Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Cancer Chemother Pharmacol. 2011 Sep;68(3):611-7. doi: 10.1007/s00280-010-1529-0. Epub 2010 Nov 30.
This single-arm, phase II clinical study evaluated the efficacy and safety of sequential treatment with S-1 followed by cisplatin in patients with advanced or recurrent gastric cancer.
Fifty patients with histologically confirmed advanced or recurrent gastric cancer and an Eastern Cooperative Oncology Group performance status of 0-2 who had measurable and/or assessable lesions and gave written informed consent were enrolled. S-1 (40 mg/m(2), bid) was administered on days 1-21, and cisplatin (70 mg/m(2)) was given as an intravenous infusion on day 22 of a 35-day cycle. Treatment was continued until disease progression or intolerable adverse events. Cisplatin was administered for 6 cycles. Adverse events were assessed according to Common Terminology Criteria of Adverse Events version 3.0, and efficacy was evaluated according to the Response Evaluation Criteria in Solid Tumors version 1.0 for patients with measurable lesions and by the criteria of the Japanese Research Society for Gastric Cancer for all patients.
Efficacy could be evaluated in 49 of the 50 enrolled patients. The median age was 62 years. Lesions were measurable in 38 patients and assessable in 11. The response rate was 44.7% in patients with measurable lesions and 40.8% overall. The progression-free survival and overall survival were, respectively, 233 days (7.8 months) and 574 days (19.0 months) in patients with measurable lesions and 192 days (6.4 months) and 402 days (13.4 months) overall. Serious adverse events (grade 3 or higher) included neutropenia (24.5%), anemia (20.4%), and anorexia (20.4%) and were safely managed.
The safety and effectiveness of sequential treatment with S-1 followed by cisplatin every 35 days is equivalent to that reported for conventional chemotherapeutic regimens in patients with advanced or recurrent gastric cancer.
这项单臂、二期临床研究评估了 S-1 序贯顺铂治疗晚期或复发性胃癌患者的疗效和安全性。
50 例组织学证实的晚期或复发性胃癌患者，ECOG 表现状态为 0-2 分，有可测量和/或可评估的病变，并签署书面知情同意书，入组本研究。S-1（40mg/m²，bid）于第 1-21 天给药，顺铂（70mg/m²）于第 22 天 35 天周期内静脉输注。治疗持续至疾病进展或不可耐受的不良反应。顺铂共给药 6 个周期。根据不良事件通用术语标准 3.0 评估不良事件，根据实体瘤反应评价标准 1.0 评估可测量病变患者的疗效，并根据日本胃癌研究协会的标准评估所有患者的疗效。
50 例入组患者中 49 例可评估疗效。中位年龄为 62 岁。38 例患者的病变可测量，11 例患者的病变可评估。可测量病变患者的缓解率为 44.7%，总体缓解率为 40.8%。可测量病变患者的无进展生存期和总生存期分别为 233 天（7.8 个月）和 574 天（19.0 个月），总体分别为 192 天（6.4 个月）和 402 天（13.4 个月）。严重不良事件（3 级或以上）包括中性粒细胞减少症（24.5%）、贫血（20.4%）和厌食（20.4%），并得到了安全管理。
S-1 序贯顺铂每 35 天治疗晚期或复发性胃癌的安全性和有效性与传统化疗方案相当。
