Triplets versus doublets, with or without cisplatin, in the first-line treatment of stage IIIB-IV non-small cell lung cancer (NSCLC) patients: a multicenter randomised factorial trial (FAST).

BACKGROUND: The FAST is a 2 × 2 factorial trial addressing two questions: (1) the role of replacing cisplatin (P) with a non-platinum agent, vinorelbine (N), and (2) the role of adding a third agent, ifosfamide (I), in a doublet based on gemcitabine (G). METHODS: A total of 433 stage IIIB-IV non-small cell lung cancer (NSCLC) patients were randomised to one of four arms: gemcitabine-cisplatin (GP), gemcitabine-vinorelbine, gemcitabine-ifosfamide-cisplatin or gemcitabine-ifosfamide-vinorelbine. Two comparisons were performed: N- vs P-containing regimens and I-triplets vs non-I doublets. RESULTS: For N- vs P-containing regimens, adjusted overall survival was 9.7 vs 11.3 months (P=0.044), progression-free survival was 4.9 vs 6.4 months (P=0.020) and response rate was 24% vs 31% (P=0.124), respectively. No statistically significant difference was observed between doublets and triplets. Grade 3-4 haematological toxicity was significantly more frequent in P-containing therapy; grade 3-4 leucopenia was significantly more common in triplets. Concerning non-haematological toxicity, grade 3-4 nausea-vomiting was significantly increased in P-containing regimens. CONCLUSIONS: This trial provides evidence of a slight survival superiority of GP-containing regimens over platinum-free N-containing chemotherapy. This trial also confirms that the addition of a third chemotherapy agent (I) to a standard G-based doublet does not improve treatment outcome.

[Acute cholestatic hepatitis caused by propafenone. Report of a case and review of the literature]. / Epatite acuta colestatica da propafenone. Descrizione di un caso e revisione della letteratura.

A case of acute cholestatic hepatitis associated with use of propafenone is reported. Hepatitis developed 3 weeks after the beginning of administration of this drug. The close time relationship between the administration of the antiarrhythmic drug and the acute onset of the liver damage, the exclusion of hepatobiliary disease and the rapid normalisation of biochemical parameters following withdrawal of the drug strongly suggest that propafenone was involved in the pathogenesis of this syndrome. Meticulous taking of patient history and clinical assessment are mandatory for the early identification of drug-induced hepatotoxicity and avoidance of more severe types of reactions, such as liver failure.

[Azithromycin-omeprazole. Treatment for the eradication of Helicobacter pylori]. / Azitromicina-omeprazolo. Trattamento per eradicazione di Helicobacter pylori.

AIM: To evaluate the benefit of 4-week regimen including azithromycin+omeprazole (vs omeprazole alone) for eradication of Helicobacter pylori. METHODS: Twenty HP positive patients with an ulcer dyspepsia (NUD) were included in this study. They were given either omeprazole 40 mg for 4 weeks alone or in combination with azithromycin 1 g/die for 1 week. Endoscopy was performed before 4 weeks after and 4 months after treatment. The presence of HP was assessed in antral and corporeal biopsies by urease test and histology. RESULTS: HP eradication was observed in 9/10 (90%) patients in the omeprazole+azithromycin group and 0/10 patients in the omeprazole alone group. CONCLUSION: Omeprazole 40 mg for 4 weeks in combination with azithromycin 1 g die for 1 week eradicates HP in 90% of these patients. The good eradication percentage and absence of collateral effect make us extend patients' number to test.

[Cyclofenil-induced acute hepatitis. A retrospective diagnosis of a case during acute hepatitis B]. / Epatite acuta da cyclofenil. Diagnosi retrospettiva di un caso in corso di epatite acuta da virus B.

We report a case of acute hepatitis due to cyclofenil retrospectively diagnosed during acute viral hepatitis (HBV). Hepatitis developed 3 months after the beginning of administration and was reversible after withdrawal of the drug. The case is documented on the basis of liver histology and the exclusion of other causes of acute hepatitis.

[Hematological complications of viral hepatitis. Case-list contribution]. / Complicazioni ematologiche dell'epatite virale. Contributo casistico.

The incidence of haematological abnormalities has been evaluated in 1170 patients affected by acute viral hepatitis. Of these patients, 665 were HBsAg+, 427 HBsAg-, 31 with IgM anti-HAV, 26 non A and non B hepatitis. 21 patients were not classified due to lack of data relating to markers for HAV or HBV. Anemia, leucopenia, thrombocytopenia and pancytopenia were found with some frequency at the haemochromocytometric examination. It is emphasized that these haematological abnormalities are often of minor relevance whereas the rarer and more serious complications such as persistent bone marrow hypoplasia or pure aplastic anemia can present difficult clinical problems regarding prognosis and therapy: in 4 cases of bone marrow hypoplasia a recovery was obtained in 1 case only, whereas the remaining cases had a fatal outcome after a period varying from 20 days to 15 months from the appearance of pancytopenia. We suggest the advisability of a closer study of the haematological and immunological aspects in patients with viral hepatitis in order to discover those elements which are useful towards a better understanding of the etiopathogenesis of the haematological abnormalities studied above. Such a detailed study would also enable further improvement in existing therapeutic measures.