Dr Peter Briggs Medical Oncologist. Lung Cancer & Mesothelioma: is it worth treating?

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1 Dr Peter Briggs Medical Oncologist Lung Cancer & Mesothelioma: is it worth treating?

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6 GOALS OF CANCER THERAPY CURE Good chance Medium chance Low chance PALLIATION Life prolonging Symptomatic improvement

7 CURATIVE THERAPY High likelihood of cure (>70%) Hodgkin s lymphoma High grade Non-Hodgkin s lymphoma Germ cell tumor Childhood ALL Most operable cancers (stage 1a NSCLC) You d be crazy not to All or nothing

8 CURATIVE THERAPY Medium likelihood of cure (30-70%) Osteosarcoma Stage 3 colorectal cancer Stage 2 Non-small cell lung cancer You d be crazy not to The chances are very good The glass is half full

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10 N0 N1

11 Stage 1 NSCLC Surgery if operable Radical radiotherapy if not Trial testing stereotactic radiation Palliative radiotherapy or wedge resection if unfit for lobectomy or radical radiotherapy

12 Stage 2 NSCLC Surgery Adjuvant chemotherapy Radical radiotherapy if not operable Combined with chemotherapy Palliative radiotherapy if not fit

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14 N2

15 N3

16 CURATIVE THERAPY Low likelihood of cure (<30%) Stage 3A Lung cancer Adult AML Solitary liver metastasis - CRC There s a lot at stake There re no guarantees Who s to say you can t be the 1 in 5 Outcome of Rx is uncertain, outcome of no Rx is certain All or nothing

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18 Age Potential toxicity Patient predeliction Family influences Physician bias Influencing Factors

19 NSCLC: Survival by stage

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22 M1a

23 M1b

24 Stage 3B & 4 NSCLC Incurable Accounts for 80% Median survival about 9 months Palliative goals are paramount Baseline prognostic variables predict survival Stage, weight loss, PS, gender

25 Palliative Treatment Prolongation of Life expectancy No prolongation of life Must involve a net improvement in QoL

26 Palliative Therapy Long term life prolongation SEVERAL YEARS Low grade Non-Hodgkin s lymphomas (life expectancy may be similar to an age-matched population) Well differentiated carcinoid tumors Myeloma Prostate cancer- hormone responsive Treatment toxicity justified!

27 Palliative treatment Medium term life prolongation Months 2 years Metastatic breast cancer Small cell lung cancer Subsets of NSCLC: EGFR, ALK, maintenance Metastatic colorectal cancer Metastatic bladder cancer Some treatment toxicity justified

28 Palliative Treatment Minimal prolongation of life Weeks Stage 4 Non-small cell lung cancer Prostate cancer hormone refractory Most second line treatments Maintenance of QoL has to be at least equally important Frequent checks during therapy Pull out promptly Minimal toxicity justified

29 Kaplan-Meier Estimates of Overall Survival (Panel A) and the Time to Progression of Disease (Panel B) in the Study Patients, According to the Assigned Treatment Schiller, J. et al. N Engl J Med 2002;346:92-98

30 Overall Survival of ALIMTA/cisplatin vs. GEMZAR/cisplatin Overall Population Median OS (95% CI) Adjusted HR (95% CI) ALIMTA + Cisplatin GEMZAR + Cisplatin (N=862) (N=863) 10.3 mos 10.3 mos (9.8, 11.2) (9.6, 10.9) 0.94 (0.84, 1.05) p<0.001* *Noninferiority p-value; Clinical Trials Registry available at (accessed April 27, 2008). Scagliotti GV et al: J Clin Oncol 2008; 26:

31 Survival Advantage for ALIMTA/cisplatin for Patients with Adenocarcinoma Median OS (95% CI) Adjusted HR (95% CI) ALIMTA + Cisplatin (N=436) GEMZAR + Cisplatin (N=411) 12.6 mos 10.9 mos 0.84 (0.71, 0.99) p=0.033* *Superiority p-value. ALIMTA approved product information, 8 th October 2008

32 Survival Advantage for ALIMTA/cisplatin for Patients with Large Cell Carcinoma Median OS (95% CI) HR (95% CI) ALIMTA + Cisplatin (N=76) GEMZAR + Cisplatin (N=77) 10.4 mos 6.7 mos 0.67 (0.48, 0.96) p=0.027* *Superiority p-value. ALIMTA approved product information, 8 th October 2008

33 Survival Advantage for GEMZAR/cisplatin in Patients with Squamous Cell Carcinoma Median OS (95% CI) HR (95% CI) ALIMTA + Cisplatin (N=244) GEMZAR + Cisplatin (N=229) 9.4 mos 10.8 mos 1.23 (1.00, 1.51) p=0.050* *Superiority p-value; ALIMTA [Summary of Product Characteristics]. Eli Lilly and Co; approved April 8, Scagliotti GV et al: J Clin Oncol 2008; 26:

34 Maintenance pemetrexed plus BSC versus placebo plus BSC for NSCLC: randomised, doubleblind phase3 study Ciuleanu et al Lancet Sept

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38 Palliative Treatment No prolongation of life expectancy Maintain Quality of Life Anaplastic thyroid cancer? 2 nd and subsequent line chemotherapy Chemotherapy for hope!!? Improper Case conferencing

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40 Quality of Life TREATMENT for QOL Good Palliative Care Useful chemotherapy Homeo pathy Ineffective chemo Treatment Burden Quackery

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42 Original Article Early Palliative Care for Patients with Metastatic Non Small-Cell Lung Cancer Jennifer S. Temel, M.D., Joseph A. Greer, Ph.D., Alona Muzikansky, M.A., Emily R. Gallagher, R.N., Sonal Admane, M.B., B.S., M.P.H., Vicki A. Jackson, M.D., M.P.H., Constance M. Dahlin, A.P.N., Craig D. Blinderman, M.D., Juliet Jacobsen, M.D., William F. Pirl, M.D., M.P.H., J. Andrew Billings, M.D., and Thomas J. Lynch, M.D. N Engl J Med Volume 363(8): August 19, 2010

43 Study Overview The authors randomly assigned patients with metastatic lung cancer to receive either standard oncologic care or early palliative care, focused on symptom control and psychosocial support for patients and families, together with standard oncologic care. Patients receiving early palliative care had lower rates of depression, a better quality of life, and better mood scores. They also received less aggressive care at the end of life, but surprisingly, had significantly longer survival than did patients receiving standard care alone.

44 Mean Change in Quality-of-Life Scores from Baseline to 12 Weeks in the Two Study Groups Temel JS et al. N Engl J Med 2010;363:

45 Twelve-Week Outcomes of Assessments of Mood Temel JS et al. N Engl J Med 2010;363:

46 Kaplan Meier Estimates of Survival According to Study Group Temel JS et al. N Engl J Med 2010;363:

47 Temel et al. NEJM Early palliative care led to significant improvements in both quality of life and mood. Patients receiving early palliative care had less aggressive care at the end of life but longer survival.? Extrapolation to Australian context

48 Patients' survival according to Charlson comorbidity index. Jacot W et al. Ann Oncol 2008;19: The Author Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please

49 Patients' survival according to simplified comorbidity score. Jacot W et al. Ann Oncol 2008;19: The Author Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please

50 Patients' survival according to patient Lung Cancer Symptoms Scale score. Jacot W et al. Ann Oncol 2008;19: The Author Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please

51 Trial Schema Eligibility (N = 451) Stage III/IV NSCLC Age years Performance status (PS) 0-2 Stratification Stage III versus Stage IV Age 80 versus >80 PS 0-1 versus 2 R Single-Agent Arm (n = 226) Vinorelbine 1 x 5 cycles erlotinib 2 or gemcitabine 1 x 5 cycles erlotinib 2 Doublet Arm (n = 225) Carboplatin + paclitaxel x 4 cycles erlotinib 2 1 Choice of vinorelbine or gemcitabine decided by center at the beginning of the study 2 Erlotinib given in cases of progressive disease or excessive toxicity Quoix EA et al. Proc ASCO 2010;Abstract 2.

52 Survival Data (ITT) Single agent (n = 226) Doublet (n = 225) p-value Progression-free survival (PFS) Median (95% CI) 1-year PFS rate (95% CI) 3.0 months ( ) 2.3% ( ) 6.1 months ( ) 15.4% ( ) <10-6 Overall survival (OS) Median (95% CI) 1-year OS rate (95% CI) 6.2 months ( ) 26.9% ( ) 10.3 months ( ) 45.1% ( ) Quoix EA et al. Proc ASCO 2010;Abstract 2.

53 Select Grade 3/4 Toxicities Gem (n = 149) Vin (n = 61) All single agent Doublet (n = 208) p-value Neutropenia 4.70% 37.70% 14.30% 54.30% <10-5 Febrile neutropenia 0% 9.84% 2.90% 9.60% Anemia 2.01% 9.84% 4.30% 7.70% 0.14 Thrombocytopenia 1.34% 0% 1.00% 6.30% Neuropathy 0% 0% 0% 2.90% Asthenia 6.04% 6.56% 6.20% 9.60% 0.19 Anorexia 1.34% 0% 1.00% 3.80% Reduced general condition 0.67% 3.28% 1.50% 1.40% 1.0 Quoix EA et al. Proc ASCO 2010;Abstract 2.

54 CONSORT diagram showing patient registration, treatment arm assignments, and exclusions. Mauro Zukin et al. JCO 2013;31: by American Society of Clinical Oncology

55 (A) Progression-free and (B) overall survival for patients randomly assigned to pemetrexed (P) or combination of carboplatin and pemetrexed (CP). Mauro Zukin et al. JCO 2013;31: by American Society of Clinical Oncology

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57 Chemo for PS 2 patients Needs confirmation in different settings May be due to variation in classification of ECOG PS 2 patients

58 Therapeutic Decision Making in Advanced NSCLC: A 2012 Perspective clinicaloptions.com/oncology

59 Clinical Trials Phase 1 Translate preclinical treatment discovery into clinical care Assess safety and toxicity Phase 2 Test efficacy in patients based on biomarkers or tumor type suggested in phase 1 Phase 3 Compare in RCT with standard therapy

60 MESOTHELIOMA

61 Mesothelioma 18 patients from GRICS in 2013/14 Relationship to asbestos exposure Medico-legal implications Phagocytosis of fibers, lymphatic transport to pleura/peritoneum Long latency median 30 years? Due to gradual acquisition of mutations leading to transformation Genetic predisposition to mineral fiber induced mesothelioma? Nature

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64 Histology JS are negative for Ber-EP4, p63 and TTF-1. sheets and clusters of tumour seen focally infiltrating into the fibrous stroma with focal infiltration into the adjacent skeletal muscle. Many of these cells show tubular papillary architecture associated with mild to moderate nuclear enlargement, atypical mitoses are present. A few of these have a central fibrovascular core. Immunostains performed show these cells are of mesothelial in origin and they are positive for CK5/6, calretinin and negative for CD15.

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71 Chemotherapy Chemo is the only therapy shown to improve survival Quality of life

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73 Second line therapy Retreatment may be effective especially for those who had PR or prolonged stable disease A long list of targeted therapies including antiangiogenic and vascular disrupting agents have not shown survival benefit Palliative benefit of radiotherapy for local symptoms

74 Role of surgery Diagnosis Controlling pleural effusion No current place for radical surgery outside a clinical trial

75 Table 1 Surgery in Mesothelioma Where Do We Go after MARS? Hiddinga, Birgitta I.; van Meerbeeck, Jan P. Journal of Thoracic Oncology. 8(5): , May doi: /JTO.0b013e d7 TABLE 1. Prospective Multicenter Phase 2 Studies of Radical Multimodality Treatment in Early-Stage Mesothelioma Copyright 2015 Journal of Thoracic Oncology. Published by Lippincott Williams & Wilkins. 75

76 Table 2 Surgery in Mesothelioma Where Do We Go after MARS? Hiddinga, Birgitta I.; van Meerbeeck, Jan P. Journal of Thoracic Oncology. 8(5): , May doi: /JTO.0b013e d7 TABLE 2. Extrapleural Pleuropneumonectomy and Pleurectomy/Decortication in Malignant Pleural Mesothelioma Copyright 2015 Journal of Thoracic Oncology. Published by Lippincott Williams & Wilkins. 76

77 Figure 1 Surgery in Mesothelioma Where Do We Go after MARS? Hiddinga, Birgitta I.; van Meerbeeck, Jan P. Journal of Thoracic Oncology. 8(5): , May doi: /JTO.0b013e d7 FIGURE 1. Design of European Organisation for Research and Treatment of Cancer 1205: a randomized noncomparative trial of P/D with (neo-)adjuvant chemotherapy. P/D, pleurectomy/decortication. Copyright 2015 Journal of Thoracic Oncology. Published by Lippincott Williams & Wilkins. 77

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