Wednesday, January 30, 2013

ASCO GU - Another Breakthrough in Pancreatic Cancer - TS-1 superior to Gemcitabine in improving overall survival in patients with resected Pancreatic Cancer

Taiho Pharmaceutical Co., Ltd.  announced results of a Randomized phase III trial of adjuvant chemotherapy with gemcitabine (GEM) versus S-1(TS-1) for patients with resected pancreatic cancer (JASPAC-01*1) (Abstract No. 145) at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology. 

The primary endpoint of the trial was to gauge non-inferiority of TS-1 to gemcitabine, however an interim analysis of survival data suggests that TS-1 is infact superior to Gemcitabine. As a result, the independent data monitoring committee has recommended  to publish the results soon.  

The HR for S-1 to GEM was 0.56 (95% CI, 0.42-0.74, p<0.0001 for non-inferiority, p<0.0001 for superiority). The 2-year survival rates were 53% (95% CI, 46-60) for GEM and 70% (63-76) for S-1.


Trial Results:  TS-1 superior to Gemcitabine in Pancreatic Cancer

From 4/2007 to 6/2010, 385 pts were enrolled (GEM: 193, S-1: 192) from 33 hospitals in Japan. In 378 pts (GEM: 191, S-1:187) of the full analysis set, background factors were well balanced between groups. Based on the interim analysis on survival data obtained by 7/2012, the independent data monitoring committee recommended to publish the results soon. The HR for S-1 to GEM was 0.56 (95% CI, 0.42-0.74, p<0.0001 for non-inferiority, p<0.0001 for superiority). The 2-year survival rates were 53% (95% CI, 46-60) for GEM and 70% (63-76) for S-1. The reasons for treatment discontinuation (recurrence/toxicity/patient’s refusal/others) were 27/48/5/2 in GEM and 9/40/3/0 in S-1. Incidences (%) of grade 3/4 toxicities in GEM/S-1 were fatigue (4.7/5.4), anorexia (5.8/8.0), leukopenia (38.7/8.6), thrombocytopenia (9.4/4.3), anemia (17.3/13.4), and elevated AST (5.2/1.1). Conclusions: S-1 adjuvant chemotherapy is shown non-inferior, and furthermore, even superior to GEM. S-1 may be considered as the new standard treatment for resected PC pts.

JASPAC - Trial Background

Gemcitabine (GEM) has been a standard treatment of adjuvant chemotherapy for resected pancreatic cancer (PC). S-1 is an oral fluoropyrimidine, and shown to be non-inferior to GEM on overall survival (OS) for unresectable PC. The aim of this study is to determine non-inferiority of S-1 to GEM on OS as an adjuvant chemotherapy for resected PC.  

JASPAC -Trial Design

Methods: Patients (pts), who met the following criteria; histologically confirmed ductal adenocarcinoma of the pancreas, R0 or R1 resection, pathological stage I, II, or III with resection of the celiac axis, age >20, no prior chemotherapy or radiotherapy within 3 years, and adequate organ functions, were randomly assigned to GEM (1000 mg/m2, div on days 1, 8 and 15, repeated every 4 weeks, for 6 courses) or S-1 (40-60 mg according to the body surface, twice a day, for 4 weeks, repeated every 6 weeks, for 4 courses). Primary endpoint was OS. With 180 pts in each, the study had 80% power to prove non-inferiority with a non-inferiority margin of hazard ratio (HR) 1.25 on the basis of expected HR 0.87, at 0.05 two-sided alpha. An interim analysis was planned after 180 deaths.

About JASPAC Trial

The trial was conducted by Pharma Valley Center, part of the Shizuoka Industrial Foundation, which is under contract with Taiho Pharmaceutical. It was a Phase III clinical trial comparing the standard treatment gemcitabine (GEM) monotherapy with TS-1 monotherapy in patients with resected pancreatic cancer. The study verified that the overall survival (OS) of patients who use TS-1 oral anti-cancer monotherapy is superior to GEM monotherapy, the standard adjuvant chemotherapy for patients with resected pancreatic cancer, and demonstrated that TS-1 greatly improved the overall survival rate.

This was the first Phase III clinical trial indicating the effectiveness of TS-1 in patients with resected pancreatic cancer.











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