019-08-21 Impact factor: 3.078