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Brent K. Hollenbeck, James E. Montie and John T. Wei

Defining surgical quality is an imperative and substantial undertaking before its measurement and ultimate improvement. This article defines quality of care and a rationale for its measurement. In the context of radical cystectomy for bladder cancer, we describe a conceptual model for measuring quality of care. Finally, we provide a framework for future research by presenting an overview of recent work pertaining to cystectomy and quality of care.

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Ying Zhou, Chenchen Zhu, Zhen Shen, Yanhu Xie, Wei Zhang, Jing Zhu, Tianjiao Zhang, Min Li, Jiwei Qin, Shuai Yin, Rongzhu Chen, Wei Wei, Sinan Sun, Guihong Wang, Zheng Zhou, Hanhui Yao, Dabao Wu and Björn Nashan

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Natasha Satkunam, Xuejiao Wei, James J. Biagi, Sulaiman Nanji and Christopher M. Booth

Background: Adjuvant oxaliplatin is now a standard treatment option for patients with early-stage colon cancer. However, treatment delivery and outcomes achieved in routine practice are not well described. Methods: All cases of colon cancer diagnosed in Ontario from 2002 to 2008 were identified using the Ontario Cancer Registry. Pathology reports were obtained for a 25% random sample to identify stage II and III cases; patients treated with adjuvant oxaliplatin were included in this analysis. Treatment records were reviewed to identify oxaliplatin dose reductions or omissions. Modified Poisson regression was used to evaluate factors associated with dose reduction/omission. Cox proportional hazards model was used to explore factors associated with cancer-specific survival (CSS) and overall survival (OS). Results: The study population included 532 patients; 88% (469/532) had stage III disease. The mean/median number of oxaliplatin cycles delivered was 10/12. A dose reduction/omission of oxaliplatin occurred in 54% of cases (288/532), and the dose was subsequently escalated in 34% of these (97/288). Women were more likely than men to have dose reduction/omission (relative risk, 1.29; 95% CI, 1.10–1.51). Dose reduction/omission was not associated with inferior CSS (hazard ratio [HR], 0.76; 95% CI, 0.51–1.14) or OS (HR, 0.81; 95% CI, 0.59–1.13). Five-year CSS and OS of all cases were 77% (95% CI, 72–81) and 72% (95% CI, 68–76), respectively. On-treatment mortality rates were 1% and 3% within 30 and 90 days of oxaliplatin, respectively. Conclusions: Dose reductions of adjuvant oxaliplatin are common in routine practice but are not associated with inferior survival. Long-term survival achieved in the general population is comparable to the results of clinical trials.

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Richard Li, Wei-Hsien Hou, Joseph Chao, Yanghee Woo, Scott Glaser, Arya Amini, Rebecca A. Nelson and Yi-Jen Chen

Background: Limited data are available to guide management of patients with stage I–III gastric cancer not undergoing potentially curative surgical resection. We compared survival outcomes associated with chemotherapy alone versus chemoradiation (CRT) in the treatment of nonmetastatic gastric cancer. Methods: Patients with gastric adenocarcinoma from 2004 to 2015 were identified using the National Cancer Database. Patients were excluded if they had surgery, metastatic disease, or T0, Tis, or T1a disease. Logistic regression was used to evaluate predictors of CRT use. Cox proportional hazards modeling was performed to compare overall survival (OS) between chemotherapy alone and CRT in overall and propensity score–matched cohorts. Results: We identified 4,795 patients with stage I–III gastric adenocarcinoma who did not undergo surgery, at a median follow-up of 11.8 months. A total of 3,316 patients (69.2%) received chemotherapy alone and 1,479 patients (30.8%) received CRT. Predictors of increased CRT use were age ≥65 years (odds ratio [OR] 1.68; 95% CI, 1.43–1.99; P<.001), Charlson-Deyo comorbidity score ≥2 (OR, 1.46; 95% CI, 1.18–1.81), and treatment at a community facility (OR, 1.27; 95% CI, 1.07–1.51; P=.006). Patients receiving CRT had a 2-year OS rate of 28.3% compared with 21.5% among those receiving chemotherapy. Multivariate analysis showed that CRT was associated with improved OS (hazard ratio [HR], 0.82; 95% CI, 0.77–0.89; P<.001). After propensity score matching, a persistent survival benefit was observed (HR, 0.80; 95% CI, 0.74–0.88; P<.001). Conclusions: In patients with stage I–III gastric cancer not undergoing surgical resection, CRT was associated with improved survival compared with chemotherapy alone. However, only 30.8% of patients received CRT in this setting.

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Jia-Wei Lv, Yu-Pei Chen, Guan-Qun Zhou, Xu Liu, Ying Guo, Yan-Ping Mao, Jun Ma and Ying Sun

Background: The reporting quality of publications is of vital importance to ensure accurate evidence dissemination. This study aimed to compare the consistency of results reporting between the ClinicalTrials.gov results database and the respective matching publications. Methods: We identified 323 phase III/IV cancer drug trials with a randomized controlled design and searched PubMed for publications in a 50% random sample (n=160). Data were extracted independently from ClinicalTrials.gov and publications. A scoring system was applied to determine characteristics associated with reporting quality. Results: Of 117 reviewed trials with publications, result reporting was significantly more complete in ClinicalTrials.gov for efficacy measurement (92.3% vs 90.6%), serious adverse events (SAEs; 100% vs 43.6%), and other adverse events (OAEs; 100% vs 62.4%). For trials with both posted and published results for design information (n=117), efficacy measurements (n=98), SAEs (n=51), and OAEs (n=73), discrepancies were found in 16 (13.7%), 38 (38.8%), 26 (51.0%), and 54 (74.0%) trials, respectively. Overreporting of treatment effects (7 trials) and alteration of primary end points favoring statistically significant outcomes (11 trials) were the major discrepancies in efficacy reporting; incomplete (66 trials) and underreporting (20 trials) of SAEs were the predominant issues in benefit/risk reporting. Median quality score was 21 (range, 14–28). Trials that had parallel assignment, were phase IV, had primary funding by industry, were completed after 2009, and had earlier results posted possessed better reporting quality. Conclusions: Although most trials showed reasonable completeness and consistency, some discrepancies are prevalent and persistent, jeopardizing evidence-based decision-making. Our findings highlight the need to consult results systematically from both ClinicalTrials.gov and publications.

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Andrew G. Robinson, Xuejiao Wei, William J. Mackillop, Yingwei Peng and Christopher M. Booth

Background: Palliative chemotherapy for advanced bladder cancer is recommended in clinical practice guidelines. Patterns of care in routine clinical practice have not been well described. This article describes use rates of chemotherapy and referral rates to medical oncology in the last year of life among patients who have died of bladder cancer. Methods: A population-based cohort of patients with bladder cancer was identified from the Ontario Cancer Registry; the study population included patients who died of bladder cancer between 1995 and 2009. Electronic records of treatment and physician billing records were used to identify treatment patterns and referral to medical oncology. Log-binomial and modified Poisson regression were used to examine factors associated with chemotherapy use and medical oncology consultation. Results: A total of 8,005 patients died of bladder cancer, 25% (n=1,964) of whom received chemotherapy in the last year of life. Use was independently associated with patient age, comorbidities, socioeconomic status, sex, time period, and treatment region. A total of 68% (n=5,426) of patients were seen by a medical oncologist. Referral to medical oncology was associated with age, comorbidities, year of death. Geographic variation was seen with chemotherapy use—from 18% to 30%—that persisted on adjusted analysis. Conclusions: The efficacy of palliative chemotherapy demonstrated in clinical trials and recommended in guidelines has not translated into widespread use in practice. Understanding the extent to which patient preferences and health system factors influence use is needed. Access to acceptable palliative systemic treatments remains an unmet need for most patients dying of bladder cancer.

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Katherine E. Hersberger, Mishal Mendiratta-Lala, Rocky Fischer, Ravi K. Kaza, Isaac R. Francis, Mirabella S. Olszewski, John F. Harju, Wei Shi, Frank J. Manion, Mahmoud M. Al-Hawary and Vaibhav Sahai

Background: Objective radiographic assessment is crucial for accurately evaluating therapeutic efficacy and patient outcomes in oncology clinical trials. Imaging assessment workflow can be complex; can vary with institution; may burden medical oncologists, who are often inadequately trained in radiology and response criteria; and can lead to high interobserver variability and investigator bias. This article reviews the development of a tumor response assessment core (TRAC) at a comprehensive cancer center with the goal of providing standardized, objective, unbiased tumor imaging assessments, and highlights the web-based platform and overall workflow. In addition, quantitative response assessments by the medical oncologists, radiologist, and TRAC are compared in a retrospective cohort of patients to determine concordance. Patients and Methods: The TRAC workflow includes an image analyst who pre-reviews scans before review with a board-certified radiologist and then manually uploads annotated data on the proprietary TRAC web portal. Patients previously enrolled in 10 lung cancer clinical trials between January 2005 and December 2015 were identified, and the prospectively collected quantitative response assessments by the medical oncologists were compared with retrospective analysis of the same dataset by a radiologist and TRAC. Results: This study enlisted 49 consecutive patients (53% female) with a median age of 60 years (range, 29–78 years); 2 patients did not meet study criteria and were excluded. A linearly weighted kappa test for concordance for TRAC versus radiologist was substantial at 0.65 (95% CI, 0.46–0.85; standard error [SE], 0.10). The kappa value was moderate at 0.42 (95% CI, 0.20–0.64; SE, 0.11) for TRAC versus oncologists and only fair at 0.34 (95% CI, 0.12–0.55; SE, 0.11) for oncologists versus radiologist. Conclusions: Medical oncologists burdened with the task of tumor measurements in patients on clinical trials may introduce significant variability and investigator bias, with the potential to affect therapeutic response and clinical trial outcomes. Institutional imaging cores may help bridge the gap by providing unbiased and reproducible measurements and enable a leaner workflow.

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Vinod Ravi, Eric M. Sanford, Wei-Lien Wang, Jeffrey S. Ross, Naveen Ramesh, Andrew Futreal, Shreyaskumar Patel, Phillip J. Stephens, Vincent A. Miller and Siraj M. Ali

Background: Angiosarcoma is a malignant neoplastic disease originating from or differentiating toward vascular endothelium, for which systemic pharmacologic treatment has limited durability. The molecular oncogenesis of angiosarcoma is often linked to inappropriate activations of vascular endothelial growth factor receptor (VEGFR) family members, which presents an opportunity for the use of therapy that selectively targets the machinery of vascular signaling. Methods: Hybridization capture of 3,320 exons of 182 cancer-related genes and the introns of 14 genes frequently rearranged in cancer was applied to more than 50 ng of DNA extracted from a formalin-fixed, paraffin-embedded biopsy of recurrent angiosarcoma and was sequenced to high, uniform coverage of 939x. Results: The angiosarcoma harbored amplifications of VEGFR2 (KDR) of 8 copies and VEGFR3 (FLT4) of 16 copies. The patient was initially treated with sorafenib, an inhibitor of VEGFR2, and developed progressive disease. The patient then received pazopanib, an inhibitor of VEGFR2 and VEGFR3 and experienced a potent antitumor response resulting in clinically stable disease for 6 months. Conclusions: This exceptional response to pazopanib treatment suggests that a subset of patients with angiosarcoma with genomic alterations in vascular signaling genes may respond well to pazopanib.

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Shankar Sellappan, Adele Blackler, Wei-Li Liao, Emily O'Day, Peng Xu, Sheeno Thyparambil, Fabiola Cecchi, Todd Hembrough and Daniel V.T. Catenacci

Protein-targeted therapies are expected to selectively kill tumor cells that express the targeted protein biomarker. Although a tumor mass may initially respond to targeted therapies based on expression of the targeted protein, all cells within a tumor may not express the targeted protein above a critical threshold level; therefore, those cells that do not express, or that downregulate expression of, the targeted protein may not be responsive to therapy. The ability to monitor the dynamic expression of these protein biomarkers throughout the course of therapy may allow for treatment to be personalized in real-time in response to the evolving nature of the tumor. This report demonstrates, by monitoring a single patient through multiple therapies, how targeted mass spectrometry is an effective, quantitative method that provides real-time analysis of multiple therapeutically associated targeted proteins that can be used to personalize a patient's treatment strategy throughout the course of care.