Summary
The investigators primary outcome was to evaluate the effectiveness in term of Overall Survival (OS) and disease free interval (DFI) of two different platinum-based chemotherapic regimen (3 and 6 cycles) for treatment of Locally Advanced Cervical Cancer (LACC) (IB2-IIB) previously treated with Neoadjuvant Chemotherapy Plus Radical Surgery (NACT+RS). The secondary outcome was to evaluate and compare safety, in term of toxicity profile, of the two treatment options.
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Inclusion Criteria: * patients with squamous cell, adenosquamous or adenocarcinoma of the cervix * Stage IB2-IIB according to the Inyernational Federation of Gynecology and Obstetrics (FIGO) * age between 18 and 75 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * normal cardiac and respiratory functions * absence of secondary malignancies * no previous surgical, chemotherapic and/or radiotherapic treatment for secondary malignancies * informed consent obtained from the patient. Exclusion Criteria: * histological confirmation of papillary serous, mucinous, clear cell, squamous cell, mixed and undifferentiated carcinoma of the uterus * abnormal hepatic function (transaminases \> 2.5 x upper limit, serum bilirubin \> 1,5 x upper limit) * abnormal renal function (creatinine clearance \<60 mL/min and/or serum creatinine\>2.0 mg/100 mL) function * abnormal bone marrow function (absolute neutrophil count \<1,5 x 109/L or platelet count \< 100 x 109/L or hemoglobin \< 9 g/dL * severe or uncontrolled infection, other systemic diseases or mental illness; and * pregnant women. Clinical staging was performed according to the NCCN criteria, and included pelvic examination, cervical biopsy, abdomen-pelvis Computed Tomography, chest X-ray; examination under anesthesia, cystoscopy and/or proctoscopy if clinically indicated (National Comprehensive Cancer Network, Clinical Practicw Guidelines in Oncology. Cervical Cancer, Version 2.2015)