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

Abstract

ObjectiveThe 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.MethodsWe 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.ResultsA 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.ConclusionThe 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.

Generalization and representativeness of phase III immune checkpoint blockade trials in non‐small cell lung cancer

“…These findings are consistent with the results of a previous study indicating that > 55% of melanoma patients were ineligible for an immunotherapy trial . Moreover, similar results were observed in studies examining eligibility for phase III trials of new drugs other than ICBs in other malignancies, such as lung, renal, breast, and pancreatic cancers . The ineligibility rate observed in our study was significantly higher than that of 4.2% (0–10.6%) reported in a study in a similar setting in Japan before 2000 .…”

“…8 Moreover, similar results were observed in studies examining eligibility for phase III trials of new drugs other than ICBs in other malignancies, such as lung, [9][10][11] renal, 12,13 breast, 14 and pancreatic cancers. 15 The ineligibility rate observed in our study was significantly higher than that of 4.2% (0-10.6%) reported in a study in a similar setting in Japan before 2000. 16 However, that study was based on trials and eligibility criteria different from our study.…”

Gemcitabine Compared With Gemcitabine and S-1 Combination Therapy in Advanced Pancreatic Cancer

“…Among the 78 articles that were selected on the basis of the inclusion/exclusion criteria, 72 articles were editorials or incomplete data and therefore excluded. Our final sample from 4 randomized clinical trials (level of evidence: 2b) 20 – 23 and 2 retrospective study (level of evidence: 3b) 24 , 25 that included 1025 patients were collected.…”

“…We collected data from 6 studies including a total of 1025 patients. All studies were conducted in Asian countries, including 5 in Japan, 20 – 22 , 24 , 25 and one Japanese–Chinese collaboration article. 23 The patient-level analyses showed that patient age varied from 40 to 70.…”

Molecular Targeted Intervention for Pancreatic Cancer

“…In the clinically ineligible arm, median PFS was 1.1 months, and median OS was 2.9 months. The outcomes for patients who did not meet the eligibility criteria were poor [ 95 ]. Hence, it is important to determine which patients could benefit from chemotherapy vs. optimal supportive care.…”