Proleukin (aldesleukin) Recombinant IL-2: Go short, think long

Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic melanoma (mM)renal cell carcinoma (mRCC).

All photos are of actual Proleukin patients who are cancer survivors.

Individual results may vary.

Stan Adler

Stan Adler

NED Since 2006

My relationship with melanoma goes back more than 30 years. At the age of 70, a mole on my father’s back began to bleed and 18 months later, he was gone. Metastatic melanoma. So, at the age of 29, I started going to the dermatologist and having myself checked regularly. Because I was so diligent, it was a surprise when 20 years later, my wife found a mole on my back in the same spot my father had his. The biopsy confirmed it was melanoma. But after a wide local excision to remove the small growth, the doctors assured me they “got it all.” They were right. But they were only correct for four years and nine months.

On a trip to the Dominican Republic in March of 2005, I began feeling sick, but thought it was something in the water – Montezuma’s Revenge. When this feeling persisted upon my return home, I went to my gastroenterologist who did a battery of tests that revealed nothing so he sent me to get a CT scan. My doctor called me after and said, “We have serious findings.” And on that phrase my life changed forever. I was told that I had tumors on my liver, lungs and lymph nodes that were “too numerous to count.” He asked me to come to the office the next day and to bring my wife. The next morning he told us we better get our affairs in order because there really wasn’t anything that could be done and that I had six months to live. He gave me the name of the head of the melanoma practice at one of the leading hospitals in New York City and wished me luck.

Even though I was only 52 years old, I felt I had gotten my good share out of life. Yet, I was determined to show them that a person could face even this ultimate challenge with dignity, grace, courage, determination and even a sense of humor.

Immersing myself in research about stage IV melanoma, I identified the top doctors and treatment centers. I met with four doctors and learned that my options were limited.

“I chose to be treated with Proleukin, despite the notoriety of the side effects, because I felt it gave me the best chance of survival.”

I had a total of 45 doses during six separate hospitalizations. Proleukin did not disappoint in terms of both the number and severity of its side effects. I had at least one of everything on the list including diarrhea, nausea and feeling like I had the worst case of the flu. But the nurses and doctors were great and the side effects reversed themselves each time. After just a few days, I was back at work in between my treatments.

Proleukin also did not disappoint in its results. My CT scans showed my tumors shrinking and disappearing.

“As of September 2006, I have been declared NED – No Evidence of Disease – as close to the word cure as they let you get.”

Since my treatment I have been blessed to see all three of my children married. I have three wonderful grandchildren with two more on the way, a completely rearranged set of priorities and it’s been quite a ride.

Now I’m determined to not fall back on “business as usual.” I have a constant awareness that I’ve been given a second chance and I’m determined to give back to those fighting this terrible disease – to try and help as many people as I can understand that knowledge is power and that they have to get involved and stay involved with their treatment. To recognize that today, more than ever, there are lots of people like me who have made it despite the odds.

Serial Hobbyist:

  • Sports
  • Furniture building
  • Gardening
  • Model railroading
  • Coin collecting among others.

Fun Facts:

  • I met my wife in summer camp when we were teenagers.
  • All three of my married kids live within 15 minutes of my refrigerator.
  • I still run the company I started when I was 26 years old.
  • I have been to 45 of the 50 states.

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Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic melanoma (mM) and metastatic renal cell carcinoma (mRCC). Individual results may vary.

Summary of Important Safety Information for Proleukin® (aldesleukin) for injection, for intravenous infusion

WARNINGS

Therapy with Proleukin® (aldesleukin) should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Extreme caution should be used in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.

Proleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

Proleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

Proleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to initiation of Proleukin therapy. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.

Proleukin administration should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

INDICATION AND USAGE

Proleukin® (aldesleukin) is indicated for the treatment of adults with metastatic renal cell carcinoma (metastatic RCC).

Proleukin is indicated for the treatment of adults with metastatic melanoma.

Careful patient selection is mandatory prior to the administration of Proleukin.

Evaluation of clinical studies to date reveals that patients with more favorable ECOG performance status (ECOG PS 0) at treatment initiation respond better to Proleukin, with a higher response rate and lower toxicity. Therefore, selection of patients for treatment should include assessment of performance status.

Experience in patients with ECOG PS >1 is extremely limited.

CONTRAINDICATIONS

Proleukin® (aldesleukin) is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the Proleukin formulation.

Proleukin is contraindicated in patients with an abnormal thallium stress test or abnormal pulmonary function tests and those with organ allografts. Retreatment with Proleukin is contraindicated in patients who have experienced the following drug-related toxicities while receiving an earlier course of therapy: Sustained ventricular tachycardia (≥5 beats), Cardiac arrhythmias not controlled or unresponsive to management, Chest pain with ECG changes, consistent with angina or myocardial infarction, Cardiac tamponade, Intubation for >72 hours, Renal failure requiring dialysis >72 hours, Coma or toxic psychosis lasting >48 hours, Repetitive or difficult to control seizures, Bowel ischemia/perforation, GI bleeding requiring surgery.

WARNINGS

Because of the severe adverse events which generally accompany Proleukin® (aldesleukin) therapy at the recommended dosages, thorough clinical evaluation should be performed to identify patients with significant cardiac, pulmonary, renal, hepatic, or CNS impairment in whom Proleukin is contraindicated. Patients with normal cardiovascular, pulmonary, hepatic, and CNS function may experience serious, life-threatening or fatal adverse events. Adverse events are frequent, often serious, and sometimes fatal.

Should adverse events, requiring dose modification occur, dosage should be withheld rather than reduced.

Proleukin has been associated with exacerbation of pre-existing autoimmune disease and inflammatory disorders. In some cases, the onset of new autoimmune diseases, such as vitiligo, may occur. Symptomatic hyperglycemia and/or diabetes mellitus have been reported during Proleukin therapy.

All patients should have thorough evaluation and treatment of CNS metastases and have a negative scan prior to receiving Proleukin therapy. New neurologic signs, symptoms, and anatomic lesions following Proleukin therapy have been reported in patients without evidence of CNS metastases. Neurologic signs and symptoms associated with Proleukin therapy usually improve after discontinuation of Proleukin therapy; however, there are reports of permanent neurologic defects. In patients with known seizure disorders, extreme caution should be exercised as Proleukin may cause seizures.

PRECAUTIONS

Patients should have normal cardiac, pulmonary, hepatic, and CNS function at the start of therapy. Capillary leak syndrome (CLS) begins immediately after Proleukin® (aldesleukin) treatment starts and is marked by increased capillary permeability to protein and fluids and reduced vascular tone.

Proleukin® (aldesleukin) treatment should be withheld for failure to maintain organ perfusion as demonstrated by altered mental status, reduced urine output, a fall in the systolic blood pressure below 90 mm Hg or onset of cardiac arrhythmias.

Recovery from CLS begins soon after cessation of Proleukin therapy. Usually, within a few hours, the blood pressure rises, organ perfusion is restored and reabsorption of extravasated fluid and protein begins.

Kidney and liver function are impaired during Proleukin treatment. Use of concomitant nephrotoxic or hepatotoxic medications may further increase toxicity to the kidney or liver.

Mental status changes including irritability, confusion, or depression which occur while receiving Proleukin may be due to bacteremia or early bacterial sepsis, hypoperfusion, occult CNS malignancy, or direct Proleukin-induced CNS toxicity. Patients should be evaluated for these and other causes of mental status changes. Alterations in mental status due solely to Proleukin therapy may progress for several days before recovery begins. Rarely, patients have sustained permanent neurologic deficits.

Proleukin enhancement of cellular immune function may increase the risk of allograft rejection in transplant patients.

Serious manifestations of eosinophilia involving eosinophilic infiltration of cardiac and pulmonary tissues can occur following Proleukin.

ADVERSE REACTIONS

The rate of drug-related deaths in the 255 metastatic RCC patients who received single-agent Proleukin® (aldesleukin) was 4% (11/255); the rate of drug-related deaths in the 270 metastatic melanoma patients who received single-agent Proleukin was 2% (6/270).

In clinical trials, the following life-threatening (Grade 4) adverse events were seen in >1% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with Proleukin: oliguria (6%), anuria (5%), hypotension (3%), respiratory disorder (3%), bilirubinemia (2%), coma (2%), diarrhea (2%), acidosis (1%), acute kidney failure (1%), apnea (1%), cardiovascular disorder (1%), coagulation disorders (1%), confusion (1%), creatinine increase (1%), dyspnea (1%), fever (1%), heart arrest (1%), infection (1%), myocardial infarction (1%), psychosis (1%), sepsis (1%), SGOT increase (1%), stupor (1%), supraventricular tachycardia (1%), thrombocytopenia (1%), ventricular tachycardia (1%), and vomiting (1%). From the same trials, the following adverse events (Grades 1-4) were seen in ≥30% of 525 patients (255 with metastatic renal cell cancer and 270 with metastatic melanoma) treated with Proleukin: hypotension (71%), diarrhea (67%), oliguria (63%), chills (52%), vomiting (50%), dyspnea (43%), rash (42%), bilirubinemia (40%), thrombocytopenia (37%), nausea (35%), confusion (34%), and creatinine increase (33%).

Please see the full Prescribing Information, including Boxed Warning, for Proleukin® (aldesleukin) for injection, for intravenous infusion.

The content contained in this website is not intended to be a substitute for professional medical advice related to any topic discussed. Patients are urged to consult with their treating physicians or other professionals. Never disregard professional, medical, or legal advice or delay seeking such advice because of something you have read on this website.