Quality of life analysis of the MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG study comparing platinum-based versus non-platinum-based chemotherapy in patients with partially platinum-sensitive recurrent ovarian cancer.

Abstract

Background

MITO-8 showed that prolonging platinum-free interval by introducing non-platinum-based chemotherapy (NPBC) does not improve prognosis of patients with partially platinum-sensitive recurrent ovarian cancer. Quality of life (QOL) was a secondary outcome.

Patients and methods

Ovarian cancer patients recurring or progressing 6-12 months after previous platinum-based chemotherapy (PBC) were randomized to receive PBC or NPBC as first treatment. QOL was assessed at baseline, 3rd and 6th cycle, with the EORTC C-30 and OV-28 questionnaires. Mean changes and best response were analysed. Progression-free survival (PFS), response rate, and toxicity are also reported for proper interpretation of data. All analyses were based on intention-to-treat.

Results

Out of 215 patients, 151 (70.2%) completed baseline questionnaire, balanced between the arms; thereafter, missing rate was higher in the NPBC arm. At mean change analysis, C30 scores were prevalently worse in the NPBC than PBC arm, statistical significance being attained for emotional functioning, global health status/QOL, fatigue and dyspnoea (effect sizes ranging from 0.30 to 0.51). Conversely, as for OV28 scale, the other chemotherapy side effects item was significantly worse with PBC at 3 and 6 cycles, with a larger effect size (0.70 and 0.54, respectively). At best response analysis, improvement of emotional functioning and pain and worsening of peripheral neuropathy and other chemotherapy side effects were significantly more frequent in the PBC arm. PFS (median 9 vs 5 months, p = 0.001) and objective response rate (51.6% vs 19.4%, p = 0.0001) were significantly better with PBC. Allergy, blood cell count, alopecia, nausea, musculoskeletal and neurologic side effects were more frequent and severe with PBC; hand-foot skin reaction, rash/desquamation, mucositis and vascular events were more frequent with NPBC.

Conclusion

MITO-8 QOL analysis shows that deterioration of some functioning and symptom scales is lower with PBC, with improvement of emotional functioning and pain, despite worsening of toxicity-related items.ClinicalTrials.gov NCT00657878