Phase II clinical study of irinotecan and cisplatin as first-line chemotherapy in metastatic or recurrent cervical cancer.
OBJECTIVE
The goal of this study was to evaluate the efficacy and tolerability of irinotecan plus cisplatin as first-line chemotherapy in metastatic or recurrent cervical cancer.


METHODS
Chemotherapy-naive patients with metastatic or recurrent disease and at least one measurable tumor site received irinotecan (60 mg/m(2) IV infusion over 90 min) on Days 1, 8, and 15, followed by cisplatin (60 mg/m(2) IV over 90 min) on Day 1, every 28 days for a maximum of six cycles.


RESULTS
Thirty patients were included in the response and toxicity analysis. The median age was 45 years (34-65). Nineteen patients had metastatic disease, 6 presented with locally recurrent disease, and 5 presented with locally recurrent plus metastatic disease. Seven patients were stage IVB at diagnosis. There were 2 complete and 18 partial responses and overall response rate was 66.7% (95% confidence interval: 47-85%). Stable disease was observed in 2 patients (6.7%) and progression in 8 (26.7%). Median time to relapse was 13.4 months, with a median survival time of 16.9 months. One-year disease-free survival and overall survival were 26.7 and 65.1%, respectively. Dose-limiting toxicity was observed in 4 patients (13.3%) with grade 3 renal toxicity. Nine patients (30%) developed grade 3 neutropenia, and only grade 1-2 acute and late diarrhea were observed in 20 and 40%, respectively. A patient developed pancolitis after the sixth cycle. There were no chemotherapy-related deaths.


CONCLUSIONS
The combination of irinotecan and cisplatin is a clinically active regimen for metastatic and/or recurrent cervical cancer with acceptable tolerability.
Chitapanarux
Imjai
I
Division of Therapeutic Radiology and Oncology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. Imjai@hotmail.com
Tonusin
Anun
A
Sukthomya
Vimol
V
Charuchinda
Chamita
C
Pukanhapan
Nantaka
N
Lorvidhaya
Vicharn
V
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; 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* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin