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Randomized Trial of Neoadjuvant Chemotherapy Comparing Paclitaxel, Ifosfamide, and Cisplatin With Ifosfamide and Cisplatin Followed by Radical Surgery in Patients With Locally Advanced Squamous Cell Cervical Carcinoma: The SNAP01 (Studio Neo-Adjuvante Portio) Italian Collaborative Study

From the Department of Obstetrics and Gynecology, University of Milano-Bicocca, San Gerardo Hospital, Monza; Istituto di Ricerche Farmacologiche "Mario Negri"; European Institute of Oncology, Milan; Cervello Hospital, Palermo; Department of Obstetrics and Gynecology, Gynecologic Oncology Unit, University of Turin; Gynecological Oncology Department, Mauriziano Umberto I Hospital Mauriziano Hospital, Turin; Department of Gynecology and Obstetrics, University of Brescia; Clinica Malzoni, Avellino; and Cannizzaro Hospital, Catania

Address reprint requests to Roldano Fossati, MD, Istituto "Mario Negri," Via Eritrea 62, Milan, Italy; e-mail: fossati{at}marionegri.it

PURPOSE: Neoadjuvant chemotherapy may represent an alternative to irradiation in locally advanced squamous cell cervical cancer. Aims of this study were to compare a three-drug (paclitaxel, ifosfamide, and cisplatin [TIP]) with a two-drug (ifosfamide and cisplatin [IP]) regimen and to assess the prognostic value of pathologic response on survival.

PATIENTS AND METHODS: Patients (n = 219) were randomly assigned to ifosfamide 5 g/m² during 24 hours plus cisplatin 75 mg/m², or paclitaxel 175 mg/m² plus ifosfamide 5 g/m² during 24 hours and cisplatin 75 mg/m² every 3 weeks for three courses.

RESULTS: Grades 3 to 4 neutropenia, anemia, and thrombocytopenia were more frequent with TIP. We recorded four deaths related to toxicity. The optimal pathologic response (OPT) rate (residual disease < 3 mm stromal invasion) was higher with TIP than with IP (48% v 23%; odds ratio, 3.22; 95% CI, 1.69 to 5.88; P = .0003). At a median follow-up of 43.4 months, 79 women experienced disease progression or died (46 in the IP arm, 33 in the TIP arm). Patients receiving TIP experienced a treatment failure rate 25% less than those receiving IP, but this difference was not statistically significant (hazard ratio [HR], 0.75; 95% CI, 0.48 to 1.17; P = .20). Sixty-one patients died (37 in the IP arm, 24 in the TIP arm), and the HR of death was in favor of TIP, although not significantly (HR, 0.66; 95% CI, 0.39 to 1.10; P = .11). In patients assessable for response (n = 189), the average death rates were higher in the group that did not achieve OPT (HR, 5.88; 95% CI, 2.50 to 13.84; P < .0001).

CONCLUSION: The TIP regimen is associated with a higher response rate than the IP regimen, without a statistically significant effect on overall survival. OPT was a prognostic factor for survival.

Support for data management was provided by Fondazione Mattioli.

Presented in part at the 39th Annual Meeting of American Society of Clinical Oncology, May 31-June 3, 2003, Chicago, IL.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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				A. A. Lissoni, N. Colombo, A. Pellegrino, G. Parma, P. Zola, D. Katsaros, S. Chiari, A. Buda, F. Landoni, M. Peiretti, et al. A phase II, randomized trial of neo-adjuvant chemotherapy comparing a three-drug combination of paclitaxel, ifosfamide, and cisplatin (TIP) versus paclitaxel and cisplatin (TP) followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: the Snap-02 Italian Collaborative Study Ann. Onc., April 1, 2009; 20(4): 660 - 665. [Abstract] [Full Text] [PDF]