Instituto do Cancer do Estado de São Paulo, São Paulo, Brazil
Samantha Silva , Renata RC Colombo Bonadio , Flavia Gabrielli , Andrea souza Aranha , Maria Luiza Genta , Vanessa Costa Miranda , Daniela Freitas , Elias Abdo Filho , Patricia Alves De Oliveira Ferreira , Karime Kalil , Mariana Scaranti , Maria Del Pilar Estevez-Diz
Background: 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 compared using log-rank test. RR was evaluated using chi-square test Results: Between July 2012 and July 2017, 107 pts were randomized. Pts characteristics were similar between groups. Median age was 47 years. The majority of the patients had squamous cell carcinoma (87.8%), and FIGO stage IIB (42.9%) or IIIB (44.8%). Median follow up was 25.5 months. PFS rates at 3 years were 41.1% (CI 95% 26.5-55.2%) in NAC group and 59.6% in the CRT alone group (CI 95% 42.5-73.1%), with an absolute difference of 18% (HR 1.48, CI 95% 0.86-2.82, p = 0.13). OS rates in 3 years were 74.2% (CI 95% 58.4-84.7%) and 81.9% (CI 95% 65.2-91.1%), respectively (HR 1.64, CI 95% 0.71-3.77, p = 0.23). CRT alone had superior complete RR (54% NAC vs 82% CRT alone, p = 0.002). No difference was seen in overall RR (92.7% NAC vs 94% CRT alone, p = 0.77). QoL improved after treatment in both groups when compared with baseline. Conclusions: This study showed that NAC is associated with inferior complete RR in comparison with standard CRT alone in the treatment of LACC, which is probably associated with the trend towards inferior PFS in NAC group. There was no statistically significant difference in OS. Clinical trial information: NCT01973101
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