Details

Autor(en) / Beteiligte

• Burstein, Harold J.
• Keshaviah, Aparna
• Baron, Ari D.
• Hart, Ronald D.
• Lambert‐Falls, Rosemary
• Marcom, P. Kelly
• Gelman, Rebecca
• Winer, Eric P.

Titel

Trastuzumab plus vinorelbine or taxane chemotherapy for HER2‐overexpressing metastatic breast cancer: The trastuzumab and vinorelbine or taxane study

Ist Teil von

• Cancer, 2007-09, Vol.110 (5), p.965-972

Ort / Verlag

Hoboken: Wiley Subscription Services, Inc., A Wiley Company

Erscheinungsjahr

2007

Quelle

Wiley-Blackwell Journals

Beschreibungen/Notizen

• BACKGROUND. The optimal trastuzumab‐based chemotherapy regimen for HER2‐overexpressing, metastatic breast cancer is not known. The trastuzumab and vinorelbine or taxane (TRAVIOTA) study was a prospective, multicenter, randomized trial that was designed to compare these regimens. METHODS. Eligible patients had HER2‐overexpressing, metastatic breast cancer and had received no prior chemotherapy for advanced disease. Patients were randomized 1:1 to receive either trastuzumab with weekly vinorelbine therapy or weekly taxane therapy (paclitaxel or docetaxel at the investigator's choice). Originally planned for 250 patients, the study was closed because of poor accrual with 81 evaluable patients, including 41 patients who received vinorelbine and 40 patients who received taxane. RESULTS. Response rates were 51% and 40% for the vinorelbine/trastuzumab arm and the taxane/trastuzumab arm, respectively (Fisher exact test; P = .37). The median time to disease progression was 8.5 months and 6.0 months for the vinorelbine‐ and taxane‐based arms, respectively (log‐rank test; P = .09). Treatment with either regimen generally was well tolerated, yielding comparable rates of neurologic and gastrointestinal toxicity. Vinorelbine‐based treatment was associated with more anemia and neutropenia and with 2 episodes of cardiotoxicity. Taxane‐based therapy was associated with more dermatologic toxicity, myalgias, and fluid retention. CONCLUSIONS. Both vinorelbine/trastuzumab and taxane/trastuzumab treatments were active as first‐line therapy for HER2‐positive, metastatic breast cancer and had comparable rates of efficacy and tolerability. The toxicities observed were the result of recognized side effects associated with each of the chemotherapy agents and schedules. These data can inform treatment decision making in this clinical setting. Cancer 2007. © 2007 American Cancer Society. Based on data from the trastuzumab and vinorelbine or taxane (TRAVIOTA) study, the authors determined that treating clinicians and their patients with breast cancer may select single‐agent chemotherapy/trastuzumab regimens based on likely their efficacy and side‐effect outcomes. The data from the TRAVIOTA trial support the ongoing development of vinca‐ and taxane‐based chemotherapy treatments paired with anti‐HER2 therapy in the management of early‐ and late‐stage, HER2‐overexpressing breast cancer.