This document provides guidance for physicians and patient organizations on information and support for patients receiving treatment with multi-kinase inhibitors (MKIs). It recommends that physicians clearly explain the expected clinical course, treatment options including active surveillance, and implications of radioiodine resistance in differentiated thyroid cancer. Information should be provided over several consultations and emphasize shared decision making. It also recommends that patient organizations support patients by providing educational materials and connecting patients to additional support resources.

1. Information and support for patients on
MKI treatment - guidance for physicians
and patient organizations
Fabián Pitoia, MD
Hospital de Clínicas
University of Buenos Aires
Argentina

2. Conflicts of interest
Consultancy & Speaker Bureau Genzyme/Sanofi
Consultancy / Ad Board / Speaker Bureau/ Steering
Comittee Bayer
2

3. 33
International patient-led workshop on “TKIs and what it
means for patients” organized by the Thyroid Cancer
Alliance (TCA), Paris, October 2014
Perea, Soledad R. Thyroid Cancer Alliance, Diss, Norfolk, United Kingdom and ACTIRA, Buenos Aires,
Argentina;
Armstrong, Nicola, Freeman Hospital, Newcastle Upon Tyne, United Kingdom;
Bartès, Beate, Vivre sans Thyroide , Paris, France;
Brose, Marcia S., University of Pennsylvania, Philadelphia, PA, United States;
Elisai, Rossella, University of Pisa, Pisa, Italy ;
Farnell, Kate, Butterfly Thyroid Cancer Trust, Newcastle, United Kingdom;
Grey, Joanna, Association for Multiple Endocrine Neoplasm Disorders, Tunbridge Wells, United Kingdom ;
Harmer, Clive, Clinical Oncologist, London, United Kingdom ;
Hobrough, Helen, Thyroid Cancer Support Group Wales, Cardiff, United Kingdom;
Luster, Markus, University of Marburg, Marburg, Germany ;
Mallick, Ujjal, Freeman Hospital, Newcastle Upon Tyne, United Kingdom ;
McGarry, Mary, Thyroid Cancer Support Group Ireland, Dublin, Ireland;
Moss, Laura, Velindre Cancer Centre, Cardiff, United Kingdom ;
Palazzo, Fausto, Hammersmith Hospital & Imperial College, London, United Kingdom ;
Porrey, Marika, Schildklier Organisaties Nederland (SON), Amersfoort, Netherlands;
Pitoia, Fabian A., Hospital de Clínicas – University of Buenos Aires, Buenos Aires, Argentina ;
Schlumberger, Martin, Centre de Lutte Contre le Cancer (CLCC) de Villejuif , Institut Gustave Roussy ,
Villejuif, France ;
Taylor, Judith, Thyroid Cancer Alliance, Diss, Norfolk, United Kingdom;
Villar, Carmen, AECAT, Madrid, Spain and Thyroid Cancer Alliance, Diss, Norfolk., United Kingdom

4. Parafollicular cells
Thyroid Cancer: Clinical Pathology
Follicular cells
Differentiated
Anaplastic
Medullary
Papillary
Follicular
Hürthle cell
Sporadic
Familial
4
1. American Cancer Society. What is thyroid cancer?
http://www.cancer.org/cancer/thyroidcancer/detailedguide/thyroid-cancer-what-is-thyroid-cancer. Accessed April 24, 2014.
2. Carling T, Udelsman R. Thyroid tumors. In: DeVita VT Jr, et al, eds. Cancer: Principles & Practice of Oncology. 9th ed. Philadelphia,
PA: Lippincott Williams & Wilkins; 2011:1457-1472.
DTC: Surgery (TT +/- LND; HT; +/- Remnant Ablation)
MTC: Surgery (TT + generally LND)

5. Differentiated Thyroid Cancer
Patients With Locally Recurrent or Metastatic
Disease May Become RAI-Refractory
• It was estimated1 that worldwide there will be
– Approximately 300,000 new cases of thyroid cancer
– Approximately 40,000 deaths due to thyroid cancer
• Approximately 7% to 23% of patients with thyroid cancer
develop distant metastases2,3
– Two-thirds of these patients become RAI-refractory2
– The most common sites of distant metastases are4
• Lung
• Bone
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RAI, radioactive iodine.
1. GLOBOCAN 2012: Estimated cancer incidence, mortality and incidence worldwide in 2012. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
Accessed March 12, 2014. 2. Brose MS, et al. Lancet. 2014;384(9940):319-328. 3. Anderson RT, et al. Thyroid. 2013;23(4):392-407. 4. Durante C, et al. J Clin
Endocrinol Metab. 2006;91(8):2892-2899.

6. • WHEN should information be provided?
– Clear and understandable explanation of the
• expected clinical course of their thyroid cancer,
• available treatment options,
- Active surveillance might also be a valid option
Considerations when a MKI is prescribed
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7. • WHAT information should be provided when a DTC
become RAI-refractory or a MTC becomes metastatic and
proggresses?
– What does radioiodine resistance in DTC mean?
– What treatments, including targeted therapies, may be
available and appropriate
– Is the treatment curative?
– If palliative: benefits (PFS, QOL, etc)
Considerations when a MKI is prescribed
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8. • WHAT information should be provided when a DTC become
RAI-refractory or a MTC becomes metastatic and
proggresses?
Intended duration of treatment
– How the patient will be monitored, how often, and what
tests will be done?
– Availability of clinical trials
– How to access supportive care (patient organizations,
community support)
– What costs are involved (co-funding in some countries)
Considerations when a MKI is prescribed
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9. • WHAT information should be provided when a DTC
become RAI-refractory or a MTC becomes metastatic and
proggresses?
– It should be made clear that:
• the course of the disease varies greatly in individuals,
• the disease may not progress for many years,
• there may be other options (surgery, radiotherapy, radioactive
isotope therapy) before considering an MKI
– The information may need to be communicated over
several consultations at different stages of the disease
Considerations when a MKI is prescribed
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10. • WHAT information should be provided when a DTC
become RAI-refractory or a MTC becomes metastatic and
proggresses?
– Decision to start a MKI therapy should not be
“paternalistic”, it should be taken together with
patients/relatives
Considerations when a MKI is prescribed
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11. • Before starting treatment
– What to expect and when
– How to take the medication and when
– What are the possible side effects and how can these be
managed
– Who is the patient’s primary medical team contact
– How to access supportive care (patient organizations, community
support)
Considerations when a MKI is prescribed
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12. • HOW should the information be provided?
– Oral information
– Patient should be encouraged to bring a relative or friend to
consultation
– QOL should be discussed
– Doctors should adapt to patient´s needs and learning level
– Preferable written info (or multimedia) should be given to patients
to allow the incorporation of the information
– Contact information nurse or doctor (telephone or e-mails)
Considerations when a MKI is prescribed
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13. • Management of side-effects of MKIs
– What side effects may occur
– What to do to prevent them
– What the medical team can do to lessen them
– How to report them, and to whom
– The importance of reporting side effects promptly (easy contact
with nurse, resident, doctor)
Considerations when a MKI is prescribed
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14. • WHO should be the patient’s primary contact person?
– Endocrinologist
– Oncologist
– Clinical nurse specialist/ nurse practitioner
Support
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15. Regional differences
Brose, Schlumberger, Pitoia et al. Expert Reviews Anticancer Therapy 2012
Pacini, Pitoia et al. Expert Reviews Endocr Metab 2012
Schlumberger & Sherman. Eur. J. Endocrinol 2011
Interdisciplinary approach
Brose, Pitoia et al. Expert Review of Endocrinol Metab. Sept 2012

16. • What role can patient organizations play in supporting
patients on MKI treatment?
– Patient information materials, jointly with clinicians, and give
feedback to the medical community on the patient perspective
– Publish patient stories and testimonials
– Help with the access to drugs, social work, welfare rights, legal
advice
– They can provide support through holding support meetings and
by one to one contact (telephone or face to face)
Support
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17. • When treatment ends
– Treatment with an MKI is not curative
– When treatment ends, the clinical team and the patient should
review together the path ahead, with an emphasis on being
realistic
– If there are other options to be explored, such as a second MKI,
or participation in a clinical trial, these should be reviewed
carefully together
– The clinical team should assess the patient’s psychological well-
being at each stage (psycological and physical impact)
Support
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18.  Together, doctors and patient´s organizations have an
important task for making MKI treatment properly
prescribed
 Doctors need to be following these patients very
closely
 Patients should participate actively in the decision of
the treatment with MKI
Conclusions
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