Logo image
Back
Three-arm randomized phase II study of carboplatin (C) and paclitaxel (P) in combination with cetuximab (CET), IMC-A12, or both for advanced non-small cell lung cancer (NSCLC) patients who will not receive bevacizumab-based therapy: An Eastern Cooperative Oncology Group (ECOG) study (E4508)
Abstract   Open access   Peer reviewed

Three-arm randomized phase II study of carboplatin (C) and paclitaxel (P) in combination with cetuximab (CET), IMC-A12, or both for advanced non-small cell lung cancer (NSCLC) patients who will not receive bevacizumab-based therapy: An Eastern Cooperative Oncology Group (ECOG) study (E4508)

Nasser H. Hanna, Suzanne Eleanor Dahlberg, Jill Kolesar, Fred R. Hirsch, Suresh S. Ramalingam and Joan H. Schiller
Journal of clinical oncology, Vol.30(15_suppl), pp.7516-7516
05/20/2012
DOI: 10.1200/jco.2012.30.15_suppl.7516
url
https://doi.org/10.1200/jco.2012.30.15_suppl.7516View
Published (Version of record) Open Access

Abstract

Abstract only 7516 Background: Pre-clinical evidence supports the clinical investigation of inhibitors to the insulin-like growth factor receptor (IGFR) and the epidermal growth factor receptor (EGFR) alone and in combination with one another in patients (pts) with NSCLC. Methods: Pts w/ chemotherapy-naïve, advanced NSCLC, not eligible for bevacizumab-based therapy, ECOG PS 0/1 were eligible. Pts with uncontrolled or untreated brain mets and/or severe hyperglycemia were ineligible. Pts were randomized to receive: C AUC 6 iv + P 200 mg/m2 iv on day 1 every 3 wks combined with either CET iv weekly (arm A), IMC-A12 iv every 2 wks (arm B), or both (arm C). Patients with non-progressive disease (PD) after 12 weeks of therapy were permitted to continue on maintenance antibody therapy until PD. The primary objective was PFS. Secondary objectives included OS and toxicity. The design required 180 eligible patients and had an 88% power to detect a 60% increase in median PFS for either comparison (arm A vs C or arm B vs C) (1-sided 0.10 level test). Results: Characteristics for arms A (n=39)/B (n=42)/C (n=48): males were 51%/57%/54%; median age was 60, 62, 60; PS 0 49%/52%/60%; stage IV 87%/83%/94%; adenocarcinoma 44%/26%/42%. The study was closed prematurely due to safety concerns after 129 eligible pts were treated. 13 patients died during treatment (A=6; B=2; C=5), including 9 w/in ~1 mo of starting therapy. G3-5 toxicities, all attributions, A/B/C: anemia 16%/7%/13%; neutropenia 27%/29%/42%; febrile neutropenia 7%/5%/4%; thrombocytopenia 7%/10%/13%; pneumonia 9%/2%/6%; hyperglycemia 2%/10%/15%; rash 5%/2%/8%; hyponatremia 2%/5%/17%; thromboembolic events 2%/10%/0%; fatigue 16%;22%/13%. The estimated median PFS and OS for arms A/B/C were 3.4, 4.3, and 4.1 mos and 11.7, 8.6, and 8.4 mos, respectively. Conclusions: Based upon apparent lack of efficacy and excessive premature deaths, this study does not support the continued investigation of C + T + IMC-A12 alone or in combination with CET in pts with advanced NSCLC not eligible for bevacizumab.

Details

Metrics

2 Record Views
Logo image