Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group Study E1594: A phase III trial in patients with metastatic nonsmall cell lung carcinoma

摘要: BACKGROUND Eastern Cooperative Oncology Group (ECOG) Study E1594 compared paclitaxel and cisplatin with three newer chemotherapy doublets in the treatment of patients advanced nonsmall cell lung carcinoma (NSCLC). The accrual an ECOG performance status (PS) 2 was discontinued due to a perceived rate unacceptable toxicity. METHODS Patients were stratified by PS randomized one following treatments: 1) (135 mg/m2) over 24 hours (75 on 21-day cycle; 2) (100 gemcitabine (1 g/m2) Days 1, 8, 15 28-day 3) docetaxel 4) (225 3 carboplatin (area under curve, 6). All tests statistical significance two-sided. RESULTS Sixty-eight enrolled, 64 evaluable for toxicity response. Fifty-six percent male, 81% had Stage IV disease. Grade 3–4 hematologic toxicities occurred > 50% each group. Nonhematologic significantly less often arm (P = 0.0032). overall did not differ from PS-0 or PS-1 cohorts. There 5 deaths (7.35%) among 68 during therapy; however, only those attributed therapy. response 14%. median survival all 2, as determined intent-to-treat analysis, 4.1 months. CONCLUSIONS Patients NSCLC experienced large number adverse reactions poor survival. A comparison 0–1 suggests that these events shorter related disease process rather than treatment. Alternative strategies need be explored therapy specifically tailored this group patients. Cancer 2001;92:2639–47. © 2001 American Society.