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Video Viewpoint Strategy Session: Expert Guidance on the Treatment of ALK-Positive Advanced Non-Small Cell Lung Cancer

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Video Viewpoint Strategy Session: Expert Guidance on the Treatment of ALK-Positive Advanced Non-Small Cell Lung Cancer

  1. 1. Clinical Tools and Resources for Self-Study and Patient Education NON-SMALL CELL LUNG CANCER REFERENCE GUIDE The clinical tools and resources contained herein are provided as educational adjuncts to the CME/NCPD-certified online activity Expert Guidance on the Treatment of ALK- Positive Advanced Non-Small Cell Lung Cancer. It has been reviewed by Mark G. Kris, MD, and Nathan Pennell, MD, PhD (2020). To access the activity and earn CME/NCPD credit, visit: https://www.i3Health.com/non-small-cell-lung-cancer CONTENTS I: TNM Staging of Lung Tumors.......................................................................................2 II: Lung Tumor Staging.....................................................................................................4 III: Personalized Medicine Synopsis Table: NSCLC..........................................................5 IV: Recommendations for Treating Biomarkers................................................................7 V: Treatment for PD-L1 ≥1% ............................................................................................8 VI: Treatment Based on Performance Score ....................................................................9
  2. 2. 138NSCLC Reference Guide I Page 2 of 9 www.i3Health.com I: TNM STAGING OF LUNG TUMORS TNM Clinical Classifications TNM Definition TX Primary tumor cannot be assessed, or tumor proven by the presence of malignant cells in sputum or bronchial washings but not visualized by imaging or bronchoscopy T0 No evidence of primary tumor Tis Carcinoma in situ T1 Tumor 3 cm or less in greatest dimension, surrounded by lung or visceral pleura, without bronchoscopic evidence of invasion more proximal than the lobar bronchus (i.e. not in the main bronchus) T1mi Minimally invasive adenocarcinoma T1a Tumor 1 cm or less in greatest dimension T1b Tumor more than 1 cm but not more than 2 cm in greatest dimension T1c Tumor more than 2 cm but not more than 3 cm in greatest dimension T2 Tumor more than 3 cm but not more than 5 cm; or tumor with any of the following features: involves main bronchus regardless of distance to the carina, but without involvement of the carina, invades visceral pleura, associated with atelectasis or obstructive pneumonitis that extends to the hilar region either involving part of or the entire lung T2a Tumor more than 3 cm but not more than 4 cm in greatest dimension T2b Tumor more than 4 cm but not more than 5 cm in greatest dimension T3 Tumor more than 5 cm but not more than 7 cm in greatest dimension or one that directly invades any of the following: parietal pleura, chest wall (including superior sulcus tumors) phrenic nerve, parietal pericardium; or separate tumor nodule(s) in the same lobe as the primary
  3. 3. 138NSCLC Reference Guide I Page 3 of 9 www.i3Health.com T4 Tumor more than 7 cm or of any size that invades any of the following: diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina; separate tumor nodule(s) in a different ipsilateral lobe to that of the primary NX Regional lymph nodes cannot be assessed N0 No regional lymph node metastases N1 Metastasis in ipsilateral peribronchial and/or ipsilateral hilar lymph nodes and intrapulmonary nodes, including involvement by direct extension N2 Metastasis in ipsilateral mediastinal and/or subcarinal lymph node(s) N3 Metastasis in contralateral mediastinal, contralateral hilar, ipsilateral or contralateral scalene, or supraclavicular lymph node(s) M1 Cancer has spread to distant sites M1a Cancer has spread to non-regional lymph nodes M1b Cancer has spread to distant bones M1c Cancer has spread to distant organs TNM = tumor/nodes/metastases. European Society for Medical Oncology (2019). Clinical Practice Guidelines in Oncology: metastatic non-small cell lung cancer. Available at https://www.esmo.org
  4. 4. 138NSCLC Reference Guide I Page 4 of 9 www.i3Health.com II: LUNG TUMOR STAGING Occult Carcinoma TX N0 M0 Stage 0 Tis N0 M0 Stage IA T1 N0 M0 Stage IA1 T1mi T1a N0 M0 Stage IA2 T1b N0 M0 Stage IA3 T1c N0 M0 Stage IB T2a N0 M0 Stage IIA T2b N0 M0 Stage IIB T1a-c, T2a, b T3 N1 N0 M0 M0 Stage IIIA T1a-c, T2a, b T3 T4 N2 N1 N0, N1 M0 M0 M0 Stage IIIB T1a-c T2a,b T3, T4 N3 N2 M0 M0 Stage IIIC T3, T4 N3 M0 Stage IV Any T Any N M1 Stage IVA Any T Any N M1a, M1b Stage IVB Any T Any N M1c European Society for Medical Oncology (2019). Clinical Practice Guidelines in Oncology: metastatic non-small cell lung cancer. Available at https://www.esmo.org
  5. 5. 138NSCLC Reference Guide I Page 5 of 9 www.i3Health.com III: PERSONALIZED MEDICINE SYNOPSIS: NSCLC Biomarker Method Use LoE, GoR EGFR Mutation Any appropriate, validated method, subject to external quality assurance To select those patients with EGFR-sensitizing mutations most likely to respond to EGFR TKI therapy I, A ALK Rearrangement Any appropriate, validated method, subject to external quality assurance. FISH is the historical standard but IHC is now becoming the primary therapy- determining test, provided the method is validated against FISH or some other orthogonal test approach. NGS is an emerging technology To select those patients with ALK gene rearrangements most likely to respond to ALK TKI therapy I, A ROS1 Rearrangement FISH is the trial-validated standard. IHC may be used to select patients for confirmatory FISH testing but currently lacks specificity. NGS is an emerging technology. External quality assurance is essential To select those patients with ROS1 gene rearrangements most likely to respond to ROS1 TKI therapy II, A BRAF Mutation Any appropriate, validated method, subject to external quality assurance To select those patients with BRAF V600- sensitizing mutations most likely to respond to BRAF inhibitor, ± MEK inhibitor therapy II, A
  6. 6. 138NSCLC Reference Guide I Page 6 of 9 www.i3Health.com PD-L1 Expression IHC to identify PD-L1 expression at the appropriate level and on the appropriate cell population(s) as determined by the intended drug and line of therapy. Only specific trial assays are validated. Internal and external quality assurance are essential To enrich for those patients more likely to benefit from anti-PD-1 or anti-PD-L1 therapy. For pembrolizumab, testing is a companion diagnostic. For nivolumab and atezolizumab, testing is complementary I, A LoE = level of evidence; GoR = grade of recommendation; EGFR = epidermal growth factor receptor; TKI = tyrosine kinase inhibitor; ALK = anaplastic lymphoma kinase; FISH = fluorescent in situ hybridization; IHC = immunohistochemistry; NGS = next-generation sequencing; MEK = mitogen-activated protein kinase; PD-L1 = programmed death-ligand 1; PD-1 = programmed cell death protein 1. European Society for Medical Oncology (2019). Clinical Practice Guidelines in Oncology: metastatic non-small cell lung cancer. Available at https://www.esmo.org
  7. 7. 138NSCLC Reference Guide I Page 7 of 9 www.i3Health.com IV: RECOMMENDATIONS FOR TREATING BIOMARKERS Biomarker Treatment ALK Rearrangement First-line options • Alectinib (preferred) • Brigatinib • Ceritinib • Crizotinib Next-in-line options • Stay on first-line treatment ± local treatment • Switch to lorlatinib • Start treatment for histologic type • Adenocarcinomas, large cell, unknown types • Squamous cell carcinoma • If crizotinib was first-line treatment, stay on crizotinib ± local treatment OR switch to alectinib, brigatinib, or ceritinib ± local treatment ROS1 Rearrangement First-line options • Crizotinib (preferred) • Ceritinib Next-in-line options • Switch to lorlatinib • Start treatment for histologic type • Adenocarcinomas, large cell, unknown types • Squamous cell carcinoma BRAF V600E Mutation • Dabrafenib plus trametinib • Start treatment for histologic type • Adenocarcinomas, large cell, unknown types • Squamous cell carcinoma NTRK Gene Fusion • Larotrectinib • Start treatment for histologic type • Adenocarcinomas, large cell, unknown types • Squamous cell carcinoma National Comprehensive Cancer Network (2019). Patient Guidelines: Non-Small Cell Lung Cancer. Available at www.nccn.org
  8. 8. 138NSCLC Reference Guide I Page 8 of 9 www.i3Health.com V: TREATMENT FOR PD-L1 ≥1% First-Line Options Next-In-Line Options • Pembrolizumab (preferred if PD-L1 is ≥50%) • Carboplatin or cisplatin + pemetrexed + pembrolizumab (preferred if PD-L1 is between 1% and 49%) • Carboplatin + paclitaxel + bevacizumab + atezolizumab • Start treatment for histologic types • Adenocarcinomas, large cell, unknown types • Squamous cell carcinoma National Comprehensive Cancer Network (2019). Patient Guidelines: Non-Small Cell Lung Cancer. Available at www.nccn.org
  9. 9. 138NSCLC Reference Guide I Page 9 of 9 www.i3Health.com VI: TREATMENT BASED ON PERFORMANCE SCORE Performance Score Treatment Options First-line treatment for adenocarcinoma, large cell, unknown types 0 or 1 • Pembrolizumab + (carboplatin or cisplatin) + pemetrexed (preferred) • Atezolizumab + carboplatin + paclitaxel + bevacizumab • Platinum-doublet chemotherapy ± bevacizumab • Other types of chemotherapy 2 • Platinum-doublet or other types of chemotherapy 3 or 4 • Supportive care Next-in-line treatment for adenocarcinoma, large cell, unknown types 0 or 1 or 2 • Nivolumab or pembrolizumab or atezolizumab (preferred) • Docetaxel or pemetrexed or gemcitabine or ramucirumab + docetaxel 3 or 4 • Supportive care First-line treatment for squamous cell carcinoma 0 or 1 • Pembrolizumab + carboplatin + paclitaxel (preferred) • Pembrolizumab + cisplatin + paclitaxel • Platinum-doublet or other types of chemotherapy 2 • Platinum-based or other types of chemotherapy 3 or 4 • Supportive care Next-in-line treatment for squamous cell carcinoma 0 or 1 or 2 • Nivolumab or pembrolizumab or atezolizumab (preferred) • Docetaxel or pemetrexed or ramucirumab + docetaxel 3 or 4 • Supportive care National Comprehensive Cancer Network (2019). Patient Guidelines: Non-Small Cell Lung Cancer. Available at www.nccn.org

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