PFS from enrollment, showing bortezomib, dexamethasone, and thalidomide by protocol step
| PFS with BSA-adjusted dosages . | PFS without BSA adjustment . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Factor . | n/N (%) . | HR (95% CI) . | P . | HR (95% CI)* . | P* . | Factor . | HR (95% CI) . | P . | HR (95% CI)* . | P* . |
| Bortezomib during induction (mg/m2) | 303/303 (100) | 0.81 (0.70, 0.94) | .005 | 0.89 (0.78, 1.02) | .106 | Bortezomib during induction (mg) | 0.90 (0.83, 0.97) | .008 | 0.93 (0.87, 1.00) | .055 |
| Bortezomib during consolidation (mg/m2) | 232/303 (77) | 0.92 (0.85, 0.99) | .019 | 0.94 (0.89, 1.00) | .038 | Bortezomib during consolidation (mg) | 0.96 (0.92, 1.00) | .039 | 0.97 (0.93, 1.00) | .034 |
| Bortezomib during maintenance (mg/m2) | 215/303 (71) | 0.99 (0.98, 1.00) | .219 | 0.99 (0.98, 1.00) | .165 | Bortezomib during maintenance (mg) | 1.00 (0.99, 1.00) | .286 | 1.00 (0.99, 1.00) | .134 |
| Dexamethasone during induction (dg/m2) | 303/303 (100) | 0.66 (0.46, 0.95) | .025 | 0.80 (0.58, 1.09) | .161 | Dexamethasone during induction (dg) | 0.75 (0.60, 0.94) | .011 | 0.82 (0.67, 1.00) | .047 |
| Dexamethasone during transplant (dg/m2) | 260/303 (86) | 0.85 (0.72, 1.01) | .067 | 0.87 (0.76, 1.01) | .060 | Dexamethasone during transplant (dg) | 0.92 (0.83, 1.01) | .078 | 0.92 (0.85, 0.99) | .036 |
| Dexamethasone during consolidation (dg/m2) | 233/303 (77) | 0.80 (0.69, 0.94) | .005 | 0.94 (0.84, 1.04) | .236 | Dexamethasone during consolidation (dg) | 0.89 (0.81, 0.97) | .007 | 0.95 (0.89, 1.02) | .165 |
| Dexamethasone during maintenance (dg/m2) | 211/303 (70) | 0.93 (0.87, 0.99) | .029 | 0.92 (0.88, 0.97) | < .001 | Dexamethasone during maintenance (dg) | 0.97 (0.93, 1.00) | .047 | 0.96 (0.93, 0.98) | .001 |
| Thalidomide during induction (g/m2) | 301/303 (99) | 0.57 (0.33, 0.97) | .039 | 0.75 (0.48, 1.16) | .191 | Thalidomide during induction (g) | 0.68 (0.50, 0.95) | .021 | 0.80 (0.62, 1.05) | .108 |
| Thalidomide during transplant (g/m2) | 253/303 (84) | 0.88 (0.77, 1.00) | .046 | 0.91 (0.83, 1.01) | .083 | Thalidomide during transplant (g) | 0.94 (0.87, 1.01) | .071 | 0.95 (0.90, 1.01) | .084 |
| Thalidomide during consolidation (g/m2) | 230/303 (76) | 0.93 (0.85, 1.02) | .142 | 0.95 (0.89, 1.02) | .171 | Thalidomide during consolidation (g) | 0.97 (0.92, 1.02) | .220 | 0.96 (0.92, 1.00) | .069 |
| Thalidomide during maintenance (g/m2) | 195/303 (64) | 1.00 (0.97, 1.02) | .761 | 0.98 (0.96, 1.00) | .092 | Thalidomide during maintenance (g) | 1.00 (0.98, 1.01) | .824 | 0.99 (0.98, 1.00) | .095 |
| PFS with BSA-adjusted dosages . | PFS without BSA adjustment . | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Factor . | n/N (%) . | HR (95% CI) . | P . | HR (95% CI)* . | P* . | Factor . | HR (95% CI) . | P . | HR (95% CI)* . | P* . |
| Bortezomib during induction (mg/m2) | 303/303 (100) | 0.81 (0.70, 0.94) | .005 | 0.89 (0.78, 1.02) | .106 | Bortezomib during induction (mg) | 0.90 (0.83, 0.97) | .008 | 0.93 (0.87, 1.00) | .055 |
| Bortezomib during consolidation (mg/m2) | 232/303 (77) | 0.92 (0.85, 0.99) | .019 | 0.94 (0.89, 1.00) | .038 | Bortezomib during consolidation (mg) | 0.96 (0.92, 1.00) | .039 | 0.97 (0.93, 1.00) | .034 |
| Bortezomib during maintenance (mg/m2) | 215/303 (71) | 0.99 (0.98, 1.00) | .219 | 0.99 (0.98, 1.00) | .165 | Bortezomib during maintenance (mg) | 1.00 (0.99, 1.00) | .286 | 1.00 (0.99, 1.00) | .134 |
| Dexamethasone during induction (dg/m2) | 303/303 (100) | 0.66 (0.46, 0.95) | .025 | 0.80 (0.58, 1.09) | .161 | Dexamethasone during induction (dg) | 0.75 (0.60, 0.94) | .011 | 0.82 (0.67, 1.00) | .047 |
| Dexamethasone during transplant (dg/m2) | 260/303 (86) | 0.85 (0.72, 1.01) | .067 | 0.87 (0.76, 1.01) | .060 | Dexamethasone during transplant (dg) | 0.92 (0.83, 1.01) | .078 | 0.92 (0.85, 0.99) | .036 |
| Dexamethasone during consolidation (dg/m2) | 233/303 (77) | 0.80 (0.69, 0.94) | .005 | 0.94 (0.84, 1.04) | .236 | Dexamethasone during consolidation (dg) | 0.89 (0.81, 0.97) | .007 | 0.95 (0.89, 1.02) | .165 |
| Dexamethasone during maintenance (dg/m2) | 211/303 (70) | 0.93 (0.87, 0.99) | .029 | 0.92 (0.88, 0.97) | < .001 | Dexamethasone during maintenance (dg) | 0.97 (0.93, 1.00) | .047 | 0.96 (0.93, 0.98) | .001 |
| Thalidomide during induction (g/m2) | 301/303 (99) | 0.57 (0.33, 0.97) | .039 | 0.75 (0.48, 1.16) | .191 | Thalidomide during induction (g) | 0.68 (0.50, 0.95) | .021 | 0.80 (0.62, 1.05) | .108 |
| Thalidomide during transplant (g/m2) | 253/303 (84) | 0.88 (0.77, 1.00) | .046 | 0.91 (0.83, 1.01) | .083 | Thalidomide during transplant (g) | 0.94 (0.87, 1.01) | .071 | 0.95 (0.90, 1.01) | .084 |
| Thalidomide during consolidation (g/m2) | 230/303 (76) | 0.93 (0.85, 1.02) | .142 | 0.95 (0.89, 1.02) | .171 | Thalidomide during consolidation (g) | 0.97 (0.92, 1.02) | .220 | 0.96 (0.92, 1.00) | .069 |
| Thalidomide during maintenance (g/m2) | 195/303 (64) | 1.00 (0.97, 1.02) | .761 | 0.98 (0.96, 1.00) | .092 | Thalidomide during maintenance (g) | 1.00 (0.98, 1.01) | .824 | 0.99 (0.98, 1.00) | .095 |
As seen with time-dependent models for OS, the univariate time-dependent models for PFS fail to show a confounding effect of BSA. Estimates of the hazard ratio remain consistent.
PFS indicates progression-free survival; n, number receiving a dose during the specified step; N, total number of patients on TT3 (2003-33); BSA, body surface area; HR, hazard ratio; and CI, confidence interval.
Data as of April 20, 2012.