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A phase 2 multicenter study of irinotecan and cisplatinum as neoadjuvant treatment in patients with locally advanced cervical cancer.

AbstractHYPOTHESIS:
To evaluate efficacy and safety of a neoadjuvant treatment with irinotecan and cisplatin [cis-diamminedichloroplatinum(II); CDDP] in patients with locally advanced cervical cancer.
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:
Irinotecan and CDDP as neoadjuvant chemotherapy in locally advanced cervical cancer showed a promising response rate. These data warrant confirmation with a phase 3 study.
AuthorsFrancesco Raspagliesi, Antonino Ditto, Luigi Selvaggi, Luigi Frigerio, Mauro Melpignano, Giovanni Scambia, Chiara Apolloni, Paolo Scollo, Sandro Pignata, Pierluigi Benedetti Panici
JournalInternational 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
PMID21119370 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Irinotecan
  • Cisplatin
  • Camptothecin
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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