Jansen E P M, Boot H, Dubbelman R, Bartelink H, Cats A, Verheij M
Department of Radiotherapy, The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Br J Cancer. 2007 Sep 17;97(6):712-6. doi: 10.1038/sj.bjc.6603965.
We hypothesised that gastric cancer outcome could be improved with more effective and intensified postoperative chemoradiotherapy. This phase I/II study was performed to determine the maximal tolerated dose (MTD) and toxicity profile of postoperative radiotherapy with concurrent daily cisplatin and capecitabine. Patients were treated with capecitabine 1000 mg m(-2) twice a day (b.i.d.) for 2 weeks. Subsequently, patients received capecitabine (250-650 mg m(-2) orally b.i.d., 5 days week(-1)) and cisplatin (3-6 mg m(-2) i.v., 5 days week(-1)) according to an alternating dose-escalation schedule. Radiotherapy was given to a total dose of 45 Gy in 25 fractions. Thirty-one patients completed treatment. During chemoradiotherapy, eight patients developed nine items of grade III and one episode of grade IV (mainly haematological) toxicity. The MTD was determined to be cisplatin 5 mg m(-2) i.v. and capecitabine 650 mg m(-2) b.i.d. orally. This phase I/II study demonstrated that chemoradiotherapy with daily cisplatin and capecitabine is feasible in postoperative gastric cancer at the defined dose level and is currently being tested in a phase III multicenter study.
我们假设，采用更有效且强化的术后放化疗可改善胃癌的治疗结果。开展这项I/II期研究旨在确定术后放疗联合每日顺铂和卡培他滨的最大耐受剂量（MTD）及毒性特征。患者接受卡培他滨1000 mg m(-2)，每日两次，共2周。随后，患者根据交替剂量递增方案接受卡培他滨（口服250 - 650 mg m(-2)，每日两次，每周5天）和顺铂（静脉注射3 - 6 mg m(-2)，每周5天）。放疗总剂量为45 Gy，分25次给予。31例患者完成治疗。在放化疗期间，8例患者出现9项III级毒性反应和1次IV级（主要为血液学）毒性反应。确定MTD为顺铂静脉注射5 mg m(-2)和卡培他滨口服650 mg m(-2)，每日两次。这项I/II期研究表明，在规定剂量水平下，每日顺铂和卡培他滨的放化疗在术后胃癌中是可行的，目前正在一项III期多中心研究中进行检验。
