Sørensen J B
Department of Oncology ONB, Finsen Institute, Copenhagen, Denmark.
Semin Oncol. 1988 Dec;15(6 Suppl 7):56-7.
The Copenhagen Lung Cancer Study Group conducted a prospective randomized trial comparing three chemotherapy regimens: (A) vindesine (VDS) 4 mg/m2 IV weekly X 8, then every second week; (B) lomustine (CCNU) 70 mg/m2 orally, cyclophosphamide (CTX) 1000 mg/m2 IV every 4 weeks, methotrexate (MTX) 20 mg/m2 orally days 15 and 18 of each course; and (C) CCNU + CTX + MTX + VDS in the same schedule as above, but with lower doses of CCNU (50 mg/m2), CTX (750 mg/m2), and VDS (2 mg/m2). Two hundred fifty-nine patients were accrued with unresectable adenocarcinoma-type non-small cell lung cancer (NSCLC); 218 were evaluable for response. Overall response rates on the chemotherapy arms were: (A) 22%, (B) 23%, and (C) 27%. Median survival rates were: 29 weeks, (B) 29 weeks, and (C) 34 weeks. Peripheral neuropathy was the major toxicity in arm A, and myelosuppression in arms B and C. The independent influence of 27 pretreatment variables were analyzed by the Cox multivariate regression model, which revealed that six have prognostic impact: performance status, nonradical resection, liver metastases, serum LDH (lactate dehydrogenase), WBC (white blood count), and serum AST (aspartate aminotransferase). The data clearly demonstrate prognostic variables in this disease and emphasize the need for better chemotherapy.
哥本哈根肺癌研究小组进行了一项前瞻性随机试验，比较了三种化疗方案：（A）长春地辛（VDS）4mg/m²静脉注射，每周1次，共8次，然后每两周1次；（B）洛莫司汀（CCNU）70mg/m²口服，环磷酰胺（CTX）1000mg/m²静脉注射，每4周1次，甲氨蝶呤（MTX）20mg/m²口服，在每个疗程的第15天和第18天服用；（C）CCNU+CTX+MTX+VDS，用药方案与上述相同，但CCNU（50mg/m²）、CTX（750mg/m²）和VDS（2mg/m²）的剂量较低。共有259例不可切除的腺癌型非小细胞肺癌（NSCLC）患者入组；218例可评估疗效。各化疗组的总缓解率分别为：（A）22%，（B）23%，（C）27%。中位生存率分别为：（A）29周，（B）29周，（C）34周。周围神经病变是A组的主要毒性反应，而B组和C组的主要毒性反应是骨髓抑制。通过Cox多因素回归模型分析了27个预处理变量的独立影响，结果显示有6个变量具有预后影响：体能状态、非根治性切除、肝转移、血清乳酸脱氢酶（LDH）、白细胞计数（WBC）和血清天冬氨酸转氨酶（AST）。这些数据清楚地证明了该疾病的预后变量，并强调了需要更好的化疗方案。
