CCA

 

Cancer Care
Associates

  Lee Riley, MD, PhD
  Darius Desai, MD
  Susan Chang, MD

801 Ostrum Street
Bethlehem, PA
18015

Voice:
(610) 954-2140

FAX:
(610) 954-6055

St. Luke's Hospital & Health Network

 

Interleukin-2

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Overview Interleukin-2

Interleukin-2 IL-2, (PROLEUKIN®) is a recombinant human interleukin-2  for the treatment of metastatic melanoma (a type of skin cancer) and metastatic renal cell carcinoma (kidney cancer).  IL-2 therapy is a treatment that uses the body's natural immune system to fight cancer.

     Overview Interleukin-2
     Differences between Interleukin-2 and Chemotherapy
    
Who is Eligible for Interleukin-2 therapy?
     Managing Side Effects of Interleukin-2 therapy
     U.S Prescribing Information


PROLEUKIN IL-2
is the ONLY therapy FDA-approved for the treatment of metastatic renal cell cancer kidney cancer) and the FIRST therapy approved for the treatment of metastatic melanoma (a type of skin cancer) in 20 years. Studies have demonstrated that PROLEUKIN IL-2 offers the possibility of a complete and long-lasting remission in these diseases.

What is IL-2?

Interleukin-2 is a protein that occurs naturally in your body and plays an important role in activating your immune system, which protects the body from foreign substances, cells, and tissues by responding and resisting diseases. PROLEUKIN IL-2 is a genetically engineered or recombinant version of IL-2.  PROLEUKIN IL-2 possesses the same properties as naturally occurring IL-2 and activates the immune system to recognize and eliminate certain kinds of cancer cells.

  What is IL-2?

Your immune system is composed of various types of cells that kill and remove foreign substances from the body. IL-2 activates specialized defense cells called T cells and natural killer (NK) cells to attack and destroy invading germs or diseases. IL-2 can also stimulate these cells to attack and destroy cancerous tumors.

Differences between Interleukin-2 and Chemotherapy

When cancer reaches the most advanced stage, it has spread throughout the body and is termed metastatic, a stage where the cancer is spreading from the original site to other parts of the body. Chemotherapy has traditionally been the only treatment option at this stage.


There are many important differences between chemotherapy and interleukin-2 therapy.

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Chemotherapy involves drugs that directly kill cancer cells.

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Chemotherapy can also kill normal, healthy cells. This is why patients undergoing chemotherapy may experience negative side effects such as hair loss, mouth sores, low red blood cell counts, and low white blood cell counts.

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Interleukin-2 therapy, also known as an immunotherapy, uses the natural immune system to fight cancer.

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IL-2 produces T cell and Natural Killer (NK) cells to target and destroy cancer cells. Toxicities are caused by overstimulation of the immune system.

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IL-2 therapy is usually short and intensive—it generally requires two, 5-day cycles separated by a 9-day rest period.
 


As with other therapy for patients with cancer, not everyone responds to IL-2 therapy.

Who is Eligible for Interleukin-2 therapy?


PROLEUKIN® IL-2 is approved by the United States Food and Drug Administration (FDA) for the treatment of patients with either metastatic melanoma or metastatic renal cell cancer.

While PROLEUKIN IL-2 is one of the most effective treatments for these cancers, this therapy may not be appropriate for all patients. People starting PROLEUKIN IL-2 therapy should be at least 18 years old and in good overall health. The patient's heart, lungs, kidney, liver and central nervous system must all be functioning normally.

Overall health status has been shown to predict how a patient will respond to PROLEUKIN IL-2 therapy. Patients with good overall health have a greater chance of responding to treatment.

For more information on Interluekin-2 therapy go to links below and talk with your physicians.


Proleukin.com
www.kidneycancerassociation.org
www.kidney.org
www.melanoma.org

www.mpip.org

 

 

Managing Side Effects of Interleukin-2 therapy


While studies have shown that PROLEUKIN® IL-2 offers the possibility of a complete and long-lasting remission from metastatic melanoma and metastatic renal cell carcinoma, nearly all patients treated with PROLEUKIN IL-2 experience some side effects. In some cases, side effects can be severe, even life threatening, making treatment difficult to endure.

Since 1985, PROLEUKIN IL-2 has been administered to thousands of patients. As experience with PROLEUKIN IL-2 has increased over the years, physicians have learned about most of the side effects that appear and how to best manage them. In the majority of patients, side effects happen only during treatment, and most side effects are treatable and resolve within three days following the end of therapy. For this reason, PROLEUKIN IL-2 therapy must be administered in a hospital setting. However, due to the potential risks posed by side effects, PROLEUKIN IL-2 is recommended only for patients who are in generally good health prior to the start of treatment.

The following is a list of side effects reported in clinical trials involving 525 patients with either >metastatic renal cell carcinoma (kidney cancer) or metastatic melanoma (a type of skin cancer) who received PROLEUKIN IL-2 therapy.

Adverse events* from patients with metastatic melanoma and metastatic renal cell carcinoma who were treated with PROLEUKIN IL-2

 

Body System Grade 3 Grade 4 All Events
Body as a Whole
Chills
Fever
Malaise
Infection

70 (13%)
29 (6%)
43 (8%)
29 (6.0%)

0 (0%)
5 (1%)
0 (0%)
7 (1%)

271 (52%)
154 (29%)
143 (27%)
66 (13%)
Cardiovascular System
low blood pressure (hypotension)
Cardiovascular disorder

205 (39)
36 (7)

15 (3%)
7 (1%)

375 (71%)
59 (11%)
Digestive System
Diarrhea
Vomiting
Nausea
Nausea and Vomiting

113 (22%)
111 (21%)
25 (5%)
25 (5%)

10 (2%)
7 (1%)
0 (0%)
2 (0%)

350 (67%)
261 (50%)
186 (35%)
101 (19%)
Hemic and Lymphatic System
Low platelet count
Low red cell count

59 (11%)
15 (3%)

5 (1%)
1 (0%)

192 (37%)
150 (29%)
Metabolic and Nutritional
Bilirubinemia
Creatinine increase
SGOT increase

30 (6%)
14 (3%)
17 (3%)

13 (2%)
5 (1%)
3 (1%)

210 (40%)
174 (33%)
122 (23%)
Nervous System
Confusion
Somnolence
 

57 (11%)
19 (4%)

5 (1%)
2 (0%)

177 (34%)
115 (22%)
Respiratory System
Shortness of breath (dyspnea)
Respiratory disorder

52 (10%)
15 (3%)

5 (1%)
14 (3%)

224 (43%)
59 (11%)
Urogenital System
Oliguria
Anuria

137 (26%)
13 (1%)

33 (6%)
25 (5%)

333 (63%)
36 (7%)

*Grade 3 or 4 adverse events in greater than or equal to 3% of all patients treated (N=525). Grade 4 refers to life-threatening adverse events.

The rate of drug-related deaths in the 255 metastatic renal cell carcinoma patients who received PROLEUKIN IL-2 was 4% (11/255); the rate of drug-related deaths in the 270 metastatic melanoma patients who received PROLEUKIN IL-2 was 2% (6/270).

PROLEUKIN IL-2 therapy often results in Capillary Leak Syndrome (CLS). CLS occurs when fluid escapes from blood vessels to the surrounding tissue. In early studies of PROLEUKIN IL-2, this syndrome was not well understood or managed. As a result, some patients died. CLS can cause a drop in blood pressure and decrease blood flow to body organs. This syndrome may have side effects such as changes in the rhythm of the heart beat, severe chest pain, difficulty breathing, heart attacks, decreased function of the kidneys, and decreased mental alertness that may result in a coma if PROLEUKIN IL-2 is not discontinued.

PROLEUKIN IL-2 can also cause infections to get worse. Any existing infection must be adequately treated before starting treatment with PROLEUKIN IL-2.

PROLEUKIN IL-2 is typically given to patients in generally good health without any previous heart, lung or kidney problems. PROLEUKIN IL-2 therapy must be administered in a hospital by a doctor and healthcare team experienced in treating patients with cancer.

 

U.S Prescribing Information

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