Front-line paclitaxel-vinorelbine versus paclitaxel-carboplatin in patients with advanced non-small-cell lung cancer: a randomized phase III trial.

PURPOSE: This randomized phase III trial of advanced or metastatic non-small-cell lung cancer (NSCLC) was designed to compare a standard treatment such as carboplatin (CRP)-paclitaxel (PCT) with a new combination, vinorelbine (VRL)-PCT-two agents acting in microtubules. PATIENTS AND METHODS: Three hundred and sixty patients (stage IIIa, IIIb and IV) were included and evaluated for response rate, survival and toxicity. Arm A patients were treated with the control combination of CRP 6 AUC and PCT 175 mg/m(2) repeated every 3 weeks for six cycles, and arm B with the investigational combination of VRL 25 mg/m(2) and PCT 135 mg/m(2) repeated every 2 weeks for nine cycles. The patients were well balanced with respect to gender, disease stage and performance status. Arm A received 849 cycles (mean 4.59 per patient) and arm B 951 cycles (mean 5.39 per patient). RESULTS: Complete and partial response rates were 45.95% and 42.86% for arms A and B, respectively. Median survival was 11 and 10 months, 1-year survival 42.7% and 37.85% and 2-year survival 10.12% and 19% for arms A and B, respectively. Toxicity was similar in all patients, except for neutropenia, which was significantly greater in arm B. CONCLUSIONS: PCT combined with VRL produces similar (non-significant) response rates, survival and toxicity (except for neutropenia, as noted above) to standard CRP-PCT treatment in untreated advanced-stage NSCLC.

Laser bronchoscopy in respiratory failure from malignant airway obstruction.

OBJECTIVE: To examine the value of laser bronchoscopy in patients with inoperable carcinoma of the lung who required ventilatory assistance for acute respiratory failure. DESIGN: Retrospective review of the medical records of all patients undergoing laser bronchoscopy. SETTING: The Lahey Clinic Medical Center, a tertiary referral center. PATIENTS: The medical records of 311 patients undergoing laser bronchoscopy at the Lahey Clinic Medical Center between 1982 and 1990 were reviewed. The 17 patients who required mechanical ventilation at the time of laser surgery formed the study group. INTERVENTIONS: All patients underwent neodymium:yttrium-aluminum-garnet laser bronchoscopy through a rigid bronchoscope in the operating room with use of jet ventilation and general anesthesia throughout the procedure. Postoperative care was directed by the same physician for all patients. MEASUREMENTS AND MAIN RESULTS: The following data were extracted from medical records: age and sex of patient, cell type and location of tumor, length of time between diagnosis and laser therapy, treatment before and after laser therapy, number of days receiving mechanical ventilation before and after laser therapy, medical and operative complications, survival, and cause of death. The patients were divided into two groups on the basis of clinical improvement that permitted elective discontinuation of mechanical ventilation. Group 1 included patients who experienced clinical improvement permitting endotracheal extubation. Group 2 was composed of patients who died while still receiving mechanical ventilatory support or who were extubated before institution of comfort measures. The two groups were compared using nonparametric tests of significance, including the Mann-Whitney test. No significant differences were apparent between groups 1 and 2 regarding clinical characteristics before laser treatment. Patients in group 1 had significantly (p = .03) shorter requirements for mechanical ventilation after laser treatment than patients in group 2 (1 vs. 6 days). Similarly, patients in group 1 were more likely to receive additional treatment after laser therapy than patients in group 2 (seven of nine patients vs. two of eight patients; p = .048). Patients in group 1 had significantly (p = .0038) longer survival than patients in group 2 (98 vs. 8.5 days). A greater endobronchial component to airway obstruction appeared to exist in patients in group 1 (nine of nine patients) vs. patients in group 2 (three of eight patients; p = .009). Extrinsic compression and submucosal tumor were more commonly seen in patients in group 2. In addition, patients in group 2 appeared to have a greater number of postoperative medical complications than patients in group 1. Operative complications were minor in both groups. CONCLUSIONS: In nine of 17 patients, laser bronchoscopy appeared to improve the clinical status, permitting removal of mechanical ventilation and extubation and provided the opportunity for further treatment modalities in seven of the nine patients. Survival was improved in this subgroup, and requirement for mechanical ventilatory support was shortened. The improved outcome after laser therapy was related to the presence of obstructing endobronchial tumor as the cause of the respiratory insufficiency. Patients with inoperable carcinoma of the lung and respiratory failure should be evaluated for the presence of an endobronchial lesion that might be responsive to laser bronchoscopy.

Tracheobronchial obstruction from esophageal carcinoma: bronchoscopic treatment with neodymium: yttrium-aluminum-garnet laser.

Tracheobronchial obstruction resulting from esophageal carcinoma is uncommon. Patients with advanced esophageal carcinoma with tracheobronchial obstruction usually present with severe dyspnea or hemoptysis or both and may die of suffocation. The Lahey Clinic experience using laser bronchoscopy for the palliation of symptoms of airway obstruction in patients with esophageal carcinoma is presented. From 1982 to 1990, nine patients were treated in 13 procedures using the neodymium: yttrium-aluminum-garnet laser. Of the patients, seven had undergone previous treatment of the primary tumor. Tumors were located in the trachea in seven patients and in the main stem bronchi in three patients. Improvement of the airway caliber was achieved in all patients with relief of the dyspnea. The mean hospital stay was 2 days. One patient lived 4 years after laser treatment with no recurrence of tumor, and one patient died 1 week after treatment as a result of his poor general condition. The rest of the patients lived 3 to 41 weeks, with a median survival of 35 weeks. No complications were related to the procedures, and in particular, no tracheoesophageal fistulas developed. Our experience indicates that bronchoscopic application of this laser in conjunction with other treatment modalities can improve the quality and duration of life in selected patients with esophageal carcinoma that invades and obstructs the trachea.

Endoscopic laser therapy for obstructing tracheobronchial lesions.

The Lahey Clinic experience using laser bronchoscopy for relief of obstructive tracheobronchial lesions during a 7-year period from 1982 to 1989 involves 269 patients treated with 400 procedures. The carbon dioxide (CO2) laser was used for tracheal stenosis and granulation tissue. The neodymium:yttrium-aluminum-garnet (Nd:YAG) laser was used for all obstructing endobronchial neoplasms. Indications for therapy included severe dyspnea, hemoptysis, and postobstructive pneumonitis. All patients had relatively central lesions. A rigid bronchoscope was used to treat 88% of patients, and 12% of patients were treated with a flexible bronchoscope. One death occurred during the intraoperative period. Eleven deaths occurred within 1 week of therapy and were related to the presence of extensive malignant lesions or to coronary artery disease. Our experience indicates that bronchoscopic application of the CO2 or Nd:YAG laser affords effective palliation for patients with obstructive tracheobronchial lesions. The Nd:YAG laser is recommended for patients with bulky vascular endobronchial neoplasms, and the CO2 laser is best reserved for patients with benign tracheal stenosis and granulation tissue.