The Survival of Patients with Inoperable Lung Cancer: A Large-Scale Randomized Study of Radiation Therapy Versus Placebo

The death toll from lung cancer, particularly for the American male in the prime of life, is beginning to approach the dimensions of a national calamity. This year we may expect 55,000 new cases and 50,000 deaths, of which 42,000 will be in males and 8,000 in females (1). Lung cancer is already responsible for 1 out of 4 deaths from cancer in men. It is imperative, therefore, that a dependable assessment be made of the patient's outlook for survival according to the stage of the disease and the therapeutic modality employed. Guide lines for such an assessment may be drawn from retrospective long-range survival studies in a single institution or center. More dependable answers can be derived from planned, prospective large-scale studies involving many patients, strict randomization with concurrent controls, and strong biostatistical support. In the hospital system of the Veterans Administration (VA), which supports 170,000 beds, nearly all the patients are males, and a large percentage are cigarette smokers in the age group prone to lung cancer. It is not surprising, therefore, that we see approximately 5,000 new cases of bronchogenic carcinoma per year. This formidable disease today accounts for nearly 10 per cent of all deaths in VA hospitals. The Department of Medicine and Surgery of the Veterans Administration is now engaged in a major investigative effort already involving more than 5,000 lung cancer patients at every clinical stage in 30 of our larger hospitals, testing the influence on longevity of surgery, radiation, and antitumor agents, employed alone and in combination. The investigators are full-time hospital specialists in surgery, radiation therapy, and internal medicine, assisted by consultants from the medical schools with which the VA hospitals are affiliated. Many of these institutions are now providing, or will soon provide, high-energy radiation therapy by means of cobalt-telecurie apparatus, 1–2 MV generators, linear accelerators, and betatrons. Modern experimental design is employed, with randomization, controls, and critical statistical analysis. Statistical support is provided by the agencies of the National Research Council. Progress reports have been presented elsewhere (12, 14, 16, 33–36) by the VA Lung Cancer Study Groups on the outcome for survival of (a) patients with disseminated lung cancer (drugs versus placebo), (b) individuals with localized, inoperable lung cancer (radiation versus drugs versus placebo), (c) operable cases (surgery versus preoperative radiationand surgery), and (d) resectable cases (surgery versus surgery and chemicals) (Table VI).