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Abstract
Introduction/Background In the SCORPION trial, neo-adjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) was shown to achieve similar survival results with lower toxicities when compared with primary debulking surgery (PDS), in patients with advanced ovarian cancer (AOC). Here, we analyze effects on quality of life (QoL).
Methodology the SCORPION trial is a single-Institution, superiority, randomized phase III trial enrolling AOC women with high tumor load assessed at staging laparoscopy. They were randomly assigned to undergo either PDS followed by systemic adjuvant chemotherapy (arm A, standard), or NACT followed by IDS (arm B, experimental). QoL was assessed as a secondary endpoint, using the EORTC quality of life questionnaire QLQC-30 and QLQ-Ov28. These were completed at study entry, at the 4th cycle or before IDS (in arm A and arm B, respectively), at the 6th cycle, and 6 months after the last cycle of chemotherapy (12 months after diagnosis).
Results 171 patients were enrolled in the study period (PDS=84; NACT=87). QoL questionnaires were completed by 142 (83%) patients at baseline, and by 119 (69.6%) at 12-months.Using cross sectional analysis, we observed no significant difference between treatment arms in any of the QoL functioning scales at 12 months. A significant change in diarrhea was found at 12-months between study groups (group A vs group B, difference in mean score -8.6636, 95% CI -15.2805–2.0467; p=0.009). At longitudinal analysis, we found lower global health scores for those undergoing PDS than those receiving NACT (group A vs group B, difference in mean score 6.27, 95% CI 0.440–12.11; p=0.035). Similar results were found with regard of emotional and cognitive functioning.
Conclusion We found no difference in global QoL between treatment groups at 12 months; however, patients undergoing NACT followed by IDS reported higher mean quality of life in all scores of QOL functioning scales.