High-dose clarithromycin is an active monotherapy for patients with relapsed/refractory extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT): the HD-K phase II trial
| Autor: | Markus Raderer, Giovanni Donadoni, Barbara Kiesewetter, Marianna Sassone, Silvia Govi, Lydia Scarfò, Andrés J.M. Ferreri |
|---|---|
| Přispěvatelé: | Ferreri, A. J. M., Sassone, M., Kiesewetter, B., Govi, S., Scarfo', L., Donadoni, G., Raderer, M. |
| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Skin Neoplasms Salvage therapy Breast Neoplasms Gastroenterology Disease-Free Survival Neoplasms Multiple Primary Stomach Neoplasms Clarithromycin Internal medicine medicine Humans Progression-free survival MALT lymphoma Extranodal marginal zone lymphoma Aged Aged 80 and over Salvage Therapy Mouth neoplasm business.industry Eye Neoplasms Lymphoma B-Cell Marginal Zone Hematology Middle Aged medicine.disease Anti-Bacterial Agents Oncology Tolerability Immunology Female Mouth Neoplasms Marginal zone B-cell lymphoma Macrolides Colorectal Neoplasms business Mucosa-associated lymphoid tissue medicine.drug |
| Zdroj: | Annals of Oncology. 26:1760-1765 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mdv214 |
| Popis: | Background Clarithromycin displays immunomodulatory and antineoplastic properties. As single agent, this macrolide is associated with tumor responses in anecdotal cases of relapsed/refractory extranodal marginal zone lymphoma (rrEMZL), with a putative dose-dependent effect. Tolerability and activity of high-dose clarithromycin (HD-K) in patients with rrEMZL were addressed in a phase II trial (clinicaltrials.gov NCT01516606). Methods HIV-negative adults with rrEMZL and at least one measurable/parametrable lesion were enrolled and treated with four courses of oral clarithromycin 2 g/day, days 1–14, every 21 days. Activity (overall response rate, ORR) was the primary end point. Results Twenty-three patients were registered (median age 70 years, range 47–88 years; M:F ratio: 0.27). HD-K was given at greater than or equal to second relapse in 11 patients. Ocular adnexae were the most commonly involved organs. Five patients had hepatitis B virus/hepatitis C virus (HBV/HCV) infections; Helicobacter pylori and Chlamydophila psittaci infections were excluded at the time of patient registration. Tolerability was excellent, even among HBV/HCV-positive patients; only two patients had grade >2 toxicity (nausea). Six patients achieved a complete remission and six a partial response (ORR = 52%; 95% confidence interval 32% to 72%). Age, previous treatment and stage did not influence activity. At a median follow-up of 24 (16–33) months, only two patients with responsive disease experienced relapse, with a 2-year progression-free survival of 56 ± 10%; all patients are alive. Conclusions HD-K is a safe and active salvage treatment in EMZL patients. This macrolide deserves to be further investigated in EMZL and other lymphoma categories. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|