What constitutes best supportive care in the treatment of advanced non-small cell lung cancer patients?--Results from the lung cancer economics and outcomes research (LUCEOR) study.

BACKGROUND: A significant proportion of advanced non-small cell lung cancer (NSCLC) patients receive supportive treatments to manage disease-related symptoms either separately or combined with systemic anti-cancer therapy (SACT). This supportive treatment is commonly referred to as best supportive care (BSC). Definition of BSC in clinical trials and its description in published comparative and real-life NSCLC studies is limited. The lack of a consensus BSC definition makes detailed evaluations of clinical trials and comparisons between clinical trials problematic. METHODS: Data were collected as part of the lung cancer economics and outcomes research (LUCEOR) study. Information on treatment and treatment outcomes from deceased stage IIIb/IV NSCLC patients across ten countries was retrospectively collected from medical records. BSC was defined as the best care available as judged by the attending physicians. RESULTS: A total of 1327 patients' data were analyzed. Of those, 774/1327 (58%), 316/631 (50%), 123/259 (47%), 25/56 (45%) and 15/26 (58%) were administered treatment defined as BSC with first, second, third, fourth and fifth-line SACT respectively. In total, 346/678 (51%), 149/335 (45%), 86/176 (49%), 11/28 (39%) and 13/25 (52%) of patients were administered treatment defined as BSC in the end-of-life setting after finishing first, second, third, fourth and fifth-line SACT respectively. BSC therapies could be grouped into 24 different categories. The most common elements did not vary substantially whether given with SACT (irrespective of treatment line), in the end-of-life setting, or between countries. The commonest categories of BSC were narcotic and non-narcotic analgesics, corticosteroids and gastrointestinal medication. CONCLUSION: There were no major differences in what constituted BSC. BSC included in all instances narcotic and non-narcotic analgesics, corticosteroids and gastrointestinal medication. To our knowledge this is the first study attempting to describe BSC in routine clinical practice. This study's results could help define a practical, up to date, evidence-based definition of BSC.

Cost-effectiveness of licensed treatment options for restless legs syndrome in the UK and Sweden.

OBJECTIVE: To estimate the cost-effectiveness of pramipexole versus no treatment and ropinirole in moderate to very severe idiopathic restless legs syndrome (RLS) in the UK and Sweden. METHODS: A Markov model was developed using clinical trial data for pramipexole and ropinirole. Model health states were based on the International RLS Study Group Rating Scale (IRLS) scores. Health states were: no (IRLS 0), mild (IRLS 1-14), moderate (IRLS 15-24), severe (IRLS 25-34), very severe RLS (IRLS 35-40) and death. Patients entered the model with an IRLS score > 15 matching the trial inclusion criteria of the pramipexole trials. Resource use and utilities were based on trial data, literature, a patient survey and a panel of physicians from the UK and Sweden in the absence of published information. A healthcare sector perspective was taken for the UK and a societal perspective for Sweden using 2004-2005 unit costs. The base case analysis took a 1-year timeframe. RESULTS: In the UK the incremental cost per quality-adjusted life year (QALY) for pramipexole was 3349 pounds sterling versus no treatment and a cost-saving of 92 pounds sterling against ropinirole. In Sweden, pramipexole produced cost-savings of Swedish Krona (SEK) 2381 (176 pounds sterling) versus no treatment and SEK 3564 (264 pounds sterling) against ropinirole. QALY gains in both countries were 0.095 versus no treatment and 0.007 versus ropinirole. Results compare well with UK cost-effectiveness thresholds of 20,000 pounds sterling/30,000 pounds sterling per QALY and are cost-saving for Sweden. One-way and probabilistic sensitivity analyses showed results to be robust. CONCLUSIONS: Pramipexole is cost-effective compared to no treatment and ropinirole for patients with moderate to very severe RLS.

Meta-analysis of the efficacy and tolerability of pramipexole versus ropinirole in the treatment of restless legs syndrome.

OBJECTIVE: In the absence of comparative trials a meta-analysis was performed to compare the efficacy and tolerability of the non-ergot derived dopamine agonists, pramipexole and ropinirole, in restless legs syndrome (RLS). METHODS: Frequentist fixed and random-effects models were pre-specified for the direct comparisons and a Bayesian approach for the indirect comparison. Efficacy outcomes included the mean change from baseline in the International RLS Study Group Rating Scale (IRLS) score and the percentage of responders on the clinical global impressions - improvement scale (CGI-I). Safety outcomes included the incidence of withdrawal and adverse events. RESULTS: The direct meta-analysis confirmed superior efficacy for both treatments versus placebo for the IRLS (pramipexole: -5.45; 95% CI: -7.70; -3.20; ropinirole: -3.16; 95% CI: -4.26; -2.05) and the CGI-I (pramipexole: OR=2.98; 95% CI: 2.08; 4.26; ropinirole: OR=1.99; 95% CI: 1.52; 2.60). Placebo comparisons showed a significantly higher incidence of nausea for pramipexole (p<0.01), whereas nausea, vomiting, dizziness, and somnolence were significantly higher for ropinirole (all p<0.01). The indirect comparison showed with a probability of > or = 95%, a superior reduction in the mean IRLS score (-2.33; 95% credibility interval [CrI]: -4.23; -0.41), higher CGI-I response rate (OR=1.50; 95% CrI: 0.97; 2.32) and significantly lower incidence of nausea, vomiting, and dizziness for pramipexole compared to ropinirole. CONCLUSION: Differences in efficacy and tolerability favouring pramipexole over ropinirole can be observed. These findings should be further confirmed in head-to-head clinical trials.