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Smyth L.M.,Sloan Kettering Cancer Center | Iyengar N.M.,Sloan Kettering Cancer Center | Chen M.F.,Sloan Kettering Cancer Center | Popper S.M.,Sloan Kettering Cancer Center | And 14 more authors.
Breast Cancer Research and Treatment | Year: 2016

We previously reported progression-free survival (PFS) results on a phase II trial of weekly paclitaxel, trastuzumab, and pertuzumab in patients with human epidermal growth factor receptor 2(HER2)–positive metastatic breast cancer (MBC) treated in the first- and second-line setting. Here, we report results for overall survival (OS) and updated PFS after an additional year of follow-up. Patients with HER2-positive MBC with 0–1 prior treatment were eligible. Treatment consisted of paclitaxel (80 mg/m2) weekly, and trastuzumab (loading dose 8 mg/kg → 6 mg/kg) and pertuzumab (loading dose 840 mg → 420 mg) every 3 weeks, all given intravenously. Primary endpoint was 6-month PFS. Secondary endpoints included median PFS, 6-month and median OS. Evaluable patients received at least one full dose of treatment. From January 2011 to December 2013, 69 patients were enrolled: 51 (74 %) and 18 (26 %) treated in first- and second-line metastatic settings, respectively. As of July 1, 2015, the median follow-up was 33 months (range 3–49 months; 67 patients were evaluable for efficacy). The median OS was 44 months (95 % CI 37.5–NR) overall and 44 months (95 % CI 38.3–NR) and 37.5 months (95 % CI 30.3–NR) for patients with 0 and 1 prior metastatic treatment, respectively; 6-month OS was 98 % (95 % CI 90-1). The 6-month PFS was 86 % (95 % CI 75–93) overall and 89 % (95 % CI 76–95) and 78 % (95 % CI 51–91) for patients with 0 and 1 prior therapy, respectively; and median PFS was 21.4 months (95 % CI 14.1–NR) overall and 25.7 months (95 % CI 14.1–NR) and 16.9 months (95 % CI 8.5–NR) for patients with 0–1 prior treatment, respectively. Treatment was well tolerated. Updated analysis demonstrates that weekly paclitaxel, when added to trastuzumab and pertuzumab, is associated with a favorable OS and PFS and offers an alternative to docetaxel-based therapy. http://www.ClinicalTrials.govNCT0127604 © 2016 Springer Science+Business Media New York


PubMed | Sloan Kettering Cancer Center, CLION and NewYork Presbyterian Lawrence Hospital
Type: Journal Article | Journal: Breast cancer research and treatment | Year: 2016

We previously reported progression-free survival (PFS) results on a phase II trial of weekly paclitaxel, trastuzumab, and pertuzumab in patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer (MBC) treated in the first- and second-line setting. Here, we report results for overall survival (OS) and updated PFS after an additional year of follow-up. Patients with HER2-positive MBC with 0-1 prior treatment were eligible. Treatment consisted of paclitaxel (80mg/m(2)) weekly, and trastuzumab (loading dose 8mg/kg6mg/kg) and pertuzumab (loading dose 840mg420mg) every 3weeks, all given intravenously. Primary endpoint was 6-month PFS. Secondary endpoints included median PFS, 6-month and median OS. Evaluable patients received at least one full dose of treatment. From January 2011 to December 2013, 69 patients were enrolled: 51 (74%) and 18 (26%) treated in first- and second-line metastatic settings, respectively. As of July 1, 2015, the median follow-up was 33months (range 3-49months; 67 patients were evaluable for efficacy). The median OS was 44months (95% CI 37.5-NR) overall and 44months (95% CI 38.3-NR) and 37.5months (95% CI 30.3-NR) for patients with 0 and 1 prior metastatic treatment, respectively; 6-month OS was 98% (95% CI 90-1). The 6-month PFS was 86% (95% CI 75-93) overall and 89% (95% CI 76-95) and 78% (95% CI 51-91) for patients with 0 and 1 prior therapy, respectively; and median PFS was 21.4months (95% CI 14.1-NR) overall and 25.7months (95% CI 14.1-NR) and 16.9months (95% CI 8.5-NR) for patients with 0-1 prior treatment, respectively. Treatment was well tolerated. Updated analysis demonstrates that weekly paclitaxel, when added to trastuzumab and pertuzumab, is associated with a favorable OS and PFS and offers an alternative to docetaxel-based therapy. http://www.ClinicalTrials.gov NCT0127604.

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