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Neoadjuvant chemotherapy with cisplatin and gemcitabine followed by chemoradiation vs chemoradiation for locally advanced cervical cancer: A randomized phase II trial

Journal of Clinical Oncology Sep 05, 2019

da Costa SCS, Bonadio RC, Gabrielli FCG, et al. - Among patients with locally advanced cervical cancer (LACC) (International Federation of Gynecology and Obstetrics stage IIB to IVA or with positive lymph nodes) enrolled in this phase II trial, researchers assessed the efficacy and safety of neoadjuvant chemotherapy (NAC) with cisplatin and gemcitabine followed by chemoradiation therapy (CRT), focusing on 3-year progression-free survival (PFS) as primary endpoint, and on response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life all assessed as secondary endpoints. Participants were randomized to 3 cycles of NAC with cisplatin and gemcitabine followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone. An inferior PFS was reported in correlation with NAC, with 3-year PFS rates of 40.9% vs 60.4% in the CRT arm. Also, a lower OS was observed in relation to NAC (3-year OS rate, 60.7% vs 86.8%). Posttreatment completion, the NAC arm as well as the CRT arm exhibited complete response rates of 56.3% and 80.3%, respectively. Findings revealed non-superiority and rather possible inferiority of treatment strategy involving the addition of NAC consisting of cisplatin and gemcitabine to standard CRT when compared with CRT alone for the treatment of LACC.
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