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Challenges to implementation of an epidermal growth factor receptor testing strategy for non-small-cell lung cancer in a publicly funded health care system.

https://arctichealth.org/en/permalink/ahliterature108458
Source
J Thorac Oncol. 2013 Sep;8(9):1136-41
Publication Type
Article
Date
Sep-2013
Author
Peter M Ellis
Sunil Verma
Sandeep Sehdev
Jawaid Younus
Natasha B Leighl
Author Affiliation
Department of Oncology, McMaster University, Juravinski Cancer Centre, Hamilton, Ontario, Canada. peter.ellis@jcc.hhsc.ca
Source
J Thorac Oncol. 2013 Sep;8(9):1136-41
Date
Sep-2013
Language
English
Publication Type
Article
Keywords
Adenocarcinoma - drug therapy - genetics - pathology
Aged
Aged, 80 and over
Canada
Carcinoma, Non-Small-Cell Lung - drug therapy - genetics - pathology
Female
Financing, Government
Follow-Up Studies
Health Plan Implementation
Health Services - trends
Humans
Lung Neoplasms - drug therapy - genetics - pathology
Male
Middle Aged
Mutation - genetics
Neoplasm Staging
Practice Guidelines as Topic - standards
Prognosis
Protein Kinase Inhibitors - therapeutic use
Quinazolines - therapeutic use
Receptor, Epidermal Growth Factor - genetics
Survival Rate
Abstract
Data from seven recent randomized clinical trials have demonstrated that epidermal growth factor (EGFR) mutation status is predictive of improved progression-free survival and quality of life from first-line EGFR tyrosine kinase inhibitor therapy compared with platinum-based chemotherapy. We examined barriers to the initial implementation of a national EGFR testing policy in Canada.
Five laboratories across Canada underwent a validation and quality-control exercise for EGFR mutation testing using reverse transcriptase-polymerase chain reaction with financial support from the pharmaceutical industry for the initial 12 months. Oncologists registered patients with nonquamous histology for EGFR mutation testing using a Web-based platform. Basic demographics were collected including age, histology, sex, smoking status, and ethnicity. The decision to prescribe gefitinib was subsequently registered on the system.
Between March and December 2010, 2104 requests were received for EGFR mutation testing. Demographic details are as follows: adenocarcinoma (91.6%); Asian ethnicity (13.9%); female (58%); light/never smoker (41.3%); stage IV disease (87.1%). The number of tests requested each month ranged from 200 to 250. Mutation testing was conducted in 1771 of 2104 requests (84%). The median turnaround time for EGFR testing was 18 days (standard deviation 9.7). Gefitinib was prescribed in 302 patients (17.1%). The number of test requests dropped to 50 to 100 per month at the end of the initial 12 months.
There was rapid uptake of EGFR mutation testing into routine clinical practice in Canada. Uptake of EGFR mutation testing dropped substantially once funding from pharmaceutical industry was discontinued. There is a need for a national strategy to ensure resources are in place to implement molecular testing for new molecularly targeted agents.
PubMed ID
23887170 View in PubMed
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Closing the personalized medicine information gap: HER2 test documentation practice.

https://arctichealth.org/en/permalink/ahliterature116602
Source
Am J Manag Care. 2013 Jan;19(1):838-44
Publication Type
Article
Date
Jan-2013
Author
Ilia L Ferrusi
Craig C Earle
Maureen Trudeau
Natasha B Leighl
Eleanor Pullenayegum
Hoa Khong
Jeffrey S Hoch
Deborah A Marshall
Author Affiliation
Centre for Evaluation of Medicines, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada.
Source
Am J Manag Care. 2013 Jan;19(1):838-44
Date
Jan-2013
Language
English
Publication Type
Article
Keywords
Breast Neoplasms - diagnosis - genetics
Female
Genetic Testing - statistics & numerical data
Humans
Individualized Medicine - statistics & numerical data
Ontario
Receptor, erbB-2 - genetics
Retrospective Studies
Abstract
Uncertainty about human epidermal growth factor receptor-2 (HER2) testing practice in Canada continues to hinder efforts to improve personalized medicine. Pathologists routinely perform HER2 assessment for all tumors > 1 cm, and pathology is reported centrally to the provincial cancer registry.
To understand patterns of HER2 test documentation for early-stage breast cancer (BC) patients in Ontario's centralized pathology reporting system.
Retrospective cohort study of central HER2 test documentation in early-stage BC patients diagnosed in 2006-2007.
Cohort and staging information was derived from cancer registry and admissions data. Linkage across administrative databases provided data on surgical and radiologic treatment, sociodemographic factors, diagnosis setting, and comorbidities. Pathology reports from the provincial cancer registry were reviewed for HER2 testing, hormone receptor, and grade. Unadjusted and adjusted odds ratios were calculated to determine factors related to HER2 documentation.
A HER2 test was documented for 66% of 13,396 patients. HER2 documentation was associated with stage, hormone receptor, and tumor grade documentation. Higher stage and grade at diagnosis were also associated with HER2 documentation. All models suggested variable regional documentation patterns. Documentation did not differ by sociodemographic factors, presence of comorbidities, or surgical procedure.
Despite a universal testing policy, the rate of centralized HER2 test documentation was lower than expected and related to disease severity. Differences in regional reporting likely reflect ascertainment bias inherent to centralized pathology reporting rather than testing access. Improved HER2 reporting is encouraged for cancer registration, quality-of-care measurement, and program evaluation.
Notes
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PubMed ID
23379747 View in PubMed
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Cost effectiveness of EML4-ALK fusion testing and first-line crizotinib treatment for patients with advanced ALK-positive non-small-cell lung cancer.

https://arctichealth.org/en/permalink/ahliterature104899
Source
J Clin Oncol. 2014 Apr 1;32(10):1012-9
Publication Type
Article
Date
Apr-1-2014
Author
Sandjar Djalalov
Jaclyn Beca
Jeffrey S Hoch
Murray Krahn
Ming-Sound Tsao
Jean-Claude Cutz
Natasha B Leighl
Author Affiliation
Sandjar Djalalov, Jaclyn Beca, and Jeffrey S. Hoch, Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital and Cancer Care Ontario; Sandjar Djalalov, Jaclyn Beca, Jeffrey S. Hoch, Murray Krahn, and Natasha B. Leighl, Canadian Centre for Applied Research in Cancer Control; Murray Krahn, Toronto Health Economics and Technology Assessment Collaborative; Ming-Sound Tsao and Natasha B. Leighl, Ontario Cancer Institute and Princess Margaret Cancer Centre, Toronto; and Jean-Claude Cutz, McMaster University, Hamilton, Ontario, Canada.
Source
J Clin Oncol. 2014 Apr 1;32(10):1012-9
Date
Apr-1-2014
Language
English
Publication Type
Article
Keywords
Antineoplastic Agents - economics - therapeutic use
Carcinoma, Non-Small-Cell Lung - chemistry - drug therapy - economics
Cost-Benefit Analysis
Gene Frequency
Humans
Immunohistochemistry - economics
Lung Neoplasms - chemistry - drug therapy - economics
Neoplasm Staging
Oncogene Proteins, Fusion - analysis - genetics
Ontario
Pyrazoles - economics - therapeutic use
Pyridines - economics - therapeutic use
Quality-Adjusted Life Years
Sensitivity and specificity
Tumor Markers, Biological - analysis
Abstract
ALK-targeted therapy with crizotinib offers significant improvement in clinical outcomes for the treatment of EML4-ALK fusion-positive non-small-cell lung cancer (NSCLC). We estimated the cost effectiveness of EML4-ALK fusion testing in combination with targeted first-line crizotinib treatment in Ontario.
A cost-effectiveness analysis was conducted using a Markov model from the Canadian Public health (Ontario) perspective and a lifetime horizon in patients with stage IV NSCLC with nonsquamous histology. Transition probabilities and mortality rates were calculated from the Ontario Cancer Registry and Cancer Care Ontario New Drug Funding Program (CCO NDFP). Costs were obtained from the Ontario Case Costing Initiative, CCO NDFP, University Health Network, and literature.
Molecular testing with first-line targeted crizotinib treatment in the population with advanced nonsquamous NSCLC resulted in a gain of 0.011 quality-adjusted life-years (QALYs) compared with standard care. The incremental cost was Canadian $2,725 per patient, and the incremental cost-effectiveness ratio (ICER) was $255,970 per QALY gained. Among patients with known EML4-ALK-positive advanced NSCLC, first-line crizotinib therapy provided 0.379 additional QALYs, cost an additional $95,043 compared with standard care, and produced an ICER of $250,632 per QALY gained. The major driver of cost effectiveness was drug price.
EML4-ALK fusion testing in stage IV nonsquamous NSCLC with crizotinib treatment for ALK-positive patients is not cost effective in the setting of high drug costs and a low biomarker frequency in the population.
Notes
Comment In: J Clin Oncol. 2014 Apr 1;32(10):983-524567437
PubMed ID
24567430 View in PubMed
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Economic analysis of the TAX 317 trial: docetaxel versus best supportive care as second-line therapy of advanced non-small-cell lung cancer.

https://arctichealth.org/en/permalink/ahliterature191261
Source
J Clin Oncol. 2002 Mar 1;20(5):1344-52
Publication Type
Article
Date
Mar-1-2002
Author
Natasha B Leighl
Frances A Shepherd
Rita Kwong
Ronald L Burkes
Ronald Feld
Pamela J Goodwin
Author Affiliation
Department of Medical Oncology, Princess Margaret Hospital/University Health Network, University of Toronto, Toronto, Ontario, Canada. Natasha.Leigh@uhn.on.ca
Source
J Clin Oncol. 2002 Mar 1;20(5):1344-52
Date
Mar-1-2002
Language
English
Publication Type
Article
Keywords
Antineoplastic Agents, Phytogenic - therapeutic use
Canada
Carcinoma, Non-Small-Cell Lung - economics - therapy
Cost-Benefit Analysis
Costs and Cost Analysis
Hospitalization - economics
Humans
Lung Neoplasms - economics - therapy
Paclitaxel - analogs & derivatives - therapeutic use
Palliative Care - economics
Radiotherapy - economics
Retrospective Studies
Sensitivity and specificity
Taxoids
Abstract
To determine the cost-effectiveness (CE) of second-line docetaxel compared with best supportive care (BSC) in the TAX 317 trial, a randomized clinical trial of second-line chemotherapy in non-small-cell lung cancer.
A retrospective CE analysis of the TAX 317 trial was undertaken, evaluating direct medical costs of therapy from the viewpoint of Canada's public health care system. Costs were derived in 1999 Canadian dollars, and resource use was determined through prospective trial data.
The incremental survival benefit in the docetaxel arm over BSC was 2 months (P =.047). The CE of docetaxel was $57,749 per year of life gained. For patients treated with docetaxel 75 mg/m(2), the CE was $31,776 per year of life gained. In univariate sensitivity analyses, CE estimates were most sensitive to changes in survival, ranging from $18,374 to $117,434 with 20% variation in survival at the recommended dose. The largest cost center in both arms was hospitalization, followed by the cost of drugs, investigations, radiotherapy, and community care. BSC patients had fewer hospitalizations than patients in the chemotherapy arm and were more often palliated at home.
Although the decision to treat should not be based on economic considerations alone, our CE estimate of $31,776 per year of life gained (at the currently recommended dose of docetaxel) is within an acceptable range of health care expenditures, and the total costs of therapy are similar to those of second-line palliative chemotherapy for other solid tumors.
Notes
Comment In: J Clin Oncol. 2002 Sep 1;20(17):3750-1;author reply 3751-212202680
PubMed ID
11870178 View in PubMed
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Economic analysis: randomized placebo-controlled clinical trial of erlotinib in advanced non-small cell lung cancer.

https://arctichealth.org/en/permalink/ahliterature145373
Source
J Natl Cancer Inst. 2010 Mar 3;102(5):298-306
Publication Type
Article
Date
Mar-3-2010
Author
Penelope A Bradbury
Dongsheng Tu
Lesley Seymour
Pierre K Isogai
Liting Zhu
Raymond Ng
Nicole Mittmann
Ming-Sound Tsao
William K Evans
Frances A Shepherd
Natasha B Leighl
Author Affiliation
NCIC Clinical Trials Group, Kingston, ON, Canada.
Source
J Natl Cancer Inst. 2010 Mar 3;102(5):298-306
Date
Mar-3-2010
Language
English
Publication Type
Article
Keywords
Adult
Aged
Angiogenesis Inhibitors - adverse effects - economics - therapeutic use
Canada
Carcinoma, Non-Small-Cell Lung - drug therapy - economics - pathology
Cost-Benefit Analysis
Drug Costs
Female
Hospitalization - statistics & numerical data
Humans
International Cooperation
Lung Neoplasms - drug therapy - economics - pathology
Male
Middle Aged
Multicenter Studies as Topic
Protein Kinase Inhibitors - economics - therapeutic use
Protein-Tyrosine Kinases - antagonists & inhibitors
Quinazolines - adverse effects - economics - therapeutic use
Randomized Controlled Trials as Topic
Receptor, Epidermal Growth Factor - antagonists & inhibitors
Retrospective Studies
Treatment Outcome
Tumor Markers, Biological - analysis
Abstract
The NCIC Clinical Trials Group conducted the BR.21 trial, a randomized placebo-controlled trial of erlotinib (an epidermal growth factor receptor tyrosine kinase inhibitor) in patients with previously treated advanced non-small cell lung cancer. This trial accrued patients between August 14, 2001, and January 31, 2003, and found that overall survival and quality of life were improved in the erlotinib arm than in the placebo arm. However, funding restrictions limit access to erlotinib in many countries. We undertook an economic analysis of erlotinib treatment in this trial and explored different molecular and clinical predictors of outcome to determine the cost-effectiveness of treating various populations with erlotinib.
Resource utilization was determined from individual patient data in the BR.21 trial database. The trial recruited 731 patients (488 in the erlotinib arm and 243 in the placebo arm). Costs arising from erlotinib treatment, diagnostic tests, outpatient visits, acute hospitalization, adverse events, lung cancer-related concomitant medications, transfusions, and radiation therapy were captured. The incremental cost-effectiveness ratio was calculated as the ratio of incremental cost (in 2007 Canadian dollars) to incremental effectiveness (life-years gained). In exploratory analyses, we evaluated the benefits of treatment in selected subgroups to determine the impact on the incremental cost-effectiveness ratio.
The incremental cost-effectiveness ratio for erlotinib treatment in the BR.21 trial population was $94,638 per life-year gained (95% confidence interval = $52,359 to $429,148). The major drivers of cost-effectiveness included the magnitude of survival benefit and erlotinib cost. Subgroup analyses revealed that erlotinib may be more cost-effective in never-smokers or patients with high EGFR gene copy number.
With an incremental cost-effectiveness ratio of $94 638 per life-year gained, erlotinib treatment for patients with previously treated advanced non-small cell lung cancer is marginally cost-effective. The use of molecular predictors of benefit for targeted agents may help identify more or less cost-effective subgroups for treatment.
Notes
Comment In: J Natl Cancer Inst. 2010 Mar 3;102(5):287-820160167
PubMed ID
20160168 View in PubMed
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Quality-adjusted time without symptoms or toxicity analysis of adjuvant chemotherapy in non-small-cell lung cancer: an analysis of the National Cancer Institute of Canada Clinical Trials Group JBR.10 trial.

https://arctichealth.org/en/permalink/ahliterature149215
Source
J Clin Oncol. 2009 Sep 10;27(26):4268-73
Publication Type
Article
Date
Sep-10-2009
Author
Raymond W Jang
Aurélie Le Maître
Keyue Ding
Tim Winton
Andrea Bezjak
Lesley Seymour
Frances A Shepherd
Natasha B Leighl
Author Affiliation
Department of Medical Oncology, Princess Margaret Hospital/University Health Network, Toronto, Ontario, Canada.
Source
J Clin Oncol. 2009 Sep 10;27(26):4268-73
Date
Sep-10-2009
Language
English
Publication Type
Article
Keywords
Antineoplastic Combined Chemotherapy Protocols - adverse effects - therapeutic use
Canada
Carcinoma, Non-Small-Cell Lung - drug therapy
Chemotherapy, Adjuvant
Cisplatin - administration & dosage - adverse effects
Humans
Lung Neoplasms - drug therapy
Outcome Assessment (Health Care) - methods
Prospective Studies
Quality of Life
Questionnaires
Randomized Controlled Trials as Topic
Survival Analysis
Vinblastine - administration & dosage - adverse effects - analogs & derivatives
Abstract
National Cancer Institute of Canada Clinical Trials Group JBR.10 demonstrated that adjuvant vinorelbine and cisplatin after resection of stage IB-II non-small-cell lung cancer (NSCLC) improved relapse-free and overall survival. However, many patients either are not referred for chemotherapy or decline treatment. To aid in treatment decision making, quality-adjusted survival estimates of the JBR.10 trial were derived using a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis.
Survival curves for treatment (N = 242) and observation groups (N = 240) were partitioned into three health states: time with >or= grade 2 (early or late) chemotherapy-related toxicity (TOX), time in relapse (REL), and time without toxicity or relapse (TWiST). Q-TWiST = u(TOX) x TOX + u(TWiST) x TWIST + u(REL) x REL, where weights u(TOX), u(TWIST), and u(REL) range from 0 to 1. Threshold utility analysis was performed to test the sensitivity of the results to changes in the weights. Weights were derived in an exploratory fashion using different methods. Methods included use of arbitrary values, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) quality-of-life data prospectively collected in JBR.10 (global assessment questions and symptom-based questions), and lastly weights European Quality of Life-Five Dimensions questionnaire collected from early-stage NSCLC (nontrial) patients after resection with discounting for toxicity and relapse. The alpha level was .05.
Threshold utility analysis revealed that adjuvant chemotherapy was preferred for all possible weight values for relapse and toxicity (u(REL), u(TOX)), although the result was not always statistically significant. The adjuvant chemotherapy group had better Q-TWiST in the range of 5 to 6 additional months, which was statistically significant using all methods.
Adjuvant chemotherapy in early-stage NSCLC improves quality-adjusted survival despite chemotherapy toxicity.
Notes
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PubMed ID
19667274 View in PubMed
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Second-hand smoke as a predictor of smoking cessation among lung cancer survivors.

https://arctichealth.org/en/permalink/ahliterature105321
Source
J Clin Oncol. 2014 Feb 20;32(6):564-70
Publication Type
Article
Date
Feb-20-2014
Author
Lawson Eng
Jie Su
Xin Qiu
Prakruthi R Palepu
Henrique Hon
Ehab Fadhel
Luke Harland
Anthony La Delfa
Steven Habbous
Aidin Kashigar
Sinead Cuffe
Frances A Shepherd
Natasha B Leighl
Andrew F Pierre
Peter Selby
David P Goldstein
Wei Xu
Geoffrey Liu
Author Affiliation
Lawson Eng, Jie Su, Xin Qiu, Prakruthi R. Palepu, Henrique Hon, Ehab Fadhel, Luke Harland, Anthony La Delfa, Steven Habbous, Aidin Kashigar, Sinead Cuffe, Frances A. Shepherd, Natasha B. Leighl, Andrew F. Pierre, David P. Goldstein, Wei Xu, and Geoffrey Liu, Princess Margaret Hospital/Ontario Cancer Institute/University Health Network, University of Toronto; Peter Selby, Centre for Addiction and Mental Health, University of Toronto, Toronto, ON, Canada.
Source
J Clin Oncol. 2014 Feb 20;32(6):564-70
Date
Feb-20-2014
Language
English
Publication Type
Article
Keywords
Adult
Aged
Aged, 80 and over
Canada - epidemiology
Female
Humans
Lung Neoplasms - epidemiology
Male
Middle Aged
Prospective Studies
Questionnaires
Smoking Cessation - statistics & numerical data
Survivors
Tobacco Smoke Pollution - statistics & numerical data
Young Adult
Abstract
Second-hand smoke (SHS; ie, exposure to smoking of friends and spouses in the household) reduces the likelihood of smoking cessation in noncancer populations. We assessed whether SHS is associated with cessation rates in lung cancer survivors.
Patients with lung cancer were recruited from Princess Margaret Cancer Centre, Toronto, ON, Canada. Multivariable logistic regression and Cox proportional hazard models evaluated the association of sociodemographics, clinicopathologic variables, and SHS with either smoking cessation or time to quitting.
In all, 721 patients completed baseline and follow-up questionnaires with a mean follow-up time of 54 months. Of the 242 current smokers at diagnosis, 136 (56%) had quit 1 year after diagnosis. Exposure to smoking at home (adjusted odds ratio [aOR], 6.18; 95% CI, 2.83 to 13.5; P
PubMed ID
24419133 View in PubMed
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A systematic review and Canadian consensus recommendations on the use of biomarkers in the treatment of non-small cell lung cancer.

https://arctichealth.org/en/permalink/ahliterature133382
Source
J Thorac Oncol. 2011 Aug;6(8):1379-91
Publication Type
Article
Date
Aug-2011
Author
Peter M Ellis
Normand Blais
Dennis Soulieres
Diana N Ionescu
Meenakshi Kashyap
Geoff Liu
Barb Melosky
Tony Reiman
Phillippe Romeo
Frances A Shepherd
Ming-Sound Tsao
Natasha B Leighl
Author Affiliation
Juravinski Cancer Centre, Hamilton, Ontario, Canada. peter.ellis@jcc.hhsc.ca
Source
J Thorac Oncol. 2011 Aug;6(8):1379-91
Date
Aug-2011
Language
English
Publication Type
Article
Keywords
Canada
Carcinoma, Non-Small-Cell Lung - diagnosis - therapy
Clinical Trials as Topic
Consensus
Humans
Lung Neoplasms - diagnosis - therapy
Practice Guidelines as Topic
Tumor Markers, Biological - analysis
Abstract
Greater understanding of molecular pathways important in cell growth and proliferation of thoracic malignancies, particularly non-small cell lung cancer (NSCLC), has resulted in intense clinical and translational research. There is now considerable interest in personalizing treatment based on an understanding of tumor histology and molecular abnormalities. However, there is a multiplicity of data, often with discordant results resulting in confusion and uncertainty among clinicians.
We conducted a systematic review and a consensus meeting of Canadian lung cancer oncologists and pathologists to make recommendations on the use of biomarkers in NSCLC. PubMed covering 2005 to March 2010 was searched using MESH terms for NSCLC and randomized trials, plus text words for the biomarkers of interest. Conference proceedings from 2005 to 2009 ASCO, ESMO, IASLC, and USCAP were also searched. The articles were reviewed by pairs of oncologists and pathologists to determine eligibility for inclusion.
Ten oncologists and pathologists reviewed and summarized the literature at a meeting attended by 37 individuals. Draft recommendations were formulated and agreed upon by consensus process. There is some evidence that histology is prognostic for survival. There is evidence from multiple randomized clinical trials to recommend the following: histologic subtype is predictive of treatment efficacy and for some agents toxicity. Immunohistochemistry testing should be performed on NSCLC specimens that cannot be classified accurately with conventional H&E staining. As EGFR mutations are predictive of benefit from tyrosine kinase inhibitors, diagnostic NSCLC samples should be routinely tested for EGFR-activating mutations. Clinical data on K-RAS mutations are inconsistent, therefore testing is not recommended. There is insufficient evidence to recommend other biomarker testing. No biomarkers to date reliably predict improved efficacy for anti-VEGF therapy. Routine assessment for EML4/ALK mutations is not recommended at present, although emerging data suggest that it may become valuable in the near future.
Assessment of NSCLC biomarkers is becoming increasingly important. Therefore, adequate diagnostic material must be obtained for accurate histologic subtyping and relevant molecular biology assays.
Notes
Comment In: J Thorac Oncol. 2012 Apr;7(4):773-4; author reply 77422425934
PubMed ID
21709590 View in PubMed
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8 records – page 1 of 1.