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Treatment Name: Inotuzumab Ozogamicin (Besponsa®)

Inotuzumab Ozogamicin (Besponsa®) is a Treatment Regimen for Acute Lymphoid Leukemia (ALL)

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References

1) Kantarjian HM, DeAngelo DJ, Stelljes M, et al. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016;375:740-753.

Created: February 14, 2019 Updated: February 14, 2019

What is Acute Lymphoid Leukemia (ALL)?

Acute Lymphoid Leukemia (ALL), also known as acute lymphoblastic leukemia, is a disease of the lymphoid cells found in the bone marrow. Lymphoid cells are responsible for developing into cells of the immune system called B-cells, T-cells, or Natural Killer cells. In ALL, immature lymphoid cells know as "blasts" replicate at a very fast rate. Sometimes blasts crowd out the normal cells in the bone marrow so that red blood cells or platelets are unable to develop.

Common symptoms of ALL include fatigue, infection, and bruising or bleeding. ALL is the most common cancer diagnosed in children, but is rare in adults. Most cases of ALL are considered "de novo" meaning that the cause is unknown; however, some cases can be linked to certain genetic syndromes. There is no staging system for ALL. Chromosomes are often analyzed to determine which mutations in the chromosomes exist. The effectiveness of the treatment may depend upon the specific chromosome mutations that are present.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose your therapy.

Common inotuzumab ozogamicin (Besponsa®) starting doses

  • Induction therapy: Inotuzumab ozogamicin 0.8 mg/m2 intravenous (I.V.) infusion over 60 minutes on Day 1, then 0.5 mg/m2 I.V. infusion over 60 minutes on Days 8 and 15
    • If in complete response: Inotuzumab ozogamicin 0.5 mg/m2 I.V. infusion over 60 minutes on Days 1, 8, and 15
    • If not in complete response: Inotuzumab ozogamicin 0.8 mg/m2 I.V. infusion over 60 minutes on Day 1, then 0.5 mg/m2 I.V. infusion over 60 minutes on Days 8 and 15

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status, 2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What is QTc interval? Arsenic

The time it takes your heart to make one beat can be measured using an electrocardiogram (ECG, or EKG) and is reported as the QTc interval. Arsenic is generally safe to give when the QTc interval for men is less than 450 milliseconds per beat, and for women, less than 460 milliseconds per beat.

The QTc interval is prolonged if the heart takes too long to make the next beat, and could lead to a dangerous heartbeat known as an arrhythmia.

Certain medications, in addition to arsenic, may prolong the QTc interval. The list includes: ondansetron (Zofran®), Levofloxacin or ciprofloxacin antibiotics. Make sure your pharmacist checks all new medications to make sure they do not prolong the QTc interval.

VOD

Veno-occlusive disease (VOD), otherwise known as sinusoidal obstructive syndrome (SOS), is a serious liver condition where the small blood vessels in the liver are damaged and become blocked by small blood clots. This can cause decreased blood flow through the liver and can severely damage liver cells and lead to liver failure.