Table 1. Characteristics of the trials.
| Study | GEST | JACCRO PC-01 | GEMSAP |
|---|---|---|---|
| Country | Japan, Taiwan | Japan | Japan |
| Study design | Phase III | r-Phase II | r-Phase II |
| Primary end point | Overall survival | Response rate | Progression-free survival |
| Treatment schedule for GEM | GEM 1000 mg m−2, days 1, 8.15. 1 course (4 weeks) | GEM 1000 mg m−2, days 1, 8.15. 1 course (4 weeks) | GEM 1000 mg m−2, days 1, 8.15. 1 course (4 weeks) |
| Treatment schedule for GS | GEM 1000 mg m−2, days 1, 8. S-1 65 mg m−2, days 1–14. One course (3 weeks) | GEM 1000 mg m−2, days 1, 8. S-1 80 mg m−2, days 1–14. One course (3 weeks) | GEM 1000 mg m−2, days 1, 15. S-1 80 mg m−2, days 1–14. One course (4 weeks) |
| Major eligibility criteria | No prior chemotherapy, locally advanced or metastatic pancreatic cancer, age ⩾20 (amended age 20–80), PS 0–1 | No prior chemotherapy, locally advanced or metastatic pancreatic cancer, measurable lesions, age 20–80, PS 0–2 | No prior chemotherapy, locally advanced or metastatic pancreatic cancer, age 20–80, PS 0–2 |
| Accrual period | July 2007 to October 2009 | March 2007 to August 2010 | July 2006 to February 2009 |
| Number of sites | 75 | 16 | 6 |
| Number of registered patients (GEM/GS) | 554 (277/277) | 117 (59/58) | 106 (53/53) |
| Main efficacy data (GEM/GS)a | |||
| Response rate (%) | 13.3/29.3 | 6.8/28.3 | 9.4/18.9 |
| Median progression-free survival (months) | 4.1/5.7 | 3.78/6.15 | 3.6/5.4 |
| Median survival time (months) | 8.8/10.1 | 8.0/13.7 | 8.8/13.5 |
| Number of overall survival events | 472 | 87 | 100 |
Abbreviations: GEM=gemcitabine; GS=gemcitabine plus S-1; JACCRO=Japan Clinical Cancer Research Organization; PS=performance status.
a
Data are publication-based (not up to date).