PURPOSE: The activity of the docetaxel-gemcitabine combination in women with disease progression after initial chemotherapy for metastatic breast cancer (MBC) was investigated in a multicenter phase II study. PATIENTS AND METHODS: Fifty-two patients with metastatic breast cancer who had disease relapse or progression after completion of an anthracycline-based front-line regimen were treated with gemcitabine 900 mg/m2 on day 1 and day 8 and docetaxel 100 mg/m2 on day 8. G-CSF 150 mucg/m2/d s.c. was given from day 9 to day 16 and the treatment was repeated every three weeks. The patients' median age was 57 years and the performance status (WHO) was 0 for 26, 1 for 20 and 2 for 6 patients. The treatment was second-line for 27 (52%) and > or = third-line for 25 (48%) patients. All patients were evaluable for response and toxicity. RESULTS: Complete response occurred in seven (14%) patients and partial response in 21 (40%) for an overall response rate of 54% (95% confidence interval (95% CI): 40%-67%). Fifteen (29%) patients had stable disease and nine (17%) progressive disease. Of 25 patients previously treated with taxanes. 11 (44%) responded (1 CR, 10 PR). Interestingly, in four patients with disease progression while receiving docetaxel or paclitaxel monotherapy, the docetaxel + gemcitabine combination achieved partial responses. Responses were observed at all metastatic sites (local disease 62%, lymph nodes 58%, skin 44%, lung 47% and liver 36%) with a median duration of response of 3.6 months (range 1-16) and a median time to disease progression of eight months (range 2-18.5). Grade 3 neutropenia developed in 10 (19%) and grade 4 in five (10%) patients. Neutropenia was associated with infection in four patients without toxic deaths. Grade 3 thrombocytopenia developed in nine (17%) patients and grade 4 in two (4%). Non-hematologic toxicity was usually mild. CONCLUSION: The docetaxel-gemcitabine combination is an active and well tolerated salvage treatment in patients with MBC. Previous treatment with taxanes does not preclude a good clinical response to this regimen.
PURPOSE: The activity of the docetaxel-gemcitabine combination in women with disease progression after initial chemotherapy for metastatic breast cancer (MBC) was investigated in a multicenter phase II study. PATIENTS AND METHODS: Fifty-two patients with metastatic breast cancer who had disease relapse or progression after completion of an anthracycline-based front-line regimen were treated with gemcitabine 900 mg/m2 on day 1 and day 8 and docetaxel 100 mg/m2 on day 8. G-CSF 150 mucg/m2/d s.c. was given from day 9 to day 16 and the treatment was repeated every three weeks. The patients' median age was 57 years and the performance status (WHO) was 0 for 26, 1 for 20 and 2 for 6 patients. The treatment was second-line for 27 (52%) and > or = third-line for 25 (48%) patients. All patients were evaluable for response and toxicity. RESULTS: Complete response occurred in seven (14%) patients and partial response in 21 (40%) for an overall response rate of 54% (95% confidence interval (95% CI): 40%-67%). Fifteen (29%) patients had stable disease and nine (17%) progressive disease. Of 25 patients previously treated with taxanes. 11 (44%) responded (1 CR, 10 PR). Interestingly, in four patients with disease progression while receiving docetaxel or paclitaxel monotherapy, the docetaxel + gemcitabine combination achieved partial responses. Responses were observed at all metastatic sites (local disease 62%, lymph nodes 58%, skin 44%, lung 47% and liver 36%) with a median duration of response of 3.6 months (range 1-16) and a median time to disease progression of eight months (range 2-18.5). Grade 3 neutropenia developed in 10 (19%) and grade 4 in five (10%) patients. Neutropenia was associated with infection in four patients without toxic deaths. Grade 3 thrombocytopenia developed in nine (17%) patients and grade 4 in two (4%). Non-hematologic toxicity was usually mild. CONCLUSION: The docetaxel-gemcitabine combination is an active and well tolerated salvage treatment in patients with MBC. Previous treatment with taxanes does not preclude a good clinical response to this regimen.
Authors: Min Kyoung Kim; Sung-Bae Kim; Jin Hee Ahn; Soon Im Lee; Sei-Hyun Ahn; Byung Ho Son; Gyungyub Gong; Hak-Hee Kim; Jung-Shin Lee; Yoon-Koo Kang; Woo Kun Kim Journal: Cancer Res Treat Date: 2006-12-31 Impact factor: 4.679
Authors: L G Estévez; P Sánchez-Rovira; M Dómine; A León; I Calvo; A Jaén; V Casado; G Rubio; M Díaz; C Miró; F Lobo; E Carrasco; M Casillas; B San Antonio Journal: Clin Transl Oncol Date: 2007-05 Impact factor: 3.405
Authors: K Kalbakis; C Kouroussis; S Kakolyris; D Mavroudis; J Souglakos; S Agelaki; L Vamvakas; M Christodoulakis; K Stylianou; V Georgoulias Journal: Br J Cancer Date: 2001-09-14 Impact factor: 7.640
Authors: V Lorusso; E Crucitta; N Silvestris; A Catino; L Caporusso; A Mazzei; M Guida; A Latorre; D Sambiasi; C D'Amico; F Schittulli; P Calabrese; M De Lena Journal: Br J Cancer Date: 2003-02-24 Impact factor: 7.640
Authors: F Cappuzzo; F Mazzoni; A Gennari; S Donati; B Salvadori; C Orlandini; G L Cetto; A Molino; E Galligioni; M Mansutti; S Tumolo; A Lucentini; F Valduga; S Bartolini; L Crinò; P F Conte Journal: Br J Cancer Date: 2004-01-12 Impact factor: 7.640
Authors: A Lortholary; T Delozier; A Monnier; H Bourgeois; P Bougnoux; N Tubiana-Mathieu; J Ch Riffaud; D Besson; V Lotz; E Gamelin Journal: Br J Cancer Date: 2003-06-02 Impact factor: 7.640