Open AccessWeekly 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
Author(s) -
Yu KeDa,
Liu GuangYu,
Chen CanMing,
Li JianWei,
Wu Jiong,
Lu JinSong,
Shen ZhenZhou,
Shao ZhiMing
Publication year - 2013
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2012-0057
Subject(s) - medicine , trastuzumab , carboplatin , hazard ratio , tolerability , axilla , gastroenterology , breast cancer , paclitaxel , lapatinib , confidence interval , clinical endpoint , oncology , clinical trial , chemotherapy , cancer , adverse effect , cisplatin
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.