To share the knowledge from 2015 GI ASCO, Dr. Al Benson, one of FightCRC Medical Advisory Board members, and Andi Dwyer discuss key highlights as they pertain to colorectal cancer from the symposium and what they mean for patients.

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2. • Speaker(s): Dr. Al Benson & Andrea Dwyer
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6. 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.

7. 2015 Gastrointestinal
Cancers Symposium
January 15-17, 2015 | San Francisco, California
AL B. BENSON III, MD FACP
Northwestern University

8. 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

9. 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

10. 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

11. 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

12. 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.

13. 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

14. 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%

15. 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

16. 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.

17. PDL-1 drugs:
Trends in Molecular Science

18. 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

19. 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

20. 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.

21. 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

22. What to Follow in 2015
 TAS-102
 http://fightcolorectalcancer.org/research-
treatment/another-treatment-option-coming-pike-tas-102/
 Biomarkers
 Immunotherapy

23. ANDI DWYER DIRECTOR OF HEALTH
PROMOTION
RESEARCH ADVOCACY TRAINING AND
SUPPORT (RATS) PROGRAM

24. 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

25. 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

26. RESEARCH ADVOCACY TRAINING AND
SUPPORT (RATS) PROGRAM
RATS VALUES
Through 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

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