Clinical implications of routine testing for epidermal growth factor receptor (EGFR) mutations in patients with nonsquamous non-small cell lung cancer (NSCLC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8113-8113
Author(s):  
Hui Zhu ◽  
Andria Valeria Arrossi ◽  
Paul Elson ◽  
Carol Farver ◽  
Raymond R. Tubbs ◽  
...  
Keyword(s):  
Egfr Mutation ◽  
Kinase Inhibitor ◽  
Small Sample Size ◽  
Performance Status ◽  
Cleveland Clinic ◽  
Growth Factor Receptor ◽  
Small Sample ◽  
Automatic Testing ◽  
Egfr Mutations ◽  
Chi Square

8113 Background: EGFR mutation (Mut) testing is recommended for all patients (pts) with advanced NSCLC to identify pts who may benefit from front-line EGFR tyrosine kinase inhibitor (TKI) therapy. In July 2010 the Cleveland Clinic initiated reflex EGFR testing of all new diagnoses of nonsquamous NSCLC, prior to which testing was done only by physician request. A retrospective study was designed to review how this change affected clinical practice in a large academic health center. Methods: All pts with NSCLC that had EGFR Mut testing performed at the Cleveland Clinic from 07/2009 to 02/2012 were included (n=287). Pt characteristics, tumor histology and stage, Mut status, treatments, and pt outcomes were collected from electronic medical records. Special attention was given to pts with EGFR Mut+ who received erlotinib (E). Data were analyzed using Fisher’s exact, chi-square and the Wilcoxon rank-sum tests. Results: See Table. Conclusions: Automatic EGFR mutation testing, recommended in an ASCO provisional clinical opinion in April 2011, was feasible in a large academic center and significantly shortened the time between diagnosis and EGFR status becoming available to guide treatment decisions. Although not statistically significant due to the small sample size, there were positive trends towards increased first line usage of E in pts with EGFR Mut+, better performance status, lower rates of E discontinuation due to toxicity, and higher response rate to E in the automatic testing group. There was no difference in overall survival between the two groups. [Table: see text]

Detection of EGFR mutations in NSCLC patients in clinical practice: Comparison between cobas and Scorpion ARMS method.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e23101-e23101
Author(s):  
Natsuki Takano ◽  
Satoru Kitazono ◽  
Ryo Ariyasu ◽  
Junji Koyama ◽  
Masafumi Saiki ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Detection Rate ◽  
Egfr Mutation ◽  
Kinase Inhibitor ◽  
De Novo ◽  
Growth Factor Receptor ◽  
Egfr Mutations ◽  
Detection Rates ◽  
Initial Biopsy ◽  
Egfr Tki

e23101 Background: Epidermal growth factor receptor (EGFR) mutation is the most important factor for determining the treatment strategy for non-small-cell lung cancers (NSCLCs). Currently, two methods (cobas and Scorpion ARMS) have been approved as companion diagnostics for using EGFR tyrosine kinase inhibitor (TKI). Although there are some differences in the spectrums and sensitivities for detecting EGFRmutations such as exon 19 deletions (ex19del), L858R and T790M mutations, the extent of the differences affecting clinical practice is unclear. Methods: All patients with NSCLC who underwent EGFR mutation tests and treated at our hospital from February 2014 to February 2016 were enrolled. To detect EGFR mutations, the Scorpion ARMS (S) method was used from 2014 to 2015 and thecobasEGFR Mutation Test (C) from 2015 to 2016. We retrospectively investigated the detection rate of each EGFRmutation type and compared the rates between the two methods. Results: A total of 1,287 patients were enrolled. To detect EGFR mutations, 627 patients were tested by the S method and 660 by the C method, respectively. Of 1287 patients, 910 patients underwent initial biopsy, whereas 121 patients underwent re-biopsy after EGFR-TKI failure. EGFRmutations were detected in 130 of 418 (31.1%) patients and 153 of 492 (31.1%) patients by the S and C methods, respectively in the initial biopsy (P = 0.982). However, the detection rate of ex19del was slightly lower in the S method (12.6%) than in the C method (16.3%) (P = 0.105). Conversely, the detection rate of L858R was lower in the C method (13.8%) than in the S method (16.7%), but the difference was not significant (P = 0.252). De novo T790M was detected in one (0.2%) patient by the S method and in none by the C method. In re-biopsy after EGFR-TKI failure, the detection rates of T790M were as follows: 19 of 55 patients (34.5%) by the S method and 20 of 66 (30.3%) by the C method (P = 0.619). Conclusions: The different spectrums and sensitivities of EGFR mutations between the S and C methods were observed; however, they did not significantly affect clinical practice.

EGFR mutation analysis and treatment outcomes with tyrosine kinase inhibitors in EGFR mutants: The Manchester Lung Cancer Group Experience.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18095-e18095
Author(s):  
Rahul Peck ◽  
Elizabeth Connolly ◽  
Paul Taylor ◽  
Corinne Faivre-Finn ◽  
Fiona Hellen Blackhall ◽  
...  
Keyword(s):  
Tyrosine Kinase ◽  
Kinase Inhibitors ◽  
Egfr Mutation ◽  
Kinase Inhibitor ◽  
Growth Factor Receptor ◽  
Response To Treatment ◽  
Smoking History ◽  
Egfr Mutations ◽  
Published Data ◽  
Duration Of Treatment

e18095 Background: The presence of Epidermal Growth Factor Receptor (EGFR) activating mutations in patients with NSCLC was first described in 2005. Tumours exhibiting these mutations show sensitivity to treatment with an oral Tyrosine Kinase Inhibitor. Testing for EGFR mutations in patients with non-squamous NSCLC began in the Greater Manchester and Cheshire network in the last quarter of 2009. Methods: We audited the notes of consecutive patients who were identified with an activating EGFR mutation by the Central Manchester Genetics Laboratory between November 2009 and October 2011. Results: A total of 110 mutations were identified in tumour tissue from 98 patients. 13.6% were in exon 18, 38.2% in exon 19, 15.4% in exon 20 and 32.8% in exon 21. 65% of patients were female. The median age was 69 years (36-89). Notes were available for 85 patients, 59 of whom received treatment with an EGFR TKi. 7 had previously received radical treatment and 19 never received treatment. 7% were current smokers, 40% were ex-smokers, 30.6% had never smoked and smoking history was not documented in 22.4%. An initial response to treatment was seen in 55%, with stable disease in 15%.The mean duration of treatment was 7.6 months (2 weeks – 23 months), with 24 patients still receiving a TKi at the time of data analysis. The most commonly seen toxicities were diarrhoea and rash. Only 1 patient had no documented toxicity from their TKi. 17 patients (29%) had treatment discontinued or interrupted because of toxicity. In 8 of these, treatment was re-introduced at a reduced dose, and 3 patients went back to full dose. Conclusions: Our results confirm that treatment with a TKi is effective for those patients whose tumours harbour EGFR mutations, with a side effect profile consistent with published data.

American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients With Advanced Non–Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy

2011 ◽  
Vol 29 (15) ◽  
pp. 2121-2127 ◽  
Author(s):  
Vicki Leigh Keedy ◽  
Sarah Temin ◽  
Mark R. Somerfield ◽  
Mary Beth Beasley ◽  
David H. Johnson ◽  
...  
Keyword(s):  
Egfr Mutation ◽  
Kinase Inhibitor ◽  
Growth Factor Receptor ◽  
Mutation Testing ◽  
Phase Iii ◽  
Egfr Mutations ◽  
First Line ◽  
First Line Therapy ◽  
Egfr Tki ◽  
Egfr Mutation Testing

Purpose An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to ASCO's membership following publication or presentation of potentially practice-changing data from major studies. This PCO addresses the clinical utility of using epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non–small-cell lung cancer (NSCLC) to predict the benefit of taking a first-line EGFR tyrosine kinase inhibitor (TKI). Clinical Context Patients with EGFR-mutated NSCLC have a significantly higher rate of partial responses to the EGFR TKIs gefitinib and erlotinib. In the United States, approximately 15% of patients with adenocarcinoma of the lung harbor activating EGFR mutations. EGFR mutation testing is widespread at academic medical centers and in some locales in community practice. As of yet, there is no evidence of an overall survival (OS) benefit from selecting treatment based on performing this testing. Recent Data One large phase III trial (the Iressa Pan-Asia Study [IPASS] trial), three smaller phase III randomized controlled trials using progression-free survival as the primary end point, and one small phase III trial with OS as the primary end point, all involving first-line EGFR TKIs and chemotherapy doublets, form the basis of this PCO. Provisional Clinical Opinion On the basis of the results of five phase III randomized controlled trials, patients with NSCLC who are being considered for first-line therapy with an EGFR TKI (patients who have not previously received chemotherapy or an EGFR TKI) should have their tumor tested for EGFR mutations to determine whether an EGFR TKI or chemotherapy is the appropriate first-line therapy. NOTE. ASCO's provisional clinical opinions (PCOs) reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision making and identify questions and settings for further research. Because of the rapid flow of scientific information in oncology, new evidence may have emerged since the time a PCO was submitted for publication. PCOs are not continually updated and may not reflect the most recent evidence. PCOs cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any PCO is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. ASCO PCOs describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of these interventions in the context of clinical trials. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's PCOs, or for any errors or omissions.

scholarly journals A Real-World, Observational, Prospective Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations upon Progression on or after First-Line Therapy with a First- or Second-Generation EGFR Tyrosine Kinase Inhibitor in EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer: The ‘LUNGFUL’ Study

Cancers ◽  
2021 ◽  
Vol 13 (13) ◽  
pp. 3172
Author(s):  
Giannis Mountzios ◽  
Anna Koumarianou ◽  
Alexandros Bokas ◽  
Dimitrios Mavroudis ◽  
Epaminondas Samantas ◽  
...  
Keyword(s):  
Molecular Epidemiology ◽  
Disease Progression ◽  
Real World ◽  
Second Generation ◽  
Egfr Mutation ◽  
Kinase Inhibitor ◽  
Performance Status ◽  
Locally Advanced ◽  
Egfr Mutations ◽  
Egfr Tki

Background: Real-world data on the molecular epidemiology of EGFR resistance mutations at or after progression with first- or second-generation EGFR-TKIs in patients with advanced NSCLC are lacking. Methods: This ongoing observational study was carried out by 23 hospital-based physicians in Greece. The decision to perform cobas®EGFR Mutation Test v2 in tissue and/or plasma at disease progression was made before enrollment. For patients with negative/inconclusive T790M plasma-based results, tissue re-biopsy could be performed. Results: Ninety-six (96) eligible patients were consecutively enrolled (median age: 67.8 years) between July-2017 and September-2019. Of the patients, 98% were tested upon progression using plasma and 2% using tissue/cytology biopsy. The T790M mutation was detected in 16.0% of liquid biopsies. Tissue re-biopsy was performed in 22.8% of patients with a T790M-negative plasma result. In total, the T790M positivity rate was 21.9%, not differing between patients on first- or second-generation EGFR-TKI. Higher (≥2) ECOG performance status and longer (≥10 months) time to disease progression following EGFR-TKI treatment initiation were associated with T790M positivity. Conclusions: Results from plasma/tissue-cytology samples in a real-world setting, yielded a T790M positivity rate lower than previous reports. Fewer than one in four patients with negative plasma-based testing underwent tissue re-biopsy, indicating the challenges in routine care settings.

scholarly journals A Real-World, Observational, Prospective Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations upon Progression on or after First-Line Therapy with a First or Second Generation EGFR Tyrosine Kinase Inhibitor in EGFR Mutation-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer: The ‘LUNGFUL’ Study

2021 ◽  
Author(s):  
Giannis Mountzios ◽  
Anna Koumarianou ◽  
Alexandros Bokas ◽  
Dimitrios Mavroudis ◽  
Epaminondas Samantas ◽  
...  
Keyword(s):  
Molecular Epidemiology ◽  
Disease Progression ◽  
Real World ◽  
Second Generation ◽  
Egfr Mutation ◽  
Kinase Inhibitor ◽  
Performance Status ◽  
Locally Advanced ◽  
Egfr Mutations ◽  
Egfr Tki

Background: Real-world data on the molecular epidemiology of EGFR resistance mutations at or after progression with first- or second-generation EGFR-TKIs in patients with advanced NSCLC are lacking. Methods: This ongoing observational study was carried out by 23 hospital-based physicians in Greece. The decision to perform Cobas® EGFR Mutation Test v2 in tissue and/or plasma at disease progression was made before enrollment. For patients with negative/inconclusive T790M plasma-based results, tissue re-biopsy could be performed. Results: Ninety-six (96) eligible patients were consecutively enrolled (median age: 67.8 years) between July-2017 and September-2019. Of the patients, 98% were tested upon progression using plasma and 2% using tissue/cytology biopsy. The T790M mutation was detected in 16.0% of liquid biopsies. Tissue re-biopsy was performed in 22.8% of patients with a T790M-negative plasma result. In total, the T790M positivity rate was 21.9%, not differing between patients on first- or second-generation EGFR-TKI. Higher (≥2) ECOG performance status and longer (≥10 months) time to disease progression following EGFR-TKI treatment initiation were associated with T790M positivity. Conclusions: Results from plasma/tissue-cytology samples in a real-world setting, yielded a T790M positivity rate lower than previous reports. Fewer than one in four patients with negative plasma-based testing underwent tissue re-biopsy, indicating the challenges in routine care settings.

Impact of the Oncology Care Model (OCM) on pain management: A retrospective cohort analysis.

2019 ◽  
Vol 37 (31_suppl) ◽  
pp. 86-86
Author(s):  
Aaron Ciner ◽  
Jacqueline Norrell ◽  
Renee Kurz ◽  
Ann W. Silk
Keyword(s):  
Pain Score ◽  
Small Sample Size ◽  
Performance Status ◽  
Cohort Analysis ◽  
Small Sample ◽  
Common Symptom ◽  
Chi Square ◽  
Pain Scores ◽  
Before And After ◽  
Pain Intervention

86 Background: Pain is a common symptom among patients with cancer and impacts performance status and quality of life. The OCM was implemented at Rutgers Cancer Institute of New Jersey (RCINJ) in July 2016 with the goal of improving many quality metrics in cancer care including documentation of pain and a plan of care for pain. Hypothesis: Documentation of pain and a plan of care for pain improved after implementation of the OCM at RCINJ. Improved documentation would correlate with a decrease in reported quantitative pain scores. Methods: Data from patients enrolled in OCM during its first year of implementation (post OCM) was compared to data from a control cohort the preceding year (pre OCM). The initial progress note and EMR flowsheet in each year were reviewed to determine pain documentation. For patients reporting a pain score ≥ 1 on a 0-10 scale, the association between documentation of a plan of care and improvement in quantitative pain score on a subsequent visit was analyzed using Chi square testing. Results: A total of 260 patient charts were analyzed. A quantitative pain score was documented in 99% of patients in the pre OCM group and 100% in the post OCM group. For those with a pain score ≥ 1, documentation of a plan of care increased from 43% to 55% after OCM implementation. Patients whose charts contained documented plans of care for pain were less likely to have decreased pain scores at a subsequent visit (51% vs 76%). Conclusions: (1) Documentation of a quantitative pain score was completed in nearly all patients before and after the implementation of OCM. (2) There was a non-statistically significant increase in documentation of plan of care for pain after OCM implementation. (3) Documentation of a plan of care was not associated with a decreased pain score at a subsequent visit. This may be the result of small sample size or related to progressive cancer-related pain or inadequate pain intervention. [Table: see text]

Immune related adverse events in NSCLC patients treated with immune checkpoint therapy who received the influenza vaccination versus no vaccination.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20657-e20657
Author(s):  
Haritha G. Reddy ◽  
Taylor Mai Weis ◽  
Shannon Hough ◽  
Stephanie Daignault ◽  
Bryan J. Schneider
Keyword(s):  
Adverse Events ◽  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Immune Checkpoint ◽  
Checkpoint Inhibitors ◽  
Small Sample Size ◽  
Performance Status ◽  
Small Sample ◽  
Ecog Performance Status ◽  
Chi Square

e20657 Background: Influenza vaccination is recommended by the CDC for cancer patients to reduce the risk of influenza-related complications. There is concern that the incidence of immune-related adverse events (irAEs) may be greater in vaccinated patients receiving immune checkpoint inhibitors (ICPI). We sought to interrogate if influenza vaccination in patients with NSCLC receiving ICPI therapy had an increased incidence of irAEs compared to non-vaccinated patients. Methods: We conducted a single-center retrospective analysis of patients with advanced NSCLC who received PD-1 or PD-L1 inhibitor monotherapy between 3/2015 – 12/2018. Influenza immunization records from both institutional and state-wide registries were obtained from 2014 -2019. Comparisons of adverse event incidence between flu vaccinated and control patients were tested using chi-square statistics. Results: 117 patients were included in our analysis, 33 (28%) were vaccinated during ICPI therapy, 19 (58%) received quadrivalent influenza vaccine, 13 (39%) received trivalent influenza vaccine and 1 (3%) was undetermined. 22 (67%) vaccinated patients had an irAE vs 53 (63%) patients who were not vaccinated during ICPI therapy (p = 0.720). 8 (24%) vaccinated patients had an irAE leading to discontinuation of therapy vs 12 (14%) patients who were not vaccinated during ICPI therapy (p = 0.198). The most frequent irAE in both groups was fatigue 16 (48%) vs 28 (33%) (p = 0.128). Notable irAEs included colitis (0 vs 1), pneumonitis (3 vs 3), hepatitis (1 vs 4) in vaccinated patients vs without vaccine, respectively. There were no statistically significant differences in baseline demographics between both groups including age, race, gender, tumor histology or ECOG performance status. Conclusions: Our study suggests that irAEs are not significantly increased with vaccination for influenza during ICPI therapy. However, there is a slight trend toward increased incidence of irAE warranting ICPI discontinuation for which further investigation is needed. Limitations of this study include a small sample size and inability to grade irAE retrospectively.

Two different patterns of lung adenocarcinoma with concomitant EGFR mutation and ALK rearrangement

2021 ◽  
pp. 030089162110055
Author(s):  
Dashi Zhao ◽  
Jun Fan ◽  
Li Peng ◽  
Bo Huang ◽  
Yili Zhu ◽  
...  
Keyword(s):  
Lung Adenocarcinoma ◽  
Egfr Mutation ◽  
Growth Factor Receptor ◽  
Egfr Mutations ◽  
Alk Rearrangement ◽  
Molecular Alterations ◽  
Anaplastic Lymphoma ◽  
Sporadic Cases ◽  
Epidermal Growth ◽  
Rare Group

Epidermal growth factor receptor ( EGFR) mutations and anaplastic lymphoma kinase ( ALK) rearrangements are considered mutually exclusive in non-small cell lung cancer (NSCLC), especially in lung adenocarcinoma (LUAC). However, sporadic cases harboring concomitant EGFR and ALK alterations have been increasingly reported. There is no consensus opinion regarding the treatment of patients positive for both molecular alterations. NSCLC with EGFR/ ALK coalterations should be separated into two subtypes: unifocal and multifocal LUAC. Here, we present an overview of the available literature regarding this rare group of patients to provide useful suggestions for therapeutic strategies.

Epidermal Growth Factor Receptor Mutations in Plasma DNA Samples Predict Tumor Response in Chinese Patients With Stages IIIB to IV Non–Small-Cell Lung Cancer

2009 ◽  
Vol 27 (16) ◽  
pp. 2653-2659 ◽  
Author(s):  
Hua Bai ◽  
Li Mao ◽  
hang Shu Wang ◽  
Jun Zhao ◽  
Lu Yang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Egfr Mutation ◽  
Tumor Response ◽  
Growth Factor Receptor ◽  
Small Cell ◽  
Egfr Mutations ◽  
Plasma Samples ◽  
Plasma Dna ◽  
Small Cell Lung ◽  
Epidermal Growth

Purpose Mutations in the epidermal growth factor receptor (EGFR) kinase domain can predict tumor response to tyrosine kinase inhibitors (TKIs) in non–small-cell lung cancer (NSCLC). However, obtaining tumor tissues for mutation analysis is challenging. We hypothesized that plasma-based EGFR mutation analysis is feasible and has value in predicting tumor response in patients with NSCLC. Patients and Methods Plasma DNA samples and matched tumors from 230 patients with stages IIIB to IV NSCLC were analyzed for EGFR mutations in exons 19 and 21 by using denaturing high-performance liquid chromatography. We compared the mutations in the plasma samples and the matched tumors and determined an association between EGFR mutation status and the patients' clinical outcomes prospectively. Results In 230 patients, we detected 81 EGFR mutations in 79 (34.3%) of the patients' plasma samples. We detected the same mutations in 63 (79.7%) of the matched tumors. Sixteen plasma (7.0%) and fourteen tumor (6.1%) samples showed unique mutations. The mutation frequencies were significantly higher in never-smokers and in patients with adenocarcinomas (P = .012 and P = .009, respectively). In the 102 patients who failed platinum-based treatment and who were treated with gefitinib, 22 (59.5%) of the 37 with EGFR mutations in the plasma samples, whereas only 15 (23.1%) of the 65 without EGFR mutations, achieved an objective response (P = .002). Patients with EGFR mutations had a significantly longer progression-free survival time than those without mutations (P = .044) in plasma. Conclusion EGFR mutations can be reliably detected in plasma DNA of patients with stages IIIB to IV NSCLC and can be used as a biomarker to predict tumor response to TKIs.

scholarly journals Frequency of EGFR Mutation and EML4-ALK fusion gene in Arab Patients with Adenocarcinoma of the Lung

2015 ◽  
Vol 6 (2) ◽  
pp. 19-23
Author(s):  
Hanan Ezzat Shafik ◽  
Mohamed Ashour
Keyword(s):  
Epidermal Growth Factor Receptor ◽  
Growth Factor ◽  
Epidermal Growth Factor ◽  
Egfr Mutation ◽  
Fusion Gene ◽  
Receptor Gene ◽  
Growth Factor Receptor ◽  
Egfr Mutations ◽  
Anaplastic Lymphoma ◽  
Epidermal Growth

Abstract Introduction: Improvement in the clinical outcome of lung cancer is likely to be achieved by identification of the molecular events that underlie its pathogenesis. The frequency of epidermal growth factor receptor (EGFR) mutations is ethnicity-dependent, with a higher proportion in Asian populations than in whites, while the incidence of EML4-ALK (echinoderm microtubule-associated-protein like 4-anaplastic lymphoma kinase) fusion gene ranged from 1.6% to 16.4% in patients with NSCLC and these individuals were distinct from those harbouring mutations in the epidermal growth factor receptor gene. This study was conducted to determine the frequency of EGFR mutation and EML4-ALK fusion gene in our population and to determine the effect of different clinicopathological features on the expression of those mutations in patients with lung adenocarcinoma. Results: EGFR mutations were detected in approximately 33% of our patients in this series; the most frequently detected mutation was exon 19 deletion. EML4-ALK fusion gene was detected in 7.3% of patients. Conclusion: Our population exhibited the incidence of EGFR mutation approximately similar to that reported in East Asia and Japanese patients, higher than that recorded in USA, and Australia. However, more studies with larger patients’ numbers are needed to verify this finding.

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