ALBERT

Description: BACKGROUND Primary cutaneous marginal zone B-cell lymphomas (PCMZL) are low-grade lymphomas with an indolent course, but with a high rate of skin relapses. Surgical excision, local radiotherapy, or combinations of both are the first-line treatment in solitary or localized disease. Therapeutic options in cases of multifocal disease or relapse, include steroids or intravenous Rituximab in monotherapy or in combination with intravenous or oral chemotherapy. The effectiveness of intralesional Rituximab (ILR) in primary cutaneous B-cell lymphomas has been described in a small multicenter series of patients. OBJECTIVE To evaluate the effectiveness and safety of ILR in patients with PCMZL. METHODS In our center ILR is used since 2010 as fist-line treatment for patients with PCMZL with single facial lesions, multifocal disease that cannot be irradiated or in relapsed disease. The treatment regimen consist of a course of three injections of 10 mg (days 1, 3 and 5) in a single week at monthly intervals. Oral paracetamol and dexclorfeniramine were administrated 30 minutes before the procedure. Courses of ILR were monthly repeated until response or in cases of relapse. The primary outcome measure of the study was the rate of remissions (complete and partial remissions). RESULTS Twelve patients with PCMZL have been treated so far, 50% as first-line. The relapsed-group had previously received a median of 3 previous treatments (range, 1-6) including radiotherapy in 5 cases, surgery in 1 case, intravenous chemotherapy in 2 cases, and topic steroids in 2 cases. Clinical characteristics of the 12 patients are shown in the table below. A total of 42 courses of ILR have been completed. All patients responded: a complete therapeutic response was achieved in 10 patients, whereas a partial response was observed in 2. No cases of progression or relapse in the site of ILR treatment were documented. Four patients experienced transitory mild perilesional erythema that did not require medication and resolved in less than 4 hours. No cases of significant adverse events occurred and none of the patients suffered severe bacterial or opportunistic infections. CONCLUSIONS In our preliminary experience, ILR is an effective and safe therapeutic approach for selected PCMZL patients with single facial lesion, multifocal disease than cannot be irradiated, or in relapsed cases. To date, this is the largest experience with ILR of a single center. Disclosures Gonzalez Barca: Roche: Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Speakers Bureau.

Description: BACKGROUND Primary cutaneous marginal zone B-cell lymphomas (PCMZL) are low-grade lymphomas with an indolent course, but with a high rate of skin relapses. Surgical excision, local radiotherapy, or combinations of both are the first-line treatment in solitary or localized disease. Therapeutic options in cases of multifocal disease or relapse, include steroids or intravenous Rituximab in monotherapy or in combination with intravenous or oral chemotherapy. The effectiveness of intralesional Rituximab (ILR) in primary cutaneous B-cell lymphomas has been described in a small multicenter series of patients. OBJECTIVE To evaluate the effectiveness and safety of ILR in patients with PCMZL. METHODS In our center ILR is used since 2010 as fist-line treatment for patients with PCMZL with single facial lesions, multifocal disease that cannot be irradiated or in relapsed disease. The treatment regimen consist of a course of three injections of 10 mg ( days 1, 3 and 5) in a single week at monthly intervals. Oral paracetamol and dexclofeniramire were administrated 30 minutes before the procedure. Courses of ILR were monthly repeated until response or in cases of relapse. The primary outcome measure of the study was the rate of remissions (complete and partial remissions). RESULTS Eleven patients with PCMZL have been treated so far: 55% as first-line treatment and 45% in the relapse setting. The relapsed-group had previously received a median of 3 previous treatments (range, 1-6) including radiotherapy in 5 cases, surgery in 1 case, intravenous chemotherapy in 2 cases, and topic steroids in 2 cases. Clinical characteristics of the 11 patients are shown in the table below. A total of 40 courses or ILR have been completed. All patients responded, with 73% complete responses, without evidence of progression or relapse in the site of ILR treatment. Four patients experienced transitory mild perilesional erythema that did not require medication and resolved in less than 4 hours. No systemic toxicities or infections were observed; the tolerance was excellent in all cases. CONCLUSIONS In our preliminary experience, ILR is an effective and safe therapeutic approach for selected PCMZL patients with single facial lesion, multifocal disease than cannot be irradiated or in relapsed cases. Further controlled studies are needed to confirm these findings. Disclosures Sureda: Takeda: Consultancy, Speakers Bureau.

Description: Introduction:Renal impairment (RI) is a common complication of multiple myeloma (MM). Almost 20% of patients (pts) present with RI at diagnosis, while approximately 40%-50% of pts will develop RI during the course of their disease. However, there is little information on the renal response of pts with relapsed refractory MM (RRMM) receiving treatment with new drugs in clinical practice. Aims: This is an observational, prospective, multicenter study conducted in pts with RRMM and RI (defined as an estimated glomerular filtration rate [eGFR] 〈 50 mL/min) to evaluate renal response to the administered therapy in pts with moderate (creatinine clearance [CrCl] 30-50 mL/min) or severe (CrCl 〈 30 mL/min) RI. Secondary objectives include MM response rate, overall survival, safety, and health resource utilization. We present results from an interim analysis 4 mos after completion of the inclusion period (cutoff: June 13, 2016). Methods:Renal and MM responses were evaluated according to International Myeloma Working Group criteria. Both eGFR by the Cockroft-Gault (CG) and Modification of Diet in Renal Disease (MDRD) formulas were compared to analyze renal response. Results:Overall, 312 pts (mean ± SD age 75 ± 9 yrs, 50% male, 57% in first relapse) were included in the study; 217 (70%) had moderate and 95 (30%) had severe RI, respectively. Anti-myeloma therapies administered were lenalidomide (LEN; 35% of pts), bortezomib (BORT; 21%), different chemotherapy regimens (CT; 22%), and other non-CT treatments (22%). Median follow-up was 7 mos (range, 0-39 mos). To date, 123 pts (39%) have discontinued treatment, 12% due to adverse events (AEs), and 37% have died. The main causes of death were disease progression (8.3%) and infections (6.4%). The mean baseline eGFR according to CG and MDRD formulas was 38.7/41.7 (± 8.5/11.8) mL/min in the moderate RI subgroup and 20.3/20.1 (± 8.0/10.1) mL/min in the severe RI group, with a strong correlation (coefficient 0.91) between the CG and MDRD eGFR. Overall, 13.5% (95% CI, 9.7%-17.2%) of patients had a renal response (5.8% renal complete response [renalCR], 0.3% renal partial response [renalPR], and 7.4% renal minor response [renalMR]) according to the CG formula while responses measured by the MDRD formula, were 17.3% (9.9% renalCR, 0.3% renalPR, and 7.1% renalMR). Median time to best renal response was 1.8 mos (range, 0.5-8.9 mos). After adjusting for demographic and clinical characteristics, there were no significant differences in GFR improvement between pts receiving LEN- and BORT-based treatments (P = 0.706). Arterial hypertension and female sex were statistically significantly associated with poor renal response. The overall MM efficacy response rate (≥ PR) was 33.4%, achieved after a median of 3.4 mos (range, 0.07-37.8 mos). For pts receiving BORT and LEN, respectively, the overall response rates were 43.5% and 44.8%, whereas only 23% of pts receiving CT achieved at least PR. Progression-free survival was 13.3 mos with LEN-based, 6.8 mos with BORT-based, and 7.5 mos with CT-based therapies (P = 0.006). Conclusions: Preliminary results of this study in pts with RRMM and RI show that LEN- and BORT-based therapies are the regimens most commonly used in clinical practice in these pts. Overall, these therapies can improve RI in approximately 13% of cases, with no differences seen in renal function improvement between LEN- and BORT-based treatments. Disclosures De La Rubia: Amgen, Bristol Myers, Celgene, Janssen: Consultancy. Morales:Celgene: Consultancy. García-Muñoz:Celgene, Roche: Consultancy. Duran:Celgene: Employment.

Description: Introduction Autologous hematopoietic transplantation (AHT) is an established therapy in multiple myeloma (MM) and lymphoma. Standard mode (CRYO) consists on collection of autologous precursors, freezing with dimethyl sulfoxide (DMSO) and subsequent thawing and reinfusion. However, this process is toxic and increases transplantation costs. Non-Cryopreserved (Non-CRYO) mode is a less expensive mode of AHT that has shown same transplantation outcomes in several single-center experiences. The Pontificia Universidad Católica de Chile transplant program began Non-CRYO AHT in 2015. In this study, we have compared patients who had Non-CRYO AHT in Chile with patients who had standard CRYO AHT in Spain at the same period of time. Aims: Our main objective was to compare short-term complications between both modes of AHT in terms of severe mucositis measured by use of morphine, total parenteral nutrition requirements, febrile neutropenia, engraftment and length of hospitalization. Other objectives were overall response, non-relapse mortality and overall survival. Methods. This is a prospective analysis of all consecutive adult patients treated with AHT in both centers from January 2015 to May 2016. CRYO mode procedure consisted of the stimulation of hematopoietic progenitors with filgrastim +/- plerixafor in both MM and lymphoma patients, CD34-apheresis on day 5, freezing of product with DMSO, subsequent thawing and reinfusion post conditioning. In Non-CRYO mode, once patients achieved the best response, they received the same filgrastim +/- plerixafor treatment followed by CD34-apheresis without DMSO freezing. Apheresis product was kept at 5°C during conditioning and then re-infused. Conditioning regimen for MM patients was high dose melphalan and for lymphoma patients BEC or BEAM protocols. All patients were hospitalized during the period of pancytopenia and received transfusions, antibiotics and symptomatic measures as usual. Patients were discharged when they reached 〉500 neutrophils/uL and 25.000 platelets/uL without the need of transfusions, and did not have active infections. Results. Since 2015, 29 Non-CRYO and 58 CRYO AHT were performed in both centers. General characteristics are detailed in table 1. No significant differences were observed regarding demographic characteristics, basal disease and status, and CD34 cellularity. 7AAD FACS viability at infusion day was greater than 92% in Non-CRYO and all patients engrafted in both groups. As we show in table 2, neutrophil and platelet engraftments were significantly earlier in Non-CRYO group vs CRYO group (p = 0.003). Less gastrointestinal toxicity was seen in Non-CRYO group in terms of morphine use (11% vs 55%, p= 0.001) and total parenteral nutrition requirements (11% vs 14%, p= 0.06). The incidence of febrile neutropenia was lower in Non-CRYO group (28% vs 85% respectively, p=0.0001). Finally, lengh of hospitalization was shorter in Non-CRYO (p=0.008). Overall response obtained after transplant was similar in both groups. Non relapse mortality was low and similar in both groups (0 vs 0.5%). We found no differences in relapse nor overall survival. Conclusions. This analysis demonstrates a clear advantage of Non-CRYO AHT over CRYO AHT in terms of short term complications, in particular, faster engraftment, shorter hospital stay and lower incidence of febrile neutropenia and severe pain manifested by morphine use. These data are especially relevant to transplant centers with high flow of patients or limited resources. The savings in costs of freezing process and shorter hospitalizations should be evaluated in further investigations. Disclosures No relevant conflicts of interest to declare.