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For more than three decades, the first-line treatment of choice for small cell lung cancer (SCLC) has been chemotherapy with or without radiatio.
In vitro studies have shown that SCLC cells have a significant growth inhibitory effect in SCLC cells treated with PARP inhibitors! As a result, the researchers carried out a study of olaparib as a maintenance treatment for SCLC, and recently made the latest progress~
Olaparib is a potent orally bioavailable PARP inhibitor that is well tolerated and well suited for maintenance therap.
A total of 220 patients were included and were randomized 2:2:1:1 to receive maintenance treatment with olaparib 300 mg BD, olaparib 200 mg TDS, placebo 300 mg BD, or placebo 200 mg TDS, consecutive 28-day cycles for two years, or until disease progression, death, unacceptable toxicity, or patient withdrawal of consen.
The primary endpoint was progression-free survival (PFS), and secondary endpoints were PFS at 4 months, overall survival (OS), overall survival at 6 months, ECOG performance status, quality of life (utility measures and visual simulations) score) and adverse event.
The results of the trial were: compared with the placebo group, patients in the olaparib group had better PFS, with median PFS of 7 and 6 months in the BD and TDS groups, respectively, compared with 5 months in the placebo group (Figure 2A, Table 2), HRs for each olaparib group compared with placebo, BD was 76 (90%CI: 57-02), and TDS was 86 (90%CI: 64, 15.
The 4-month PFS rate showed a benefit in the olaparib group (45% for both) compared to the placebo group (36%.
107 (49%) reported at least one adverse event of grade 3 or highe.
discuss
This randomized phase II trial evaluated the efficacy and safety of oral olaparib as maintenance therapy in patients who have completed first-line treatment of SCLC with platinum-based chemotherap.
In our study, two dose regimens of olaparib were compared with placebo: olaparib 300 mg twice daily (BD group) and olaparib 200 mg three times daily (TDS group.
The investigators concluded that olaparib monotherapy was well tolerated and the observed data showed some benefit, but our trial did not meet the pre-planned level of evidence for its role in SCLC in an unselected populatio.
References:
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