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• W2892146871 abstract "e20522 Background: Phosphatidylinositol 3-kinase (PI3K) pathway activation may contribute to primary and secondary resistance to platinum (Pt)-based chemotherapy (CT) in sqNSCLC. The pan-PI3K inhibitor buparlisib (BUP) was assessed for first-line (BASALT2; NCT01820325) or second-line (BASALT-3; NCT01911325) treatment of sqNSCLC. Methods: BASALT-2 and BASALT-3 were phase Ib/II trials designed to establish the maximum tolerated dose (MTD) of BUP and CT (in phase Ib). In BASALT-2, patients (pts) with untreated Stage IV sqNSCLC received BUP 80 mg/day (continuous or intermittent [5 days on/2 days off] schedules in 21-day cycles) with 3-weekly carboplatin (CBP) AUC = 6 and paclitaxel (PAC) 200 mg/m2. In BASALT-3, pts with Stage IIIb/IV sqNSCLC pretreated with one Pt-based CT received BUP 80 or 100 mg/day with 3-weekly docetaxel (DOC) 75 mg/m2. Dose escalation was guided by an adaptive Bayesian logistic regression model with overdose control. MTD was based on dose-limiting toxicities (DLTs) reported in Cycle 1. Results: In BASALT-2, 6 pts received BUP 80 mg (continuous [n = 5] or intermittent [n = 1]). Median age was 69 years and 50% of pts were male. Of 3 evaluable pts, 2 had DLTs of Grade (Gr) 3 stomatitis and Gr4 neutropenia (n = 1 each). One pt had a partial response (PR) and 3 had stable disease (SD). The most common primary reason for treatment discontinuation was pt decision (n = 3). MTD for BUP + CBP + PAC was not determined due to early study closure. In BASALT-3, 27 pts received BUP 80 mg (n = 16) or 100 mg (n = 11). Median age was 65 years and 89% of pts were male. DLTs were Gr3 asthenia (n = 1) and Gr2 mood altered (n = 1) at 80 mg; and Gr4 neutropenia (n = 1) and Gr2 and Gr3 hyperglycemia (n = 1 each) at 100 mg. MTD was declared as BUP 80 mg + DOC. Median progression-free survival was 2.8 months at both dose levels. Overall response rate (complete response + PR) was 6% at 80 mg and 18% at 100 mg. All pts discontinued treatment, most frequently due to disease progression (38% of pts at 80 mg and 36% at 100 mg). Conclusions: Based on the challenging safety profile observed in both studies, as well as the evolving treatment landscape, buparlisib will not be further developed in lung cancer. Clinical trial information: NCT01820325; NCT01911325." @default.
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• W2892146871 date "2016-05-20" @default.
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• W2892146871 title "Safety and efficacy of buparlisib (BKM120) and chemotherapy in advanced, squamous non-small cell lung cancer (sqNSCLC): Results from the phase Ib/II BASALT-2 and BASALT-3 studies." @default.
• W2892146871 doi "https://doi.org/10.1200/jco.2016.34.15_suppl.e20522" @default.
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