演題抄録

一般演題 (示説)

開催概要
開催回
第54回・2016年・横浜
 

Phase 2 study of irinotecan plus panitumumab as 2nd-line therapy for esophageal adenocarcinoma(EAC): Update of survival and correlative biomarkers

演題番号 : P25-5

[筆頭演者]
Gibson Michael K.:1 
[共同演者]
Karapetyan Lilit:1、Fu Pingfu:1、Kresak Adam:1

1:Case Western Reserve University, USA・Medical Oncology・Medicine

 

Background: EAC is a lethal cancer with increasing incidence. We demonstrated that over-expression of the epidermal growth factor receptor (EGFR) correlated with reduced survival. Panitumumab (P) is a fully human IgG2 monoclonal antibody against human EGFR. Cetuximab (C) combined with irinotecan (I) is active for 2nd-line treatment of colorectal cancer (CRC). A phase II study was designed to evaluate P + I as second-line therapy for advanced EAC.
Methods: Primary endpoint is response rate (RR). Secondary endpoints overall survival, safety/toxicity and correlates. Patients with one prior treatment were given P 9 mg/m2 D1 and I 125 mg/m2 on D1 and D8 of each 21 D cycle. Inc. criteria: confirmed EAC, meas dz, no prior I or P, PS < 2, normal organ function. Simon twostage design with power 80% and a type I error of 0.05 was used: 18 patients stage 1, with cessation if 2 or less responders, up to 43 patients.
Results: Between 2009 and 2013, 24 patients were enrolled: 18 eligible/evaluable. All caucasian, median age = 62.5 (range: 33-79), male/female = 15/3.Median cycles = 3.5. Most common G1-2 AEs were: fatigue (72%), diarrhea (72%), anemia (83%),leukocytopenia (72%) and hypoalbuminemia (72%). Grade 3-4 AEs included heme (9/18, 50%), GI (8/18, 44%), electrolyte (6/18, 33%), rash (1/18, 6%), fatigue (3/18, 17%) and weight loss (3/18, 17%). Median follow-up was 7.2 mos (range: 2.3-14 mos). The PR rate was 6% (1/18) with 95% CI (0.01, 0.26). The clinical benefit (PR+SD)rate was 50% (9/18) with 95% CI (0.29, 0.71). The median OS was 7.2 months with 95% CI (4.1, 8.9) months with 1-year survival of 11.1%. The median PFS was 2.9 months with 95% CI (1.6, 5.3) months. Biomarker analyses for the role of FCγ-R receptor polymorphisms, EGFR pathway and KRAS will be presented at the Meeting.
Conclusions: Irinotecan and Panitumumab as 2nd line treatment for advanced
EAC is not indicated. Correlative studies to assess mechanisms of action and resistance will be presented.

キーワード

臓器別:食道

手法別:トランスレーショナルリサーチ

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