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• W2952202698 abstract "Introduction: Treatment of Diffuse Large B cell lymphoma (DLBCL) in the elderly population is challenging as many patients (pts) are not eligible to receive standard curative therapy, due to comorbid conditions and to a higher susceptibility to the side effects of standard anthracycline containing regimens. Among currently available active drugs, Lenalidomide has been used in the setting of relapsed/refractory DLBCL both as monotherapy and in combination with rituximab, showing a good activity and an acceptable safety profile. We started a prospective, multicenter, single arm, phase II trial to demonstrate activity and safety of lenalidomide + rituximab combination in elderly (≥ 70 years) untreated pts with DLBCL who were prospectively defined as frail according to a simplified comprehensive geriatric assessment (CGA). Patients and methods: Pts were eligible if they were previously untreated DLBCL patients, older than 69 years and defined as frail according to CGA. The treatment consisted of a 28-day cycle (R2) combining oral Lenalidomide (20 mg/m2/d on days 1 to 21) and i.v. Rituximab (375 mg/m2 on day 1); a maximum number of 6 cycles was planned; response assessment was performed after cycles 4 and 6. At the end of the 6th cycle, patients with partial or complete response continued treatment with Lenalidomide 10mg/d on days 1 to 21 every 28 days, until cycle 12 or unacceptable toxicity. Final response was evaluated within 28 days after the last study drug administration. Primary study endpoint was Overall Response Rate (ORR) after 6 R2 cycles, defined according to Lugano 2014 criteria; co-primary endpoint was the rate of extra-hematological toxicity with CTCAE grade >2 and of death for any cause during the treatment. The study was planned according to a two stage Simon design. A total of 68 pts had to be enrolled to complete the study: 23 pts were required in the first stage. Second stage could be activated with at least 12 patients showing a Partial or Complete Response (PR/CR) in stage I. According to the Ray and Rai method less than 15/23 adverse events were also required for the safety coprimary endpoint. Results: From January 2017 to December 2017, 24 newly diagnosed frail DLBCL were enrolled in 8 Italian centers. Median age was 83 years (range 76-89) and 79% had stage III/IV; 42% of pts were male, and 44%, had elevated LDH. All pts were confirmed eligible and started R2 treatment. The planned 6 courses of R2 were completed in 13 pts (54%). The median number of R2 cycles was 4.6. Treatment was discontinued in 11 pts for the following reasons: lymphoma progression in 4 cases, malignancy in 2, extra-hematological toxicities in 2 cases, consent withdrawal and investigator choice after 4 cycles in CR in 1 case each. Response assessment after 6 R2 cycles showed 12 pts in CR, that was higher than the inferior limit of 11 required by the Simon optimal design. Regarding safety coprimary endpoint 13 events were reported including 9 extra-hematological toxicities > grade 2 CTCAE (3 cardio-vascular and 6 respiratory events, all resolved) and 4 deaths (2 patients due visceral arterial ischemia and 2 due infectious disease). The rate of adverse events was lower than the superior limit of 15 allowed the first stage of the study, according to Ray and Rai method. Conclusions: The results of the planned interim analysis of our study confirmed the initial efficacy and safety hypotheses of R2 combination in untreated elderly pts with DLBCL. Since August 2018 the enrollment in the stage II of the trial has been resumed and it is currently ongoing. Treatment of elderly frail DLBCL pts with R2 holds promise in terms of both ORR and safety. Keywords: diffuse large B-cell lymphoma (DLBCL); elderly; lenalidomide." @default.
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• W2952202698 date "2019-06-01" @default.
• W2952202698 modified "2023-09-26" @default.
• W2952202698 title "LENALIDOMIDE AND RITUXIMAB (ReRi) AS FRONT LINE THERAPY OF ELDERLY FRAIL PATIENTS WITH DIFFUSE LARGE B-CELLS LYMPHOMA. FIRST PLANNED INTERIM ANALYSIS OF A PHASE II STUDY OF THE FONDAZIONE ITALIANA LINFOMI (FIL)" @default.
• W2952202698 doi "https://doi.org/10.1002/hon.99_2631" @default.
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