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Optimizing Personalized Care Plans for Patients With Advanced Non-Small Cell Lung Cancer

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Optimizing Personalized Care Plans for Patients With Advanced Non-Small Cell Lung Cancer

  1. 1. www.i3Health.com 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- approved online activity Optimizing Personalized Care Plans for Patients With Advanced Non-Small Cell Lung Cancer. It has been reviewed by Mark A. Socinski, MD, Maureen F. Zakowski, MD, and Victoria Sherry, DNP, CRNP, AOCNP (February 2020). To access the activity and earn CME/NCPD credit, visit: www.i3Health.com/NSCLC-Tumor-Board Contents I. TNM Staging of Non-Small Cell Lung Cancer.............................................................................................2 II. NSCLC Treatment By Cancer Stage ...........................................................................................................5 III. Initial Systemic Therapy for Advanced/Metastatic Disease ......................................................................6 IV. Emerging Biomarkers to Guide Treatment Selection.................................................................................7 V. Targeted Therapy for Advanced/Metastatic Disease.................................................................................8 VI. EGFR TKI Toxicity: Rash Acneiforma (CTCAE v5.0)..................................................................................9 VII. MASCC Rash Prevention and Treatment Guidelines .............................................................................10 VIII. EGFR TKI Toxicity: Diarrhea (CTCAE v5.0) ..........................................................................................11 IX. NSCLC Survivorship Care......................................................................................................................12
  2. 2. 111NSCLC Reference Guide | Page 2 of 12 www.i3Health.com I. TNM STAGING OF NON-SMALL CELL LUNG CANCER AJCC Stage TNM Stage Description Occult cancer TX N0 M0 Main tumor can’t be assessed, or cancer cells are seen in a sample of sputum or other lung fluids, but the cancer isn’t found with other tests, so its location can’t be determined. The cancer is not thought to have spread to nearby lymph nodes or to distant parts of the body 0 Tis N0 M0 Tumor found only in top layers of cells lining the air passages, but it has not invaded deeper into other lung tissues (Tis). The cancer has not spread to nearby lymph nodes or to distant parts of the body IA1 T1mi N0 M0 Cancer is minimally invasive adenocarcinoma. Tumor is ≤3 cm across, and the part that has invaded into deeper lung tissues is no more than ½ cm across. The cancer has not spread to nearby lymph nodes or to distant parts of the body OR T1a N0 M0 Tumor is ≤1 cm across, has not reached the membranes that surround the lungs, and does not affect the main branches of the bronchi. The cancer has not spread to nearby lymph nodes or distant parts of the body IA2 T1b N0 M0 Tumor is >1 cm but ≤2 cm across. It has not reached the membranes that surround the lungs, and it does not affect the main branches of the bronchi. The cancer has not spread to nearby lymph nodes or to distant parts of the body IA3 T1c N0 M0 Tumor >2 cm but ≤3 cm across. It has not reached the membranes that surround the lungs, and it does not affect the main branches of the bronchi (T1c) IB T2a N0 M0 The tumor has one or more of the following features (T2a): • >3 cm but ≤4 cm across • Grown into a main bronchus, but is not within 2 cm of the carina and ≤4 cm across • Grown into the visceral pleura and ≤4 cm across • Partially clogging the airways (and ≤4 cm across) IIA T2b N0 M0 The tumor has one or more of the following features (T2b): • >4 cm but ≤5 cm across • Has grown into the visceral pleura and >4 cm but ≤5 cm across • Partially clogging the airways (and is >4 cm but ≤5 cm across) IIB T1a/b/c N1 M0 The tumor is ≤3 cm across, has not grown into the membranes that surround the lungs, and does not affect the main branches of the bronchi (T1). It has spread to lymph nodes within the lung and/or around the area where the bronchus enters the lung. These lymph nodes are on the same side as the cancer (N1) OR T2a/b N1 M0 The tumor has one or more of the following features (T2): • >3 cm but ≤5 cm across • Grown into main bronchus, but not within 2 cm of carina and ≤5 cm across • Grown into the visceral pleura • Partially clogging airways OR
  3. 3. 111NSCLC Reference Guide | Page 3 of 12 www.i3Health.com T3 N0 M0 The tumor has one or more of the following features (T3): • >5 cm but ≤7 cm across • Grown into the chest wall, parietal pleura, phrenic nerve, or parietal pericardium • 2 or more separate tumor nodules in the same lobe of a lung IIIA T1a/b/c N2 M0 The tumor is ≤3 cm across but has not grown into membranes that surround the lungs and does not affect the main branches of the bronchi (T1). It has spread to lymph nodes around the carina or mediastinum which are on the same side as main lung tumor OR T2a/b N2 M0 The tumor has one or more of the following features (T2): • Larger than 3 cm but not larger than 5 cm across • Grown into main bronchus, but not within 2 cm of carina • Grown into visceral pleura • Partially clogging airways Cancer has spread to lymph nodes on same side as main lung tumor. Cancer has not spread to distant parts of body OR T3 N1 M0 The tumor has one or more of the following features (T3): • >5 cm but ≤7 cm across • Grown into chest wall, lining of chest wall, phrenic nerve, or membranes of the sac surrounding the heart • 2 or more separate tumor nodules in the same lobe of a lung Spread to lymph nodes within the lung and/or around area where bronchus enters lung on same side as main lung tumor. Cancer has not spread to distant parts of body OR T4 N0/N1 M0 The tumor has one or more of the following features (T4): • >7 cm across • Grown into mediastinum, heart, large blood vessels near heart, trachea, esophagus, diaphragm, backbone, or carina • 2 or more separate tumor nodules in different lobes of same lung Cancer may or may not have spread to lymph nodes within the lung and/or hilar lymph nodes. Affected lymph nodes on same side as cancer. Cancer has not spread to distant parts of body IIIB T1a/b/c N3 M0 Tumor is ≤3 cm across, has not grown into membranes that surround the lungs, and does not affect main branches of the bronchi. Cancer has spread to lymph nodes near the collarbone on either side of the body, and/or has spread to hilar or mediastinal lymph nodes on other side of the body from main tumor. Cancer has not spread to distant parts of the body OR T2a/b N3 M0 Tumor has one or more of the following features (T2): • >3 cm but ≤5 cm across • Grown into main bronchus, but not within 2 cm of carina • Grown into visceral pleura • Partially clogging airways Cancer has spread to lymph nodes near collarbone on either side of body, and/or has spread to hilar or mediastinal lymph nodes on the other side of body from the main tumor. Cancer has not spread to distant parts of body OR
  4. 4. 111NSCLC Reference Guide | Page 4 of 12 www.i3Health.com T3 N2 M0 Tumor has one or more of the following features (T3): • >5 cm but ≤7 cm across • Grown into chest wall, parietal pleura, phrenic nerve, or parietal pericardium • 2 or more separate tumor nodules in same lobe of lung Cancer has spread to lymph nodes around carina. Lymph nodes are on same sides as main lung tumor. Cancer has not spread to distant parts of body OR T4 N2 M0 The tumor has one or more of the following features (T4): • >7 cm across • Grown into the space between the lungs, heart, large blood vessels near heart, windpipe, esophagus, diaphragm, backbone, or carina • 2 or more separate tumor nodules in different lobes of the same lung Cancer has spread to lymph nodes around carina. Lymph nodes are on same sides as main lung tumor. Cancer has not spread to distant parts of body IIIC T3 N3 M0 The tumor has one or more of the following features (T3): • >5 cm but ≤7 cm across • Grown into chest wall, parietal pleura, phrenic nerve, parietal pericardium • 2 or more separate tumor nodules in the same lobe of a lung Cancer has spread to lymph nodes near collarbone on either side of the body, and/or has spread to hilar or mediastinal lymph nodes on other side of body from main tumor. Cancer has not spread to distant parts of body OR T4 N3 M0 Tumor has one or more of the following features (T4): • >7 cm across • Grown into mediastinum, heart, large blood vessels near heart, trachea, esophagus, diaphragm, spine, carina • 2 or more separate tumor nodules in different lobes of the same lung Cancer has spread to lymph nodes near the collarbone on either side of the body, and/or spread to hilar or mediastinal lymph nodes on other side of the body from main tumor. Cancer has not spread to distant parts of the body IVA Any T Any N M1a Cancer can be any size and may have grown into nearby structures and reached nearby lymph nodes. In addition, any of the following is true: • Cancer has spread to other lung • Cancer cells found in fluid around lung and/or heart OR Any T Any N M1b Cancer can be any size and may have grown into nearby structures and reached nearby lymph nodes. Has spread as a single tumor outside of chest, such as distant lymph node or an organ such as liver, bones, or brain IVB Any T Any N M1c Cancer can be any size and may have grown into nearby structures. It may have reached nearby lymph nodes. It has spread as more than one tumor outside the chest, such as to distant lymph nodes TNM = Tumor, Node, Metastasis. AJCC = American Joint Committee on Cancer. American Cancer Society (2020). Non-small cell lung cancer stages. Available at: http://www.cancer.org
  5. 5. 111NSCLC Reference Guide | Page 5 of 12 www.i3Health.com II. NSCLC TREATMENT BY CANCER STAGE Primary Treatment Used for Which Stage? Surgery • Stage I • Stage II • Stage III (N0 or N1) • Not many stage III (N2) Radiation therapy • Stage I • Stage II in lung only Chemoradiation • Stage IIB outside of lung • Stage III (N0, N1) • Many stage III (N2) • All stage III (N3) National Comprehensive Cancer Network (2019). Clinical Practice Guidelines in Oncology: non-small cell lung cancer. Version 2.2020. Available at: http://www.nccn.org
  6. 6. 111NSCLC Reference Guide | Page 6 of 12 www.i3Health.com III. INITIAL SYSTEMIC THERAPY FOR ADVANCED/METASTATIC DISEASE Lung Cancer Type Therapy Adenocarcinoma, Large Cell, NSCLC No contraindications to PD-1 or PD-L1 inhibitors Preferred • Pembrolizumab/carboplatin/pemetrexed • Pembrolizumab/cisplatin/pemetrexed Other recommended • Atezolizumab/carboplatin/paclitaxel/bevacizumab • Atezolizumab/carboplatin/albumin-bound paclitaxel Contraindications to PD-1 or PD-L1 inhibitors Useful in certain circumstances • Bevacizumab/carboplatin/paclitaxel • Bevacizumab/carboplatin/pemetrexed • Bevacizumab/cisplatin/pemetrexed • Carboplatin/etoposide • Carboplatin/pemetrexed • Cisplatin/pemetrexed Advanced or metastatic squamous cell carcinoma No contraindications to PD-1 or PD-L1 inhibitors Preferred • Pembrolizumab/carboplatin/paclitaxel • Pembrolizumab/carboplatin/albumin-bound paclitaxel Both types No contraindications to PD-1 or PD-L1 inhibitors Other recommended • Nivolumab/ipilimumab Contraindications to PD-1 or PD-L1 inhibitors Useful in certain circumstances • Carboplatin/albumin-bound paclitaxel • Carboplatin/docetaxel • Carboplatin/gemcitabine • Carboplatin/paclitaxel • Cisplatin/docetaxel • Cisplatin/etoposide • Cisplatin/gemcitabine • Cisplatin/paclitaxel • Gemcitabine/docetaxel • Gemcitabine/vinorelbine National Comprehensive Cancer Network (2019). Clinical Practice Guidelines in Oncology: non-small cell lung cancer. Version 2.2020. Available at: http://www.nccn.org
  7. 7. 111NSCLC Reference Guide | Page 7 of 12 www.i3Health.com IV. EMERGING BIOMARKERS TO GUIDE TREATMENT SELECTION Genetic Alteration (ie, Driver Event) Targeted Agents Used to Fight Driver Event High-level MET amplification or MET exon 14 skipping mutation • Crizotinib RET rearrangements • Cabozantinib • Vandetanib ERBB2 (HER2) mutations • Ado-trastuzumab emtansine Tumor mutational burden • Nivolumab/ipilimumab • Nivolumab NSCLC = non-small cell lung cancer. National Comprehensive Cancer Network (2019). Clinical Practice Guidelines in Oncology: non-small cell lung cancer. Version 2.2020. Available at: http://www.nccn.org
  8. 8. 111NSCLC Reference Guide | Page 8 of 12 www.i3Health.com V. TARGETED THERAPY FOR ADVANCED/METASTATIC DISEASE Gene Mutation Therapy Sensitizing EGFR Mutation Positive First-line therapy • Afatinib • Erlotinib • Dacomitinib • Gefitinib • Osimertinib • Erlotinib/ramucirumab • Erlotinib/bevacizumab (nonsquamous) Subsequent therapy • Osimertinib ALK Rearrangement Positive First-line therapy • Alectinib • Brigatinib • Ceritinib • Crizotinib Subsequent therapy • Alectinib • Brigatinib • Ceritinib • Lorlatinib ROS1 Rearrangement Positive First-line therapy • Ceritinib • Crizotinib • Entrectinib BRAF V600E Mutation Positive First-line therapy • Dabrafenib/trametinib Subsequent therapy • Dabrafenib/trametinib NTRK Gene Fusion Positive First-line/Subsequent therapy • Larotrectinib • Entrectinib PD-L1 ≥1% First-line therapy • Pembrolizumab • (Carboplatin or cisplatin)/pemetrexed/pembrolizumab (non-squamous) • Carboplatin/paclitaxel/bevacizumab/atezolizumab (nonsquamous) • Carboplatin/paclitaxel or albumin-bound paclitaxel/pembrolizumab (squamous) • Carboplatin/albumin-bound paclitaxel/atezolizumab • Nivolumab/ipilimumab EGFR = epidermal growth factor receptor; PD-L1 = programmed death-ligand 1. National Comprehensive Cancer Network (2019). Clinical Practice Guidelines in Oncology: non-small cell lung cancer. Version 2.2020. Available at: http://www.nccn.org
  9. 9. 111NSCLC Reference Guide | Page 9 of 12 www.i3Health.com VI. EGFR TKI TOXICITY: RASH ACNEIFORMA (CTCAE V5.0) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Mild Moderate Severe or medically significant, but not immediately life threatening Life-threatening consequences Death related to AE Papules and/or pustules covering <10% BSA, which may or may not be associated with symptoms of pruritus or tenderness Papules and/or pustules covering 10%- 30% BSA, which may or may not be associated with symptoms of pruritus or tenderness; associated with psychosocial impact; limiting instrumental ADLb papules and/or pustules covering >30% BSA with or without mild symptoms Papules and/or pustules covering >30% BSA with moderate or severe symptoms; limiting self- care ADLc; associated with local superinfection with oral antibiotics indicated Papules and/or pustules covering any % BSA, which may or not be associated with symptoms of pruritus or tenderness and are associated with extensive superinfection with IV antibiotics indicated Death aDefined as a disorder characterized by an eruption of papules and pustules, typically appearing in face, scalp, upper chest, and back. bInstrumental ADL: preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. cSelf-care ADL: bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not being bedridden. CTCAE = Common Terminology Criteria for Adverse Events; AE = adverse event; BSA = body surface area; ADL = activities of daily living; IV = intravenous. National Cancer Institute (2017): Common terminology criteria for adverse events (CTCAE). Version 5.0. Available at: cancer.gov
  10. 10. 111NSCLC Reference Guide | Page 10 of 12 www.i3Health.com VII. MASCC RASH PREVENTION AND TREATMENT GUIDELINES Recommended Not Recommended Level of Evidence Recommendation Grades Comments Preventive Topical • Hydrocortisone 1% cream with moisturizer and sunscreen BID • Pimecrolimus 1% cream • Tazarotene 0.05% cream • Sunscreen as single agent IIa C Systemic • Minocycline 100 mg daily • Doxycycline 100 mg BID • Tetracycline 550 mg BID IIa A Doxycycline is preferred in patients with renal impairment. Minocycline is less photosensitizing aEGFRI study. MASCC = Multinational Association of Supportive Care in Cancer; BID = twice a day. Lacouture ME, Anadkat MJ, Bensadoun RJ, et al (2011). Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer, 19(8):1079-1095. DOI:10.1007/s00520-011-1197-6 Recommended Not Recommended Level of Evidence Recommendation Grades Comments Treatment Topical • Alclometasone 0.05% cream • Fluocinonide 0.05% cream BID • Clindamycin 1% Vitamin K1 cream IVa C Fluocinonide 0.05% cream BID should not be used on the face for more than 2 weeks at a time Systemic • Doxycycline 100 mg BID • Minocycline 100 mg daily • Isotretinoin at low doses (20-30 mg/day) Acitretin IVa C Isotretinoin is photosensitizing and can cause xerosis. Monitor lipids and liver enzymes with retinoids aEGFRI study. Lacouture ME, Anadkat MJ, Bensadoun RJ, et al (2011). Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer, 19(8):1079-1095. DOI:10.1007/s00520-011-1197-6
  11. 11. 111NSCLC Reference Guide | Page 11 of 12 www.i3Health.com VIII. EGFR TKI TOXICITY: DIARRHEA (CTCAE V5.0) Adverse Event Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Diarrhea Increase of <4 stools/day over baseline; mild increase in ostomy output compared with baseline Increase of 4- 6 stools/day over baseline; moderate increase in ostomy output compared with baseline Increase of ≥7 stools/day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared with baseline; limiting self-care activities of daily living Life-threatening consequence; urgent intervention indicated Death Lacouture ME, Anadkat MJ, Bensadoun RJ, et al (2011). Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer, 19(8):1079-1095. DOI:10.1007/s00520-011-1197-6 Grade Intervention 1: Mild • Stop laxatives. Drink 8-10 glasses of clear fluids daily. “BRAT” diet. Immediately start loperamide 4 mg (2 tablets) followed by 2 mg (1 tablet) after each loose stool (up to 16 mg daily) until bowel movements cease for 12 hours • Maintain dose level of EGFR TKI 2: Moderate • See grade 1 • Continue loperamide. Assess for dehydration and electrolyte imbalance. Consider intravenous fluids and electrolyte replacement 3: Severe • See grade 2 • Plus: Use stool cultures to rule out an infectious process. Apply aggressive intravenous fluid replacement for 24 hours or more. Use hospitalization to monitor the patient’s progress. Consider prophylactic antibiotics if the patient is also neutropenic • Temporarily discontinue EGFR TKI. Upon improvement to grade 1, restart EGFR TKI at a reduced dose (except gefitinib, which should be restarted at the original dose). Permanently discontinue EGFR TKI if diarrhea does not return to grade 1 within 14 days despite treatment discontinuation and best supportive care 4: Life-threatening • See grade 3 5: Death BRAT = bananas, rice, applesauce, toast. Hirsch V, Blais N, Burkes R, et al (2014). Management of diarrhea induced by epidermal growth factor receptor tyrosine kinase inhibitors. Curr Oncol, 21(6):329-336. DOI:10.3747/co.21.2241
  12. 12. 111NSCLC Reference Guide | Page 12 of 12 www.i3Health.com IX. NSCLC SURVIVORSHIP CARE NSCLC Long-Term Follow-up Care • Cancer surveillance • Immunizations o Annual influenza vaccination o Herpes zoster vaccine o Pneumococcal vaccination with revaccination as appropriate Counseling Regarding Health Promotion and Wellness • Maintain a healthy weight • Adopt a physically active lifestyle (Regular physical activity: 30 minutes of moderate-intensity physical activity on most days of the week) • Consume a healthy diet with emphasis on plant sources • Limit consumption of alcohol if one consumes alcoholic beverages Additional Health Monitoring • Routine blood pressure, cholesterol, and glucose monitoring • Bone health: Bone density testing as appropriate • Dental health: Routine dental examinations • Routine sun protection Cancer Screening Recommendations These recommendations are for average-risk individuals and high-risk patients should be individualized. • Colorectal cancer • Prostate cancer • Breast cancer National Comprehensive Cancer Network (2019). Clinical Practice Guidelines in Oncology: non-small cell lung cancer. Version 2.2020. Available at: http://www.nccn.org

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