Abstract
e13551 Background: IGF-1R regulates cell growth, proliferation and apoptosis. Adenocarcinoma and never smokers have higher expression of IGF-1R and it is associated with worse survival. MK is a humanized monoclonal antibody that targets IGF-1R. P has higher activity in NSQL. We initiated a randomized phase II trial to evaluate the combination of P and C +/- MK in NSQL. Methods: Eligibility criteria: untreated NSQL stage IIIB or IV, ECOG 0 or 1, measurable disease, adequate organ function and no other intercurrent illness. Standard B12 and folic acid were given. P at 500mg/m2 and C at 75mg/m2 IV were given every 3 weeks. MK was given at the dose of 10mg/kg IV weekly on days 1, 8 and 15 of every 3 week cycle in the experimental group. The patients had radiographic assessment after every 2 cycles and treated for a maximum of 6 cycles if there was either response or stable disease. The primary objective of the study was to estimate the individual response rate of standard and experimental arm. IRB reviewed and approved the study at participating institutions. Results: From 1/2009 to 2/2011, the study accrued 26 patients, 16 male, 10 female, median age 59 yo. 14 patients were treated with PC and 12 patients were treated with PC +MK. In the PC arm we observed 2 partial responses (PR), 7 stable disease (SD), 3 had progression (PD) and 2 were not evaluable (NE). In the MK arm there were 3 PRs, 4 SD, 4 PD and 1 NE. In both arms, hematologic adverse events(AE) observed were: grade 3 neutropenia(5), hemoglobin (3), febrile neutropenia (2), platelet (2) leukopenia (1), lymphopenia (1); grade 4 platelet (2), hemoglobin (1); Grade 3 non-hematological AE were: hyperglycemia (4) and 1 occurrence each of hearing deficit, pain in extremity, hyponatremia, urinary tract infection, fatigue, dyspnea, laboratory, hypokalemia, esophageal stenosis, hypoxia, dysphagia and muscle weakness; Grade 4 hypoxia and hyperglycemia. The study was closed due to termination of funding. Conclusions: PC with MK had a similar response rate to PC. There was a higher rate of hyperglycemia in the MK group. Identification of a response predictive marker would be critical in order to continue the study of this agent.
Published Version
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