@article {Raspagliesi1569, author = {Francesco Raspagliesi and Antonino Ditto and Luigi Selvaggi and Luigi Frigerio and Mauro Melpignano and Giovanni Scambia and Chiara Apolloni and Paolo Scollo and Sandro Pignata and Pierluigi Benedetti Panici}, title = {A Phase 2 Multicenter Study of Irinotecan and Cisplatinum as Neoadjuvant Treatment in Patients With Locally Advanced Cervical Cancer}, volume = {20}, number = {9}, pages = {1569--1575}, year = {2010}, doi = {10.1111/IGC.0b013e3181cc71f7}, publisher = {BMJ Specialist Journals}, abstract = {Hypothesis: 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.}, issn = {1048-891X}, URL = {https://ijgc.bmj.com/content/20/9/1569}, eprint = {https://ijgc.bmj.com/content/20/9/1569.full.pdf}, journal = {International Journal of Gynecologic Cancer} }