Definitive Results of the French FFCE-SFRO 2000-01 Study: Phase III Trial Comparing Chemoradiotherapy (Cisplatin and Infusional 5-FU) Followed by Gemcitabine vs. Gemcitabine Alone in Patients with Locally Advanced Non Metastatic Pancreatic Cancer
Scientific Session: Definitive Results of the French FFCE-SFRO 2000-01 Study: Phase III Trial Comparing Chemoradiotherapy (Cisplating and Infusional 5-FU) Followed by Gemcitabine vs. Gemcitabine Alone in Patients with Locally Advanced Non Metastatic Pancreatic Cancer
There is no consensus on standard therapy for locally advanced pancreatic cancer. Studies have identified a benefit to a combination of chemotherapy and radiation therapy, while others favor chemotherapy alone. Gemcitabine is approved for use in pancreatic cancer, but when combined with radiation, it has resulted in severe toxicity. This study compared chemoradiotherapy with 5-FU / cisplatin and concurrent radiation followed by gemcitabine, versus gemcitabine alone, for locally advanced, non-metastatic pancreatic cancer that is unresectable.
120 patients from 22 European centers participated and were randomized to receive chemoradiotherapy (CRT) or chemotherapy alone (GEM). 83% of patients tolerated the planned radiation (meaning they got at least 75% of the dose). At least 75% of planned chemotherapy doses were delivered to 54% of those receiving 5FU, 51% receiving cisplatin, and 73% receiving gemcitabine.
Median * survival was 8.6 months in the CRT arm versus 13 months in the GEM arm. Progression-free survival (meaning no progression of disease was observed for this period) was 6 versus 6.7 months, respectively. One-year overall survival ** was 32% versus 53% in the CRT arm versus GEM and 1 year progression free survival was 14% versus 32%, respectively. None of these differences was statistically significant, meaning that they could have just happened by chance. However, there was a "trend" with the numbers leaning in favor of the GEM arm.
The study presenters did not share the radiation techniques used or the supportive care that was provided to patients, if any. These could be major reasons for the poorer tolerability of the CRT arm. Supportive care including hydration, addressing of nutritional issues, and aggressive management of GI toxicity are all crucial to increasing tolerability, and may lead to better outcomes in the CRT arm. Further information regarding these factors would be of assistance in properly interpreting the results of this trial.
* The median is the "middle of the pack", where half of the patients have died and half are alive. For instance, at 9 months, 50 patients had died and 50 were alive, 9 months is the mid point of survival, or the median. It is different from the mean, which would be average survival time.
** Overall survival is the number of patients alive, regardless of whether they have active disease or disease progression.
Partially funded by an unrestricted educational grant from Bristol-Myers Squibb.