Abstract | HYPOTHESIS: METHODS: A phase 2 study was conducted at 13 centers located in Italy. Eighty-seven were enrolled between 2000 and 2003. Patients received irinotecan 175 mg/m2 on day 1 every 3 weeks followed by CDDP 80 mg/m2. Each patient was to receive 3 cycles of treatment. Tumor response was to be evaluated by magnetic resonance imaging 3 weeks after the end of the third cycle. At the end of therapy, all patients were to be examined for radical surgery. RESULTS: Of 71 patients included in the primary analysis, 9 (12.7%) showed a complete response; and 43 (60.6%), a partial response for an overall response rate of 73.2% (95% confidence interval [CI], 61.4%-83.1%). Complete pathological responses were observed in 13.6% of the patients (95% CI, 7.0%-23.0%). Overall survival rate at 4 years was 87.0% (95% CI, 79.5%-94.5%).There were no study-related deaths. Most common adverse events were alopecia in 76 patients (87.4%) and gastrointestinal disorders in 79 patients (90.8%). Serious adverse events were vomiting in 18 patients (20.7%), nausea in 14 (16.1%), diarrhea in 8 (9.2%), and neutropenia in 50 (57.5%). A total of 3 patients (3.4%) were discontinued from the study owing to the occurrence of 1 or more serious adverse event. CONCLUSIONS:
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Authors | Francesco Raspagliesi, Antonino Ditto, Luigi Selvaggi, Luigi Frigerio, Mauro Melpignano, Giovanni Scambia, Chiara Apolloni, Paolo Scollo, Sandro Pignata, Pierluigi Benedetti Panici |
Journal | International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
(Int J Gynecol Cancer)
Vol. 20
Issue 9
Pg. 1569-75
(Dec 2010)
ISSN: 1525-1438 [Electronic] England |
PMID | 21119370
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Irinotecan
- Cisplatin
- Camptothecin
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Camptothecin
(administration & dosage, adverse effects, analogs & derivatives)
- Carcinoma, Squamous Cell
(drug therapy, mortality, pathology)
- Cisplatin
(administration & dosage, adverse effects)
- Disease Progression
- Female
- Humans
- Irinotecan
- Middle Aged
- Neoadjuvant Therapy
- Neoplasm Staging
- Survival Analysis
- Treatment Outcome
- Uterine Cervical Neoplasms
(drug therapy, mortality, pathology)
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