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• Speaker(s): Dr. Al Benson & Andrea Dwyer

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Disclaimer:

The information and services provided by Fight Colorectal Cancer are for

general informational purposes only. The information and services are not

intended to be substitutes for professional medical advice, diagnoses or

treatment.

If you are ill, or suspect that you are ill, see a doctor immediately. In an

emergency, call 911 or go to the nearest emergency room.

Fight Colorectal Cancer never recommends or endorses any specific

physicians, products or treatments for any condition.

Speakers:Dr. Al Benson is the associate director of cooperative groups at

Northwestern University. He has served on a number of American

Society of Clinical Oncology (ASCO) committees, and is currently a

member of the Task Force on Quality of Cancer Care, the Co-Chair

of ASCO’s Colorectal Cancer Guidelines Subcommittee, the Stage II

Colon Cancer Guidelines Panel and the Guidelines Panel for use of

Radiofrequency Ablation for Colorectal Cancer Hepatic Metastases.

Dr. Benson’s research is primarily in the areas of gastrointestinal

cancer clinical trials, cancer clinical trials and biologic therapies.

Andrea (Andi) Dwyer is a public health practitioner from the

University of Colorado Cancer Center and Colorado School of Public

Health. She joined Fight Colorectal Cancer in 2014, bringing nearly

ten years experience in cancer prevention and survivorship, with a

special concentration in colorectal cancer.

2015 Gastrointestinal

Cancers SymposiumJanuary 15-17, 2015 | San Francisco, California

AL B. BENSON III, MD FACPNorthwestern University

Vitamin D in CRC

Patients

A large phase 3 trial (CALGB 80405) was conducted to compare

chemo plus bev to chemo plus cetux for patients with newly

diagnosed metastatic CRC, to see if one regimen was better than

the other. They turned out to be basically the same.

As part of this study, the study participants had blood drawn and

their vitamin D levels were tested. Patients filled out

questionnaires that asked them what supplements they were

taking, including vitamin D.

A “normal” vitamin D level is 30.0 to 74.0 nanograms per

milliliter (ng/mL). The median vitamin D level for patients on

the trial was 17.2 ng/mL, which is low.

Low vitamin D associated with:

Older, black, lower dietary and supplemental vitamin D intake,

higher BMI, lower physical activity and blood draws in winter /

spring

Patients with the highest vitamin D levels lived longer than

people with the lowest (32.6 months vs 24.5 months).

Abstract Title:

Vitamin D status and survival of metastatic colorectal cancer patients: Results from CALGB/SWOG 80405 (Alliance). (Abstract 507)

Presenting Author: Kimmie Ng

Vitamin D in CRC Patients: What

does this mean?

Vitamin D levels are important, BUT we don’t know is whether taking a supplement

will help patients live longer.

The patients on the trial who had high vitamin D levels were healthier in general

than the patients with low vitamin D.

What does this mean for patients?

If you want to know your vitamin D levels, talk to your doctor about getting the

test.

Vitamin D levels can be increased naturally. Sunlight and Dietary Sources. Vitamin

D can also be obtained through dietary supplements.

Don’t just start taking a lot of vitamin D pills. Too much vitamin D can be harmful

because it increases calcium levels, which can lead to calcinosis (the deposit of

calcium salts in soft tissues, such as the kidneys, heart, or lungs)

and hypercalcemia (high blood levels of calcium).

http://www.cancer.gov/cancertopics/factsheet/prevention/vitamin-D

Rectal Preservation

after Chemo-radiation

For patients with rectal cancer, surgery following pre-surgical chemo-radiation is the standard of care at many cancer centers.

At some cancer centers, they don’t always do surgery – if the chemo-radiation looks like it’s killed all the cancer cells, they do “non-operative management” or watchful waiting to see if the tumor starts to re-grow.

They do this to avoid the surgery – allowing rectal preservation and avoidance of some of the side effects of surgery (adhesions)

In this study, presented by Jesse Smith from Memorial Sloan Kettering Cancer Center, they looked back at two groups of patients:

Patients who had chemo-radiation followed by surgery and didn’t have cancer cells in their tissue

Patients who didn’t have surgery because it looked like the chemo-radiation had killed all the cancer cells

These patients were closely monitored; if the tumors appeared to come back, they had the standard rectal surgery.

Organ preservation in patients with rectal cancer with clinical complete response after neoadjuvant therapy. (Abstract 509)

Presenting Author: Jesse Joshua Smith

Rectal Preservation after Chemo-radiation

Surgery No surgery

Number of patients 72 73

Regrowth of tumor at original site in rectum

0 19

Local regrowth after surgery 0 0

Metastatic disease 5 9

% patients alive after 4 years 70 (96%) 69 (91%)

# patients with rectal preservation

56 (72%) 0

Rectal Preservation after Chemo-

radiation: What does this mean?

Suggests that watchful waiting might be an option for a carefully chosen

group of patients

To really validate this, a trial randomizing patients to watchful waiting vs

surgery needs to be done.

Phase III Irinotecan,

Folinic Acid, and FOLFIRI

plus RAM or placebo Angiogenesis is the formation of new blood vessels.

Tumors need blood vessels to grow and spread.

Angiogenesis inhibitors are designed to prevent the

formation of new blood vessels, thereby stopping or

slowing the growth or spread of tumors.

There are two drugs currently approved for colorectal

cancer that target VEGF – they are bev and ziv-aflib.

At the conference, results of a different vegf targeting

drug were given. This drug is called ramucirumab

Approved for gastric cancer, lung cancer

Design – 2nd line treatment after FOLFOX/bev;

patients randomized to FOLFIRI vs FOLFIRI + RAM

RAISE: A randomized, double-blind, multicenter phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab (RAM) or placebo (PBO) in patients (pts) with metastatic colorectal carcinoma (CRC) progressive during or following first-line combination therapy with bevacizumab (bev), oxaliplatin (ox), and a fluoropyrimidine (fp). (Abstract 512)

Presenting Author: Josep Tabernero

Phase III Irinotecan, Folinic Acid, and

FOLFIRI plus RAM or placebo

FOLFIRI alone FOLFIRI + RAM

# patients 536 536

Median survival 11.7 months 13.3 months

Progression free survival 4.5 months 5.7months

Neutropenia 28.3% 38.45%

High blood pressure 2.8% 11.2%

Diarrhea 9.7% 10.8%

Fatigue 7.8% 11.5%

Phase III Irinotecan, Folinic Acid, and FOLFIRI

plus RAM or placebo: What does this mean?

Ramucirumab increased overall survival slightly – about 6 weeks

Side effects are similar to other drugs of this type

If approved by FDA, it will offer a treatment option

What we don’t know:

We can’t predict which patients will respond well to any of these drugs – there are

no genetic tests that can tell us “this person will do well”

If patients receive FOLFIRI/bev in first line, will FOLFIRI/RAM help them in second

line

For more info about angiogenesis drugs, check out

http://www.cancer.gov/cancertopics/factsheet/Therapy/angiogenesis-inhibitors

PDL-1 drugs:

Lots of interest in

immunotherapies that target the

Programmed Death Ligand (PDL).

Most research in these drugs in

CRC is in phase 1 or phase 2

trials.

PDL-1 drugs:

Trends in Molecular Science

PDL-1 drugs:

Very preliminary data were presented from a phase 1b

trial looking at MPDL3280A (an anti-PDL1 drug):

Safety and efficacy of MPDL3280A (anti-PDL1) in combination with bevacizumab (bev) and/or FOLFOX in patients (pts) with metastatic colorectal cancer (mCRC).

A pilot study of AMP-224 —a PD-1 inhibitor—in combination with stereo- tactic body radiation therapy (SBRT) in patients with metastatic colorectal cancer.

Presenting Author: Austin G. Duffy, National Cancer Institute at the National Institutes of Health, Bethesda, MD

MPD + bev / refractory

MPD + bev + folfox / oxali-naïve

Number of patients 14 30

# prior lines of therapy >= 3 lines 70% had no prior

therapy

Unconfirmed response rate (the tumors shrank)

1 in 13 (8%)9 in 25 (36%)8 in 18 (44%) for naïve patients

PDL-1 drugs: Another trial was presented – this trial opened in November 2014, and

is currently recruiting patients.

Looking to see if AMP-224, another anti-PDL drug, combined with

targeted radiation, can shrink liver mets that chemo hasn’t shrunk.

The clinical trial can be found at

https://clinicaltrials.gov/ct2/show/NCT02298946

PDL-1 drugs

What does this mean?

All of the immunotherapy drugs look interesting but we need a lot

more data before we know how to use them and who will benefit.

If you are interested in finding a trial talk with your doctor.

BIOMARKERS Lots of work going on to find biomarkers – changes in the cancer cells

that will predict who will respond to treatment – Personalized Medicine!

To date, only RAS mutations are really helpful- patients with RAS mutations do not benefit from treatment with cetuximab or panitumumab

A very early phase 1 trial was presented with MM-151, a drug that targets the EGFR receptor for patients who do NOT have a KRAS, NRAS or BRAF mutation. This trial was for people with CRC (29), NSCLC (9) and HNSCC (8). Some had prior cetuximab, others didn’t.

Side effects were expected – rash, diarrhea, fatigue. Many people had an allergic reaction to MM151, which is controlled with pre-treatment benedryl and steroids.

Initial data suggests that this drug may work best in patients with unmutated KRAS / NRAS / BRAF, EGFR + colorectal cancer, so the company is continuing research in this patient population.

These are very early data, and it will take several years of additional research to see whether these preliminary results can translate to more patients, and it illustrates the importance of RESEARCH –funding it, participating in it.

Safety, pharmacology, and preliminary clinical activity of MM-151: An oligoclonal anti-EGFR therapeutic in patients with cetuximab-resistant CRC and other refractory solid tumors.

Presenting Author: Christopher Lieu, MD

What to Follow in 2015

TAS-102

http://fightcolorectalcancer.org/research-

treatment/another-treatment-option-coming-pike-tas-102/

Biomarkers

Immunotherapy

ANDI DWYER DIRECTOR OF HEALTH

PROMOTION

RESEARCH ADVOCACY TRAINING AND

SUPPORT (RATS) PROGRAM

RESEARCH ADVOCACY TRAINING AND

SUPPORT (RATS) PROGRAM

What is a RESEARCH ADVOCATE?

A research advocate brings a patient viewpoint to the

research process and communicates a collective patient

perspective

Fight CRC’s RATS Program:

• In partnership with academic institutions and their partners; pharmaceutical,

governmental agency, and industry sites

• Goal is to improve the ability of research advocates to effectively participate in

the research process.

• Application process open to cancer survivors, caregivers, and champions

• In person meetings, online trainings, and webinars.

• Continued education and ongoing training and support

RESEARCH ADVOCACY TRAINING AND

SUPPORT (RATS) PROGRAM

• After graduating RATS advocates have served on

various review panels to include:

The Food and Drug Administration (FDA)

National Cancer Institute (NCI)

Cooperative Groups

Specialized Programs of Research Excellence

(SPOREs)

Local Institutional Review Boards (IRBs) or Data

Safety Monitoring Boards (DSMBs)

• Ongoing connection and training opportunities

RESEARCH ADVOCACY TRAINING AND

SUPPORT (RATS) PROGRAM

RATS VALUESThrough the RAT program, Fight Colorectal Cancer is committed to excellence

in research, advocacy, education, and collaboration, upholding the following

values:

1. We value the achievement of advocates at all levels and promotion of their

accomplishments nationally and locally.

2. We value the development of an inclusive learning community.

3. We value the support of creative, critical and reflective thinking and practice.

4. We value ethical conduct by our advocates.

Interested in Learning More?

• Session at our Annual Call-on Congress Event in DC March 16th

• Visit our website

• Accepting applications in June 2015

Question & Answer:

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