A Comparative Study of Two Protocols of Concurrent Chemotherapy with External Beam Radiotherapy in Treatment of Locally Advanced Cervical Cancer: Cisplatin Versus Cisplatin Plus Capecitabine Combination

Abstract

Cervical carcinoma is one of the commonest cancers affecting women in the low- and middle-income countries. The standard treatment of locally advanced cases by external beam radiotherapy (EBRT) along with single-agent cisplatin-based concurrent chemotherapy is effective, but rates of treatment failure and recurrence remain high. There exists a need to augment the treatment protocol. One modality to do that is by addition of another radiosensitizer/chemotherapeutic agent. In total, 40 women with histologically proven locally advanced cervical cancer were included in the study. The first 20 (Arm 1) were treated with EBRT along with concurrent cisplatin at 40 mg/m2 (maximum 70 mg). The next 20 patients (Arm 2) received the same treatment but also received oral capecitabine 460 mg/m2 during EBRT. Treatment-related toxicity and disease response rates at 6 months were compared in the two arms. Overall survival at 5 years of patients in the two arms was also compared. During treatment, 40% of patients in Arm 1 developed anemia compared to 45% in Arm 2. In total, 5% patients in Arm 1 and 10% in Arm 2 developed grade 2 leucopenia. A higher incidence of proctitis and diarrhea was seen in Arm 2 (30%) than in Arm 1 (15%). The grade of proctitis and diarrhea was also higher in Arm 2 than in Arm 1. None of the patients developed hand-foot syndrome. All the complications were managed symptomatically and did not cause significant treatment break in either treatment arms except in one patient in Arm 2. At 6-month follow-up, four patients (20%) in both arms had residual or progressive disease. At the end of 5 years, the mean overall survival in the two Arms 1 and 2 was 47.9 and 48.4 months, respectively. The addition of capecitabine to standard concurrent chemoradiotherapy with cisplatin for locally advanced cervical cancer is well tolerated even on an OPD basis though there is increased incidence of acute proctitis and diarrhea with this combination. No difference in treatment efficacy or improvement in survival between the two protocols was seen in our study though this may have been influenced by the small sample size and short period of follow-up of our study. We recommend a phase II/III study to further evaluate the efficacy and tolerability of this regimen.