BACKGROUND: Docetaxel and gemcitabine are active against breast cancer. The purpose of this phase II study was to evaluate the efficacy and safety of monthly docetaxel combined with weekly gemcitabine in patients with chemotherapy-pretreated metastatic breast cancer. PATIENTS AND METHODS: Thirty-nine patients were enrolled, of whom thirty had received prior chemotherapy in the adjuvant setting, seven for metastatic disease, and two for both, including prior anthracycline in 33 patients. Treatment was gemcitabine 800 mg/m2 days 1, 8, 15 and docetaxel 100 mg/M2 on day 1, with cycles repeated every four weeks. RESULTS: Response rate was 79% (95% confidence interval (CI): 63%-91%), with 2 complete and 29 partial responses. Twenty-five of the responders remained progression-free for more than six months. Median survival was 24.5 months. Delivered dose intensity of gemcitabine was lower than expected (63% of planned). The predominant hematologic toxicity was grade 4 neutropenia in 36 patients, complicated by fever in three patients. With the exception of asthenia, severe non-hematological toxicities were infrequent. CONCLUSIONS: Monthly docetaxel, combined with weekly gemcitabine, has significant but manageable hematologic toxicity. Despite frequent dose adjustments, this doublet is very active in metastatic breast cancer, producing a high proportion of durable responses associated with favorable survival.
BACKGROUND:Docetaxel and gemcitabine are active against breast cancer. The purpose of this phase II study was to evaluate the efficacy and safety of monthly docetaxel combined with weekly gemcitabine in patients with chemotherapy-pretreated metastatic breast cancer. PATIENTS AND METHODS: Thirty-nine patients were enrolled, of whom thirty had received prior chemotherapy in the adjuvant setting, seven for metastatic disease, and two for both, including prior anthracycline in 33 patients. Treatment was gemcitabine 800 mg/m2 days 1, 8, 15 and docetaxel 100 mg/M2 on day 1, with cycles repeated every four weeks. RESULTS: Response rate was 79% (95% confidence interval (CI): 63%-91%), with 2 complete and 29 partial responses. Twenty-five of the responders remained progression-free for more than six months. Median survival was 24.5 months. Delivered dose intensity of gemcitabine was lower than expected (63% of planned). The predominant hematologic toxicity was grade 4 neutropenia in 36 patients, complicated by fever in three patients. With the exception of asthenia, severe non-hematological toxicities were infrequent. CONCLUSIONS: Monthly docetaxel, combined with weekly gemcitabine, has significant but manageable hematologic toxicity. Despite frequent dose adjustments, this doublet is very active in metastatic breast cancer, producing a high proportion of durable responses associated with favorable survival.
Authors: Min-Young Lee; Ki Sun Jung; Hae Su Kim; Ji Yun Lee; Sung Hee Lim; Moonjin Kim; Hyun Ae Jung; Sung Min Kim; Jong Mu Sun; Myung-Ju Ahn; Jeeyun Lee; Se Hoon Park; Seong Yoon Yi; In Gyu Hwang; Sang-Cheol Lee; Hee Kyung Ahn; Do Hyoung Lim; Soon Il Lee; Keon Woo Park Journal: World J Gastroenterol Date: 2015-04-14 Impact factor: 5.742
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: 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