Tuesday, October 12, 2010

JCO: Gem+RT vs Gem alone in Pancreatic CA


Pancreatic cancer continues to be a difficult tumor to treat, where even the largest recent advances (EGRF inhibition, Gemcitabine) provide very modest benefit at best. Gemcitabine + RT was a subject of some excitement due to the radiosensitizing properties of the drug, but unfortunately in many centers it was found to also sensitize to normal tissue as well. Thus the US approach has been Gem alone, and RT + 5FU or capecitabine if used at all.

The study at hand is at once great in terms of concept by looking at Gem alone vs Gem concurrently with RT , but unfortunately limited by it's scope. As a randomized phase II, little can be concluded, asside from the fact that the toxicities as less than otherwise expected in the concurrent arm. There is not however evidence of a large therapeutic benefit with the approach, thus I feel that, as before, this is a disease in desperate need of a breakthrough.

Link and Abstract

Adjuvant Gemcitabine Alone Versus Gemcitabine-Based Chemoradiotherapy After Curative Resection for Pancreatic Cancer: A Randomized EORTC-40013-22012/FFCD-9203/GERCOR Phase II Study [Gastrointestinal Cancer]: "Purpose

The role of adjuvant chemoradiotherapy (CRT) in resectable pancreatic cancer is still debated. This randomized phase II intergroup study explores the feasibility and tolerability of a gemcitabine-based CRT regimen after R0 resection of pancreatic head cancer.

Patients and Methods

Within 8 weeks after surgery, patients were randomly assigned to receive either four cycles of gemcitabine (control arm) or gemcitabine for two cycles followed by weekly gemcitabine with concurrent radiation (50.4 Gy; CRT arm). The primary objective was to exclude a < 60% treatment completion and a > 40% rate of grade 4 hematologic or GI toxicity in the CRT arm with type I and II errors of 10%. Secondary end points were late toxicity, disease-free survival (DFS), and overall survival (OS).


Between September 2004 and January 2007, 90 patients were randomly assigned (45:45). Patient characteristics were similar in both arms. Treatment was completed per protocol by 86.7% and 73.3% (80% CI, 63.1% to 81.9%; 95% CI, 58.1% to 85.4%) in the control and CRT arms, respectively, and grade 4 toxicity was 0% and 4.7% (two of 43; 80% CI, 1.2% to 11.9%), respectively. In the CRT arm, three patients experienced grade 3–related late toxicity. Median DFS was 12 months in the CRT arm and 11 months in the control arm. Median OS was 24 months in both arms. First local recurrence was less frequent in the CRT arm (11% v 24%).


Adjuvant gemcitabine-based CRT is feasible, well-tolerated, and not deleterious; adding this treatment to full-dose adjuvant gemcitabine after resection of pancreatic cancer should be evaluated in a phase III trial.


No comments: