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

Abstract

ObjectivesThe aim of this study was to compare 4 versus 6 courses of adjuvant chemotherapy after neo-adjuvant chemotherapy plus radical surgery in terms of overall survival (OS), disease-free survival (DFS), recurrence rate and toxicity profile. MethodsWe randomly assigned 200 patients with IB2-IIB cervical cancer to receive 4 (Group A) or 6 (Group B) courses of cisplatin 100mg/mq and paclitaxel 175mg/mq every 21days. ResultsAt 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%). ConclusionsAdjuvant 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.