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Final Results of a Phase I Trial of WST-11 (TOOKAD Soluble) Vascular-targeted Photodynamic Therapy for Upper Tract Urothelial Carcinoma.
Yip, Wesley; Sjoberg, Daniel D; Nogueira, Lucas M; Tracey, Andrew T; Alvim, Ricardo G; Reisz, Peter A; Demac, Quinlan; Benfante, Nicole E; Vanden Berg, Rand W; Kim, Kwanghee; Al-Ahmadie, Hikmat; Lin, Oscar; Bochner, Bernard H; Dalbagni, Guido; Donat, S Machele; Pietzak, Eugene J; Hakimi, A Ari; Solit, David B; Scherz, Avigdor; Bajorin, Dean F; Coleman, Jonathan A.
Afiliación
  • Yip W; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Sjoberg DD; Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Nogueira LM; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Tracey AT; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Alvim RG; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Reisz PA; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Demac Q; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Benfante NE; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Vanden Berg RW; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Kim K; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Al-Ahmadie H; Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Lin O; Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Bochner BH; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Dalbagni G; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Donat SM; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Pietzak EJ; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Hakimi AA; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Solit DB; Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Scherz A; Weizmann Institute of Science, Rehovot, Israel.
  • Bajorin DF; Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Coleman JA; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
J Urol ; 209(5): 863-871, 2023 05.
Article en En | MEDLINE | ID: mdl-36724067
PURPOSE: Vascular-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 METHODS: Nineteen 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. RESULTS: Fourteen (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. CONCLUSIONS: Vascular-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.
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Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Fotoquimioterapia / Neoplasias Ureterales / Neoplasias de la Vejiga Urinaria / Carcinoma de Células Transicionales Idioma: En Revista: J Urol Año: 2023 Tipo del documento: Article

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Fotoquimioterapia / Neoplasias Ureterales / Neoplasias de la Vejiga Urinaria / Carcinoma de Células Transicionales Idioma: En Revista: J Urol Año: 2023 Tipo del documento: Article