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These are the final results of the Ofatumumab in MALT lymphoma study (O-MA 1), a pilot phase II trial evaluating the capacity and safety of ofatumumab to induce objective responses in patients with Helicobacter pylori eradication refractory or extragastric MALT lymphoma. Ofatumumab was given at 4 weekly doses (1000 mg) followed by 4 doses at 2-month intervals starting at week 8. According to protocol, a total of 16 patients were recruited (median age 69 years; range 38-85). Thirty one percent (5/16) of patients had primary gastric MALT lymphoma while the remaining 69% (11/16) presented with extragastric manifestations. Seventy-five percent (12/16) had localized lymphoma and 4 patients disseminated disease. The overall response rate to treatment with ofatumumab was 81% (13/16), with the median time to best response being 5.5 months. In detail, 50% (8/16) achieved complete remission; 31% (5/16), partial remission; and 19% (3/16), disease stabilization as best response. However, 1 patient with gastric lymphoma and complete remission at second restaging had a relapse at final assessment but ongoing complete remission during further follow-up. Tolerability was excellent accept low-grade infusion reactions occurring in 86% (14/16). At a median follow-up time of 25 months only 1 patient has relapsed suggesting durable responses in the majority of patients. This pilot trial shows clearly that ofatumumab is active and safe for the treatment of MALT lymphoma. [ABSTRACT FROM AUTHOR]

Objectives: Gender-related aspects have been investigated in a variety of tumor entities including results on sex-specific differences in non-Hodgkin lymphoma. However, there are no data on gender differences in mucosa-associated lymphoid tissue (MALT) lymphoma. Methods: We have analyzed 327 patients treated between 1999 and 2015 with a median follow-up time of 55.2 months. Results: There was a female predominance, with 197 female (60.2%) and 130 male patients (39.8%, female-to-male ratio 1.5). The mean age was comparable between female and male patients (61.2 vs. 61.7 years, p = 0.777). Female patients less frequently had gastric MALT lymphoma (31.5 vs. 39.2%), but this was not statistically significant (p = 0.149). Extragastric manifestations were equally distributed, except for parotid (p = 0.003) and breast lymphoma (n = 8,100% female) showing a female predominance. This was most likely related toa higher rate of active autoimmune disorders in women (35.6 vs. 11.0%, p < 0.001 ). β2-Microglobulin elevation at diagnosis occurred more often in female patients (42.8 vs. 26.0%; p = 0.008). However, this did not translate into a worse progression-free survival for female (56.0 months, 95% CI 30.1-81.9) versus male patients (49.0 months, 95%CI 25.4-72.5, p = 0.433). Overall survival did not differ between groups. Conclusion: Our data show surprisingly little differences between female and male patients with MALT lymphoma. Both sexes appeared to have well-balanced clinical features and an identical prognosis. [ABSTRACT FROM AUTHOR]

Background. The immunomodulatory drugs (IMiDs) thalidomide and lenalidomide have both been tested for treatment of mucosa-associated lymphoid tissue (MALT) lymphoma, with lenalidomide, in particular, showing promising activity. However, long-term results are missing. Because of the late-onset remissions registered in individual patients, we have systemically analyzed the patients treated with IMiDs at our institution for long-term results. Methods. Within the present retrospective analysis, we identified 25 patients who had been treated with lenalidomide (n 5 18) or thalidomide (n =7) and were available for long-term assessments of outcome. All patients were followed up according to a standardized follow-up protocol. Results. Of the 25 patients, 7 (28%) experienced delayed-onset responses without further treatment (thalidomide, n = 2; lenalidomide, n =5). In 4 patients (16%), the initial outcome switched to a better result (partial remission [PR] to complete remission [CR], n = 1; stable disease [SD] to PR, n = 1; SD to CR, n = 1; and PD to CR, n =1) after a median time of 19.5 months (range, 10.9-32.0). Furthermore, 2 patients showed ongoing shrinkage of the target lesion for 47.41 and 43.51 months, respectively, and 1 patient had durable disease stabilization for 16.21 months. The median time to the best response for all responding patients (13 of 25; 53%) was 7.3 months (interquartile range [IQR], 5.6-22.5). After a median follow-up of 46 months (IQR, 32.0-58.5), 23 of 25 patients (92%) were alive. Conclusion. Our findings suggest that late-onset remissions might be a common phenomenon in the use of IMiDs for the treatment of MALT lymphoma. Thus, sufficient follow-up time after treatment before the initiation of further therapy appears crucial to assess the full effect of therapy and avoid unnecessary overtreatment. [ABSTRACT FROM AUTHOR]

Simple Summary: The Division of Oncology at the Medical University Vienna is a tertiary referral center for extranodal lymphoma of mucosa-associated lymphoid tissue (MALT)-type and currently oversees more than 400 patients with this diagnosis, including a relevant percentage of patients being treated with systemic therapies. In the current analysis, we present response and long-term data of 159 patients (not eligible for Helicobacter pylori eradication) treated upfront with systemic treatment focusing on chemotherapy- versus immunotherapy-based strategies. We show that despite higher response and complete remission rates for chemo- versus immunotherapy, there appears to be no difference in progression-free survival, thus suggesting comparable long-term results. Considering the biological background of MALT lymphoma—and particularly its high dependence on the tumor microenvironment—but also the favorable toxicity profile of assessed immunomodulatory agents such as IMiD lenalidomide or macrolide clarithromycin, we suggest that these data support further investigation of chemotherapy-free treatment concepts for MALT lymphoma. There is no clear therapeutic algorithm for mucosa-associated lymphoid tissue (MALT) lymphoma beyond Helicobacter pylori eradication and while chemotherapy-based regimens are standard for MALT lymphoma patients in need of systemic treatment, it appears of interest to also investigate chemotherapy-free strategies. We have retrospectively assessed MALT lymphoma patients undergoing upfront systemic treatment, classified either as chemotherapy (=classical cytostatic agents +/− rituximab) or immunotherapy (=immunomodulatory agents or single anti-CD20 antibodies) at the Medical University Vienna 1999–2019. The primary endpoint was progression-free survival (PFS). In total, 159 patients were identified with a median follow-up of 67 months. The majority of patients had extragastric disease (80%), but we also identified 32 patients (20%) with Helicobacter pylori negative or disseminated gastric lymphoma. Regarding the type of first line treatment and outcome, 46% (74/159) received a chemotherapy-based regimen and 54% (85/159) immunotherapy including IMiDs lenalidomide/thalidomide (37%), anti-CD20-anitbodies rituximab/ofatumumab (27%), macrolides clarithromycin/azithromycin (27%) and proteasome inhibitor bortezomib (9%). Median PFS was 76 months (95%CI 50–102), and while the overall response (90% vs. 68%, p < 0.01) and the complete remission rate (75% vs. 43%, p < 0.01) was significantly higher for chemotherapy, there was no difference in PFS between chemotherapy (median 81 months, 95%CI 47–116) and immunotherapy (76 months, 95%CI 50–103, p = 0.57), suggesting comparable long-term outcomes. To conclude, our data show higher response rates with chemo- compared to immunotherapy, but this did not translate into a superior PFS. Given the biological background of MALT lymphoma, and the favorable toxicity profile of novel immunomodulatory treatments, this should be further investigated. [ABSTRACT FROM AUTHOR]

Gastric mucosa-associated lymphoid tissue (MALT) lymphoma responding to upfront treatment has an excellent outcome and no further therapy is recommended, even in the presence of residual disease. However, no data exist on the influence of initial depth of remission on progression-free survival (PFS). Methods: We investigated a correlation between PFS and depth of response, categorizing them as complete remission (CR), partial remission (PR) and stable disease (SD) in 137 consecutive patients at the Medical University Vienna. Results: All patients with Helicobacter pylori (H. pylori)-positive, localized disease received H. pylori eradication (70%, 96/137), while the remaining patients were treated with various modalities. The response rate was 67% for the entire collective and 58% for eradication only, with corresponding CR-rates of 48% and 38%. At a median follow-up of 56.2 months, the estimated PFS for the entire cohort was 34.2 months (95% Confidence Interval 16.0–52.4). Responding patients (=CR/PR) had a significantly longer PFS compared to SD (68.3 vs. 17.3 months, p < 0.001). This was also applicable to the eradication only cohort (49.0 vs. 17.3 months, p < 0.001) and remained significant after correction for MALT-IPI. Furthermore, CR significantly prolonged PFS over PR (p = 0.007 entire cohort, p = 0.020 eradication). Conclusions: Remission status correlated significantly with PFS, suggesting depth of remission as prognostic marker for long-term relapse-free survival. [ABSTRACT FROM AUTHOR]