Table 5.
Feasibility testing of the ESMO-MCBS v1.1 for indolent non-Hodgkin and relapsed/refractory setting of non-DLBCL and Hodgkin’s lymphoma (n=12)
| Medication | Trial name | Setting | Primary outcome | PFS control | PFS gain | PFS HR | OS control | OS gain | OS HR | RR (DOR) | QOL | Toxicity | ESMO-MCBS score | ESMO-MCBS form | Reference(s) |
| Obinutuzumab-Chemo versus R-Chemo | GALLIUM | Follicular lymphoma, first line | PFS | 73% (3 years) |
7% | 0.66 (0.51–0.85) | Not scoreable | 2b | 46 | ||||||
| VR-CAP versus R-CHOP | LYM-3002 | Mantle cell lymphoma first line, not eligible for transplant | PFS | 14.4 months | 10.3 months | 0.63 (0.5–0.79) | 55.7 months |
35
months
(7 year survival gain >5% with plateau) |
0.66 (0.51– 0.85) | Increased in experimental arm | A/4 | 1/2a | 47 48 | ||
| R-Bendamustine versus R-CHOP/R-CVP | BRIGHT study | Indolent and mantle cell lymphoma, first line | Non-inferiority in CRR (margin: 0.88) | Non-inferiority met 1.26 (0.93–1.73) 31% versus 25%, 6% gain |
Improved | Not scoreable | 2c | 49 50 | |||||||
| R-Bendamustine versus R-CHOP | STiL Trial NHL 1-2003 | Indolent and mantle cell lymphoma, first line | Non-inferiority in PFS (margin: 1.32) | 31.2 months | 38.3 months | 0.58 (0.44–0.74) Non-inferiority met |
Less adverse events in experimental arm | 4 | 2c | 51 | |||||
|
Bendamustine±
Obinutuzumab |
GADOLIN | Rituximab-refractory indolent non-Hodgkin’s lymphoma | PFS | 14.9 months | NA | 0.55 (0.40–0.74) | NR | >10% at 5 years | 0.67 (0.47– 0.96) | Delayed deterioration in QOL | 5 | 2a | 52–54 | ||
| Ibrutinib versus Temsirolimus | Relapsed/refractory mantle cell lymphoma | PFS | 6.2 months | 8.4 months | 0.43 (0.32–0.58) | Improved (+1 point) | 4 | 2b | 55 | ||||||
| Lenalidomide versus Investigator’s choice | MCL-002 SPRINT | Relapsed/refractory mantle cell lymphoma | PFS | 5.2 months | 3.5 months | 0.61 (0.44–0.84) | Improved (+1 point) | 4 | 2b | 56 | |||||
| Ibrutinib | PCYC-1104-CA | Relapsed/refractory mantle cell lymphoma | ORR | 13.9 months | 68% | 3 | 3 | 57 | |||||||
| Ibrutinib | Relapsed/refractory marginal zone lymphoma | ORR | 14.2 months | 48% | Relevant toxicity but not meeting criteria for downgrading | 3 | 3 | 58 | |||||||
| Idealisib | DELTA (101-09) | Relapsed/refractory indolent lymphoma | ORR | 11 months | 57% (12.5 months) | 3 | 3 | 59 | |||||||
| Pembrolizumab | KEYNOTE- 087 |
Relapsed/refractory Hodgkin lymphoma | ORR | 69% | Improved (+1 point) | 4 | 3 | 60 | |||||||
| Nivolumab | Check Mate 205 |
Relapsed/refractory Hodgkin lymphoma | ORR | 14.7 months | 69% | Improved (+1 point) | 4 | 3 | 61 62 |
chemo, chemotherapy; CRR, complete response rate;DLBCL, non-diffuse large B-cell lymphoma; DOR, duration of response;ESMO-MCBS v1.1, European Society for Medical Oncology—Magnitude of Clinical Benefit Scale, version 1.1; NA, not applicable; NR, not reached; ORR, overall response rate; OS, overall survival;PFS, progression-free survival; QOL, quality of life; R, rituximab; R-CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; R-CVP, rituximab, cyclophosphamide, vincristine and prednisone; RR, response rate; VR-CAP, bortezomib, rituximab, cyclophosphamide, doxorubicin and prednisone.