Khushalani’s team is looking at pathologic complete response rate and toxicity in a Phase II trial involving 36 patients with stage II-IVa esophageal cancer, 29 of whom (81%) have undergone surgery in the course of their treatment. Treatment consisted of three 85 mg/m2 doses of oxaliplatin over the course of a month, 625 mg/m2 twice daily dose of oral capecitabine and radiation therapy, followed by surgery four to six weeks later. Two cycles of oxaliplatin and capecitabine were given post-operatively. Gene expression profiling using Agilent microarrays was conducted on primary tumor tissue.
In early results, eight of the 29 patients who had their esophagus removed following the oxaliplatin regimen had no cancer in the surgical specimen — a 28% pathologic complete response (pCR) rate.
“Another clear result is that this regimen is very well-tolerated by patients without significant side effects,” says Dr. Khushalani. And while the gene expression data are preliminary, “There appear to be several gene pathways that are enriched when studying different sub-groups — the pCR group versus the non-pCR group.”
The study continues to accrue patients, and Dr. Khushalani expects to have mature survival data by fall 2010. ”I believe this is an efficacious regimen, and it’s definitely well-tolerated,” he says. “We hope that the exploratory gene expression profiling results will translate into clinically meaningful hypotheses that can be validated in a large, preferably multi-center study.””.
The study was approved and funded by the National Comprehensive Cancer Network (NCCN) from general research support provided by Roche Laboratories, Inc.
Dr. Khushalani will also be presenting the background and schema of a Phase I clinical trial that seeks to identify dosage and toxicity levels of sunitinib in combination with a standard course of FOLFIRI (irenotecan/5-fluorouracil/leucovorin) chemotherapy in stage IV esophageal cancer patients.
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Editor’s note: The oxaliplatin study presentation, “Gene expression profile for the prediction of pathologic complete response: Preliminary data from a neoadjuvant study of capecitabine, oxaliplatin, and radiation for esophageal cancer,” will be part of the Gastrointestinal (Noncolorectal) Cancer general poster session at the ASCO meeting, June 6 from 2pm to 6pm in the McCormick Place Convention Center, S Hall 2. The sunitinib trial results will be shared June 7 from 8am to noon in S Hall A2 as part of the Trials in Progress poster session.
Annie Deck-Miller, Senior Media Relations Manager