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Original Article
Volume 330:153-158 January 20, 1994 Number 3
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A Randomized Trial Comparing Preoperative Chemotherapy Plus Surgery with Surgery Alone in Patients with Non-Small-Cell Lung Cancer
Rafael Rosell, Jose Gomez-Codina, Carlos Camps, Jose Maestre, Jose Padille, Antonio Canto, Jose Luis Mate, Shanrong Li, Jorge Roig, Angel Olazabal, Mercedes Canela, Aurelio Ariza, Zdenek Skacel, Jose Morera-Prat, and Albert Abad

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ABSTRACT

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 those treated with surgery alone (P = 0.05). Most of the patients treated with chemotherapy plus surgery had tumors that consisted of diploid cells, whereas the patients treated with surgery alone had tumors with aneuploid cells.

Conclusions Preoperative chemotherapy increases the median survival in patients with non-small-cell lung cancer.


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From the Departments of Medical Oncology (R.R., S.L., Z.S., A.A.), Thoracic Surgery (J.M., M.C.), Pneumology (J.R., J.M.-P.), Radiology (A.O.), and Pathology (J.L.M., A.A.), University of Barcelona, Hospital de Badalona Germans Trias i Pujol, Barcelona; the Departments of Medical Oncology (J.G.-C.) and Thoracic Surgery (J.P.), Hospital La Fe, Valencia; and the Departments of Medical Oncology (C.C.) and Thoracic Surgery (A.C.), Hospital General, Valencia -- all in Spain. Presented in part at the 28th annual meeting of the American Society of Clinical Oncology, San Diego, Calif., May 17-19, 1992.

Address reprint requests to Dr. Rosell at the Medical Oncology Department, University Hospital Germans Trias i Pujol, Box 72, 08916 Badalona (Barcelona), Spain.

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Related Letters:

Chemotherapy plus Surgery versus Surgery Alone in Non-Small-Cell Lung Cancer
Cocquyt V., De Neve W., Van Belle S. J.-P., Chanarin N., Mills N. E., Fishman C. L., Jacobson D. R., McLachlan S.-A., Stockler M., Rosell R.
Extract | Full Text  
N Engl J Med 1994; 330:1756-1757, Jun 16, 1994. Correspondence

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