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Courage HEREDITERY RISK AND GENETICS OF CANCER he genetic mutations associated with more than 50 hereditary cancer syndromes, which play a major role in the development of about 5% to 10% of all cancers, have been identified, and genetic tests can help tell whether a person from a family with such a syndrome has one of these mutations. JOURNEY of T 16 October 2013 PharmaVOICE Merck’s Lauri Ford del Rio is a role model for others who are afflicted with genetic-based cancers and the radical choices to be made. By Taren Grom and Denise Myshko (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] Compliments of PharmaVOICE

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Page 1: Courage - NoStomachForCancerDigestive cancer, includ-ing gastric cancer, is second only to respiratory cancer in terms of estimated deaths. Almost 1 million people are diagnosed with

CourageHEREDITERY RISK AND GENETICS OF CANCER

he genetic mutations associated with more than

50 hereditary cancer syndromes,which play a major role in the development of about 5% to 10%of all cancers, have been identified, and genetic tests canhelp tell whether a person from a family with such a syndrome has one of these mutations.

JOURNEY of

T

16 October 2013 � PharmaVOICE

Merck’s Lauri Ford del Rio is a rolemodel for others who are afflictedwith genetic-based cancers andthe radical choices to be made.

By Taren Grom and Denise Myshko

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Page 2: Courage - NoStomachForCancerDigestive cancer, includ-ing gastric cancer, is second only to respiratory cancer in terms of estimated deaths. Almost 1 million people are diagnosed with

Angelina Jolie carries amutation of the BRCA1

gene, which sharplyincreases the risk of

breast and ovarian cancer.

SPOTLIGHT: Genetics of Cancer

Ms. Chelcun Schreiber had her stomach re-moved as a preventive measure in November2008. Pathology revealed cancer foci in herstomach, which is typical in these cases.“We originally started a website called Be

Strong Hearted in 2008 to help people in ourfamily understand this type of stomach cancer,as well as make resources available for otherpeople,” Ms. Chelcun Schreiber says. “We alsolearned that there are a lot of people in themedical community who don’t know aboutHDGC, they don’t know there is a hereditaryform of stomach cancer and they don’t knowanything about this gene mutation.”The family also established the Chelcun

Family Fund for Stomach Cancer Research atthe Community Foundation of Central Wis-

tremely active since its inception in 2009, andin November 2010 it successfully champi-oned and celebrated the first official StomachCancer Awareness Month in the UnitedStates. There is a great deal of focus on food,nourishment, and family during the holidays,and that can be challenging for people dealingwith stomach cancer, and for those living

without a stomach.Supporters hope that

greater awareness andknowledge will lead to ear-lier detection of stomachcancer, which is directly as-sociated with higher long-term survival rates, and thatmoney raised for stomachcancer research will result inbetter detection, treat-ments, improved survivalrates, and ultimately a cure

for this deadly disease.Ms. Chelcun Schreiber’s crusade began in

September 2007 after her brother, Greg, at56, became the second person in the family tobe diagnosed with stomach cancer. Theirmother had died in 1982 from the disease atthe age of 52. “The doctors had told us that stomach can-

cer was rare, so I was curious as to why twopeople in our family had gotten this cancer,”she says. “I didn’t know anything about stom-ach cancer. I was looking for more informa-tion, and I came upon an article from StanfordUniversity about this hereditary cancer syn-drome caused by a gene mutation. I stronglysuggested that my brother be tested, and hewas positive. After that a lot of family mem-bers started getting tested and most of us hadpositive results.”Ms. Chelcun Schreiber herself was positive

for the CDH1 gene mutation, which put herat a more than 85% risk of developing a formof stomach cancer called hereditary diffusegastric cancer (HDGC). The only currenttreatment for those with this cancer syndromeis preventive removal of the stomach.

Angelina Jolie madeheadlines in May when sheunderwent a preventive dou-ble mastectomy after learningthat she carries a mutation ofthe BRCA1 gene, which in-creases the risk of breast andovarian cancer. The Hollywood actress brought public at-

tention to a genetic and hereditary mutationfor breast cancer, but less well-known is thatmore than 50 hereditary cancers have beenidentified. While breast and ovarian cancers receive

the lion’s share of publicity, they are not theleading causes of cancer death worldwide. Digestive cancer, includ-

ing gastric cancer, is secondonly to respiratory cancer interms of estimated deaths.Almost 1 million people arediagnosed with a form of di-gestive cancer each year, andof these, about 700,000 willlose their lives. Digestivecancer is the fourth-mostcommon cause of cancerworldwide, and gastric can-cer has been identified as oneof the known 50 hereditary cancers associatedwith gene mutation.

DIGESTING STOMACH CANCER

Karen Chelcun Schreiber, founder of thenonprofit organization No Stomach for Can-cer, aims to shine a spotlight on gastric cancer.One of her goals is for people to know as muchabout stomach cancer risk and prevention asthey do about breast cancer risk and preven-tion.“The organization’s goals are to raise

money to advance stomach cancer research,raise awareness about stomach cancer, and ad-vance education about stomach cancer, notonly in the general public but also in the med-ical community,” she says. “We provide infor-mation, resources, and support for patientsand families affected by stomach cancer, andcontinue to build a support network — aworldwide community — where they cansupport one another and become involved inraising awareness about this disease.”No Stomach For Cancer has been ex-

started with the breasts, as my riskof breast cancer was higher thanmy risk of ovarian cancer and thesurgery is much more complex.

Angelina JolieActress

I

Genetic Testing for Hereditary Cancer Syndromes

• Genetic mutations play a role in the development of all cancers. Most ofthese mutations occur during a person’slifetime, but some mutations, includingthose that are associated with hereditarycancer syndromes, can be inherited froma person’s parents.

• Inherited mutations play a major role inthe development of about 5% to 10% ofall cancers.

• The genetic mutations associated withmore than 50 hereditary cancer syndromes have been identified, and genetic tests can help tell whether a person from a family with such a syndrome has one of these mutations.

• A genetic counselor, doctor, or otherhealthcare professional trained in genetics can help an individual or familyunderstand genetic test results.

Source: National Cancer Institute

DIGESTIVE CANCER,

INCLUDING GASTRIC

CANCER, IS SECOND

ONLY TO RESPIRATORY

CANCER IN TERMS OF

ESTIMATED DEATHS.

• • •

17PharmaVOICE � October 2013

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Page 3: Courage - NoStomachForCancerDigestive cancer, includ-ing gastric cancer, is second only to respiratory cancer in terms of estimated deaths. Almost 1 million people are diagnosed with

18 October 2013 � PharmaVOICE

and her family with a tremendous amount ofsupport.(Editors’ Note: see more details about

Lauri Ford del Rio’s patient journey in the ac-companying side bar.)

RESEARCH IN GASTRIC CANCER

About 15% of stomach cancers occur inpatients with a family history of stomach can-cer. Several genes have been implicated in gas-tric cancer. One of these is the HER2 gene,which is typically associated with breast andovarian cancer. Roche and Genentech’s Her-ceptin (trastuzumab) was approved in October2010 to treat HER2-positive gastric cancer.The development of other therapies for

gastric cancer have experienced some recentsetbacks because of less than positive clinicalresults. The most recent setback was Glaxo-SmithKline’s announcement in June of thisyear that Tykerb in combination withchemotherapy in patients with HER2-posi-tive advanced gastric cancer did not meet theprimary endpoint of improved overall survivalcompared with chemotherapy alone.“This is an extremely difficult-to-treat on-

cology indication,” says Rachel Webster,D.Phil., senior director, oncology group, atDecision Resources. “This is not dissimilar towhat we see in some other indications withshort survival times and in tumor types thatare chemo resistant. Part of the problem withgastric cancer is that the majority of patientsare not diagnosed until an advanced stage.But when symptoms are more overt, advancedor metastatic disease has likely developed.”A December 2012 Decision Resources re-

port predicts that the gastric cancer therapymarket will experience slow annual growthfrom 2011 to 2016 (2.4%) but then rapidlyexpand thereafter, achieving annual growth of13.7% from 2016 to 2021. Dr. Webster points out that those thera-

pies that have failed to meet endpoints in gas-tric cancer have had demonstrated success inother oncology indications, such as breast, col-orectal, and renal cancers.Research into next-generation HER2 ther-

apies continue. For example, Genentech’s Per-jeta (pertuzumab) was approved in June 2012to treat HER2-positive metastatic breast can-cer in combination with Herceptin.

tested positive for the hereditary gene, whichtraces back, as far as they know, to her pater-nal grandfather. Some of the family memberswho have tested positive have or are planningto undergo prophylactic gastrectomy.“My gastroenterologist never heard of it,

my gynecologist never heard of it, and myother doctors never heard of it,” Ms. Ford delRio says. Ms. Ford del Rio credits the No Stomach

for Cancer organization with providing her

consin to raise money for stomach cancer re-search.“The website drew visitors from all over

the world almost immediately,” she says. “Aswe learned more, our mission expanded to en-compass all forms of stomach cancer. In 2009,the growth of the website was more than Icould handle on my own. And I wanted tobuild an organization that would go on longafter me. No Stomach For Cancer Inc. wasfounded as a nonprofit organization in 2009and received its tax exempt status in 2010.We continue to build and grow the organiza-tion and expand our reach globally.”Ms. Chelcun Schreiber and patient Lauri

Ford del Rio both have a genetic mutationthat results in a rare stomach cancer. An esti-mated 1% to 3% of cases of gastric cancer arecaused by HDGC. The CDH1 mutation is adominant gene, meaning that children ofthose with the mutation have a 50% chance ofinheriting the mutation as well. It is esti-mated that three out of every four CDH1 genemutation carriers will go on to develop gastriccancer, with an average age at diagnosis of 38.Ms. Ford del Rio’s family is one of only

150 families worldwide reported to have thisparticular gene mutation. She and seven other family members have

SPOTLIGHT: Genetics of Cancer

NO STOMACH FOR CANCER

ince its inception in 2009, No Stomach For Cancer(NSFC) has been an advocate and voice for those af-fected by gastric cancer.

Each November, NSFC encourages patients, caregivers, families, friends,businesses, and organizations to participate in Stomach Cancer Awareness Month in a va-

riety of ways: putting a face to the disease by sharingpersonal stories through local, national, and interna-tional media; through awareness activities in theirneighborhoods and local communities; through ac-tive engagement on its Facebook pages and Websiteforum and other social media; through third-partyevents; and though participation in the annual NoStomach For Cancer Walk.The second annual No Stomach For Cancer Walk

will be Nov. 2, 2013, and will kick off the 4th An-nual Stomach Cancer Awareness Month. “It has been very exciting to watch the momen-

tum of this important awareness initiative building,”says Karen Chelcun Schreiber, founder of the organi-zation. “We see growing interest and involvement bypeople who care about this cause, not only in theUnited States but also in countries throughout theworld. The word is getting out and the passion to

help others and to make a difference is evident everywhere.”

For more information or to learn how to join the walk, please visit nostomachforcancer.org.

S

No Stomach For Cancer 2013 WalkWhen: Saturday, Nov. 2, 2013Where: Everywhere in the world

e want to be able to provide a support network for those affected by stomach cancer.

Karen Chelcun SchreiberNo Stomach for Cancer

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Page 4: Courage - NoStomachForCancerDigestive cancer, includ-ing gastric cancer, is second only to respiratory cancer in terms of estimated deaths. Almost 1 million people are diagnosed with

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Page 5: Courage - NoStomachForCancerDigestive cancer, includ-ing gastric cancer, is second only to respiratory cancer in terms of estimated deaths. Almost 1 million people are diagnosed with

20 October 2013 � PharmaVOICE

auri Ford del Rio’s family lived withthe omnipresent specter of cancer.

And while the family made light of the factthat they were all doomed to contract stomachcancer someday, they didn’t know at the timethat their black humor would someday proveto be true. Ms. Ford del Rio’s family tree tells the story

of hereditary genetic cancer mutation. Hergrandfather passed away from stomach cancer,as did her father and uncle.“My dad was diagnosed with stomach can-

cer in 2011 and he was the fifth person in hisfamily to get it,” Ms. Ford del Rio says. “Hesurvived until he was 83; the rest of the familydidn’t live one year after diagnosis.”It was during her father’s treatment that

Ms. Ford del Rio remarked to the radiation on-cologist that there had to be some type of a ge-netic link because one just didn’t hear aboutstomach cancer.“The oncologist sent us to a genetic

counselor to have my dad tested and of

Journeycourse he tested positive,” she recalls. “Thenthe rest of the family began getting tested;right now I think there are six of us whotested positive with the CDH1 gene and fourof us who have had our stomachs removed, in-cluding one of my cousins. My other cousin isgoing in this month for the surgery and thenmy cousin’s daughter is going next summerbecause she just had a baby.”Ms. Ford del Rio credits her father for sav-

ing not just her life but those of her many rel-atives.“My dad didn’t die until he was 83 and he

was healthy as an ox until then,” she says. “Ifhe didn’t get tested, we wouldn’t have uncov-ered the link until it was too late. The geneticcounselor told us that he had an 87% chancehe would contract this form of gastric cancerwith only a 3% survival rate. The odds werereally against him.”

Ms. Ford del Rio and her familyare significantly increasing theirodds for survival by undergoing

SPOTLIGHT: Genetics of Cancer

Patient

Positive and Died from Disease

Tested Positive

Tested Negative

Yet to be Tested

NAPOLITANOFAMILY TREE

Trastuzumab has paved the way for otherHER2-targeted therapies in gastric cancer,Ms. Webster says. “We expect the HER2-positive segment to

become very crowded and competitive and tobe dominated by Roche,” she says. “We envi-sion that the HER2-positive segment is goingto mirror what is happening in the HER2-pos-itive breast cancer space.”There are other promising therapies in the

pipeline addressing the larger segment ofHER2 negative gastric cancer.One such product is Lilly’s ramu-

cirumab, which in its first Phase III trialdemonstrated overall survival and also showedprolonged progression-free survival. Thismonoclonal antibody is being studied as a sec-ond-line treatment in patients with metastaticgastric and gastroesophageal junction cancers.Decision Resources expects this product

will secure robust uptake in the HER2 nega-tive market, with more than $250 million insales, or about 10% of the market, in 2021.Developing treatments for gastric cancer

has historically been a challenge due to a lim-ited understanding of the underlying molecu-lar mechanisms driving the disease, says ChrisBowden, M.D., VP, bio-oncology, clinical de-velopment, at Genentech. “But as we learn more about the molecular

basis of gastric cancer, the treatment landscapeis beginning to change,” he says. “For exam-ple, now people diagnosed with gastric cancercan have their tumor tested to confirm HER2status and determine if they could be a candi-date for Herceptin.”Another promising area of research is ad-

dressing c-Met, which makes a protein thatsome tumors use to grow and spread. Twotherapies under study are Genentech’s onar-tuzumab and Amgen’s rilotumumab, whichDecisions Resources researchers expect tolaunch for c-Met-overexpressing gastric cancerin 2017. Genentech’s onartuzumab is a first-in-class

monoclonal monovalent antibody in PhaseII and Phase III trials. It is designed to in-hibit Met signalling in cancer cells by bind-ing to the extracellular domain of Met,thereby blocking HGF-mediated activa-tion. The Met receptor (also known as c-Met) is

a protein on the surface of cells that is associ-ated with cell growth, survival, motility, mi-gration, and invasion. When overexpressed,Met may play an important role in the devel-opment of cancer.“Onartuzumab is the first investigational

antibody designed to specifically bind to theMet receptor and inhibit Met signaling,” Dr.Bowden says. Onartuzumab is a unique one-armed anti-

Lauri Ford del Rio

LREMOVING THE STOMACH TO CUT CANCER RISK

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Page 6: Courage - NoStomachForCancerDigestive cancer, includ-ing gastric cancer, is second only to respiratory cancer in terms of estimated deaths. Almost 1 million people are diagnosed with

21PharmaVOICE � October 2013

Eight members of the extended Napolitano family carry the gene mutation.Another 12 relatives have yet to be testedfor the gene. Lauri Ford del Rio (right) andher cousin Deb Napolitano hope to be rolemodels to all of them.

Deb Napolitano and Lauri (Napolitano) Ford del Rio

SHARING FAMILY INFORMATION

amilies share more than genes, physical features, andmedical traits.

Other common elements — backgrounds, relationships, and dynamics —sometimes affect communication between family members.In some families, cancer, breasts, and ovaries are considered very private matters never

to be discussed. Cancer and other illnesses are often associated with a stigma in our society.Some family members may be superstitious about discussing cancer, believing that may in-vite the disease and make it more likely to happen. This lack of communication can im-pede sharing of critically important health information between relatives. Despite thesechallenges, it is important to share medical information with relatives. Cancer and manyother diseases can have a hereditary component. Screening or risk-management recom-mendations are different for people who are considered “high risk” due to a family history.The best way to discuss health information is individual and depends on your rela-

tionship with relatives. Here are some tips for sharing:• Be sensitive to family members’ situations and feelings.• Give relatives the names of genetics specialists in their area to ensure that they receive up-to-date information.

• Avoid pressuring relatives to make a particular decision.• Respect their right to gather information from experts and make their own informed decisions.

• Prepare for your conversation ahead of time by writing down what you want to tell them.

Source: Facing Our Risk of Cancer Empowered Inc. (FORCE). FORCE has a printablepage for sharing information with relatives. For more information, visit acingourrisk.org.

F

prophylactic gastrectomy, in other word, hav-ing their stomachs removed. Unfortunately, CDH1 also is linked to lob-

ular cancer, which can lead to breast cancer.Fortunately, Ms. Ford del Rio has an incredi-ble support group and she and her cousin un-derwent the gastric surgery together, sharedthe intimacy of recovery, and were each others’cheerleaders. The two cousins will once again face the

daunting experience of undergoing anotherradical surgery together. The two cousins areeach having double mastectomies.“We decided it doesn’t seem fair that if we

went through all we did to remove our stom-achs to then get breast cancer,” Ms. Ford delRio says.And when Ms. Ford del Rio talks about her

journey she does so without self pity or re-morse. She is remarkably up-beat, positive,and eager to elevate the conversation aroundgastric cancer education.The only time Ms. Ford del Rio reveals any

crack in her good-humor is when she speaksabout her three children. Because the gene isdominant, they have a 50% chance of beingpositive. She adds encouragingly that becauseher sister tested negative for the gene, it stopswith her and Ms. Ford del Rio’s niece andnephew are not at risk.“The interesting thing is that my dad’s only

remaining brother who is 90 years old, whoalso tested positive is among the 13% whonever manifest the disease, and it’s his three

kids — my cousins — who also tested posi-tive,” she says. When people ask her why she would un-

dergo such a radical surgery, her response is:“With an 87% chance that I was going to getthis horrible horrible cancer and knowing thatI was going to die if I did, to me it was a no-brainer.”Removing a stomach is a major procedure,

but a relatively low-risk one, says Dr. SamYoon, the surgeon who operated on Ms. Forddel Rio and her cousin Deb Napolitano, at Me-morial Sloan Kettering Cancer Center in NewYork.“It turns out the stomach is less crucial than

you might think, because most nutrients areabsorbed through the small intestine,” he says.“The stomach is basically a reservoir for thefood eaten. Patients who have had their stom-achs removed can eat three meals a day. With-out a stomach they can lead a pretty normallife, but they need to eat a little bit constantly.I tell patients they’re going to need to grazelike a cow.”And how is life after surgery a year later?

Ms. Ford del Rio says she is adjusting withouta stomach by amending her eating habits,monitoring her vitamin B12 and calcium, andmost importantly, living life to its fullest.

SPOTLIGHT: Genetics of Cancer

If we had a good screening test, wewould screen patients every six monthsor so to look for gastric cancer. But wedon’t have good tests, so the main treatment we have is removing thewhole stomach.

Dr. Sam YoonSurgeon at Memorial Sloan KetteringCancer Center in New York

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Page 7: Courage - NoStomachForCancerDigestive cancer, includ-ing gastric cancer, is second only to respiratory cancer in terms of estimated deaths. Almost 1 million people are diagnosed with

dress this problem, Genentech researcherscreated a one-armed antibody that is designedto prevent Met signaling by blocking hepato-cyte growth factor/scatter factor (HGF/SF)from binding to Met without causing Met re-ceptors to form pairs.”The company is investigating onar-

tuzumab across a number of cancers. For gas-tric cancer, Genentech has initiated Phase IIand Phase IIIs trial that will compare onar-tuzumab plus mFOLFOX6 chemotherapy tomFOLFOX6 chemotherapy alone in peoplewith previously untreated HER2-negative,Met-positive metastatic gastric cancer. Another company researching Met expres-

sion is Amgen. Last year, the company an-nounced results from an exploratory bio-marker analysis evaluating Met expression asa predictor of clinical response to rilotu-mumab, a human monoclonal antibody. Thisanalysis, conducted on a previously reportedPhase II study of rilotumumab in patientswith locally advanced or metastatic gastric orgastroesophageal cancer, showed that treat-ment with rilotumumab in combination withchemotherapy improved median overall sur-vival in patients whose tumors exhibited highMet protein expression.Amgen plans to conduct a Phase III study

to confirm the efficacy of rilotumumab in ad-vanced gastric and gastroesophageal cancerwith high Met expression. The company hasteamed with Dako to develop and evaluatethe use of a companion diagnostic test.Decision Resources analysts anticipate

that Roche’s onartuzumab and Amgen’s rilo-tumumab will capture a significant patientshare within one of the largest and currentlyunderserved drug-treatable gastric cancerpopulations — the first-line metastaticHER2-negative population (about 83% offirst-line patients). Their uptake will be theprimary driver of market growth over the sec-ond half of Decision Resources’ forecast pe-riod. Combined, these agents will hold one-third of the market in 2021. Furthermore,these agents will be prescribed in combina-tion with standard chemotherapy regimensand will, therefore, contribute additional salesrather than erode the sales of currently mar-keted therapies.In the area of the gastric cancer caused by

CDH1 gene mutation, research is just begin-ning. The CDH1 gene, located on chromo-some 16, normally encodes for a proteincalled E-cadherin. The normal function of E-cadherin is to allow cells and tissues to adhereto one another.“CDH1 is mutated in diffuse gastric can-

cer and lobular breast cancer, and down regu-lated in many other late-stage epithelial can-cers,” says Parry Guilford, director of the

Centre for Translational Cancer Research,Cancer Genetics Laboratory, at University ofOtago in New Zealand. “Although the loss ofE-cadherin increases tumor development, webelieve it also causes vulnerabilities in the can-cer cell. These vulnerabilities appear to belargely associated with weaknesses in thefunction of the cytoskeleton.”Dr. Guilford says five classes of drugs look

promising for this syndrome — HDAC in-hibitors, JAK inhibitors, EGFR family in-hibitors, PI3K inhibitors, and Ros1 inhibitors— and researchers are beginning work to val-idate those drugs with in vitro assays.“We believe these drugs/drug targets will

be important for the chemoprevention ofHDGC, but also the treatment of all diffusegastric cancers and lobular breast cancers,” hesays. “The HDAC inhibitors are most prom-ising. We have strong data for several drugsfrom this class including entinostat, mo-cetinostat, vorinostat, and pracinostat. As wellas the HDAC inhibitors alone, we have ob-served that vorinostat in combination withthe microtubule stabilizing agent Taxol has apowerful effect on CDH1 negative cells com-pared to wild type cells.”No Stomach for Cancer, with matching

funding from the De Gregario Family Trust, issupporting a 114,000-compound screenagainst the isogenic MCF10a cells. Researchershope to find drug candidates that work on anytumor with CHD1 mutation. This research isbeing done by Dr. Guilford and his colleagues.No Stomach For Cancer has provided a grant of$20,000 for this research. PV

eveloping treatments for gastriccancer has historically been a challengedue to a limited understanding of theunderlying molecular mechanismsdriving the disease.

Dr. Chris BowdenGenentech

SPOTLIGHT: Genetics of Cancer

DHEREDITARY CANCERS

hanges in BRCA1 and BRCA2are most closely associated with increasedrisk for breast cancer and ovarian cancer.Other cancer syndromes can increase the riskfor breast or ovarian cancer and may have other

signs as well.

Hereditary Non-Polyposis Colorectal Cancer(HNPCC) is a hereditary syndrome that can increase the risk for the following cancers:

• Colon (particularly under age 50)• Ovarian• Endometrial (uterine)• Stomach• Small intestine• Bile duct

Cowden Syndrome can increase the risk for the fol-lowing cancers:

• Breast• Thyroid (non-medullary)

Peutz-Jegher Syndrome can increase the risk for thefollowing cancers:

• Colon• Breast• Pancreas

Li-Fraumeni Syndrome can increase the risk for thefollowing cancers:

• Breast• Sarcomas (bony and soft-tissue)• Brain tumors• Childhood adrenocortical carcinomas

Other hereditary mutations have been identified thatdon’t increase the risk for breast or ovarian cancersbut do increase the risk for other cancers. Any familywith multiple individuals with the same cancer, veryyoung onset cancers, or rare cancer types should con-sult with a genetics specialist regarding whether thecancer in family might be hereditary.

Source: Facing Our Risk of Cancer Empowered Inc.

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body targeted against the c-Met receptor. An-tibodies usually have two arms, each of whichcan bind to a target. “But preclinical studies of Met revealed

that two-armed antibodies caused Met recep-tors to form pairs (dimerize) and activated Metsignaling, which led to uncontrolled cell repli-cation and spread,” Dr. Bowden says. “To ad-

22 October 2013 � PharmaVOICE

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Page 8: Courage - NoStomachForCancerDigestive cancer, includ-ing gastric cancer, is second only to respiratory cancer in terms of estimated deaths. Almost 1 million people are diagnosed with

No doubt about it. This is an exciting time for specialty pharmaceuticals. Many new products are nearing the end of the pipeline. Some of these new medications will offer improved benefi ts that enhance the quality of patients’ lives. Those benefi ts are easy to see. But other innovations have already been introduced, providing benefi ts specialty pharmacies and healthcare providers may not easily see. The Cubixx consignment system from ASD Healthcare is one of those innovations.

Cubixx is a storage and monitoring system designed to help hospitals and specialty pharmacies manage and track inventories of high-cost, complex biological drugs. Cubixx provides custom-made refrigerators to store the specialty inventory. Inside, each box of product is tagged with a radio-frequency identifi cation tag (RFID), which contains product data. With an RFID tag, no one needs to scan each box; it is scanned automatically as it’s removed from

inventory. The Cubixx system tracks brand, IU, lot number, expiration date and individual serial numbers. This lets manufacturers, distributors and sellers follow each product from the manufacturing plant to the patient who uses the medication.

Cubixx works on a consignment model. In other words, facilities or pharmacies pay for only what they sell. ASD Healthcare provides product to healthcare facilities such as hospitals, specialty pharmacies, HTCs, etc., and bills them only for the product actually used. The Cubixx system reduces the need for facilities to purchase and hold these expensive inventories, which may or may not be sold. Cubixx also helps eliminate the added expense of lost, stolen or expired products.

The distribution of specialty pharmacy product presents many unique logistical challenges with many medications requir-ing “cold-chain” handling to keep them

refrigerated in transit. These medications are also very ex-pensive. Stakeholders – from physicians to payers and manufacturers – want clear visibility to see how these products are used. Cubixx can track this information on each specialty product as it is sold from the manufacturer to the dis-tributor to a health care facility and fi nally to a patient.

ASD Healthcare has a 20-year history of serving the specialty pharmaceutical sector. We’re committed to fi nding innovative solutions for the facilities that care for patients who require specialty therapies. The Cubixx consignment system is one of these innovations. By helping facilities reap so many benefi ts, Cubixx helps them provide the highest-quality care to the patients they serve.

Cubixx®: An Innovative Solution for Specialty Pharmaceutical InventoriesBy Christopher Flori

www.asdhealthcare.com

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Economic

The bene� ts of Cubixx consignment inventory are signi� cant. Paying for products only when they’re used, while still having access to the range of products needed, provides savings for healthcare facilities and specialty pharmacies alike. Freight expenses and � nancial losses due to expired or unsold products are eliminated. With Cubixx, rather than invest in product and holding expensive inventory, facilities can redirect their money for other uses.

Operational

Cubixx does the heavy lifting for product reorders. It produces purchase orders, manages day-to-day product inventory and allows the facility to log onto the Cubixx website to view its inventory of products anytime. This takes the administrative burden off the healthcare facility or pharmacy staff.

Clinical

As one of the largest specialty distribu-tors in the United States, we have access to commercial product and 340B product in a breadth and depth that gives clini-cians the widest possible selections of products at their � ngertips. This Cubixx bene� t gives facilities instant access to more product options to meet a wider range of their patients’ needs.

The Cubixx system reduces three major challenges for facilities and pharmacies.

Christopher Flori is Vice President of Business Innovation at ASD Healthcare,

an AmerisourceBergen Specialty Group. For more information on Cubixx,

please contact him at 469.365.7841 or [email protected].

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