Il Paziente anziano con malattia oncologica avanzata: il tumore del polmone

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Joleen Francis
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1 Il Paziente anziano con malattia oncologica avanzata: il tumore del polmone Andrea Luciani MD, PhD U.O. Oncologia Medica Ospedale S. Paolo- Polo Universitario ASST Santi Paolo e Carlo Milan, Italy 1

2 Disclosure I declare no Conflicts of Interests.

3 Median age at death 72 Median age at diagnosis 70

5 Elderly Cancer Patients Enrolled on Clinical Trials Supporting FDA Approval Compared with SEER Cancer Incidence by Age Group

6 Elderly Patients with Lung Cancer Enrolled on FDA Registration Trials Compared with New Cases by Age Group

8 Walter et al JAMA

10 Under representation in trials Socioeconomic Cost of treatment Dependence on others Decrease in functional status BARRIERS TO TREATMENT Presence of co-morbid conditions Hesitation to treat and/or to treat aggressively Elderly have less aggressive cancers Elderly do not want aggressive therapy Elderly cannot tolerate aggressive therapy Elderly have different wishes with respect to prolongation of life Psycological ( treatment is worse than the disease )

75 yr old No major comorbidities Exercising

50-70% Life expectancy 10 years Dementia

11 75 yr old No major comorbidities Exercising No geriatric syndromes Toxicity risk < 50% Life expectancy > 15 years Compensated comorbidity Independent + falls Toxicity risk 50-70% Life expectancy 10 years Dementia Dependent + falls Toxicity risk 90% Life expectancy <10 years

Clinical Question 1 Should geriatric assessment (GA) be used in older adults with cancer to predict adverse outcomes from chemotherapy? Recommendation 1.

12 Clinical Question 1 Should geriatric assessment (GA) be used in older adults with cancer to predict adverse outcomes from chemotherapy? Recommendation 1. In patients age 65 and older receiving chemotherapy, geriatric assessment (GA) the evaluation of functional status, physical performance and falls, comorbid medical conditions, depression, social activity/support, nutritional status, and cognition should be used to identify vulnerabilities Evidence quality: high; Strength of recommendation: strong Clinical Question 2 For older patients who are considering undergoing chemotherapy, which GA tools should clinicians use to predict adverse outcomes (including chemotherapy toxicity and mortality)? Recommendation 2. The evidence supports, at a minimum, assessment of function, comorbidity, falls, depression, cognition, and nutrition. Evidence quality: high; Evidence quality: moderate to recommend specific tools. Strength of recommendations: moderate

13 Institutional database between January 1, 2002, and January 1, 2014 on 2237 eligible patients with NSCLC and tumor genotyping results 712 patients (32%) possessed a targetable genomic alteration (ie, EGFR kinase mutation, ALK or ROS1 rearrangement, ERBB2 kinase mutation, or BRAFV600E)

the upper quartiles 59% increased chance of detecting a

14 Those younger than 54 years (the 25th percentile) had a 46% higher frequency of targetable genotypes compared with those in the upper quartiles 59% increased chance of detecting a targetable alteration in a patient younger than 50 compared with an older patient

trade-off between efficacy, QoL and toxicity Adaptive

15 Trials based on composite end points will be declared successful if the new treatment is an adequate trade-off between efficacy, QoL and toxicity Adaptive (Bayesian) trial design is also a useful design in frail populations.

17 CHEMIOTERAPIA

20 Grade 3 4 neutropenia, febrile neutropenia,!! thrombopenia, anaemia and sensory neuropathy were significantly more frequent in the doublet arm! Qouix et al; Lancet Sep 17;378(9796):

21 Efficacy of the addition of cisplatin to single-agent first-line chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). A joint analysis of the multicentre, randomized phase 3 MILES-3 and MILES-4 studies<br />

22 Study design

23 Study flow

24 Overall survival (primary end-point)

25 NO Geriatric Assessment was considered in the protocol before patients allocations

29 IMMUNOTERAPIA

30 Keynote 24 Checkmate 17 OAK Checkmate 57

31 KEYNOTE-024: Pembrolizumab vs chemotherapy as First-line Therapy for Advanced NSCLC

32 KEYNOTE-024: Pembrolizumab vs chemotherapy as First-line Therapy for Advanced NSCLC (50% TPS)

33 Nivolumab (BMS ) Expanded Access Named Patient Program (NPP) in Non-Squamous NSCLC Clinical Activity

EAP - Elderly patients ( 70 yrs) Best overall response Overall survival General Population (n = 1585) Elderly Pts (n=520) BORR, n (%) 284 (18) 102 (20) Best overall response, n (%) Complete response

34 EAP - Elderly patients ( 70 yrs) Best overall response Overall survival General Population (n = 1585) Elderly Pts (n=520) BORR, n (%) 284 (18) 102 (20) Best overall response, n (%) Complete response Partial response Stable disease Mixed response a Progressive disease Unable to determine b 10 (<1) 274 (17) 398 (25) 18 (1) 664 (42) 221 (14) 2 (<1) 100 (19) 136 (26) 6 (1) 199 (38) 77 (15) Median OS: 12.5 months ( ) Median follow-up of 6,2 months (1-18,8). a. Includes pts with different responses (diameter not available) in different metastatic sites. b. Includes patients without even a tumor assessment, based on length of treatment.

35 EAP - Elderly patients ( 75 yrs) Best overall response Overall survival General Population (n = 1585) Elderly Pts (n=230) BORR, n (%) 284 (18) 56 (24) Best overall response, n (%) Complete response Partial response Stable disease Mixed response a Progressive disease Unable to determine b 10 (<1) 274 (17) 398 (25) 18 (1) 664 (42) 221 (14) 0 56 (24) 60 (26) 3 (1) 87 (38) 24 (11) Median OS: 12.3 months ( ) Median follow-up of 6,2 months (1-18,8). a. Includes pts with different responses (diameter not available) in different metastatic sites. b. Includes patients without at least one tumor assessment, based on length of treatment.

38 ONCOGENE ADDICTED NSCLC

41 ARCHER 1050: Study Design Tony Mok at 2017 ASCO Annual

42 Adverse Events from Any Cause Tony Mok at 2017 ASCO Annual

43 Dose Modification Tony Mok at 2017 ASCO Annual Meeting

44 Patient-Reported Outcomes <br />EORTC-QLQ-C30 and LC13 Wo et al Lancet Oncol 20

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.

49 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. 151 pts patients: newly diagnosed NSCLC early palliative care integrated with standard oncologic Care Vs standard oncologic care alone Quality of life and mood were assessed at baseline and at 12 weeks with the use of the Functional Assessment of Cancer Therapy Lung (FACT-L)

50 KEY POINTS IN ADVANCED DISEASE A better prediction of noncancer-related mortality and a better prediction of treatment-related toxicity would greatly facilitate therapeutic selection for elderly patients (es CRASH, CARG). Define the role of immunotherapy in very old patients (immunosenescence?) Definitive validation/exclusion of combination chemotherapy, eventually tailored to different risk categories Evidence-based data for tailored strategies for patients aged more than 80 years Modified from Gridelli et al Clinical Lung Cancer, Vol 16,No. 5,

51 NEMO EST TAM SENEX QUI SE ANNUM NON PUTET POSSE VIVERE GRAZIE PER L ATTENZIONE (Cicero, De Senectute, VII, 24)

Transitioning to palliative care: How early is early palliative care?

Transitioning to palliative care: How early is early palliative care? Cancer: a growing problem Cancer is an increasing health care problem It is estimated that by 2020, there will be 20 million new cases