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Article ; Online: Continuation of Third-Generation Tyrosine Kinase Inhibitors in Second-Line Trials for

Goulart, Bernardo H L / Larkins, Erin / Beaver, Julia A / Singh, Harpreet

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2023 Volume 41, Issue 23, Page(s) 3905–3908

MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Tyrosine Kinase Inhibitors ; Erlotinib Hydrochloride ; Protein Kinase Inhibitors/therapeutic use ; Protein Kinase Inhibitors/pharmacology ; ErbB Receptors/genetics ; Mutation
Chemical Substances	Tyrosine Kinase Inhibitors ; Erlotinib Hydrochloride (DA87705X9K) ; Protein Kinase Inhibitors ; ErbB Receptors (EC 2.7.10.1) ; EGFR protein, human (EC 2.7.10.1)
Language	English
Publishing date	2023-06-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.23.00154
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Article ; Online: Value: The Next Frontier in Cancer Care.

Goulart, Bernardo H L

The oncologist

2016 Volume 21, Issue 6, Page(s) 651–653

MeSH term(s)	Delivery of Health Care/economics ; Humans ; Neoplasms/drug therapy ; Neoplasms/economics ; United States
Language	English
Publishing date	2016-05-25
Publishing country	United States
Document type	Editorial ; Introductory Journal Article
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1634/theoncologist.2016-0174
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Zs.A 4845: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Access to Tyrosine Kinase Inhibitors and Survival in Patients with Advanced EGFR

Goulart, Bernardo H L / Chennupati, Shasank / Fedorenko, Catherine R / Ramsey, Scott D

Clinical lung cancer

2021 Volume 22, Issue 5, Page(s) e723–e733

Abstract: Introduction: We assessed the proportion of patients with advanced epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) positive non-small-cell lung cancer (NSCLC) who receive tyrosine kinase inhibitors (TKIs) in the real-world, ... ...

Abstract	Introduction: We assessed the proportion of patients with advanced epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) positive non-small-cell lung cancer (NSCLC) who receive tyrosine kinase inhibitors (TKIs) in the real-world, predictors of TKI use, and impact of TKI therapy on overall survival (OS). Materials and methods: We identified patients diagnosed with stage IV EGFR Results: Of 117 eligible patients (median age = 69; 62% women; 88% EGFR Conclusion: Approximately 18% of patients with advanced EGFR
MeSH term(s)	Aged ; Anaplastic Lymphoma Kinase ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/pathology ; Enzyme Inhibitors ; ErbB Receptors ; Female ; Health Services Accessibility ; Humans ; Lung Neoplasms/drug therapy ; Lung Neoplasms/pathology ; Male ; Middle Aged ; Protein Kinase Inhibitors/therapeutic use ; Registries ; United States
Chemical Substances	Enzyme Inhibitors ; Protein Kinase Inhibitors ; Anaplastic Lymphoma Kinase (EC 2.7.10.1) ; EGFR protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2021-02-04
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2145146-1
ISSN	1938-0690 ; 1525-7304
ISSN (online)	1938-0690
ISSN	1525-7304
DOI	10.1016/j.cllc.2021.01.019
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Zs.A 5893: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: The Value of Lung Cancer CT Screening: It Is All about Implementation.

Goulart, Bernardo H L

American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

2016 , Page(s) e426–33

Abstract: Hospitals have been gradually implementing new lung cancer CT screening programs following the release of the U.S. Preventive Services Task Force grade B recommendation to screen individuals at high risk for lung cancer. Policy makers have legitimately ... ...

Abstract	Hospitals have been gradually implementing new lung cancer CT screening programs following the release of the U.S. Preventive Services Task Force grade B recommendation to screen individuals at high risk for lung cancer. Policy makers have legitimately questioned whether adoption of CT screening in the community will reproduce the mortality benefits seen in the National Lung Screening Trial (NLST) and whether the benefits of screening will justify the potentially high costs. Although three annual CT screening exams proved cost-effective for the patient population enrolled in the NLST, uncertainty still exists about whether CT screening will be cost-effective in practice. The value of CT screening will depend largely on the strategies used to implement it. This manuscript reviews the current reimbursement policies for CT screening and explains the relationship between implementation strategies and screening value on the basis of the NLST cost-effectiveness analysis and other published data. A subsequent discussion ensues about the potential implementation inefficiencies that can negatively affect the value of CT screening (e.g., selection of low-risk individuals for screening, inappropriate follow-up visits for screening-detected lung nodules, failure to offer smoking cessation interventions, and overuse of medical resources for clinically irrelevant incidental findings) and the actions that can be taken to mitigate these inefficiencies and increase the value of screening.
MeSH term(s)	Early Detection of Cancer/economics ; Female ; Humans ; Lung Neoplasms/mortality ; Male
Language	English
Publishing date	2016-07-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ISSN	1548-8756 ; 1092-9118 ; 1548-8748
ISSN (online)	1548-8756
ISSN	1092-9118 ; 1548-8748
DOI	10.14694/EdBook_AM.2015.35.e426
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Article ; Online: Impact of Clinical Trial Participation on Survival of Patients with Metastatic Non-Small Cell Lung Cancer.

Merkhofer, Cristina M / Eaton, Keith D / Martins, Renato G / Ramsey, Scott D / Goulart, Bernardo H L

Clinical lung cancer

2021 Volume 22, Issue 6, Page(s) 523–530

Abstract: Introduction: The impact of clinical trial participation on overall survival is unclear. We hypothesized that enrollment in a therapeutic drug clinical trial is associated with longer overall survival in patients with metastatic non-small cell lung ... ...

Abstract	Introduction: The impact of clinical trial participation on overall survival is unclear. We hypothesized that enrollment in a therapeutic drug clinical trial is associated with longer overall survival in patients with metastatic non-small cell lung cancer (NSCLC). Patients and methods: We linked electronic medical record and Washington State cancer registry data to identify patients with metastatic NSCLC diagnosed between January 1, 2007, and December 31, 2015 who received treatment at a National Cancer Institute-designated cancer center. The exposure was trial enrollment. The primary outcome was overall survival, defined as the date of second-line treatment initiation to date of death or last follow-up. We used a conditional landmark analysis starting at the date of second-line treatment initiation and propensity scores with inverse probability of treatment weighting to estimate the association between trial enrollment and survival. Results: Of 215 patients, 40 (19%) participated in a second-line trial. Trial participants were more likely to be never smokers (45% vs 27%), have a good performance status (88% vs 77%) and have EGFR (48% vs 14%) and ALK mutations (8% vs 5%) than nonparticipants. Trial participants had similar overall survival to nonparticipants (HR 1.05; 95% CI, 0.72, 1.53; p = 0.81) after adjusting for sociodemographic and disease characteristics. Conclusion: Accounting for the immortal time bias and selection bias, trial participation does not appear detrimental to survival. This finding may be reassuring to patients and supports programs and policies to improve clinical trial access.
MeSH term(s)	Aged ; Carcinoma, Non-Small-Cell Lung/pathology ; Clinical Trials as Topic ; Female ; Humans ; Lung Neoplasms ; Male ; Middle Aged ; Mutation ; Neoplasm Metastasis ; Patient Participation ; Registries ; Survival Analysis ; Washington
Language	English
Publishing date	2021-04-22
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2145146-1
ISSN	1938-0690 ; 1525-7304
ISSN (online)	1938-0690
ISSN	1525-7304
DOI	10.1016/j.cllc.2021.04.003
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Zs.A 5893: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Impact of Diagnostic Delays on Lung Cancer Survival Outcomes: A Population Study of the US SEER-Medicare Database.

Romine, Perrin E / Sun, Qin / Fedorenko, Catherine / Li, Li / Tang, Mariel / Eaton, Keith D / Goulart, Bernardo H L / Martins, Renato G

JCO oncology practice

2022 Volume 18, Issue 6, Page(s) e877–e885

Abstract: Purpose: Time from diagnosis to treatment has been associated with worse survival outcomes in non-small-cell lung cancer (NSCLC). However, little is known about the impact of delay in time to diagnosis. We aimed to evaluate the impact of time from ... ...

Abstract	Purpose: Time from diagnosis to treatment has been associated with worse survival outcomes in non-small-cell lung cancer (NSCLC). However, little is known about the impact of delay in time to diagnosis. We aimed to evaluate the impact of time from radiographic suspicion to histologic diagnosis on survival outcomes using the US SEER-Medicare population database. Methods: We identified patients from the SEER-Medicare data set diagnosed with any stage NSCLC between January 1, 2011, and December 31, 2015, who received stage-appropriate treatment and had a computed tomography scan within 1 year of diagnosis. Time to confirmation was determined as the interval between most recent computed tomography imaging and date of histologic diagnosis. Our primary outcome was overall survival (OS). Results: In total, 10,824 eligible patients were identified. The median time to confirmation was 20 (range 0-363) days. Using multivariate Cox regression models, longer time to confirmation was associated with improved OS in all comers driven by stage IV patients after adjustment for age, sex, diagnosis year, histology, and comorbidity index. In a separate landmark analysis excluding patients deceased within 6 months of diagnosis, the association between time to diagnosis and survival was no longer evident. Conclusion: Time to confirmation of NSCLC was inversely associated with OS in this US SEER population study. This association was lost when patients deceased within 6 months of diagnosis were excluded, suggesting that retrospective registry-claims databases may not be the optimal data source to study time to diagnosis as a quality metric because of the unaccounted confounding effects of tumor behavior. Prospective evaluations of clinically enriched data sources may better serve this purpose.
MeSH term(s)	Aged ; Carcinoma, Non-Small-Cell Lung/diagnosis ; Carcinoma, Non-Small-Cell Lung/pathology ; Delayed Diagnosis ; Humans ; Lung Neoplasms/diagnosis ; Medicare ; Retrospective Studies ; SEER Program ; United States/epidemiology
Language	English
Publishing date	2022-02-04
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	3028198-2
ISSN	2688-1535 ; 2688-1527
ISSN (online)	2688-1535
ISSN	2688-1527
DOI	10.1200/OP.21.00485
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Early Steps in the Value of Cancer Care-Many Paths Remain Unexplored.

Goldstein, Daniel A / La Vecchia, Carlo / Goulart, Bernardo H L

The oncologist

2018 Volume 23, Issue 4, Page(s) 391–392

MeSH term(s)	Cost-Benefit Analysis ; Delivery of Health Care/economics ; Health Care Costs ; Humans ; Neoplasms/economics ; Neoplasms/therapy ; Stakeholder Participation
Language	English
Publishing date	2018-02-07
Publishing country	United States
Document type	Editorial
ZDB-ID	1409038-7
ISSN	1549-490X ; 1083-7159
ISSN (online)	1549-490X
ISSN	1083-7159
DOI	10.1634/theoncologist.2017-0611
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Zs.A 4845: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Out-of-Pocket Costs for Tyrosine Kinase Inhibitors and Patient Outcomes in

Goulart, Bernardo H L / Unger, Joseph M / Chennupati, Shasank / Fedorenko, Catherine R / Ramsey, Scott D

JCO oncology practice

2020 Volume 17, Issue 2, Page(s) e130–e139

Abstract: Purpose: We investigated the association of out-of-pocket (OOP) costs for tyrosine kinase inhibitors (TKIs) with overall survival (OS) in epidermal growth factor receptor (: Methods: We used the Hutchinson Institute for Cancer Outcomes Research ... ...

Abstract	Purpose: We investigated the association of out-of-pocket (OOP) costs for tyrosine kinase inhibitors (TKIs) with overall survival (OS) in epidermal growth factor receptor ( Methods: We used the Hutchinson Institute for Cancer Outcomes Research registry-claims database to identify patients with stage IV Results: Seventy-eight and twenty-seven patients comprised the Q1-3 and Q4 groups, respectively. Median monthly TKI OOP costs were $1,431 (Q1-3) Conclusion: Among patients with advanced
MeSH term(s)	Anaplastic Lymphoma Kinase/genetics ; Carcinoma, Non-Small-Cell Lung/drug therapy ; ErbB Receptors/genetics ; Health Expenditures ; Humans ; Lung Neoplasms/drug therapy ; Mutation ; Protein Kinase Inhibitors/therapeutic use
Chemical Substances	Protein Kinase Inhibitors ; Anaplastic Lymphoma Kinase (EC 2.7.10.1) ; EGFR protein, human (EC 2.7.10.1) ; ErbB Receptors (EC 2.7.10.1)
Language	English
Publishing date	2020-12-07
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	3028198-2
ISSN	2688-1535 ; 2688-1527
ISSN (online)	2688-1535
ISSN	2688-1527
DOI	10.1200/OP.20.00692
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Article ; Online: Correlations of response rate and progression-free survival with overall survival in immunotherapy trials for metastatic non-small-cell lung cancer: an FDA pooled analysis.

Goulart, Bernardo Haddock Lobo / Mushti, Sirisha L / Chatterjee, Somak / Larkins, Erin / Mishra-Kalyani, Pallavi S / Pazdur, Richard / Kluetz, Paul G / Singh, Harpreet

The Lancet. Oncology

2024 Volume 25, Issue 4, Page(s) 455–462

Abstract: Background: Radiographic changes might not fully capture the treatment effects of immune checkpoint inhibitors (ICIs). We aimed to assess correlations of overall response rate and progression-free survival with overall survival in trials of ICIs for ... ...

Abstract	Background: Radiographic changes might not fully capture the treatment effects of immune checkpoint inhibitors (ICIs). We aimed to assess correlations of overall response rate and progression-free survival with overall survival in trials of ICIs for metastatic non-small-cell lung cancer (NSCLC). Methods: To assess trial-level and patient-level correlations of overall response rate and progression-free survival with overall survival, we conducted a pooled analysis of first-line randomised trials (including patients aged ≥18 years with metastatic squamous and non-squamous NSCLC and an Eastern Cooperative Oncology Group performance status of 0-1) submitted to the US Food and Drug Administration from June 24, 2016, to March 16, 2021. Eligible trials evaluated at least one ICI in the experimental group versus chemotherapy in the control group. At the trial level, we used weighted linear regression to derive coefficients of determination (R Findings: A total of 13 trials including 9285 patients evaluated ICIs alone or in combination with chemotherapy versus chemotherapy alone. At the trial level, the R Interpretation: Correlations of overall response rate and progression-free survival with overall survival were generally moderate in this pooled analysis. The findings support routine analysis of mature overall survival data, where feasible, in first-line randomised trials of ICIs for metastatic NSCLC. Funding: US Food and Drug Administration.
MeSH term(s)	Humans ; Adolescent ; Adult ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Progression-Free Survival ; Lung Neoplasms/drug therapy ; Immunotherapy ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
Language	English
Publishing date	2024-03-05
Publishing country	England
Document type	Journal Article
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(24)00040-8
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Zs.A 5696: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Effect of Clinical Trial Participation on Costs to Payers in Metastatic Non-Small-Cell Lung Cancer.

Merkhofer, Cristina / Chennupati, Shasank / Sun, Qin / Eaton, Keith D / Martins, Renato G / Ramsey, Scott D / Goulart, Bernardo H L

JCO oncology practice

2021 Volume 17, Issue 8, Page(s) e1225–e1234

Abstract: Purpose: The costs associated with clinical trial enrollment remain uncertain. We hypothesized that trial participation is associated with decreased total direct medical costs to health care payers in metastatic non-small-cell lung cancer.: Methods: ... ...

Abstract	Purpose: The costs associated with clinical trial enrollment remain uncertain. We hypothesized that trial participation is associated with decreased total direct medical costs to health care payers in metastatic non-small-cell lung cancer. Methods: In this retrospective cohort study, we linked clinical data from electronic medical records to sociodemographic data from a cancer registry and claims data from Medicare and two private insurance plans. We used a difference-in-difference analysis to estimate mean per patient per month total direct medical costs for patients enrolled on a second-line (2L) trial versus patients receiving standard-of-care 2L systemic therapy. Results: Among 70 eligible patients, the difference-in-difference of mean per patient per month total direct medical costs between 2L trial participants and nonparticipants was -$6,663 ( Conclusion: Participation in a 2L trial was associated with a $6,663 per month cost savings to health care payers for the duration of trial participation. Further studies are necessary to elucidate differences in cost savings from trial participation for Medicare and commercial payers. If confirmed, these results support health care payer investment in programs to improve clinical trial access and enrollment.
MeSH term(s)	Aged ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Clinical Trials as Topic ; Costs and Cost Analysis ; Humans ; Lung Neoplasms/drug therapy ; Medicare ; Retrospective Studies ; United States
Language	English
Publishing date	2021-08-02
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	3028198-2
ISSN	2688-1535 ; 2688-1527
ISSN (online)	2688-1535
ISSN	2688-1527
DOI	10.1200/OP.20.01092
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