Multicenter extension and switch study evaluating the safety of long-term treatment with abiraterone acetate fine particle formulation (AAFP) in patients with metastatic castration-resistant prostate cancer (mCRPC): The STAAR-E study
| Autor: | Bill Bosch, William Oh, Richard Levin, Jillian Chapas-Reed, Robert Given, Paul Nemeth |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Cancer Research
medicine.medical_specialty business.industry Incidence (epidemiology) Abiraterone acetate Urology Castration resistant medicine.disease chemistry.chemical_compound Prostate cancer Oncology chemistry Methylprednisolone Prednisone Medicine In patient Adverse effect business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 36:181-181 |
| ISSN: | 1527-7755 0732-183X 0296-2284 |
| DOI: | 10.1200/jco.2018.36.6_suppl.181 |
| Popis: | 181 Background: The STAAR-study results showed novel AAFP 500 mg is therapeutically equivalent to originator abiraterone acetate (OAA) 1000 mg in men with mCRPC (Stein et al. Urologic Oncol). This STAAR-extension study evaluates the safety of ≤ 1 year of additional AAFP treatment in men with mCRPC. Methods: Patients were enrolled in the extension if they had: 1) mCRPC; 2) successfully completed 84 days of treatment with either AAFP + methylprednisolone (MP) or OAA + prednisone (PDN) in the STAAR-study; and 3) received their last dose of STAAR-study treatment < 45 days of starting this extension study. All patients continued or switched to AAFP 500 mg QD + 4 mg MP BID. Serum testosterone and PSA levels are measured at 6 and 12 months. Safety evaluations include adverse event (AE) incidence, clinical laboratory test results, and vital signs. Results: 20 patients were enrolled in the ongoing study (11 were switched to AAFP from OAA and 9 continued on AAFP). Median age is 76.5 years, and median AAFP treatment duration (STAAR + STAAR-E) is 178 days as of 8/16/17. Ten patients have been treated with AAFP > 9 months; 3 of these for > 1 year. Three patients discontinued due to progressive disease (n=1), fatigue (n=1), and a fall (non-AAFP related) resulting in death (n=1). No adverse events related to liver enzyme or bilirubin increases have been reported (Table). Conclusions: In this extension study in men with mCRPC, the safety profile of AAFP, regardless of prior treatment with OAA or AAFP, is consistent with that of OAA reported in the literature. Based on these results, longer-term treatment with AAFP + MP has acceptable safety, and patients on OAA + PDN treatment can switch to AAFP + MP successfully. Clinical trial information: NCT02962284. [Table: see text] |
| Databáze: | OpenAIRE |
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