Yoshioka Takashi, Sakata Yuh, Terashima Masanori, Sekikawa Kouji, Gamoh Makio, Mitachi Yasushi, Saitoh Soh, Kanamaru Ryunosuke
Department of Clinical Oncology, Institute of Development, Aging and Cancer, Tohoku University, 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan.
Gastric Cancer. 2003;6(3):153-8. doi: 10.1007/s10120-003-0244-5.
Both docetaxel (TXT) and irinotecan (CPT-11) are active chemotherapeutic agents for gastric cancer. We designed a biweekly administration regimen of TXT combined with CPT-11 for 4 weeks as one cycle in patients with inoperable or recurrent gastric cancer, and conducted a dose-escalation study.
Patients with histologically confirmed gastric cancer were treated with the regimen. The dosage levels of TXT and CPT-11 were as follows: level 1, 30 mg/m(2) and 50 mg/m(2); level 2, 35 and 50 mg/m(2); level 3, 40 and 50 mg/m(2); level 4, 40 and 60 mg/m(2); and level 5, 50 and 60 mg/m(2). The dose escalation was based on the dose-limiting toxicity (DLT) observed during the first cycle.
Grade 4 neutropenia was observed at level 3, but no other DLT was observed at less than level 4 during the first cycle. However, three patients at level 3 could not continue treatment without a decrease in the dosage after the second cycle. Based on these results, level 2 was considered to be the clinically recommended dosages.
Biweekly TXT and CPT-11 was well tolerated. The recommended dosages of TXT and CPT-11 for a phase II trial are 35 mg/m(2) and 50 mg/m(2), respectively.
多西他赛（TXT）和伊立替康（CPT-11）都是治疗胃癌的有效化疗药物。我们设计了一种每两周给药一次的方案，将TXT与CPT-11联合使用4周作为一个周期，用于治疗无法手术或复发的胃癌患者，并进行了剂量递增研究。
组织学确诊为胃癌的患者接受该方案治疗。TXT和CPT-11的剂量水平如下：1级，30mg/m²和50mg/m²；2级，35mg/m²和50mg/m²；3级，40mg/m²和50mg/m²；4级，40mg/m²和60mg/m²；5级，50mg/m²和60mg/m²。剂量递增基于第一个周期观察到的剂量限制性毒性（DLT）。
在3级水平观察到4级中性粒细胞减少，但在第一个周期中低于4级水平未观察到其他DLT。然而，3级的3名患者在第二个周期后如果不降低剂量就无法继续治疗。基于这些结果，2级被认为是临床推荐剂量。
每两周一次的TXT和CPT-11耐受性良好。II期试验中TXT和CPT-11的推荐剂量分别为35mg/m²和50mg/m²。
