A patient’s overall health status is an extremely important factor in identifying your adult mRCC or mM patients who may benefit from Proleukin. Nearly all the patients in the pivotal Proleukin clinical trials had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.1,2,*
Both younger and older patients may be candidates for Proleukin
A patient’s physiological age may actually be younger (or older) than their calendar age. Performance status is determined by multiple physiological factors, and age should not be a limiting factor when considering treatment with Proleukin.3 Of those patients who experienced a durable complete response in the Proleukin clinical trials, their age at treatment varied by decades.1,2
What does ECOG PS 0 or 1 mean?
- PS 0: patient is fully active and able to carry on all predisease performance without restriction4,5
- PS 1: patient is restricted in physically strenuous activity, but ambulatory, and is able to carry out work of a light or sedentary nature (eg, light housework, office work)4,5
Setting patients' treatment schedule expectations
With Proleukin, patients should expect to commit to (typically) two 5-day treatment cycles in a specialized IL-2 Treatment Center, with 9 days of rest in between.3
Does your patient have other serious health problems?
Only patients with normal cardiac and pulmonary functions should receive Proleukin. The checklist below provides important patient selection considerations that can make all the difference with Proleukin.
Careful patient selection is mandatory prior to the administration of Proleukin. Please see “CONTRAINDICATIONS,” “WARNINGS,” and “PRECAUTIONS” sections in the full Prescribing Information, regarding patient screening, including recommended cardiac and pulmonary function tests and laboratory tests.
*mRCC: PS 0 = 65% and PS 1 = 31%; mM: PS 0 = 71% and PS 1 = 27%.1,2
Adult mRCC or mM patients with ECOG PS of 0 or 1.a
No: active CNSb metastases, organ transplants, autoimmune diseases, inflammatory disorders, infection.
Normal: pulmonary, cardiac, renal, hepatic, CNS function.
Patient is referred to a specialized IL-2 Treatment Center.
Proleukin treatment cycle 1 is administered over 5 days.c
Patient rests at home for about 9 days.
Proleukin treatment cycle 2 is administered over 5 days.c
Or an equivalent Karnofsky score.
CNS = central nervous system.
Treatment with Proleukin is typically based on two 5-day cycles that constitute 1 course of therapy, with 9 days of rest in between. Patients who respond to Proleukin can go on to receive additional courses, while nonresponders are typically eligible for other treatment options.3
Use this checklist to help determine if Proleukin may be right for your patients. If you check all the boxes, consider referring your patient to a specialized IL-2 Treatment Center for Proleukin therapy.
- ECOG PS of 0 or 1,3 or an equivalent Karnofsky score
- Active central nervous system (CNS) metastases
- Any organ transplant
- Autoimmune diseases, including scleroderma, bullous pemphigoid, and myasthenia gravis
- Inflammatory disorders, including Crohn’s disease, inflammatory arthritis, and thyroiditis
- Pulmonary: FEV1 > 2 liters or ≥ 75% of predicted for height and age3
- Cardiac: normal ejection fraction and unimpaired wall motion on thallium stress test3
- Renal: serum creatinine ≤ 1.5 mg/dL and creatinine clearance > 60 mL/min3,6
- Hepatic: bilirubin ≤ 2 mg/dL7
- CNS: normal CNS function3
References: 1. Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995;13(3):688-696. 2. Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17(7):2105-2116. 3. Proleukin [package insert]. Yardley, PA: Clinigen, Inc; 2019. 4. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655. 5. Sørensen JB, Klee M, Palshof T, Hansen HH. Performance status assessment in cancer patients. An inter-observer variability study. Br J Cancer. 1993;67(4):773-775. 6. Jarkowski A III, Wong MKK. A re-assessment of the safety and efficacy of interleukin-2 for the treatment of renal cell carcinoma. Clin Med Ther. 2009;1:527-540. 7. Schwartzentruber DJ. Guidelines for the safe administration of high-dose interleukin-2. J Immunother. 2001;24(4):287-293.