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Successful recovery from multiple organ failure associated with bicalutamide and leuprorelin acetate for prostate cancer.

ABSTRACT: I report a case of multiple organ failure (acute kidney injury, interstitial pneumonitis and liver dysfunction) associated with combined androgen blockade(CAB) with bicalutamide and leuprorelin acetate for prostate cancer that was successfully managed by prompt hemodialysis and withdrawal of medications. Finally, patient received orchiectomy for the treatment of prostate cancer, and the histology of renal biopsy revealed drug-induced tubulointerstitial nephritis. Although the condition is extremely rare, urologists should be aware of CAB-induced organ failures such as those of the lung, kidney and liver. It should also be noted that urologists should not initially prescribe long-acting Gn-RH.

SUBMITTER: Saito S

PROVIDER: S-EPMC6951477 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Successful recovery from multiple organ failure associated with bicalutamide and leuprorelin acetate for prostate cancer.

Saito Seiichi S

Urology case reports 20191219

I report a case of multiple organ failure (acute kidney injury, interstitial pneumonitis and liver dysfunction) associated with combined androgen blockade(CAB) with bicalutamide and leuprorelin acetate for prostate cancer that was successfully managed by prompt hemodialysis and withdrawal of medications. Finally, patient received orchiectomy for the treatment of prostate cancer, and the histology of renal biopsy revealed drug-induced tubulointerstitial nephritis. Although the condition is extrem ...[more]

PMID: 31934548

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Project description:BackgroundThe incidence and mortality rate of men with prostate cancer have been increasing in Asia. ELIGARD® is a formulation of leuprorelin acetate whose safety and efficacy have been well-established in Western regions. However, limited safety data are available for Asian populations.MethodsELIGANT (ELIGard AsiaN sTudy) was a Phase 4, multicenter, prospective, single-arm, interventional study. Men with locally advanced or metastatic prostate cancer without concomitant chemotherapy, or another androgen receptor pathway inhibitor, were enrolled across Asia to receive ELIGARD® (22.5 mg subcutaneous depot injection) every 3 months for 15 months, with a follow-up visit at 18 months. The primary objective was to establish the safety of ELIGARD® in Asian men with hormone-dependent prostate cancer. The secondary objectives were to assess efficacy, via prostate-specific antigen (PSA) progression and testosterone levels, and health-related quality of life (HRQoL).ResultsIn total, 106 patients were included in the safety analysis set (SAF). The most common treatment-emergent adverse events (TEAEs) included PSA increase, cough, back pain, hot flush, anemia, and upper respiratory tract infection. TEAEs considered related to ELIGARD® were reported in 13.2% of patients (n=14), two of which were serious. In the full analysis set (FAS) (n=105), 81.2% (n=56) and 68.5% (n=61) of patients achieved a PSA reduction of ≥90% from baseline at 12 and 18 months, respectively. At 18 months, the numbers of patients with testosterone levels <20, 20-50, and >50 ng/dL were 65 (61.9%), 17 (16.2%), and two (1.9%), respectively; 20% had missing testosterone measurements. HRQoL remained stable throughout the study with minimal change from baseline at study completion.ConclusionsIn conclusion, the safety profile of ELIGARD® (22.5 mg) in Asian men with hormone-dependent prostate cancer is comparable to previous studies in Western regions.Trial registrationClinical trial registration number NCT03035032.

Dataset Information

Successful recovery from multiple organ failure associated with bicalutamide and leuprorelin acetate for prostate cancer.

Publications

Successful recovery from multiple organ failure associated with bicalutamide and leuprorelin acetate for prostate cancer.

Similar Datasets

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