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Front-Line Chemotherapy with Docetaxel and Gemcitabine Administered Every Two Weeks in Patients with Metastatic Breast Cancer: A Multicenter Phase II StudyMavroudis D.a · Malamos N.b · Polyzos A.c · Kouroussis C.a · Christophilakis C.d · Varthalitis I.e · Androulakis N.a · Kalbakis K.a · Milaki G.a · Georgoulias V.a
aDepartment of Medical Oncology, University General Hospital of Heraklion, Crete, bOncology Unit of ‘Marika Heliadis’ Hospital of Athens, cFirst Department of Propedeutic Medicine, Laikon Hospital, dMedical Oncology Unit, 401 Military Hospital of Athens, Athens, and eMedical Oncology Unit, General Hospital of Chania, Crete, Greece
Objective: To evaluate the docetaxel-gemcitabine combination administered every 2 weeks in women with untreated metastatic breast cancer (MBC). Methods: Fifty-two patients with MBC received docetaxel 65 mg/m2 as front-line chemotherapy intravenously over 1 h followed by gemcitabine 1,500 mg/m2 intravenously over 30 min on days 1 and 14. Cycles were repeated every 28 days without prophylactic growth factor support. Twenty-eight (54%) patients had previously received chemotherapy as adjuvant or neoadjuvant treatment. Thirty-six (69%) patients had visceral disease including 20 (38%) with liver metastases. All patients were evaluated for toxicity and 45 for response. Results: In an intention-to-treat analysis, a complete response occurred in 7 (13%) patients and partial response in 24 (46%) for an overall response rate of 59% (95% CI: 46.3–73.0%). The response rate was 68% for the 28 patients who had previously received adjuvant or neoadjuvant chemotherapy and 67% for the 36 patients with visceral metastases. The median duration of response was 6.1 months and the median time to disease progression 10.9 months. A total of 254 cycles were administered with dose reduction in 26 (10%) cycles and no lethal toxicity. Grade III–IV neutropenia occurred in 17 (33%) patients and thrombocytopenia in 3 (6%). Febrile neutropenia developed in 3 (6%) patients. Nonhematological toxicity was generally mild. Conclusion: The docetaxel-gemcitabine combination is an active and well-tolerated front-line treatment for patients with MBC. This regimen represents a suitable option especially for women relapsing after anthracycline-based adjuvant chemotherapy.
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