Evidence map›Paper›PMID 36724067›Full record

ArticleThe Journal of urology2023

Final Results of a Phase I Trial of WST-11 (TOOKAD Soluble) Vascular-targeted Photodynamic Therapy for Upper Tract Urothelial Carcinoma.

Wesley Yip, Daniel D Sjoberg, Lucas M Nogueira, Andrew T Tracey, Ricardo G Alvim, Peter A Reisz, Quinlan Demac, Nicole E Benfante, Rand W Vanden Berg, Kwanghee Kim and 11 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in The Journal of urology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
7.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03617003 phase1completednot on this map

Phase I Study of WST11 Phototherapy for Upper Tract Urothelial Carcinoma

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2018 to 2025Enrolled30ConditionsUpper Tract Urothelial CarcinomaArmsWST11 mediated vascular targeted phototherapy (VTP), Endoscopy
NCT04620239 phase3active not recruitingnot on this map

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (Padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

TypeinterventionalSponsorSteba Biotech S.A.Ran2021 to 2028Enrolled89ConditionsTransitional Cell Cancer of Renal Pelvis and UreterArmspadeliporfin VTP
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 22 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 2 institutions in 3 countries.

Wesley YipUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-2389-3046
Daniel D SjobergDepartment of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Lucas M NogueiraUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Andrew T TraceyUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Ricardo G AlvimUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Peter A ReiszUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Quinlan DemacDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Nicole E BenfanteDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Rand W Vanden BergUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Kwanghee KimDepartment of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Hikmat Al-AhmadieDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Oscar LinDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Bernard H BochnerUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Guido DalbagniUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
S Machele DonatUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Eugene J PietzakUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
A Ari HakimiUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
David B SolitGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Avigdor ScherzWeizmann Institute of Science, Rehovot, Israel.
Dean F BajorinGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Jonathan A ColemanUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Memorial Sloan Kettering Cancer Center · USWeizmann Institute of Science · IL

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
UROLOGY ONCOLOGY RESEARCH TRAINING GRANTT32CA082088 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Brett Stewart Carver · 1999 to 2026
$7.1M
NCATS NIH HHS UL1 TR001873NCATS NIH HHS UL1 TR002384NCI NIH HHS P30 CA008748NCI NIH HHS T32 CA082088
6 · The paper itself

Abstract

purposeVascular-targeted photodynamic therapy with the intravascular photosensitizing agent padeliporfin (WST-11/TOOKAD-Soluble) has demonstrated therapeutic efficacy as an ablative treatment for localized cancer with potential adaptation for endoscopic management of upper tract urothelial carcinoma. This Phase I trial (NCT03617003) evaluated the safety of vascular-targeted photodynamic therapy with WST-11 in upper tract urothelial carcinoma. MATERIALS AND

methodsNineteen patients underwent up to 2 endoscopic vascular-targeted photodynamic therapy treatments, with follow-up for up to 6 months. Patients who had residual or recurrent upper tract urothelial carcinoma (any grade/size) failing prior endoscopic treatment or unable or unwilling to undergo surgical resection were eligible for inclusion. The primary endpoint was to identify the maximally tolerated dose of laser light fluence. A dose escalation model was employed, with increasing light fluence (100-200 mW/cm) using a modified continual reassessment method. The secondary endpoint was treatment efficacy, defined by absence of visible tumor and negative urine cytology 30 days posttreatment.

resultsFourteen (74%) patients received the maximally tolerated dose of 200 mW/cm, 2 (11%) of whom experienced a dose-limiting toxicity. The initial 30-day treatment response rate was 94% (50% complete, 44% partial). Eight patients underwent a second treatment, with a final observed 68% complete response rate. Leading toxicities were flank pain (79%) and hematuria (84%), which were transient. No ureteral strictures associated with treatment were identified during follow-up.

conclusionsVascular-targeted photodynamic therapy with WST-11 has an acceptable safety profile with strong potential as an effective, kidney-sparing endoscopic management option for upper tract urothelial carcinoma. The recently initiated multicenter Phase 3 ENLIGHTED trial (NCT04620239) is expected to provide further evidence on this therapy.

Indexed as

Carcinoma, Transitional CellPhotochemotherapyUreteral NeoplasmsUrinary Bladder NeoplasmsBacteriochlorophyllsHumansNeoplasm Recurrence, LocalUreteroscopyBacteriochlorophyllspadeliporfinpalladium-bacteriopheophorbidephototherapyureteroscopyurogenital neoplasms

Identifiers

PMID36724067
PMCPMC10265489
OpenAlexW4318754582

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.