Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). This study evaluated addition of daratumumab (D) to RVd in ASCT-eligible NDMM patients. Patients (N=207) were randomized 1:1 to receive RVd ±D induction (4 cycles), ASCT, RVd ±D consolidation (2 cycles), and lenalidomide ±D maintenance (26 cycles). At the primary endpoint analysis, the stringent complete response (sCR) rate by the end of post-ASCT consolidation favored D-RVd over RVd (42.4% vs 32.0%; odds ratio, 1.57; 95% confidence interval [CI], 0.87-2.82; 1-sided P=0.068) and met the prespecified 1-sided alpha of 0.10. With longer follow-up (median, 22.1 months), responses continued to deepen; rates of sCR improved for D-RVd versus RVd (62.6% vs 45.4%; P=0.0177), as did rates of minimal residual disease negativity (10−5 threshold) in the intent-to-treat population (51.0% vs 20.4%; P<0.0001). Four (3.8%) and 7 (6.8%) patients in the D-RVd and RVd groups progressed, respectively, and 24-month progression-free survival rates were 95.8% (D-RVd) and 89.8% (RVd). Grade 3/4 hematologic adverse events were more common with D-RVd. More infections occurred with D-RVd, but rates of grade 3/4 infections were similar. Median CD34+ cell yield was 8.2´106/kg for D-RVd and 9.4´106/kg for RVd, although plerixafor use was more common in the D-RVd arm. There was no difference in median times to neutrophil or platelet engraftment. In summary, daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns. Clinicaltrials.gov NCT02874742.
Background-Apolipoprotein (apo) A-I and apoA-I-mimetic peptides showed promise to prevent atherosclerosis development. Using a bypassed vein graft model in apoE-null mice, we evaluated the effects of oral or intraperitoneal administration of an apoA-I-mimetic peptide on evolving atherosclerotic lesions in the vein graft and compared such effects on the established atherosclerotic lesions in aortic sinus in the same mice. Methods and Results-We used apoE-null mice in which a segment of inferior vena cava was grafted into the right carotid artery at 16 weeks of age. Native aortic atherosclerotic lesions (established atherosclerosis) and vein-graft atherosclerotic lesions (evolving atherosclerosis) were assessed 4 weeks after daily oral (0.3 mg/mL) or intraperitoneal (50 g in 200 L saline) administration of an apoA-I-mimetic peptide, D4F. Mice receiving saline or water without D4F served as controls. Both oral and intraperitoneal administration of D4F reduced vein-graft atherosclerotic (evolving lesions) plaque size by 43% and 42%, plaque lipid by 70% and 49%, and macrophage immunoreactivity by 63% and 62%, respectively, compared with controls. In contrast, D4F had no effect on the native aortic sinus atherosclerotic lesions (established lesions). Conclusions-Oral and intraperitoneal administration of the apoA-I-mimetic peptide D4F significantly reduced rapidly evolving atherosclerotic lesions in vein grafts but not established atherosclerotic lesions in aortic sinus. These observations suggest that the type of atherosclerotic lesions and the time of initiation during the course of lesion evolution modulate the beneficial effects of apoA-I-mimetic peptides on atherosclerosis.
Over 50% of girls with Turner syndrome have an abnormal BP circadian rhythm, which is similar to adult patients with secondary hypertension. Patients with Turner syndrome have higher blood pressure measurements compared to published population standards, as evidenced by the shift to the right of both the systolic and diastolic BP SDS. These findings suggest that girls with Turner syndrome should be carefully monitored in childhood and adulthood for blood pressure and other cardiovascular risk factors.
People living with HIV (PLWH) are diagnosed with cancer at an increased rate over the general population and generally have a higher mortality due to delayed diagnoses, advanced cancer stage, comorbidities, immunosuppression, and cancer treatment disparities. Lack of guidelines and provider education has led to substandard cancer care being offered to PLWH. To fill that gap, the NCCN Guidelines for Cancer in PLWH were developed; they provide treatment recommendations for PLWH who develop non-small cell lung cancer, anal cancer, Hodgkin lymphoma, and cervical cancer. In addition, the NCCN Guidelines outline advice regarding HIV management during cancer therapy; drug-drug interactions between antiretroviral treatments and cancer therapies; and workup, radiation therapy, surgical management, and supportive care in PLWH who have cancer.
QUESTION ASKED: Does a computer-based approach for collecting geriatric assessment information provide a practical and efficient means of obtaining reliable and reproducible data from older adults with cancer?SUMMARY ANSWER: Computer-based geriatric assessment provides a feasible, reliable, and valid approach in older adults with cancer. WHAT WE DID:Older patients ($ 65 years) with cancer were randomly assigned to one of four treatment arms to compare the feasibility, reliability, and validity of two computer-based platforms for geriatric assessment with traditional paper-and-pencil data capture.WHAT WE FOUND: Completion times were similar for computer-based and paper-and-pencil assessments (Fig), and data gathered via computer-based assessment showed high test-retest reliability as well as internal consistency. BIAS, CONFOUNDING FACTOR(S), REAL-LIFE IMPLICATIONS:Many of the patients in our study were white, non-Hispanic, and college-educated older adults. This patient population may be more comfortable using computer technologies than other demographic groups; thus our results may not be generalizable to other segments of the patient population. Older patients with cancer are at increased risk for treatment toxicity. Geriatric assessment captures a range of physiological and psychological metrics that predict toxicity and survival, and thus have high utility in guiding interventions. In the current study, we found that computer-based geriatric assessment provides an efficient method for acquiring reliable and valid data. Adoption of computer-based geriatric assessment into oncology practice thus can provide a cost-and time-efficient approach for acquiring high-value data to be used in formulating treatment decisions for older adults with cancer. Completion Time (minutes) Abstract PurposeThe goal of this study was to evaluate the feasibility, reliability, and validity of a computerbased geriatric assessment via two methods of electronic data capture (SupportScreen and REDCap) compared with paper-and-pencil data capture among older adults with cancer. MethodsEligible patients were $ 65 years old, had a cancer diagnosis, and were fluent in English.Patients were randomly assigned to one of four arms, in which they completed the geriatric assessment twice: (1) REDCap and paper and pencil in sessions 1 and 2; (2) REDCap in both sessions; (3) SupportScreen and paper and pencil in sessions 1 and 2; and (4) SupportScreen in both sessions. The feasibility, reliability, and validity of the computer-based geriatric assessment compared with paper and pencil were evaluated. ResultsThe median age of participants (N = 100) was 71 years (range, 65 to 91 years) and the diagnosis was solid tumor (82%) or hematologic malignancy (18% ). There were no significant differences in completion times between SupportScreen and paper and pencil (P = .50). The computer-based geriatric assessment was feasible. Few participants (8%) needed help with completing the geriatric assessment (REDCap, n = 7 and SupportScreen, n = 1), 89% reported th...
Over 30% of patients with Turner syndrome were found to be mildly hypertensive and over 50% had an abnormal diurnal blood pressure profile. In this study we were unable to demonstrate that the presence of renal or cardiac abnormalities had an effect on recorded blood pressure. The use of growth hormone and oestrogen to manage growth failure and pubertal delay did not seem to affect blood pressure. This study suggests that there is a high prevalence of raised blood pressure in Turner syndrome patients. The 24 h-ambulatory blood pressure monitoring profile suggests that this may be secondary in origin, but we were unable to demonstrate an underlying mechanism with the renal and cardiac investigations performed.
Patient eligibilityPatients over the age of 18 with histologically or cytologically confirmed indolent non-Hodgkin lymphoma were eligible including: untreated, relapsed, or refractory follicular lymphomas of any grade, marginal zone B-cell lymphoma (nodal and extranodal), and mantle cell lymphoma. Patients may have had up to 4 prior regimens, not including steroids alone, rituximab alone, or local radiation. Treatment and evaluationOne cycle of therapy consisted of oral vorinostat 200 mg twice daily for 14 days followed by a 7-day break, and intravenous rituximab 375 mg/m 2 on day 1 of a 21-day cycle. Radiological assessment by computed tomography (CT) and/or positron emission tomography (PET) scan was performed at baseline and after every three cycles. Patients with measurable responses or stable disease were allowed to continue vorinostat and rituximab until progression. Patients who achieved CR received two further cycles of vorinostat and rituxmab and stopped treatment. Patients who stopped treatment in CR were allowed to resume the regimen in the event of relapse.Toxicity was assessed on days 1 and 8 of each cycle, and graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Treatment was held for patients who presented with non-hematologic toxicity of grade 3 or 4, until toxicity resolved to less than grade 2. These patients resumed treatment with vorinostat at a reduced dose of 100 mg daily. If grade 3 or greater toxicity occurred at the reduced dose, the patient was taken off treatment.Initially, CT or PET scans were performed after every three cycles of treatment to assess response. After one year of treatment, if the patient had achieved PR on two consecutive CT or PET scans, subsequent radiographic assessment was performed after every four cycles. If a patient achieved CR for more than one year, subsequent radiographic studies were performed every six months rather than every three cycles.Bone marrow biopsy for the presence of marrow involvement was performed at baseline and every three cycles if the base-line examination revealed marrow involvement. Responses were assessed according to the 2007 Cheson criteria. 12,13 Study designThe primary study objective was to evaluate the anti-tumor activity of vorinostat plus rituximab as assessed by overall response rate (ORR=CR+PR). The secondary study objectives were to evaluate the toxicity profile of vorinostat plus rituximab, time to progression, and progression-free survival. The Simon 2-stage optimal design was used to assess the overall response rate. In the first stage, 17 patients were enrolled, with the design specifying that if 4 or more patients achieved CR or PR, accrual would continue to a total of 33 patients, with 10 or more responses regarded as evidence of sufficient activity to warrant further investigation. CorrelativesThe effects of treatment on systemic blood levels of immune cytokines were evaluated by cytokine bead array analysis using Luminex X-MAP bead array technology ...
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