Weekly paclitaxel with trastuzumab and pertuzumab in patients with HER2-overexpressing metastatic breast cancer: overall survival and updated progression-free survival results from a phase II study

• Published in: Breast cancer research and treatment Vol. 158; no. 1; pp. 91 - 97
• Main Authors: Smyth, L. M., Iyengar, N. M., Chen, M. F., Popper, S. M., Patil, S., Wasserheit-Lieblich, C., Argolo, D. F., Singh, J. C., Chandarlapaty, S., Sugarman, S. M., Comen, E. A., Drullinsky, P. R., Traina, T. A., Troso-Sandoval, T., Baselga, J., Norton, L., Hudis, C. A., Dang, C. T.
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.07.2016; Springer; Springer Nature B.V
• Subjects: Administration, Intravenous; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - metabolism; Cancer metastasis; Cancer research; Cancer therapies; Care and treatment; Chemotherapy; Clinical outcomes; Clinical Trial; Clinical trials; Disease-Free Survival; Drug Administration Schedule; Female; Gene expression; Humans; Medicine; Medicine & Public Health; Metastasis; Middle Aged; Oncology; Paclitaxel - administration & dosage; Paclitaxel - therapeutic use; Patient outcomes; Receptor, ErbB-2 - metabolism; Survival Analysis; Trastuzumab - administration & dosage; Trastuzumab - therapeutic use; Treatment Outcome; HER2 positive; Breast cancer; Metastatic; Pertuzumab; Trastuzumab; Paclitaxel
• ISSN: 0167-6806; 1573-7217
• DOI: 10.1007/s10549-016-3851-7

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/m 2 ) 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.gov NCT0127604