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Muss H.,University of North Carolina at Chapel Hill | Cortes J.,University of Barcelona | Vahdat L.T.,New York Medical College | Cardoso F.,Jules Bordet Institute | And 6 more authors.
Oncologist | Year: 2014

Purpose. Following the demonstrated efficacy and safety of eribulin mesylate in heavily pretreated patients with metastatic breast cancer, an exploratory analysis was performed to investigate the effect of age in these patients. Methods. Data were pooled from two single-arm phase II studies and one open-label randomized phase III study inwhich patients received eribulin mesylate at 1.4 mg/m2 as 2- to 5- minute intravenous infusions on days 1 and 8 of a 21-day cycle. The effect of age on median overall survival (OS), progressionfree survival (PFS), overall response rate (ORR), clinical benefit rate (CBR), and incidence of adverse events (AEs) was calculated for four age groups (<50 years, 50-59 years, 60-69 years,≥70 years). Results. Overall, 827 patients were included in the analysis (<50 years, n = 253; 50-59 years, n = 289; 60-69 years, n = 206; ≥70 years, n = 79). Age had no significant impact on OS (11.8 months, 12.3 months, 11.7 months, and 12.5 months, respectively; p =.82),PFS (3.5months, 2.9months, 3.8months, and 4.0 months, respectively; p =.42), ORR (12.7%, 12.5%, 6.3%, and 10.1%, respectively), or CBR (20.2%, 20.8%, 20.4%, and 21.5%, respectively). Although some AEs had higher incidence in either the youngest or the oldest subgroup, there was no overall effect of age on the incidence of AEs (including neuropathy, neutropenia, and leukopenia). Conclusion. Eribulin monotherapy in these selected older patients with good baseline performance status led to OS, PFS, ORR, CBR, and tolerability similar to those of younger patients with metastatic breast cancer.The benefits and risks of eribulin appear to be similar across age groups. © AlphaMed Press 2014. Source

Ubel P.A.,Duke University | Berry S.R.,University of Toronto | Berry S.R.,Sunnybrook Odette Cancer Center | Nadler E.,Baylor Charles mmons Cancer Center | And 6 more authors.
Health Affairs | Year: 2012

Amid calls for physicians to become better stewards of the nation's health care resources, it is important to gain insight into how physicians think about the cost-effectiveness of new treatments. Expensive new cancer treatments that can extend life raise questions about whether physicians are prepared to make "value for money" tradeoffs when treating patients. We asked oncologists in the United States and Canada how much benefit, in additional months of life expectancy, a new drug would need to provide to justify its cost and warrant its use in an individual patient. The majority of oncologists agreed that a new cancer treatment that might add a year to a patient's life would be worthwhile if the cost was less than $100,000. But when given a hypothetical case of an individual patient to review, the oncologists also endorsed a hypothetical drug whose cost might be as high as $250,000 per life-year gained. The results show that oncologists are not consistent in deciding how many months an expensive new therapy should extend a person's life before the cost of therapy is justified. Moreover, the benefit that oncologists demand from new treatments in terms of length of survival does not necessarily increase according to the price of the treatment. The findings suggest that policy makers should find ways to improve how physicians are educated on the use of cost-effectiveness information and to influence physician decision making through clinical guidelines that incorporate cost-effectiveness information. © 2012 Project HOPE-The People-to-People Health Foundation, Inc. Source

Abbott D.M.,Baylor Charles mmons Cancer Center
Compendium of continuing education in dentistry (Jamesburg, N.J. : 1995) | Year: 2013

Implementing an oral health/systemic health wellness plan for patients can be an important part of a dental practice's proactive approach to healthcare that emphasizes early detection and treatment of disease. As an adjunct to clinical observations, medical history, and patient information gathered and assessed by the practitioner, utilization of screening and diagnostic technology, including oral cancer screening devices, salivary diagnostic tests, and caries detection devices, can aid in the early detection of disease. These tests, which are usually billable, can aid in providing timely, effectual wellness services to patients by enabling practitioners to supply these services more effectively and at an early stage to the benefit of the patient's overall health. Source

Blum J.L.,Baylor Charles mmons Cancer Center | Barrios C.H.,Pontifical Catholic University of Rio Grande do Sul | Feldman N.,View Medical | Verma S.,University of Toronto | And 4 more authors.
Breast Cancer Research and Treatment | Year: 2012

We assessed the efficacy and safety of capecitabine across treatment lines, and the impact of patient and disease characteristics on outcomes using data from phase II/III trials. Individual patient data were pooled from seven Roche/Genentech-led trials conducted from 1996 to 2008 where single-agent capecitabine was the test or control regimen for metastatic breast cancer (MBC). Data were analyzed from 805 patients: 268 in the first-line metastatic setting and 537 in the second-line or later setting. Baseline characteristics were balanced across treatment lines. Patients receiving second-line or later versus first-line capecitabine had lower objective response rates (ORR: 19.0 vs. 25.0 %, respectively, odds ratio 0.70; 95 % CI: 0.5-1.0) and significantly shorter progression-free survival (PFS: median 112.0 days [3.7 months] vs. 150.0 days [4.9 months]; p < 0.0001) and overall survival (OS: median 396.0 days [13.0 months] vs. 666.0 days [21.9 months]; p < 0.0001). In multivariate analysis by backward elimination, significantly improved ORR (p = 0.0036), PFS (p < 0.0001) and OS (p < 0.0001) with capecitabine were demonstrated in patients with estrogen receptor (ER) and/or progesterone receptor (PgR)-positive versus both ER and PgR-negative tumors. Hand-foot syndrome (HFS) was the most common adverse event (AE) in 63 % of patients. Overall, 7 % of patients discontinued and two patients (<1 %) died from treatment-related AEs. Significantly improved survival was observed in patients developing capecitabine-related HFS (p < 0.0001 PFS/OS) or diarrhea (p = 0.004 OS; p = 0.0045 PFS) versus patients without these events. In this pooled analysis of individual patient data, first-line capecitabine was associated with improved ORR, PFS, and OS versus second or later lines. Multivariate analyses identified greater ORR, PFS, and OS with capecitabine in patients with ER and/or PgR-positive versus ER/PgR-negative tumors. Safety was in-line with previous phase III trials in MBC. © 2012 Springer Science+Business Media New York. Source

Crown J.,St Vincents University Hospital | Crown J.,Dublin City University | O'Shaughnessy J.,Baylor Charles mmons Cancer Center | Gullo G.,St Vincents University Hospital
Annals of Oncology | Year: 2012

Standard chemotherapy regimens can prove effective for patients with early triple-negative breast cancer (TNBC); however, patients with advanced disease typically respond poorly and rapidly progress, and the outcome is poor. New targeted therapies are therefore an urgent unmet medical need for this patient population. Translational and clinical studies into new TNBC treatments have been facilitated by the increased understanding of the aberrant signal transduction pathways regulating growth and survival and the development of chemoresistance in TNBC. Some of the established targeted agents that have been approved in other indications may prove beneficial to patients with TNBC; however, in the absence of approved targeted agents for the treatment of TNBC, most new agents remain experimental. Increased understanding of molecular profiles of TNBC subtypes is likely to improve therapeutic strategies with targeted agents. Novel strategies have reached clinical evaluation in patients with TNBC, including targeting angiogenesis vascular endothelial growth factor and proliferation signalling (receptor tyrosine kinases and mammalian target of rapamycin). Aggressive TNBCs have been found to associate closely with BRCA1 mutation or dysregulation. The recent development of new investigational agents targeting DNA repair, either directly with poly(adenosine disphosphate-ribose) polymerase inhibitors or indirectly through DNA-binding or DNA-damage potentiation, is a major focus of current clinical studies. These and other targeted therapies represent a new approach to TNBC therapy. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source

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