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N = 28
MEDIAN AGE = 56 years
AGE RANGE = 25–83 years
MALES = 17
KEY DISEASE CHARACTERISTICS: Most had received previous chemotherapy and/or radiotherapy and had multiple disease sites. The most common disease site was non-small-cell lung.
EXCLUSION CRITERIA: Patients were excluded if they were scheduled for major surgery, radiotherapy, or chemotherapy within 28 days of study entry or had brain metastases, serious infections, or psychiatric disorders that would interfere with consent or follow-up; pre-existing moderate-to-severe peripheral neuropathy; or cardiac disease. Pregnant or lactating women also were excluded.
Patients randomly were selected to receive etanercept/docetaxel. Less fatigue was self-reported in comparison to patients who received docetaxel only (p < 0.001). The FSI Interference score of Cohort A was significantly greater than the score of Cohort B (p < 0.001). Patients receiving additional cycles for treatment (Cohorts B,C, and D) did not experience worsening fatigue.