BACKGROUND:On the basis of a previous meta-analysis, the International Adjuvant Lung Cancer Trial was designed to evaluate the effect of cisplatin-based adjuvant chemotherapy on survival after complete resection of non-small-cell lung cancer.METHODS:We randomly assigned patients either to three or four cycles of cisplatin-based chemotherapy or to observation. Before randomization, each center determined the pathological stages to include, its policy for chemotherapy (the dose of cisplatin and the drug to be combined with cisplatin), and its postoperative radiotherapy policy. The main end point was overall survival.RESULTS:A total of 1867 patients underwent randomization; 36.5 percent had pathological stage I disease, 24.2 percent stage II, and 39.3 percent stage III. The drug allocated with cisplatin was etoposide in 56.5 percent of patients, vinorelbine in 26.8 percent, vinblastine in 11.0 percent, and vindesine in 5.8 percent. Of the 932 patients assigned to chemotherapy, 73.8 percent received at least 240 mg of cisplatin per square meter of body-surface area. The median duration of follow-up was 56 months. Patients assigned to chemotherapy had a significantly higher survival rate than those assigned to observation (44.5 percent vs. 40.4 percent at five years [469 deaths vs. 504]; hazard ratio for death, 0.86; 95 percent confidence interval, 0.76 to 0.98; P<0.03). Patients assigned to chemotherapy also had a significantly higher disease-free survival rate than those assigned to observation (39.4 percent vs. 34.3 percent at five years [518 events vs. 577]; hazard ratio, 0.83; 95 percent confidence interval, 0.74 to 0.94; P<0.003). There were no significant interactions with prespecified factors. Seven patients (0.8 percent) died of chemotherapy-induced toxic effects.CONCLUSIONS:Cisplatin-based adjuvant chemotherapy improves survival among patients with completely resected non-small-cell lung cancer.
Purpose: To evaluate whether preoperative chemotherapy (PCT) could improve survival in resectable stage 1 (except T1 N0), II, and IIIA non-small-cell lung cancer (NSCLC).Patients and Methods: A randomized trial compared PCT to primary surgery (PRS). PCT consisted of two cycles of mitomycin (6 mg/m(2), day 1), ifosfamide (1.5 g/m(2), days 1 to 3) and cisplatin (30 mg/m2, days 1 to 3), and two additional postoperative cycles for responding patients. In both arms, patients with pT3 or pN2 disease received thoracic radiotherapy.Results: Three hundred fifty-five eligible patients were randomized. Overall response to PCT was 64%. There were two preoperative toxic deaths. Postoperative mortality was 6.7% in the PCT arm and 4.5% in the PRS arm (P =.38). Median survival was 37 months (95% confidence interval [CI], 26.7 to 48.3) for PCT and 26.0 months (95% CI, 19.8 to 33.6) for PRS (P =.15). Survival differences between both arms increased from 3.8% (95% C1, 1.3% to 25.1%) at 1 year to 8.6% (95% CI, 2.64% to 24.4%) at 4 years. A quantitative interaction between N status and treatment was observed, with benefit confined to N0 to N1 disease (relative risk [RR], 0.68; 95% Cl, 0.49 to 0.96; P =.027). After a nonsignificant excess of deaths during treatment, the effect of PCT was significantly favorable on survival (RR, 0.74; 95% CI, 0.56 to 0.99; P =.044). Disease-free survival time was significantly longer in the PCT arm (P =.033).Conclusion: Although impressive differences in median, 3-year, and 4-year survival were observed, they were not statistically significant, except for stage I and II disease. (C) 2001 by American Society of Clinical Oncology.
Purpose: To evaluate whether preoperative chemotherapy (PCT) could improve survival in resectable stage I (except T1N0), II, and IIIA non–small-cell lung cancer (NSCLC). Patients and Methods: A randomized trial compared PCT to primary surgery (PRS). PCT consisted of two cycles of mitomycin (6 mg/m 2 , day 1), ifosfamide (1.5 g/m 2 , days 1 to 3) and cisplatin (30 mg/m 2 ,d ays 1t o 3), and two additional postoperative cycles for responding patients. In both arms, patients with pT3 or pN2 disease received thoracic radiotherapy. Results: Three hundred fifty-five eligible patients were randomized. Overall response to PCT was 64%. There were two preoperative toxic deaths. Postoperative mortality was 6.7% in the PCT arm and 4.5% in the PRS arm (P .38). Median survival was 37 months (95% confidence interval [CI], 26.7 to 48.3) for PCT and 26.0 months (95% CI, 19.8 to 33.6) for PRS (P .15). Survival differences between both arms increased from 3.8% (95% CI, 1.3% to 25.1%) at 1 year to 8.6% (95% CI, 2.64% to 24.4%) at 4 years. A quantitative interaction between N status and treatment was observed, with benefit confined to N0 to N1 disease (relative risk [RR], 0.68; 95% CI, 0.49 to 0.96; P .027). After a nonsignificant excess of deaths during treatment, the effect of PCT was significantly favorable on survival (RR, 0.74; 95% CI, 0.56 to 0.99; P .044). Disease-free survival time was significantly longer in the PCT arm (P .033). Conclusion: Although impressive differences in median, 3-year, and 4-year survival were observed, they were not statistically significant, except for stage I and II disease. J Clin Oncol 20:247-253. © 2001 by American Society of Clinical Oncology.
The authors report the results of a study into mycobacterial contamination of bronchial fibroscopes over a 6 year period during which 8,750 fibroscopies were performed. On 19 occasions, there were two positive results on the same day which could have led to contamination (0.07 p. 100). In 12 cases, there was heavy bacterial contamination on the first examination and at least 5 colonies on the second. Crossed transmission was not observed. The authors emphasize the role of the accessory parts and connections which are often neglected and which may lead to false positive results in the following patients; a sterilisation procedure is proposed which seems to be effective as no mycobacterial contamination has been observed since it was introduced.
A case of severe diffuse interstitial pneumonia is reported in a 69 year old after 5 weeks treatment with gold salts. Regression of symptoms on withdrawal of gold salts and under steroid therapy, the similarity with previously published cases, the absence of another cause lead us to incriminate the gold salts. The case is documented with optical and electronic microscopic studies of transbronchial biopsy and repeated examination of bronchoalveolar lavage fluid. A general review of the literature is included with a critical discussion of the physiopathogenic mechanisms. The results of the examination of the bronchoalveolar lavage fluid are further evidence in favour of cell-mediated hypersensitivity reaction.
The authors studied the ultrastructural morphology of the lung in one case of Bourneville's tuberous sclerosis with pulmonary involvement. The observations in this report are similar to those previously reported in pulmonary lymphangioleiomyomatosis and further emphasize the striking resemblance between the two diseases.
A case of generalised scleroderma is reported in a dental technician exposed to the risk of silicosis. A study of the occupational toxic risks in this patient showed pulmonary overload with silica and metallic particles composed of chromium, cobalt and tungsten. The job also involved the handling of vinyl chloride and its stable polymer. This chemical is known to give rise to scleroderma-type skin disease. The relationship between these occupational factors leads to a difficult physio-pathological problem and justifies preventative measures, even though they may be costly and demanding.