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FOLFOX plus cetuximab produced ORR of 77% in cardia, esophageal cancer

2011 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 population.

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 generally well-tolerated.

There was one death after chemoradiation due to esophagitis with gastrointestinal bleeding. - by Jason Harris

For more information:

Dr. de Gramont has served as a consultant/advisor to Roche.

PERSPECTIVE

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 the results.

Peter C. Enzinger, MD
Clinical Director, Gastrointestinal Cancer Center,
Dana-Farber Cancer Institute

Dr. Enzinger serves as a consultant for Genentech.

Twitter Follow HemOncToday.com on Twitter.

2011 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 population.

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 generally well-tolerated.

There was one death after chemoradiation due to esophagitis with gastrointestinal bleeding. - by Jason Harris

For more information:

Dr. de Gramont has served as a consultant/advisor to Roche.

PERSPECTIVE

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 the results.

Peter C. Enzinger, MD
Clinical Director, Gastrointestinal Cancer Center,
Dana-Farber Cancer Institute

Dr. Enzinger serves as a consultant for Genentech.

Twitter Follow HemOncToday.com on Twitter.

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