Table 1 Characteristics of included randomized controlled trials
Characteristics | Tabernero et al. [22] | Rivera et al. [23] | Stemmler et al. [24] | Schröder et al. [25] |
|---|---|---|---|---|
Year of publication | 2004 | 2008 | 2010 | 2011 |
Population | mBC | mBC | mBC | mBC |
Phase | Phase II | Phase III | Phase III | Phase III |
Total patients Randomized | 83 | 125 | 102 | 161 |
Total patients Evaluable | 82, 83 c | 118 | 102 | 156, 143 c |
 Weekly arm (QW) | 41 | 59 | 48 | 79, 81 c |
 Three-weekly arm (Q3W) | 41, 42 c | 59 | 54 | 77, 78 c |
Breast cancer subtype | ||||
 Oestrogen receptor positive | QW: 56.1% Q3W: 52.4% | QW: 55.6% Q3W: 48.4% | QW: 75.0% Q3W: 64.8% | QW: unknown Q3W: unknown |
 Her-2 positive | QW: unknown Q3W: unknown | QW: 4.7% Q3W: 12.9% | QW: 12.5% Q3W: 11.1% | QW: unknown Q3W: unknown |
 Triple negative | QW: unknown Q3W: unknown | QW: unknown Q3W: unknown | QW: unknown Q3W: unknown | QW: unknown Q3W: unknown |
Prior anthracyclines | QW: 82.9% Q3W: 78.6% | QW: 61.9% Q3W: 66.1% | QW: 20.8% Q3W: 29.6% | QW: 95.1% Q3W: 93.6% |
Age (median (range)) | QW: 56 (25–75) Q3W: 55 (33–72) | QW: 54 (32–86) Q3W: 56 (36–82) | QW: 73 (58–84) Q3W: 71 (60–82) | QW: 56 (29–74) Q3W: 53 (30–79) |
Performance status | QW: 61% PS0, 34% PS1, 5% PS2 d Q3W: 57% PS0, 38% PS1, 2% PS2 d | QW: NR Q3W: NR | QW: median 80%, range 60–100% e Q3W: median 80%, range 60–100%e | QW: 35% PS0, 47% PS1, 19% PS2 d Q3W: 28% PS0, 51% PS1, 21% PS2 d |
Primary endpoint | Toxicity | Response and toxicity | Hematological toxicity | Toxicity |
Accrual period | 23 months November 1999 – October 2001 | 44 months January 2001 – September 2004 | 85 months July 2001 – August 2008 | 62 months February 2001 – April 2006 |
Median follow-up | 10 mo (95% CI 0.5–24 mo) (QW) 10.2 mo(95% CI 0.3–26.7 mo)(Q3W) | 15.1 mo (range 0.5—51.6 months) | 14.4 months b (range 1.2—77.7 months) | 8.9 months (range, not reported) |
Docetaxel treatment | ||||
 QW | 40 mg/m2 Weekly for 6 weeks, 2 weeks rest | 35–40 mg/m2 Weekly for 3 weeks, 1 week rest | 30 mg/m2 Weekly for 3 weeks, 1 week rest | 36 mg/m2 Weekly for 6 weeks, 2 weeks rest |
 Q3W | 100 mg/m2 Every 3 weeks | 75–100 mg/m2 Every 3 weeks | 75 mg/m2 Every 3 weeks | 100 mg/m2 Every 3 weeks |
Dexamethasone dose f | QW: 24Â mg Q3W: 48Â mg | QW: 12Â mg Q3W: 48Â mg | QW: NR Q3W: NR | QW: 16Â mg Q3W: 32Â mg |