Yoshida M, Boku N, Ohtsu A, Muto M, Nagashima F, Yoshida S
Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Gastric Cancer. 2001;4(3):144-9. doi: 10.1007/pl00011737.
A previous phase II study showed that a combination of irinotecan (CPT-11) with cisplatin (CDDP) was effective for advanced gastric cancers, but was associated with substantial neutropenia and diarrhea. The aim of this retrospective study was to evaluate the efficacy and feasibility of the combination in clinical practice.
The subjects comprised 65 patients with advanced gastric cancer treated with CPT-11 (70mg/m2, day 1, day 15) and CDDP (80mg/m2, day 1) as first-line chemotherapy between April 1993 and March 1999. Patient backgrounds, response rates, response durations, times to progression, and survival rates were investigated retrospectively.
The overall response rate and the response rates for measurable metastatic lesions and primary sites were 43% (28/65), 48% (31/64), and 24% (10/42). Leucopenia of grade 4 and diarrhea of grade 3 or 4 were observed in 6 (9%) and 5 (8%) patients, respectively. Among the 19 patients with peritoneal metastasis, leucopenia of grade 4 and diarrhea of grade 3 or 4 were observed in only 1 of the 18 patients who received sufficient oral intake (6%). There were no treatment-related or early deaths within 30 days from the last treatment day. The median survival times of all patients, patients with an intestinal type of adenocarcinoma, and patients with a diffuse type were 365, 472, and 291 days, respectively. Multivariate analysis showed that the histological type of cancer was a significant independent prognostic factor (P = 0.0169).
This retrospective study confirmed the efficacy and feasibility of this combination therapy in clinical practice.
先前的一项II期研究表明，伊立替康（CPT - 11）与顺铂（CDDP）联合应用对晚期胃癌有效，但会导致严重的中性粒细胞减少和腹泻。这项回顾性研究的目的是评估该联合方案在临床实践中的疗效和可行性。
研究对象为1993年4月至1999年3月期间接受CPT - 11（70mg/m²，第1天、第15天）和顺铂（80mg/m²，第1天）作为一线化疗的65例晚期胃癌患者。回顾性调查患者的背景、缓解率、缓解持续时间、疾病进展时间和生存率。
总体缓解率以及可测量转移病灶和原发部位的缓解率分别为43%（28/65）、48%（31/64）和24%（10/42）。分别有6例（9%）患者出现4级白细胞减少，5例（8%）患者出现3级或4级腹泻。在19例有腹膜转移的患者中，18例口服摄入充足的患者中只有1例出现4级白细胞减少和3级或4级腹泻（6%）。自最后治疗日起30天内无治疗相关死亡或早期死亡。所有患者、肠型腺癌患者和弥漫型患者的中位生存时间分别为365天、472天和291天。多因素分析显示癌症的组织学类型是一个显著的独立预后因素（P = 0.0169）。
这项回顾性研究证实了该联合治疗方案在临床实践中的疗效和可行性。
