Article Tools
ASCO SPECIAL ARTICLES
Article Tools
Therapy for Stage IV Non–Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline
, MD, DM1; Sarah Temin , MSPH2; Sherman Baker Jr, MD3; Elizabeth Blanchard, MD4; Julie R. Brahmer , MD5; Paul Celano, MD6; Narjust Duma , MD7; Peter M. Ellis, MD, PhD8; Ivy B. Elkins, MBA9; Rami Y. Haddad, MD10; Paul J. Hesketh , MD11; Dharamvir Jain, MD12; David H. Johnson , MD13; Natasha B. Leighl , MD14; Hirva Mamdani , MD15; Gregory Masters , MD16; Pamela R. Moffitt17; Tanyanika Phillips, MD18; Gregory J. Riely , MD, PhD19; Andrew G. Robinson , MD20; Rafael Rosell , MD21; Joan H. Schiller , MD22; Bryan J. Schneider, MD23; David R. Spigel , MD24; and Ishmael A. Jaiyesimi, MD, MS25 Show More
*I.A.J. and N.S. were Expert Panel co-chairs.
Abstract
Living guidelines are routinely updated guidelines that are developed for selected topic areas with rapidly evolving evidence that drives frequent change in clinical practice. These guidelines are updated on a regular schedule, based on the work of a standing panel that reviews the literature on a continuous basis. Updates will be made regularly and can be found at https://ascopubs.org/nsclc-da-living-guideline.
To provide evidence-based recommendations updating the 2021 ASCO and Ontario Health (Cancer Care Ontario) guideline on systemic therapy for patients with stage IV non–small-cell lung cancer (NSCLC) with driver alterations.
ASCO updated recommendations on the basis of an ongoing systematic review of randomized control trials from 2020 to 2021.
This guideline update reflects changes in evidence since the previous update. Two studies provide the evidence base. Outcomes of interest include efficacy and safety.
For patients with an anaplastic lymphoma kinase rearrangement, a performance status (PS) of 0-2, and previously untreated NSCLC, clinicians should offer alectinib or brigatinib or lorlatinib. For patients with an anaplastic lymphoma kinase rearrangement, a PS of 0-2, and previously untreated NSCLC, if alectinib, brigatinib, or lorlatinib are not available, clinicians should offer ceritinib or crizotinib. For patients with a RET rearrangement, a PS of 0-2, and previously untreated NSCLC, clinicians may offer selpercatinib or pralsetinib. In second line, for patients with a RET rearrangement who have not received RET-targeted therapy, clinicians may offer selpercatinib or pralsetinib.
Additional information is available at www.asco.org/thoracic-cancer-guidelines.
The purpose of this guideline update is to rapidly update the ASCO and Ontario Health (Cancer Care Ontario) guidelines on the systemic treatment of patients with stage IV non–small-cell lung cancer (NSCLC) last published in February 2021. The update is a result of potentially practice-changing evidence published since the last update. ASCO published the last full clinical practice guideline update on systemic therapy for patients with stage IV NSCLC that included patients whose cancer have driver alterations, in February 2021.
This update is based on two trials that directly affected clinical questions 3 and 11.
Therapy for Stage IV Non–Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline
What systemic therapy treatment options should be offered to patients with stage IV non–small-cell lung cancer (NSCLC) with driver alterations, depending on the specific alteration of the patient's cancer?
Patients with stage IV NSCLC with driver alterations
Oncology care providers (including primary care physicians, specialists, nurses, social workers, and any other relevant member of a comprehensive multidisciplinary cancer care team), patients, and their caregivers in North America and beyond.
An Expert Panel was convened to update clinical practice guideline recommendations on the basis of a systematic review of the medical literature.
For patients with an anaplastic lymphoma kinase (ALK) rearrangement, a performance status (PS) of 0-2, and previously untreated NSCLC, clinicians should offer alectinib or brigatinib (Type: Evidence based; benefits outweigh harms; Evidence quality: High; Strength of recommendation: Strong) or lorlatinib (Type: Evidence based; benefits outweigh harms; Evidence quality: Low; Strength of recommendation: Weak).
For patients with an ALK rearrangement, a PS of 0-2, and previously untreated NSCLC, if alectinib, brigatinib, or lorlatinib are not available, clinicians should offer ceritinib or crizotinib (Type: Evidence based; benefits outweigh harms; Evidence quality: High; Strength of recommendation: Strong).
For patients with a RET rearrangement, a PS of 0-2, and previously untreated NSCLC, clinicians may offer selpercatinib or pralsetinib (Type: Informal consensus; Evidence quality: Low; Strength of recommendation: Weak).
For patients with RET rearrangement who have not received RET targeted therapy, clinicians may offer selpercatinib (Type: Informal consensus; Evidence quality: Low; Strength of recommendation: Moderate) or pralsetinib (Type: Informal consensus; Evidence quality: Low; Strength of recommendation: Weak).
Definitions for the quality of the evidence and strength of recommendation ratings are available in Appendix Table A1 (online only). More information, including a supplement with additional evidence tables, slide sets, and clinical tools and resources, is available at www.asco.org/thoracic-cancer-guidelines. The Methodology Manual (available at www.asco.org/guideline-methodology) provides additional information about the methods used to develop this guideline. Patient information is available at www.cancer.net.
ASCO believes that cancer clinical trials are vital to inform medical decisions and improve cancer care, and that all patients should have the opportunity to participate.
This clinical practice guideline addresses one overarching clinical question with three subquestions: What systemic therapy treatment options should be offered to patients with stage IV NSCLC with driver alterations, depending on the subtype of the patient's cancer?
What is the most effective first-line therapy?
What is the most effective second-line therapy?
Is there a role for a third-line therapy or beyond?
The update does not apply to patients with stage IV NSCLC without known driver alterations. The guideline also does not apply to patients with stage IV NSCLC with rarer histologies, eg, large cell, neuroendocrine, etc.
FIG 1. Algorithms. (A) First-line treatment options for patients with stage IV NSCLC with driver alterations. (B) Second- and third-line treatment options for patients with stage IV NSCLC with driver alterations. aFor alterations without targeted therapy options, refer to the non-driver mutation guideline (Hanna et al14). New active targeted therapies are anticipated soon. ALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; HER2, human epidermal growth factor receptor 2; NRG1, Neuregulin 1; NSCLC, non–small-cell lung cancer; NTRK, neurotrophic tropomyosin receptor kinase; PS, performance status.
This systematic review–based guideline product was developed by a multidisciplinary Expert Panel, which included two patient representatives and an ASCO guidelines staff member with health research methodology expertise (Appendix Table A2, online only). ASCO reconvened the original guideline Expert Panel, with some new members. The Expert Panel met via webinar and corresponded through e-mail. Based upon the consideration of the evidence, the authors were asked to contribute to the development of the guideline, provide critical review, and finalize the guideline recommendations (Table 1). The guideline recommendations were sent for an open comment period of two weeks, allowing the public to review and comment on the recommendations after submitting a confidentiality agreement. These comments were taken into consideration while finalizing the recommendations. Members of the Expert Panel were responsible for reviewing and approving the penultimate version of the guideline, which was then circulated for external review, and submitted to the Journal of Clinical Oncology (JCO) for editorial review and consideration for publication. All ASCO guidelines are ultimately reviewed and approved by the Expert Panel and the ASCO Evidence Based Medicine Committee (EBMC) before publication. All funding for the administration of the project was provided by ASCO.
|
In 2021, ASCO published an update of its guideline on systemic therapy for patients with stage IV NSCLC with driver alterations. The current recommendations were developed by using a systematic review of evidence identified through a targeted electronic literature search of PubMed from June 2018 through December 2021 to identify any trials meeting the inclusion criteria of the 2021 update, published since then, and clinical experience. Articles were selected for inclusion in the systematic review on the basis of the following criteria:
• Population: Patients with stage IV NSCLC whose test results show cancer is:
∘ With driver alterations in epidermal growth factor receptor (EGFR), ALK, ROS1 fusions, BRAF V600e mutations, RET fusions, MET exon 14 skipping mutations, human epidermal growth factor receptor 2 alterations, and NTRK fusions (with known marker status test results available to the clinician).
• Interventions: Chemotherapy, monoclonal antibodies, targeted therapy, palliative care, and no treatment
• Comparisons: Chemotherapy, monoclonal antibodies, targeted therapy, palliative care, and no treatment
• Outcomes: Included progression-free survival (PFS), overall survival (OS), treatment toxicity (adverse events [AEs]; usually grade 3-4 AEs), overall response rates, and quality of life (if reported).
• Sample size:
∘ With driver alterations: Minimum sample size of 20 or 1% of target population required to have the actionable driver alteration of total participants
Articles were excluded from the systematic review if they were (1) meeting abstracts not subsequently published in peer-reviewed journals; (2) editorials, commentaries, letters, news articles, case reports, and narrative reviews; and (3) published in a non-English language. The guideline recommendations are crafted, in part, using the Guidelines Into Decision Support (GLIDES) methodology and accompanying BRIDGE-Wiz software.1 In addition, a guideline implementability review was conducted. On the basis of the implementability review, revisions were made to the draft to clarify recommended actions for clinical practice. Ratings for type and strength of the recommendation, and evidence quality are provided with each recommendation. The quality of the evidence for each outcome was assessed using the Cochrane Risk of Bias tool and elements of the GRADE quality assessment and recommendations development process.2,3 GRADE quality assessment labels (ie, high, moderate, low, and very low) were assigned for each outcome by the project methodologist in collaboration with the Expert Panel co-chairs and reviewed by the full Expert Panel.
The ASCO Expert Panel and guidelines staff will work with co-chairs to keep abreast of any substantive updates to the guideline. On the basis of formal review of the emerging literature, ASCO will determine the need to update. The ASCO Guidelines Methodology Manual (available at www.asco.org/guideline-methodology) provides additional information about the guideline update process. This is the most recent information as of the publication date.
The Clinical Practice Guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc (ASCO) to assist providers in clinical decision making. The information herein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating provider, as the information does not account for individual variation among patients. Recommendations specify the level of confidence that the recommendation reflects the net effect of a given course of action. The use of words like “must,” “must not,” “should,” and “should not” indicates that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating provider in the context of treating the individual patient. Use of the information is voluntary. ASCO does not endorse third-party drugs, devices, services, or therapies used to diagnose, treat, monitor, manage, or alleviate health conditions. Any use of a brand or trade name is for identification purposes only. ASCO provides this information on an “as is” basis and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information, or for any errors or omissions.
The Expert Panel was assembled in accordance with ASCO's Conflict of Interest Policy Implementation for Clinical Practice Guidelines (“Policy,” found at https://www.asco.org/guideline-methodology). All members of the Expert Panel completed ASCO's disclosure form, which requires disclosure of financial and other interests, including relationships with commercial entities that are reasonably likely to experience direct regulatory or commercial impact as a result of promulgation of the guideline. Categories for disclosure include employment; leadership; stock or other ownership; honoraria, consulting or advisory role; speaker's bureau; research funding; patents, royalties, other intellectual property; expert testimony; travel, accommodations, expenses; and other relationships. In accordance with the Policy, the majority of the members of the Expert Panel did not disclose any relationships constituting a conflict under the Policy.
After applying the eligibility criteria, one randomized control trial (RCT) and one single-arm study remained, forming the evidentiary basis for the guideline recommendations.4,5
The identified trials were published between 2020 and 2021. The primary outcome for the RCT was therapeutic efficacy4; morbidities was a coprimary outcome for one of the studies,5 although they were framed in a variety of ways such as PFS and OS. The cohort study5 reported a mix of efficacy and AE-related outcomes. Tables 2-6 present the included articles from the literature search pertinent to the development of the recommendations. Evidence supporting unchanged recommendations is reviewed in the previous guideline publications.7,8
|
|
|
|
|
Study design aspects related to individual study quality, quality of evidence, strength of recommendations, and risk of bias were assessed. Refer to the Methodology Manual for more information and for definitions of ratings for overall potential risk of bias.
As seen in Tables 4 and 6, study quality was formally assessed for the one RCT and one cohort study identified. Evidence quality (ie, certainty of the evidence) for each outcome was assessed using elements of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) quality assessment and recommendations development process. To facilitate the quality assessment ratings, MAGIC App guideline development software was used; within this framework, outcomes from randomized controlled trials are rated high quality and can subsequently be downgraded as factors that affect quality are identified. Observational nonrandomized studies are rated as low quality and can be upgraded for factors such as large magnitude of effect. GRADE quality assessment labels of high, moderate, low, or very low and a recommendation strength of strong or weak were assigned by the project methodologist in collaboration with the Expert Panel cochairs and reviewed by the full Expert Panel. Definitions for these ratings are provided in Appendix Table A1.
What is the most effective therapy for patients with ALK rearrangement and previously untreated NSCLC?
For patients with an ALK rearrangement, a PS of 0-2, and previously untreated NSCLC, clinicians should offer alectinib or brigatinib (Type: Evidence based; benefits outweigh harms; Evidence quality: High; Strength of recommendation: Strong) or lorlatinib (Type: Evidence based; benefits outweigh harms; Evidence quality: Low; Strength of recommendation: Weak).
For patients with an ALK rearrangement, a PS of 0-2, and previously untreated NSCLC, if alectinib, brigatinib, or lorlatinib are not available, clinicians should offer ceritinib or crizotinib (Type: Evidence based; benefits outweigh harms; Evidence quality: High; Strength of recommendation: Strong).
The CROWN trial included 296 patients who received either lorlatinib or crizotinib4 (crizotinib data were reviewed in prior guideline updates). A difference in OS was not observed, but the survival data were immature at the time of the analysis. There was an improvement in PFS compared with crizotinib. The PFS difference result was hazard ratio = 0.28 (95% CI, 0.19 to 0.41). There was an increase in grade 3-4 AEs with lorlatinib, with an absolute increase of 167 more per 1,000. With the GRADE assessment, certainty of the evidence was low for OS and grade 3-4 AEs, and moderate for PFS.
Although lorlatinib is effective in patients with ALK-rearranged stage IV NSCLC and may be considered as another option for first-line treatment in this patient population, clinicians need awareness of its AE profile. Notably, neurocognitive and mood disorders (both any grade), grade 3-4 hypercholesterolemia, and hypertriglyceridemia were increased. Weight gain and hypertension were also increased in the lorlatinib arm. Because of immature OS results, a wide CI for PFS, methodologic risk of bias, and toxicity, the strength of the recommendation is weak. Although no head-to-head comparison of alectinib and lorlatinib has occurred, longer follow-up data with alectinib and its more favorable safety profile still make it the preferred first-line treatment for patients with ALK-rearranged stage IV NSCLC. Brigatinib was discussed in the previous version of the guideline; there was no new evidence to add in this update.
What is the most effective therapy for patients with RET rearrangement?
For patients with a RET rearrangement, a PS of 0-2, and previously untreated NSCLC, clinicians may offer selpercatinib or pralsetinib (Type: Informal consensus; Evidence quality: Low; Strength of recommendation: Weak).
2021 additional option: For patients with a RET rearrangement, a performance status of 0-2, and previously untreated NSCLC, clinicians may offer standard therapy following the non-driver mutation guideline (Type: Informal consensus; Evidence quality: Low; Strength of recommendation: Moderate).
What is the most effective second-line therapy for patients with stage IV NSCLC with RET rearrangement with a PS 0-2?
For patients with RET rearrangement who have not received RET targeted therapy, clinicians may offer selpercatinib (Type: Informal consensus; Evidence quality: Low; Strength of recommendation: Moderate) or pralsetinib (Type: Informal consensus; Evidence quality: Low; Strength of recommendation: Weak).
2021 additional option: For patients with RET rearrangement who have had previous RET targeted therapy, clinicians may offer treatment per the non-driver mutation guideline (Type: Informal consensus; Evidence quality: Low; Strength of recommendation: Moderate).
The ARROW trial was a single-arm study in the first line and the second line.5,6 One open-label phase I-II trial reporting on pralsetinib in this setting was obtained, comprising all the available evidence. In this trial, patients were consecutively enrolled in the phase I portion of the trial and retained in the phase II portion. The primary end point was objective response, and the secondary end point was duration of response. Study outcomes of interest are presented in Tables 5 and 6.
One hundred fourteen patients whose cancer had a RET alteration, in the second-line setting, received pralsetinib. The primary outcome was response rate. The response rate was 70% for patients who had not received prior treatment and 61% for those with prior treatment. The certainty of the evidence was low due to factors such as single-arm trial design, small sample size, and more. The sample size for those in the first line did not meet the criteria for inclusion in this guideline.
The only change is combining the two recommendations and downgrading the recommendation strength to weak. RET rearrangements are seen in approximately 1-2 percent of patients with NSCLC.7 Two selective RET antagonists selpercatinib and pralsetinib have now been shown to produce high response rates in patients whose cancer is treatment-naive as well as those who have been previously treated. Given the tolerable toxicity, these are now approved for patients with RET rearranged stage IV NSCLC first- or subsequent-line therapy following chemotherapy and/or immunotherapy on the basis of the results of the respective phase I-II studies. This recommendation does not apply to patients with large cell or neuroendocrine tumors. The Expert Panel understands the limitations of these studies and encourages patient participation in ongoing phase III studies comparing selpercatinib or pralsetinib to standard first-line treatments to help confirm the efficacy of these novel targeted therapies.
The draft recommendations were released to the public for open comment from January 10, 2022, through January 24, 2022. Response categories of “Agree as written,” “Agree with suggested modifications” and “Disagree. See comments” were captured for every proposed recommendation with 22 written comments received. A total of 91% of the 22 respondents' responses either agreed or agreed with slight modifications to the recommendations and 9% of the responses disagreed. Expert Panel members reviewed comments from all sources and determined whether to maintain original draft recommendations, revise with minor language changes, or consider major recommendation revisions. All changes were incorporated before EBMC review and approval.
The draft was submitted to one external reviewer with content expertise. It was rated as high quality, and it was agreed it would be useful in practice. Review comments regarding lorlatinib were reviewed by the Expert Panel and integrated into the final manuscript before approval by the EBMC.
ASCO guidelines are developed for implementation across health settings. Each ASCO guideline includes a member from ASCO's Practice Guideline Implementation Network (PGIN) on the panel. The additional role of this PGIN representative on the guideline panel is to assess the suitability of the recommendations to implementation in the community setting, but also to identify any other barrier to implementation a reader should be aware of. Barriers to implementation include the need to increase awareness of the guideline recommendations among front-line practitioners and survivors of cancer and caregivers, and also to provide adequate services in the face of limited resources. The guideline Bottom Line Box was designed to facilitate implementation of recommendations. This guideline will be distributed widely through the ASCO PGIN. ASCO guidelines are posted on the ASCO website and most often published in the Journal of Clinical Oncology.
Limitations of the research include that there was a single RCT on lorlatinib and that the pralsetinib study was a single-arm study. After the closing date parameter of the systematic review, the US Food and Drug Administration (FDA) approved two agents via breakthrough designation: telisotuzumab vedotin (ABBV-399; teliso-V)10 and patritumab deruxtecan.11
In addition, the Expert Panel is following ongoing trials on sotorasib, pyrotinib, adagrasib, and others, listed in the Data Supplement (online only). The Expert Panel suggests more research on both US Food and Drug Administration breakthrough designation–awarded agents and ongoing trials and will review in future updates.
ASCO believes that cancer clinical trials are vital to inform medical decisions and improve cancer care, and that all patients should have the opportunity to participate.
More information, including a supplement with additional evidence tables, slide sets, and clinical tools and resources, is available at www.asco.org/thoracic-cancer-guidelines. Patient information is available at www.cancer.net.
• Integration of Palliative Care into Standard Oncology Care12 (http://ascopubs.org/doi/10.1200/JCO.2016.70.1474)
• Patient-Clinician Communication13 (http://ascopubs.org/doi/10.1200/JCO.2017.75.2311)
• 2020 Update for Stage IV NSCLC Without Driver Alterations14 (https://ascopubs.org/full/doi/10.1200/JCO.19.03022)
• 2021 Update for Stage IV NSCLC With Driver Alterations7 (https://ascopubs.org/doi/full/10.1200/JCO.20.03570)
• Molecular Testing for the Selection of Patients With Lung Cancer for Treatment With Targeted Tyrosine Kinase Inhibitors15 (http://ascopubs.org/doi/10.1200/JCO.2017.76.7293)
Evidence Based Medicine Committee approval: March 22, 2022
This American Society of Clinical Oncology (ASCO) Clinical Practice Guideline provides recommendations, with comprehensive review and analyses of the relevant literature for each recommendation. Additional information, including a supplement with additional evidence tables, slide sets, clinical tools and resources, and links to patient information at www.cancer.net, is available at www.asco.org/thoracic-cancer-guidelines.
Conception and design: All authors
Administrative support: Sarah Temin
Collection and assembly of data: All authors
Data analysis and interpretation: All authors
Manuscript writing: All authors
Final approval of manuscript: All authors
Accountable for all aspects of the work: All authors
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.
Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).
Sherman Baker Jr
Consulting or Advisory Role: Boehringer Ingelheim
Elizabeth Blanchard
Travel, Accommodations, Expenses: Mitra Biotech
Julie R. Brahmer
Honoraria: Janssen
Consulting or Advisory Role: Bristol Myers Squibb, Lilly, Merck, Amgen, Genentech, GlaxoSmithKline, AstraZeneca, Regeneron, Sanofi, Eisai, Turning Point Therapeutics
Research Funding: Bristol Myers Squibb (Inst), AstraZeneca (Inst), Spectrum Pharmaceuticals (Inst), Revolution (Inst), RAPT Therapeutics (Inst)
Other Relationship: Bristol Myers Squibb
Narjust Duma
Consulting or Advisory Role: AstraZeneca, Pfizer, NeoGenomics Laboratories, Janssen, Bristol Myers Squibb/Medarex, Merck, Mirati Therapeutics
Speakers' Bureau: MJH Life Sciences
Peter M. Ellis
Honoraria: AstraZeneca, Pfizer, Takeda, Lilly, Bristol Myers Squibb, Merck, Jazz Pharmaceuticals, Novartis Canada Pharmaceuticals Inc, Janssen Oncology
Ivy B. Elkins
Honoraria: Bayer, Janssen, Sanofi, Daiichi, Merck
Consulting or Advisory Role: AstraZeneca, BMS, Boehringer Ingelheim, Blueprint Medicines
Uncompensated Relationships: Lilly
Rami Y. Haddad
Consulting or Advisory Role: Aptitude Health, MJH Healthcare Holdings, LLC, Cardinal Health, Rigel, Puma Biotechnology
Travel, Accommodations, Expenses: Pharmacyclics
Paul J. Hesketh
Consulting or Advisory Role: UpToDate
David H. Johnson
Consulting or Advisory Role: Merck, Pfizer, Aileron Therapeutics, Boston University
Natasha B. Leighl
Research Funding: Roche Canada (Inst), Guardant Health (Inst), MSD (Inst), EMD Serono (Inst), Lilly (Inst), AstraZeneca Canada (Inst), Takeda (Inst), Amgen (Inst), Bayer (Inst), MSD Oncology (Inst)
Travel, Accommodations, Expenses: Merck Sharp & Dohme
Hirva Mamdani
Consulting or Advisory Role: Zentalis, MorphoSys, Seattle Genetics
Tanyanika Phillips
Travel, Accommodations, Expenses: City of Hope
Gregory J. Riely
Research Funding: Novartis (Inst), Roche/Genentech (Inst), GlaxoSmithKline (Inst), Pfizer (Inst), Infinity Pharmaceuticals (Inst), Mirati Therapeutics (Inst), Merck (Inst), Takeda (Inst)
Patents, Royalties, Other Intellectual Property: Patent application submitted covering pulsatile use of erlotinib to treat or prevent brain metastases (Inst)
Other Relationship: Pfizer, Roche/Genentech, Takeda, Mirati Therapeutics
Andrew G. Robinson
Honoraria: Merck
Consulting or Advisory Role: AstraZeneca, Merck, Amgen
Research Funding: AstraZeneca (Inst), Merck (Inst), Bristol Myers Squibb (Inst), Roche Canada (Inst)
Rafael Rosell
Consulting or Advisory Role: Blueprint Medicines, Merck KGaA
Joan H. Schiller
Consulting or Advisory Role: Genentech/Roche, Merck, Cancer Expert Now, AstraZeneca
Other Relationship: Lung Cancer Research Foundation
Bryan J. Schneider
Research Funding: Merck
David R. Spigel
Leadership: ASCO (Inst)
Consulting or Advisory Role: Genentech/Roche (Inst), Novartis (Inst), Bristol Myers Squibb (Inst), AstraZeneca (Inst), Pfizer (Inst), GlaxoSmithKline (Inst), EMD Serono (Inst), Molecular Templates (Inst), Amgen (Inst), Curio Science (Inst), Intellisphere (Inst), Jazz Pharmaceuticals (Inst), Mirati Therapeutics (Inst), Puma Biotechnology (Inst), Sanofi/Aventis (Inst), Exelixis (Inst), Regeneron (Inst), Lilly (Inst), Janssen (Inst), Evidera (Inst), BeiGene (Inst), Novocure (Inst)
Research Funding: Genentech/Roche (Inst), Novartis (Inst), Celgene (Inst), Bristol Myers Squibb (Inst), Lilly (Inst), AstraZeneca (Inst), University of Texas Southwestern Medical Center—Simmons Cancer Center (Inst), Merck (Inst), G1 Therapeutics (Inst), Neon Therapeutics (Inst), Takeda (Inst), Nektar (Inst), Celldex (Inst), Clovis Oncology (Inst), Daiichi Sankyo (Inst), EMD Serono (Inst), Astellas Pharma (Inst), GRAIL (Inst), Transgene (Inst), Aeglea Biotherapeutics (Inst), Ipsen (Inst), BIND Therapeutics (Inst), Eisai (Inst), ImClone Systems (Inst), Immunogen (Inst), Janssen Oncology (Inst), MedImmune (Inst), Molecular Partners (Inst), Agios (Inst), GlaxoSmithKline (Inst), Tesaro (Inst), cyteir (Inst), Apollomics (Inst), Novocure (Inst), Elevation Oncology (Inst), Calithera Biosciences (Inst), Arcus Biosciences (Inst), Arrys Therapeutics (Inst), Bayer (Inst), BeiGene (Inst), Blueprint Medicines (Inst), Boehringer Ingelheim (Inst), Denovo Biopharma (Inst), Hutchison MediPharma (Inst), Incyte (Inst), Kronos Bio (Inst), Loxo (Inst), Macrogenics (Inst), Molecular Templates (Inst), Oncologie (Inst), Pfizer (Inst), PTC Therapeutics (Inst), PureTech (Inst), Razor Genomics (Inst), Repare Therapeutics (Inst), Rgenix (Inst), Tizona Therapeutics, Inc (Inst), Verastem (Inst), Evelo Biosciences (Inst), BioNTech (Inst)
Travel, Accommodations, Expenses: AstraZeneca, Genentech, Novartis
No other potential conflicts of interest were reported.
ACKNOWLEDGMENT
The Expert Panel wishes to thank Dr Edwin Yau, Dr Anthony Provenzano, Dr Zeina Nahleh, and the Evidence Based Medicine Committee for their thoughtful reviews and insightful comments on this guideline. In addition, the Expert Panel wishes to thank Dr Nasser H. Hanna and Bryan S. Rumble for systematic review assistance and Kari Bohlke.
| 1. | Shiffman RN, Michel G, Rosenfeld RM, et al: Building better guidelines with BRIDGE-Wiz: Development and evaluation of a software assistant to promote clarity, transparency, and implementability. J Am Med Inform Assoc 19:94-101, 2012 Crossref, Medline, Google Scholar |
| 2. | Cumpston M, Li T, Page MJ, et al: Updated guidance for trusted systematic reviews: A new edition of the Cochrane Handbook for systematic reviews of interventions. Cochrane Database Syst Rev 10:Ed000142, 2019 Medline, Google Scholar |
| 3. | Balshem H, Helfand M, Schunemann HJ, et al: GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 64:401-406, 2011 Crossref, Medline, Google Scholar |
| 4. | Shaw AT, Bauer TM, de Marinis F, et al: First-line lorlatinib or crizotinib in advanced ALK-positive lung cancer. N Engl J Med 383:2018-2029, 2020 Crossref, Medline, Google Scholar |
| 5. | Gainor JF, Curigliano G, Kim D-W, et al: Registrational dataset from the phase I/II ARROW trial of pralsetinib (BLU-667) in patients (pts) with advanced RET fusion+ non-small cell lung cancer (NSCLC). J Clin Oncol 38, 2020 (suppl 15; abstr 9515) Link, Google Scholar |
| 6. | Gainor JF, Curigliano G, Kim DW, et al: Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): A multi-cohort, open-label, phase 1/2 study. Lancet Oncol 22:959-969, 2021 Crossref, Medline, Google Scholar |
| 7. | Hanna NH, Robinson AG, Temin S, et al: Therapy for stage IV non-small-cell lung cancer with driver alterations: ASCO and OH (CCO) joint guideline update. J Clin Oncol 39:1040-1091, 2021 Link, Google Scholar |
| 8. | Hanna N, Johnson D, Temin S, et al: Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 35:3484-3515, 2017 Link, Google Scholar |
| 9. | Camidge DR, Kim HR, Ahn M-J, et al: Brigatinib versus crizotinib in advanced ALK inhibitor-naive ALK-positive non-small cell lung cancer: Second interim analysis of the phase III ALTA-1L trial. J Clin Oncol 38:3592-3603, 2020 Link, Google Scholar |
| 10. | Telisotuzumab vedotin receives breakthrough therapy status from FDA for select NSCLC. https://www.onclive.com/view/telisotuzumab-vedotin-receives-breakthrough-therapy-status-from-fda-for-select-nsclc Google Scholar |
| 11. | FDA grants breakthrough therapy status to patritumab deruxtecan for lung cancer subset. https://www.healio.com/news/hematology-oncology/20220103/fda-grants-breakthrough-therapy-status-to-patritumab-deruxtecan-for-lung-cancer-subset Google Scholar |
| 12. | Ferrell BR, Temel JS, Temin S, et al: Integration of palliative care into standard oncology care: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 35:96-112, 2017 Link, Google Scholar |
| 13. | Gilligan T, Coyle N, Frankel RM, et al: Patient-clinician communication: American Society of Clinical Oncology consensus guideline. J Clin Oncol 35:3618-3632, 2017 Link, Google Scholar |
| 14. | Hanna NH, Schneider BJ, Temin S, et al: Therapy for stage IV non-small-cell lung cancer without driver alterations: ASCO and OH (CCO) joint guideline update. J Clin Oncol 38:1608-1632, 2020 Link, Google Scholar |
| 15. | Kalemkerian GP, Narula N, Kennedy EB, et al: Molecular testing guideline for the selection of patients with lung cancer for treatment with targeted tyrosine kinase inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology clinical practice guideline update. J Clin Oncol 36:911-919, 2018 Link, Google Scholar |
