Experience of 25 patients treated with echoendoscopically implanted <sup>32</sup> P microparticles associated with chemotherapy in locally advanced pancreatic adenocarcinoma.

e16455 Background: Phosphorous 32 microparticle ( 32 P) brachytherapy delivered by echoendoscopy (EUS) represents an innovative therapy in pancreatic cancer (PC). Our aim is to evaluate efficacy and safety outcomes for Spanish patients in real clinical practice. Methods: After being assessed by a multidisciplinary committee and meeting eligibility criteria (Table 1), patients signed consent to receive intratumoural 32 P by EUS within the international observational registry OSPREY (March 2022-January 2025). Complications associated with intratumoural 32P injection via EUS, associated adverse events (AEs) and preliminary efficacy results (progression-free survival [PFS] and overall survival [OS]) were analysed. Results: Twenty-five patients (16 females and 9 males; age 67 years [range 48, 80]; 20 ECOG 1 and 5 ECOG 0) with unresectable locally advanced PC (16 in head, 4 in uncinate and 5 in body; tumour size 31.5 mm [range 12, 60]) were included. Seven patients (28%) had received a previous treatment. 23 patients (92%) received gemcitabine-based chemotherapy concomitant with intratumoural 32P (17 gemcitabine plus nabpaclitaxel; 6 gemcitabine monotherapy), 1 patient FOLFIRINOX and 1 patient did not receive concomitant chemotherapy. Two patients had AEs related to 32P injection by EUS: G2 asthenia and G1 abdominal pain, respectively. Seventeen patients (68%) had chemotherapy-related AEs, with 3 cases of G3 neutropenia and 1 of G3 thombopenia; 14 had G1-2 toxicities: neutropenia (3), thrombopenia (4), neurotoxicity (4), anaemia (2), asthenia (3), hyporexia (1), nausea (1), diarrhea (1) and constipation (1) . Four (16%) patients underwent surgery after intratumoural treatment. With a median follow-up of 17.2 months after injection, 14 patients (56%) have progressed, 13 distantly and 7 also locoregionally; 1 patient progressed only locally. The median PFS since 32P injection is 8.4 months (95% CI 4.3, 17.0). 12 patients are alive at the end of follow-up (48%) with a median OS since 32P injection of 13.8 months (95% CI 9.4, 26,9]. Conclusions: The experience of Spanish centres suggests that intratumoural 32P associated with gemcitabine-based chemotherapy is safe and achieve long survival. Our ongoing prospective registry will allow evaluation of the oncological outcomes of this therapy at longer follow-up times. Eligibility criteria. Inclusion criteria Exclusion criteria - Patients eligible for and undergo 32P implantation at an eligible treatment facility according to the approved instructions for use, as part of their clinical care. - Patients participating in an interventional clinical study. - Patients who have completed and signed the patient informed consent form (PICF) for the OSPREY Patient Registry. - Patients using an investigational agent at the time of enrolment.

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Journal
Journal of Clinical Oncology
Published
2025-05-28
DOI
https://doi.org/10.1200/jco.2025.43.16_suppl.e16455
Primary Topic
Pancreatic and Hepatic Oncology Research
Type
article
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article

Experience of 25 patients treated with echoendoscopically implanted 32 P microparticles associated with chemotherapy in locally advanced pancreatic adenocarcinoma.

Ignacio Juez Martel, I. Navales, Mariano Ponz‐Sarvisé, Victoria López-Gómez et al.
Journal of Clinical Oncology
Pancreatic and Hepatic Oncology Research
article

Experience of 25 patients treated with echoendoscopically implanted 32 P microparticles associated with chemotherapy in locally advanced pancreatic adenocarcinoma.

Ignacio Juez Martel, I. Navales, Mariano Ponz‐Sarvisé, Victoria López-Gómez, Carmen Guillén‐Ponce, Jorge Adeva, Maria Purificacion Rodriguez Cernuda, Sonia Candamio Folgar, Ana García García de Paredes, Fayna Armas, Rebeca Chulvi, Alejandra Giménez, Rafael Álvarez, Marisol Huerta, Javier Zamora
article en

Abstract

e16455 Background: Phosphorous 32 microparticle ( 32 P) brachytherapy delivered by echoendoscopy (EUS) represents an innovative therapy in pancreatic cancer (PC). Our aim is to evaluate efficacy and safety outcomes for Spanish patients in real clinical practice. Methods: After being assessed by a multidisciplinary committee and meeting eligibility criteria (Table 1), patients signed consent to receive intratumoural 32 P by EUS within the international observational registry OSPREY (March 2022-January 2025). Complications associated with intratumoural 32P injection via EUS, associated adverse events (AEs) and preliminary efficacy results (progression-free survival [PFS] and overall survival [OS]) were analysed. Results: Twenty-five patients (16 females and 9 males; age 67 years [range 48, 80]; 20 ECOG 1 and 5 ECOG 0) with unresectable locally advanced PC (16 in head, 4 in uncinate and 5 in body; tumour size 31.5 mm [range 12, 60]) were included. Seven patients (28%) had received a previous treatment. 23 patients (92%) received gemcitabine-based chemotherapy concomitant with intratumoural 32P (17 gemcitabine plus nabpaclitaxel; 6 gemcitabine monotherapy), 1 patient FOLFIRINOX and 1 patient did not receive concomitant chemotherapy. Two patients had AEs related to 32P injection by EUS: G2 asthenia and G1 abdominal pain, respectively. Seventeen patients (68%) had chemotherapy-related AEs, with 3 cases of G3 neutropenia and 1 of G3 thombopenia; 14 had G1-2 toxicities: neutropenia (3), thrombopenia (4), neurotoxicity (4), anaemia (2), asthenia (3), hyporexia (1), nausea (1), diarrhea (1) and constipation (1) . Four (16%) patients underwent surgery after intratumoural treatment. With a median follow-up of 17.2 months after injection, 14 patients (56%) have progressed, 13 distantly and 7 also locoregionally; 1 patient progressed only locally. The median PFS since 32P injection is 8.4 months (95% CI 4.3, 17.0). 12 patients are alive at the end of follow-up (48%) with a median OS since 32P injection of 13.8 months (95% CI 9.4, 26,9]. Conclusions: The experience of Spanish centres suggests that intratumoural 32P associated with gemcitabine-based chemotherapy is safe and achieve long survival. Our ongoing prospective registry will allow evaluation of the oncological outcomes of this therapy at longer follow-up times. Eligibility criteria. Inclusion criteria Exclusion criteria - Patients eligible for and undergo 32P implantation at an eligible treatment facility according to the approved instructions for use, as part of their clinical care. - Patients participating in an interventional clinical study. - Patients who have completed and signed the patient informed consent form (PICF) for the OSPREY Patient Registry. - Patients using an investigational agent at the time of enrolment.

Journal of Clinical OncologyVol. 43(16_suppl)
Universitat de València (ES), Instituto Cajal (ES), Hospital Universitario Insular de Gran Canaria (ES), Instituto de Salud Carlos III (ES), Hospital Universitari i Politècnic La Fe (ES), Research Institute Hospital 12 de Octubre (ES), Complejo Hospitalario Universitario de Santiago (ES), Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (ES), Hospital Universitario Doctor Peset (ES), Instituto Ramón y Cajal de Investigación Sanitaria (ES), Vall d'Hebron Hospital Universitari (ES), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (ES), Clinica Universidad de Navarra (ES), Hospital Universitario HM Sanchinarro (ES), Hospital Universitario de Fuenlabrada (ES), Hospital Clínico Universitario de Valladolid (ES), INCLIVA Health Research Institute (ES), Centro de Investigación Biomédica en Red de Cáncer (ES), Hospital Universitario Ramón y Cajal (ES)
Openalex Percentile: Top 82%
Pancreatic and Hepatic Oncology Research
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