CLINICAL RESEARCH ON TREATMENT OF LOCALLY ADVANCED LUNG-CANCER - FINAL REPORT OF VALG PROTOCOL 13-LIMITED

This is a final report on the treatment of 346 patients entered in the Protocol 13L. The study was activated March 1972, and closed for the patient accession March 1975. All patients had a histologic or cytologic diagnosis of primary lung cancer limited disease. Limited disease was defined by VALG as a tumor involving one hemithorax without evidence of pleural effusion or distant metastases. Patients were randomized into two groups, radiotherapy alone or radiotherapy with CCNU and hydroxyurea. Both groups received the same dose of radiotherapy, which was given in the same fashion (5000 to 6000 rads given in 28 to 42 days). The chemotherapy program was: CCNU‐100 mg/m2, orally every six weeks and Hydroxyurea‐1 g/m2 orally twice a week. Chemotherapy demonstrated an early benefit in small cell carcinoma with 18 weeks extension of the median survival (p = 0.07). However, among patients surviving beyond the median survival, radiotherapy alone was the most effective treatment. At 24 months, 15% of the patients were alive in the radiotherapy alone group, versus 7% in the radiotherapy‐chemotherapy group (p = 0.02). Chemotherapy did not modify the appearance time, pattern of, or survival after the first evidence of metastasis. Local toxicity of radiotherapy was not increased by chemotherapy. Severe or life threatening hematologic toxicity was present in one of every four patients at the end of radiotherapy. Those patients who developed moderate and severe hematologic toxicity at the end of radiotherapy survived longer than the patients who experienced mild toxicity or no toxicity (p = 0.03). The performance status effect seen early had disappeared at 10 weeks. In long‐term survivors, no common factors could be identified except that more patients in the radiotherapy alone group are surviving from all cell types (p = 0.02). Copyright © 1978 American Cancer Society