Treatment with Iressa® (gefitinib) slowed disease progression and improved quality of life in patients with metastatic esophageal cancer, according to the results of a phase III trial presented at the ESMO 2012 Congress of the European Society for Medical Oncology in Vienna.
The esophagus is a muscular tube that food and liquids pass through on their on their way to the stomach. Each year in the United States, more than 17,000 people are diagnosed with cancer of the esophagus and more than 15,000 die of the disease. Currently, there is no standard systemic therapy for metastatic esophageal cancer that progresses after first- or second-line chemotherapy.
The human epidermal growth factor receptor (EGFR) is a protein that is found on the surface of cells and is involved in cellular growth, spread, and replication. Cancerous cells often overexpress EGFR or have mutations within EGFR, leading to uncontrolled growth or spread of the cancer cells. High EGFR expression is associated with poor prognosis in esophageal cancer.
Iressa is an oral agent that is targeted specifically against EGFR. It works by binding to EGFR and halts or reduces its effects on cancer cells.
The COG (Cancer Oesophagus Gefitinib) study included 450 patients from 51 UK centers whose disease had already progressed after first-line treatment with up to two chemotherapy regimens. Patients were randomized to receive Iressa or placebo and were treated until their disease progressed.
The results indicated modest improvements with Iressa. The median progression-free survival was 49 days for patients who received Iressa compared to 35 days for those who received placebo. What’s more—patients who received Iressa experienced improved quality of life, notably experiencing improved dysphagia (difficulty swallowing) and odynophagia (painful swallowing), both important quality-of-life indicators among these patients. There was no improvement in overall survival.
The researchers concluded that Iressa provided a 21 percent reduction in the risk of progression among patients receiving second- or third-line treatment for metastatic esophageal cancer. A follow-up study, TRANSCOG, will look at predictive biomarkers and attempt to identify a subgroup of patients who might experience benefit from Iressa.
Ferry DR, Dutton SJ, Mansoor W, et al. Phase III multi-centre, randomised, double-blind, placebo-controlled trial of gefitinib versus placebo in esophageal cancer progressing after chemotherapy, COG (Cancer Oesophagus Gefitinib). Presented at the 37th Congress of the European Society for Medical Oncology (ESMO), Vienna, Austria, September 28-October 2, 2012. Abstract LBA20.