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OsteosarcomaSpectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Osteosarcoma is a cancer of the bone that usually affects the large bones of the arm or leg. This cancer can also be called osteogenic sarcoma. This type of cancer usually starts in osteoblasts, which are a type of bone cell that grow into new bone tissue. Osteosarcoma is most common in teenagers and young adults. It commonly forms in the ends of the long bones of the body, which include bones of the arms and legs. In children and teenagers, it often develops around the knee. Rarely, osteosarcoma may be found in soft tissue or organs in the chest or abdomen.

Osteosarcoma can be localized or metastatic. If the osteosarcoma is localized the cancer has not spread out of the bone where it started. There may be one or more areas of cancer in the bone that can be removed during surgery. Metastatic osteosarcoma has spread from the bone in which the cancer began to other parts of the body. The cancer most often spreads to the lungs, but it may also spread to other bones. Whether the cancer is localized or metastatic will determine how the osteosarcoma is treated.

Possible signs of osteosarcoma include pain and swelling over a bone or a bony part of the body. These and other symptoms may be caused by osteosarcoma. Other conditions may cause the same symptoms. A doctor should be consulted if any of the following problems occur:

  • Swelling over a bone or bony part of the body.
  • Pain in a bone or joint.
  • A bone that breaks for no known reason.

After osteosarcoma has been diagnosed, tests are done to find out if cancer cells have spread to other parts of the body. The process used to find out if cancer has spread to other parts of the body is called staging. For osteosarcoma, most patients are grouped according to whether cancer is found in only one part of the body or has spread. The following tests and procedures may be used:

  • CT scan (CAT scan): A procedure that makes a series of detailed pictures of areas inside the body, such as the chest, taken from different angles. The pictures are made by a computer linked to an x-ray machine. A dye may be injected into a vein or swallowed to help the organs or tissues show up more clearly. This procedure is also called computed tomography, computerized tomography, or computerized axial tomography.
  • MRI (magnetic resonance imaging): A procedure that uses a magnet, radio waves, and a computer to make a series of detailed pictures of areas inside the body. This procedure is also called nuclear magnetic resonance imaging (NMRI).
  • Chest x-ray: An x-ray of the organs and bones inside the chest. An x-ray is a type of energy beam that can go through the body and onto film, making a picture of areas inside the body.
  • Bone scan: A procedure to check if there are rapidly dividing cells, such as cancer cells, in the bone. A very small amount of radioactive material is injected into a vein and travels through the bloodstream. The radioactive material collects in the bones and is detected by a scanner.

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Treatment for Osteosarcoma

There are different types of treatment for patients with osteosarcoma.

Different types of treatment are available for children with osteosarcoma. Some treatments are standard (the currently used treatment), and some are being tested in clinical trials. A treatment clinical trial is a research study meant to help improve current treatments or obtain information on new treatments for patients with cancer. When clinical trials show that a new treatment is better than the standard treatment, the new treatment may become the standard treatment.

Because cancer in children is rare, taking part in a clinical trial should be considered. Some clinical trials are open only to patients who have not started treatment. A link to a list of current clinical trials can be found on the National Cancer Institute website (http://www.cancer.gov).

Four types of standard treatment are used:

Surgery to remove the entire tumor will be done when possible. Chemotherapy may be given first, to make the tumor smaller so less tissue and bone needs to be removed. This is called neoadjuvant chemotherapy.

The following types of surgery may be done:

  • Wide local excision: Surgery to remove the cancer and some healthy tissue around it.
  • Limb-sparing surgery: Removal of the tumor in a limb (arm or leg) without amputation, so the use and appearance of the limb is saved. Most patients with osteosarcoma in a limb can be treated with limb-sparing surgery. The tumor is removed by wide local excision. Tissue and bone that are removed may be replaced with a graft using tissue and bone taken from another part of the patient's body, or with an implant such as artificial bone. If a fracture is found at diagnosis or during chemotherapy before surgery, limb-sparing surgery may still be possible in some cases. If the surgeon is not able to remove all of the tumor and enough healthy tissue around it, an amputation may be done.
  • Amputation: Surgery to remove part or all of an arm or leg. This may be done when it is not possible to remove all of the tumor in limb-sparing surgery. The patient may be fitted with a prosthesis (artificial limb) after amputation.
  • Rotationplasty: Surgery to remove the tumor and the knee joint. The part of the leg that remains below the knee is then attached to the part of the leg that remains above the knee, with the foot facing backward and the ankle acting as a knee. A prosthesis may then be attached to the foot.

Studies have shown that survival is the same whether the first surgery done is a limb-sparing surgery or an amputation. Even if the doctor removes all the cancer that can be seen at the time of the surgery, some patients may be given chemotherapy or radiation therapy after surgery to kill any cancer cells that are left. The treatment given after the surgery, either chemotherapy or radiation is called adjuvant therapy. The goal of adjuvant therapy is to lower the risk that the cancer will come back.

Chemotherapy is a cancer treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. When chemotherapy is taken by mouth or injected into a vein or muscle, the drugs enter the bloodstream and can reach cancer cells throughout the body (systemic chemotherapy). When chemotherapy is placed directly into the spinal column, an organ, or a body cavity such as the abdomen, the drugs mainly affect cancer cells in those areas (regional chemotherapy). Combination chemotherapy is the use of more than one anticancer drug. The way the chemotherapy is given depends on the type and stage of the cancer being treated.

Radiation therapy is a cancer treatment that uses high-energy x-rays or other types of radiation to kill cancer cells or keep them from growing. There are two types of radiation therapy. External radiation therapy uses a machine outside the body to send radiation toward the cancer. Internal radiation therapy uses a radioactive substance sealed in needles, seeds, wires, or catheters that are placed directly into or near the cancer. The way the radiation therapy is given depends on the type and stage of the cancer being treated.

Osteosarcoma is not killed easily by radiation therapy. This therapy may be used when a small amount of cancer is left after surgery or used together with other treatments.

Samarium is a radioactive drug that targets areas where bone cells are growing, such as tumor cells in bone. It helps relieve pain caused by cancer in the bone and it also kills blood cells in the bone marrow. Before treatment with samarium, stem cells (immature blood cells) are removed from the blood or bone marrow of the patient and are frozen and stored. After treatment with samarium is complete, the stored stem cells are thawed and given back to the patient through an infusion. These reinfused stem cells grow into (and restore) the body's blood cells.

The standard treatment options for osteosarcoma are determined based on the localized or metastatic state of the cancer.

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Localized Osteosarcoma

Treatment may include the following:

  • Surgery followed by adjuvant chemotherapy or radiation therapy. Most patients also receive chemotherapy before the surgery called neoadjuvant therapy.
  • Radiation therapy when the tumor cannot be completely removed by surgery.
  • A clinical trial of chemotherapy given before and after surgery, with or without biologic therapy.

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Metastatic Osteosarcoma

Lung Metastasis

When osteosarcoma spread, it usually spreads to the lung. Treatment of osteosarcoma and MFH with lung metastasis is usually chemotherapy followed by surgery to remove the cancer that has spread to the lung.

Bone Metastasis or Bone with Lung Metastasis

Osteosarcoma may spread to bone and/or the lung. Treatment may include the following:

  • Chemotherapy followed by surgery to remove the cancer followed by combination chemotherapy.
  • Surgery to remove the primary tumor followed by chemotherapy and surgery to remove cancer that has spread to other parts of the body.
  • A clinical trial of chemotherapy given before and after surgery, with or without biologic therapy.

Recurrent Osteosarcoma

Treatment of recurrent osteosarcoma may include the following:

  • Surgery to remove the tumor with or without chemotherapy.
  • Samarium followed by stem cell transplant using the patient's own stem cells, as palliative treatment to relieve pain and improve the quality of life.
  • A clinical trial of new types of treatment for patients whose cancer cannot be removed by surgery.

INDICATIONS AND USAGE

FUSILEV® (levoleucovorin) for injection is a folate analog indicated for:
Rescue after high-dose methotrexate therapy in osteosarcoma.
Diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.
Use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.

LIMITATIONS OF USE

FUSILEV is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress.

IMPORTANT SAFETY INFORMATION

Contraindications
FUSILEV is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.

Warnings and Precautions
Due to Ca++ content, no more than 16 mL (160 mg) of levoleucovorin solution should be injected intravenously per minute
FUSILEV enhances the toxicity of fluorouracil.
Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in HIV patients was associated with increased rates of treatment failure in a placebo-controlled study.

Adverse Reactions
Allergic reactions were reported in patients receiving FUSILEV.
Vomiting (38%), stomatitis (38%) and nausea (19%) were reported in patients receiving FUSILEV as rescue after high dose methotrexate therapy.
The most common adverse reactions (>50%) in patients with advanced colorectal cancer receiving Fusilev in combination with 5-FU were diarrhea, nausea and stomatitis.

Drug Interactions
FUSILEV may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible patients.

Reporting of Suspected Adverse Reactions
You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the FUSILEV (levoleucovorin) for injection full prescribing information for complete safety information.

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