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


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 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.


CONCLUSIONS
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.
Benedetti-Panici
Pierluigi
P
Campus Bio-Medico Free University, Via E Longoni, 8300155, Rome, Italy. p.panici@unicampus.it
Greggi
Stefano
S
Colombo
Alessandro
A
Amoroso
Mariangela
M
Smaniotto
Daniela
D
Giannarelli
Diana
D
Amunni
Gianni
G
Raspagliesi
Francesco
F
Zola
Paolo
P
Mangioni
Costantino
C
Landoni
Fabio
F
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000532:radiotherapy / Q000628:therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007044:Hysterectomy; D007558:Italy / Q000453:epidemiology; D008197:Lymph Node Excision; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects; D011183:Postoperative Complications / Q000453:epidemiology; D016016:Proportional Hazards Models; D011832:Radiation Injuries / Q000453:epidemiology; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000532:radiotherapy / Q000628:therapy*
D000970:Antineoplastic Agents