Table 5.
The number of studies included in the subgroup analysis.
| Subgroup | Studies included, No. (%) | |
|---|---|---|
| SR-aGVHD1 | SR-cGVHD1 | |
| ORR | ||
| At any time | n = 17 | n = 16 |
| Retrospective studies | 15 (88.2) | 15 (93.8) |
| Prospective unrandomized studies | 2 (11.8) | 1 (6.2) |
| RCT | NA | NA |
| At day 28 | n = 5 | NA |
| Retrospective studies | 2 (40.0) | NA |
| Prospective unrandomized studies | 2 (40.0) | NA |
| RCT | 1 (20.0) | NA |
| At week 24 | NA | n = 7 |
| Retrospective studies | NA | 6 (85.7) |
| Prospective unrandomized studies | NA | NA |
| RCT | NA | 1 (14.3) |
| CRR | ||
| At any time | n = 21 | n = 18 |
| Retrospective studies | 18 (85.7) | 16 (88.9) |
| Prospective unrandomized studies | 3 (14.3) | 2 (11.1) |
| RCT | NA | NA |
| At day 28 | n = 7 | NA |
| Retrospective studies | 4 (57.1) | NA |
| Prospective unrandomized studies | 2 (28.6) | NA |
| RCT | 1 (14.3) | NA |
| At week 24 | NA | n = 6 |
| Retrospective studies | NA | 5 (83.3) |
| Prospective unrandomized studies | NA | NA |
| RCT | NA | 1 (16.7) |
| Involved Organ Response | ||
| ORR 2 | n = 9 | n = 13 |
| Skin | 8 (88.9) | 13 (100.0) |
| Gut | 9 (100.0) | 11 (84.6) |
| Liver | 8 (88.9) | 9 (69.2) |
| Mouth | NA | 8 (61.5) |
| Eye | NA | 10 (76.9) |
| Lung | NA | 12 (92.3) |
| Joints and fascia | NA | 8 (61.5) |
| Esophagus | NA | 1 (7.7) |
| CRR 2 | n = 8 | n = 11 |
| Skin | 7 (87.5) | 11 (100.0) |
| Gut | 8 (100.0) | 9 (81.8) |
| Liver | 7 (87.5) | 7 (63.6) |
| Mouth | NA | 7 (63.6) |
| Eye | NA | 7 (63.6) |
| Lung | NA | 10 (90.9) |
| Joints and fascia | NA | 7 (63.6) |
| Esophagus | NA | 1 (9.1) |
| Hematologic Toxicities | ||
| Cytopenia 3 | n = 6 | n = 9 |
| Grades I–IV | 5 (83.3) | 9 (100.0) |
| Grades III–IV | 3 (50.0) | 5 (55.3) |
| Anemia 3 | n = 10 | n = 10 |
| Grades I–IV | 8 (80.0) | 8 (80.0) |
| Grades III–IV | 9 (90.0) | 10 (100.0) |
| Leukopenia 3 | n = 12 | n = 12 |
| Grades I–IV | 10 (83.3) | 9 (75.0) |
| Grades III–IV | 11 (91.7) | 10 (83.3) |
| Thrombocytopenia 3 | n = 14 | n = 12 |
| Grades I–IV | 12 (85.7) | 9 (75.0) |
| Grades III–IV | 11 (78.6) | 11 (91.7) |
| Infections4 | n = 14 | n = 18 |
| Total | 12 (85.7) | 16 (88.9) |
| Viral | 8 (57.1) | 9 (50.0) |
| Bacterial | 5 (35.7) | 8 (44.4) |
| Fungal | 4 (28.6) | 7 (38.9) |
| OS5 | n = 7 | n = 12 |
| 6 months | 7 (100.0) | 3 (25.0) |
| 1 year | – | 6 (50.0) |
| 2 years | – | 6 (50.0) |
CRR, complete response rate; NA, not available; ORR, overall response rate; OS, overall survival; RCT, randomized controlled trials; SR-aGVHD, steroid-refractory acute graft-versus-host disease; SR-cGVHD, steroid-refractory chronic graft-versus-host disease.
1 Twelve studies included both in the SR-aGVHD and SR-cGVHD analysis;
2 Twenty-one studies involved multiple organs in the analysis of ORRs;
Eighteen studies involved multiple organs in the analysis of CRRs.
3 Seven studies included both in the analysis of overall (grades I–IV) and severe (grades III–IV) cytopenia;
Fifteen studies included both in the analysis of overall (grades I–IV) and severe (grades III–IV) anemia;
Sixteen studies included both in the analysis of overall (grades I–IV) and severe (grades III–IV) leukopenia;
Seventeen studies included both in the analysis of overall (grades I–IV) and severe (grades III–IV) thrombocytopenia.
4 Fourteen studies involved in the analysis of multiple types of infection.
5 Three studies included both in the analysis of 6-month, 1-year, and 2-year OS in SR-cGVHD.
The bold values represent the total number of studies included in the analysis.