A Phase III Intergroup Trial (RTOG 97-04) of Adjuvant Pre- and Post-chemoradiation (CRT) 5-FU vs. Gemcitabine (G) for Resected Pancreatic Adenocarcionma

Reviewer: Christopher Dolinsky, MD
Abramson Cancer Center of the University of Pennsylvania
Last Modified: November 7, 2006

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Presenter: Abrams, R et al.
Presenter's Affiliation: University of Maryland School of Medicine
Type of Session: Scientific

Background

  • Pancreatic cancer is a very difficult cancer to treat and cure
  • A previously published phase II trial of locally advanced and/or metastatic pancreatic cancer demonstrated improved outcomes with gemcitabine compared to 5-FU (the current standard of care)
  • This phase III prospective randomized trial was originally undertaken to determine whether the addition of gemcitabine to postoperative 5-FU with radiation would improve outcomes in patients with resected pancreatic adenocarcinomas
  • Numerous multi-institution studies have been performed which show that there are considerable differences in the way that radiation is planned and delivered for pancreatic cancer
  • previous studies have suggested that the quality of radiation that is delivered impacts patient outcomes
  • This analysis was performed in order to see if a correlation exists between the quality of radiation therapy and patient survival

Materials and Methods

  • This trial included patients following curative gross total resection of T1-4, N0-1, M0 pancreatic adenocarcinoma
  • 442 patients were randomized to either gemcitabine before and after concurrent 5-FU and radiation versus 5-FU before and after concurrent 5-FU and radiation
  • Patients were stratified by nodal status, primary tumor diameter, and surgical margin status and received a median dose of 50.4 Gy in 1.8 Gy fractions
  • The primary endpoint was survival
  • This analysis sought to elucidate whether the quality of the radiation delivered to patients influenced outcomes
  • Quality assurance checks for the radiation delivered were re-analyzed by 2 of the study investigators: Drs. Regine and Abrams
  • Radiation was scored as 1) per protocol 2) variation acceptable 3) variation unacceptable or 4) data incomplete to analyze

Results

  • Of the 451 patients analyzable, 35 had radiation that was not documented sufficiently to analyze
  • Overall survival was significantly improved for patients who received radiation per protocol compared to patients who did not (HR 0.78, p=0.04)
  • this benefit was greater in patients with pancreatic head cancers
  • There was no correlation between radiation quality and toxicity
  • When analyzed by center, there was no relationship between patients treated at a high-volume center versus a low-volume center

Author's Conclusions

  • Patients who were considered to received radiation per protocol had significantly improved survival compared to patients who did not
  • Radiation quality assurance must be carefully considered in the design and execution of further trials for pancreatic cancer

Clinical/Scientific Implications

This is an interesting analysis of a well-designed clinical trial for pancreatic cancer. These data suggest that the quality and execution of radiation will impact the outcomes for patients treated. Although this seems intuitive, these data are important in that they can quantify the magnitude of this effect. The only confounding factor for this analysis is that it is difficult to ascertain whether the design of the radiation is actually a surrogate for the quality of overall management, or whether the actual radiation field design influences outcomes. Regardless, these data will certainly assist future investigators in designing novel clinical trials. The quality of radiation therapy delivered at specific institutions needs to be studied in a controlled fashion; otherwise, it will be difficult to discern how much new therapeutics influence outcomes when compared to standard techniques.



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