Table 1. Profile of 6 FOLFOX4 Studies.
| Items | Asian Studies | Western Studies | |||||
|---|---|---|---|---|---|---|---|
| J-PMS | MASCOT | EFC2962 | N9741 | EFC4584 | MOSAIC | ||
| PUT | PT | ||||||
| Phase of Study | PMS | IV | III | III | III | III | |
| Patients | Metastatic | Stage II/III | Metastatic | Metastatic | Metastatic | Stage II/III | |
| Treatment Line | First | ≥Second | Adjuvant | First | First | Second | Adjuvant |
| Arms | NA | 1 | 2 | 3 | 3 | 2 | |
| Primary Endpoint | Safety | Safety | PFS | TTP | OS | DFS | |
| Patient Number of FOLFOX4 Arm | |||||||
| ITT Population | NA | NA | 162 | 210 | 267 | 271 | 1123 |
| Safety population | 222 | 1134 | 159 | 209 | 259 | 268 | 1108 |
| Enrollment Period (Range) | April 2005; March 2006 | August 2004; December 2006 | August 1995; July 1997 | May 1999; April 2001 | November 2000; February 2002 | October 1998; January 2001 | |
| Study Countries | Japan | Asia, 5 countries | Europe, Israel | United States, Canada | North America | Europe, Australia, Israel, Singapore | |
Abbreviations: DFS = disease-free survival; FOLFOX4 = 5-fluorouracil/leucovorin/oxaliplatin; ITT = intent to treat; J-PMS = Post Marketing Surveillance study; NA = not applicable; OS = overall survival; PFS = progression-free survival; PT = previously treated with chemotherapy; PUT = previously untreated with chemotherapy; TTP = time to tumor progression.