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 Journal Article


Authors: Dang, C.; Iyengar, N.; Datko, F.; D'Andrea, G.; Theodoulou, M.; Dickler, M.; Goldfarb, S.; Lake, D.; Fasano, J.; Fornier, M.; Gilewski, T.; Modi, S.; Gajria, D.; Moynahan, M. E.; Hamilton, N.; Patil, S.; Jochelson, M.; Norton, L.; Baselga, J.; Hudis, C.
Article Title: 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
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.
Keywords: adult; controlled study; aged; middle aged; major clinical study; overall survival; drug tolerability; fatigue; cancer combination chemotherapy; diarrhea; drug efficacy; drug safety; side effect; treatment duration; paclitaxel; cancer adjuvant therapy; cancer patient; outcome assessment; follow up; anorexia; progression free survival; drug eruption; multiple cycle treatment; phase 2 clinical trial; sensory neuropathy; mucosa inflammation; peripheral neuropathy; epidermal growth factor receptor 2; furosemide; alanine aminotransferase blood level; arthralgia; aspartate aminotransferase blood level; coughing; dyspnea; loading drug dose; alanine aminotransferase; aspartate aminotransferase; heart failure; acne; peripheral edema; hot flush; kaplan meier method; trastuzumab; breast metastasis; dyspepsia; hand foot syndrome; dry skin; alopecia; epistaxis; pertuzumab; lisinopril; carvedilol; left ventricular systolic dysfunction; human; female; priority journal; article; xerophthalmia
Journal Title: Journal of Clinical Oncology
Volume: 33
Issue: 5
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2015-02-10
Start Page: 442
End Page: 447
Language: English
DOI: 10.1200/jco.2014.57.1745
PROVIDER: scopus
PUBMED: 25547504
PMCID: PMC5747317
DOI/URL:
Notes: Export Date: 2 March 2015 -- Source: Scopus
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Citation Impact
MSK Authors
  1. Sujata Patil
    441 Patil
  2. Mary Ellen Moynahan
    104 Moynahan
  3. Clifford Hudis
    891 Hudis
  4. Larry Norton
    660 Norton
  5. Chau Dang
    195 Dang
  6. Diana E Lake
    77 Lake
  7. Maura N Dickler
    252 Dickler
  8. Farrah Mikhail Datko
    9 Datko
  9. Monica Nancy Fornier
    143 Fornier
  10. Devika Gajria
    27 Gajria
  11. Shanu Modi
    161 Modi
  12. Julie Fasano
    10 Fasano
  13. Neil Mukund Iyengar
    80 Iyengar
  14. Jose T Baselga
    461 Baselga