Chemotherapy with gemcitabine, cisplatin, and docetaxel in the treatment for patients with muscle-invasive bladder cancer: a multicenter phase II study of the Hellenic Oncology Research Group (HORG) |
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Authors: | Ioannis Boukovinas Nikolaos Androulakis Nikolaos Kentepozidis Aris Polyzos Pavlos Papakotoulas Nikolaos Ziras Athanasios Kotsakis Nikolaos Vardakis Athanasios Karampeazis Vassilis Markos Athanasios Kostakopoulos Constantine A Constantinides George Samonis Dimitris Mavroudis Vassilis Georgoulias |
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Institution: | 1. Hellenic Oncology Research Group (HORG), 55 Lomvardou str, 11740, Athens, Greece 2. 2nd Department of Medical Oncology, ??Theagenion?? Anticancer Hospital, 2 Symeonidou str, 54639, Thessaloniki, Greece
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Abstract: | Purpose To assess the antitumor activity and toxicity of gemcitabine, cisplatin, and docetaxel (GCD) regimen in patients with locally advanced or metastatic urothelial cancer. Patient and methods Chemotherapy-na?ve patients, aged ??70?years with measurable or evaluable disease and a performance status (PS) of 0?C2 were treated with sequential cisplatin 80?mg/m2 (d1), gemcitabine 1,100?mg/m2 (d1 and d14), and docetaxel 80?mg/m2 (d14) every 28?days. Results Sixty patients with an ECOG PS of 0?C2 were enroled. Most (71.7%) patients had stage IV disease. A median number of 4 chemotherapy cycles per patient (range, 1?C9) was administered. Eight (13.3%) patients achieved a CR and 16 (26.7%) a partial response (PR) (intention-to-treat: ORR 40%; 95% CI 27.6?C52.4%). Thirteen (21.7%) and 23 (38.3%) patients experienced stable and progressive disease, respectively. The median time to progression (TTP) was 7.7?months (range, 0.7?C43.4), and the median overall survival 21.4?months (range, 0.7?C68.6). Grade 3 and 4 neutropenia occurred in 27 (45%) patients and grade 3 and 4 thrombocytopenia in five (8.3%). Three (5%) patients developed febrile neutropenia. There were no treatment-related deaths. Severe non-haematological toxicity was infrequent. Conclusions The GCD combination is an active and well-tolerated regimen in patients with chemotherapy-naive locally advanced or metastatic TCC and merits to be further investigated. |
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