Lenvatinib, as compared with placebo, was associated with significant improvements in progression-free survival and the response rate among patients with iodine-131-refractory thyroid cancer. Patients who received lenvatinib had more adverse effects. (Funded by Eisai; SELECT ClinicalTrials.gov number, NCT01321554.).
Direct evidence from randomized controlled trials does not support the routine use of adjuvant chemotherapy for patients with stage II colon cancer. Patients and oncologists who accept the relative benefit in stage III disease as adequate indirect evidence of benefit for stage II disease are justified in considering the use of adjuvant chemotherapy, particularly for those patients with high-risk stage II disease. The ultimate clinical decision should be based on discussions with the patient about the nature of the evidence supporting treatment, the anticipated morbidity of treatment, the presence of high-risk prognostic features on individual prognosis, and patient preferences. Patients with stage II disease should be encouraged to participate in randomized trials.
Context Specialized palliative care teams are increasingly providing care for the terminally ill. However, the impact of such teams on quality of life, satisfaction with care, and economic cost has not been examined systematically using detailed criteria for study quality.Objective To systematically review the evidence for effectiveness of specialized palliative care.
Data SourcesWe performed a keyword search of the following databases from their inception to January 2008: MEDLINE, Ovid Healthstar, CINAHL, EMBASE, and the Cochrane Central Register of Controlled Trials.
Study SelectionWe included all randomized controlled trials in which specialized palliative care was the intervention and for which outcomes included quality of life, satisfaction with care, or economic cost. Data Extraction Data on population, intervention, outcome, methods, and methodological quality were extracted by 2 investigators using standardized criteria.
ResultsOf 396 reports of randomized controlled trials, 22 met our inclusion criteria. There was most consistent evidence for effectiveness of specialized palliative care in improvement of family satisfaction with care (7 of 10 studies favored the intervention). Only 4 of 13 studies assessing quality of life and 1 of 14 assessing symptoms showed a significant benefit of the intervention; however, most studies lacked statistical power to report conclusive results, and quality-of-life measures were not specific for terminally ill patients. There was evidence of significant cost savings of specialized palliative care in only 1 of the 7 studies that assessed this outcome. Methodological limitations were identified in all trials, including contamination of the control group, failure to account for clustering in cluster randomization studies, and substantial problems with recruitment, attrition, and adherence.
ConclusionsThe evidence for benefit from specialized palliative care is sparse and limited by methodological shortcomings. Carefully planned trials, using a standardized palliative care intervention and measures constructed specifically for this population, are needed.
Potential drug interactions were common among cancer patients and most often involved medications to treat comorbid conditions. Duplicate medications were infrequent.
Interpretation: There is a strong stigma attached to palliative care, which may persist even after positive experiences with an early palliative care intervention. Education of the public, patients and health care providers is paramount if early integration of palliative care is to be successful.
AbstractCMAJ Podcasts: author interview at
Oncologists referred patients frequently to SPC, but generally late in the disease course for patients with uncontrolled symptoms. Availability of comprehensive SPC, especially for patients receiving chemotherapy, and persisting definitional issues seem to be the main barriers preventing timely referral.
Context Large clinical trials are the criterion standard for making treatment decisions, and nonpublication of the results of such trials can lead to bias in the literature and contribute to inappropriate medical decisions. Objectives To determine the rate of full publication of large randomized trials presented at annual meetings of the American Society of Clinical Oncology (ASCO), quantify bias against publishing nonsignificant results, and identify factors associated with time to publication. Design Survey of 510 abstracts from large (sample size, Ն200), phase 3, randomized controlled trials presented at ASCO meetings between 1989 and 1998. Trial results were classified as significant (PՅ.05 for the primary outcome measure) or nonsignificant (PϾ.05 or not reported), and the type of presentation and sponsorship were identified. Subsequent full publication was identified using a search of MEDLINE and EMBASE, completed November 1, 2001; the search was updated in November 2002, using the Cochrane Register of Controlled Trials. Authors were contacted if the searches did not find evidence of publication. Main Outcome Measures Publication rate at 5 years; time from presentation to full publication. Results Of 510 randomized trials, 26% were not published in full within 5 years after presentation at the meeting. Eighty-one percent of the studies with significant results had been published by this time compared with 68% of the studies with nonsignificant results (PϽ.001). Studies with oral or plenary presentation were published sooner than those not presented (P=.002), and studies with pharmaceutical sponsorship were published sooner than studies with cooperative group sponsorship or studies for which sponsorship was not specified (P=.02). These factors remained significant in a multivariable model. The most frequent reason cited by authors for not publishing was lack of time, funds, or other resources. Conclusions A substantial number of large phase 3 trials presented at an international oncology meeting remain unpublished 5 years after presentation. Bias against publishing nonsignificant results is a problem even for large randomized trials. Nonpublication breaks the contract that investigators make with trial participants, funding agencies, and ethics boards.
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