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Grant Details

Grant Number: 5R01CA202956-04 Interpret this number
Primary Investigator: Wisnivesky, Juan
Organization: Icahn School Of Medicine At Mount Sinai
Project Title: Optimizing Treatment of Lung Cancer Patients with Comorbidities
Fiscal Year: 2019


PROJECT SUMMARY The overall goal of this project is to improve the management of lung cancer patients with comorbidities. Lung cancer is the leading cause of cancer death in the US. Most patients have serious comorbidities (such as chronic pulmonary disease, cardiac disease, and chronic kidney disease), related to smoking and aging (mean age at diagnosis is 70 years). Up to 30% of lung cancer cases are diagnosed at a loco-regional stage, can be treated with a curative intent, and may experience relatively good long-term survival. However, the risk/benefit ratio of cancer therapies can be substantially altered in patients with comorbidities because of differences in toxicity, functional status, life expectancy, and quality of life. Unfortunately, patients with comorbidities are consistently excluded from randomized controlled trials (RCTs) generating an important gap in knowledge regarding their management. Lack of data relevant to patients with comorbidities has profound negative impacts including undertreatment, increased morbidity, and decreased survival. Thus, optimizing the management of these patients is a major public health priority. In this study, we will use simulation modeling, an approach complementary to RCTs, to determine the optimal treatment of early stage lung cancer patients with comorbidities. The Specific Aims are to: 1) enhance and validate the Lung Cancer Policy Model (LCPM) to simulate the management and subsequent outcomes of patients with early stage lung cancer and specific comorbidities; 2) determine the optimal management and indications for lobectomy, elective limited resection, stereotactic body radiotherapy, and other treatments in stage I NSCLC patients with chronic lung and heart disease as well as by overall burden of comorbidities; 3) determine the optimal indications for adjuvant chemotherapy in patients with stage II and IIIA NSCLC and chronic lung, heart, or renal disease and by overall burden of comorbidities; and 4) compare outcomes following different treatment strategies (surgery, chemotherapy, or chemoradiotherapy) for patients with limited-stage SCLC and chronic lung, heart, or renal disease. To achieve these Aims, we will use an enhanced version of the LCPM, a well validated mathematical model of lung cancer progression. In Aim 1, we will use data from several population-based registries to substantially enhance, calibrate, and validate the LCPM by incorporating functional status, frailty, treatments, complications of surgery and chemotherapy toxicity, outcomes, survival and quality of life of patients with comorbidities. Then, we will assess the optimal management, in terms of reducing toxicity and maximizing survival and quality of life, of patients with early stage lung cancer. Our study is innovative in applying modeling approaches, mostly used to evaluate cancer screening, to the optimization of lung cancer therapies. The results of the study will directly inform the management of large numbers of lung cancer patients with comorbidities, a vulnerable and understudied group that currently experience substantially worse outcomes.


Assessment of treatment strategies for stage I non-small cell lung cancer in patients with comorbidities.
Authors: Sigel K. , Yin Kong C. , Leiter A. , Kale M. , Mhango G. , Huang B. , Gould M.K. , Wisnivesky J. .
Source: Lung cancer (Amsterdam, Netherlands), 2022 Aug; 170, p. 34-40.
EPub date: 2022-05-30.
PMID: 35700630
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Risk of Cardiovascular Toxicity According to Tumor Laterality Among Older Patients With Early Stage Non-small Cell Lung Cancer Treated With Radiation Therapy.
Authors: Liu B.Y. , Rehmani S. , Kale M.S. , Marshall D. , Rosenzweig K.E. , Kong C.Y. , Wisnivesky J. , Sigel K. .
Source: Chest, 2022 Jun; 161(6), p. 1666-1674.
EPub date: 2022-01-19.
PMID: 35063448
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The benefits and harms of adjuvant chemotherapy for non-small cell lung cancer in patients with major comorbidities: A simulation study.
Authors: Leiter A. , Kong C.Y. , Gould M.K. , Kale M.S. , Veluswamy R.R. , Smith C.B. , Mhango G. , Huang B.Z. , Wisnivesky J.P. , Sigel K. .
Source: PloS one, 2022; 17(11), p. e0263911.
EPub date: 2022-11-15.
PMID: 36378625
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Cost-effectiveness of pembrolizumab for advanced non-small cell lung cancer patients with varying comorbidity burden.
Authors: Criss S.D. , Palazzo L. , Watson T.R. , Paquette A.M. , Sigel K. , Wisnivesky J. , Kong C.Y. .
Source: PloS one, 2020; 15(1), p. e0228288.
EPub date: 2020-01-29.
PMID: 31995619
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Cost and Utilization of Lung Cancer End-of-Life Care Among Racial-Ethnic Minority Groups in the United States.
Authors: Chen Y. , Criss S.D. , Watson T.R. , Eckel A. , Palazzo L. , Tramontano A.C. , Wang Y. , Mercaldo N.D. , Kong C.Y. .
Source: The oncologist, 2020 Jan; 25(1), p. e120-e129.
EPub date: 2019-09-09.
PMID: 31501272
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Cost-effectiveness of Atezolizumab Combination Therapy for First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer in the United States.
Authors: Criss S.D. , Mooradian M.J. , Watson T.R. , Gainor J.F. , Reynolds K.L. , Kong C.Y. .
Source: JAMA network open, 2019-09-04; 2(9), p. e1911952.
EPub date: 2019-09-04.
PMID: 31553470
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Disparities and Trends in Genetic Testing and Erlotinib Treatment among Metastatic Non-Small Cell Lung Cancer Patients.
Authors: Palazzo L.L. , Sheehan D.F. , Tramontano A.C. , Kong C.Y. .
Source: Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2019 May; 28(5), p. 926-934.
EPub date: 2019-02-20.
PMID: 30787053
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Cost-effectiveness and Budgetary Consequence Analysis of Durvalumab Consolidation Therapy vs No Consolidation Therapy After Chemoradiotherapy in Stage III Non-Small Cell Lung Cancer in the Context of the US Health Care System.
Authors: Criss S.D. , Mooradian M.J. , Sheehan D.F. , Zubiri L. , Lumish M.A. , Gainor J.F. , Reynolds K.L. , Kong C.Y. .
Source: JAMA oncology, 2019-03-01; 5(3), p. 358-365.
PMID: 30543349
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