Abstract
Objectives: To evaluate the efficacy of adjuvant chemotherapy (ACT) in locally advanced stage cervical cancer after concurrent chemoradiation (CCRT) comparing to CCRT alone in terms of response rate, progression-free survival (PFS), and overall survival (OS). Methods: Patients with FIGO stage IIB to IVA, aged between 18-70 years, had ECOG performance score 0-2, had histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, and had no para-aortic lymph node enlargement were randomized to CCRT (arm A) or CCRT and ACT (arm B). The patients in both arms had concurrent cisplatin weekly along with pelvic radiation. After a 4-week period after CCRT, the patients in arm B had paclitaxel plus carboplatin every 4 weeks for 3 cycles. Results: Data analysis of 259 patients showed no significant difference of complete responses: 94.1% in arm A vs 87.0% in arm B (p=0.154). With the median follow-up of 27.4 months (range 3.2 – 49.0 months), 15.5% of patients in arm A and 10.8% in arm B experienced recurrences: (p=0.123). There were no significant differences regarding the loco-regional failure but the patients in arm B had significantly lower systemic recurrences, 10.1% vs 5.4% (p=0.029). The 3-year PFS and 3-year OS of the patients in arm A were not significantly different from those of arm B: 66.6% (95% CI, 57.4-75.8%) vs 63.4% (95% CI, 54.6-72.2%) for PFS and 80.1% (95% CI, 71.9-88.3%) vs 69.5% (95% CI, 59.3-79.7%) for OS. The hazard ratio of PFS and OS arm B compared to arm A were 1.26 (95% CI 0.82-1.96) and 1.42 (95% CI 0.81-2.49) respectively. Conclusions: Adjuvant chemotherapy with 3 cycles of paclitaxel plus carboplatin after CCRT did not improve response rates and survivals compared to CCRT alone. There were no differences of loco-regional failure but a significant decrease of systemic recurrences by adjuvant chemotherapy.
