Gastrointestinal Cancers Symposium
SAN FRANCISCO – Chemoradiation with FOLFOX and
cetuximab was effective in adults with locally advanced cardia and esophageal
cancer in a phase 2 study, according to Aimery de Gramont, MD. Now,
researchers want to see the regimen evaluated in a phase 3 trial.
“The study reached its objective for
efficacy,” said de Gramont, professor of oncology and head of Internal
Medicine in Oncology at the Hôpital Saint-Antoine in Paris. “We are
performing ongoing analysis on overall survival, surgery after chemoradiation
and quality of life.”
Eighty patients with stage III squamous cell or
adenocarcinoma of the esophagus or gastroesophageal junction were assigned to
two cycles of FOLFOX induction therapy plus cetuximab (400 mg/m2
first infusion then once weekly 250 mg/m2) followed by 50.4 Gy
radiotherapy with FOLFOX plus cetuximab.
Patients were recruited into the phase 2 GERCOR study
from November 2007 to February 2010 at 12 centers. The intent-to-treat
population was 79 patients and the full analysis set was 67 patients.
Fifty-three patients had squamous cell disease, 25 had adenocarcinoma and one
had undifferentiated disease. Seventy-four patients had esophageal cancer.
Median age was 63 years.
De Gramont said the ORR was 77.2% in the intent-to-treat
population and 80% in the full analysis set. Complete response rate was 40%.
Six patients had stable disease and nine had disease progression. Response was
similar in adenocarcinoma and squamous cell tumors.
Median PFS was 13.8 months in the intent-to-treat
Grade 3/grade 4 adverse events were greater with
chemoradiation compared with induction chemotherapy, except for allergy (8.9%
vs. 0.0%) and diarrhea (3.8% vs. 2.7%), but de Gramont said the regimen was
There was one death after chemoradiation due to
esophagitis with gastrointestinal bleeding. - by Jason Harris
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Dr. de Gramont has served as a consultant/advisor to
The authors have concluded that this strategy of FOLFOX
and cetuximab should be evaluated in a randomized trial. I would argue that
there is no clear signal as yet from the data available, and the RTOG 0436
study in the United States should raise some flags of caution concerning
toxicity in older patients. One should certainly proceed with cetuximab if the
ongoing stage 3 studies are encouraging and positive, but as yet we do not know
Peter C. Enzinger, MD
Gastrointestinal Cancer Center,
Dana-Farber Cancer Institute
Dr. Enzinger serves as a consultant for Genentech.