Berenberg J L, Tangen C, Macdonald J S, Barlogie B, Laufman L R
Cancer Research Center of Hawaii, Honolulu.
Invest New Drugs. 1993 Nov;11(4):333-4. doi: 10.1007/BF00874433.
The Southwest Oncology Group conducted a trial of VM-26 (teniposide) in patients with advanced gastric cancer. VM-26 60 mg/m2 i.v. infusion over 30-45 minutes was given daily for 5 days every 21 days. Twenty-one eligible patients with measurable disease and a SWOG performance status of 0-2 were analyzed for response and toxicity. Partial responses were seen in 2 of the 21 eligible patients (9.5%). Median survival was 3.8 months. Severe of life-threatening toxicity was observed in 13/21 (62%) patients. This included two drug related deaths related to neutropenic sepsis and seven other patients with grade 4 granulocytopenia (< 500/mm3). Liver dysfunction and hypotension were seen less often and were not dose limiting. Although the modest activity seen was comparable to that of VP-16 (etoposide) as a single agent, the hematologic toxicity observed in this trial would likely preclude further trials of VM-26 (teniposide) in advanced gastric cancer.
西南肿瘤协作组对晚期胃癌患者进行了一项关于VM - 26(替尼泊苷)的试验。每21天为一个周期,每天静脉输注VM - 26 60 mg/m²,持续30 - 45分钟,共5天。对21例符合条件、具有可测量病灶且西南肿瘤协作组体能状态评分为0 - 2的患者进行了疗效和毒性分析。21例符合条件的患者中有2例(9.5%)出现部分缓解。中位生存期为3.8个月。13/21(62%)的患者出现严重或危及生命的毒性反应。这包括2例与中性粒细胞减少性败血症相关的药物相关死亡以及另外7例4级粒细胞减少(< 500/mm³)的患者。肝功能障碍和低血压较少见,且不是剂量限制性毒性。尽管观察到的适度疗效与单药VP - 16(依托泊苷)相当,但该试验中观察到的血液学毒性可能会排除VM - 26(替尼泊苷)在晚期胃癌中进一步试验的可能性。