Randomized Phase II Trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer

Giampietro Gasparini, Massimo Gion, Luigi Mariani, Paola Papaldo, Diana Crivellari, Gianfranco Filippelli, Alessandro Morabito, Vittorio Silingardi, Francesco Torino, Antonella Spada, Matelda Zancan, Livia De Sio, Antonio Caputo, Francesco Cognetti, Antonio Lambiase, Dino Amadori

Research output: Contribution to journalArticlepeer-review

Abstract

Background: A randomized Phase II study evaluated the activity of weekly paclitaxel versus its combination with trastuzumab for treatment of patients with advanced breast cancer overexpressing HER-2. Patients and methods: Among 124 patients randomized, 123 are assessable for toxicity and 118 for response. Patients received weekly paclitaxel single agent (80 mg/m2) or combined with trastuzumab (4 mg/kg loading dose, then weekly 2 mg/kg). HER-2 overexpression was determined by immunohistochemistry (IHC). Patients with 2+/3+ IHC scores were eligible. IHC was compared with HER-2 serum extracellular domain (ECD). Results: Patient characteristics were similar in the two arms. Both treatments were feasible and well tolerated with no grade 4 hematologic toxicity. No patient developed cardiac toxicity. The combined treatment was statistically significant superior for overall response rate (ORR) (75% vs. 56.9%; P = 0.037), particularly in the subset of IHC 3+ patients (84.5% vs. 47.5%; P = 0.00050). A statistically significant better median time to progression was seen in the subgroup with IHC 3+ (369 vs. 272 days; P = 0.030) and visceral disease (301 vs. 183 days; P = 0.0080) treated with combination. Multivariable analysis of predictive factors showed that only IHC score retained statistically significant value for ORR (P = 0.0035). Conclusion: Weekly paclitaxel plus trastuzumab is highly active and safe and it is superior to paclitaxel alone in patients with IHC score of 3+.

Original languageEnglish
Pages (from-to)355-365
Number of pages11
JournalBreast Cancer Research and Treatment
Volume101
Issue number3
DOIs
Publication statusPublished - Mar 2007

Keywords

  • Breast cancer
  • Paclitaxel
  • Trastuzumab

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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