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Vinayak Muralidhar, Paul J. Catalano, Gally Reznor, Brandon A. Mahal, Toni K. Choueiri, Christopher J. Sweeney, Neil E. Martin, Clair J. Beard, Yu-Wei Chen, Michelle D. Nezolosky, Karen E. Hoffman, Felix Y. Feng, Quoc-Dien Trinh and Paul L. Nguyen

Background: The current NCCN Clinical Practice Guidelines in Oncology for Prostate Cancer recommend long-term androgen deprivation therapy (ADT) for all men with high-risk prostate cancer treated with external-beam radiation therapy (EBRT). We determined whether the use of long-term ADT varied by the recently defined subcategories of high-risk disease (favorable, other, and very high) versus unfavorable intermediate-risk disease. Methods: We identified 5,524 patients with unfavorable-risk prostate cancer diagnosed from 2004 to 2007 and managed with EBRT using the SEER-Medicare linked database. Patients were stratified by risk group: unfavorable intermediate-risk, favorable high-risk (previously defined and validated as clinical stage T1c, Gleason score of 4 + 4 = 8, and prostate-specific antigen [PSA] level <10 ng/mL, or clinical stage T1c, Gleason score of 6, and PSA level >20 ng/mL), very-high-risk (clinical stage T3b–T4 or primary Gleason pattern 5), or other high risk (ie, neither favorable nor very high). We used multivariable competing risks regression to estimate the rates of long-term (≥2 years) ADT by group. Results: Men with favorable high-risk prostate cancer were significantly less likely to receive long-term ADT than those with other high-risk disease (15.4% vs 24.6%, adjusted hazard ratio [AHR], 0.68; 95% CI, 0.60–0.76; P<.001), and similarly likely as those with unfavorable intermediate-risk disease (AHR, 1.10; 95% CI, 0.99–1.23; P=.087). Other high-risk disease was less likely to receive long-term ADT than very high-risk cancer (24.6% vs 30.8%; AHR, 0.83; 95% CI, 0.74–0.93; P=.002). Conclusions: Despite current guidelines, patients with EBRT-managed high-risk prostate cancer received significantly different rates of long-course ADT based on subclassification. Our results suggest that oncologists view these patients as a heterogeneous group with favorable high-risk cancer warranting less aggressive therapy than other high-risk or very high-risk disease.

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Wei Nie, Jie Qian, Mi-Die Xu, Kai Gu, Fang-Fei Qian, Jun Lu, Xue-Yan Zhang, Hui-Min Wang, Bo Yan, Bo Zhang, Shu-Yuan Wang, Fang Hu, Chang-Hui Li, Hua Zhong and Bao-Hui Han

Background: Biomarkers for chemotherapy efficacy in non–small cell lung cancer (NSCLC) are lacking. This retrospective study assesses the association between blood-based tumor mutational burden (bTMB) and clinical benefit of chemotherapy. Methods: Clinical and targeted next-generation sequencing data from the OAK trial (training set; n=318) and POPLAR trial (validation set; n=106) in the docetaxel arm were analyzed. The cutoff value of bTMB for outcome prediction was determined based on a time-dependent receiver operating characteristic curve in the training set, and propensity score matching (PSM) was conducted. The primary outcome was overall survival (OS). Durable clinical benefit (DCB) was defined as OS lasting >12 months. Interaction between treatment and bTMB was assessed in the combined set. Results: A lower bTMB was observed in patients with DCB compared with no durable benefit, and in those with a partial response and stable disease compared with progressive disease. The optimized cutoff value of bTMB for predicting OS was 7 single-nucleotide variants per megabase. In the training set, a low bTMB was significantly associated with longer OS and progression-free survival (PFS). The prognostic value of bTMB was confirmed in the validation set and PSM set. The interaction between bTMB and treatment was significant for PFS (interaction P=.043) in the combined set. Mutations in KEAP1 were associated with high bTMB and a lack of benefit from chemotherapy. Conclusions: Low bTMB is associated with a survival advantage in patients with NSCLC treated with docetaxel, suggesting the prognostic and predictive potential of bTMB for determining chemotherapy efficacy.

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Mark H. Kawachi, Robert R. Bahnson, Michael Barry, J. Erik Busby, Peter R. Carroll, H. Ballentine Carter, William J. Catalona, Michael S. Cookson, Jonathan I. Epstein, Ruth B. Etzioni, Veda N. Giri, George P. Hemstreet III, Richard J. Howe, Paul H. Lange, Hans Lilja, Kevin R. Loughlin, James Mohler, Judd Moul, Robert B. Nadler, Stephen G. Patterson, Joseph C. Presti, Antoinette M. Stroup, Robert Wake and John T. Wei

The NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer Early Detection (to view the most recent version of these guidelines, visit the NCCN Web site at www.NCCN.org) provide a set of sequential recommendations detailing a screening and subsequent workup strategy for maximizing the detection of prostate cancer in an early, organ-confined state and attempting to minimize unnecessary procedures. These guidelines were developed for men who have elected to participate in prostate cancer screening; they are not meant to address the controversy regarding population screening. Overview Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer death in American men. More than 192,000 men will be diagnosed with prostate cancer in 2009, and an estimated 27,360 men will die of this disease.1 During the same period, nearly 20 million men in the United States will be confronted with important decisions regarding early detection for prostate cancer. Men in the United States have an approximately 1 in 6 chance of eventually being diagnosed with this malignancy and about 1 in 30 chance of eventually dying of it.2 African-American men and men with a first-degree relative with prostate cancer (especially cancer found at a younger age) have a higher risk for developing prostate cancer.2–4 In a recent study of 26,111 men, the baseline prostate-specific antigen (PSA) value was found to be a stronger predictive factor than a positive family history or being of African-American heritage.5 Men who undergo regular PSA tests have a higher chance of undergoing a...
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Douglas E. Wood, Ella A. Kazerooni, Scott L. Baum, George A. Eapen, David S. Ettinger, Lifang Hou, David M. Jackman, Donald Klippenstein, Rohit Kumar, Rudy P. Lackner, Lorriana E. Leard, Inga T. Lennes, Ann N.C. Leung, Samir S. Makani, Pierre P. Massion, Peter Mazzone, Robert E. Merritt, Bryan F. Meyers, David E. Midthun, Sudhakar Pipavath, Christie Pratt, Chakravarthy Reddy, Mary E. Reid, Arnold J. Rotter, Peter B. Sachs, Matthew B. Schabath, Mark L. Schiebler, Betty C. Tong, William D. Travis, Benjamin Wei, Stephen C. Yang, Kristina M. Gregory and Miranda Hughes

Lung cancer is the leading cause of cancer-related mortality in the United States and worldwide. Early detection of lung cancer is an important opportunity for decreasing mortality. Data support using low-dose computed tomography (LDCT) of the chest to screen select patients who are at high risk for lung cancer. Lung screening is covered under the Affordable Care Act for individuals with high-risk factors. The Centers for Medicare & Medicaid Services (CMS) covers annual screening LDCT for appropriate Medicare beneficiaries at high risk for lung cancer if they also receive counseling and participate in shared decision-making before screening. The complete version of the NCCN Guidelines for Lung Cancer Screening provides recommendations for initial and subsequent LDCT screening and provides more detail about LDCT screening. This manuscript focuses on identifying patients at high risk for lung cancer who are candidates for LDCT of the chest and on evaluating initial screening findings.