Cancer
-
Randomized Controlled Trial Multicenter Study
Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study.
Aberrant DNA methylation, which results in leukemogenesis, is frequent in patients with myelodysplastic syndromes (MDS) and is a potential target for pharmacologic therapy. Decitabine indirectly depletes methylcytosine and causes hypomethylation of target gene promoters. ⋯ Decitabine was found to be clinically effective in the treatment of patients with MDS, provided durable responses, and improved time to AML transformation or death. The duration of decitabine therapy may improve these results further.
-
Randomized Controlled Trial
Impact of coping skills intervention with family caregivers of hospice patients with cancer: a randomized clinical trial.
Family caregivers for cancer patients experience high levels of stress and burden and diminished quality of life (QOL). Interventions to improve coping skills of caregivers have been shown to be effective with other populations, but their impact has not been assessed in the difficult context of hospice care. The purpose of this study was to determine whether hospice plus a coping skill training intervention improved family caregivers' QOL, burden, coping, and mastery, compared with hospice plus emotional support, and usual hospice care. ⋯ The coping skills intervention was effective in improving caregiver QOL, reducing burden related to patients' symptoms, and caregiving tasks compared with hospice care alone or hospice plus emotional support. Structured caregiver skill-training interventions for caregivers are promising even in the difficult environment of end-of-life care and for families already receiving benefits of hospice care.
-
Randomized Controlled Trial Multicenter Study
Four versus six courses of a dose-escalated cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen plus etoposide (megaCHOEP) and autologous stem cell transplantation: early dose intensity is crucial in treating younger patients with poor prognosis aggressive lymphoma.
Patients with aggressive lymphoma and high-risk features at the time of diagnosis are reported to have a poor prognosis with standard therapy. Attempts to improve the results achieved with the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) using second-generation or third-generation chemotherapy have failed. In the current study, the authors increased the doses and dose intensity of drugs used for the conventional first-line therapy of aggressive lymphoma and designed a Phase II randomized trial that compared four and six courses of dose-escalated CHOP plus etoposide (megaCHOEP) supported by the transplantation of peripheral blood stem cells. ⋯ The results of the current study demonstrate that dose intensity, in particular early dose intensity, significantly influences disease control with high-dose therapy (HDT) and autologous stem cell transplantation. These results also may explain the failure of HDT with low early dose intensity to improve the results obtained with conventional chemotherapy.
-
Randomized Controlled Trial Multicenter Study
Twelve-year mortality results of a randomized trial of 2 versus 5 years of adjuvant tamoxifen for postmenopausal early-stage breast carcinoma patients (SITAM 01).
This study evaluated the impact on overall survival (OS) of 2 versus 5 years adjuvant tamoxifen in early breast carcinoma patients after 12 years of follow-up. ⋯ The benefits of longer TAM on OS start to emerge only after 9 years from diagnosis and seem to be more relevant in younger ER-positive women.
-
Randomized Controlled Trial Comparative Study
Randomized phase II study of weekly docetaxel plus trastuzumab versus weekly paclitaxel plus trastuzumab in patients with previously untreated advanced nonsmall cell lung carcinoma.
Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor-2 (HER-2). Nonsmall cell lung carcinoma (NSCLC) overexpresses HER-2 protein in approximately 20% of cases. In the current study, the authors combined trastuzumab with weekly taxanes in an attempt to improve outcomes over standard chemotherapy in patients with advanced NSCLC. ⋯ The expression of HER-2 protein in patients with advanced NSCLC in this study was found to be similar to that reported in previous series. The response rates and toxicities for patients treated with docetaxel and trasuzumab or paclitaxel and trasuzumab were not significantly different, though survival in both arms was better than expected. HER-2 expression status did not appear to affect outcomes for this uniform group of patients who were treated in a comparable fashion. Because of the infrequency of HER-2 overexpression, and the absence of improved outcomes in patients with NSCLC who were treated with trastuzumab plus chemotherapy in other studies, neither regimen tested will be advanced to a Phase III trial.