*=pathological complete response, which is felt to be a surrogate (substitute) for efficacy
Their assertion is that it only holds for her2+s that are also ER+ ie those Luminal B tumors that are ER+, but only 56 patients were enrolled-- this study definitely needs to be repeated on more patients
Weekly Paclitaxel/Carboplatin/Trastuzumab Therapy Improves Pathologic Complete Remission in Aggressive HER2-Positive Breast Cancers, Especially in Luminal-B Subtype, Compared With a Once-Every-3-Weeks Schedule
Ke-Da Yu, Guang-Yu Liu, Can-Ming Chen, Jian-Wei Li, Jiong Wu, Jin-Song Lu, Zhen-Zhou Shen and Zhi-Ming Shao
+ Author Affiliations
Department of Breast Surgery, Cancer Center and Cancer Institute, Shanghai Medical College, Fudan University, Shanghai, China
Correspondence: Zhi-Ming Shao, M.D., Department of Breast Surgery, Cancer Center and Cancer Institute, Shanghai Medical College, Fudan University, 399 Ling-Ling Road, Shanghai, 200032, China. Telephone: +86-21-64175590-8807; Fax: +86-21-64434556; E-Mail:
zhimingshao@yahoo.com
Received February 6, 2012.
Accepted March 12, 2013.
First published online in THE ONCOLOGIST Express on May 1, 2013.
Disclosures of potential conflicts of interest may be found at the end of this article.
Abstract
Background. The efficacy and tolerability of two different schedules of paclitaxel, carboplatin, and trastuzumab (PCarH) for HER2-positive, locally aggressive (stage IIB–IIIC) breast cancers were evaluated in this phase II trial.
Methods. Patients were randomly assigned to receive either weekly (12 doses over 16 weeks) or once-every-3-weeks (4 doses over 12 weeks) treatment. The primary endpoint was pathologic complete remission (pCR) in the breast and axilla. To detect an assumed 35% pCR absolute difference between the two schedules, a minimum of 26 assessable patients in each group was required (two-sided α = 0.05, β = 0.2).
Results. A total of 56 patients were enrolled (weekly group, n = 29; every-3-weeks group, n = 27). In the intent-to-treat analysis, pCR in the breast/axilla were found in 31 patients (55%; 95% confidence interval [CI]: 41%–69%). Compared with the every-3-weeks schedule, the weekly administration achieved higher pCR (41% vs. 69%; p = .03). After adjustment for clinical and pathological factors, the weekly administration was more effective than the every-3-weeks schedule, with hazard ratio of 0.3 (95% CI: 0.1–0.9; p = .03). Interestingly, weekly administration resulted in high pCR rates in both luminal-B (HER2-positive) and ERBB2+ tumors (67% vs. 71%; p = .78), whereas luminal-B (HER2-positive) tumors benefited less from the every-3-weeks schedule compared with the ERBB2+ tumors (21% vs. 62%, p = .03). These results remain after multivariate adjustment, showing weekly administration was more effective in the luminal-B (HER2-positive) subgroup (p = .02) but not in the ERBB2+ subgroup (p = .50).
Conclusion. A more frequent administration might improve the possibility of eradicating invasive cancer in the breast and axilla, especially in the luminal-B (HER2-positive) subtype. Further studies to validate our findings are warranted.
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