Introduction/Background Maintenance therapy with PARP inhibitor, olaparib, showed its efficacy in term of prolonged progression-free survival (PFS) and some others endpoints in platinum-sensitive, BRCA1/2-dependent, recurrent ovarian cancer (BRCA1/2-PSROC) in phase 2 and 3 clinical trials. The aim of the study was to analyze real-world effect of olaparib treatment in BRCA1/2-PSROC patients in Poland.
Methodology Olaparib therapy was funded by Polish Ministry of Health for patients with deleterious BRCA1/2 mutations. Inclusion and exclusion criteria consistent with, ‘Study 19’ ones were strictly kept and noted in medical records. Follow-up included monthly visits with basic lab tests, Ca125 level and computer tomography (CT) performed three-monthly or if progression was suspected. Treatment was stopped when progression by RECIST criteria was seen, in case of allergy to the drug or long-term grade ≥3 NCI CTC toxicity. No treatment beyond progression was allowed. Date of progression consistent with CT scan date was noted in medical records. Patients were followed until progression or treatment discontinuation. Time to olaparib discontinuation (TTD) as a surrogate of PFS were plotted using Kaplan-Meier survival curves.
Results Between 19/09/2016 and 30/07/2018, 311 patients with BRCA1/2-PSROC started maintenance therapy with olaparib, 400 mg twice daily (capsules). Finally, data on follow-up time and TTD from 301 patients were available for the analysis. The end of therapy in analyzed period was noted in 63 (21%) of patients. Median follow up time was 245 days (range 29–668; SD=152,6). Median of TTD was not reached at 22 months.
Conclusion The effect of olaparib maintenance therapy in platinum-sensitive recurrent ovarian cancer patients in Poland confirms its effectiveness in term of TTD, calculated as a surogat of PFS, when strict inclusion and exclusion criteria are kept.
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