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
Altmetric Score
MSK Authors
  1. Sujata Patil
    383 Patil
  2. Clifford Hudis
    840 Hudis
  3. Larry Norton
    562 Norton
  4. Chau Dang
    156 Dang
  5. Diana E Lake
    70 Lake
  6. Maura N Dickler
    237 Dickler
  7. Farrah Mikhail Datko
    8 Datko
  8. Monica Nancy Fornier
    136 Fornier
  9. Devika Gajria
    23 Gajria
  10. Shanu Modi
    132 Modi
  11. Julie Fasano
    9 Fasano
  12. Neil Mukund Iyengar
    63 Iyengar
  13. Jose T Baselga
    395 Baselga