Nandrolone decanoate treatment in anemia of patients with cancer: Phase II clinical study.

Abstract

e19581 Background: Anemia is an important clinical problem in cancer patients. Nandrolone decanoate is an anabolic steroid that has been used to treat anemia in renal failure. It is considered one of the least virilizing preparations. We perform a study to evaluate the efficacy, safety and tolerability of nandrolone decanoate. Methods: Cancer patients(pts) with Hemoglobin (Hb) level < 10 g/dL, age ≥18 and ≤ 65 years,perfomance status (PS) 0-2, adequate hepatic functions,normal serum calcium and prothrombin time, life expectancy of at least 12 weeks, recovery from all acute toxicities of prior therapies were eligible. Weekly nandrolone decanoate was given intramuscularly 200 mg in male and 100 mg in female pts for 12 weeks. Target Hb was 12 g/dL.The research was approved by local ethics committee and funding by Thorek memorial foundation. Results: Twenty five out of thirty enrolled pts who were receving chemotherapy from 16 May 2008 to 4 October 2010 were eligible: 8 males,17 females,median age was 58 years (range 33-65),with 13 had lung cancer, 5 had cholangiocarcinoma and 1each patient for bladder, breast,stomach, rectum,colon, small cell cancer of orbit, giant cell tumor with lung metastasis. Reasons for 5 ineligible pts were increased liver enzyme (1), high fasting blood glucose (2), pneumonia (1), and history of erythropoietin usage(1). Twelve pts(48%) were responders (Hb increase ≥ 1 g/dL), by 24% respond within 4 weeks and 24% respond within 8 weeks. However the mean Hb at baseline, 4wk, 8wk and 12 wk were 9.1±0.6, 9.2±0.8, 9.5±1.1 and 9.9±1.7 g/dL respectively, which do not different significantly (p=.06) by repeated ANOVA test. Four pts (12%) did not comple the study because need blood transfusion. The common adverse events were smooth ski n (92%) weight gain (84%),mild erythema of face (64%), increased appetite (52%), mood swing (40%), edema (32%) and hoarseness (28%), fatigue (24%), myalgia/arthralgia (24%), increased LDL-cholesterol (20%), increased fasting blood glucose (16%), increased serum creatinine (16%), and penile erection(12%). Conclusions: Nandrolone decanoate appears to be feasible and safe allowing treatment of anemia in cancer pts. It may be an alternative choice of treatment of anemia in the future.