Palliative chemotherapy beyond three courses conveys no survival or consistent quality-of-life benefits in advanced non-small-cell lung cancer

This randomised multicentre trial was conducted to establish the optimal duration of palliative chemotherapy in advanced non-small-cell lung cancer (NSCLC). We compared a policy of three vs six courses of new-generation platinum-based combination chemotherapy with regard to effects on quality of life (QoL) and survival. Patients with stage IIIB or IV NSCLC and WHO performance status (PS) 0–2 were randomised to receive three (C3) or six (C6) courses of carboplatin (area under the curve (AUC) 4, Chatelut's formula, equivalent to Calvert's AUC 5) on day 1 and vinorelbine 25 mg m−2 on days 1 and 8 of a 3-week cycle. Key end points were QoL at 18 weeks, measured with EORTC Quality of Life Questionnaire (QLQ)-C30 and QLQ-LC13, and overall survival. Secondary end points were progression-free survival and need of palliative radiotherapy. Two hundred and ninety-seven patients were randomised (C3 150, C6 147). Their median age was 65 years, 30% had PS 2 and 76% stage IV disease. Seventy-eight and 54% of C3 and C6 patients, respectively, completed all scheduled chemotherapy courses. Compliance with QoL questionnaires was 88%. There were no significant group differences in global QoL, pain or fatigue up to 26 weeks. The dyspnoea palliation rate was lower in the C3 arm at 18 and 26 weeks (P<0.05), but this finding was inconsistent across different methods of analysis. Median survival in the C3 group was 28 vs 32 weeks in the C6 group (P=0.75, HR 1.04, 95% CI 0.82–1.31). One- and 2-year survival rates were 25 and 9% vs 25 and 5% in the C3 and C6 arm, respectively. Median progression-free survival was 16 and 21 weeks in the C3 and C6 groups, respectively (P=0.21, HR 0.86, 95% CI 0.68–1.08). In conclusion, palliative chemotherapy with carboplatin and vinorelbine beyond three courses conveys no survival or consistent QoL benefits in advanced NSCLC

Protection against cold air and exercise-induced bronchoconstriction while on regular treatment with Oxis

This study aimed to compare the duration of protection against exercise-induced bronchoconstriction (EIB) after inhalation of formoterol (Oxis) Turbuhaler with that of terbutaline Turbuhaler and placebo Turbuhaler in asthmatic patients treated regularly with formoterol Turbuhaler 9 microg b.i.d. and inhaled steroids. The study. performed at three centres (Goteborg and Lund, Sweden, and Trondheim, Norway), consisted of an open-label part with formoterol Turbuhaler 9 microg b.i.d. and a randomized, double-blind, cross-over part with a single dose (on top of the regular treatment) of either formoterol Turbuhaler 9 microg, terbutaline Turbuhaler 0.5 mg or placebo Turbuhaler. The patients attended the clinic six times: twice for screening visits, three times for randomized treatment and once for a follow-up visit. Patients received regular b.i.d. treatment with formoterol 9 microg for a mean period of 16 days. Formoterol gave a post-exercise fall of 12, 10, 15 and 17% in forced expiratory volume in 1 sec (FEV1) 15 min, 4, 8 and 12 h after inhalation. The differences compared with placebo (falls of 26, 22, 23 and 22%) and terbutaline (falls of 17, 18, 22 and 22%) were all statistically significant (P<0.05 for all comparisons). Patients on regular treatment with formoterol Turbuhaler 9 microg b.i.d. have a significant protection against EIB up to 12 h after inhalation of formoterol 9 microg. The protection was also significantly better than that of terbutaline Turbuhaler 0.5 mg