Key Points• Patients with relapsed or refractory transformed indolent lymphoma and DLBCL have similar outcomes with salvage therapy and ASCT.• This therapy should be considered the standard of care for previously treated transformed indolent lymphoma.The treatment of transformed indolent lymphoma (TRIL) often includes salvage chemotherapy (SC) and autologous stem cell transplant (ASCT). NCIC CTG LY12 is a randomized phase 3 trial comparing gemcitabine, dexamethasone, and cisplatin (GDP) with dexamethasone, cytarabine, and cisplatin (DHAP) before ASCT. This analysis compares the results of SC and ASCT for TRIL with de novo diffuse large B-cell lymphoma (DLBCL). Sixhundred nineteen patients with relapsed/refractory aggressive non-Hodgkin lymphoma were randomized to GDP or DHAP; 87 patients (14%) had TRIL and 429 (69%) had DLBCL. The response rate to SC was 47% in TRIL and 45% in DL (P 5 .81). Transplantation rates were similar: TRIL 53% and DL 52% (P 5 1.0). With a median follow-up of 53 months, 4 year overall survival was 39% for TRIL and 41% for DL (P 5 .78); 4 year event-free survival (EFS) was 27% for TRIL and 27% for DL (P 5 .83). Post-ASCT, 4-year EFS was 45% for TRIL and 46% for DL. Histology (TRIL or DL) was not a predictor of any outcome in multivariate models. Patients with relapsed or refractory TRIL and DLBCL have similar outcomes with SC and ASCT; this therapy should be considered the standard of care for patients with TRIL who have received prior systemic chemotherapy. NCIC CTG LY12 is registered at ClinicalTrials.gov as #NCT00078949. (Blood. 2015;126(6):733-738)

, 32 patients were entered in cohorts of three at three dose levels. The median age was 64 years, 59% were male, with a median two prior regimens. Responding patients could stay on treatment until progression. The full-dose CPR regimen produced no dose-limiting toxicity and was delivered for a median of 16 months (3Á5-65 months) with acceptable safety and tolerance. The overall response rate (≥ partial response) was 94% at a median follow up of 28 months. The median progression-free survival was 16Á1 months [95% confidence interval (CI); 10Á9-22Á5 months], while the median overall survival was 27Á6 months (95% CI; 16Á8-36Á6 months). Only the beta-2 microglobulin level at protocol entry correlated with a better survival (P = 0Á047). These observations compare favourably with other 2-and 3-drug combinations for relapsed/refractory myeloma, and suggest that CPR should be evaluated further in the setting of relapsed/refractory disease, or in newly diagnosed patients.

Anemia is a common cause of cancer-related fatigue. A systematic review of the literature was performed to establish guidelines on the use of epoetin alfa for the treatment of anemia. The evidence in support of these guidelines was selected, reviewed, and summarized by the members of the Canadian Cancer and Anemia Guidelines Development Group. The effects of epoetin alfa on quality of life (QOL) in patients with cancer were examined in 5 randomized, placebo-controlled trials and 2 large, open-label, nonrandomized, community-based studies. The effects of epoetin alfa on red blood cell transfusion requirements were examined in 19 randomized controlled trials (RCTs) with 21 comparisons. All trials compared epoetin alfa to a suitable control group, examined specified outcome measures that could be analyzed, and studied patients with cancer who were receiving chemotherapy. Trials involving patients with hematologic malignancies originating in the bone marrow were excluded. Outcome measures included 1) quality of life (QOL) (as measured by scales including the Linear Analogue Self-Assessment [LASA] and the Functional Assessment of Cancer Therapy [FACT] subscales), and 2) transfusion requirements (as measured by the proportion of patients requiring transfusion and amount of transfusion). The analysis confirmed that epoetin alfa produced statistically significant and clinically relevant improvements in QOL in patients with cancer. The overall relative risk ratio for transfusion among patients receiving epoetin alfa was calculated to be 0.60 (95% Cl, 0.53-0.69; P < 0.00001), representing a 40% reduction in the proportion of patients requiring transfusion. These results support recommendations for the use of epoetin alfa in patients with cancer-related anemia.

Background:The American Society of Hematology Practice Improvement Modules (ASH PIMs) are online tools designed for clinicians to monitor the quality of care in their practice. The ASH PIM for non-Hodgkin lymphoma (NHL) was designed by a committee of NHL experts and was recently released in the ASH Academy. The ASH PIM for NHL defines quality metrics in six areas: pathological diagnosis, staging, Hepatitis B testing, use of growth factors, vaccination, and fertility counseling. Objectives:1) Use the ASH PIM for NHL to measure quality of care at 4 cancer centers in the Greater Toronto Area. 2) Assess the feasibility, reliability, and usefulness of the ASH PIM for NHL. Methods:To measure quality of care, 78 patients undergoing first line chemotherapy for NHL were reviewed at 4 cancer centers (3 academic centers and 1 community center) near Toronto, Canada. Two hematology fellows independently scored each patient chart for the 6 quality metrics in the ASH PIM. After data collection, interviews (using structured questionnaires) were conducted with the chart reviewers as well as with physicians experienced at treating NHL. Results: Three out of the 4 cancer centers had high performances (>90%) in pathological diagnosis and staging. Two of the 4 centers had high performances for Hepatitis B testing. Zero of the 4 centers had high performances for documenting growth factor use, vaccinations and fertility counseling. A feasibility questionnaire revealed that each chart required 15 minutes for review. Reviewers noted that the ASH PIM for NHL was clear for how to score pathological diagnosis, staging, and hepatitis B testing (mean score >4 out of 5 for clarity), but unclear for how to score the use of vaccinations (mean 2.3/5). Reviewers were able to accurately score pathological diagnosis, staging, and hepatitis B (mean >4/5 for perceived accuracy), but were unable to accurately score vaccination and fertility counseling (mean <3/5). Interviews revealed concern that practices around vaccination and fertility counseling were not being well documented in the medical record. Inter-rater reliability was high across all 6 metrics (Gwet’s first order agreement coefficient 0.81 – 0.97). Of the 6 metrics, experienced NHL physicians rated pathological diagnosis and staging as most important, with vaccination and growth factor use rated as least important. When provided with the performance data for their own center, the results were perceived to accurately reflect patient care in 5 out of 6 of the metrics. Performance on fertility counseling was thought to be under-estimated due to poor documentation. Overall, the ASH PIM for NHL was perceived to capture the quality of patient care moderately well. Areas not captured by the ASH PIM, but perceived to be important to NHL patient care included: the reduction of delays between lymphoma suspicion and first treatment, patient satisfaction, and advanced care planning. Conclusions: The ASH PIM for NHL is feasible, reliable, and measures a number of important aspects of patient care. Some metrics could be made clearer by including more explicit definitions. Performance on the metrics relying on clinical documentation was not as high as for those relying on objective testing. The performance of cancer centers in the Greater Toronto Area on the ASH PIM for NHL suggests specific areas for quality improvement at each center. Disclosures Hicks: Gilead: Research Funding.

1874 Poster Board I-899 Lenalidomide (Revlimid®) and dexamethasone is an effective regimen in relapsed/refractory multiple myeloma (MM) patients (pts), with an overall response rate of 60.6% and median time to progression (TTP) of 13.4 months (Dimopoulos MA, et al, Leukemia 2009 Jul 23 [Epub ahead of print]). Oral cyclophosphamide and prednisone is an older regimen with excellent patient tolerance, and we sought to enhance the efficacy of lenalidomide by adding oral cyclophosphamide and prednisone in this phase I-II trial. The CPR regimen consisted of cyclophosphamide on days 1, 8 and 15; lenalidomide on days 1–21; and prednisone 100 mg every other day in a 28 day cycle. ASA 81 mg/day was given to all pts as DVT prophylaxis. Three dose levels were evaluated using a 3 by 3 dose escalation design. Between 11/2007–07/2009, 31 pts with relapsed/refractory MM who had not previously received lenalidomide were entered onto study. Median age was 61 (40–78) years and 61% were male. Immunoglobulin subtype was IgG in 19 pts (61%), IgA in 8 pts (26%) and light chain only in 4 pts (13%). Median number of prior regimens was 2 (1–5) and 28 pts had undergone previous ASCT, including double transplants in 6 pts. Prior therapy included thalidomide in 9 (29%) and bortezomib in 15 (48%). FISH cytogenetics were available in 13 pts; one had 13q deletion but none had t(4;14) or p53 deletion. At the time of protocol entry, median β 2-microglobulin level was 246 (92–767) nm/L, albumin 39 (34–48) g/L, creatinine 83 (50–126) μmol/L, platelet count 230 (75–337) × 109/L and ANC 2.5 (1.1–6.1) x 109/L. Protocol treatment is summarized in Table 1. Dose limiting toxicity was not observed during cycle 1 at any dose level. Grade 3–4 toxicities included thrombocytopenia in 5 pts (16%) and neutropenia in 9 pts (29%). These were managed with dose reduction and/or growth factor support. Four episodes of febrile neutropenia occurred. Other grade 3–4 non-hematologic toxicities included abdominal pain/bacteremia in 1 pt in cohort 1; hypokalemia in 1 pt in cohort 2; and DVT in 2 pts, dizziness in 2 pts and fatigue in 1 pt in cohort 3. Using the International uniform response criteria (Durie BG, et al, Leukemia 2006; 20:1467–1473), the best response was documented at a median of 6 (1–5) cycles and included the following: dose level 1 (1 CR, 2 PR); dose level 2 (1 VGPR, 2 PR); dose level 3 (5 CR, 9 VGPR, 9 PR, 1 MR and 1 stable disease). At a median follow-up (F/U) of 12 (8–21) months, 20 pts remain on study, 2 have withdrawn and 9 pts have progressed at a median of 9 (4–13) months; only 1 one has died (due to MM). We conclude: 1) the combination of full doses of the agents in CPR can be given in a 28 day cycle with minimal toxicity; 2) the overall response rate (CR + VGPR + PR) in 31 pts to date is 93%; 3) at a median F/U of 1 year, only 9 pts (29%) have progressed; 4) longer follow-up is required to assess the TTP and survival of the CPR regimen. Disclosures: Reece: Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Off Label Use: Lenalidomide in combination with drugs other than dexamethasone. Anglin:Celgene: Honoraria. Chen:Celgene: Honoraria, Research Funding. Kukreti:Celgene: Honoraria. Mikhael:Celgene: Honoraria. Trudel:Celgene: Honoraria.