Clinical Decision Making: How and when. Jan B. Vermorken, MD, PhD Department of Medical Oncology Antwerp University Hospital Edegem, Belgium

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1 Clinical Decision Making: How and when Jan B. Vermorken, MD, PhD Department of Medical Oncology Antwerp University Hospital Edegem, Belgium Preceptorship Course in Head and Neck Cancer Management, Kashiwa, Japan, July 11, 2016

2 Conflict of Interest Disclosure Consultancy or advisory role: Amgen, AstraZeneca, Boehringer-Ingelheim, Debiopharma, F-Star Biotechnology Ltd, Merck-Serono, Innate Pharma, Merck Sharp & Dome Corp, PCI Biotech, Pierre Fabre, Synthon Biopharmaceuticals, SMS-Oncology, Vaccinogen Lecturer fee from: Merck-Serono, Vaccinogen

3 Head and Neck Cancer (HNC) A changing population Worldwide HNC is still increasing ( in 2012) Majority still tobacco and alcohol related Increase of viral-associated OPC, less so in elderly 1 SEER data: 47% of SCCHN patients >65 years of age The incidence of HNC among older patients is expected to increase 34% over the next 10 years, and 64% over the next 20 years 2. Most studies use the age of 70 (or even 75) as a cut-off for being old 1 Gugic and Strojan. Rep Pract Oncol Radiother 2013; 18: 16-25; 2 SEER Stat Database, Nov 2011

4 Head and Neck Cancer (HNC) A changing disease HPV-pos HPV-neg Anatomical Tonsil, base of tongue All sites Histology Non-keratinized Keratinized Age Younger cohorts Olders cohorts Sex ratio 3:1 men 3:1 men Stage Tx, T1-2 Variable Risk factors Sexual behaviour Alcohol, tobacco Incidence Increasing Decreasing Survival Improved Unchanging Marur et al, 2010

5 Changing Treatments: Innovations Head and neck cancer Surgery - reconstructive surgery - organ sparing techniques - TORS Radiotherapy - altered fractionation schedules - Better targeting (CT-MRI, PET, IGRT) - New RT techniques (IMRT, STRT, PT) - Combined approached: CT, TT, hypoxic cell modifiers Systemic therapy - New cytotoxic agents - Molecular targeted therapies - Immunotherapy

6 Standard Treatment Options in SCCHN 2016 Early-stage SCCHN (stage I-II) - ERT vs BT vs S (depending on patient/disease factors) 1 Locoregionally advanced SCCHN (stages III-IV) - Surgery followed by RT or CCRT has level IA evidence 2 - Concurrent CRT (CCRT) has level IA evidence 2 - CCRT and ICT (C)RT options for organ preservation 2 - RT + cetuximab an alternative for CCRT 2 Recurrent/metastatic SCCHN - Surgery if possible: postop RT or CCRT (if not complete) 3 - Nonresectable: RT or CCRT (if no organ dysfunction/morbidiy) 3 - R/M-SCCHN: PF+cetuximab (fit pts); single drug (PS2), BSC 2 1 Corvo R. Radiother Oncol 2007 Oct;85(1):156-70; 2 Gregoire V et al, Ann Oncol 2010: 21 (suppl 5): VI84-VI86; 3 Strojan et al. Head & Neck- DOI /hed.23542

7 Results of Present Therapies 2016 Early stages (I and II) single modality TRT 5-yr S: 60-90% Advanced stages (III and IV) combined modality 5-yr S: 20-80% HPV(-) cases: Resectable: > 60% LRR, 20% DM, 10-40% SPT Unresectable: 5-yr S 20%, majority < 18 months Recurrent/metastatic disease systemic therapy Median survival 6-12 months, 1-year survival 20-40%

8 Multidisciplinary Team (MDT) Meetings Medical oncologist Head and neck surgeon Speech therapist Guidelines Radiologist Biologist, pathologist Patient Radiation oncologist Anesthesiologist, internist, general practitioner Oncologic dentist Physical therapist, dietitian, social worker, psychologist a/o psychiatrist Clinical trials

9 Decision Making during MDT Meetings SCCHN patients Disease factors (e.g. site, stage, biology [HPV, EGFR], specific risk factors for locoregional or distant relapse) Patient factors (e.g. age, sex, performance status, nutritional status, comorbid chronic disease, oral health, lifestyle habits, socio-economic status) Treatment factors (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy) Communication / information / support / taking into account the wish of the patient

10 What do Patients Look For? Prioritizing Treatment Outcomes Survival seems to be of paramount importance to both patient and non patient groups, overshadowing associated toxicities and potential dysfunction List MA er al. Head Neck 2004;26:

11 Multidisciplinary Cancer Care Cancer care is undergoing an important paradigm shift Disease focused patient-centered approach - psychological aspects - quality of life - patients rights and empowerment - survivorship MDTs emerge as a practical necessity for optimal coordination among health professionals and clear communication with patients Borras JM et al, EJC 2014; 50:

12 Multidisciplinary Teams (MDTs) New definition (EPAAC) Multidisciplinary teams (MDTs) are an alliance of all medical and health care professionals related to a specific tumour disease whose approach to cancer care is guided by their willingness to agree on evidence-based clinical decisions and to co-ordinate the delivery of care at all stages of the process, encouraging patients in turn to take an active role in their care EPAAC = European Partnership for Action Against Cancer

13 International Trend towards Mandatory Guidelines/ Legislation to ensure Multidisciplinary Cancer Care Country 1 Legally mandatory Recommended in guidelines Australia Belgium Canada France Netherlands UK In Italy and Germany, it is mandatory for cancer patients to be treated in expert centers, with Germany requiring certification The importance of MDTs in cancer care is becoming widely recognized, as shown by international adoption of mandatory guidelines/legislation 1. State Government Victoria DoH. Multidisciplinary cancer care Available at: Presented by L.Licitra, St.Petersburg 2015; MDT, Multidisciplinary Team Last accessed January 2015

14 Expert Consensus on Multidisciplinary Care Care objectives* Cancer diagnosis initiate MDT monitoring Patients early access to MDT ensure appropriate treatment selection based on preoperative assessment of imaging and pathology results After staging, MDT consensus and patient consent on an evidence-based treatment plan is required Patient should have ready access to counseling for psychosocial support (screening for distress, supportive needs) After active treatment follow-up should begin with a joint survivorship care plan together with the patient (routine surveillance; post-treatment needs) *Policy statement on mutidisciplinary cancer care (European Partnership for Action against Cancer (EPAAC), Borras JM et al. EJC 2014; 50:

15 Expected emotions and reactions from the patient Reich M et al. Ann Oncol 2014; 25:

16 Recommended actions from the health care professional to provide patient emotional support Reich M et al. Ann Oncol 2014; 25:

17 Multidisciplinary Teams (MDT) Is there evidence of benefit? Data supporting the utility of MDT meetings (MDM) in the management of head and neck cancer is scarce

18 Systematic Review: MDTs and Their Impact on Patient Outcome 51 studies, peer-reviewed ( ) MDTs resulted in better clinical and process outcomes for cancer patients, with evidence of improved survival among colorectal, head and neck, breast, esophageal and lung cancer patients in the study period Also, it was observed that MDTs have been associated with changes in clinical diagnostic and treatment decision-making with respect to urological, pancreatic, gastro-esophageal, breast, melanoma, bladder, colorectal, prostate, head and neck and gynecological cancer Prades et al, Health Policy 2015; 119:

19 MDTs and their Impact on Patient Outcome in Head and Neck Cancer Friedland et al. Brit J Cancer 2011; 104: retrospective review of hospital registry database ( ) - Higher survival for MDT patients compared to individually managed patients (HR=0.69; 95%CI= at 5 years for stage IV patients), and there were more pts that received CCRT in MDT group (P=0.004) Wang et al. Oral Oncol 2012; 48: retrospective study - national health database ( ; 19,513 oral cavity cancer cases) - Higher survival among MDT-participants vs non-mdt participants patients (HR=0.84; 95%CI= at 5 years survival) cases of primary HNC patients; 2 In total, 9297 patients were observed until 2008; 3099 MDT, 6198 non-mdt participants

20 Friedland et al. Brit J Cancer 2011; 104:

21 Prospective Study of Clinical Impact of MDTs in 120 H&N Tumor Patients Prospective study (Wheless et al) Type of change resulting from MDT meeting No change in either diagnosis or treatment 79/120 (66%) Change in either diagnosis or treatment 32/120 (27%) - Change in TRT plan with change in DX 19/120 (16%) - Change in DX without change in TRT plan 10/120 (8%) - Change in both DX and TRT 3/120 (3%) Other* 9/120 (7%) Wheless et al. Otolaryngol Head Neck Surg 2010; 143: (*if they required further DX work-up) Change in treatment significantly more common in the 84 malignant cases vs the 36 benign tumors (24% vs 6%)

22 MDTMs for the Management of HNC Patients Prospective study (Brunner et al) 120 patients (70%) Plan unchanged 172 HNC Patients 52 patients (30%) Plan changed 35 (67%) Major 12 (33%) Minor Brunner et al, Head Neck 2015; 37:

23 MDTMs for the Management of HNC Patients Details on changes (Brunner et al) Changes by initial plan* (C) RT alone 71% NC 4% Minor 25% Major Surgery ± (C) RT 80% NC 10% Minor 10% Major Changes by physician type** Surgeon 72% NC 10% Minor 18% Major Med Onc /Rad Onc 58% NC 8% Minor 34% Major Brunner et al. Head Neck 2015; 37: (*p=0.001[any change]; **p=0.05 [major change])

24 Reduction in Waiting Time for Diagnosis and Treatment: A fast Track Study Measurements taken to reduce time intervals: Establishing a case manager function (patient coordinator) Changing the referral procedures from paper to oral, by enabling direct call to case manager (a hotline) Introducing pre-booked slots in the outpatient clinic on the ENT department Faster pathology reports and imaging procedures Establishing a mutidisciplinary tumor board Toustrup et al. Acta Oncol 2011; 50:

25 Reduction in Waiting Time for Diagnosis and Treatment: A fast Track Study Toustrup et al. Acta Oncol 2011; 50: ,

26 Reduction in Waiting Time for Diagnosis and Treatment: A fast Track Study Toustrup et al. Acta Oncol 2011; 50:

27 Treatment Delay and Local Control in Oropharynx Cancer Waaijer et al. Radiother Oncol 2003; 66:

28 Treatment Delay and Survival on HNC Systematic review and meta-analysis Seoane et al. Clin Otolaryngol 2012

29 Head and Neck Cancer Care Organization in the Netherlands Courtesy of Langendijk and Leemans (NWHHT)

30 Head & Neck Cancer Care: the Netherlands Criteria for treatment of patients Each HNC patient should be referred to a HNOC (Head & Neck Oncology Center) Each patient should be discussed in a multidisciplinary HNC board of a HNOC - Approved treatment plan, including: Summary of diagnostic procedures and conclusion Which treatment protocol / guideline Which center / coordinating physician (s) Case manager (direct contact person for patient) - Patient file should be accessable NWHHT

31 Head & Neck Cancer Care: the Netherlands Criteria for centers Patient volume - HNOC at least 200 HNC patients / year Specified ICD-codes Minimal team requirements (1) - At least 3 head and neck cancer surgeons (certified) - At least 1 plastic surgeon / specialist in reconstructive head and neck surgery - At least 2 specialized radiation oncologists (at least 100 patients per year) - At least 1 specialized medical oncologist with back up NWHHT

32 Head & Neck Cancer Care: the Netherlands Criteria for centers Minimal team requirements (2): - Radiologist - Nuclear physician - Pathologist - Dietician - Physiotherapist - Speech specialist - Oral care specialist - Special dentistry / maxillofacial prosthetist - Psychosocial care specialist - Case manager NWHHT

33 Head & Neck Cancer Care: the Netherlands Criteria for centers Weekly multidisciplinary board meetings Strong preference for multidiciplinary outpatient department clinic Work in progress (HNC Audit) - Prospective data registration - Outcome data: Treatment efficacy Complications Patient-rated outcome measures NWHHT

34 Multidisciplinary Cancer Care Conclusions Head and neck cancer management is a typical example of complex treatment involving multiple disciplines Multidisciplinary cancer care (MCC) is needed for adequate coordination of the multidisciplinary care pathway with respect to: logistics; reduction of treatment delays and communication with patients MCC improves patient management (decision making) Improves outcome: tumor control, survival,qol, satisfaction

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