Neoadjuvant chemotherapy with cisplatin and gemcitabine followed by chemoradiation with cisplatin in locally advanced cervical cancer: A phase II, prospective, randomized, trial.

5523Background: Chemoradiation with cisplatin (CRT) is the standard treatment for patients (pts) with locally advanced cervical cancer (LACC). However, 40% of pts has disease relapse. Adjuvant chemotherapy with gemcitabine plus cisplatin improves overall survival, with high toxicity. The role of the addition of neoadjuvant chemotherapy (NAC) to definitive CRT is still a matter of debate. We conducted a trial to investigate if NAC with cisplatin and gemcitabine followed by CRT would improve outcomes. Methods: LACC pts (FIGO IIB-IVA) were randomized to 3 cycles of NAC with cisplatin 50 mg/m2 D1 and gemcitabine 1000mg/m2 D1 and D8 followed by standard CRT with weekly cisplatin 40mg/m2/w/6w plus pelvis radiotherapy (50.4Gy) followed by brachytherapy (BCT) or to the standard CRT and BCT alone. Progression-free survival (PFS) in 3 years was the primary endpoint. Secondary endpoint were response rate (RR), overall survival (OS) and toxicity. Kaplan-Meier method was used for survival analysis and curves were comp...