ALBERT

Description: Abstract 1639 Objectives To evaluate the efficacy and safety of rituximab-bendamustine-mitoxantrone-dexamethasone (R-BMD) in patients with relapsed or refractory follicular lymphoma, (R/R FL) to first-line therapy with R-chemotherapy (R-ChemoT), followed by maintenance with R. Methods Phase II trial including 61 patients with R/R LF, after a 1st R-ChemoT line. Induction treatment: Rituximab 375 mg/m2 iv, day 1; bendamustine 90 mg/m2 iv, days 1 and 2; mitoxantrone 6 mg/m2/day iv, day 1; oral dexamethasone 20 mg / day, days 1 to 5. Cycles of 28 days. Evaluation of response after 3rd cycle. If stable disease or progression: withdrawal from the study. If complete response (CR) or complete response unconfirmed (CRu): administration of a 4th cycle. If partial response (PR): administration up to 6 cycles. If CR, CRu or PR at the end of induction: patients receive maintenance with R 375 mg/m2/day every 12 weeks for 2 years. Primary objective: Complete responses (CR + CRu). Results are presented as valid % and median [range]. Results Results from 46 patients who completed induction period. 52.2% women, age 63 [32–76] years. Ann Arbor stage III / IV 75.6% (31/41) and III / IV-B 22.6% (7/31). FLIPI: intermediate risk 28.9% (11/38); high-risk 23.7% (9/38). Number of administered cycles: 4 [1–6]. Overall response 93.5% (43/46); CR: see Table 1. Progression Free Survival –median (CI95%)-: 14.5 (11.6-NA) months. The most relevant grade 3/4 toxicity: neutropenia 52% (n = 24; 17 patients received G-CSF) and thrombocytopenia 4.3% (n = 2). Infections grade 3/4: 6.5% (n = 3). One patient died due to CMV reactivation. No skin reactions were reported. There are maintenance available data from 15 patients: 3 patients sustained CR at the end of this period, and 2 patients progressed. Conclusions R-BMD is a treatment schedule effective and a safe alternative for patients with R/R FL, after a 1st line with R-ChemoT. No skin reactions were reported, possibly due to the inclusion of dexamethasone in the treatment scheme. Additional follow up is required to achieve more conclusive findings. Disclosures: No relevant conflicts of interest to declare.

Description: The Internet is changing the way that people learn about health and illness. At present do not exist data of the use of Internet by patients of lymphoma and her caregivers in Spain. OBJECTIVE: To investigate the distribution and patterns of Internet use by patients with lymphoma and her caregivers. PATIENTS AND METHODS: 585 subjects (258 patients, 264 relatives and 63 health professionals), 228 male and 357 female, they have responded a questionnaire on diverse aspects of the use of Internet. RESULTS: Two hundred fifty (42,7%) subjects use Internet, although only 27% make to obtain data on lymphoma. With respect to the group of patients 31% recognize to use Internet, but only the 23,3% do it by questions related to their disease. The main reasons for Internet use are to obtain information about treatments (74.7%) or second opinion medical (9.3%). The 77,6% have been using Internet for more than 3 years; the 47,2% have university studies and the 58,4% have between 33–50 years. Mainly the information search is made in Spanish language and through the Google finder. They consider that Information on lymphoma is acceptable (44.9%) or of enough quality (43.7%), trustworthy (50.6%) or of enough reliability (33.5%) and useful (45.6%) or quite useful (37.3%). COMMENTARIES: This study contributes data on the use of Internet by patients with lymphoma and her caregivers in Spain. Oncologists should be familiar with this important resource to help patients access appropriate material.

Description: Five randomised trials have reported that rituximab maintenance therapy leads to a progression free survival advantage in indolent NHL, with the largest trial (EORTC 20981) showing a progression-free survival benefit of 3 years in patients with follicular lymphoma compared to observation, and a significant overall survival benefit approximately halving the hazard of death. The primary objective of the current study, which involves 23 countries, initiated in August 2006, and aiming to recruit approximately 500 patients, is to extend the safety database for rituximab maintenance within a less stringent setting, allowing for a wide range of induction therapies. The study also examines the ‘real life’ safety associated with rapid-infusion of rituximab. The sample size has been calculated to detect at least one rare event with a true incidence of 0.32% with 80% power. Patients with first line or relapsed/refractory follicular lymphoma achieving a response after rituximab containing induction therapy are eligible to receive rituximab at the standard dose of 375 mg/m2 every eight weeks for 2 years. One-hundred-and-thirty-nine patients have been enrolled to date for whom demographic data is available: Median age of the patient population is 56 years [range: 29 to 82]. Forty-eight percent of the patients are male. Fifty-nine percent of the patients have no relevant medical history except for NHL. Among those who do, cardiovascular diseases is the most common. Most patients (∼ 74%) have a pre-induction FLIPI score of 2 or less. Thirty-five and 49% of the patients, respectively, have grade 1 or 2 follicular NHL. Most patients (75%) have received one line of treatment (including present study induction) since diagnosis, but some patients have received up to 4 previous lines of treatment. Sixty-two percent of the patients received an anthracycline-based regimen in combination with rituximab as induction therapy, whilst 25% and 9% respectively received an alkylating-based or purine analogue-based regimen. Ninety-four patients have received at least one infusion of rituximab as maintenance therapy, less than 40% of these patients having received two or more infusions to date. In total, 162 infusions of rituximab have been administered, 25% (40/162) of these having been administered as rapid infusion. Twenty events unrelated to study medication have been reported in 9 patients, with most of these events (19/20) being CTC grade 1 or 2. There was one patient who experienced a CTC grade 1 infusion related adverse event (erythema) which was not associated with rapid infusion. At the time of the report, there were no SAEs in the clinical database, but 4 SAEs had been reported to Roche, including 1 death resulting from pre-existing cardiac arrhythmia and not related to rituximab. Based on this initial sample, there does not appear to be any safety issue associated with 2-monthly rituximab maintenance therapy, whether administered as rapid infusion or not.

Description: Abstract 3654 Background: Diffuse large B-cell lymphoma (DLBCL) is a heterogeneous entity, showing affected patients a highly variable outcome. The improvement in survival gained with the addition of rituximab to CHOP chemotherapy (R-CHOP) led to re-define the international prognostic index (IPI). The new index, known as revised IPI (R-IPI), showed to be simpler as it groups the patients in only 3 risk groups. However, the effect of prior rituximab-therapy upon the usefulness and significance of previously recognized prognostic factors on patients relapsed or refractory and receiving subsequent treatment with rituximab plus chemotherapy in DLBCL remains unexplored. Biological parameters, including expression of Bcl-6, Bcl-2, p53 and MUM-1 have been described as IPI-independent prognostic factors. Objectives: The objective of this study was to evaluate the benefit of the R-IPI to predict the outcome of DLBCL patients at the relapse time following a front line treatment with chemotherapy and rituximab. We also aimed to establish in this population the relationship between immunohistochemical expression of biological parameters and outcome. Patients and methods: this was a multicentric, observational, post-authorization and cross-sectional study (ClinicalTrials.gov identifier: NCT01369784). Inclusion criteria were: patients with age ≥ 18 years with DLBCL refractory/relapsed after first line treatment with rituximab, with or without transplantation. Patients must have finished a rescue treatment including rituximab. Written informed consent was obtained from participants. When the data of the biopsies at diagnosis and relapse were available, immunohistochemical results of bcl-2, bcl-6, p53 and MUM-1 were obtained. Results: 152 patients were included (146 evaluables) with a median age of 58 years. At LDBCG diagnosis 48% had 〉 1 extranodal localization (29% had bone marrow disease), and 30% had ECOG 2 or greater. Eighty-one percent presented stages III or IV and 72% had elevated LDH. Three percent had very good prognosis R-IPI, 69% good prognosis R-IPI and 27% poor prognosis R-IPI. Most patients received R-CHOP as first line therapy. Overall response rate was 79% (40% complete remission). Relapse was confirmed with biopsy and histological study in 55 patients. At relapse 31% presented 〉 1 extranodal localization, 30% ECOG 2–4, 64% stages III-IV and 72% elevated LDH. R-IPI prognostic groups distribution at relapse were as follows: 8% very good, 75% good and 27% poor. R-ESHAP and R-GEMOX were the two more used rescue therapies resulting in 60% overall response rate (31% complete remission). R-IPI at relapse was significantly associated (p 〈 0,05) with overall response rate following R-chemotherapy rescue therapy. None of the immunohistochemical parameters analized correlated with rescue therapy results. Conclusions: This is the largest reported series analizing R-IPI in DLBCL at relapse/refractory in patients receiving R-chemotherapy. In this series of patients R-IPI calculated at the relapse time was the only prognostic factor capable of predicting the overall response to the second line of treatment. Thus R-IPI prognostic score is a simple and useful predictor for outcome in DLBCL at relapse/refractory Disclosures: No relevant conflicts of interest to declare.

Description: The addition of Rituximab to CHOP-like chemotherapy (CT) regimens has improved survival in diffuse large B-cell lymphoma (DLBCL). For this reason, Rituximab is also extensively used in combination with salvage CT regimens, although the information published on this setting is scarce. In the present study, we have analysed a large series of patients (pt) treated with R-ESHAP. 151 pt with relapsed or refractory DLBCL received R-ESHAP (Rituximab, etoposide, cytarabine, cisplatinum and methylprednisolone) as salvage therapy between May 2000 and March 2007. Median age was 54 years (19–70). 22% of pt were refractory to front-line therapy, 19% were partial responders, and 56% had relapsed disease. 56% of pt had received Rituximab in addition to CT as first-line treatment. 15 pt had been treated with autologous stem-cell transplantation (ASCT) prior to R-ESHAP. Patients received a median of 3 cycles of R-ESHAP (1–6). Overall response (OR) rate was 72%, with 69 pt (46%) achieving complete response (CR) and 40 (26%) partial response (PR). Factors with significant influence on CR rates in multivariate analysis were: absence of bulky disease (RR: 3.1), PR to first-line treatment (RR: 3.9) or relapsed disease (RR: 5.8), low-risk IPI (RR: 6.6), and administration of ≥3 cycles (RR: 5). Patients who had received Rituximab prior to R-ESHAP had lower CR (39 vs 54%) and OR (66 vs 80%) rates than patients who had not received it, but the difference did not reach statistical significance. In total, 94 out of 151 pt underwent transplantation after the salvage therapy (91 autologous, and 3 allogeneic). With a median follow-up of 22 months (3–73), the 4-year freedom from treatmet failure (FFTF) and overall survival (OS) were 49% and 48%, respectively. Patients who received Rituximab prior to R-ESHAP had a significantly worse FFTF (26 vs 67% at 4 years) and OS (30 vs 63% at 4 years) as compared with patiens who did not receive it. On multivariate analysis, factors significantly associated with a poor OS were: prior exposure to Rituximab (RR: 2.8), high-risk IPI (RR: 5.2), thrombocytopenia