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Dueck A.C.,Mayo Medical School | Mendoza T.R.,University of Houston | Mitchell S.A.,National Cancer Institute | Reeve B.B.,University of North Carolina at Chapel Hill | And 21 more authors.
JAMA oncology | Year: 2015

IMPORTANCE: To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).OBJECTIVE: To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items.DESIGN, SETTING, AND PARTICIPANTS: A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit.MAIN OUTCOMES AND MEASURES: Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30).RESULTS: A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P<.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P<.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r=0.43 [0.10-.56]; all P≤.006).CONCLUSIONS AND RELEVANCE: Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.


Tobias K.,Arizona Cancer Center | Gillis T.,Helen aham Cancer Center and Research Institute | Gillis T.,Jefferson Medical College
Journal of Surgical Oncology | Year: 2015

Although relatively rare, soft tissue sarcomas cause significant morbidity and mortality due to their advanced stage at initial diagnosis. Rehabilitation and surgical outcomes have traditionally focused on physical parameters to assess function and recovery, emphasizing return to ambulation, activities of daily living (ADLs) and community re-integration. Assessments of functional impairment and other quality-of-life parameters are necessary to better understand the experience of the patient with extremity soft tissue sarcoma and thereby improve outcomes. J. Surg. Oncol. 2015 111:615-621. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.


Manahan E.,Southeastern Breast Care Specialists | Wang L.,Penn State Milton rshey Medical Center | Chen S.,Oasis MD | Dickson-Witmer D.,Helen aham Cancer Center and Research Institute | And 4 more authors.
Annals of Surgical Oncology | Year: 2015

Background: Breast surgeons negotiating employment agreements have little national data available. To reduce this knowledge gap, the Education Committee of the American Society of Breast Surgeons conducted a survey of its membership. Methods: In 2014, survey questionnaires were sent to society members. Data collected included gender, type of practice, percentage devoted to breast surgery, volume of breast cases, work relative value units, location, benefits, and salary. Descriptive statistics were provided, and a multinomial logistic regression was performed to analyze the impact of various potential factors on salary. Results: Of the 2784 members, a total of 843 observations were included. Overall, 54 % of respondents dedicated 100 % of their practice to breast surgery, 64.3 % were female, and 40 % were fellowship-trained in breast surgery or surgical oncology. The mean income in 2013 was $330.7k. Results from a multinomial model showed gender (p < 0.0001), ownership (p = 0.03), years of practice (p < 0.0001), practice setting (p < 0.0001), practice volume (p < 0.0001), and geographic location (p = 0.05) were statistically significant. After adjusting for other variables, the expected income was higher for males ($378k vs. $310k). The lowest expected income by practice setting was in solo private practice ($249.2k), followed by single-specialty private practice ($285.8k), and academic ($308.5k), with the highest being multispecialty group private practice ($346.6k) and hospital-employed practice ($368.0k). Practice 100 % dedicated to breast surgery had a lower than expected income ($326k vs. $343k). Conclusions: Salary-specific data for breast surgeons are limited, and differences in salary were seen across geographic regions, type of practice, and gender. This type of breast-surgeon-specific data may be helpful in ensuring equitable compensation. © 2015, Society of Surgical Oncology.


Gumireddy K.,Wistar Institute | Li A.,Wistar Institute | Chang D.H.,Center for Cancer Research and Genomic Medicine | Liu Q.,Wistar Institute | And 9 more authors.
Oncotarget | Year: 2015

Cancer testis antigens (CTAs) are widely expressed in tumor tissues, circulating tumor cells (CTCs) and in cancer derived exosomes that are frequently engulfed by lymphoid cells. To determine whether tumor derived CTA mRNAs could be detected in RNA from purified peripheral blood mononuclear cells (PBMC) of non-small cell lung cancer (NSCLC) patients, we assayed for the expression of 116 CTAs in PBMC RNA in a discovery set and identified AKAP4 as a potential NSCLC biomarker. We validated AKAP4 as a highly accurate biomarker in a cohort of 264 NSCLCs and 135 controls from 2 different sites including a subset of controls with high risk lung nodules. When all (264) lung cancers were compared with all (135) controls the area under the ROC curve (AUC) was 0.9714. When 136 stage I NSCLC lung cancers are compared with all controls the AUC is 0.9795 and when all lung cancer patients were compared to 27 controls with histologically confirmed benign lung nodules, a comparison of significant clinical importance, the AUC was 0.9825. AKAP4 expression increases significantly with tumor stage, but independent of age, gender, smoking history or cancer subtype. Follow-up studies in a small number of resected NSCLC patients revealed a decrease of AKAP4 expression post-surgical resection that remained low in patients in remission and increased with tumor recurrence. AKAP4 is a highly accurate biomarker for the detection of early stage lung cancer.


Kumar V.,Wistar Institute | Cheng P.,H. Lee Moffitt Cancer Center and Research Institute | Condamine T.,Wistar Institute | Mony S.,Wistar Institute | And 12 more authors.
Immunity | Year: 2016

Recruitment of monocytic myeloid-derived suppressor cells (MDSCs) and differentiation of tumor-associated macrophages (TAMs) are the major factors contributing to tumor progression and metastasis. We demonstrated that differentiation of TAMs in tumor site from monocytic precursors was controlled by downregulation of the activity of the transcription factor STAT3. Decreased STAT3 activity was caused by hypoxia and affected all myeloid cells but was not observed in tumor cells. Upregulation of CD45 tyrosine phosphatase activity in MDSCs exposed to hypoxia in tumor site was responsible for downregulation of STAT3. This effect was mediated by the disruption of CD45 protein dimerization regulated by sialic acid. Thus, STAT3 has a unique function in the tumor environment in controlling the differentiation of MDSC into TAM, and its regulatory pathway could be a potential target for therapy. © 2016 Elsevier Inc.

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