PURPOSE To compare pemetrexed/carboplatin with a standard regimen as first-line therapy in advanced non-small-cell lung cancer NSCLC. PATIENTS AND METHODS Patients with stage IIIB or IV NSCLC and performance status of 0 to 2 were randomly assigned to receive pemetrexed 500 mg/m(2) plus carboplatin area under the curve (AUC) = 5 (Calvert's formula) on day 1 or gemcitabine 1,000 mg/m(2) on days 1 and 8 plus carboplatin AUC = 5 on day 1 every 3 weeks for up to four cycles. The primary end point was health-related quality of life (HRQoL) defined as global quality of life, nausea/vomiting, dyspnea, and fatigue reported on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and the lung cancer-specific module LC13 during the first 20 weeks. Secondary end points were overall survival and toxicity. Results Four hundred thirty-six eligible patients were enrolled from April 2005 to July 2006. Patients who completed the baseline questionnaire were analyzed for HRQoL (n = 427), and those who received > or = one cycle of chemotherapy were analyzed for toxicity (n = 423). Compliance of HRQoL questionnaires was 87%. There were no significant differences for the primary HRQoL end points or in overall survival between the two treatment arms (pemetrexed/carboplatin, 7.3 months; gemcitabine/carboplatin, 7.0 months; P = .63). The patients who received gemcitabine/carboplatin had more grade 3 to 4 hematologic toxicity than patients who received pemetrexed/carboplatin, including leukopenia (46% v 23%, respectively; P < .001), neutropenia (51% v 40%, respectively; P = .024), and thrombocytopenia (56% v 24%, respectively; P < .001). More patients on the gemcitabine/carboplatin arm received transfusions of RBCs and platelets, whereas the frequencies of neutropenic infections and thrombocytopenic bleedings were similar on both arms. CONCLUSION Pemetrexed/carboplatin provides similar HRQoL and survival when compared with gemcitabine/carboplatin with less hematologic toxicity and less need for supportive care.
BackgroundAn increasing number of individuals with complex health care needs now receive life-long and life-prolonging ventilatory support at home. Family members often take on the role of primary caregivers. The aim of this study was to explore the experiences of families giving advanced care to family members dependent on home mechanical ventilation.MethodsUsing qualitative research methods, a Grounded Theory influenced approach was used to explore the families' experiences. A total of 15 family members with 11 ventilator-dependent individuals (three children and eight adults) were recruited for 10 in-depth interviews.ResultsThe core category, "fighting the system," became the central theme as family members were asked to describe their experiences. In addition, we identified three subcategories, "lack of competence and continuity", "being indispensable" and "worth fighting for". This study revealed no major differences in the families' experiences that were dependent on whether the ventilator-dependent individual was a child or an adult.ConclusionsThese findings show that there is a large gap between family members' expectations and what the community health care services are able to provide, even when almost unlimited resources are available. A number of measures are needed to reduce the burden on these family members and to make hospital care at home possible. In the future, the gap between what the health care can potentially provide and what they can provide in real life will rapidly increase. New proposals to limit the extremely costly provision of home mechanical ventilation in Norway will trigger new ethical dilemmas that should be studied further.
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