Introduction/Background Despite recent progress regarding surgical and medical management of primary ovarian cancer, relapses are still frequent and one of the most critical challenges in the clinical routine. There is a broad consensus that quality of life (QoL) should be one of the most relevant goals of any therapy in relapsed ovarian cancer.
Methodology We report the results of a data look of the multicentre, randomized (1:1), active-controlled, open-label phase IV NOGGO-S16/COMPASS trial performed in patients with recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer. The scope of this trial is to evaluate QoL with EORTC QLQ-C30 and QLQ-OV28 questionnaires during/after chemotherapy either with platinum/taxane-free combination of trabectedin (Yondelis®) plus PLD or with standard platinum-based chemotherapy comprising combination of carboplatin with PLD, gemcitabine or paclitaxel. The current data look serves to characterise the included patient population.
Results Data from 76 patients screened have been analysed. Patients have a median age of 63 years (range: 21–82), the performance status score of 0/1 was recorded in 75 patients (98.7%), and most are BRCA-negative (77.4%). They are diagnosed with primary ovarian carcinoma (83.6%), primary peritoneal carcinoma (9.6%) and fallopian carcinoma (6.8%), and 79% of patients have a grade 3 histopathological staging. Poly (ADP-ribose) polymerase inhibitors or bevacizumab were given as prior maintenance therapy to 15.3% and 76.4% of patients, respectively. Overall, 60% of patients had a platinum-free interval of >12 months before randomization and 45.8% of patients finished COMPASS trial as per protocol. The main reasons for withdrawal were progression under treatment (18.6%), toxicity (15.3%), death (13.6%) and patient wish (6.8%). Post-protocol maintenance therapy was given to 23.8% of patients. No differences in patient characteristics were observed.
Conclusion Based on this data look no significant signal for a non-inferiority of the study arms have been observed. Study is ongoing and open for recruitment.
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