Table 2.
Adjusted Effect of Baseline Creatinine Clearance on Study End Points by Regimen
| End Point by Regimen | % Who Met End Point* | OR/HR (95% CI)† | P‡ |
|---|---|---|---|
| Was dose modified | |||
| CMF | 71/70 | 1.14 (0.85 to 1.52) | NS |
| AC | 18/12 | 1.13 (0.84 to 1.49) | NS |
| Capecitabine | 68/61 | 1.10 (0.91 to 1.34) | NS |
| Completed all treatment | |||
| CMF | 65/65 | 0.90 (0.69 to 1.18) | NS |
| AC | 94/94 | 0.96 (0.62 to 1.48) | NS |
| Capecitabine | 84/80 | 1.15 (0.90 to 1.47) | NS |
| Experienced grade ≥ 3 AE | |||
| Hematologic | |||
| CMF | 49/52 | 0.92 (0.72 to 1.18) | NS |
| AC | 56/53 | 0.97 (0.78 to 1.20) | NS |
| Capecitabine | 3/2 | 1.37 (0.80 to 2.35) | NS |
| Nonhematologic | |||
| CMF | 41/40 | 1.07 (0.83 to 1.38) | NS |
| AC | 14/31 | 0.69 (0.52 to 0.91) | .008 |
| Capecitabine | 39/31 | 1.21 (1.00 to 1.47) | .052 |
| Either hematologic or nonhematologic | |||
| CMF | 70/68 | 1.05 (0.80 to 1.38) | NS |
| AC | 59/59 | 0.93 (0.75 to 1.15) | NS |
| Capecitabine | 40/32 | 1.23 (1.01 to 1.45) | .035 |
| RFS§ | |||
| CMF | 27/39 | 1.06 (0.86 to 1.33) | NS |
| AC | 34/36 | 1.08 (0.90 to 1.28) | NS |
| Capecitabine | 34/45 | 0.93 (0.80 to 1.08) | NS |
| OS§ | |||
| CMF | 22/33 | 1.10 (0.87 to 1.41) | NS |
| AC | 27/33 | 1.05 (0.87 to 1.27) | NS |
| Capecitabine | 29/38 | 0.92 (0.78 to 1.09) | NS |
Abbreviations: AC, cyclophosphamide/doxorubicin; AE, adverse event; CMF, cyclophosphamide/methotrexate/fluorouracil; HR, hazard ratio; NS, not significant; OR, odds ratio; OS, overall survival; RFS, relapse-free survival.
Stage of renal function at baseline (early stage/late stage).
OR for the following end points: was dose modified, completed all treatment, and experienced grade ≥ 3 toxicity; taken from the corresponding logistic regression. The OR represents a 10-unit increase in baseline creatinine clearance. HR for the following end points: RFS and OS; taken from the corresponding proportional hazards regression. The HR represents a 10-unit increase in baseline creatinine clearance. ORs and HRs are adjusted for race, age, number of positive nodes, tumor size, and hormone receptor status.
From Wald χ2 test of main effect of creatinine clearance from multivariable models.
Met end point for RFS or OS means the patient experienced an RFS or OS event, respectively.