IC prolongs survival in ED SCLC with slightly better scores for QOL.

Background-Pregnant women with heart disease (HD) are at increased risk for cardiac (CV) complications. However, the frequency of neonatal (NE) complications in pregnant women with HD relative to pregnant women without HD has not been examined. Methods and Results-Pregnant women with HD were prospectively monitored during 302 pregnancies. The frequency of NE and CV complications was compared with those in a control group without HD during 572 pregnancies. The frequency of NE complications was higher in the HD group (18% versus 7%; HD versus controls). The NE complication rate was lowest in pregnancies of women age 20 to 35 years who did not smoke during pregnancy, did not receive anticoagulants, and had no obstetric risk factors: 4% in control patients, 5% in HD patients with no cardiac risk factors for NE complications (left heart obstruction, poor functional class, or cyanosis), and 7% in HD patients with Ն1 such risk factor. In contrast, the event rate in pregnancies of controls age Ͻ20 or Ͼ35 years who had obstetric risk factors or multiple gestation or who smoked was 11%. In the HD group, women age Ͻ20 or Ͼ35 years who had obstetric risk factors or multiple gestation, who smoked, or who received anticoagulants experienced an even higher NE complication rate (27% with no cardiac risks for NE events and 33% in the presence of Ն1 cardiac risk factors). The frequency of CV complications was higher in the HD group (17% versus 0%; HD versus controls). Conclusion-Pregnant women with HD are at increased risk for both NE and CV complications. The risk for NE adverse events in pregnant women with HD is highest in those with both obstetric and cardiac risk factors for NE complications.

This randomised multicentre trial was conducted to establish the optimal duration of palliative chemotherapy in advanced non-smallcell 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 À2 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 ninetyseven patients were randomised (C3 150, C6 147). Their median age was 65 years, 30% had PS 2 and 76% stage IV disease. Seventyeight 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 (Po0.05), 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 ¼ 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 ¼ 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.