Innovations: Randomized phase II trial of erlotinib (E)/bevacizumab (B) compared with cisplatin (P)/gemcitabine (G) plus B in first-line treatment of advanced nonsquamous (NS) non-small cell lung cancer (NSCLC).
2011; Lippincott Williams & Wilkins; Volume: 29; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2011.29.15_suppl.7504
ISSN1527-7755
AutoresM. Thomas, Alexander Reuß, J.R. Fischer, Stefan Andreas, C. Kortsik, C. Grah, Monika Serke, M. von Eiff, Claudia M. Witt, Jens Kollmeier, E.W. Muller, Lothar Müller, Michael Schenk, Rob ter Heine, D. Behringer, M. Schroeder, Niels Reinmuth, P. Schnabel, Thomas Acker, M. Wolf,
Tópico(s)Hepatocellular Carcinoma Treatment and Prognosis
Resumo7504 Background: Combining EGFR kinase inhibition (E) with an anti-VEGF strategy (B) showed promising activity (RR 20%; PFS 6.2 months) in recurrent NS-NSCLC (J Clin Oncol (2005) 23: 2544). To assess feasibility and efficacy in the first-line setting E + B was compared with P/G+B in cisplatin eligible patients (pts). Methods: Stage IIIB/IV pts. were randomized on E (150 mg/daily) / B (15 mg/kg d1, q d 22) until progressive disease (PD) or P (80 mg/m2 d1, q d22) / G (1250 mg/m2 d1, q d22) up to 6 cycles+ B (15 mg/kg d1, q d 22) until PD. Primary end point was PFS in both arms. Results: 224 patients were randomized (EB, 111 / PGB, 113). Baseline characteristics were well balanced: age (median; range) 62.5; 39.5-84.6 / 59.9; 35.7-83.0; female 43%/44%; ECOG 0 – 1 – 2, 43% - 55% - 2% / 47% - 50% - 4%; never smoker – light former smoker – former smoker – smoker - missing 18.9% - 1.8% - 46.9% - 28.8% - 3.6% / 16.8% - 5.3% - 40.7% - 32.7% - 4.4%;histology: adenocarcinoma 85.6%/92.0%, large cell carcinoma 3.6%/2.7%, other 9.0%/4.4%, missing 1.8%/0.9%; EGFR mutation analysis available in 161 pts (71.9%/71.2%): wild-type (wt) 53.2%/62.0%, del 19 3.6%/1.8%, L858R 4.5%/2.7%, further mutations 9.0%/7.1%. Treatment conduction: E, duration in weeks 12.6; number of cycles (median) B, 5.0 / P, 5.5; G, 6.0; B, 4.0. Toxicity: hematologic grade 3 6.5%/27.3%; grade 4 0.9%/27.3%; non-hematologic grade 3 34.3%/34.6%; grade 4 9.3%/24.6%; treatment related mortality 4.6%/4.6%. Conclusions: PGB showed significant superiority to EB for RR (p < 0.0001) as well as PFS (HR = 0.6 [95%-CI 0.44-0.82], p = 0.0006) and favoured OS (HR = 0.73 [95%-CI 0.50-1.06], p = 0.1). EGFR mutations identify pts most likely to benefit from EB. Further biomarker exploitation is performed. Treatment N RR (%) PFS OS Median (mo) 95%-CI (%) Median (mo) 95% CI (%) EB Total 111 12.6 3.7 2.8-4.3 12.6 10.3-16.2 EGFR eval. 79 12.7 3.8 2.8-4.5 12.6 9.1-17.7 EGFR-mut 20 25.0 4.4 2.1-8.3 16.9 10.3-24.0 EGFR-wt 59 8.5 3.5 2.5-4.4 10.3 8.0- – PGB Total 113 33.6 7.2 6.0-8.9 15.7 11.9-21.7 EGFR eval. 82 35.4 7.3 5.9-9.5 15.0 11.9-29.2 EGFR-mut 12 16.7 5.7 2.8-8.4 10.0 6.0-19.8 EGFR-wt 70 38.6 8.1 6.5-9.7 18.1 12.0- –
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