ASSESSMENT OF PAIN ASSOCIATED WITH INJECTION AND SKIN REACTIONS ASSOCIATED WITH DEGARELIX INJECTION IN PROSTATE CANCER PATIENTS
—COMPARISON WITH CONVENTIONAL LEUPROLIDE AND GOSERELIN ACETATE—
○ Hidero Minami, Osamu Ueki, Sawako Ikeda, Yuko Kitano, Kouhei Kawaguchi
Department of Urology, and Outpatient Oncology Unit, Noto General Hospital,Nanao,Ishikawa,Japan
Purpose: Degarelix may lay an additional burden on patients compared with conventional LH-RH agonists because of, for example, two-site injections required for the initial administration. We therefore conducted a comparative assessment of pain associated with the initial injection of degarelix versus second and third injections, and we investigated skin reactions following the injections. Additionally, we also compared degarelix with leuprolide and goserelin acetate in pain associated with the injections
Patients and Methods: This study involved prostate cancer patients (N=62) who underwent following treatments at our hospital between October 2012 and March 2014: 25 patients who received degarelix (with 25G needles); 26 who completed at least 3 administrations of 11.25 mg leuprolide (with 23G needles); and 11 who completed at least 3 administrations of 10.8 mg goserelin acetate (with 14G needles). Nurses in the outpatient chemotherapy room injected the drugs to all patients subcutaneously in the abdomen without anesthesia. Immediately after the injections, pain was assessed using Visual Analogue Scale (VAS) and face scale (FS). Skin reactions were investigated by patient interview on the subsequent re-examination day. Pain assessment for the third administration of degarelix was used for comparison with other drugs.
Results: The assessment with VAS, but not FS, showed significant differences in pain between the initial and second injections (VAS:mean±SD: 27.54±22.21 vs. 17.77±18.78, p<0.05; FS: mean±SD: 1.40±0.90 vs. 1.36±0.95, p=0.84), and between the initial and third injections (VAS:mean±SD:27.54±22.21 vs. 18.45±20.03, p=0.06) (FS:mean±SD: 1.40±0.90 vs. 1.36±0.95, p=0.84).
No significant difference was noted in comparison with any other drugs regardless of VAS or FS: degarelix vs. leuprolide (VAS:mean±SD:19.27±17.94 vs. 14±10.42, p=0.23; FS:mean±SD:1.36±0.95 vs. 1.03±0.44, p=0.15); degarelix vs. goserelin acetate (VAS:mean±SD: 19.27±17.94 vs. 15.36±14.80, p=0.53; FS: 1.36±0.95 vs. 1.27±0.78, p=0.78).
Degarelix could be administered at least 3 times in 22 of 25 patients. Two patients requested to switch to a different drug because of pain from the skin reaction. One patient stopped visiting the doctor for the same reason and the treatment was difficult to continue.
Regarding skin reactions, itchiness was found in 13 of 22 patients (59%); induration, 6 of 22 (27%); swelling, 3 of 22 (14%); pain, 20 of 22 (90%); and erythema, 5 of 22 (23%).
Skin reactions that occurred in individuals varied. Symptoms were not necessarily alleviated with repeated administrations, and patients with no specific skin reactions upon the third injection were only 4 of 22 (18%).
Discussion:In a phase III clinical trial (CS21) conducted overseas, 57 of 207 cases (27.5 %) experienced injection-site pain and 36 of 207 cases (17.4%) experienced injection-site erythema. Post-injection skin reactions caused by Degarelix appear to be a serious issue. There was no difference in site pain by Degarelix compared with the other two drugs, regardless of the fact that the thinnest needle was used. Is this because of the skill of the medical staff injecting the individuals or the difference in individual pain sensation?
Conclusion:Degarelixshowed no significant difference from the other drugs regarding pain associated with the third injection, but significant pain was accompanied with the initial administration of degarelix, which involved two-site injections. Including pain from the skin reaction that rendered the treatment difficult to continue in 3 patients, skin reactions occurred with a large inter-patient variability and were suggested to have a major impact on QOL of patients.