Search

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.

Background: Regionally advanced, surgically unresectable non-small-cell lung cancer represents a disease with an extremely poor prognosis. External-beam irradiation to the primary tumor and regional lymphatics is generally accepted as standard therapy. The use of more aggressive radiation regimens and the addition of cytotoxic chemotherapy to radiotherapy have yielded conflicting results. Recently, however, results from clinical trials using innovative irradiation delivery techniques or chemotherapy before irradiation have indicated that patients treated with protocols that incorporate these modifications may have higher survival rates than patients receiving standard radiation therapy. Purpose: On the basis of these results, the Radiation Therapy Oncology Group RTOG)-Eastern Cooperative Oncology Group (ECOG) elected to conduct a phase III trial comparing the following regimens: 1) standard radiation therapy, 2) induction chemotherapy followed by standard radiation therapy, and 3) twice-daily radiation therapy. Methods: Patients with surgically unresectable stage II, IIIA, or IIIB non-small-cell lung cancer were potential candidates. Staging was nonsurgical. Patients were required to have a Karnofsky performance status of 70 or more and weight loss less than 5% for 3 months prior to entry into the trial, to be older than 18 years of age, and to have no metastatic disease. Of the 490 patients registered in the trial, 452 were eligible. The disease in 95% of the patients was stage IIIA or IIIB. More than two thirds of the patients had a Karnofsky performance status of more than 80. Patients were randomly assigned to receive either 60 Gy of radiation therapy delivered at 2 Gy per fraction, 5 days a week, over a 6-week period (standard radiation therapy); induction chemotherapy consisting of cisplatin (100 mg/m[sup.2]) on days 1 and 29 and 5 mg/m[sup.2] vinblastine per week for 5 consecutive weeks beginning on day 1 with cisplatin, followed by standard radiation therapy starting on day 50; or 69.6 Gy delivered at 1.2 Gy per fraction twice daily (hyperfractionated radiation therapy). Results: Toxicity was acceptable, with four treatment-related deaths. Three patients subsequently died of chronic pulmonary complications. Compliance with protocol treatment was acceptable. One-year survival (%) and median survival (months) were as follows: standard radiation therapy - 46%, 11.4 months; chemotherapy plus radiotherapy - 60%, 13.8 months; and hyperfractionated radiation therapy - 51%, 12.3 months. The chemotherapy plus radiotherapy arm was statistically superior to the other two treatment arms (logrank P = .03). Conclusions: In 'good-risk' patients with surgically unresectable non-small-cell lung cancer, induction chemotherapy followed by irradiation was superior to hyperfractionated radiation therapy or standard radiation therapy alone, yielding a statistically significant short-term survival advantage.

Radiation Therapy Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group Study objectives: The purpose of this phase III clinical trial was to test whether chemotherapy followed by radiation [...]

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.)