Biweekly oxaliplatin and irinotecan chemotherapy in advanced gastric cancer. A first-line multicenter phase II trial of the Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT).

BACKGROUND: The aim of the study was to evaluate the feasibility and efficacy of an outpatient oxaliplatin/irinotecan chemotherapy in chemonaive patients suffering from unresectable gastric cancer. MATERIALS AND METHODS: Biweekly oxaliplatin (85 mg/m2) and irinotecan (125 mg/m2) was chosen since it has been shown previously in colorectal cancer that oxaliplatin (85 mg/m2) is superior to a lower dose and toxicity of irinotecan is much lower if given fractionated. The irinotecan dose below the maximum tolerated dose takes into consideration concerns about increased toxicity in gastric cancer patients. RESULTS: Forty-three patients with histologically proven gastric adenocarcinoma and no previous palliative chemotherapy were selected. WHO grade 3 and 4 toxicities included neutropenia in 2/43 patients, anemia in 3/43 patients, nausea in 2/43 patients and diarrhea in 4/43 patients. Response rates were assessable in 38 patients as follows: complete response in three patients (8%), partial response in 19 (50%), stable disease in 11 (29%), and progressive disease in 5 patients (13%). The median time-to-progression was 53 months and median overall survival was 9.5 months. CONCLUSION: The outpatient combination of biweekly oxaliplatin/irinotecan was well tolerated and showed a response rate within the range of other first-line combination therapies. The favorable toxicity profile, however, renders oxaliplatin/irinotecan as an alternative first-line regimen.

A new approach to combining clinical relevance and statistical significance for evaluation of quality of life changes in the individual patient.

OBJECTIVE: Empirical investigation of formerly proposed criteria for relevant changes of health-related quality of life (QOL) regarding their use for monitoring changes in the individual patient. Suggestion of a new criterion trying to overcome the drawbacks of former criteria. STUDY DESIGN AND SETTING: QOL data were collected longitudinally in 160 cancer patients receiving chemotherapy at an oncological outpatient unit, giving rise to a total of 975 QOL assessments. QOL was measured using the European Organization on Research and Treatment of Cancer Quality of Life Core Questionnaire. Several formerly suggested criteria of relevant change (distribution based, anchor based) were compared in terms of both prevalence and statistical significance of the resulting relevant changes. RESULTS: When considering criteria of relevant change suggested in the literature, high proportions (average: 42.3-48.3%) of reputedly relevant changes were found. The majority of these changes (average: 55.8-62.2%) were statistically insignificant. Combination of an increased threshold for clinical relevance with the concept of statistical significance resulted in a more meaningful change criterion. CONCLUSION: Formerly recommended thresholds of relevant change in QOL appear to be unduly low when focusing on the individual patient. A modified criterion is therefore suggested for this case. However, more research is needed for validation and refinement of the proposed criterion.

[Acute fatty liver in pregnancy with consumption coagulopathy]. / Akute Schwangerschaftsfettleber mit Verbrauchskoagulopathie.

Acute idiopathic fatty liver of pregnancy was observed in a 34-year-old patient. Mother and child survived this complication which has happened in only 10% of the 69 histologically verified cases. On the basis of coagulation studies it may be assumed that consumption coagulopathy had been present initially. This could be pathogenetically relevant in the development of fatty liver of pregnancy.