Randomized phase 3 trials investigating P-gp modulators in AML
Study group . | Reference no. . | Modulator (dose) . | Diagnosis . | No. of patients . | Chemotherapy . | Outcome; P < .05 . |
|---|---|---|---|---|---|---|
| GOELAMS-MAQ2 | Solary et al 86 | Quinine (30 mg/kg/d) | AL | 315 | ID Ara-C + mitox (induction only) | Lower resistance; increased induction deaths |
| GFM and GOELAMS | Wattell et al87 | Quinine (30 mg/kg/d) | RAEB+t, MDS-AML | 131 | ID Ara-C + mitox (induction only) | Increased CR and OS in P-gp* patients |
| MRC | Liu Yin et al89 | CsA (2.5-5 mg/kg) | AML (RoR) | 235 | ADE vs timed sequential HiDAC-DE (induction only) | Negative |
| SWOG 9126 | List et al84 | CsA (16 mg/kg/d) | RAEB-t, AML (RoR, 2°) | 231 | HiDAC + DNR (induction and consolidation) | Lower resistance; increased RFS and OS |
Study group . | Reference no. . | Modulator (dose) . | Diagnosis . | No. of patients . | Chemotherapy . | Outcome; P < .05 . |
|---|---|---|---|---|---|---|
| GOELAMS-MAQ2 | Solary et al 86 | Quinine (30 mg/kg/d) | AL | 315 | ID Ara-C + mitox (induction only) | Lower resistance; increased induction deaths |
| GFM and GOELAMS | Wattell et al87 | Quinine (30 mg/kg/d) | RAEB+t, MDS-AML | 131 | ID Ara-C + mitox (induction only) | Increased CR and OS in P-gp* patients |
| MRC | Liu Yin et al89 | CsA (2.5-5 mg/kg) | AML (RoR) | 235 | ADE vs timed sequential HiDAC-DE (induction only) | Negative |
| SWOG 9126 | List et al84 | CsA (16 mg/kg/d) | RAEB-t, AML (RoR, 2°) | 231 | HiDAC + DNR (induction and consolidation) | Lower resistance; increased RFS and OS |
GFM denotes Groupe Francais des Myelodysplasies; CsA, cyclosporin-A; AL, acute leukemia; RoR, relapsed or refractory; 2°, secondary AML; 1°, primary AML; ID, intermediate-dose cytarabine; Ara-C, cytarabine; HiDAC, high-dose cytarabine; mitox, mitoxantrone; DNR, daunorubicin; VAD, infusional vincristine, doxorubicin, and dexamethasone; 6TG, 6-thioguanine; RFS, relapse-free survival; OS, overall survival.