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.
*Division of Clinical Research, †Department of Radiotherapy, and‡Unit of Biomedical Research on Cancer, Instituto de Investigaciones Biomédicas, Universidad Nacional Autonoma de Mexico, Instituto Nacional de Cancerologia, México City, Mexico.
Address correspondence and reprint requests to Alfonso Duenas-Gonzalez, MD, PhD, Unit of Biomedical Research on Cancer, Instituto de Investigaciones Biomédicas, Universidad Nacional Autonoma de Mexico, Instituto Nacional de Cancerologia, Mexico City, Mexico. E-mail: firstname.lastname@example.org.
Oral vinorelbine was donated by Pierre Fabre Farma de Mexico Sa de CV, Manuel Avila Camacho 191 Col Los Morales Polanco, Mexico City, Mexico (E-mail: email@example.com).
The authors declare no conflicts of interest.
Received October 29, 2012
Accepted March 1, 2013