Carboplatin and low-dose paclitaxel. An effective regimen in older and comorbid patients with advanced cervical cancer. A phase II study.

Objective: To investigate the efficacy and safety of low-dose weekly paclitaxel and carboplatin in elderly and/or any age comorbid patients with FIGO Stage IVB, recurrent or persistent cervical cancer. Materials and Methods: Thirty patients were accrued. Eligibility criteria included older than 65 years, or any age with uncontrolled diabetes and/or blood hypertension and other comorbid conditions. Treatment consisted of six 28-day cycles of carboplatin at AUC of 5 at day 1, and low-dose paclitaxel at 50 mg/m² at days 1, 8, and 15 infused in two hours. Metabolic response was evaluated by [18F]-FDG uptake (PET-CT) and toxicity with the NCI CTC v2. Results: From January 2012 to January 2015 a total of 30 patients were included in the study. The median number of chemotherapy cycles administered was five (1-6). Three (10%) had complete response and nine (30%) partial response for an overall response rate of 48%. One patient (4%) had stable disease and 17 (56%) showed progressive disease. At a median follow-up time of 12.5 (1-37) months, the median progression-free survival (PFS) and overall survival (OS) were 7.7 and 14.3 months, respectively. Grade 4 toxicities were anemia in three patients (10%), grade 3 neutropenia and vomiting occurred in one (3%), and one (3%) respectively. All other toxicities were grades 1 and 2. A substantial proportion of patients had grade zero toxicity. Conclusion: This study shows that this 28-day regimen of low-dose carboplatin and paclitaxel is effective and safe in an elderly and/or comorbid population of advanced cervical cancer.

Advanced cervical cancer; First-line chemotherapy; Low-dose paclitaxel; Carboplatin; Aged; Comorbid.

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