Baseline demographic and clinical characteristics of the multicenter R/R cohort treated with combination duv/romi
| Characteristic . | All∗ (N = 38) . | nTFH (n = 17) . | Non-nTFH (n = 21) . | P value† . |
|---|---|---|---|---|
| Age at diagnosis, median (IQR), y | 62 (53-72) | 65 (61-71) | 56 (50-72) | .4 |
| Biological sex, n (%) | ||||
| Female | 19 (50) | 9 (53) | 10 (48) | >.99 |
| Male | 19 (50) | 8 (47) | 11 (52) | |
| Race, self-identified, n (%) | ||||
| White | 28 (74) | 13 (76) | 15 (71) | .7 |
| African American or Black | 1 (3) | 1 (6) | 0 | |
| Asian | 3 (8) | 2 (12) | 1 (5) | |
| Other | 1 (3) | 0 | 1 (5) | |
| Unknown | 3 (8) | 01 (6) | 34 (19) | |
| Ethnicity, self-identified, n (%) | ||||
| Hispanic | 4 (11) | 3 (18) | 1 (5) | .2 |
| Non-Hispanic | 32 (84) | 13 (76) | 19 (90) | |
| Other | 1 (3) | 0 | 1 (5) | |
| Unknown | 1 (3) | 1 (6) | 0 | |
| Histological subtype, n (%) | ||||
| nTFH | 17 (48) | 17 (100) | 0 | — |
| AITL | 13 (34) | 13 (76) | 0 | |
| ALK– ALCL | 1 (3) | 0 | 1 (5) | |
| ATLL | 1 (3) | 0 | 1 (5) | |
| CTCL | 3 (8) | 0 | 3 (14) | |
| MF | 1 (3) | 0 | 1 (6) | |
| SS | 1 (3) | 0 | 1 (5) | |
| GD | 1 (3) | 0 | 1 (5) | |
| ENKTCL | 1 (3) | 0 | 1 (5) | |
| HSTCL | 1 (3) | 0 | 1 (5) | |
| PTCL-NOS | 14 (37) | 0 | 14 (67) | |
| IPI at diagnosis, n (%) | ||||
| 0 | 0 | 0 | 0 | .2 |
| 1 | 5 (13) | 1 (6) | 4 (19) | |
| 2 | 14 (37) | 9 (53) | 5 (24) | |
| 3 | 10 (26) | 3 (18) | 7 (33) | |
| 4 | 4 (11) | 2 (12) | 2 (10) | |
| 5 | 0 | 0 | 0 | |
| NA | 5 (13) | 2 (12) | 3 (14) | |
| PIT at diagnosis, n (%) | ||||
| 0 | 1 (3) | 0 | 1 (5) | .6 |
| 1 | 14 (37) | 6 (35) | 8 (38) | |
| 2 | 14 (37) | 8 (47) | 6 (29) | |
| 3 | 4 (11) | 1 (6) | 3 (14) | |
| 4 | 0 | 0 | 0 | |
| NA | 5 (13) | 2 (12) | 3 (14) | |
| PIRT at diagnosis, n (%) | ||||
| Low (0-1) | 1 (3) | 1 (6) | 0 | .009 |
| Intermediate (2-3) | 16 (42) | 11 (65) | 5 (24) | |
| High (4-6) | 6 (16) | 0 | 6 (29) | |
| NA | 15 (39) | 5 (29) | 10 (48) | |
| Previous lines of therapy, median (IQR) | 1 (1-2) | 1 (1-2) | 1 (1-2) | .1 |
| Prior therapies received, frontline, n (%) | 38 (100) | 17/17 (100) | 21/21 (100) | |
| CHOP | 12 (32) | 7 (41) | 5 (24) | |
| Mini-CHOP | 2 (5) | 1 (6) | 1 (65) | |
| CHOEP | 9 (24) | 3 (17) | 6 (29) | |
| CEOP‡ | 1 (3) | 1 (6) | 0 | |
| CHOP + azacitidine | 2 (5) | 2 (12) | 0 | |
| BV-CHP | 3 (8) | 0 | 3 (14) | |
| Alemtuzumab | 1 (3) | 0 | 1 (5) | |
| Azacitidine + romi | 2 (5) | 2 (12) | 0 | |
| Extracorporeal photopheresis + bexarotene | 1 (3) | 0 | 1 (5) | |
| Methotrexate + prednisolone | 2 (5) | 0 | 2 (10) | |
| ICE | 2 (5) | 0 | 2 (10) | |
| Pola-R-CHP§ | 2 (5) | 2 (12) | 0 | |
| CHP‖ | 1 (3) | 1 (6) | 0 | |
| Previous therapies received, second line, n (%) | 10/38 (26) | 4/17 (24) | 6/21 (29) | |
| BV-CHP | 2 (5) | 0 | 2 (10) | — |
| Alemtuzumab | 1 (3) | 0 | 1 (5) | |
| Azacitidine | 1 (3) | 1 (6) | 0 | |
| Romi | 2 (5) | 1 (6) | 1 (5) | |
| Azacitidine + romi | 2 (5) | 2 (12) | 0 | |
| Gemcitabine + oxaliplatin | 1 (3) | 0 | 1 (5) | |
| Pegasparaginase | 1 (3) | 0 | 1 (5) | |
| Previous therapies received, third line and onward, n (%) | 5/38 (13) | 0 | 5/21 (24) | — |
| Romi | 2 (5) | 2 (10) | ||
| Pralatrexate | 1 (3) | 1 (5) | ||
| Alemtuzumab | 1 (3) | 1 (5) | ||
| Pembrolizumab | 1 (3) | 1 (5) | ||
| Ruxolitinib | 1 (3) | 1 (5) | ||
| IVAC | 1 (3) | 1 (5) | ||
| DHAP + cytarabine | 2 (5) | 2 (10) | ||
| Gemcitabine + oxaliplatin | 2 (5) | 2 (10) | ||
| Nivolumab | 1 (3) | 1 (5) | ||
| Brentuximab vedotin | 1 (3) | 1 (5) | ||
| Brentuximab vedotin + gemcitabine | 1 (3) | 1 (5) | ||
| Denileukin diftitox (NCT01871727) | 1 (3) | 1 (5) | ||
| Received HSCT before duv/romi, n (%) | 8/38 (21) | 5/17 (29) | 3/21 (14) | — |
| Autologous | 5 (13) | 4 (24) | (5) | |
| Allogeneic | 3 (8) | 1 (6) | 2 (10) | |
| Response to therapy preceding duv/romi,¶ n (%) | ||||
| Relapsed | 15 (39) | 6 (35) | 9 (43) | .9 |
| Primary refractory | 23 (61) | 11 (65) | 12 (57) |
| Characteristic . | All∗ (N = 38) . | nTFH (n = 17) . | Non-nTFH (n = 21) . | P value† . |
|---|---|---|---|---|
| Age at diagnosis, median (IQR), y | 62 (53-72) | 65 (61-71) | 56 (50-72) | .4 |
| Biological sex, n (%) | ||||
| Female | 19 (50) | 9 (53) | 10 (48) | >.99 |
| Male | 19 (50) | 8 (47) | 11 (52) | |
| Race, self-identified, n (%) | ||||
| White | 28 (74) | 13 (76) | 15 (71) | .7 |
| African American or Black | 1 (3) | 1 (6) | 0 | |
| Asian | 3 (8) | 2 (12) | 1 (5) | |
| Other | 1 (3) | 0 | 1 (5) | |
| Unknown | 3 (8) | 01 (6) | 34 (19) | |
| Ethnicity, self-identified, n (%) | ||||
| Hispanic | 4 (11) | 3 (18) | 1 (5) | .2 |
| Non-Hispanic | 32 (84) | 13 (76) | 19 (90) | |
| Other | 1 (3) | 0 | 1 (5) | |
| Unknown | 1 (3) | 1 (6) | 0 | |
| Histological subtype, n (%) | ||||
| nTFH | 17 (48) | 17 (100) | 0 | — |
| AITL | 13 (34) | 13 (76) | 0 | |
| ALK– ALCL | 1 (3) | 0 | 1 (5) | |
| ATLL | 1 (3) | 0 | 1 (5) | |
| CTCL | 3 (8) | 0 | 3 (14) | |
| MF | 1 (3) | 0 | 1 (6) | |
| SS | 1 (3) | 0 | 1 (5) | |
| GD | 1 (3) | 0 | 1 (5) | |
| ENKTCL | 1 (3) | 0 | 1 (5) | |
| HSTCL | 1 (3) | 0 | 1 (5) | |
| PTCL-NOS | 14 (37) | 0 | 14 (67) | |
| IPI at diagnosis, n (%) | ||||
| 0 | 0 | 0 | 0 | .2 |
| 1 | 5 (13) | 1 (6) | 4 (19) | |
| 2 | 14 (37) | 9 (53) | 5 (24) | |
| 3 | 10 (26) | 3 (18) | 7 (33) | |
| 4 | 4 (11) | 2 (12) | 2 (10) | |
| 5 | 0 | 0 | 0 | |
| NA | 5 (13) | 2 (12) | 3 (14) | |
| PIT at diagnosis, n (%) | ||||
| 0 | 1 (3) | 0 | 1 (5) | .6 |
| 1 | 14 (37) | 6 (35) | 8 (38) | |
| 2 | 14 (37) | 8 (47) | 6 (29) | |
| 3 | 4 (11) | 1 (6) | 3 (14) | |
| 4 | 0 | 0 | 0 | |
| NA | 5 (13) | 2 (12) | 3 (14) | |
| PIRT at diagnosis, n (%) | ||||
| Low (0-1) | 1 (3) | 1 (6) | 0 | .009 |
| Intermediate (2-3) | 16 (42) | 11 (65) | 5 (24) | |
| High (4-6) | 6 (16) | 0 | 6 (29) | |
| NA | 15 (39) | 5 (29) | 10 (48) | |
| Previous lines of therapy, median (IQR) | 1 (1-2) | 1 (1-2) | 1 (1-2) | .1 |
| Prior therapies received, frontline, n (%) | 38 (100) | 17/17 (100) | 21/21 (100) | |
| CHOP | 12 (32) | 7 (41) | 5 (24) | |
| Mini-CHOP | 2 (5) | 1 (6) | 1 (65) | |
| CHOEP | 9 (24) | 3 (17) | 6 (29) | |
| CEOP‡ | 1 (3) | 1 (6) | 0 | |
| CHOP + azacitidine | 2 (5) | 2 (12) | 0 | |
| BV-CHP | 3 (8) | 0 | 3 (14) | |
| Alemtuzumab | 1 (3) | 0 | 1 (5) | |
| Azacitidine + romi | 2 (5) | 2 (12) | 0 | |
| Extracorporeal photopheresis + bexarotene | 1 (3) | 0 | 1 (5) | |
| Methotrexate + prednisolone | 2 (5) | 0 | 2 (10) | |
| ICE | 2 (5) | 0 | 2 (10) | |
| Pola-R-CHP§ | 2 (5) | 2 (12) | 0 | |
| CHP‖ | 1 (3) | 1 (6) | 0 | |
| Previous therapies received, second line, n (%) | 10/38 (26) | 4/17 (24) | 6/21 (29) | |
| BV-CHP | 2 (5) | 0 | 2 (10) | — |
| Alemtuzumab | 1 (3) | 0 | 1 (5) | |
| Azacitidine | 1 (3) | 1 (6) | 0 | |
| Romi | 2 (5) | 1 (6) | 1 (5) | |
| Azacitidine + romi | 2 (5) | 2 (12) | 0 | |
| Gemcitabine + oxaliplatin | 1 (3) | 0 | 1 (5) | |
| Pegasparaginase | 1 (3) | 0 | 1 (5) | |
| Previous therapies received, third line and onward, n (%) | 5/38 (13) | 0 | 5/21 (24) | — |
| Romi | 2 (5) | 2 (10) | ||
| Pralatrexate | 1 (3) | 1 (5) | ||
| Alemtuzumab | 1 (3) | 1 (5) | ||
| Pembrolizumab | 1 (3) | 1 (5) | ||
| Ruxolitinib | 1 (3) | 1 (5) | ||
| IVAC | 1 (3) | 1 (5) | ||
| DHAP + cytarabine | 2 (5) | 2 (10) | ||
| Gemcitabine + oxaliplatin | 2 (5) | 2 (10) | ||
| Nivolumab | 1 (3) | 1 (5) | ||
| Brentuximab vedotin | 1 (3) | 1 (5) | ||
| Brentuximab vedotin + gemcitabine | 1 (3) | 1 (5) | ||
| Denileukin diftitox (NCT01871727) | 1 (3) | 1 (5) | ||
| Received HSCT before duv/romi, n (%) | 8/38 (21) | 5/17 (29) | 3/21 (14) | — |
| Autologous | 5 (13) | 4 (24) | (5) | |
| Allogeneic | 3 (8) | 1 (6) | 2 (10) | |
| Response to therapy preceding duv/romi,¶ n (%) | ||||
| Relapsed | 15 (39) | 6 (35) | 9 (43) | .9 |
| Primary refractory | 23 (61) | 11 (65) | 12 (57) |
AITL, angioimmunoblastic T-cell lymphoma; ALCL, anaplastic large cell lymphoma; ALK–, anaplastic lymphoma kinase–negative; ATLL, adult T-cell leukemia/lymphoma; BV-CHP, brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone; CEOP, cyclophosphamide, etoposide, vincristine, and prednisone; CHOEP, cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone; CHOP, cyclophosphamide, doxorubicin, vincristine, and prednisone; CHP, cyclophosphamide, doxorubicin, and prednisone; DHAP, dexamethasone, doxorubicin, and cisplatin; ENKTCL, extranodal natural killer/T-cell lymphoma; GD, gamma-delta; HSTCL, hepatosplenic T-cell lymphoma; ICE, ifosfamide, carboplatin, and etoposide; IPI, International Prognostic Index; IVAC, ifosfamide, vinblastine, and cytarabine; MF, mycosis fungoides; mini-CHOP, CHOP administered at abbreviated doses; NA, not available; Pola-R-CHP, polatuzumab, rituximab, cyclophosphamide, doxorubicin, and prednisone; SS, Sézary syndrome.
Two patients received retreatment with duv/romi in discrete lines of therapy, and treatment response was assessed independently for each line of therapy. Hence, 38 lines of therapy were evaluated among 36 patients.
P values for the comparison between patients in different national cohorts were calculated using Kruskal-Wallis and χ2 tests for nonnormally distributed continuous variables and categorical variables, respectively.
One patient received CHOP in the first cycle followed by CEOP in cycles 2 to 6.
One patient was treated with frontline rituximab-CHOP for diffuse large B-cell lymphoma (DLBCL). Upon relapse, they received 4 cycles of Pola-R-CHP, followed by 2 cycles of Pola-R-cyclophosphamide, etoposide phosphate, prednisone (CEP), to which they were primarily refractory, and were subsequently diagnosed with AITL. Another patient received frontline Pola-R-CHP for primary cutaneous DLBCL and second-line duv/romi for nTFH.
One patient received CHOP for 5 weeks, which was complicated by Pneumocystis jirovecii pneumonia, respiratory failure requiring mechanical ventilation, anuric acute kidney injury status after dialysis, Pseudomonas urinary tract infection, and sepsis requiring vasopressors, and was thus switched to CHP chemotherapy after 5 weeks. They received CHP for 2 weeks before switching to second-line azacitidine + romi.
“Relapsed” defined as disease recurrence after achieving CR to previous therapy, and “primary refractory” defined as failure to achieve CR by the end of previous therapy.