Pilot study of UFT combined with 5 consecutive days cisplatin in non-small cell lung cancer.
Pilot study of UFT combined with 5 consecutive days cisplatin in non-small cell lung cancer.
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UFT联合连续5天顺铂治疗非小细胞肺癌的初步研究。
DOI：
10.1016/s0169-5002(97)00068-8
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发表时间：
1997
期刊：
影响因子：
5.3
通讯作者：
Y. Nakai
中科院分区：
文献类型：
--
作者：
S. Koinumaru;T. Matsuda;J. Saitoh;Y. Nakai
联合使用5-氟尿嘧啶（5-FU）和顺铂已被证明有协同作用，在许多实验系统和临床研究。UFT是尿嘧啶和替加氟以4：1摩尔比的口服制剂，据报道，与单独的5-FU或替加氟相比，对各种人类肿瘤具有增强的活性。基于这些结果，我们进行了一项初步研究，以证实UFT联合顺铂治疗晚期非小细胞肺癌（NSCLC）患者的可行性和抗肿瘤作用。按照逐步延长给药期的方案，如步骤I第1-14天，步骤II第1-21天，步骤III第1- 28天，UFT以400 mg/m2的剂量口服给药。在此期间，顺铂在第8天至第12天以20 mg/m2/天的固定剂量给药。每4周重复一次。步骤I、II、III中入组的患者数量分别为6例、10例和6例（共22例）。有3名女性和19名男性，PS评分0/1/2=7/14/1，IIIA/IIIB/IV期=3/8/11。腺癌/鳞状细胞癌/大细胞癌=11/7/4，中位年龄68岁（范围52-79）。所有22例患者均可评价毒性，21例可评价疗效。UFT的依从性随着给药时间的延长而下降。在第I步中，1例患者发生中性粒细胞减少症、血小板减少症、恶心/呕吐和腹泻的3级毒性。在步骤II中，在4名患者中观察到3、4级中性粒细胞减少症，在1名患者中观察到3级血小板减少症和厌食症，在4名患者中观察到3级恶心/呕吐。在第III步中，2例患者发生3级中性粒细胞减少症，1例患者发生3级厌食症。所有其他毒性均为轻度。总体缓解率为38%（1例CR和7例PR，95% CI：21-59%）。口服UFT联合顺铂5天输注治疗晚期NSCLC是可行的，具有显著的抗肿瘤作用。由于UFT依从性在步骤III中降低（步骤III中没有患者接受>2个疗程的治疗），我们认为步骤II时间表值得在联合II期研究中进一步评估。
Combined use of 5-fluorouracil (5-FU) and cisplatin has proven to have synergistic effects in many experimental systems and clinical studies. UFT, an oral preparation of uracil and tegafur in a 4:1 molar ratio, was reported to have enhanced activity as compared with 5-FU or tegafur alone against various human tumors. Based on those results, we conducted a pilot study to confirm the feasibility and antitumor effect of UFT in combination with cisplatin in patients with advanced non-small cell lung cancer (NSCLC). UFT was orally administered at a dose of 400 mg/m2according to a protocol for step-wise prolongation of the administration period, such as days 1–14 in step I, days 1–21 in step II, days 1–28 in step III. During to course, cisplatin was administered at a fixed dose of 20 mg/m2/day on days 8 through 12. The course was repeated every 4 weeks. Numbers of patients enrolled in steps I, II, III were six, ten and six (a total of 22), respectively. There were three females and 19 males, PS scored 0/1/2=7/14/1, stage IIIA/IIIB/IV=3/8/11. Adenocarcinoma/squamous cell carcinoma/large cell carcinoma=11/7/4, and median age 68 (range 52–79). All 22 patients were evaluable for toxicity, and 21 for efficacy. Compliance of UFT declined as the administration period of UFT was prolonged. In step I, one patient had grade 3 toxicity of each neutropenia, thrombocytopenia, nausea/vomiting and diarrhea. In step II, grade 3, 4 neutropenia was seen in four patients, grade 3 thrombocytopenia and anorexia in one patient, and grade 3 nausea/vomiting in four patients. In step III, there was grade 3 neutropenia in two patients and grade 3 anorexia in one patient. All other toxicities were mild. The overall response rate was 38% (one CR and 7 PR, 95% C.I.: 21–59%). Combination therapy with oral UFT and 5-day infusion of cisplatin is feasible with substantial antitumor effect against advanced NSCLC. Since UFT compliance decreased in step III (no patient in step III received >2 courses of treatment), we considered the step II schedule to be worth for further evaluation in a combination phase II study.
DOI：
10.1073/pnas.83.23.8923
发表时间：
1986-12-01
影响因子：
11.1
作者：
SCANLON, KJ;NEWMAN, EM;PRIEST, DG
通讯作者：
PRIEST, DG
顺铂连续 5 天输注给药：血浆铂水平和尿铂排泄。
DOI：
--
发表时间：
1986
期刊：
Cancer treatment reports
影响因子：
--
作者：
Belliveau,JF;Posner,MR;Ferrari,L;Crabtree,GW;Cummings,FJ;Wiemann,MC;O'LearyJr,GP;Griffin,H;Phaneuf,MA;O'Rourke,A
通讯作者：
O'Rourke,A