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C. Pawlyn et al.
Table 2. Baseline characteristics of patients in the age-matched groups. All
TE-ASCT n=404
66.0 (64.0-70.0)
264 (65.3) 140 (34.7)
160 (39.6) 173 (42.8) 41 (10.1) 7 (1.7) 23 (5.7)
125 (30.9) 164 (40.6) 79 (19.6) 36 (8.9)
86 (51.8) 55 (33.1) 25 (15.1)
194 (48.0) 210 (52.0)
303 (75.0) 101 (25.0)
243 (80.2) 47 (15.5) 13 (4.3)
51 (12.6) 286 (70.8) 65 (16.1) 2 (0.5)
Age-matched groups TE-noASCT n=129
67.0 (64.0-70.0)
73 (56.6) 56 (43.4)
44 (34.1) 51 (39.5) 20 (15.5) 10 (7.8) 4 (3.1)
29 (22.5) 52 (40.3) 43 (33.3) 5 (3.9)
37 (57.8) 19 (29.7) 8 (12.5)
62 (48.1) 67 (51.9)
106 (82.2) 23 (17.8)
60 (56.6) 26 (24.5) 20 (18.9)
10 (7.8) 97 (75.2) 19 (14.7) 3 (2.3)
TNE n=237
68.0 (64.0-70.0)
134 (56.5) 103 (43.5)
65 (27.4) 97 (40.9) 48 (20.3) 17 (7.2) 10 (4.2)
45 (19.0) 102 (43.0) 73 (30.8) 17 (7.2)
61 (61.6) 31 (31.3) 7 (7.1)
89 (37.6) 148 (62.4)
237 (100) 0 (0)
127 (53.6) 79 (33.3) 31 (13.1)
33 (13.9) 171 (72.2) 30 (12.7) 3 (1.3)
Age, years; median (range)
Sex, n (%) Male
Female
Performance status, (WHO), n (%) 0
1
2
≥3
Not available
International Staging System, n (%) I
II
III
Not available
Cytogenetic profile#, n (%) Standard risk
High risk
Ultrahigh risk
Induction Randomisation Treatment, n (%) CTD/CTDa
CRD/CRDa
MRP possible to define, n (%) Yes
No
MRP risk (% based on those patients with all MRP data available), n (%)
Low Intermediate High
Patients’ response after Induction (+intensification where received), n (%)
Complete response
Very good partial response Partial response
Minimal response
n=770
67.0 (64.0-70.0)
471 (61.2) 299 (38.8)
269 (34.9) 321 (41.7) 109 (14.2) 34 (4.5) 37 (4.8)
199 (25.8) 318 (41.3) 195 (25.3) 58 (7.5)
184 (55.9) 105 (31.9) 40 (12.2)
345 (44.8) 425 (55.2)
646 (83.9) 124 (16.1)
430 (66.6) 152 (23.5) 64 (9.9)
94 (12.2) 554 (72.0) 114 (14.8) 8 (1.0)
# data available for 329 of 770 (42.7%) patients (166 of 404 [41.1%] TE-ASCT patients, 64 of 129 [49.6%] TE-noASCT patients and 99 of 237 [41.8%] TNE patients). Percentages given are of those with data available.TE: transplant eligible, ASCT: autologous stem cell transplant; TNE: not eligible for transplantation; WHO: World Health Organization; CTD: cyclophosphamide, thalidomide and dexamethasone; CRD: cyclophosphamide, lenalidomide and dexamethasone; CTDa: attenuated CTD; CRDa: attenuated CRD; MRP: UK Myeloma Research Alliance Myeloma Risk Profile.
serious adverse events and deaths reported within 100 days of the end of induction (± intensification). Two hun- dred and three serious adverse events were reported within 100 days: 132 events in 105 patients in the TE- ASCT group (26.0% of patients), 70 events in 49 patients in the TE-noASCT group (38.0%) and 65 events in 53 patients in the TNE group (22.4%). Five patients died within 100 days: none in the TE-ASCT group, two in the TE-noASCT group (2.7%) and three in the TNE group (2.18%). Thirty-seven patients died within 365 days: nine in the TE-ASCT group (2.2%), 14 in the TE-noASCT group (10.9%) and 14 in the TNE group (5.9%). Discussion
These results demonstrate that ASCT is safe and effec- tive for selected, fit, myeloma patients up to the age of 75. In an age-matched population treated with similar induc- tion therapy there was a significant benefit for PFS and OS
associated with the use of ASCT compared to no ASCT. The study showed that even in a group of patients ini- tiallyfelttobeeligiblefortransplantationbytheirtreating clinician, there was a clear fall in the proportion of patients undergoing stem cell harvest and ASCT with increasing age. This likely reflects clinicians’ enthusiasm for giving patients the option of having an ASCT, by enrolling the patients in the TE pathway, but a subsequent realization that the patients were not fit enough. Commencing inten- sive induction therapy and using this as a therapeutic trial of fitness before making the final decision regarding ASCT may represent a valid approach to therapy especially in
the intermediate age group of those aged 65-75 years. Although the median CD34+ harvest cell count was lower in older patients it is not certain whether this reflects a true difference in mobilization. The percentage of patients from whom enough stem cells were collected for one ASCT (2x106 CD34+ cells/kg) was very high across
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haematologica | 2022; 107(1)