A Randomized Trial Comparing Preoperative Chemotherapy Plus Surgery with Surgery Alone in Patients with Non-Small-Cell Lung Cancer

作者：Rafael Rosell, José Gómez‐Codina, Carlos Camps, J Maestre, Jose Padille, Antonio Cantó, José Luís Mate, Shanrong Li, Jorge Roig, Ángel Olazábal, Mercedes Canela, Aurelio Ariza, Zdenek Skacel, Josep Morera-Prat, Albert Abad · 发表于：New England Journal of Medicine · 年份：1994 · DOI：10.1056/nejm199401203300301 · 被引用次数：1273 · 研究领域：Lung Cancer Diagnosis and Treatment、Cancer, Stress, Anesthesia, and Immune Response、Lung Cancer Treatments and Mutations

BACKGROUND: The efficacy of surgery for patients with non-small-cell lung cancer is limited, although recent studies suggest that preoperative chemotherapy may improve survival. We conducted a randomized trial to examine the possible benefit of preoperative chemotherapy and surgery for the treatment of patients with non-small-cell lung cancer. METHODS: We studied 60 patients (59 men and 1 woman) with stage IIIA non-small-cell lung cancer. The patients were randomly assigned to receive either surgery alone or three courses of chemotherapy (6 mg of mitomycin per square meter of body-surface area, 3 g of ifosfamide per square meter, and 50 mg of cisplatin per square meter) given intravenously at three-week intervals and followed by surgery. All patients received mediastinal radiation after surgery. The resected tumors were evaluated by means of K-ras oncogene analysis and flow cytometry. RESULTS: The median period of survival was 26 months in the patients treated with chemotherapy plus surgery, as compared with 8 months in the patients treated with surgery alone (P < 0.001); the median period of disease-free survival was 20 months in the former group, as compared with 5 months in the latter (P < 0.001). The rate of recurrence was 56 percent in the group treated with chemotherapy plus surgery and 74 percent in the group treated with surgery alone. The prevalence of mutated K-ras oncogenes was 15 percent among the patients receiving preoperative chemotherapy and 42 percent among t...