Table 2.
Treatment outcome in ≥75-year-old patients enrolled in phase III clinical trials at relapse.
| TRIAL | Regimen | Age, Median (Range); Pts aged ≥ 75 Years, % |
Median PFS in the Overall Population, Months |
Median PFS in Pts Aged ≥ 75 Years, Months |
Main G ≥ 3 Adverse Events *in Pts Aged ≥75 Years |
Discontinuation Due to Adverse Events in Pts Aged ≥75 Years |
|---|---|---|---|---|---|---|
| ASPIRE [17,63,64] | KRd vs. Rd | 64 (31–91) 12% |
26.3 vs. 17.6 m HR 0.69 (95% CI 0.57–0.83) |
30.3 vs. 16.6 m HR 0.62 (95% CI 0.36–1.08) |
[in pts aged ≥70 years]: neutropenia 36.9% vs. 23.2%; thrombocytopenia 20.45 vs. 25.2%; pneumonia 15.5% vs. 14.3%; hypertension 5.8% vs. 1.8%; cardiac failure 8.7% vs. 1.8% |
[in pts aged ≥70 years]: 34% vs. 34.8% |
| ENDEAVOR [18,65] | Kd vs. Vd | 65 (30–89) 15% |
18.7 vs. 9.4 m HR 0.53 (95% CI 0.44–0.65) |
18.7 vs. 8.9 m HR 0.38 (95% CI 0.22–0.64) |
Thrombocytopenia 7.8% vs. 9.2%; cardiac failure 10.4% vs. 3.1%; hypertension 11.7% vs. 3.1%; pneumonia 7.8% vs. 12.3% |
26% vs. 35.4% |
| TOURMALINE-MM1 [62] | IRd vs. Rd | 66 (30–91) 15% |
20.6 vs. 14.7 m HR 0.74 (95% CI 0.59–0.94) |
18.5 vs. 13.1 m HR 0.87 (95% CI na) |
na | na |
| POLLUX [66,67] | Dara-Rd vs. Rd | 65 (34–89) 11% |
44.5 vs. 17.5 m HR 0.44 (95% CI 0.35–0.55) |
28.9 vs. 11.4 m HR 0.27 (95% CI 0.10–0.69) |
Neutropenia 44.8% vs. 31.4%; thrombocytopenia 10.3% vs. 14%; pneumonia 17.2% vs. 11.4%; pulmonary embolism 3.4% vs. 11%; infusion reaction 13.8% |
17% vs. 17% |
| CASTOR [67,68] | Dara-Vd vs. Vd | 64 (30–88) 12% |
16.7 vs. 7.1 m HR 0.31 (95% CI 0.24–0.39) |
17.9 vs. 8.1 m HR 0.26 (95% CI 0.10–0.65) |
Thrombocytopenia 45% vs. 37.1%; neuropathy 10% vs. 5.7%; diarrhea 10% vs. 0; pneumonia 15% vs. 17%; infusion reaction 10% |
17% vs. 20% |
| ELOQUENT-2 [69] | Elo-Rd vs. Rd | 66 (37–91) 20% |
19.4 vs. 14.9 m HR 0.44 (0.59–0.86) |
Na HR 0.63 (95% CI 0.41–0.96) |
na | na |
| ICARIA-MM [70] | Isa-Pd vs. Pd | 67 (36–86) 20% |
11.5 vs. 6.5 m HR 0.60 (95% CI 0.44–0.81) |
11.4 vs. 4.5 m HR 0.48 (95% CI 0.24–0.95) |
neutropenia 50% vs. 46.4%; thrombocytopenia 15.6% vs. 10.7%; infection 46.9% vs. 35.7%; infusion reaction 3.1% |
15.6% vs. 14.3% |
| ELOQUENT-3 [71] | Elo-Pd vs. Pd | 67 (36–81) 21% |
10.3 vs. 4.7 m HR 0.54 (95% CI 0.34–0.86) |
Na HR 0.62 (95% CI 0.23–1.67) |
na | na |
| OPTIMISMM [72] | PVd vs. Vd | 68 (59–73) 16% |
11.2 vs. 7.1 m HR 0.61 (95% CI 0.49–0.77) |
Na HR 0.78 (0.46–1.32) |
na | na |
Abbreviations: Pts, patients; PFS, progression-free survival; m, months; HR, hazard ratio; CI, confidence interval; p, p-value; na, not available; RD, carfilzomib, lenalidomide, dexamethasone; Rd lenalidomide, dexamethasone; Kd, carfilzomib, dexamethasone; Vd, bortezomib, dexamethasone; IRd, ixazomib, lenalidomide, dexamethasone; Dara, daratumumab; Elo, elotuzumab; Isa, isatuximab; Pd, pomalidomide, dexamethasone; PVd, pomalidomide, bortezomib, dexamethasone; G, grade.