Mitchell S. Wachtel¹, K. Tom Xu², Yan Zhang², Maurizio Chiriva-Internati³ and Eldo E. Frezza⁴

¹Department of Pathology, Texas Tech University Health Sciences Center, Lubbock Texas. ²Department of Family and Community Medicine, Texas Tech University Health Sciences Center, Lubbock Texas. ³Department of Microbiology and Immunology, Texas Tech University Health Sciences Center, Lubbock Texas. ⁴Department of Surgery, Texas Tech University Health Sciences Center, Lubbock Texas.

Abstract

After multiple positive studies, gemcitabine, approved for the treatment of pancreas cancer by the FDA in 1977, became standard of care. Whether this therapeutic advance has translated into longer survival for pancreas cancer patients in general has not been established. This study, derived from SEER (Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute) data, compared the survival experiences of the gemcitabine (1998 – 2004) and pre-gemcitabine (1988-1997) eras for 7,151 patients who had metastatic disease and did not undergo extirpative surgery , 14,369 patients who had not undergone surgery and had metastases, 5,042 patients who had undergone surgery and did not have metastases, and 5,011 patients who had undergone surgery and had metastases. Calculated survival time ratios (TR) were adjusted for radiotherapy history, grade, nodal status, loco-regional extent of disease, age, race, and gender. For those who did not undergo extirpative surgery, improvements in survival in the gemcitabine era (1998-2004) versus the prior time period (1988-1997) seen for patients with metastatic cancer (TR = 1.20, 95% c.i. 1.15 – 1.25) were not seen for those without metastatic cancer (TR = 1.05, 95% c.i. 1.00 – 1.15). For those who did undergo extirpative surgery, improvements were much more dramatic for those with metastatic cancer (TR = 1.61, 95% c.i. 1.45 – 1.80) than those without metastases (TR = 1.23, 95% c.i. 1.15 – 1.31). The results are consistent with the notion that the promising findings with respect to gemcitabine in the controlled clinical trials have found expression in the general population of patients with pancreas cancer.