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16.10.2018 | Original Article—Alimentary Tract

Sequential H. pylori eradication and radiation therapy with reduced dose compared to standard dose for gastric MALT lymphoma stages IE & II1E: a prospective randomized trial

verfasst von: Renate Schmelz, Stephan Miehlke, Christian Thiede, Stefan Brueckner, Monic Dawel, Matthias Kuhn, Agnes Ruskoné-Formestraux, Manfred Stolte, Christina Jentsch, Jochen Hampe, Andrea Morgner

Erschienen in: Journal of Gastroenterology | Ausgabe 5/2019

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Abstract

Background

In Helicobacter pylori (H. pylori) positive stage I gastric low-grade MALT lymphoma, eradication is the accepted first-line therapy. The role of eradication therapy in lymphoma > stage IE is still unclear. However, about 20% of patients show persistent lymphoma following successful eradication or primary H. pylori-negative lymphoma. A prospective study for salvage radiation therapy with standard 36 Gy in comparison to a reduced dose of 25.2 Gy is still missing.

Methods

A prospective, multicentre study investigated the efficacy of eradication in H. pylori-positive gastric low-grade MALT lymphoma stages IE and II1E (HELYX I). Refractory lymphoma or H. pylori-negative patients were treated in a prospective, randomised, multicentre, phase II study to receive either 25.2 Gy or 36 Gy radiotherapy (HELYX II).

Results

102 patients (3 drop outs) were included in HELYX I: 75/99 (75.8%) showed complete remission after a median of 2.8 months. 18 (18.2%) had partial remission (PR) and 6 (6.0%) no change (NC). 29 patients (7 drop outs) were randomized in HELYX II (7 primarily H. pylori-negative, 15 patients from HELYX I with refractory disease after eradication). All patients achieved stable CR irrespective of radiation dose. Both presence of the t(11,18) translocation (OR 9.0, p = 0.01) and monoclonality of the tumour cells (OR 6.3, p = 0.006) were predictors for persistant lymphoma after eradication therapy.

Conclusions

Most H. pylori-positive low grade gastric MALT lymphoma stage IE and II1E respond with stable CR after eradication therapy. In patients with refractory disease or H. pylori negative low grade gastric MALT lymphoma a dosage-reduced radiation therapy with 25.2 Gy is an effective standard dose in stage IE and II1E.

Trial registration

ClinicalTrials.gov: NCT00154440.

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Titel: Sequential H. pylori eradication and radiation therapy with reduced dose compared to standard dose for gastric MALT lymphoma stages IE & II1E: a prospective randomized trial
verfasst von: Renate Schmelz
Stephan Miehlke
Christian Thiede
Stefan Brueckner
Monic Dawel
Matthias Kuhn
Agnes Ruskoné-Formestraux
Manfred Stolte
Christina Jentsch
Jochen Hampe
Andrea Morgner
Publikationsdatum: 16.10.2018
Verlag: Springer Japan
Erschienen in: Journal of Gastroenterology / Ausgabe 5/2019
Print ISSN: 0944-1174
Elektronische ISSN: 1435-5922
DOI: https://doi.org/10.1007/s00535-018-1517-4

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Abstract

Background

Methods

Results

Conclusions

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