Table 1.
Year of Approval | Type of Approval | Drugs | No. of Patients | Drug Doses | End Points | HR | 95% CI | Log-Rank P |
---|---|---|---|---|---|---|---|---|
1994 | RA | P | 471 | P: 175 mg/m2 v 135 mg/m2 | TTP: median, 4.2 v 3.0 months | 0.75 | .027 | |
1996 | AA | D | 309 | D: 100 mg/m2 | ORR: 37.9% | 31.0 to 44.8 | ||
1998 | RA | D | 392 | D: 100 mg/m2 v M: 12 mg/m2 + V: 6 mg/m2 | OS: median 11.4 v 8.7 months | 0.73 | 0.58 to 0.93 | .01 |
1998 | RA | T | 222 | T: 4 mg/kg load, 2 mg/kg weekly | ORR: PR, 12%; CR, 2% | 7.73 to 16.3 | ||
1998 | AA | C | 162 | C: 2,500 mg/m2 | ORR: 25.6% | 13.5 to 41.2 | ||
2001 | RA | C/D | 511 | C: 2,500 mg/m2 + D: 75 mg/m2 v D: 100 mg/m2 | OS: median, 442 v 352 days | 0.77 | 0.63 to 0.95 | .01 |
2005 | RA | A-bound P | 460 | A: 260 mg/m2 | ORR: 21.5% | 16.2 to 26.7 | .003 | |
P: 175 mg/m2 | ORR: 11.1% | 6.9 to 15.1 | ||||||
2007 | RA | L/C | 399 | L: 1,250 mg + C: 2,000 mg/m2 v C: 2,500 mg/m2 | TTP: median IND, 27.1 v 18.6 weeks | 0.57 | 0.43 to 0.77 | < .001 |
TTP: median INV, 23.9 v 18.3 days | 0.72 | 0.56 to 0.92 | .008 | |||||
OS: median, 75 v 65.8 weeks | 0.89 | 0.71 to 1.10 | .276 | |||||
2007 | RA | I | 126 | 40 mg/m2 | ORR: 12.4% DR: median, 6 months | 6.9 to 9.9 | ||
2007 | RA | I/C | 752 | I: 40 mg/m2 + C: 2,000 mg/m2 v C: 2,500 mg/m2 | PFS: median, 5.7 v 4.1 months | 0.69 | 0.58 to 0.83 | < .001 |
OS: median, 12.9 v 11.1 months* | 0.90 | 0.77 to 1.05 | .19 | |||||
2010 | RA | E | 762 | E: 1.4 mg/m2 v PC | OS: median, 13.1 v 10.6 months | 0.81 | 0.66 to 0.99 | .041 |
Abbreviations: A, albumin; AA, accelerated approval; C, capecitabine; D, docetaxel; DR, duration of response; E, eribulin; HR, hazard ratio; I, ixabepilone; IND, independent assessment; INV, investigator assessment; L, lapatinib; M, mitomycin; ORR, objective response rate; OS, overall survival; P, paclitaxel; PC, physician's choice; PFS, progression-free survival; RA, regular approval; RR, response rate; T, trastuzumab; TTP, time to progression; V, vinblastine.
Updated OS.