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Title: Results of a single-arm pilot study of 32P microparticles in unresectable locally advanced pancreatic adenocarcinoma with gemcitabine/nab-paclitaxel or FOLFIRINOX chemotherapy.
Austin Authors: Ross, P J;Wasan, H S;Croagh, D;Nikfarjam, Mehrdad ;Nguyen, N;Aghmesheh, M;Nagrial, A M;Bartholomeusz, D;Hendlisz, A;Ajithkumar, T;Iwuji, C;Wilson, N E;Turner, D M;James, D C;Young, E;Harris, M T
Affiliation: Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust, Leicester, UK..
The Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead, Australia..
Guy's & St Thomas' Hospital NHS Foundation Trust, London, UK..
Imperial College Healthcare NHS Trust, London, UK..
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK..
Southern Star Research Pty Ltd, Gordon, Australia..
Monash Health, Clayton, Australia..
OncoSil Medical Limited, Sydney, Australia..
Southern Medical Day Care Centre, Wollongong, Australia..
Austin Health
Royal Adelaide Hospital, Adelaide, Australia..
Institut Jules Bordet, Brussels, Belgium..
Issue Date: Feb-2022
Date: 2021-12-23
Publication information: ESMO Open 2022; 7(1): 100356
Abstract: Unresectable locally advanced pancreatic cancer (LAPC) is generally managed with chemotherapy or chemoradiotherapy, but prognosis is poor with a median survival of ∼13 months (or up to 19 months in some studies). We assessed a novel brachytherapy device, using phosphorous-32 (32P) microparticles, combined with standard-of-care chemotherapy. In this international, multicentre, single-arm, open-label pilot study, adult patients with histologically or cytologically proven unresectable LAPC received 32P microparticles, via endoscopic ultrasound-guided fine-needle implantation, planned for week 4 of 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (FOLFIRINOX) or gemcitabine/nab-paclitaxel chemotherapy, per investigator's choice. The primary endpoint was safety and tolerability measured using Common Terminology Criteria for Adverse Events version 4.0. The lead efficacy endpoint was local disease control rate at 16 weeks. Fifty patients were enrolled and received chemotherapy [intention-to-treat (ITT) population]. Forty-two patients received 32P microparticle implantation [per protocol (PP) population]. A total of 1102 treatment-emergent adverse events (TEAEs) were reported in the ITT/safety population (956 PP), of which 167 (139 PP) were grade ≥3. In the PP population, 41 TEAEs in 16 (38.1%) patients were possibly or probably related to 32P microparticles or implantation procedure, including 8 grade ≥3 in 3 (7.1%) patients, compared with 609 TEAEs in 42 (100%) patients attributed to chemotherapy, including 67 grade ≥3 in 28 patients (66.7%). The local disease control rate at 16 weeks was 82.0% (95% confidence interval: 68.6% to 90.9%) (ITT) and 90.5% (95% confidence interval: 77.4% to 97.3%) (PP). Tumour volume, carbohydrate antigen 19-9 levels, and metabolic tumour response at week 12 improved significantly. Ten patients (20.0% ITT; 23.8% PP) had surgical resection and median overall survival was 15.2 and 15.5 months for ITT and PP populations, respectively. Endoscopic ultrasound-guided 32P microparticle implantation has an acceptable safety profile. This study also suggests clinically relevant benefits of combining 32P microparticles with standard-of-care systemic chemotherapy for patients with unresectable LAPC.
DOI: 10.1016/j.esmoop.2021.100356
ORCID: 0000-0003-4866-276X
Journal: ESMO Open
PubMed URL: 34953400
PubMed URL:
Type: Journal Article
Subjects: (32)P microparticles
local disease control rate
locally advanced pancreatic cancer
safety profile
Appears in Collections:Journal articles

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