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Rituximab plus subcutaneous cladribine in patients with extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue: a phase II study by the Arbeitsgemeinschaft Medikamentose Tumortherapie
- Source :
- Haematologica. 98:264-268
- Publication Year :
- 2012
- Publisher :
- Ferrata Storti Foundation (Haematologica), 2012.
-
Abstract
- Currently, there is no standard systemic treatment for extranodal marginal zone B-cell lymphoma of the mucosa-associated lymphoid tissue. Both rituximab and cladribine have shown some activity in this disease, but the combination has not been tested so far. In view of this, we initiated a phase II study to assess the activity and safety of rituximab and cladribine in patients with histologically verified mucosa-associated lymphoid tissue lymphoma. Treatment consisted of rituximab 375 mg/m(2) i.v. day 1 and cladribine 0.1 mg/kg s.c. days 1 - 4 every 21 days. In case of complete remission after two courses, another two cycles of therapy were administered, while patients with a partial response or stable disease were scheduled to receive six cycles of treatment. Out of 40 evaluable patients (14 female, 26 male), 39 received treatment as scheduled while one patient died before initiation of therapy and was rated as having progressive disease in the intent-to-treat analysis. Twenty-one patients had gastric lymphoma, while 19 suffered from extragastric mucosa-associated lymphoid tissue lymphoma. Side effects consisted mainly of hematologic toxicity including leukopenia, lymphopenia, anemia and thrombocytopenia. Twenty-three patients had a complete remission (58%) and nine had a partial remission (23%) for an overall response rate of 81%, while five had stable disease (13%) and two progressed during therapy. After a median follow-up of 16.7 months (interquartile range: 15.9 - 18.7 months), 35 patients are alive (88%) while four patients have died and one patient withdrew consent and did not allow further follow up. Our data demonstrate that rituximab plus cladribine is active and safe in patients with mucosa-associated lymphoid tissue lymphoma.
- Subjects :
- Male
medicine.medical_specialty
Antibodies, Monoclonal, Murine-Derived
hemic and lymphatic diseases
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Cladribine
Neoplasm Staging
Leukopenia
business.industry
Gastric lymphoma
Articles
Lymphoma, B-Cell, Marginal Zone
Hematology
Middle Aged
medicine.disease
Marginal zone
Lymphoma
Surgery
Treatment Outcome
Female
Rituximab
medicine.symptom
business
Mucosa-associated lymphoid tissue
Progressive disease
medicine.drug
Subjects
Details
- ISSN :
- 15928721 and 03906078
- Volume :
- 98
- Database :
- OpenAIRE
- Journal :
- Haematologica
- Accession number :
- edsair.doi.dedup.....c849ab935d8a67ca2efbdb0790f8d0db