Learn more

about bone pain

and its treatment

Cancer-Related Bone Pain

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IntroductionThis booklet has general informationabout metastasis (the spread of cancer),bone metastasis, bone pain and treat-ments. While your doctors are working on treating your cancer they are also looking to take care of other health problems. Pain can be a real problem. You can help your doctor help you by talking about pain.

What are metastases?Cancer cells can spread from the originaltumor (cancer) and be carried to otherparts of the body. When the cancer cellsstart growing in these new areas, theseare metastatic sites (sometimes alsocalled metastases or lesions). The mostcommon places for cancer to spread arethe lymph nodes, lungs, bones, liver, and brain.1

Sometimes there are no symptoms frommetastatic cancer. Metastases are oftenfound by x-rays, scans and other tests.Metastatic cancer may be treated withchemotherapy, radiation, hormone therapy, surgery, or other approaches.1

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Bone metastases and bone painSome cancers are more likely to spread to the bone than others. Prostate cancerand breast cancer are examples of tumorsthat tend to spread to bone when theymetastasize.1

The most common symptom of bonemetastases is bone pain. However, not all bone pain is caused by metastasesand not all bone metastases are painful. A doctor will find out the cause of bonepain and decide on the proper treatment.2

Some of the tests used to decide whetherpain is from bone metastases are x-raysand bone scans.

Bone pain may come and go at first, thenworsen over time. At first, the pain may beworse at night or when resting.2 Somepeople have more pain when they move.3

Your right to pain reliefYou can have pain during any part of thecancer treatment experience. Tell yourdoctor if you are having pain. You shouldnot have to trade off treatment of cancerfor treatment of pain. Your doctor under-stands the need to take care of both.

Pain does not mean that you are sicker oryour treatment will be stopped. Living withthe pain does not help make you better. Infact, you may feel more ready to fight thecancer when your pain is under control.

There are a number of ways to treat pain.These may be used alone or together tokeep pain under control. What you aregiven for pain may change over time. Ask for additional or different pain treat-ments if you need them. You have theright to ask that everything reasonable be done to manage your pain.

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Measuring painYour health care team will ask you questions about your pain. They may askyou about the kind of pain—sharp, dull,burning, etc. They will also ask how badthe pain is (“pain intensity”). This tellsthem if pain treatments are helping or ifthe pain is getting worse. Most often, thepain intensity is measured on a scale ofzero (no pain) to ten (worst pain possible).

Preparing for your office visit

To make the most of your time with thedoctor and nurse, and to help them bet-ter control your pain, it may be helpfulto think about these questions prior toyour visit.

• Where do I feel pain?

• How bad is the pain?

• What does the pain feel like (aching,burning, throbbing, stabbing, othersensations)?

• Has the pain changed over time? How?

• What makes the pain better or worse?

• What effect does the pain have on myability to sleep?

• What effect does the pain have on my appetite?

• How has the pain prevented movement or mobility?

• Does pain limit any of my daily activities?

• Are my current pain treatments working?

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Treating bone painTreatments specifically meant to addressthe pain of bone metastases include: analgesics (pain medicines), externalbeam radiation, and radiopharmaceuti-cals. These can be used alone or in combination.

AnalgesicsPain medicines may be added or given in higher doses when there is bone pain.Sometimes nonsteroidal anti-inflammatorydrugs (NSAIDs), such as acetaminophenand ibuprofen, are enough. When thesearen’t enough, morphine or morphine-likedrugs (sometimes called opioid analgesics)may be added.

External beam radiationFor bone pain limited to a few places, the doctors may use external radiation.Radiation treatment of bone metastasesusually takes 2 to 3 weeks of daily treatments.

RadiopharmaceuticalsA radiopharmaceutical combines aradioactive isotope with a drug that targets bone. After it is injected, the drugcarries most of the radiation to the areasof the bone where the cancer has spread.The rest of the medication not in the bone,including radiation, is washed out of thebody. Radiopharmaceuticals are used todeliver radiation therapy to multiple areasof bone metastases at the same time.

The rest of this booklet is about oneradiopharmaceutical, Quadramet®

(samarium Sm 153 lexidronam injection).

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What is Quadramet®?Quadramet® is a radiopharmaceutical indicated for relief of pain in patients whohave been confirmed to have metastaticbone lesions that can be seen on bone scans.

Quadramet® was made to accumulate inareas of bone turnover4 which commonlyoccurs when tumors spread to bone. The radiation in Quadramet® has a shorthalf-life, which means that it only lasts forabout a week. (Although the radiation isgone quickly, the pain relief effects canlast for months.) There’s more informationon radiation safety in the “precautions”section of this booklet.

Quadramet® is given by injection into avein, usually as an outpatient procedure.Although the injection itself only takes afew minutes, it takes time for the effectsof the treatment to be felt. In patientswhose pain decreases, relief will usuallybegin about one week after injection. In a small number of people (about 7% inclinical studies), pain will briefly get worse(pain flare). This pain is usually mild andgoes away on its own. During the flare the pain can be treated with analgesics.The greatest pain relief will usually happen3 to 4 weeks after the injection ofQuadramet®.4

What are the benefits ofQuadramet®?Quadramet® has lowered pain scores ofpeople in randomized clinical trials.4-6

Not all patients respond to Quadramet®.If you have pain relief, your doctor maysuggest that you lower your dose of painmedications. (Lowering doses of opioidsshould be done with the help of a doctoror nurse.) Pain relief may last for an average of 16 weeks following a singleinjection.6

Most patients who have relief can getanother injection if there is bone pain thatrecurs after the first injection.7

What are the side effects ofQuadramet®?The most common side effect withQuadramet® is bone marrow toxicity(white blood cell and platelet countsdecrease). This may increase the risk of infections or bleeding. In clinical trials,bone marrow toxicity occurred in 47% of patients. Other types of side effectsoccurring in at least 5% of patients andmore commonly than with a placeboincluded pain flare (7.0% vs 5.6% forplacebo), diarrhea (6.0% vs 3.3%), infection (7.0% vs 4.4%), spinal cordcompression (6.5% vs 5.5%), heartrhythm problems (5.0% vs 2.2%) andblood in the urine (5.0% vs 3.3%).4

What precautions must be takenafter Quadramet® administration?

Radiation safety4

• For several hours following administra-tion, radioactivity will be present in the urine

• To help protect yourself and othersaround you, care must be taken for 12 hours following administration

• Whenever possible, a toiletshould be used, rather thana urinal, and the toiletshould be flushed severaltimes after each use

• Spilled urine should becleaned up completely andhands washed thoroughly

• If blood or urine gets onto clothing, the clothingshould be washed sepa-rately, or stored for 1-2weeks to allow for decayof the radioactivity

• Drinking a minimum of 500 mL (8 oz) of fluids and urinating as often aspossible during the first few hours after the injectionminimizes radiation exposure in the bladder

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What other safety informationshould be considered?Due to the effects of Quadramet® on bloodcells, the doctor will take into account ifthere were problems with other treatmentsthat can lower blood counts beforeQuadramet® is selected. Becausechemotherapy and radiation therapy mayhave similar side effects, Quadramet® shouldnot be given at the same time as such treat-ments unless the clinical benefits outweighthe risks as determined by a doctor.

Caution should be exercised in treating peoplewith cancer whose platelet counts are fallingor who have other clinical or laboratory findingsthat may indicate conditions in which theblood’s ability to clot is reduced or impaired.

People taking Quadramet® should haveblood counts checked periodically for about8 weeks, or until their blood counts arereturning toward normal values.

Women of childbearing age should have anegative pregnancy test before administrationof Quadramet®. If Quadramet® is administeredto a nursing mother, formula feeding shouldbe substituted for breast feeding. Due to theradioactive nature of the product, men andwomen receiving Quadramet® should use aneffective method of contraception afteradministration.

Quadramet® should not be used in patientswho have known allergic reactions to thecomponents of Quadramet® or other similarphosphonate compounds.

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Another word about painYour doctors and nurses want to help you.Speak up about your pain so that you andyour healthcare team can work together toget it under control.

Notes and contact information

For more information about Quadramet®,please visit www.quadramet.com,www.cytogen.com or call us at 1-800-833-3533 and select option 5.

Additional helpful informationThese web sites are maintained by thirdparties. Cytogen Corporation is notresponsible for the content of these or anyother third party sites.

General cancer and pain resources:• American Cancer Society (cancer.org)

• American Pain Foundation (painfoundation.com)

• Cancer Care, Inc. (cancercare.org)

• Cancer Information Service of the NationalCancer Institute (cancer.gov)

Breast cancer resources:• BreastCancer.Org (breastcancer.org)

• National Breast Cancer Coalition (natlbcc.org)

• Y-ME National Breast Cancer Organization (y-me.org)

Prostate cancer resources:• National Prostate Cancer Coalition (4npcc.org)

• Prostate Cancer Foundation (prostatecancerfoundation.org)

• Us Too! (ustoo.com)

Multiple myeloma resources:• Multiple Myeloma Research Foundation

(multiplemyeloma.org)

• Leukemia and Lymphoma Society (leukemia.org)

© 2007 CYTOGEN Corporation All rights reserved. Q-0236-07

References:

1. National Cancer Institute. Fact Sheet: Metastatic Cancer: Questions and Answers. Version 6.20, 9/1/04. Available at:http://www.cancer.gov/PDF/FactSheet/fs6_20.pdf.Accessed May 11, 2007.

2. The Cancer Information Network. NCI Booklet: Dealing With BoneMetastasis. Available at:http://thecancer.net/article.php?id=28&cate1=Types%20of%20Cancer&cate2=Metastatic%20Cancer&cate3=Bone%20Metastasis.Accessed May 11, 2007.

3. Mercadante S, Villari P, Ferrera P, Casuccio A. Optimization of opioid therapy for preventing incident pain associated with bone metastases. J Pain Symptom Manage. 2004;28:505-510.

4. Quadramet (samarium Sm-153 lexidronam injection) prescribing information. September 2003.

5. Sartor O, Reid RH, Hoskin PJ, et al. Samarium-153-Lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer. Urology. 2004;63:940-945.

6. Serafini AN, Houston SJ, Resche I, et al. Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam:a double-blind placebo-controlled clinical trial. J Clin Oncol.1998;16:1574-1581.

7. Sartor O, Reid RH, Bushnell DL, Quick DP, Ell PJ. Safety and efficacyof repeat administration of samarium Sm-153 lexidronam to patients with metastatic bone pain. Cancer. 2007;109:637-643.