Phase II study of irinotecan combined with mitomycin-C for advanced or recurrent squamous cell carcinoma of the uterine cervix: the JGOG study.
OBJECTIVE
The efficacy and toxicity of combined therapy with irinotecan (CPT-11) plus mitomycin-C (MMC) were evaluated in patients with advanced or recurrent squamous cell carcinoma (SCC) of the uterine cervix.


METHODS
CPT-11 (100 mg/m(2)) was administered on days 1, 8, and 15 by intravenous (iv) infusion over 90 min, while MMC (10 mg/m(2) iv) was given on day 1. This regimen was repeated every 28 days and at least two courses were given.


RESULTS
Among 51 eligible patients (median age: 52 years; range: 25-72 years), 2 showed complete response (CR) and 24 showed PR, for an overall response rate (ORR) of 51.0% (95% confidence interval: 36.6-65.3%). In patients without prior chemotherapy, the ORR was 54.8% (38.7-70.2%). Twenty-five patients (Ib2:3, IIb:17, and IIIb:5) received this regimen as neoadjuvant chemotherapy and their ORR was 76% (54.9-90.6%). Twenty-two patients were able to undergo radical surgery after NAC. The major toxicity was neutropenia, which was grade 3-4 in 59% of the patients. Grade 3-4 thrombocytopenia and anemia were also seen in 26% of the patients each. The most common nonhematologic toxicity was diarrhea (grade 3-4 in 12%).


CONCLUSIONS
CPT-11 combined with MMC can be effective against advanced or recurrent SCC of the uterine cervix.
Umesaki
Naohiko
N
Department of Obstetrics and Gynecology, Wakayama Medical University, Wakayama 641-0012, Japan. umesaki@wakayama-med.ac.jp
Fujii
Tuneo
T
Nishimura
Ryuichiro
R
Tanaka
Tetsuji
T
Nishida
Masato
M
Fushiki
Hiroshi
H
Takizawa
Ken
K
Yamamoto
Kaichiro
K
Hasegawa
Kazuo
K
Izumi
Rikuichi
R
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
D016685:Mitomycin; D000077146:Irinotecan; D002166:Camptothecin