Randomized phase II-III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer: results from the IFCT-0802 trial†.

BACKGROUND: This randomized phase II-III trial sought to evaluate the efficacy and safety of adding bevacizumab (Bev) following induction chemotherapy (CT) in extensive small-cell lung cancer (SCLC). PATIENTS AND METHODS: Enrolled SCLC patients received two induction cycles of CT. Responders were randomly assigned 1:1 to receive four additional cycles of CT alone or CT plus Bev (7.5 mg/kg), followed by single-agent Bev until progression or unacceptable toxicity. The primary end point was the percentage of patients for whom disease remained controlled (still in response) at the fourth cycle. RESULTS: In total, 147 patients were enrolled. Partial response was observed in 103 patients, 74 of whom were eligible for Bev and randomly assigned to the CT alone group (n = 37) or the CT plus Bev group (n = 37). Response assessment at the end of the fourth cycle showed that disease control did not differ between the two groups (89.2% versus 91.9% of patients remaining responders in CT alone versus CT plus Bev, respectively; Fisher's exact test: P = 1.00). Progression-free survival (PFS) since randomization did not significantly differ, with a median PFS of 5.5 months [95% confidence interval (CI) 4.9% to 6.0%] versus 5.3 months (95% CI 4.8% to 5.8%) in the CT alone and CT plus Bev groups, respectively [hazard ratio (HR) for CT alone: 1.1; 95% CI 0.7% to 1.7%; unadjusted P = 0.82]. Grade ≥2 hypertension and grade ≥3 thrombotic events were observed in 40% and 11% of patients, respectively, in the CT plus Bev group. Serum vascular endothelial growth factor (VEGF) and soluble VEGF receptor titrations failed to identify predictive biomarkers. CONCLUSION: Administering 7.5 mg/kg Bev after induction did not improve outcome in extensive SCLC patients.

[Bilateral diaphragmatic paralysis: sequelae of neuralgic amyotrophy]. / Paralysie diaphragmatique bilatérale: séquelle d'une névralgie amyotrophique.

Diaphragmatic paralysis is rare in neuralgic amyotrophy. Total quick recovery is usual. We report a case with a diaphragmatic paralysis still present more than 30 years after the onset of a bilateral and recurrent neuralgic amyotrophy. Neuralgic amyotrophy should be considered as a possible cause of chronic diaphragmatic paralysis.

[Treatment of severe hemoptysis with terlipressin. Study of the efficacy and tolerance of this product]. / Traitement des hémoptysies graves par la terlipressine. Etude de l'efficacité et de la tolérance du produit.

Terlipressin (Glypressin) is a "pro-hormone"; after intravenous injection the glycyl radicals are slowly cleaved by enzymatic action, liberating vasopressin. We have assessed the efficacy of terlipressin in the treatment of severe hemoptysis. The study was performed on 20 patients: in 5 cases there was very copious hemoptysis and in 15 cases there was repeated hemoptysis of lesser volume. The cause was distributed as follows: 6 cases of neoplasms, 5 were sequelae of tuberculosis, bronchial dilatation 2 cases, pneumonia with abscess 2 cases, chronic airflow obstruction (COPD) 2 cases and 3 cases of silicosis. The treatment consisted of a slow intravenous injection of 2 mgm 4 times per day (9 patients), then in 11 patients an injection of 2 mgm at the time of acute episodes followed by 1 mgm every 6 hours. The patients received an average of between 15 and 20 mgm of the product for a treatment lasting over 5 days at the maximum. The results were as follows: total success 12 cases; partial success (a reduction to at least one-third of the initial hemoptysis): 5 cases; failure: 3 cases. The failures were linked in two cases to neoplastic disease and in one case there was an intolerance to the drug which did not allow the treatment to be pursued.(ABSTRACT TRUNCATED AT 250 WORDS)