Integrated Oncology and Palliative Care – Part 1 PD Florian Strasser, MD ABHPM Oncological Palliative Medicine Oncology Dept. Internal Medicine & Palliative Center, Cantonal Hospital St.Gallen, Switzerland
Overview Contents and timeframe of Palliative Care Disease-specific treatments in palliative intention Service models: early integration until death ESMO Designated Center Program on Integration of Oncology & Palliative Care Start & develop “my” own service: key hurdles and catalysers
Content and timeframe of Palliative Care
The “official” Definition from WHO
“Palliative care is an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.” 2002 http://www.who.int/cancer/palliative/definition/en/
Content and timeframe of Palliative Care Palliative Care • • • • • • • • •
provides relief from pain and other distressing symptoms; affirms life and regards dying as a normal process; intends neither to hasten or postpone death; integrates the psychological & spiritual aspects of patient care; offers a support system to help patients live as actively as possible until death; offers a support system to help the family cope during the patients illness and in their own bereavement; uses a team approach to address the needs of patients and their families, including bereavement counseling, if indicated; will enhance quality of life, and may also positively influence the course of illness; is applicable early in the course of illness, in conjunction with other therapies that are intended to prolong life, such as chemotherapy or radiation therapy, and includes those investigations needed to better understand and manage distressing clinical complications. http://www.who.int/cancer/palliative/definition/en/
Content and timeframe of Palliative Care ESMO Policy on Supportive and Palliative Care – Definitions
Supportive care:
Care that aims to optimize the comfort, function and social support of the patient and their family at all stages of the illness.
Palliative care:
Care that aims to optimize the comfort, function and social support of the patient and their family when cure is not possible.
End of life care:
Palliative care when death is imminent.
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5 Cherny NI et al., Ann Oncol 2003;14(9):1335-1337
Timeframe of Palliative Care EAPC White Paper on standards and norms for hospice and Palliative Care in Europe
European Association of Palliative Care: year(s) before death
With permission from European Association for Palliative Care via CCC, Radbruch L, et al. European Journal of Palliative Care, 2009; 16(6): 278-289
Timeframe of Palliative Care American Society of Clinical Oncology 2009 Palliative Cancer Care
With permission from American Society of Clinical Oncology, Ferris FD, et al., J Clin Oncol 2009, 27(18):3052-3058
Content of Palliative Care
Key Palliative Care values & principles 1/2 Dignity, autonomy, effective communication processes (including trustworthy disclosure and active integration of existential themes) Quality-of-life & priorities directed problem-based decision-seeking, advanced directive process, preparing transitions
1Lorenz
KA et al, Ann Int Med 2008;148-147; 2Tieman J et al. J Clin Oncol 2008;26:5679
Content of Palliative Care
Key Palliative Care values & principles 1/2 Multidimensional assessment and management (physical, psychological, social, and spiritual issues & symptoms and acknowledgment of their interactions) of patient & family Relief of suffering across the trajectory of disease, continuous coordination of services including end-of-life & bereavement care Multi-professional approaches
1Lorenz
KA et al, Ann Int Med 2008;148-147; 2Tieman J et al. J Clin Oncol 2008;26:5679
Content of Palliative Care Cancer-“specific” Palliative Care issues Cancer-specific symptoms & complications Anticancer interventions to improve symptom control in the context of state-of-the-art symptom control, patient-reported outcomes, true clinical benefit Supportive Care: side-effect alleviation or prevention Cancer-specific communication processes, prognosis, false and essential hope …
Content of Palliative Care
Integrated Oncology and Palliative Care: developing subspecialty of both palliative care and oncology
Key Palliative Care values & principles
Cancer-“specific” Palliative Care issues
It matters for patients, families, and institutions THAT palliative cancer care IS available and provided on an international best practice standard, it may be less important WHICH formal discipline is assigned.
Overview Contents and timeframe of Palliative Care Disease-specific treatments in palliative intention Service models: early integration until death ESMO Designated Center Program on Integration of Oncology & Palliative Care Start & develop “my” own service: key hurdles and catalysers
Anticancer treatment to alleviate or prevent cancer-related suffering Decisional processes about anticancer treatment Information from high-quality clinical trials and guidelines on: Tumor control Toxicity
disease-free survival, response rates, progression-free survival, et al. hematological, non-hematological
Gives essential guidance for oncologists and patients to discuss individually * trade-offs of - life prolongation and - side-effects of chemotherapy * Transfer of information from a clinical trial situation (selected patient population, variable results according to specific patient characteristics) to the actual patient situation. 13
O’Brien MA, et al. J Clin Oncol 2009; 27(6):974-985
Anticancer treatment to alleviate or prevent cancer-related suffering Toxicity criteria are not identical to patient-reported symptoms: side-effects of anticancer treatment may get underestimated.1
Patients should be given the opportunity to judge and quantify themselves the sideeffects (and burden) of anticancer treatment.
2
1Savage C,
et al. ASCO 2003 Abstr. 1540; Basch EM, et al. JCO 2006 ASCO Abstr. 8515; Basch A et al. Lancet Oncol 2006;11:903-911. With permission from American Society of Clinical Oncology, 2Trotti A et al. J Clin Oncol 2007;25:5121-5127
Anticancer treatment to alleviate or prevent cancer-related suffering Toxicity criteria: new developments to enhance patients’ voice New subjective assessments: sensorial neuropathy 1 Translation of CTC Gradings into “patient-language”2
1Kuroi
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C et al., Supp Care Cancer 2008. With permission from American Society of Clinical Oncology, 2Trotti A et al. J Clin Oncol 2007; 25:5121-5127 15
Anticancer treatment to alleviate or prevent cancer-related suffering Decisional processes about anticancer treatment In patients with advanced, incurable, and symptomatic cancer disease, the criteria tumor control and toxicity
.
are essential but not sufficient to guide decision processes. Additional criteria gain importance:1 Cancer-related symptoms (improvement, stabilization) Function (physical, social, emotional role)
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1Matsuyama
R, et al. J Clin Oncol 2006;24(21):3490-3496
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Anticancer treatment to alleviate or prevent cancer-related suffering Patient-derived “Clinical Benefit”: prospective monitoring of cancer-related symptoms and syndromes, staged & treated with “evidenced-based supportive and palliative cancer care”
With permission from American Society of Clinical Oncology, Koeberle D, et al;. Patient-reported outcomes of patients with advanced biliary tract cancers receiving gemcitabine plus capecitabine: a multicenter, phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol 2008;26(22):3702-3708
Anticancer treatment to alleviate or prevent cancer-related suffering Decisional processes about anticancer treatment For some tumors these criteria, cancer-related symptoms and function were conceptualized as: Patient-derived clinical benefit criteria1 The term “Clinical Benefit” is also used based only on tumor-size response criteria: stable disease, partial and complete response. However, this tumor-derived “extrapolated” clinical benefit is NOT equal to a “true” patient derived clinical benefit.
1Ohorodnyk
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P, et al., Eur J Cancer 2009;45(13):2249-2252
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Palliative Care to alleviate or prevent cancer-related suffering Consider Effectiveness of Palliative Care1 How was the quality of symptom control before chemotherapy decisions? Systematic Literature Review2 24423 titles, 6381 abstracts, 1274 articles, 33 high-quality systematic reviews & 89 intervention trials
INTERVENTIONS Pain Shortness of breath Depression Advanced Directives Continuity Family distress care
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EVIDENCE (+++: high, +: low) +++ Medications, + Teams + Opioids, Oxygen +++ Medications ++ Multiple Interventions ++ Multidisciplinary Teams ++ Comprehensive care
1Tieman 2Lorenz
J, et al. J Clin Oncol. 2008;26:5679-83 KA et al. Ann Intern Med. 2008;148:147-159
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Criticism of “Best” Supportive Care
“Best Supportive Care” in Medical Oncology The concept of “Best Supportive Care” as control arm for medical oncology RCT has been challenged Insufficient definition of practices applied to achieve supportive care The term “best” suggests a quality label, but it just signifies the local, institutional current practice The effectiveness of modern palliative care interventions raises concerns about variability in control arms The lack of placebo controls augments the risk of bias
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Criticism of “Best” Supportive Care There is substantial evidence* to indicate that “routine supportive care” often features: Inability to appreciate the presence and/or severity of symptoms; inadequate evaluation of pain Substandard pain treatment, poor symptom control Lack of attention to psychological or existential distress, or to family support Oncologists frequently feel inadequately prepared for this aspect of their work; but also lack of consultation with experts in pain or palliative care
*
MacDonald N CMAJ.1998 158(13):1709–16; Cullen M Lancet Oncol. 2001 2(3):173–5; Ahmed N et al. Cochrane Database Syst Rev. 2004(3):CD003445;
Zafar SY et al. JCO 2008 26 No 31:5139-40; Sapir R et al. JPSM 1999 7:233-43; Von Roenn JH et al. Ann Intern Med.1993 July 119(2):121-26; Grossman SA et al. J Pain Symptom Manage 1991 6(2):53-57; Yennurajalingam S et al. SCC 2007 109:2229-38; Dhillon N et al. J Pall Med 2008 14:491-500; Feyer P et al. Support Care Cancer 2008 16:567-75; Homsi J et al. Support Care Cancer 2006 14:444-53; Osta BE J Pall Med 2008 11(5):707-16; Fadul N et al. J Pall Med 2007 21:559-65; Kochhar R et al. Supportive Oncology 2003 5(2):1-14; Cherny NI et al. Proc ASCO 1994 13:434-38; Lagman R et al. Eur J Palliat Care 2007 14:17-20; Pigott C et al. Supportive Care in Cancer 17 N1:33-45; Li J et al. Psychooncol 2006 66: A239-A239; Cherny NI et al. Cancer 2003 25(2):150–68; Emanuel EJ et al. AIM 2000 283(20):2701-11; Hilden JM et al. JCO 2001 24 No 7:1099-1104; Buss MK JCO 2005 23 No 30:7411-16
Scientific Evaluation of “Best” Supportive Care “Best” Supportive Care in Randomized Controlled Trials in Medical Oncology Systematic literature review Medline & Cancerlit 1966–2008, Supp/Pall, Cancer, RCT New systemic anticancer treatment, no standard 20 RCT’s treatment +SC vs. SC, 12 RCT’s treat. vs. SC (16 NSCLC; 5 colorectal; 3 gastric; 2 pancreatic; 6 other) Analysis: Quality criteria “Supp Care” Helsinki CONSORT Ethical Research
Cherny N et al. J Clin Oncol 2009;27:5476-5486
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Scientific Evaluation of “Best” Supportive Care Analysis of 10 quality criteria Studies that tested Treatment plus SC n=20
Studies that tested SC alone
Literature Review Includes Review of SC Standards for Disease
0 (1)
0
BSC Described (full, partial, minimal)
1,3,15
0,0,9
Reference Standard for SC (limited!)
0 (9)
0 (1)
Structured Symptom Reporting
3
2
Credentialing SC Capacity
1
0
Standardization of BSC
0
0
Documented Actual SC Delivery
0 (4)
0 (4)
SC (bias...) addressed in Discussion
2
0
QOL Assessment
16
2 (5)
Country: Poor opioid availability 20.3.12
3
1
n=12
23
Adapted from: Cherny N et al. J Clin Oncol 2009; 27:5476-5486
Scientific Evaluation of “Best” Supportive Care
Consort standards for “SC”: they would be available Consolidated Standards of Reporting Trials 22 Points CONSORT Checklist (2001) for RCT1
1Altman DG
et al. Ann Intern Med 2001;134:663-694
Standards of Randomized Controlled Trials: CONSORT
#4 Interventions Precise details of the interventions intended for each group and how and when they were actually administered
#6 Outcomes Cleary defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).
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25 Altman DG, et al. CONSORT 2001 Statement, Ann Intern Med 2001; 134:663-694
Scientific evaluation of “Best” Supportive Care
Consolidated Standards of Reporting Trials Amendment (2008) for Studies that involve complex, nonpharmacologic interventions: SC (1) Careful description of the care providers and the centers (professional qualifications, expertise, …) (2) Detail: treatment components that may influence the (individual) outcome effect (3) Detail: how interventions were standardized across centers
Boutron I et al. Ann Intern Med 2008; 148:295-309
Scientific evaluation of “Best” Supportive Care Ethical value of “SC”
1
Social value Social value Scientific validity Scientific validity Fair participant selection Fair participant selection Balancing risks/benefits Balancing Independentrisks/benefits review Informed consent Independent review Respect forconsent participants Informed
The ethical value of current “BSC”-trials2 is challengeable
1Emanuel
EJ, et al. JAMA 2000; 283:2701- 2711 With permission from American Society of Clinical Oncology, 2Cherny N et al. J Clin Oncol 2009;27(32):5476-5486
Scientific Evaluation of “Best” Supportive Care
From “Best Supportive Care” in Medical Oncology to “Evidenced-Based” Supportive Care
Follow-up paper (Delphi) among trialists & experts Agreement on key contents for evidence-based SC
Zafar Y et al., Lancet Oncology 2011, in press
Anticancer treatment to alleviate or prevent cancer-related suffering Is chemotherapy in the last weeks of life always “aggressive management”?
Chemotherapy before death: New regimen 30 days, or last dose
