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Randomized, Double-Blind, Phase II Study of Temozolomide in Combination With Either Veliparib or Placebo in Patients
M Catherine Pietanza1, Saiama N Waqar1, Lee M Krug1
1M. Catherine Pietanza, Lee M. Krug, Mark G. Kris, and Charles M. Rudin, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College; Kaitlin M. Woo, Yevgeniva Bensman, Brenda Hurtado, and Martin Fleisher, Memorial Sloan Kettering Cancer Center, New York, NY; Saiama N. Waqar, Washington University School of Medicine in St. Louis, St Louis, MO; Afshin Dowlati, Case Western Reserve University and University Hospitals Seidman Cancer Center, Cleveland, OH; Christine L. Hann, Johns Hopkins University, Baltimore; Alice Chen, National Institutes of Health, Bethesda, MD; Alberto Chiappori, H. Lee Moffitt Cancer Center, Tampa, FL; Taofeek K. Owonikoko, Emory University, Atlanta, GA; and Robert J. Cardnell, Junya Fujimoto, Lihong Long, Lixia Diao, Jing Wang, Patricia de Groot, Erik P. Sulman, Ignacio I. Wistuba, John V. Heymach, and Lauren Averett Byers, The University of Texas MD Anderson Cancer Center, Houston, TX.
Abstract:
Purpose Both temozolomide (TMZ) and poly (ADP-ribose) polymerase (PARP) inhibitors are active in small-cell lung cancer (SCLC). This phase II, randomized, double-blind study evaluated whether addition of the PARP inhibitor veliparib to TMZ improves 4-month progression-free survival (PFS). Patients and Methods A total of 104 patients with recurrent SCLC were randomly assigned 1:1 to oral veliparib or placebo 40 mg twice daily, days 1 to 7, and oral TMZ 150 to 200 mg/m2/day, days 1 to 5, of a 28-day cycle until disease progression, unacceptable toxicity, or withdrawal of consent. Response was determined by imaging at weeks 4 and 8, and every 8 weeks thereafter. Improvement in PFS at 4 months was the primary end point. Secondary objectives included overall response rate (ORR), overall survival (OS), and safety and tolerability of veliparib with TMZ. Exploratory objectives included PARP-1 and SLFN11 immunohistochemical expression, MGMT promoter methylation, and circulating tumor cell quantification. Results No significant difference in 4-month PFS was noted between TMZ/veliparib (36%) and TMZ/placebo (27%; P = .19); median OS was also not improved significantly with TMZ/veliparib (8.2 months; 95% CI, 6.4 to 12.2 months; v 7.0 months; 95% CI, 5.3 to 9.5 months; P = .50). However, ORR was significantly higher in patients receiving TMZ/veliparib compared with TMZ/placebo (39% v 14%; P = .016). Grade 3/4 thrombocytopenia and neutropenia more commonly occurred with TMZ/veliparib: 50% versus 9% and 31% versus 7%, respectively. Significantly prolonged PFS (5.7 v 3.6 months; P = .009) and OS (12.2 v 7.5 months; P = .014) were observed in patients with SLFN11-positive tumors treated with TMZ/veliparib. Conclusion Four-month PFS and median OS did not differ between the two arms, whereas a significant improvement in ORR was observed with TMZ/veliparib. SLFN11 expression was associated with improved PFS and OS in patients receiving TMZ/veliparib, suggesting a promising biomarker of PARP-inhibitor sensitivity in SCLC.
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