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Apalutamide plus an...
Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer : A subgroup analysis of the randomised clinical TITAN study
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- Merseburger, Axel S. (författare)
- University Medical Center Schleswig-Holstein
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- Agarwal, Neeraj (författare)
- Huntsman Cancer Institute
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- Bhaumik, Amitabha (författare)
- Janssen Research & Development, Belgium
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- Lefresne, Florence (författare)
- Janssen Research & Development, Belgium
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Karsh, Laurence I. (författare)
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Pereira de Santana Gomes, Andrea J. (författare)
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Soto, Álvaro Juárez (författare)
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- Given, Robert W. (författare)
- Eastern Virginia Medical School
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- Brookman-May, Sabine D. (författare)
- Janssen Research & Development, Belgium,Ludwig-Maximilian University of Munich
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- Mundle, Suneel D. (författare)
- Janssen Research & Development, Belgium
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- McCarthy, Sharon A. (författare)
- Janssen Research & Development, Belgium
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- Uemura, Hirotsugu (författare)
- Kindai University Hospital
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- Chowdhury, Simon (författare)
- St Thomas' Hospital
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Chi, Kim N. (författare)
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- Bjartell, Anders (författare)
- Lund University,Lunds universitet,Avdelningen för translationell cancerforskning,Institutionen för laboratoriemedicin,Medicinska fakulteten,Urologisk cancerforskning, Malmö,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Division of Translational Cancer Research,Department of Laboratory Medicine,Faculty of Medicine,Urological cancer, Malmö,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Skåne University Hospital
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(creator_code:org_t)
- 2023
- 2023
- Engelska.
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Ingår i: European Journal of Cancer. - 0959-8049. ; 193
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Background: Whether disease burden in patients with metastatic castration-sensitive prostate cancer (mCSPC) predicts treatment outcomes is unknown. We assessed apalutamide treatment effect in TITAN patients with mCSPC by disease volume, metastasis number and timing of metastasis presentation. Methods: These protocol-defined and post hoc analyses of the phase III randomised TITAN study evaluated clinical outcomes in patients receiving 240 mg/day apalutamide (n = 525) or placebo (n = 527) plus androgen-deprivation therapy (ADT). Subgroups were defined by volume (high: visceral and ≥1 bone metastases or ≥4 bone lesions with ≥1 beyond vertebral column/pelvis), development of metastases per conventional imaging (synchronous: at initial diagnosis; metachronous: after localised disease) and oligometastases (≤5 bone-only metastases) or polymetastases (>5 in bone ± other locations or ≤5 in bone plus other locations). Overall survival (OS), radiographic or second progression-free survival, and time to prostate-specific antigen progression or castration resistance were assessed using Cox proportional hazards models. Results: Of 1052 patients, 63%, 81%, 54%, 27%, 5.7%, and 8.0% had high-volume, synchronous, synchronous/high-volume, synchronous/low-volume, metachronous/high-volume, and metachronous/low-volume disease, respectively. The OS benefit favoured apalutamide plus ADT versus ADT alone in synchronous/high-volume (hazard ratio = 0.68 [95% confidence interval: 0.53–0.87]; p = 0.002), synchronous/low-volume (0.65 [0.40–1.05]; p = 0.08), metachronous/high-volume (0.69 [0.33–1.44]; p = 0.32) and metachronous/low-volume (0.22 [0.09–0.55]; p = 0.001) subgroups. Apalutamide improved other clinical outcomes regardless of subgroup, with similar safety profiles. Most favourable outcomes were observed in oligometastatic disease. Conclusion: TITAN patients derived a robust benefit with apalutamide plus ADT regardless of disease volume and timing of metastasis presentation without differences in safety, supporting early apalutamide intensification in mCSPC. Clinical Trial Registration: NCT02489318.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- High-volume
- Low-volume
- mCSPC
- Metachronous
- Oligometastatic
- Polymetastatic
- Synchronous
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Merseburger, Axe ...
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Agarwal, Neeraj
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Bhaumik, Amitabh ...
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Lefresne, Floren ...
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Karsh, Laurence ...
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Pereira de Santa ...
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Soto, Álvaro Juá ...
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Given, Robert W.
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Brookman-May, Sa ...
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Mundle, Suneel D ...
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McCarthy, Sharon ...
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Uemura, Hirotsug ...
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Chowdhury, Simon
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Chi, Kim N.
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Bjartell, Anders
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