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

Alessandro Buda, Roldano Fossati, Nicoletta Colombo, Francesca Fei, Irene Floriani, Desiderio Gueli Alletti, Dionyssios Katsaros, Fabio Landoni, Andrea Lissoni, Carmine Malzoni, Enrico Sartori, Paolo Scollo, Valter Torri, Paolo Zola, Costantino Mangioni

Research output: Contribution to journalArticlepeer-review

Abstract

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/m 2 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.

Original languageEnglish
Pages (from-to)4137-4145
Number of pages9
JournalJournal of Clinical Oncology
Volume23
Issue number18
DOIs
Publication statusPublished - 2005

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this