Survival outcomes in patients with early stage, resectable pancreatic cancer - a comparison of gemcitabine and 5-fluorouracil based treatment regimens. Open Access

Kizilbash, Sani Haider (2011)

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Survival outcomes in patients with early stage, resectable pancreatic cancer -
a comparison of gemcitabine and 5-fluorouracil based treatment regimens.

Sani Haider Kizilbash

PURPOSE: Pancreatic cancer is the fourth leading cause of cancer mortality. Beyond curative
surgery, the optimal treatment for early stage pancreatic cancer is still a matter of debate.
METHODS: We conducted a population based, retrospective cohort study using SEER-Medicare
data to evaluate survival outcomes of patients with early stage pancreatic cancer. Patients
diagnosed between the years 1998 and 2005 who had received curative surgery followed by
adjuvant chemotherapy with either 5-fluorouracil or gemcitabine were examined. These groups
were further divided based on the use of radiotherapy. Survival analyses and Cox proportional
hazards modeling were conducted.
RESULTS: - 705 patients were studied of which 359 received 5-fluorouracil and 346 received
gemcitabine. When compared to chemoradiation with 5-fluorouracil, survival outcomes for
patients who received chemoradiation with gemcitabine did not differ (hazard ratio (HR) =
0.979 for high grade tumors (HGT), HR = 1.043 for low grade tumors (LGT)). Patients who
received gemcitabine alone had worse survival (HR = 1.499 for HGT, 1.320 for LGT). However,
survival outcomes of patients who received 5-fluorouracil alone varied with tumor grade. In low
grade tumors, patients have increased survival with 5-fluorouracil when compared with
chemoradiation with 5-fluorouracil (HR = 0.427). In high grade tumors, patient survival was
worse (HR 2.099).
CONCLUSION: - Among patients who received chemoradiation, there was no difference in
survival outcomes between patients receiving either 5-fluorouracil or gemcitabine. Patients
with low grade resectable pancreatic cancer may have better outcomes with 5-fluorouracil
based chemotherapy without radiation. Future clinical trials may need to be stratified or
randomized based on tumor grade to resolve the debate on the role of chemoradiotherapy in
resectable pancreatic cancer.

Table of Contents

Contents: Abstract 4 Background 5 Methodology 6 Statistical Methods 9 Results 10 Discussion 12 Limitations 14 Conclusions 17 Acknowledgements 17 Tables 19 Table 1 - Codes used to identify surgery, chemotherapy and radiotherapy 19 Table 2 - Frequency table 19 Table 3 - Kaplan Meier analysis based survivals 20 Table 4 - Univariate analysis 21 Table 5 - Multivariable analysis (stratified by grade) 23 Table 6 - Survival and grade distribution in clinical trials involving 5-fluorouracil based treatment 24 Appendices 25 Research objective 25 Research questions 25 Detailed literature review 26 Details on treatment regimen identification 29 References 34

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