Treatment outcome of advanced pancreatic cancer patients who are ineligible for a clinical trial

OBJECTIVE: The aim of this study was to evaluate the outcome of patients with advanced pancreatic cancer in clinical practice, and assess whether chemotherapy provided a clinical benefit for patients who did not meet the eligibility criteria of the clinical trial. METHODS: We retrospectively analyzed the medical records of 75 patients who received first-line chemotherapy for pancreatic cancer between April 2006 and September 2011. Patients were treated with gemcitabine (GEM) alone, S-1 (tegafur, gimeracil, and oteracil potassium) alone, or GEM plus S-1. Patients were divided into the clinical trial eligible group (arm eligible) or the ineligible group (arm ineligible). We evaluated the efficacy and the safety of the chemotherapy. RESULTS: A total of 23 patients out of 75 (31%) belonged to the ineligible group, for the following reasons: 20 patients had poor performance status, eight had massive ascites, one had synchronous malignancy, and one had icterus. The median progression-free survival (PFS) was 3.5 months, and the median overall survival (OS) was 6.7 months in all patients. In arm eligible, median PFS was 4.5 months, and median OS was 10.5 months. In arm ineligible, median PFS was 1.1 months, and median OS was 2.9 months. CONCLUSION: The outcome of the patients who did not meet the eligibility criteria was very poor. It is important to select the patients that could benefit from either chemotherapy or optimal supportive care.