Neoadjuvant chemotherapy and radical surgery versus exclusive radiotherapy in locally advanced squamous cell cervical cancer: Results from the Italian multicenter randomized study

• Published in: Journal of clinical oncology Vol. 20; no. 1; pp. 179 - 188
• Main Authors: BENEDETTI-PANICI, Pierluigi, GREGGI, Stefano, LANDONI, Fabio, COLOMBO, Alessandro, AMOROSO, Mariangela, SMANIOTTO, Daniela, GIANNARELLI, Diana, AMUNNI, Gianni, RASPAGLIESI, Francesco, ZOLA, Paolo, MANGIONI, Costantino
• Format: Journal Article
• Language: English
• Published: Baltimore, MD Lippincott Williams & Wilkins 2002
• Subjects: Adult; Aged; Analysis of Variance; Antineoplastic agents; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - radiotherapy; Carcinoma, Squamous Cell - therapy; Combined treatments (chemotherapy of immunotherapy associated with an other treatment); Disease-Free Survival; Female; Humans; Hysterectomy; Italy - epidemiology; Lymph Node Excision; Medical sciences; Middle Aged; Neoadjuvant Therapy - adverse effects; Pharmacology. Drug treatments; Postoperative Complications - epidemiology; Proportional Hazards Models; Radiation Injuries - epidemiology; Survival Rate; Uterine Cervical Neoplasms - mortality; Uterine Cervical Neoplasms - radiotherapy; Uterine Cervical Neoplasms - therapy; Italy; Antineoplastic agent; Human; Squamous cell carcinoma; Prognosis; Malignant tumor; Uterine cervix; Radiotherapy; Cisplatin; Neoadjuvant treatment; Female genital diseases; Alkylating agent; Chemotherapy; Treatment; Surgery; Advanced stage; Combined treatment; Preoperative; Uterine cervix diseases; Comparative study; Platinum II Complexes
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/jco.2002.20.1.179

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 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). Of 441 patients randomly assigned to NACT+RS 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, NACT+RS), 46.4% and 46.7% (stage IB2-IIB, RT) (P =.005 andP =.02), 41.6% and 41.9% (stage III, NCAT+RS), 36.7% and 36.4% (stage III, RT) (P =.36 and P =.29), respectively. Treatment had a significant impact on OS and PFS. Although significant only for the stage IB2 to IIB group, a survival benefit seems to be associated with the NACT+RS compared with conventional RT.