1. Radium-223 for patients with metastatic castration-resistant prostate cancer with asymptomatic bone metastases progressing on first-line abiraterone acetate or enzalutamide: A single-arm phase II trial.
- Author
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Carles, Joan, Alonso-Gordoa, Teresa, Mellado, Begoña, Méndez-Vidal, María J., Vázquez, Sergio, González-del-Alba, Aránzazu, Piulats, Josep M., Borrega, Pablo, Gallardo, Enrique, Morales-Barrera, Rafael, Paredes, Pilar, Reig, Oscar, Garcías de España, Carmen, Collado, Ricardo, Bonfill, Teresa, Suárez, Cristina, Sampayo-Cordero, Miguel, Malfettone, Andrea, and Garde, Javier
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RADIUMTHERAPY , *ANTIANDROGENS , *CLINICAL trials , *CONFIDENCE intervals , *METASTASIS , *ABIRATERONE acetate , *BONE tumors , *GENE expression , *ANEMIA , *EXTRACELLULAR space , *DRUG side effects , *THROMBOCYTOPENIA , *NUCLEIC acids , *PATIENT safety - Abstract
The paper aims to evaluate the efficacy and safety of 223Ra in patients who progressed after first-line androgen deprivation therapy. EXCAAPE (NCT03002220) was a multicentre, single-arm, open-label, non-controlled phase IIa trial in 52 patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases who have progressed on abiraterone acetate or enzalutamide, up to six doses of 223Ra (55 kBq/kg of body weight per month). The primary end-point was radiographic progression-free survival (rPFS). Secondary end-points included rPFS based on androgen receptor splice variant 7 (AR-V7) expression in circulating tumour cells (CTCs), overall survival, and safety. Median rPFS was 5.5 months (95% CI 5.3–5.5). Median rPFS of patients with AR-V7(−) CTCs was longer than that of patients with AR-V7(+) CTCs (5.5 versus 2.2 months, respectively; P = 0.056). Median overall survival was 14.8 months (95% CI 11.2–not reached) and was significantly greater for AR-V7(−) patients than for AR-V7(+) patients (14.8 months versus 3.5 months, respectively; P < 0.01). 223Ra was well tolerated; anaemia and thrombocytopenia were the most common grade 3/4 adverse events (5.8% and 11.5%, respectively). 223Ra seems to be a reasonable treatment for patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases progressing on novel hormonal therapy and had an acceptable safety profile. • 223Ra had a promising antitumour activity in patients with metastatic castration-resistant prostate cancer with asymptomatic bone metastases. • 223Ra showed an acceptable safety profile similar to that reported in other studies. • Overall survival of androgen receptor splice variant 7 (−) patients was significantly higher than androgen receptor splice variant 7 (+) patients. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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