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Article ; Online: Long-Term Results of a Phase 1 Dose Escalation Trial of Ablative Stereotactic Body Radiation Therapy.

Mercier, Carole / Billiet, Charlotte / Ost, Piet / Joye, Ines / Meijnders, Paul / Vermeulen, Peter / Dirix, Luc / Verellen, Dirk / Dirix, Piet

International journal of radiation oncology, biology, physics

2023 Volume 118, Issue 5, Page(s) 1490–1496

Abstract: Purpose: Stereotactic body radiation therapy is increasingly used for oligometastatic disease as well as palliation, but treatment protocols for nonspine bone and nodal metastases are lacking, with a wide variety of schedules applied.: Methods and ... ...

Abstract	Purpose: Stereotactic body radiation therapy is increasingly used for oligometastatic disease as well as palliation, but treatment protocols for nonspine bone and nodal metastases are lacking, with a wide variety of schedules applied. Methods and materials: A prospective dose-escalation trial was initiated, involving 90 patients, among whom 52 (58%) had primary prostate tumors, 13 had breast tumors (14%), and 25 (28%) had other primary tumor types. All visible lymph node or nonspine bone oligometastases were treated in 3 consecutive cohorts: 5 × 7.0 Gy, 3 × 10.0 Gy, or 1 × 20.0 Gy. Results: Initial results revealed no dose-limiting toxicity after a median follow-up of 17.2 months. This update provides information on long-term toxicity, local failure (LF), and progression-free survival (PFS). After a median follow-up of 50 months, no new safety signals were observed. Grade 2 toxicity was 13%, 7% and 10% in the respective cohorts (P = .9), without grade 3 to 5 toxicities. LF rates were 9%, 3%, and 6% (P = .5) for the respective treatment groups, with an overall cumulative risk of LF of 7% (95% CI, 2-12) at 4 years. Median PFS was 16.5 months (95% CI, 9.8-21.5), and 4-year PFS was 21% (95% CI, 14-32). Median overall survival across groups was not reached (95% CI, 52.8 - not reached), 4-year OS was 68% (95% CI, 59-78). A subset of patients (23%) remained long-term disease-free, 37% had oligoprogressive disease at first recurrence and 40% developed polymetastatic relapse. Conclusions: The safe and effective use of dose-escalated single-fraction stereotactic body radiation therapy for bone and lymph node metastases is supported by this trial, especially considering patient-convenience and cost-effectiveness. Caution is needed when generalizing these outcomes beyond breast and prostate cancer, given their underrepresentation in our study.
MeSH term(s)	Male ; Humans ; Prospective Studies ; Neoplasm Recurrence, Local/radiotherapy ; Radiosurgery/adverse effects ; Radiosurgery/methods ; Progression-Free Survival ; Prostatic Neoplasms/radiotherapy ; Prostatic Neoplasms/pathology
Language	English
Publishing date	2023-12-25
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article
ZDB-ID	197614-x
ISSN	1879-355X ; 0360-3016
ISSN (online)	1879-355X
ISSN	0360-3016
DOI	10.1016/j.ijrobp.2023.12.021
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Article ; Online: A geometry and dose-volume based performance monitoring of artificial intelligence models in radiotherapy treatment planning for prostate cancer.

De Kerf, Geert / Claessens, Michaël / Raouassi, Fadoua / Mercier, Carole / Stas, Daan / Ost, Piet / Dirix, Piet / Verellen, Dirk

Physics and imaging in radiation oncology

2023 Volume 28, Page(s) 100494

Abstract: Background and purpose: Clinical Artificial Intelligence (AI) implementations lack ground-truth when applied on real-world data. This study investigated how combined geometrical and dose-volume metrics can be used as performance monitoring tools to ... ...

Abstract	Background and purpose: Clinical Artificial Intelligence (AI) implementations lack ground-truth when applied on real-world data. This study investigated how combined geometrical and dose-volume metrics can be used as performance monitoring tools to detect clinically relevant candidates for model retraining. Materials and methods: Fifty patients were analyzed for both AI-segmentation and planning. For AI-segmentation, geometrical (Standard Surface Dice 3 mm and Local Surface Dice 3 mm) and dose-volume based parameters were calculated for two organs (bladder and anorectum) to compare AI output against the clinically corrected structure. A Local Surface Dice was introduced to detect geometrical changes in the vicinity of the target volumes, while an Absolute Dose Difference (ADD) evaluation increased focus on dose-volume related changes. AI-planning performance was evaluated using clinical goal analysis in combination with volume and target overlap metrics. Results: The Local Surface Dice reported equal or lower values compared to the Standard Surface Dice (anorectum: (0.93 ± 0.11) vs (0.98 ± 0.04); bladder: (0.97 ± 0.06) vs (0.98 ± 0.04)). The ADD metric showed a difference of (0.9 ± 0.8)Gy for the anorectum Conclusions: Combining dose-volume and geometrical metrics allowed detection of clinically relevant changes, applied to both auto-segmentation and auto-planning output and the Local Surface Dice was more sensitive to local changes compared to the Standard Surface Dice. This monitoring is able to evaluate AI behavior in clinical practice and allows candidate selection for active learning.
Language	English
Publishing date	2023-09-23
Publishing country	Netherlands
Document type	Journal Article
ISSN	2405-6316
ISSN (online)	2405-6316
DOI	10.1016/j.phro.2023.100494
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Article ; Online: Radiotherapy Combined with a Radiosensitizer for Bacillus Calmette-Guérin-unresponsive Non-muscle-invasive Carcinoma In Situ Bladder Cancer: An Open-label, Single-arm, Multicenter, Phase 2 European Organisation for Research and Treatment of Cancer Trial.

Achard, Vérane / Fournier, Béatrice / D'Haese, David / Krzystyniak, Joanna / Tombal, Bertrand / Roupret, Morgan / Sargos, Paul / Dirix, Piet

European urology oncology

2024

Abstract: Radical cystectomy with pelvic lymph node dissection and urinary diversion is the standard of care for patients with bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC). However, many patients are unwilling or unable to ...

Abstract	Radical cystectomy with pelvic lymph node dissection and urinary diversion is the standard of care for patients with bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC). However, many patients are unwilling or unable to undergo such major surgery associated with high morbidity and a negative impact on quality of life. Chemoradiotherapy is an established treatment option for muscle-invasive bladder cancer. However, it has not been investigated adequately in NMIBC until now. The European Organisation for Research and Treatment of Cancer (EORTC) 2235 study (NCT06310369) is designed as a multicenter, prospective, international, phase 2 trial of moderate hypofractionated radiotherapy combined with a radiosensitizer in BCG-unresponsive NMIBC patients with carcinoma in situ (CIS) who are not eligible for or declined to undergo radical cystectomy. Patients who have received nadofaragene firadenovec or TAR-200 are eligible. The primary endpoint is the 6-mo complete response (CR) rate defined by the absence of CIS proven by a control biopsy of the bladder. The secondary endpoints include overall survival, progression-free survival, durability of CR, grade 3-4 adverse events rate, patients' quality of life, and organ preservation rate. PATIENT SUMMARY: Intravesical instillation of bacillus Calmette-Guérin is the standard treatment of non-muscle-invasive, also coined as superficial, bladder cancer. In case the cancer recurs, even superficially, there is no other proven treatment than a radical cystectomy-the surgical removal of the bladder. Although the surgical technique has improved dramatically over the past few years, it remains contraindicated in patients with severe comorbidities. In addition, because it affects the quality of life, patients may reject this option. This study will assess the efficacy of external beam radiotherapy, a robust alternative to surgery in muscle-invasive bladder cancer. Radiotherapy will be administered 5 d a week for 4 wk. It will be associated with a "radiosensitizer," an intravenous or oral drug, during the radiotherapy treatment. The study will measure the proportion of patients remaining recurrence free at 6 mo and thereafter. It will also evaluate the safety of the treatment and its impact on quality of life.
Language	English
Publishing date	2024-03-30
Publishing country	Netherlands
Document type	Journal Article
ISSN	2588-9311
ISSN (online)	2588-9311
DOI	10.1016/j.euo.2024.03.008
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Article ; Online: Re: Fabian Lohaus, Klaus Zöphel, Steffen Löck, et al. Can Local Ablative Radiotherapy Revert Castration-resistant Prostate Cancer to an Earlier Stage of Disease? Eur Urol 2019;75:548-51.

Dirix, Piet R / Mercier, Carole / Dirix, Luc Y

European urology

2019 Volume 76, Issue 4, Page(s) e101–e102

MeSH term(s)	Humans ; Male ; Prostatic Neoplasms ; Prostatic Neoplasms, Castration-Resistant
Language	English
Publishing date	2019-06-27
Publishing country	Switzerland
Document type	Letter ; Comment
ZDB-ID	193790-x
ISSN	1873-7560 ; 1421-993X ; 0302-2838
ISSN (online)	1873-7560 ; 1421-993X
ISSN	0302-2838
DOI	10.1016/j.eururo.2019.06.022
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Zs.A 1247: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Stereotactic Body and Conventional Radiotherapy for Painful Bone Metastases: A Systematic Review and Meta-Analysis.

Bindels, Bas J J / Mercier, Carole / Gal, Roxanne / Verlaan, Jorrit-Jan / Verhoeff, Joost J C / Dirix, Piet / Ost, Piet / Kasperts, Nicolien / van der Linden, Yvette M / Verkooijen, Helena M / van der Velden, Joanne M

JAMA network open

2024 Volume 7, Issue 2, Page(s) e2355409

Abstract: Importance: Conventional external beam radiotherapy (cEBRT) and stereotactic body radiotherapy (SBRT) are commonly used treatment options for relieving metastatic bone pain. The effectiveness of SBRT compared with cEBRT in pain relief has been a subject ...

Abstract	Importance: Conventional external beam radiotherapy (cEBRT) and stereotactic body radiotherapy (SBRT) are commonly used treatment options for relieving metastatic bone pain. The effectiveness of SBRT compared with cEBRT in pain relief has been a subject of debate, and conflicting results have been reported. Objective: To compare the effectiveness associated with SBRT vs cEBRT for relieving metastatic bone pain. Data sources: A structured search was performed in the PubMed, Embase, and Cochrane databases on June 5, 2023. Additionally, results were added from a new randomized clinical trial (RCT) and additional unpublished data from an already published RCT. Study selection: Comparative studies reporting pain response after SBRT vs cEBRT in patients with painful bone metastases. Data extraction and synthesis: Two independent reviewers extracted data from eligible studies. Data were extracted for the intention-to-treat (ITT) and per-protocol (PP) populations. The study is reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Main outcomes and measures: Overall and complete pain response at 1, 3, and 6 months after radiotherapy, according to the study's definition. Relative risk ratios (RRs) with 95% CIs were calculated for each study. A random-effects model using a restricted maximum likelihood estimator was applied for meta-analysis. Results: There were 18 studies with 1685 patients included in the systematic review and 8 RCTs with 1090 patients were included in the meta-analysis. In 7 RCTs, overall pain response was defined according to the International Consensus on Palliative Radiotherapy Endpoints in clinical trials (ICPRE). The complete pain response was reported in 6 RCTs, all defined according to the ICPRE. The ITT meta-analyses showed that the overall pain response rates did not differ between cEBRT and SBRT at 1 (RR, 1.14; 95% CI, 0.99-1.30), 3 (RR, 1.19; 95% CI, 0.96-1.47), or 6 (RR, 1.22; 95% CI, 0.96-1.54) months. However, SBRT was associated with a higher complete pain response at 1 (RR, 1.43; 95% CI, 1.02-2.01), 3 (RR, 1.80; 95% CI, 1.16-2.78), and 6 (RR, 2.47; 95% CI, 1.24-4.91) months after radiotherapy. The PP meta-analyses showed comparable results. Conclusions and relevance: In this systematic review and meta-analysis, patients with painful bone metastases experienced similar overall pain response after SBRT compared with cEBRT. More patients had complete pain alleviation after SBRT, suggesting that selected subgroups will benefit from SBRT.
MeSH term(s)	Humans ; Bone Neoplasms/radiotherapy ; Bone Neoplasms/secondary ; Pain/etiology ; Pain/radiotherapy ; Radiosurgery ; Cancer Pain/radiotherapy ; Pain Management ; Pathologic Complete Response ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2024-02-05
Publishing country	United States
Document type	Meta-Analysis ; Systematic Review ; Journal Article
ISSN	2574-3805
ISSN (online)	2574-3805
DOI	10.1001/jamanetworkopen.2023.55409
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Article ; Online: A geometry and dose-volume based performance monitoring of artificial intelligence models in radiotherapy treatment planning for prostate cancer

Geert De Kerf / Michaël Claessens / Fadoua Raouassi / Carole Mercier / Daan Stas / Piet Ost / Piet Dirix / Dirk Verellen

Physics and Imaging in Radiation Oncology, Vol 28, Iss , Pp 100494- (2023)

2023

Abstract: Background and Purpose: Clinical Artificial Intelligence (AI) implementations lack ground-truth when applied on real-world data. This study investigated how combined geometrical and dose-volume metrics can be used as performance monitoring tools to ... ...

Abstract	Background and Purpose: Clinical Artificial Intelligence (AI) implementations lack ground-truth when applied on real-world data. This study investigated how combined geometrical and dose-volume metrics can be used as performance monitoring tools to detect clinically relevant candidates for model retraining. Materials and Methods: Fifty patients were analyzed for both AI-segmentation and planning. For AI-segmentation, geometrical (Standard Surface Dice 3 mm and Local Surface Dice 3 mm) and dose-volume based parameters were calculated for two organs (bladder and anorectum) to compare AI output against the clinically corrected structure. A Local Surface Dice was introduced to detect geometrical changes in the vicinity of the target volumes, while an Absolute Dose Difference (ADD) evaluation increased focus on dose-volume related changes. AI-planning performance was evaluated using clinical goal analysis in combination with volume and target overlap metrics. Results: The Local Surface Dice reported equal or lower values compared to the Standard Surface Dice (anorectum: (0.93 ± 0.11) vs (0.98 ± 0.04); bladder: (0.97 ± 0.06) vs (0.98 ± 0.04)). The ADD metric showed a difference of (0.9 ± 0.8)Gy for the anorectum D1cm3. The bladder D5cm3 reported a difference of (0.7 ± 1.5)Gy. Mandatory clinical goals were fulfilled in 90 % of the DLP plans. Conclusions: Combining dose-volume and geometrical metrics allowed detection of clinically relevant changes, applied to both auto-segmentation and auto-planning output and the Local Surface Dice was more sensitive to local changes compared to the Standard Surface Dice. This monitoring is able to evaluate AI behavior in clinical practice and allows candidate selection for active learning.
Keywords	Performance monitoring ; Artificial intelligence ; SBRT prostate ; Deep Learning Segmentation ; Deep Learning Planning ; Clinical metrics ; Medical physics. Medical radiology. Nuclear medicine ; R895-920 ; Neoplasms. Tumors. Oncology. Including cancer and carcinogens ; RC254-282
Subject code	616
Language	English
Publishing date	2023-10-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Magnetic resonance imaging sequences for prostate cancer triage: two is a couple, three is a crowd?

Dirix, Piet / Van Bruwaene, Siska / Vandeursen, Hendrik / Deckers, Filip

Translational andrology and urology

2020 Volume 8, Issue Suppl 5, Page(s) S476–S479

Language	English
Publishing date	2020-01-23
Publishing country	China
Document type	Editorial ; Comment
ZDB-ID	2851630-8
ISSN	2223-4691 ; 2223-4691 ; 2223-4683
ISSN (online)	2223-4691
ISSN	2223-4691 ; 2223-4683
DOI	10.21037/tau.2019.09.42
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Article ; Online: Time for More Inclusive Cancer Trials.

Dirix, Piet / Wyld, Lynda / Paluch-Shimon, Shani / Poortmans, Philip

Journal of the National Comprehensive Cancer Network : JNCCN

2020 Volume 18, Issue 10, Page(s) 1431–1434

MeSH term(s)	Humans ; Neoplasms
Language	English
Publishing date	2020-10-01
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	2250759-0
ISSN	1540-1413 ; 1540-1405
ISSN (online)	1540-1413
ISSN	1540-1405
DOI	10.6004/jnccn.2020.7652
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Article ; Online: Palliative bladder radiotherapy: caveats in a changing landscape.

Dirix, Piet / Strijbos, Michiel / Van den Mooter, Tom / Vandeursen, Hendrik

Annals of palliative medicine

2020 Volume 9, Issue 3, Page(s) 1269–1271

MeSH term(s)	Humans ; Palliative Care ; Rare Diseases ; Retrospective Studies ; Urinary Bladder Neoplasms
Language	English
Publishing date	2020-03-24
Publishing country	China
Document type	Journal Article ; Comment
ZDB-ID	2828544-X
ISSN	2224-5839 ; 2224-5820
ISSN (online)	2224-5839
ISSN	2224-5820
DOI	10.21037/apm.2020.03.03
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Article: Survival Outcomes and Pattern of Relapse After SABR for Oligometastatic Prostate Cancer.

Mercier, Carole / Claessens, Marc / De Troyer, Bart / Debacker, Tibaut / Fransis, Karen / Vandeursen, Hendrik / Ost, Piet / Dirix, Piet

Frontiers in oncology

2022 Volume 12, Page(s) 863609

Abstract: Introduction: The addition of stereotactic ablative radiotherapy (SABR) to standard of care for patients with oligometastatic prostate cancer has the potential of improving survival and delaying further metastases. The primary aim of this analysis is to ...

Abstract	Introduction: The addition of stereotactic ablative radiotherapy (SABR) to standard of care for patients with oligometastatic prostate cancer has the potential of improving survival and delaying further metastases. The primary aim of this analysis is to report survival outcomes and pattern of recurrence of patients with hormone-sensitive (HSPC) and castrate-resistant (CRPC) oligometastatic prostate cancer treated with SABR. Methods: This is a single-center retrospective study of patients with oligometastatic prostate cancer treated in Iridium Network between 2014 and 2018. All patients with oligometastatic (≤3 active lesions) HSPC and CRPC treated with SABR were included. Data were collected using electronic records. Patterns of first progression following SABR were reported. Kaplan-Meier methods were used to determine survival outcomes. Results: Eighty-seven men received SABR to 115 metastases. Nineteen patients were castrate-resistant and 68 hormone-sensitive at the time of SABR. Median follow-up was 41.6 months. In 25% of patients, no decline from baseline PSA was recorded. Median bPFS was 11.7 months (95% CI 7.6 - 18.3) for HSPC as well as CRPC (95% CI 6.4 - 24.0) (p=0.27). Median DMFS was 21.8 (95% CI 16.9 - 43.2) versus 17.6 months (95% CI 6.7 - 26.2) for HSPC versus CRPC, respectively (p=0.018). Median OS was 72.6 months (95% CI 72.6 - not reached) for HSPC and not reached for CRPC (95% CI 35.4 months - not reached) (p=0.026). For the subgroup of oligorecurrent HSPC, short-term androgen-deprivation therapy was associated with improved bPFS (median 6.0 vs. 18.3 months, HR 0.31, p<0.001) and DMFS (median 15.8 vs 29.6 months, HR 0.5, p=0.06). Information on pattern of relapse was retrieved for 79 patients: 45% (36/79) of these patients were long-term disease-free (>18 months), 28% (22/79) of patients wmere oligoprogressive (≤3 new lesions) and 27% (21/79) developed a polymetastatic relapse. Conclusion: In this cohort, oligometastatic HSPC showed potential benefit from SABR with a median DMFS of 21.8 months. Well-selected patients with oligometastatic CRPC may also benefit from SABR. For patients with metachronous and repeat oligorecurrent HSPC, combining SABR with short-term androgen-deprivation therapy was associated with improved bPFS and DMFS. Overall, 36/87 (41%) of patients were still free from clinical relapse at 18 months.
Language	English
Publishing date	2022-04-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2022.863609
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