Neoadjuvant C hemotherapy a nd R adical S urgery V ersus Exclusive R adiotherapy i n L ocally A dvanced S quamous C ell Cervical C ancer: R esults F rom t he I talian M ulticenter Randomized S tudy

Purpose: Neoadjuvant chemotherapy (NACT) and radical surgery (RS) have emerged as a possible alternative to conventional radiation therapy (RT) in locally advanced cervical carcinoma. In 1990, a phase III trial was undertaken to verify such a hypothesis in terms of survival and treatment-related morbidity. Patients and Methods: Patients with squamous cell, International Federation of Gynecology and Obstetrics stage IB2 to III cervical cancer were eligible for the study. They received cisplatin-based NACT followed by RS (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external-beam RT (45 to 50 Gy) followed by brachyradiotherapy (20 to 30 Gy) (arm B). Results: Of 441 patients randomly assigned to NACTRS or RT, eligibility was confirmed in 210 and 199 patients, respectively. Treatment was administered according to protocol in 76% of arm A patients and 72% of arm B patients. Adjuvant treatment was delivered in 48 operated patients (29%). There was no evidence for any significant excess of severe morbidity in one of the two arms. The 5-year overall survival (OS) and progression-free survival (PFS) rates were 58.9% and 55.4% for arm A and 44.5% and 41.3% for arm B (P .007 and P .02), respectively. Subgroup survival analysis shows OS and PFS rates of 64.7% and 59.7% (stage IB2-IIB, NACTRS), 46.4% and 46.7% (stage IB2-IIB, RT) (P .005 andP .02), 41.6% and 41.9% (stage III, NCATRS), 36.7% and 36.4% (stage III, RT) (P .36 and P .29), respectively. Treatment had a significant impact on OS and PFS. Conclusion: Although significant only for the stage IB2 to IIB group, a survival benefit seems to be associated with the NACTRS compared with conventional RT. J Clin Oncol 20:179-188. © 2001 by American Society of Clinical Oncology.