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.


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Publication History

Article published online:
25 March 2024

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