Educating and Managing Rare Cancer Patients in Clinical Trials Eric - - PowerPoint PPT Presentation

Eric T. Wong, M.D.

Brain Tumor Center & Neuro-Oncology Unit Beth Israel Deaconess Medical Center Dana Farber/Harvard Cancer Center Harvard Medical School Boston, Massachusetts

A teaching hospital of Harvard Medical School

Educating and Managing Rare Cancer Patients in Clinical Trials

Definition

• A rare disease is any disease affected

fewer than 200,000 Americans (<1%

• f population in United States)
• A rare cancer is any cancer affecting

fewer than 15 out of 100,000 people per year or less than ~45,000 Americans per year

Common vs Rare Cancers

• Breast Cancer (female) vs Breast Cancer (male)
• Prostate Cancer vs Urethral Carcinoma
• Lung Cancer vs Small Cell Lung Cancer
• Skin Cancer vs Stage III, IV Metastatic

Melanoma

• Colorectal Cancer vs GIST

https://www.cancer.gov/publications/dictionaries/cancer-terms/def/791790

Definition of Rare Cancers

A Few Examples of Rare Cancers

Nervous System Cancers

• Glioblastoma (Grade IV Astrocytoma)
• Anaplastic Astrocytoma
• Low Grade Glioma
• Medullablastoma
• Meningioma
• Metastatic Brain Tumors

Organ Specific Tumors

• Breast Cancer (male)
• Urethral Carcinoma
• Small Cell Lung Cancer
• Thyroid Cancer
• Adrenocortical Carcinoma

Hematologic Malignancies

• Leukemias
• ALL, CLL, AML, CML
• Hodgkin Lymphoma
• Large B-cell Lymphoma
• Myelofibrosis

Soft Tissue Tumors

• Alveolar Soft Part Sarcoma
• Clear Cell Sarcoma
• Desmoid Tumors
• Kaposi Sarcoma
• Malignant mesenchymoma

No treatment available

Why Participate in a Clinical Trial?

Current treatment not safe Advancing science Access to new treatment Current treatment not effective Other reasons (i.e. minority, registry for disease, risk factors)

Common Cancers Rare Cancers

Phase 1 Phase 2 Phase 3 10-100 patients 100-500 500-5000 5-20 patients 5-40 10-500 Inclusion Criteria Very strict Strict Exclusion Criteria Very strict Strict Number of locations Numerous Few Recruiting patients Easier More Difficult

Common vs Rare Cancer Trials

Talking to Patients About Clinical Trials

Gather information

• Is there a clinical trial running?
• Check www.clinicaltrials.gov & other

websites

• Is the patient likely eligible
• Check inclusion & exclusion criteria
• Location from home & time commitment?
• What type of clinical trial is it (phase I, II or

III)?

Schedule a meeting

• Quiet room with no interruptions
• Invite caregiver, friends and/or relatives to

attend

• Make available pen, paper, laptop for a

designated person to take notes

During the meeting

• Explain trial participation is voluntary
• It is helpful to repeat several times
• Explain the disease, current treatment options
• and then introduce clinical trial
• Use understandable terminology
• Listen to the patient (the patient needs to make

an informed decision)

After the meeting

• Reinforce the notion that the patient has rights
• Schedule a call/meeting with the principal

investigator or his/her staff

• Determine your role in helping the patient

National Institutes of health (NIH): Talking to Your Patient About a Clinical Trial. https://www.nih.gov/health-information/nih-clinical-research-trials- you/talking-your-patient-about-clinical-trial Accessed Aug 2019

How to Research Clinical Trials (www.clinicaltrials.gov)

Study Title Condition Intervention Locations

Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma Recurrent Glioblastoma Phase II drug & radiation trial: Pembrolizumab + Radiation or Pembrolizumab + Bevacizumab + Radiation Beth Israel Deaconess Medical Center; Dana- Farber Cancer Institute; Massachusetts General Hospital Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR) Recurrent anaplastic astrocytoma Phase III drug trial: Lomustine with or without Eflornithine Beth Israel Deaconess Medical Center; Dana- Farber Cancer Institute; Massachusetts General Hospital Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC) Brain metastasis from non- small cell lung cancer Phase III device trial: Radiosurgery with or without Tumor Treating Fields Beth Israel Deaconess Medical Center/Dana Farber Harvard Cancer Center; Tufts Medical Center

Search Results (recruiting neuro-oncology trials):

Three examples below

Pros and Cons of Participating in a Clinical Trial

Pros

• Focused care with experts in the field
• Advancing science
• New treatment
• Treatment not covered by insurer

Cons

• Travel expenses (reimbursement from NIH)
• Time commitment
• Presence of a placebo arm? (uncommon for

cancer clinical trials)

• Safety and efficacy trade offs?

Case Study of a Glioblastoma Patient

10/14/13 11/17/14 11/5/18 5/22/19

Patient

• 56-year-old man
• Recurrent glioblastoma
• Patient has recurrence after standard

treatment Pros and Cons

• Patient wanted to be enter clinical trial

(Pembrolizumab + Bevacizumab + Radiation) but had some questions concerning:

• Time commitment and travel to medical center
• Cost
• The impact the trial will have on work
• Being treated by a different doctor (not an issue)

Summary

• Gather appropriate information for the patient
• Help him/her to make an informed decision
• If a clinical trial is appropriate, set up an appointment with your

patient and their caregiver to discuss (refer to modules 1 – 3 of this CME/CE series)