POFv.s.IF一线治疗晚期胃癌Ⅱb期临床研究课件.pptVIP

POF v.s. IF一线治疗晚期胃癌Ⅱb期临床研究 福建省肿瘤医院内科 林榕波 FOLFOX RR 38％－45％ OS 8.6－11.2个月 毒性可以接受 有效率（IIa期） 生存曲线（IIa期，N＝27） 治疗相关毒性 V325DCF v.s. CF Cutsem EV,et al. J Clin Oncol 24:4991-4997. 2006 MST 小于10个月 延长生存时间小于1个月 毒性显著 PAC/FU v.s. DOC/FU REAL-2 FLO v.s. FLP 奥沙利铂能增强紫杉醇在胃癌细胞株上的杀瘤作用 POF v.s. IF IIb期病人特征[例(%)] POF v.s. IF IIb期有效率及生存率 POF v.s. IF IIb期治疗相关的毒性[例(%)] POF v IF 多中心随机III期临床研究 An open question remains in the interpretation of these results. The MST of the DCF arm was less than 10 months and survival improvement was less than 1 month as compared with CF, despite substantial toxicity. These facts cause many investigators to hesitate in accepting this regimen as the standard treatment. However, this study clearly demonstrated the efficacy of docetaxel, and this agent should constitute part of the frontline therapies for advanced gastric cancer. 他为什么会在2006年四月份通过FDA批准？These efficacy results with DCF are particularly important given that a new drug has not been approved for the treatment of advanced gastric cancer in the last 20 years and, of the few randomized trials performed, nearly all have been disappointing 5-9 (mostly due to poor efficacy). V325也认为：DCF should be considered as one of the reference regimens. But the quest to find more active combinations must continue. To make considerable improvements in the coveted end points (particularly, OS), the addition of targeted agents to active chemotherapy will be required. Such efforts could lead to a prolongation of TTP beyond 6 months and OS beyond 12 months, more consistently. Grade 3 to 4 neutropenia was more frequent with DCF, as was complicated neutropenia (febrile neutropenia or neutropenic infection: 29% with DCF and 12% with CF). In the DCF arm, complicated neutropenia was 27% without and 12% with the use of secondary granulocyte colony-stimulating factor prophylaxis. In patients age 65 years or older, grade 3 to 4 infection (related to treatment) was more frequent with DCF (20%) than CF (9%). The number o