Infection remains a significant contributor to morbidity and mortality in patients with myeloma. This guideline was developed by a multidisciplinary group of clinicians who specialise in the management of patients with myeloma and infection from the medical and scientific advisory group from Myeloma Australia and the National Centre for Infections in Cancer. In addition to summarising the current epidemiology and risk factors for infection in patients with myeloma, this guideline provides recommendations that address three key areas in the prevention of infection: screening for latent infection, use of antimicrobial prophylaxis and immunoglobulin replacement and vaccination against leading respiratory infections (severe acute respiratory syndrome coronavirus 2, influenza and Streptococcus pneumoniae) and other preventable infections. This guideline provides a practical approach to the prevention of infection in patients with myeloma and harmonises the clinical approach to screening for infection, use of prophylaxis and vaccination to prevent infectious complications.
3612 The incidence of Acute Myeloid Leukaemia increases with age and advanced age is a major adverse prognostic marker. Elderly patients treated with intensive chemotherapy experience high treatment-related mortality, low rates of remission and early relapse. Elderly patients are often unsuitable for intensive chemotherapy due to multiple medical comorbidities and poor risk disease, so have limited treatment options. Our centre is using a novel treatment strategy of prolonged low-dose cytarabine and thioguanine in combination with peg-filgrastim administered in the outpatient setting. Preliminary findings demonstrate a surpising efficacy for this regimen. This is an updated report on our experience. Method: A retrospective single-centre study was performed at Royal North Shore Hospital, NSW, Australia. The study includes patients who were diagnosed with AML between April 2009 and April 2012 and treated using the low-dose chemotherapy protocol. The group includes de novo AML patients as well as patients refractory to other therapies. The analysis included an oncology pharmacy audit as well as review of medical records and pathology results. Treatment consists of daily subcutaneous cytarabine 20mg/m2 and oral thioguanine 80mg for 14 to 21 day periods on monthly cycles with continued treatment for a period of 2 years. Peg-filgrastim is given concomittently with chemotherapy when patients become neutropenic. Response is assessed by bone marrow aspiration after treatment cycles. Routine supportive care is provided. Results: Between March 2009 and May 2012, a total of 21 patients (13 with de novo AML and 9 with refractory/relapsed AML) received the low dose protocol. The median patient age was 75 (range 52 to 89 years). 12 (57%) patients had treatment-related or MDS-related AML. 7 (33%) patients had poor risk cytogenetics. A CR or CRi was achieved in 13 (62%) patients. The median follow-up time is 11.9 months. Of those that achieved CR or CRi, 9 patients (43%) have remained in remission with Kaplan-Meier estimated mean leukamia-free survival of 23.3 months (14–32.5, 95%CI). The Kaplan-Meier estimated mean overall survival for the group is 22.4 months (14.3–30.5, 95%CI). 6 patients have crossed over to other treatment modalities. 5 of 7 patients with poor cytogenetics achieved CR/CRi. 3 patients with abnormal cytogenetics achieved both morphologic and cytogenetic remission. The treatment was generally well tolerated. Outpatient administration of cytarabine is managed well with assistance from community nursing. Conclusion: The results reported here provide longer follow-up time and a larger number of patients as further evidence for the efficacy of the low-dose chemotherapy protocol and its feasibility in the outpatient setting. The remission rates acheived are comparable to those reported for intensive therapy with potential benefits of reduced toxicity, lower cost, fewer hospital admissions and improved quality of life. We suggest that this low-dose protocol may be a consideration for elderly patients deemed unsuitable or ineligible for intensive chemotherapy or azacitidine. A prospective study is underway to further evaluate this protocol. Disclosures: No relevant conflicts of interest to declare.
2624 The incidence of acute myeloid leukemia (AML) increases with age and outcomes for elderly patients remain poor. Furthermore, intensive induction chemotherapy is often unsuitable for elderly patients and can result in significant periods of inpatient care. Recent understanding of leukemia stem cell cycling suggests that prolonged cytotoxic exposure, e.g. >14–21 days, could provide a more effective anti-leukemic effect than the typical 5–7 days schedules during which time very few leukemic stem cells would be likely to undergo cell division. We have been using prolonged low-dose cytarabine schedules as reported 20 years ago (Hellstrom-Lindberg, Brit J Haem,1992;81:503), however we have combined this with oral thioguanine, a purine analogue that may synergize with cytarabine. Concomitant filgrastim or pegfilgrastim was given to minimize neutropenia and for its possible synergizing anti-leukemic effect when combined with cytotoxic agents. Encouraging experience with this schedule in a few relapsed/refractory elderly AML patients prompted us to use this strategy in elderly de-novo patients unsuitable for standard induction. Surprisingly good results prompted us to report our preliminary experience with this novel strategy. This report is a retrospective, single-center analysis of outcomes in elderly patients with AML managed as outpatients in an ambulatory care day unit. Between April 2009 and March 2011, 14 patients with either relapsed/refractory AML (n=5) or de novo AML (n=9) unsuitable for intensive therapy were treated using prolonged, low-dose cytarabine 20mg/m2/day subcutaneously and thioguanine 80mg/day orally. Treatment was given for 21 days followed by a 14 day break after which the schedule was repeated until remission. After obtaining remission, patients received a maintenance schedule consisting of 14 days on treatment with rest periods increasing from 14 to 28 days according to tolerance and time on therapy, with an intention to continue maintenance for 2 years. All patients received the treatment in an ambulatory care unit with supportive care including filgrastim or pegfilgrastim, blood and platelet transfusion as required, regular clinical review and prophylactic antibiotics and antifungal agents. Patient age ranged from 52 to 89 years (median 75y). All patients had intermediate or poor risk cytogenetics. A morphologic remission according to bone marrow aspirate was obtained in 8 patients (57.1%), with relapse seen in 1 patient at 2.6 months follow-up. Remission was maintained in 7 patients (50%) with follow-up ranging from 4.7 to 26.6 months (median 9.7 months), including 1 patient who was refractory to standard first and second-line induction chemotherapy. Refractoriness to treatment occurred in 5 patients (35.7%). Mortality relating to disease progression occurred in 3 patients (21.4%) and 1 patient died secondary to infection. All patients developed grade 3/4 neutropenia and thrombocytopenia but severe mucositis was not seen. The infection rate was low and hospital admission was uncommon. Nausea was common but manageable and significant liver toxicity was not observed. This study demonstrates that effective management of AML in elderly patients can be achieved in the outpatient setting. The data suggests a surprising efficacy for this strategy, with a remission rate comparable to that reported using standard induction chemotherapy but with a potentially favorable toxicity profile. A prospective study is now underway to further evaluate this protocol. Disclosures: Arthur: AMGEN: Honoraria.
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