演題抄録

International Session(Oral)

開催概要
開催回
第51回・2013年・京都
 

Phase II Study of Panitumumab + CPT-11 as 2nd-line Therapy for Esophageal AC

演題番号 : ISO1-2

[筆頭演者]
Michael K Gibson:1 
[共同演者]
Yang Liu :4、Harry Yoon:2、Arlene Forastiere:3

1:Seidman Cancer Center, University Hospitals Case Medical Center, USA、2:Mayo Clinic, USA、3:Johns Hopkins University, USA、4:University of Pittsburgh, USA

 

Background: Esophageal adenocarcinoma (EAC) is a lethal cancer, and the incidence is increasing. Over-expression of the EGFR) correlates with reduced survival. Panitumumab (P) is a fully human IgG2 mAb against EGFR that is active in EGFR-expressing CRC. We observed activity of cetuximab + I as 3rd-line treatment for EAC. As such, this phase II study was designed to evaluate P + I as 2nd-line therapy for EAC.Trial Design: Primary endpoint overall response (OR). Secondary: OS, safety and correlates. Patients with confirmed EAC, measurable dz, PS <2 and failure of one prior regimen that did not contain P or I were treated with P 9 mg/m2 D1 and I 125 mg/m2 on D 1 and 8 of each 21-day cycle. A Simon two-stage design with type I/II errors of 0.05 and 0.2 allowed enrollment of 18 patients in stage I. With 2 or fewer responded\s, the trial stopped. 43 patients could be enrolled. Blood and tissue were obtained to analyze FC-R receptor polymorphisms, EGFR pathway and kras mutations.Preliminary results: 18 patients treated between 5/2009 and 5/2013. Ages 33-70 (median 65); Gender (14M/4F); Race (all Caucasian). Toxicities: GI (8/18; N/V/D); myelosuppression (9/18); neutropenia (5/18), anemia (3/18), platelets (0/18); acneiform rash (1/18), fatigue (3/18); weight loss >10% (3/18). No grade 3/4 SAEs. One patient died while on study, and this was coded as possibly related to study treatment. Response: PD (5); SD (9); PR (4); DCR (13, 72%). Median TTP 88 days. Survival not reached, 3 patients remain alive. Conclusion: This trial did not reach the primary endpoint (ORR) for efficacy and was closed after stage 1. The regimen is active based on DCR, which was not the primary endpoint. The regimen was manageable. FFPE and blood is banked for all patients, and analysis of correlates is underway.

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