• 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, and Dino Amadori.
• Medical Oncology Division, San Filippo Neri Hospital, Unità Operativa Complessa di Oncologia Medica, Azienda Complesso Ospedaliero di Rilevanza Nazionale S. Filippo Neri , Via G. Martinotti, 20-00135 Rome, Italy. gasparini.oncology@tiscalinet.it
• Breast Cancer Res. Treat. 2007 Mar 1; 101 (3): 355-65.

BackgroundA 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 MethodsAmong 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).ResultsPatient 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).ConclusionWeekly paclitaxel plus trastuzumab is highly active and safe and it is superior to paclitaxel alone in patients with IHC score of 3+.

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