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 Journal Article


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.
Article Title: 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
Abstract: 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
Keywords: paclitaxel; breast cancer; docetaxel; amplification; trastuzumab; erbb2; therapy; metastatic; pertuzumab; women; growth; cardiac safety; her2 positive; plus trastuzumab
Journal Title: Breast Cancer Research and Treatment
Volume: 158
Issue: 1
ISSN: 0167-6806
Publisher: Springer  
Date Published: 2016-07-01
Start Page: 91
End Page: 97
Language: English
ACCESSION: WOS:000379494200010
DOI: 10.1007/s10549-016-3851-7
PROVIDER: wos
PUBMED: 27306421
PMCID: PMC5017157
Notes: Article -- Source: Wos
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MSK Authors
  1. Sujata Patil
    386 Patil
  2. Clifford Hudis
    848 Hudis
  3. Larry Norton
    581 Norton
  4. Chau Dang
    161 Dang
  5. Elizabeth Comen
    47 Comen
  6. Tiffany A Traina
    154 Traina
  7. Neil Mukund Iyengar
    63 Iyengar
  8. Jose T Baselga
    410 Baselga
  9. Jasmeet Chadha Singh
    11 Singh
  10. Lillian   Smyth
    20 Smyth
  11. Melanie Fanny Chen
    6 Chen
  12. Steven Michael Popper
    1 Popper