Clinical data for evaluable patients receiving etanercept
| Patient no. . | Hemoglobin level before Rx (g/dL) . | Hemoglobin level after Rx (g/dL) . | Receiving transfusion support? If so, how often? Any change during the trial?* . | ANC before Rx (× 109/L) . | ANC after Rx (× 109/L) . | Platelet count before Rx (× 109/L) . | Platelet count after Rx (× 109/L) . | Spleen size before Rx†(cm) . | Spleen size after Rx† (cm) . | Weight loss?‡ (kg) . | Weight change?2-153 (kg) . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 12-155 | 14.2 | 16 | No | 8.7 | 13.1 | 161 | 98 | 18 | 15 | Y/6 | Gain/2.7 |
| 2 | 8.6 | 9.1 | Yes/q2wk/NC | 0.7 | 0.6 | 69 | 60 | 20 | 20 | N | Stable |
| 32-155,2-154# | 7.7 | 8.2 | Yes/q1mo/NC | 2.7 | 2.4 | 600 | 451 | S | S | Y/5 | Stable |
| 4 | 9.6 | 9.0 | Yes/q1mo/NC | 1.7 | 1.4 | 45 | 39 | 0 | 0 | N | Gain/4.5 |
| 52-154 | 7.1 | 8.0 | Yes/q5wk/NC | 3.0 | 1.8 | 577 | 460 | S | S | N | Stable |
| 6 | 11.4 | 9.2 | Yes/q2wk/NC | 70.6 | 68.9 | 47 | 54 | S | S | N | Stable |
| 72-155# | 10.3 | 9.5 | No | 5.9 | 3.9 | 164 | 122 | 5 | 5 | Y/5 | Gain/5 |
| 8 | 9.9 | 10.2 | No | 12.5 | 9.6 | 246 | 365 | 4 | 4 | N | Stable |
| 92-155#2-160 | 8.22-160 | 11.32-160 | Yes/q8wk/∅2-160 | 40 | 59.8 | 162-160 | 1822-160 | 20 | 20 | Y/23 | Gain/2.3 |
| 10 | 8.2 | 6.3 | No/q1wk | 2.6 | 0.6 | 166 | 136 | 8 | 14 | N | Stable |
| 112-155# | 12.5 | 11.4 | No | 13.6 | 11.1 | 190 | 166 | 9 | 10 | Y/9 | Gain/2.7 |
| 12# | 10.0 | 9.2 | Yes/q5mo/q1wk | 8.8 | 15.7 | 58 | 78 | 20 | 17 | N | Stable |
| 13 | 9.7 | 9.4 | No | 2.7 | 3.2 | 224 | 268 | 7 | 7 | N | Gain/3.2 |
| 14# | 10.3 | 11.5 | Yes/q2wk/NC | 10.5 | 5.9 | 31 | 32 | 0 | < 1 | N | Gain/1.8 |
| 15#2-160 | 9.42-160 | 10.72-160 | No | 6.6 | 4.6 | 192 | 173 | 0 | 0 | N | Stable |
| 162-155,2-154#2-160 | 10.02-160 | 12.02-160 | Yes/q1wk/q7wk2-160 | 4.1 | 2.6 | 162 | 129 | 0 | 0 | Y/14 | Stable |
| 172-155,2-154#2-160 | 11.9 | 12.4 | No | 7.8 | 8.6 | 100 | 86 | 102-160 | 22-160 | Y/7 | Gain/1.2 |
| 18 | 9.7 | 10.0 | No | 2.8 | 3.7 | 257 | 223 | 5 | 5 | N | Stable |
| 192-154# | 7.5 | 7.1 | Yes/q1mo/NC | 5.8 | 7.1 | 79 | 86 | 19 | 18 | N | Gain/1.5 |
| 20 | 9.6 | 8.2 | No | 18.1 | 22.2 | 390 | 382 | 28 | 30 | N | Stable |
| Patient no. . | Hemoglobin level before Rx (g/dL) . | Hemoglobin level after Rx (g/dL) . | Receiving transfusion support? If so, how often? Any change during the trial?* . | ANC before Rx (× 109/L) . | ANC after Rx (× 109/L) . | Platelet count before Rx (× 109/L) . | Platelet count after Rx (× 109/L) . | Spleen size before Rx†(cm) . | Spleen size after Rx† (cm) . | Weight loss?‡ (kg) . | Weight change?2-153 (kg) . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 12-155 | 14.2 | 16 | No | 8.7 | 13.1 | 161 | 98 | 18 | 15 | Y/6 | Gain/2.7 |
| 2 | 8.6 | 9.1 | Yes/q2wk/NC | 0.7 | 0.6 | 69 | 60 | 20 | 20 | N | Stable |
| 32-155,2-154# | 7.7 | 8.2 | Yes/q1mo/NC | 2.7 | 2.4 | 600 | 451 | S | S | Y/5 | Stable |
| 4 | 9.6 | 9.0 | Yes/q1mo/NC | 1.7 | 1.4 | 45 | 39 | 0 | 0 | N | Gain/4.5 |
| 52-154 | 7.1 | 8.0 | Yes/q5wk/NC | 3.0 | 1.8 | 577 | 460 | S | S | N | Stable |
| 6 | 11.4 | 9.2 | Yes/q2wk/NC | 70.6 | 68.9 | 47 | 54 | S | S | N | Stable |
| 72-155# | 10.3 | 9.5 | No | 5.9 | 3.9 | 164 | 122 | 5 | 5 | Y/5 | Gain/5 |
| 8 | 9.9 | 10.2 | No | 12.5 | 9.6 | 246 | 365 | 4 | 4 | N | Stable |
| 92-155#2-160 | 8.22-160 | 11.32-160 | Yes/q8wk/∅2-160 | 40 | 59.8 | 162-160 | 1822-160 | 20 | 20 | Y/23 | Gain/2.3 |
| 10 | 8.2 | 6.3 | No/q1wk | 2.6 | 0.6 | 166 | 136 | 8 | 14 | N | Stable |
| 112-155# | 12.5 | 11.4 | No | 13.6 | 11.1 | 190 | 166 | 9 | 10 | Y/9 | Gain/2.7 |
| 12# | 10.0 | 9.2 | Yes/q5mo/q1wk | 8.8 | 15.7 | 58 | 78 | 20 | 17 | N | Stable |
| 13 | 9.7 | 9.4 | No | 2.7 | 3.2 | 224 | 268 | 7 | 7 | N | Gain/3.2 |
| 14# | 10.3 | 11.5 | Yes/q2wk/NC | 10.5 | 5.9 | 31 | 32 | 0 | < 1 | N | Gain/1.8 |
| 15#2-160 | 9.42-160 | 10.72-160 | No | 6.6 | 4.6 | 192 | 173 | 0 | 0 | N | Stable |
| 162-155,2-154#2-160 | 10.02-160 | 12.02-160 | Yes/q1wk/q7wk2-160 | 4.1 | 2.6 | 162 | 129 | 0 | 0 | Y/14 | Stable |
| 172-155,2-154#2-160 | 11.9 | 12.4 | No | 7.8 | 8.6 | 100 | 86 | 102-160 | 22-160 | Y/7 | Gain/1.2 |
| 18 | 9.7 | 10.0 | No | 2.8 | 3.7 | 257 | 223 | 5 | 5 | N | Stable |
| 192-154# | 7.5 | 7.1 | Yes/q1mo/NC | 5.8 | 7.1 | 79 | 86 | 19 | 18 | N | Gain/1.5 |
| 20 | 9.6 | 8.2 | No | 18.1 | 22.2 | 390 | 382 | 28 | 30 | N | Stable |
Rx indicates therapy with etanercept; ANC, absolute neutrophil count.
For patients who were receiving transfusion support, the average frequency of transfusion during the 6 months before trial enrollment is listed (transfusion threshold of approximately 8.0 g/dL was used for patients without cardiovascular disease), followed by the frequency of transfusion requirement during the trial. NC indicates there was no change in the frequency of transfusion requirement during the trial. ∅ identifies the patient who achieved transfusion independence during the trial. Patient 10 became transfusion dependent during the trial, and the study medication was discontinued because of pancytopenia.
S indicates patients who had undergone a splenectomy before trial enrollment. All measurements for spleen size are centimeters below the left costal margin on shallow inspiration.
Self-reported unintentional weight loss in the 6 months before trial enrollment.
Measured weight change during therapy with etanercept. Patients who gained weight but had not described problematic cachexia are not included as responders.
Experienced weight gain.
Experienced complete cessation of night sweats. Patient 11 had a more than 75% reduction in night sweats. Patients 1 and 6 had night sweats, but there was no response to etanercept therapy. Patient 13 actually developed night sweats while enrolled in the trial.
#Experienced an improvement in their level of fatigue and general performance status during the trial. All patients complained of fatigue at trial enrollment.
Considered to have at least a partial hemoglobin or platelet count or spleen size response (details in text).