AIM OF THE STUDY: In this report we describe experience with gemcitabine-docetaxel in pediatric patients with relapsed or refractory sarcomas. PATIENTS AND METHODS: Ten relapsed/refractory pediatric sarcoma patients including 6 Ewing sarcoma, 2 synovial sarcoma, 1 osteosarcoma, and 1 undifferentiated sarcoma, were treated prospectively, in an outpatient setting, with gemcitabine 1000 mg/m over 90 minutes on day 1 and 8, and docetaxel 100 mg/m over 2 to 4 hours on day 8 of a 21-day cycle, as an investigational rescue therapy. RESULTS: The patients (ages 4 to 18) received a total of 70 cycles of therapy (median 6 cycles; range: 4 to 10 y). All symptomatic patients responded clinically to the new regimen. By Response Evaluation Criteria in Solid Tumors criteria, 4 (40%) patients had a complete response (CR), 1 (10%) had a partial response (PR), 3 (30%) had stable disease (SD), and 2 (20%) had a progressive disease (PD), which provides an objective response rate (CR+PR) of 50%. Median duration of response (CR+PR+SD) was 10 months (range: 6 to 32+ mo). Five out of the 10 patients (50%) are alive, with a median follow-up of 48 months from diagnosis. Mild toxicities (no grades 3 to 4) were encountered and managed in the ambulatory setting. CONCLUSIONS: The gemcitabine-docetaxel regimen demonstrated antitumor activity against advanced pediatric (mainly Ewing) sarcomas, allowing for good quality of life. Evaluation in a large, formal phase 2 trials for Ewing patients is ongoing.
AIM OF THE STUDY: In this report we describe experience with gemcitabine-docetaxel in pediatric patients with relapsed or refractory sarcomas. PATIENTS AND METHODS: Ten relapsed/refractory pediatric sarcomapatients including 6 Ewing sarcoma, 2 synovial sarcoma, 1 osteosarcoma, and 1 undifferentiated sarcoma, were treated prospectively, in an outpatient setting, with gemcitabine 1000 mg/m over 90 minutes on day 1 and 8, and docetaxel 100 mg/m over 2 to 4 hours on day 8 of a 21-day cycle, as an investigational rescue therapy. RESULTS: The patients (ages 4 to 18) received a total of 70 cycles of therapy (median 6 cycles; range: 4 to 10 y). All symptomatic patients responded clinically to the new regimen. By Response Evaluation Criteria in Solid Tumors criteria, 4 (40%) patients had a complete response (CR), 1 (10%) had a partial response (PR), 3 (30%) had stable disease (SD), and 2 (20%) had a progressive disease (PD), which provides an objective response rate (CR+PR) of 50%. Median duration of response (CR+PR+SD) was 10 months (range: 6 to 32+ mo). Five out of the 10 patients (50%) are alive, with a median follow-up of 48 months from diagnosis. Mild toxicities (no grades 3 to 4) were encountered and managed in the ambulatory setting. CONCLUSIONS: The gemcitabine-docetaxel regimen demonstrated antitumor activity against advanced pediatric (mainly Ewing) sarcomas, allowing for good quality of life. Evaluation in a large, formal phase 2 trials for Ewingpatients is ongoing.
Authors: Ya Zhang; Jingqing Yang; Na Zhao; Cao Wang; Santosh Kamar; Yonghong Zhou; Zewei He; Jifei Yang; Bin Sun; Xiaoqian Shi; Lei Han; Zuozhang Yang Journal: Oncol Lett Date: 2018-09-12 Impact factor: 2.967
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