Nuklearmedizin 2024; 63(02): 100
DOI: 10.1055/s-0044-1782313
Abstracts
Leuchtturm-Sitzungen
Leuchtturm-Sitzung 6: Radioligandentherapie

Tolerability of Lutetium-177 vipivotide tetraxetan by treatment exposure in patients with metastatic castration-resistant prostate cancer (mCRPC): a VISION study subgroup analysis

K. Herrmann
1   University Hospital Essen, Essen, Germany
,
S. T. Tagawa
2   Weill Cornell Medicine, New York, NY, USA
,
A. J. Armstrong
3   Duke University School of Medicine, Durham, NC, USA
,
B. J. Krause
4   Rostock University Medical Center, Rostock, Germany
,
K. Rahbar
5   University Hospital Münster, Münster, Germany
,
J. de Bono
6   The Institute of Cancer Research and Royal Marsden Hospital, London, UK
,
N. Adra
7   Indiana University Simon Comprehensive Cancer Center, Indianapolis, IN, USA
,
M. DeSilvio
8   Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
,
R. Messmann
8   Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
,
G. Holder
9   Advanced Accelerator Applications, a Novartis Company, Basel, Switzerland
,
K. N. Chi
10   British Columbia Cancer Agency, Vancouver, BC, Canada
› Author Affiliations
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Ziel/Aim: In the phase 3 VISION study, Lutetium-177 vipivotide tetraxetan+SoC improved clinical benefit and was generally well tolerated despite a higher rate of adverse events (AEs) than SoC alone. Here, we assess AE incidence by exposure to Lutetium-177 vipivotide tetraxetan.

Methodik/Methods: VISION was an international, open-label study of Lutetium-177 vipivotide tetraxetan in adults with PSMA-positive mCRPC previously treated with≥1 androgen receptor pathway inhibitor and 1–2 taxane regimens. Patients received Lutetium-177 vipivotide tetraxetan (7.4 GBq every 6 weeks,≤6 cycles)+SoC or SoC alone. rPFS and OS were primary endpoints; safety was a secondary endpoint. AE analysis by exposure to Lutetium-177 vipivotide tetraxetan was carried out in pre-specified subgroups. Lutetium-177 vipivotide tetraxetan cycle duration was generally ~6 weeks and cycle 6 duration was until the earliest date of subsequent treatment, and date of last administration of randomized treatment (including SoC)+30 days. The cycle of onset in which an AE first occurred in a patient at maximum grade was assessed.

Ergebnisse/Results: The median duration of cycle of onset for cycles 1 to 5 was 6 weeks; for cycle 6, it was 26.6 weeks. Of the 529 patients in Lutetium-177 vipivotide tetraxetan group, 240 (45.4%) received≤4 cycles and 289 (54.6%) received 5–6 cycles of treatment. In patients who received≤4 or 5–6 cycles, 234 (97.5%) and 285 (98.6%) treatment-emergent AEs (TEAEs); 100 (41.7%) and 92 (31.8%) serious TEAEs; 205 (85.4%) and 246 (85.1%) treatment-related AEs; and 13 (5.4%) and 6 (2.1%) fatal TEAEs, respectively, were observed [1].

Schlussfolgerungen/Conclusions: Over 50% of patients with mCRPC received 5–6 cycles of Lutetium-177 vipivotide tetraxetan. For cycles 1–5, TEAEs occurred at every cycle, with similar frequency. More TEAEs were observed in cycle 6, reflecting its longer median duration than other cycles.



Publication History

Article published online:
25 March 2024

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