Ridwelski K, Gebauer T, Fahlke J, Kröning H, Kettner E, Meyer F, Eichelmann K, Lippert H
Department of Surgery, Otto von Guericke University Medical School, Städtisches Klinikum, Magdeburg, Germany.
Ann Oncol. 2001 Jan;12(1):47-51. doi: 10.1023/a:1008328501128.
Poor treatment results obtained with palliative chemotherapy for advanced gastric cancer indicate the need for new effective and well-tolerated regimens.
Forty-three patients with locally advanced or metastatic gastric cancer were enrolled in a phase II study to evaluate the efficacy and safety of combination chemotherapy with doxetacel 75 mg/m2 and cisplatin 75 mg/m2 given every three weeks.
Thirty-nine patients were evaluable for response. Four achieved a complete response and twelve a partial response, for an overall response rate of 37.2% (16 of 43 patients; 95% confidence interval (CI): 22.98-53.72). Median time to progression was 6.1 months and median overall survival 10.4 months. Forty-two percent of all patients were still alive at one year and twelve percent at two years. The major toxicity was leukopenia which reached grade 3-4 in 18.6% (n = 8) of the patients. However, no febrile neutropenia occurred. Non-haematological toxicities were usually mild to moderate. Grade 3 toxicities included diarrhea (9% of the patients), nausea and vomiting (7%), and alopecia (7%). Severe ototoxicity with or without peripheral neuropathy developed after completion of chemotherapy in two patients.
These results suggest that the combination of docetaxel and cisplatin has moderate toxicity and is an effective regimen for the treatment of advanced gastric cancer, both with regard to response rate and survival.
晚期胃癌姑息化疗的治疗效果不佳，这表明需要新的有效且耐受性良好的治疗方案。
43例局部晚期或转移性胃癌患者参加了一项II期研究，以评估每三周给予多西他赛75mg/m²和顺铂75mg/m²联合化疗的疗效和安全性。
39例患者可评估疗效。4例患者达到完全缓解，12例患者达到部分缓解，总缓解率为37.2%（43例患者中的16例；95%置信区间(CI)：22.98 - 53.72）。中位疾病进展时间为6.1个月，中位总生存期为10.4个月。所有患者中42%在1年时仍存活，12%在2年时仍存活。主要毒性为白细胞减少，18.6%（n = 8）的患者白细胞减少达到3 - 4级。然而，未发生发热性中性粒细胞减少。非血液学毒性通常为轻度至中度。3级毒性包括腹泻（9%的患者）、恶心和呕吐（7%）以及脱发（7%）。两名患者在化疗完成后出现了伴有或不伴有周围神经病变的严重耳毒性。
这些结果表明，多西他赛和顺铂联合化疗毒性中等，在缓解率和生存期方面都是治疗晚期胃癌的有效方案。
