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Background. Clinical trials of hyperfractionated radiation therapy and induction chemotherapy followed by standard radiation therapy have shown improved survival in patients with unresectable nonsmall cell lung cancer (NSCLC). Radiosensitization may improve local tumor control when chemotherapy is given concurrently with hyperfractionated radiation therapy, but also may increase toxicity. A Phase I/II trial, Radiation Therapy Oncology Group 90-15, was designed to evaluate whether this strategy could improve survival with acceptable toxicity and be part of a Phase III trial of chemoradiation sequencing. Methods. Vinblastine (5 mg/[M.sup.2] weekly x 5 weeks) and cisplatin (75 Mg/[M.sup.2] days 1, 29, and 50) were given during twice-daily irradiation (1.2 Gy, 6 hours apart) to 69.6 Gy in 58 fractions in 6 weeks. Eligible patients had American Joint Committee on Cancer (AJCC) Stage II (unresected) or IIIA-B NSCLC and Karnofsky performance status 70 or greater; there were no weight loss restrictions. Results. Of 42 eligible patients, 76% had greater than 5% weight loss, 45% had T4 primary tumors, and 62% were Stage IIIB. All protocol treatment was completed in 53%. Acute toxicity was predominantly hematologic with 19 of 42 (45%) having Grade 4 toxicity or higher, three (7%) with septic death. Ten of 42 (24%) had Grade 3 or higher esophagitis. There were two (4.7%) patients with Grade 3 or higher (1 lung and 1 esophagus) and two (4.7%) with Grade 4 or higher (1 lung and 1 hematologic) late toxicities. Median survival time was 12.2 months, with an overall 1-year survival of 54%, an estimated 2 year survival of 28% and a 1-year progression free survival of 38%. Conclusions. For patients with unresectable nonsmall cell lung cancer, who were not selected on the basis of weight loss, concurrent hyperfractionated irradiation and chemotherapy had more intense acute toxicity than hyperfractionation alone, but late toxicity was acceptable. One and 2-year survival rates were 54 and 28%, respectively. Cancer 1995;75:2337-44.

Patients with primary tumors of the trachea often have respiratory symptoms and hemoptysis (coughing up blood). Unfortunately, the tumors are frequently in an advanced stage at the time of diagnosis. Surgery is the primary treatment for tumors of the trachea which results in a 20 to 40 percent 5-year survival rate for epidermoid cancers (from epidermal cells), and a 60 to 100 percent 5-year survival for adenoid (gland-like) cystic cancers. However, recent advances in radiotherapy have improved the chances of achieving good control and possible cure for cancer of the trachea. Over a 27-year period, 24 patients with primary cancer of the trachea were treated with either radiation alone or in conjunction with surgery. Overall survival was 25 percent at 5 years and 13 percent at 10 years after treatment. Control of local tumor was achieved in 10 of the 24 patients, and was more likely in patients receiving both surgery and radiation. For those receiving radiotherapy alone, local control was related to the dose. Six out of seven patients receiving greater than 6,000 cGy achieved complete remission, compared with 1 out of 11 remissions in patients who received a lower dose. Five patients developed complications from the radiotherapy; three patients died of these complications, although these deaths were at least partially attributable to surgery. The results of these cases suggest that surgery is the recommended treatment, and that radiotherapy should be used in cases where surgery is impossible or the risk of recurrence is high. When radiotherapy is indicated, the dose should be between 6,000 and 6,600 cGy. Lower doses are not completely effective, and higher doses create an unacceptable risk of complications. (Consumer Summary produced by Reliance Medical Information, Inc.)