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PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer

BACKGROUND: Endobiliary stenting is standard practice for palliation of obstructive jaundice due to biliary tract cancer (BTC). Photodynamic therapy (PDT) may also improve biliary drainage and previous small studies suggested survival benefit. AIMS: To assess the difference in outcome between patien...

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Autores principales: Pereira, Stephen P, Jitlal, Mark, Duggan, Marian, Lawrie, Emma, Beare, Sandy, O’Donoghue, Pam, Wasan, Harpreet S, Valle, Juan W, Bridgewater, John
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069917/
https://www.ncbi.nlm.nih.gov/pubmed/30094069
http://dx.doi.org/10.1136/esmoopen-2018-000379
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author Pereira, Stephen P
Jitlal, Mark
Duggan, Marian
Lawrie, Emma
Beare, Sandy
O’Donoghue, Pam
Wasan, Harpreet S
Valle, Juan W
Bridgewater, John
author_facet Pereira, Stephen P
Jitlal, Mark
Duggan, Marian
Lawrie, Emma
Beare, Sandy
O’Donoghue, Pam
Wasan, Harpreet S
Valle, Juan W
Bridgewater, John
author_sort Pereira, Stephen P
collection PubMed
description BACKGROUND: Endobiliary stenting is standard practice for palliation of obstructive jaundice due to biliary tract cancer (BTC). Photodynamic therapy (PDT) may also improve biliary drainage and previous small studies suggested survival benefit. AIMS: To assess the difference in outcome between patients with BTC undergoing palliative stenting plus PDT versus stenting alone. METHODS: 92 patients with confirmed locally advanced or metastatic BTC, ECOG performance status 0–3 and adequate biliary drainage were randomised (46 per group) to receive porfimer sodium PDT plus stenting or stenting alone. The primary end point was overall survival (OS). Toxicity and progression-free survival (PFS) were secondary end points. Treatment arms were well balanced for baseline factors and prior therapy. RESULTS: No significant differences in grade 3–4 toxicities and no grade 3–4 adverse events due to PDT were observed. Thirteen (28%) PDT patients and 24 (52%) stent alone patients received subsequent palliative chemotherapy. After a median follow-up of 8.4 months, OS and PFS were worse in patients receiving PDT compared with stent alone group (OS median 6.2 vs 9.8 months (HR 1.56, 95% CI 1.00 to 2.43, p=0.048) and PFS median 3.4 vs 4.3 months (HR 1.43, 95% CI: 0.93 to 2.18, p=0.10), respectively). CONCLUSION: In patients with locally advanced or metastatic BTC, PDT was associated with worse outcome than stenting alone, explained only in part by the differences in chemotherapy treatments. We conclude that optimal stenting remains the treatment of choice for malignant biliary obstruction and the use of PDT for this indication cannot be recommended outside of clinical trials. TRIAL REGISTRATION NUMBER: ISRCTN 87712758; EudraCT 2005-001173-96; UKCRN ID: 1461.
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spelling pubmed-60699172018-08-09 PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer Pereira, Stephen P Jitlal, Mark Duggan, Marian Lawrie, Emma Beare, Sandy O’Donoghue, Pam Wasan, Harpreet S Valle, Juan W Bridgewater, John ESMO Open Original Research BACKGROUND: Endobiliary stenting is standard practice for palliation of obstructive jaundice due to biliary tract cancer (BTC). Photodynamic therapy (PDT) may also improve biliary drainage and previous small studies suggested survival benefit. AIMS: To assess the difference in outcome between patients with BTC undergoing palliative stenting plus PDT versus stenting alone. METHODS: 92 patients with confirmed locally advanced or metastatic BTC, ECOG performance status 0–3 and adequate biliary drainage were randomised (46 per group) to receive porfimer sodium PDT plus stenting or stenting alone. The primary end point was overall survival (OS). Toxicity and progression-free survival (PFS) were secondary end points. Treatment arms were well balanced for baseline factors and prior therapy. RESULTS: No significant differences in grade 3–4 toxicities and no grade 3–4 adverse events due to PDT were observed. Thirteen (28%) PDT patients and 24 (52%) stent alone patients received subsequent palliative chemotherapy. After a median follow-up of 8.4 months, OS and PFS were worse in patients receiving PDT compared with stent alone group (OS median 6.2 vs 9.8 months (HR 1.56, 95% CI 1.00 to 2.43, p=0.048) and PFS median 3.4 vs 4.3 months (HR 1.43, 95% CI: 0.93 to 2.18, p=0.10), respectively). CONCLUSION: In patients with locally advanced or metastatic BTC, PDT was associated with worse outcome than stenting alone, explained only in part by the differences in chemotherapy treatments. We conclude that optimal stenting remains the treatment of choice for malignant biliary obstruction and the use of PDT for this indication cannot be recommended outside of clinical trials. TRIAL REGISTRATION NUMBER: ISRCTN 87712758; EudraCT 2005-001173-96; UKCRN ID: 1461. BMJ Publishing Group 2018-07-23 /pmc/articles/PMC6069917/ /pubmed/30094069 http://dx.doi.org/10.1136/esmoopen-2018-000379 Text en © Author (s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ on behalf of the European Society for Medical Oncology. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Original Research
Pereira, Stephen P
Jitlal, Mark
Duggan, Marian
Lawrie, Emma
Beare, Sandy
O’Donoghue, Pam
Wasan, Harpreet S
Valle, Juan W
Bridgewater, John
PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer
title PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer
title_full PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer
title_fullStr PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer
title_full_unstemmed PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer
title_short PHOTOSTENT-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer
title_sort photostent-02: porfimer sodium photodynamic therapy plus stenting versus stenting alone in patients with locally advanced or metastatic biliary tract cancer
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6069917/
https://www.ncbi.nlm.nih.gov/pubmed/30094069
http://dx.doi.org/10.1136/esmoopen-2018-000379
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