Wednesday, February 25, 2009

CT vs CTRT before surgery for Esophageal Cancer

In this week's JCO there is an important article comparing two approaches for esophageal cancer.

Initially presented at ASCO 2007, this is a German trial from Stahl, randomizing uT3-4NXM0 adenocarcinoma of the lower esophagus or gastric cardia to induction chemotherapy (CDDP+5FU+leucovorin x 15 weeks) followed by surgery (arm A) vs chemotherapy (same x 12 weeks) followed by chemoradiotherapy (30Gy @ 2Gy/day with concurrent CDDP+etoposide) followed by surgery. 

Power calculation: Primary outcome was overall survival time, and 354 patients were needed to detect anincrease in 3-year survival from 25% to 35% by addition of radiation therapy.  Unfortunately the trial failed to meet accrual goals and closed.

Results: Median f/u 4years. CTRT associated with increased pCR rates (15.6% v 2.0%) and pN0 disease (64.4% v 37.7%).  3-year survival rate from 27.7% to 47.4% (p =0.07).  Postoperative mortality 10.2% CTRT v 3.8% CT (p=0.26).

This is an important trial as there are now competing philosophies in the treatment of gastric and esophageal adenocarcinoma, perioperative chemotherapy as in the MAGIC trial, and preoperative CTRT as in the CALGB approach.  This is an underpowered trial with a very provocative survival result.  Though stastically insignificant, this difference would be extremely clinically significant.



No comments: