Ccc Kidney Cancer

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Progress in theTreatment o Kidney CancerPresented by

Brian Rini, MDCleveland Clinic Taussig Cancer Institute

David McDermott, MDBeth Israel Deaconess Medical Center

Keith Lyons, MSWCancer Care

Find out about: Current treatment options Advances in research The role of clinical trials Ways to cope with cancer

Help and Hope

KIDNEY CANCER


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National O fceCancer Care 275 Seventh Avenue New York, NY 10001 Email: [email protected]

Services Tel: 212-712-8080 1-800-813-HOPE (4673)

AdministrationTel: 212-712-8400 Fax: 212-712-8495 Email: [email protected] Website: www.cancercare.org

Cancer Care is a national nonpro t organization that provides free supportservices to anyone affected by cancer: people with cancer, caregivers, children,loved ones, and the bereaved. Cancer Care programsincluding counseling andsupport groups, education, nancial assistance, and practical helpare providedby professional oncology social workers and are completely free of charge.Founded in 1944, Cancer Care provided individual help to more than 100,000people last year and had more than 1 million unique visitors to our websites. For more information, call 1-800-813-HOPE (4673) or visit www.cancercare.org .Contacting Cancer Care

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KIDNEY CANCER

Progress in the Treatmentof Kidney Cancer

The in ormation in this booklet is based on the Cancer Care Connect Telephone Education Workshop Progress in the Treatment o Renal

Cell Carcinoma, which took place in April 2008. The workshop wasconducted by Cancer Care in partnership with the American Cancer Society, American Society o Clinical Oncology, American Urological

Association Foundation, Association o Clinicians or the Underserved, Association o Oncology Social Work, Black Womens Health Imperative,Cancer Patient Education Network, Education Network to Advance Cancer Clinical Trials, Intercultural Cancer Council, Kidney Cancer Association,Multinational Association o Supportive Care in Cancer, National Center

or Frontier Communities, National Coalition or Cancer Survivorship,Research Advocacy Network, and The Wellness Community.

This patient booklet was made possible by aneducational grant rom Wyeth Pharmaceuticals.

INTRODUCTION page 2

FREQUENTLY ASKED QUESTIONS page 11

GLOSSARY (defnitions o blue bold aced words in the text) page 14

RESOURCES page 16

Presented by

Brian Rini, MDSta

Cleveland Clinic Taussig Cancer InstituteGlickman Urological Institute Associate Pro essor o MedicineCCF-CWRU Lerner College o MedicineCleveland, Ohio

David McDermott, MDClinical Director, Biologic Therapy ProgramBeth Israel Deaconess Medical Center

Assistant Pro essor o Medicine, Harvard Medical SchoolBoston, Massachusetts

Keith Lyons, MSWOncology Social Worker Cancer Care New York, NY


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Researchers have madeexciting progress in thetreatment of kidney cancer.

Each year, more than 54,000 people in the United States arediagnosed with kidney cancer. This type o cancer accounts or about two to three percent o adult cancers. No one knowswhat causes this cancer, but it usually occurs or no obviousreason and is rarely inherited. Kidney cancer is more commonin men than in women and usually a ects people between theages o 50 and 70.

Kidney cancer tends to be silent, causing no symptoms untilit has spread beyond the kidneys. In act, about 25 percent to30 percent o kidney cancers have already spread to other partso the body by the time they are diagnosed. The most commonsymptoms are blood in the urine, pain or pressure in the side or back, and a lump in the side or back (see box on page 5).

There are several di erent types o kidney cancer. Each is

named based on how its cancer cells look under a microscope.The most common, called clear cell kidney cancer, makes upabout 80 percent o all cases. The second most common type,called papillary, is ound in about 10 percent to 12 percent o people diagnosed. Other types, which occur rarely, includechromophobe, collecting duct cell, and undi erentiatedkidney cancer.

During the past 10 years, researchers have made a number o important discoveries about how kidney tumors develop. For example, researchers have ound changes in the genes thatpromote the growth o kidney cancer. These ndings have ledto the development o new types o medications or treatingkidney cancer.


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How the Kidneys WorkThe two kidneys, which are each about the size o a st, arelocated on both sides o the spine, in the back o the body.The kidneys serve as the bodys ltration system. Each daythey remove excess saltsand other substances

rom the roughly 200quarts o blood that

fows through them.

In the process, the kidneysproduce about two quartsof urine a day, which carrieswaste out of the body.The kidneys also producehormones that performmany functions, such ascontrolling blood pressure.

Each kidney worksindependently. Peoplecan live with only one kidney. I both kidneys ail to work, a dialysis machine can be used to lter the blood.

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Stages o Kidney CancerThe stage o kidney cancer is based on the size o the tumor and whether it has spread to other parts o the body. Knowingthe stage o the cancer helps determine the course o treatment. Kidney cancer is divided into our stages:

Stage I The tumor is small (less than 7 centimeters) andhas not spread beyond the kidney.

Stage II The tumor is larger than 7 centimeters.

Stage III The tumor has either:n begun to grow out o the kidney, into the

surrounding at tissue, or


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n spread to a nearby ly n de , or

n spread to the major blood vessels o the kidney.Stage IV The tumor has spread into more than one lymph

node, or it has spread extensively to other areas o the body, such as the lungs, bone, or brain.

Treatment OptionsSURGERYSurgery is the main treatment or kidney cancer that has not

yet spread. One technique that surgeons are using moreo ten is la ar sc y . For this technique, the surgeon makesseveral small incisions in the abdomen to insert a tiny light, acamera, and instruments used to view and remove the tumor.This type o surgery has been shown to be just as e ective as

traditional surgery and easier to recover rom.I cancer has spread beyond the kidneys, it is usually treatedwith surgery. A number o large studies o etastatic kidneycancer have shown that people whose tumors are removedlive longer than those whose tumors are not removed.

ImmUNoThERApYIn another type o treatment, called i un t era y ,medications are used to increase the bodys natural abilityto ght cancer. Two such drugsinterleukin-2 (Proleukin)and inter eron al a (Intron A, Ro eron-A)can cause somekidney tumors to shrink by more than hal . However,immunotherapy works in only 10 percent to 15 percent o patients.

Still, in about 5 percent to 10 percent o people with kidneycancer, interleukin-2 can lead to a long-term re issi n o metastatic cancer. In some cases the tumors evendisappear, and people have lived more than 20 years a ter their kidney cancer diagnosis. Researchers are trying to nd


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Signs and Symptomso Kidney Cancer p eople with kidney cancer may experience:n Blood in the urinen Pain or pressure in the side or backn

A lump in the side or backn Ankle and leg swellingn High blood pressuren Ane ia (low levels o red blood cells)n Weakness and atiguen Loss o appetiten Weight lossn Frequent evers

ways to identi y those patients most likely to bene t romimmunotherapy. Immunotherapy is o ten combined withnewer medications called targeted treatments.

TARGETED TREATmENTSUnlike chemotherapy, targeted treatments attack speci cmolecules and cell mechanisms thought to be important or cancer cell survival and growth. This speci c targeting helpsto spare healthy tissues and causes less severe side e ects.Research has shown that in general, adding these targetedtreatments to immunotherapyor using them instead o immunotherapynearly doubles the length o the time thatthe cancer is stopped rom growing.

Today, three targeted treatments are approved or peoplewith metastatic kidney cancer: sora enib (Nexavar), sunitinib(Sutent), and temsirolimus (Torisel).


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S ra enib (Nexavar) Sora enib was approved by the

U.S. Food and Drug Administration (FDA) in 2005 to treatmetastatic kidney cancer. It can be taken in pill orm.

Sora enib has been shown to shrink kidney tumors in manypeople who have already tried other treatments that didntwork. In a study o more than 900 people with kidney cancer,sora enib shrank kidney tumors in about 80 percent o patients.In addition, it was very e ective in slowing tumor growth.

Common side e ects o the medication, such as loose stools,are generally easy to treat.

Sora enib as well as sunitinib, discussed below, takes advantageo one o the things we know about how kidney tumors grow.

Much like normal tissues,tumors need to have ablood supply. Blood vessels

grow in several ways. Oneway is through the presenceo proteins called vascular endothelial g rowth actor (VEGF) and p latelet derivedg rowth actor ( pDGF ).These proteins stimulate

blood vessels to grow intotumors. When tumor cells spread through the body, theyrelease VEGF and PDGF to create new blood vessels. Theseblood vessels supply oxygen, minerals, and other nutrients to

eed the tumor. Sora enib works by stopping VEGF and PDGF rom stimulating the growth o new blood vessels in tumors.Because normal tissues have an established blood supply, theyare not a ected by the medication.

Sunitinib (Sutent) In 2006, the FDA approved sunitinib or treatment o metastatic kidney cancer. Like sora enib, sunitinibis a pill that can be taken by mouth. It is taken once a day or

our weeks, ollowed by a two-week break, then another our-week cycle.


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In clinical trials comparing sunitinib with the immunotherapy

inter eron, sunitinib was shown to stop the growth o metastatic kidney tumors or twice as long as inter eron.Because it is so e ective, sunitinib is o ten used as a rsttreatment or metastatic kidney cancer.

Researchers also have shown that sunitinib can shrinkkidney tumors in many people who have already tried other treatments that did not work. For example, in one study,

sunitinib was given to people who had been treated withimmunotherapy rst. Within about two months o takingsunitinib, more than 40 percent o these peoples tumors hadshrunk signi cantly. Tumors also shrank in another 25 percento these patients, though not as much. This res nse lasted

or at least a year.

The side e ects o sunitinib include atigue, mouth pain, hand

and oot pain, diarrhea, and high blood pressure.Te sir li us (T risel) In May 2007, the FDA approvedtemsirolimus or the treatment o metastatic kidney cancer.Temsirolimus works by blocking the actions o ToR , asubstance that acts like a master switch, turning on di erentmechanisms in cells that promote cancer growth. In clinicaltrials, people treated with temsirolimus were shown to livelonger than those treated with inter eron.

The side e ects o temsirolimus are similar to those o the other targeted treatments used or metastatic kidney cancer. Theyinclude rash, mouth sores, atigue, nausea, and sometimes lowblood cell counts.

On the HorizonClinical trials are currently under way to study a number o important issues:

n Researchers are trying to determine which medicationswork best or people with kidney cancer who have not

yet been treated. For example, researchers are looking or


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The Importance o Clinical TrialsTheres no question that clinical trials have led to advances incancer treatment, creating a brighter uture or people withcancer. Clinical trials are the standard by which we measurethe worth o new treatments and quality o li e as patients gothrough those treatments. For this reason, doctors and scientistsurge patients to take part.

Your doctor can guide you in making a decision about whether a clinical trial is right or you. Here are a ew things you shouldknow:

n O ten, patients who take part in clinical trials gain access to andbene t rom new treatments.

n Be ore you participate in a trial, you will be ully in ormed as tothe risks and bene ts o the trial.

n No patient receives a placebo (a look alike treatment with noactive ingredient) i there is a standard treatment available or the disease. Most trials are designed to test a new treatmentagainst a standard treatment to nd out whether the newtreatment has any added bene t.

n You can stop taking part in a clinical trial at any time or anyreason.

ways to identi y people who are most likely to bene t romtreatment with interleukin-2. Other clinical trials are trying toidenti y genetic changes in tumors that might help predictwhich patients will respond to a new medication, not yetapproved by the FDA, called everolimus, which blocks theactions o mTOR.

n Several large clinical trials are testing combinations o medications to treat kidney cancer. One o the largest iscalled the BeST trial, comparing various combinations


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o Bevacizumab (Avastin), Sora enib, and Temsirolimus.

The hope is that researchers will be able to identi y acombination that is more e ective than one drug alone.Bevacizumab is an FDA-approved targeted treatment or metastatic colon (or rectal), lung, and breast cancers. It isbeing studied alone and with other medications or peoplewith metastatic kidney cancer.

n Researchers are trying to nd the best time to start kidney

cancer treatment. While beginning treatment right a ter diagnosis is best or somepeople, waiting mightbe more appropriate or others.

n A number o clinical trialsare trying to understand

what happens when apatients treatment stopsworking against his or her kidney cancer. Tothat end, researchersare studying the newmedications axitinib, which blocks VEGF, and everolimus in

people whose cancer has stopped responding to treatmentwith sora enib and sunitinib. Like everolimus, axitinib has not yet been approved by the FDA.

n Researchers are testing the use o targeted treatments inpeople who have just had surgery or kidney cancer. Thehope is that treatment with sunitinib and sora enib a ter surgery might prevent a recurrence o kidney cancer.

Your Support Team When you are diagnosed with kidney cancer, youre aced witha series o choices that will have a major e ect on your li e, andmaybe youre not sure where to turn. But help is available. Your health care team, amily members, and riends will likely be an


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invaluable source o support at this time. You can also turn to

these resources:onc l gy s cial w rkers provide emotional support or people with cancer and their loved ones. These pro essionalscan help you cope with the challenges o a kidney cancer diagnosis and guide you to resources. Cancer Care o ers

ree counseling rom oncology social workers on sta whounderstand the challenges aced by people with kidney

cancer. We can work with you one-on-one to developstrategies or coping.

Su rt gr u s Many support groups are available or people with kidney cancer. Support groups provide a caring

environment inwhich you can share

your concerns with

others in similar circumstances.Support groupmembers cometogether to helpone another,providing insights

and suggestions onways to cope. AtCancer Care , people

living with cancer, caregivers, and loved ones can take part insupport groups in person, online, or on the telephone.

Financial assistance is o ered by a number o organizations,including Cancer Care , or cancer-related costs such as

transportation to treatment, child care, or help neededaround the home. Cancer Care also provides re errals to other organizations that o er assistance.

T learn re ab ut w Cancer Care el s, call us at1-800-813-hopE (4673) r visit www.cancercare. rg.


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KIDNEY CANCER

Q Is bevacizu ab ever c bined wit sunitinib r

s ra enib as a treat ent r kidney cancer?

A Yes. Although bevacizumab is not yet approved bythe FDA or kidney cancer, it is being tested in combinationwith sunitinib and sora enib in clinical trials. Combining themedications has to be done very care ully, however, becausesome o the side e ects o these medications are similar and

their severity may be increased when they are taken together.For example, all o these drugs can raise blood pressure,so blood pressure would have to be checked requently insomeone who takes both drugs at the same time. Until theresults o clinical trials are available, patients should not betaking more than one o these targeted treatments at a time.

Q Is s ra enib e ective in tu rs t at c ntaina illary cancer cells, r is it nly el ul againsttu rs wit clear cells?

A Sora enib has been tested mainly in people with clear cellkidney tumors, the most common type. But some preliminaryresearch suggests that the medication also may be e ective intreating papillary tumors, the second most common type o

kidney cancer. The FDA has approved sora enib or treatmento all types o metastatic kidney cancer, so the drug is an option or people with papillary tumors. However, more research iswarranted and clinical trials are o ten the best option or thosewith non-clear cell kidney cancer.

Frequently AskedQuestions


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Q I was taking s ra enib, and y d ct r decidedt l wer y d se because I was aving tr uble c ingwit t e side e ects t e drug. Is a l wer d se s ra enib as e ective as t e riginal, ull d se?

A At this time, we dont know. Lower doses may be just ase ective as higher doses, but this has never really been testedin a clinical trial. Thats why doctors try to start patients on therecommended dose and maintain that level.

Q Can e le be treated wit radiati n w ile t eyare taking ne t e new targeted treat ents?

A Right now, we dont have any research to show whether it would be sa e to undergo radiation while taking one o these new medications. However, studies designed to test the

sa ety and e ectiveness o combining radiation with targetedtreatment are now under way. Your doctor might be able togive you in ormation about whether such a clinical trial couldbe right or you.

Q my usband as a s all kidney tu rab uttw t t ree centi eters. We kn w e needs surgery,

but w at a ens a ter t at? A Generally, surgery is the only treatment required or tumors that small. Your doctor will discuss the type o procedure he or she recommends, but chances are the tumor will be removed with laparoscopy, in which a small openingis made in the abdomen. The surgeon will want to see your husband a ter the operation to make sure he is recovering well.

A ter that, your medical oncologist will ollow up with periodicblood tests to check kidney unction, as well as chest x-raysand scans o the abdomen and chest to make sure the kidneytumor has not come back. You can expect your husband tohave a checkup every three months or the rst year, every

our months or the second to th year, and yearly a ter that.


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Because there are currently no medicines that are proven to

prevent kidney cancer rom coming back a ter surgery, itsimportant to continue these screening tests.

Q I g ing t be treated wit interleukin-2 r etastatic kidney cancer. my d ct r says Ill ave t

be s italized during treat ent. W y is t at?

A Interleukin-2 is the most power ul medication currentlyused to treat metastatic kidney cancer. High doses o interleukin-2 cause severe side e ects in about 50 percent to60 percent o people. These e ects include low blood pressure,excess fuid in the lungs, kidney damage, heart attacks,bleeding, chills, and ever. For that reason, people treated withinterleukin-2 need to be watched care ully in the hospital, or aslong as 10 days. Only hospitals and cancer centers experienced

in treating people with high-dose interleukin-2 shouldrecommend (or advise against) its use.

Some doctors and hospitals use lower doses o interleukin-2,which have ewer and milder side e ects. But lower doses donot seem to be as e ective in treating kidney cancer as highdoses o the drug.

Q my d ct r believesand I agreet at sunitinibis rig t r e. But y ealt insurance d esnt c ver t e c st. h w can I get s e fnancial assistance?

A For many people, expensive cancer medicines pose a nancial challenge. Fortunately, there are more than 475programs that help those who quali y to get medications

or ree or at a low cost. For more in ormation, contact thePartnership or Prescription Assistance, listed among theresources on page 16. Cancer Care also provides nancialhelp to eligible amilies or cancer-related costs such astransportation to treatment, child care, or help neededaround the home. Contact us at 1-800-813-HOPE (4673) tolearn more.


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Glossary

ane ia A condition that can cause atigue, shortness o

breath, and other symptoms due to low levels o red bloodcells.

dialysis A process in which a persons blood is run through amachine that lters impurities. Dialysis is used in people whosekidneys are unable to lter blood.

i un t era y The use o medications that increase thebodys natural ability to ght cancer.

la ar sc y A surgical procedure in which several smallincisions in the abdomen are made to insert a tiny light, acamera, and instruments that view and remove the tumor.

ly n de A small ltering station that removes wasteand fuids and helps ght in ections. When invaded by cancer cells, lymph nodes are a jumping-o point rom which tumors

can spread throughout the body.etastatic Cancer that has spread rom its original site (in

this case, the kidney) to nearby lymph nodes or more distantparts o the body.

ToR A substance that acts like a master switch, turning ona number o di erent reactions in cells that promote cancer growth.


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pDGF This substance, p latelet d erived g rowth actor, plays

an important role in promoting the growth o blood vesselsthat eed tumors.

re issi n When a cancer responds to treatment or is under control. In a complete remission, none o the signs andsymptoms o the cancer can be detected through any availabletests. In a partial remission, the cancer shrinks but does notcompletely disappear. Remissions can last rom several weeks tomany years. I the cancer returns, another remission can occur with urther treatment.

res nse A medications e ect on a tumoreither shrinking itor stopping its growth.

VEGF This substance, vascular endothelial g rowth actor,stimulates blood vessels to grow in tumors. When tumor cellsspread throughout the body, they release VEGF and createnew blood vessels that supply the tumor cells with oxygen,minerals, and other nutrients.


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Resources

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Cancer Care 1-800-813-4673www.cancercare.org

A erican Cancer S ciety1-800-227-2345www.cancer.org

Cancer.Net(Patient website o the American Society o Clinical Oncology)www.cancer.net

Kidney Cancer Ass ciati n1-800-516-8051www.kidneycancer.org

Nati nal Cancer InstituteCancer In ormation Service1-800-422-6237www.cancer.gov

Nati nal C aliti n r Cancer Surviv rs i1-888-650-9127www.canceradvocacy.org

partners i r prescri ti n Assistance1-888-477-2669www.pparx.org

T e Wellness C unity1-888-793-9355www.thewellnesscommunity.org

T fnd ut ab ut clinical trials:Coalition o Cancer Cooperative Groupswww.CancerTrialsHelp.orgNational Cancer Institutewww.cancer.gov/clinicaltrials


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The information presented in this patient booklet is provided for your generalinformation only. It is not intended as medical advice and should not be reliedupon as a substitute for consultations with quali ed health professionals whoare aware of your speci c situation. We encourage you to take information andquestions back to your individual health care provider as a way of creating adialogue and partnership about your cancer and your treatment.

All people depicted in the photographs in this booklet are models and are used for illustrative purposes only.

This booklet was edited and produced by Elsevier Oncology.

2008 Cancer Care , Inc. All rights reserved.


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