Treatment course and acute adverse events
| Characteristic . | Overall, N = 72 . | Standard chemotherapy (COM), n = 32 . | R + standard chemotherapy (R-COM), n = 40 . | P value∗ . |
|---|---|---|---|---|
| First-line treatment duration, median (IQR), wk | 14 (7-17) | 10 (2-16) | 15 (12-17) | .023 |
| Completed first-line cycles, median (IQR), number of cycles | 6.00 (2.75-6.00) | 3.00 (1.00-6.00) | 6.00 (3.75- 6.00) | .003 |
| Interval between first-line cycles, median (IQR), wk | 2.00 (1.75- 3.00) | 2.00 (1.00- 3·00) | 3.00 (2.00-3.00) | .13 |
| Received second-line treatment, n (%) | 23 (32) | 6 (19) | 17 (43) | .032 |
| All adverse events, n | 63 | 17 | 46 | |
| Patients who experienced adverse events, n (%) | 20 (28) | 5 (16) | 15 (38) | .039 |
| Patients with grade 3/4 adverse events, n (%) | 12 (17) | 5 (16) | 7 (18) | .8 |
| Patients with grade 3/4 hematological adverse events† , n (%) | 6 (8.3) | 3 (9.4) | 3 (7.5) | >.9 |
| Anemia | 1 (1.4) | 1 (3.1) | 0 (5.0) | .4 |
| Neutropenia | 6 (8.3) | 3 (9.4) | 3 (7.5) | >.9 |
| Patients with grade 3/4 nonhematological adverse events† , n (%) | 12 (17) | 5 (16) | 7 (18) | .8 |
| Febrile neutropenia | 6 (8.3) | 3 (9.4) | 3 (7.5) | >.9 |
| Sepsis | 6 (8.3) | 3 (9.4) | 3 (7.5) | >.9 |
| Oral mucositis | 2 (2.8) | 1 (3.1) | 1 (2.5) | >.9 |
| Fever | 1 (1.4) | 1 (3.1) | 0 (0) | .4 |
| Nausea | 1 (1.4) | 0 (0) | 1 (2.5) | >.9 |
| Vomiting | 1 (1.4) | 0 (0) | 1 (2.5) | >.9 |
| Diarrhea | 1 (1.4) | 0 (0) | 1 (2.5) | >.9 |
| Hypotension | 1 (1.4) | 0 (0) | 1 (2.5) | >.9 |
| Acute kidney injury | 1 (1.4) | 1 (3.1) | 0 (0) | >.9 |
| Infusion-related reactions | 0 (0.0) | 0 (0.0) | 0 (0) |
| Characteristic . | Overall, N = 72 . | Standard chemotherapy (COM), n = 32 . | R + standard chemotherapy (R-COM), n = 40 . | P value∗ . |
|---|---|---|---|---|
| First-line treatment duration, median (IQR), wk | 14 (7-17) | 10 (2-16) | 15 (12-17) | .023 |
| Completed first-line cycles, median (IQR), number of cycles | 6.00 (2.75-6.00) | 3.00 (1.00-6.00) | 6.00 (3.75- 6.00) | .003 |
| Interval between first-line cycles, median (IQR), wk | 2.00 (1.75- 3.00) | 2.00 (1.00- 3·00) | 3.00 (2.00-3.00) | .13 |
| Received second-line treatment, n (%) | 23 (32) | 6 (19) | 17 (43) | .032 |
| All adverse events, n | 63 | 17 | 46 | |
| Patients who experienced adverse events, n (%) | 20 (28) | 5 (16) | 15 (38) | .039 |
| Patients with grade 3/4 adverse events, n (%) | 12 (17) | 5 (16) | 7 (18) | .8 |
| Patients with grade 3/4 hematological adverse events† , n (%) | 6 (8.3) | 3 (9.4) | 3 (7.5) | >.9 |
| Anemia | 1 (1.4) | 1 (3.1) | 0 (5.0) | .4 |
| Neutropenia | 6 (8.3) | 3 (9.4) | 3 (7.5) | >.9 |
| Patients with grade 3/4 nonhematological adverse events† , n (%) | 12 (17) | 5 (16) | 7 (18) | .8 |
| Febrile neutropenia | 6 (8.3) | 3 (9.4) | 3 (7.5) | >.9 |
| Sepsis | 6 (8.3) | 3 (9.4) | 3 (7.5) | >.9 |
| Oral mucositis | 2 (2.8) | 1 (3.1) | 1 (2.5) | >.9 |
| Fever | 1 (1.4) | 1 (3.1) | 0 (0) | .4 |
| Nausea | 1 (1.4) | 0 (0) | 1 (2.5) | >.9 |
| Vomiting | 1 (1.4) | 0 (0) | 1 (2.5) | >.9 |
| Diarrhea | 1 (1.4) | 0 (0) | 1 (2.5) | >.9 |
| Hypotension | 1 (1.4) | 0 (0) | 1 (2.5) | >.9 |
| Acute kidney injury | 1 (1.4) | 1 (3.1) | 0 (0) | >.9 |
| Infusion-related reactions | 0 (0.0) | 0 (0.0) | 0 (0) |