Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I to IIIA Completely Resected Non–Small-Cell Lung Cancers
Publication Date: February 17, 2022
Last Updated: March 27, 2023
Treatment
Adjuvant Systemic Therapy for NSCLCs
Stage IA: Adjuvant chemotherapy is NOT recommended. (EB/PC, H, M, S)
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New Recommendations from 2021 Guideline Rapid Recommendation Update
Stage IB (3< T ≤ 4 cm, N0M0). Adjuvant osimertinib is recommended for patients with sensitizing epidermal growth factor receptor (EGFR) (Ex19del or L858R) mutations. (EB, B, H, S)
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Adjuvant cisplatin-based chemotherapy and/or atezolizumab are NOT recommended for routine use in this patient group. A postoperative multimodality evaluation, including a consultation with a medical oncologist, is recommended to assess benefits and risks of adjuvant therapies for each patient. Factors to consider other than tumor stage when making a recommendation for adjuvant therapy are outlined after the adjuvant systemic therapy section of the 2017 guideline. (EB/PC, B, I, M)
Benefits/Harms: B [especially in patients with larger tumors]
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Stages IIA, IIB, and IIIA. Adjuvant cisplatin-based chemotherapy is recommended for all patients. Adjuvant osimertinib is recommended after chemotherapy for patients with tumors with sensitizing EGFR mutations, regardless of PD-L1 status. Adjuvant atezolizumab is recommended for all patients with PD-L1 ≥1% after cisplatin-based chemotherapy except for patients with sensitizing EGFR mutations. (EB/PC, B, H, S)
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Adjuvant Radiation Therapy for NSCLCs
Stage IA/B and IIA/B: Adjuvant radiation therapy is NOT recommended. (EB/PC, H, I, S)
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Stage IIIA (N2): Adjuvant radiation therapy is NOT recommended for routine use. A postoperative multimodality evaluation, including a consultation with a radiation oncologist, is recommended to assess benefits and risks for adjuvant radiotherapy for each patient with N2 disease. (EB/PC, B, I, M)
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Recommendation Grading
Disclaimer
The information in this patient summary should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.
Overview
Title
Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I to IIIA Completely Resected Non–Small-Cell Lung Cancers
Authoring Organizations
American Society of Clinical Oncology
Cancer Care Ontario
Publication Month/Year
February 17, 2022
Last Updated Month/Year
February 7, 2024
Supplemental Implementation Tools
Document Type
Guideline
External Publication Status
Published
Country of Publication
US
Target Patient Population
Patients with completely resected stage I to IIIA NSCLCs
Target Provider Population
Surgical oncologists, medical oncologists, radiation oncologists, and other clinicians who treat patients in the target population.
Inclusion Criteria
Male, Female, Adolescent, Adult, Child, Older adult
Health Care Settings
Ambulatory, Hospital, Outpatient, Operating and recovery room
Intended Users
Nurse, nurse practitioner, physician, physician assistant
Scope
Treatment, Management
Keywords
lung cancer, non-small cell lung cancer, Non Small Cell Lung Cancer, Resected, non_small_cell_lung_cancer, Adjuvant Radiation Therapy, Adjuvant Systemic Therapy
Source Citation
Pisters K, Kris MG, Gaspar LE, et al. Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I to IIIA Completely Resected Non-Small-Cell Lung Cancer: ASCO Guideline Rapid Recommendation Update. J Clin Oncol. 2022 Feb 15. doi:10.1200/JCO.22.00051.
Kris MG, Gaspar LE, Chaft JE, et al. Adjuvant Systemic Therapy and Adjuvant Radiation Therapy for Stage I to IIIA Completely Resected Non-Small-Cell Lung Cancers: American Society of Clinical Oncology/Cancer Care Ontario Clinical Practice Guideline Update. J Clin Oncol. 2017 Sep 1;35(25):2960-2974.
Supplemental Methodology Resources
Methodology
Number of Source Documents
88
Literature Search Start Date
March 1, 2013
Literature Search End Date
June 21, 2016
Description of External Review Process
The Expert Panel included medical oncology, radiation oncology, surgical oncology, and patient/advocacy representation. ASCO has a rigorous review process for guidelines. After the draft has been approved by the Expert Panel, the guideline is independently reviewed and approved by the Clinical Practice Guideline Oversight Committee (CPGC). Select members of the CPGC are asked to critically review the guideline prior to the next scheduled CPGC meeting. The CPGC members then present the results of their reviews to the full committee, discuss the review with the full committee, and the CPGC votes on whether to approve the guideline (with recusals from members who have relationships with affected companies). Approved ASCO Guidelines are then submitted to the Society’s journal for consideration of publication. No dates provided
Specialties Involved
Oncology, Pulmonology, Medical Oncology, Surgical Oncology, Radiation Oncology, Oncology, Oncology, Oncology
Description of Systematic Review
In 2007, ASCO and CCO published a joint guideline on adjuvant chemotherapy and adjuvant radiation therapy for stage I to IIIA resectable NSCLC.2 CCO recently updated the systematic review on adjuvant chemotherapy, bringing it current to January 2016, and expanded the search strategy to include recent trials of targeted therapy and immunotherapy.3 That CCO systematic review and accompanying guideline recommendations serve as the basis for the adjuvant systemic therapy portion of this updated CCO/ASCO joint guideline. To improve the currency of the evidence base, a final literature search for any additional adjuvant systemic therapy trials published between January and June 2016 was conducted.
In 2015, ASCO endorsed ASTRO’s evidence-based guideline on adjuvant radiation therapy in locally advanced NSCLC,4,5 with a systematic review that was current to March 2013. The ASTRO systematic review and accompanying guideline recommendations serve as the basis for the adjuvant radiation therapy portion of this guideline. To update the evidence base, a search for any additional adjuvant radiation therapy trials that were published between March 2013 and June 2016 was conducted.
List of Questions
The panel updated the American Society of Clinical Oncology adjuvant therapy guideline for resected non–small-cell lung cancers. This clinical practice guideline addresses two overarching clinical questions:
What is the benefit of adjuvant systemic therapy in patients with completely resected stage I to IIIA NSCLCs?
What is the benefit of adjuvant radiation therapy in patients with completely resected stage I to IIIA NSCLCs?
Description of Study Criteria
Publications with the following study designs were eligible for inclusion in the evidence base:
Systematic reviews of randomized controlled trials (RCTs) with or without meta-analyses,
Phase III RCTs,
Observational comparative studies based on the:
NCDB, a large, prospectively acquired database that is gathered and maintained by the American College of Surgeons, the Commission on Cancer, and the American Cancer Society;6
SEER Program database, which collects registry data on cancer cases from various locations and sources throughout the United States (seer.cancer.gov/about).
Studies were considered for inclusion if they reported the following outcomes by TNM stage for comparisons of surgery alone versus surgery plus adjuvant systemic therapy or surgery plus radiation therapy with or without systemic therapy in the target population of patients with completely resected lung cancers (ie, no macroscopic disease and uninvolved resection margins after surgery):
Overall survival (OS),
Disease-free survival (DFS),
Adverse events.
Articles were not considered if they were:
Published only as an abstract;
Trials of neoadjuvant (ie, preoperative) chemotherapy;
Trials of tegafur and uracil;
Included patients with incomplete resections (ie, had positive margins or macroscopic residual disease);
Noncomparative study designs, including editorials, commentaries, letters, news articles, case reports, and narrative reviews;
Non-English language publications.
Description of Search Strategy
MEDLINE was searched using PubMed on June 21, 2016, using keywords and MeSH terms related to NSCLC and chemotherapy, radiation therapy, targeted therapy, and immunotherapy. The complete literature search strategy used in the PubMed database is available in Data Supplement 1. Reference lists of included articles were scanned for additional eligible citations.
Description of Study Selection
Publications with the following study designs were eligible for inclusion in the evidence base:
Systematic reviews of randomized controlled trials (RCTs) with or without meta-analyses,
Phase III RCTs,
Observational comparative studies based on the:
NCDB, a large, prospectively acquired database that is gathered and maintained by the American College of Surgeons, the Commission on Cancer, and the American Cancer Society;6
SEER Program database, which collects registry data on cancer cases from various locations and sources throughout the United States (seer.cancer.gov/about).
Studies were considered for inclusion if they reported the following outcomes by TNM stage for comparisons of surgery alone versus surgery plus adjuvant systemic therapy or surgery plus radiation therapy with or without systemic therapy in the target population of patients with completely resected lung cancers (ie, no macroscopic disease and uninvolved resection margins after surgery):
Overall survival (OS),
Disease-free survival (DFS),
Adverse events.
Articles were not considered if they were:
Published only as an abstract;
Trials of neoadjuvant (ie, preoperative) chemotherapy;
Trials of tegafur and uracil;
Included patients with incomplete resections (ie, had positive margins or macroscopic residual disease);
Noncomparative study designs, including editorials, commentaries, letters, news articles, case reports, and narrative reviews;
Non-English language publications.
Description of Evidence Analysis Methods
ASCO guideline recommendations are crafted, in part, using the GuideLines Into DEcision Support (GLIDES) methodology. ASCO adopted a five‐step approach to carry out quality appraisal, strength of evidence ratings and strength of recommendations ratings. The ASCO approach was primarily adapted from those developed by the AHRQ,, USPSTF, and GRADE, however with the validation of the GRADE methodology, the sole use of GRADE is being evaluated by the Clinical Practice Guidelines Committee.
Description of Evidence Grading
High: High confidence that the available evidence reflects the true magnitude and direction of the net effect (i.e., balance of benefits v harms) and that further research is very unlikely to change either the magnitude or direction of this net effect.
Intermediate: Moderate confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research is unlikely to alter the direction of the net effect; however, it might alter the magnitude of the net effect.
Low: Low confidence that the available evidence reflects the true magnitude and direction of the net effect. Further research may change either the magnitude and/or direction this net effect.
Insufficient: Evidence is insufficient to discern the true magnitude and direction of the net effect. Further research may better inform the topic. The use of the consensus opinion of experts is reasonable to inform outcomes related to the topic.
Description of Recommendation Grading
ASCO uses a formal consensus methodology based on the modified Delphi technique in clinically important areas where there is limited evidence or a lack of high‐quality evidence to inform clinical guidance recommendations.
Evidence Based: There was sufficient evidence from published studies to inform a recommendation to guide clinical practice.
Formal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. Therefore, the Expert Panel used a formal consensus process to reach this recommendation, which is considered the best current guidance for practice. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak"). The results of the formal consensus process are summarized in the guideline and reported in the Data Supplement (see the Supporting Documents" field).
Informal Consensus: The available evidence was deemed insufficient to inform a recommendation to guide clinical practice. The recommendation is considered the best current guidance for practice, based on informal consensus of the Expert Panel. The Panel agreed that a formal consensus process was not necessary for reasons described in the literature review and discussion. The Panel may choose to provide a rating for the strength of the recommendation (i.e., "strong," "moderate," or "weak").
No recommendation: There is insufficient evidence, confidence, or agreement to provide a recommendation to guide clinical practice at this time. The Panel deemed the available evidence as insufficient and concluded it was unlikely that a formal consensus process would achieve the level of agreement needed for a recommendation.
Description of Funding Source
ASCO provides funding for Guideline Development.
Company/Author Disclosures
ASCO Conflict of Interest Policy complies with the CMSS Code for Interactions with Companies. ASCO requires disclosure by individuals involved in drafting, reviewing, and approving guideline recommendations.
Percentage of Authors Reporting COI
100