A randomized controlled trial comparing four versus six courses of adjuvant platinum-based chemotherapy in locally advanced cervical cancer patients previously treated with neo-adjuvant chemotherapy plus radical surgery.

OBJECTIVES. The aim of this study was to compare 4 versus 6 courses of adjuvant chemotherapy after neoadjuvant chemotherapy plus radical surgery in terms of overall survival (OS), disease-free survival (DFS), recurrence rate and toxicity profile. METHODS. We randomly assigned 200 patients with IB2-IIB cervical cancer to receive 4 (Group A) or 6 (Group B) courses of cisplatin 100 mg/mq and paclitaxel 175 mg/mq every 21 days. RESULTS. At 4-years follow-up, the comparison of recurrence rate (p = 1; RR = 1.005; 95% CI = 0.87 to 1.161), OS (p = 0.906) and DFS (p = 0.825) did not show statistically significant differences between the two groups. Data analysis showed statistically significant differences between the two groups in term of episodes of leukopenia (p = 0.0072; RR = 1.513; 95% CI = 1.127-2.03), anemia (p = 0.048; RR = 1.188; CI = 1.012-1.395) and febrile neutropenia (p = 0.042; RR = 1.119; 95% CI = 1.014-1.235), in favor of Group A. As regards non-hematological toxicities, there were no statistically significant differences in terms of gastrointestinal symptoms (p = 0.49; RR = 1.046; CI = 0.948-1.153. On the contrary, there was a statistically significant difference regarding neurological symptoms (p=0.014; RR=1.208; CI=1.046-1.395), that were less frequent in Group A (13%) than in Group B (28%). CONCLUSIONS. Adjuvant treatment with 4 or 6 courses of platinum-based chemotherapy showed similar results in terms of OS and DSF, with a favorable toxicity profile in favor of the first regimen.

RCT Entities:   Population Interventions Outcomes