Skip to main content
Article thumbnail
Location of Repository

Chlorambucil versus observation after anti-Helicobacter therapy in gastric MALT lymphomas: results of the international randomised LY03 trial

By Barry W Hancock, Wendi Qian, David Linch, Jean-Charles Delchier, Paul Smith, Ira Jakupovic, Cathy Burton, Robert Souhami, Andrew Wotherspoon, Christiane Copie-Bergman, Carlo Capella, Catherine Traulle, Michael Levy, Sergio Cortelazzo, Andres J M Ferreri, Achille Ambrosetti, Graziella Pinotti, Giovanni Martinelli, Umberto Vitolo, Franco Cavalli, Christian Gisselbrecht and Emanuele Zucca


Gastric mucosa-associated lymphoid tissue (MALT) lymphomas are uncommon tumours characterised by a tendency to remain localised for long periods. The aetiological association between MALT lymphomas and Helicobacter pylori is well established. The role of additional chemotherapy after H. pylori eradication in localised MALT lymphomas is unclear. The LY03 trial was designed to establish whether chlorambucil after treatment for H. pylori would help prevent recurrence. Patients were treated with antibiotics for H. pylori infection. Those with successful eradication of H. pylori and no evidence of progression of lymphoma were eligible for randomisation to chlorambucil or observation. Two hundred and thirty-one patients were registered. Ninety-seven percent patients had H. pylori eradicated after antibiotics and 59% achieved macroscopically normal gastric mucosa. One hundred and ten patients were randomised. With a median follow-up of 58 months, six patients were dead and 17 had recurrent/progressive disease. The recurrence/progression rates at 5 years were 11% for chlorambucil, and 21% for observation with a difference of 10%, 95% confidence interval (CI) = −9% to 29%, P = 0·15. No difference was detected in recurrence/progression-free survival [Hazard Ratio (HR) = 0·96, 95% CI = 0·41–2·2, P = 0·91] or overall survival (HR = 1·93, 95% CI = 0·39–9·58, P = 0·42). This is the first randomised trial to show there is no good evidence to support that additional single agent chemotherapy to anti-H. pylori treatment contributes to prevent recurrence in localised gastric MALT lymphomas

Topics: Research Paper
Publisher: Blackwell Publishing Ltd
OAI identifier:
Provided by: PubMed Central

Suggested articles


  1. (2008). Chlorambucil Versus Observation in Gastric MALT Lymphomas ª
  2. (2005). Clinical activity of rituximab in gastric marginal zone nonHodgkin’s lymphoma resistant to or not eligible for anti-Helicobacter pylori therapy.
  3. (1997). Clinical features, treatment and outcome in a series of 93 patients with low-grade gastric MALT lymphoma.
  4. (1995). Efficacy of single-agent chemotherapy in low-grade B-cell mucosa-associated lymphoid tissue lymphoma with prominent gastric expression.
  5. (1995). Eradication of Helicobacter pylori infection in primary low- grade gastric lymphoma of mucosa-associated lymphoid tissue.
  6. (2002). Helicobacter and gastric MALT lymphoma.
  7. (1991). Helicobacter pylori-associated gastritis and primary B-cell gastric lymphoma.
  8. (2002). International Extranodal Lymphoma Study Group and United Kingdom Lymphoma Group. Molecular follow-up in gastric mucosa-associated lymphoid tissue lymphomas: early analysis of the LY03 co-operative trial.
  9. Liu,H.,Ye,H.,Ruskone-Fourmestraux,A.,DeJong,D.,Pileri,S.,Thiede, C.,Lavergne,A.,Boot,H.,Caletti,G.&Wundisch,T.(2002)T(11;18) isamarkerforallstagegastricMALTlymphomasthatwillnotrespond to H. pylori eradication.
  10. (2007). Long term outcome of gastric MALT lymphoma patients treated with anti-Helicobacter (antibiotic and proton-pump inhibitor) regimens.
  11. (2005). Long-term follow-up of gastric MALT after Helicobacter pylori eradication.
  12. (1983). Malignant lymphoma of mucosa associated lymphoid tissue: a distinctive type of B-cell lymphoma.
  13. (1987). Malignant lymphoma of mucosaassociated lymphoid tissue.
  14. (2008). MALT lymphoma pathology, initial diagnosis, and posttreatment evaluation. In:
  15. (2007). Most patients with minimal histological residuals of gastric MALT lymphoma after B. W. Hancock et al ª
  16. (2001). Predictive factors for regression of gastric MALT lymphoma after anti-Helicobacter pylori treatment.
  17. (2007). Primary gastric lymphoma pathogenesis and treatment: what has changed over the past 10 years?
  18. (2005). Prognostic value of translocation t(11;18) in tumour response of low-grade gastric lymphoma of mucosa-associated lymphoid tissue type to oral chemotherapy.
  19. (1995). Regression of primary gastric lymphoma of mucosa-associated lymphoid tissue type after cure of Helicobacter pylori infection.
  20. (1993). Regression of primary low grade B-cell gastric lymphoma of mucosa associated lymphoid tissue (MALT) type following eradication of Helicobacter pylori.
  21. (1994). Report on a workshop convened to discuss the pathological and staging classifications of gastrointestinal tract lymphoma.
  22. (2005). State-of-the-art therapeutics:marginalzone lymphoma.
  23. (2004). The diminishing role of surgery in the treatment of gastric lymphoma.
  24. (2005). Treatment results in localized primary gastric lymphoma: data of patients registered within the German multicenter study (GIT NHL 02/96).

To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.