Phase II study of paclitaxel given once per week along with trastuzumab and pertuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer

Chau Dang, Neil Iyengar, Farrah Datko, Gabriella D'Andrea, Maria Theodoulou, Maura Dickler, Shari Goldfarb, Diana Lake, Julie Fasano, Monica Fornier, Theresa Gilewski, Shanu Modi, Devika Gajria, Mary Ellen Moynahan, Nicola Hamilton, Sujata Patil, Maxine Jochelson, Larry Norton, Jose Baselga, Clifford Hudis

Research output: Contribution to journalArticlepeer-review

65 Scopus citations

Abstract

Purpose: The CLEOPATRA (Clinical Evaluation of Trastuzumab and Pertuzumab) study demonstrated superior progression-free survival (PFS) and overall survival when pertuzumab was added to trastuzumab and docetaxel. Paclitaxel given once per week is effective and less toxic than docetaxel. We performed a phase II study to evaluate the efficacy and safety of pertuzumab and trastuzumab with paclitaxel given once per week. Patients and Methods: Patients with metastatic human epidermal growth factor receptor 2-positive breast cancer with zero to one prior therapy were enrolled. Treatment consisted of paclitaxel 80 mg/m2 once per week plus trastuzumab (8 mg/kg loading dose 虠 6 mg/kg) once every 3 weeks plus pertuzumab (840 mg loading dose 虠 420 mg) once every 3 weeks, all given intravenously. The primary end point was 6-month PFS assessed by Kaplan-Meier methods. Results: From January 2011 to December 2013, we enrolled 69 patients: 51 (74%) and 18 (26%) treated in first- and second-line metastatic settings, respectively. At a median follow-up of 21 months (range, 3 to 38 months), 6-month PFS was 86% (95% CI, 75% to 92%). The median PFS was 19.5 months (95% CI, 14 to 26 months) overall. PFS was 24.2 months (95% CI, 14 months to not reached [NR]) and 16.4 months (95% CI, 8.5 months to NR) for those without and with prior treatment, respectively. At 1 year, Kaplan-Meier PFS was 70% (95% CI, 56% to 79%) overall, 71% (95% CI, 55% to 82%) for those without prior therapy, and 66% (95% CI, 40% to 83%) for those with prior therapy. Treatment was well-tolerated; there was no febrile neutropenia or symptomatic left ventricular systolic dysfunction. Conclusion: Paclitaxel given once per week with trastuzumab and pertuzumab is highly active and well tolerated and seems to be an effective alternative to docetaxel-based combination therapy.

Original languageEnglish
Pages (from-to)442-447
Number of pages6
JournalJournal of Clinical Oncology
Volume33
Issue number5
DOIs
StatePublished - 10 Feb 2015
Externally publishedYes

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