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Pemetrexed plus cetuximab in patients (pts) with recurrent non-small cell lung cancer (NSCLC): A phase I-IIa dose-ranging study from the Hoosier Oncology Group

2007; Lippincott Williams & Wilkins; Volume: 25; Issue: 18_suppl Linguagem: Inglês

10.1200/jco.2007.25.18_suppl.7698

1527-7755

Shadia I. Jalal, David Waterhouse, Martin J. Edelman, Sreenivasa Nattam, Rafat Ansari, Karuna Koneru, Mengjun Yu, Jie Shen, T. Breen, Nasser H. Hanna,

Colorectal Cancer Treatments and Studies

7698 Background: Both pemetrexed (P) and cetuximab (C) have single agent activity in NSCLC, non-overlapping toxicities and different mechanisms of action, making the combination of P and C an attractive option to evaluate. This study evaluates the feasibility of combining these agents, and tests the activity and toxicity of this regimen in pts with recurrent NSCLC. Methods: Eligible pts had stage IIIB/IV NSCLC, previously treated ≥ 1 prior platinum containing regimen, PS 0–1. Prior use of EGFR tyrosine kinase inhibitors was permitted. The phase I portion determined the MTD (Bedano Proc ASCO et al., 2006). The primary endpoint of the phase II portion was to estimate TTP using Kaplan-Meier analysis (5% alpha, 80% beta), requiring 25 pts to demonstrate a TTP of ≥ 24 weeks vs. historical control of 12 weeks. Following a loading dose of C at 400 mg/m 2 on week 1, pts received P at 750 mg/m 2 iv q3wks and C at 250 mg/m 2 iv weekly. Cycles were repeated every 21 days. After completing at least 4 cycles, pts with non-progressive disease (PD) were allowed to continue C alone until PD. Results: Eligible and treated phase II pts (n=23) received a median of 4 cycles (range 1–12). Pt characteristics: M:F 57%:43%; median age 64 (range 43–80), stage IIIB: IV 17%:83%; adeno:squamous cell 61%:30%; smoking status: current/former/never: 29%/62%/10%. Prior regimens, median 2 (range 1–6). G3/4/5 toxicities included: 4.3% neutropenia, 13% infection, 4.3% hemorrhage, 22% skin. There were no G3/4 episodes of anemia, TCP, febrile neutropenia, liver toxicity or diarrhea. Response data was available for 18 patients. Partial responses were seen in 2 pts (8.7 %), SD in 8 patients (34.8%). Median TTP was 25 weeks. Conclusion: It is feasible and safe to combine P at 750 mg/m 2 every 21 days and C at 400 mg/m 2 week 1 and 250 mg/m 2 weekly thereafter. This combination resulted in longer TTP when compared with historical controls of P at 500 mg/m 2 alone. No significant financial relationships to disclose.