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International Journal of Gynecological Cancer:
doi: 10.1097/IGC.0b013e3182915c69
Cervical Cancer

A Randomized Comparison of Cisplatin and Oral Vinorelbine as Radiosensitizers in Aged or Comorbid Locally Advanced Cervical Cancer Patients

Coronel, Jaime Alberto MD*; Cetina, Lucely del Carmen MD*; Cantú, David MD, PhD*; Cerezo, Oscar MD*; Hernández, Cintia Sánchez MD*; Rivera, Lesbia MD; Chacón, Adela Poitevin MD; Duenas-Gonzalez, Alfonso MD, PhD

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Abstract

Objective: Chemoradiation with cisplatin is considered the standard of care for patients with locally advanced cervical cancer; however, cisplatin could be difficult to use in aged patients or patients with comorbidities such as diabetes mellitus and blood hypertension; hence, it is important to investigate nonplatinum drugs for radiosensitization. In addition, oral cytotoxics may overcome the drawbacks of intravenous infusions and could be of easier administration.

Methods: In this small randomized trial, we tested cisplatin against oral vinorelbine as radiosensitizers in these patients. A total of 39 patients 65 years or older or diabetic and hypertensive patients of any age were randomized to cisplatin or oral vinorelbine at 40 mg/m2 or 60 mg/m2, respectively. Both drugs were administered weekly for 6 courses during pelvic external-beam radiotherapy and brachytherapy radiation. Efficacy and safety were assessed.

Results: Nineteen patients received oral vinorelbine, and 20 patients received cisplatin. The median cumulative dose to point A was 80.8 Gy for both groups, and the overall treatment time was 48 (42–54) and 50 (43–55) days for vinorelbine and cisplatin groups, respectively. Patients in both arms received a median of 5 applications of chemotherapy. Treatment was well tolerated in both arms. The most frequent toxicity in both arms was lymphopenia grades 2 and 3. At a median follow-up time of 16 months (4–19), there were no differences in either progression-free survival or overall survival between groups.

Conclusions: Our results suggest that these patient populations can safely be treated with either cisplatin or navelbine as radiosensitizers; however, a larger randomized study is needed to demonstrate the noninferiority of oral vinorelbine as an easier and practical alternative for radiosensitization in cervical cancer.

Copyright © 2013 by IGCS and ESGO

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