Phase 1/2 study of concurrent chemoradiotherapy with weekly irinotecan hydrochloride for advanced/recurrence uterine cancer:A multi-institutional study of Kansai Clinical Oncology Group  

作　　者：Satoshi Takeuchi Haruo Kuroboshi Taisuke Mori Kimihiko Ito Eiji Kondo Tsutomu Tabata Yoshio Itani Ryuji Kawaguchi Kyosuke Takeuchi Toshinori Soejima Ryohei Sasaki 

机构地区：[1]Department of Obstetrics and Gynecology,National Hospital Organization Kobe Medical Center,Kobe 6540155,Japan [2]Division of Gynecologic Oncology,Department of Gynecology,Women Health Care,Kobe Tokushukai Hospital,Kobe 6500017,Japan [3]Department of Obstetrics and Gynecology,Kyoto Prefectural University of Medicine,Kyoto 6028566,Japan [4]Department of Obstetrics and Gynecology,Kansai Rosai Hospital,Amagasaki 6608511,Japan [5]Department of Obstetrics and Gynecology,Mie University Graduate Medical School Faculty of Medicine,Tsu,5148507,Japan [6]Department of Obstetrics and Gynecology,Tokyo Women’s Medical University,Tokyo 1628666,Japan [7]Department of Obstetrics and Gynecology,Nara Prefectural Nara Hospital(Nara Prefectural General Medical Center),Nara 6308581,Japan [8]Department of Palliative Care,Palliative Care Center of Yao-city Hospital,Osaka 5810069,Japan [9]Department of Obstetrics and Gynecology,Nara Medical University,Nara 6348521,Japan [10]I0Department of Radiation Oncology,Kobe University Graduate School of Medicine,Kobe 6500017,Japan [11]departm ent of Radiation Oncology,Hyogo Ion Beam Medical Center Kobe Proton Center,Kobe 6500047,Japan

出　　处：《Chinese Journal of Cancer Research》2020年第2期218-227,共10页中国癌症研究（英文版）

基　　金：supported by grant of Japanese Foundation for Multidisciplinary Treatment of Cancer(JFMC)for Cancer Research in 2005(26 th)。

摘　　要：Objective:Concurrent chemoradiotherapy using cisplatin was thought to be standard treatment for squamous cell carcinoma of cervix,but it had not been effective for adenocarcinoma.Concurrent chemoradiotherapy using irinotecan hydrochloride(CPT-11)had been effective for colorectal cancer,thus,we chose CPT-11 as a candidate for gynecologic adenocarcinoma.To evaluate the maximum tolerated dose(MTD)of weekly CPT-11 with external pelvic radiotherapy,a phase 1/2 study was conducted according to modified Fibonacci method.Methods:Eligible patients were advanced uterine cancer with measurable diseases[performance score(PS):0-2].Study period was from August 1 st,2002 to December 31 st,2008.The starting dose level(DL)of CPT-11 was 30 mg/m2(DL1)given weekly for 4 weeks.Subsequently,dose escalation was scheduled in 10 mg/m2 increments to 60 mg/m^2(DL4).The fixed radiotherapy consisted of whole pelvic 1.8 Gy/d,once a day in weekday for five weeks and it amounted to 45 Gy(25 fractions)in total.Results:Seventeen patients were enrolled.As for toxicities,one(1/17:5.9%)grade(G)4 neutropenia lasting 7 days had been seen in DL4.G2 diarrhea was identified in 35.3%(6/17)of the patients,and 11.8%(2/17)G3 diarrhea was observed in DL3 and DL4.Thus,the MTD of CPT-11 was defined as dose of 60 mg/m^2.The recommended dose was decided as 50 mg/m^2.The response rate was 88.2%[9 complete response(CR),3 partial response(PR),3 stable disease(SD),2 not evaluable(NE)].Disease control rate at 1 month after treatment completion was 100%but distant metastases were found in 24%(4/17)in longer outcome.Conclusions:MTD was 60 mg/m^2 and recommended dose was set as 50 mg/m2.This concurrent chemoradiation using weekly CPT-11 was feasible at 50 mg/m^2,and it might be effective even in adenocarcinoma of the uterus.

关 键 词：Concurrent chemoradiotherapy(CCRT) irinotecan hydrochloride(CPT-11) cervical adenocarcinoma endometrial cancer 

分 类 号：R737.33[医药卫生—肿瘤]