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June 25, 2008

Survival for Patients With Pancreatic Cancer After Addition of Gemcitabine to Fluorouracil Chemoradiation—Reply

JAMA. 2008;299(24):2852-2853. doi:10.1001/jama.299.24.2852-c

In Reply: In response to Dr Fujita and Dr Vikram, our study had 2 primary end points: survival for all patients and survival for patients with pancreatic head tumors. The median survival times for all eligible patients were 16.9 and 18.8 months for the chemoradiation plus fluorouracil and the chemoradiation plus gemcitabine treatment groups, respectively, as indicated in Figure 2. Stratification factors were chosen in 1997 when this trial was designed, based on data available then, and were accounted for in the multivariate analysis. Because the study was not powered to look for treatment differences within varying levels of stratification factors, including lymph node status, providing such results in the limited format of a letter reply could lead to misinterpretation. We will consider looking at the treatment effect within the stratification variables and reporting them completely in a future analysis.