Abstract
ObjectiveConcurrent 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.MethodsEligible patients were advanced uterine cancer with measurable diseases [performance score (PS): 0−2]. Study period was from August 1st, 2002 to December 31st, 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/m2 (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. ResultsSeventeen 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/m2. The recommended dose was decided as 50 mg/m2. 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. ConclusionsMTD was 60 mg/m2 and recommended dose was set as 50 mg/m2. This concurrent chemoradiation using weekly CPT-11 was feasible at 50 mg/m2, and it might be effective even in adenocarcinoma of the uterus.
Highlights
In Japan, the recommendation of vaccination of human papillomavirus (HPV) by the Ministry of Health, Welfare, and Labor has been suspended, the number of patients with cervical cancer has increased in conjunction with lower receiving ratio of Pap smear test as 37.3%−42.3% in 2016 [1]
The issues of uterine cervical cancer are the increase of the disease in adolescents and young adults generation (AYA generation) and the percentage of adenocarcinoma of cervix which has been increased in comparison with that of squamous histology [squamous cell carcinoma (SCC)] [2]
This study was approved by institutional review board (IRB) of each institution in Kansai Clinical Oncology Group (KCOG), and written informed consent was obtained from each accrued patient
Summary
In Japan, the recommendation of vaccination of human papillomavirus (HPV) by the Ministry of Health, Welfare, and Labor has been suspended, the number of patients with cervical cancer has increased in conjunction with lower receiving ratio of Pap smear test as 37.3%−42.3% in 2016 [1]. The issues of uterine cervical cancer are the increase of the disease in adolescents and young adults generation (AYA generation) and the percentage of adenocarcinoma of cervix which has been increased in comparison with that of squamous histology [squamous cell carcinoma (SCC)] [2]. As for diagnosis in cervical adenocarcinoma, it is very difficult to detect in early stage by yearly screening of Pap smear test. Even if cervical adenocarcinoma is detected at earlier stages, it causes ovarian metastases more frequent than that of SCC [3,4]. Because of its dependency on estrogen in proliferation, the treatment of cervical adenocarcinoma with fertility preservation in AYA generation has been restricted to very early stage such as IB1 stage with small volume disease. In Japan, 5 year-survival of SCC and adenocarcinoma of cervix showed 58.7% and 40.0% (P
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