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

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

Source: Breast Cancer Research and Treatment, Volume 101, Number 3, March 2007 , pp. 355-365(11)

Publisher: Springer

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Abstract:

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.

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).

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).

Weekly paclitaxel plus trastuzumab is highly active and safe and it is superior to paclitaxel alone in patients with IHC score of 3+.

Keywords: Breast cancer; Trastuzumab; Paclitaxel

Document Type: Research article

DOI: http://dx.doi.org/10.1007/s10549-006-9306-9

Affiliations: 1: Email: gasparini.oncology@tiscalinet.it

Publication date: 2007-03-01

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

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