scholarly journals THERAPEUTIC OPTIONS FOR PATIENTS WHO ARE NOT ELIGIBLE FOR INTENSIVE CHEMOTHERAPY

2013 ◽  
Vol 5 (1) ◽  
pp. e2013050 ◽  
Author(s):  
Elihu Estey
Keyword(s):  
Life Expectancy ◽  
Supportive Care ◽  
Low Dose ◽  
Best Supportive Care ◽  
Therapeutic Options ◽  
Intensive Chemotherapy ◽  
Principal Problem

Although “less intense” therapies are finding more use in AML, the principal problem in AML remains lack of efficacy rather than toxicity. Hence less intense therapies are of little use if they are not more effective as well as less toxic than standard therapies.. Assignment of patients to less intense therapies should be based on other factors in addition to age. Azacitidine and decitabine, the most commonly used less intense therapies in AML very probably produce better OS than best “supportive care” or “low-dose” ara-C. However improvement is relatively small when compared to expected life expectancy in the absence of disease. Accordingly, while azacitidine or decitabine should be considered the standards against which newer therapies are compared, continued investigation of potentially more effective therapies needs to continue. Better means for evaluating the large number of these therapies (and their combinations) are also needed.   

Low-Dose Decitabine Versus Best Supportive Care in Elderly Patients With Intermediate- or High-Risk Myelodysplastic Syndrome (MDS) Ineligible for Intensive Chemotherapy: Final Results of the Randomized Phase III Study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group

2011 ◽  
Vol 29 (15) ◽  
pp. 1987-1996 ◽  
Author(s):  
Michael Lübbert ◽  
Stefan Suciu ◽  
Liliana Baila ◽  
Björn Hans Rüter ◽  
Uwe Platzbecker ◽  
...  
Keyword(s):  
Myelodysplastic Syndrome ◽  
Supportive Care ◽  
Low Dose ◽  
Progression Free Survival ◽  
Best Supportive Care ◽  
Phase Iii ◽  
Intensive Chemotherapy ◽  
Free Survival ◽  
Patient Reported ◽  
Grade 3

Purpose To compare low-dose decitabine to best supportive care (BSC) in higher-risk patients with myelodysplastic syndrome (MDS) age 60 years or older and ineligible for intensive chemotherapy. Patients and Methods Two-hundred thirty-three patients (median age, 70 years; range, 60 to 90 years) were enrolled; 53% had poor-risk cytogenetics, and the median MDS duration at random assignment was 3 months. Primary end point was overall survival (OS). Decitabine (15 mg/m2) was given intravenously over 4 hours three times a day for 3 days in 6-week cycles. Results OS prolongation with decitabine versus BSC was not statistically significant (median OS, 10.1 v 8.5 months, respectively; hazard ratio [HR], 0.88; 95% CI, 0.66 to 1.17; two-sided, log-rank P = .38). Progression-free survival (PFS), but not acute myeloid leukemia (AML) –free survival (AMLFS), was significantly prolonged with decitabine versus BSC (median PFS, 6.6 v 3.0 months, respectively; HR, 0.68; 95% CI, 0.52 to 0.88; P = .004; median AMLFS, 8.8 v 6.1 months, respectively; HR, 0.85; 95% CI, 0.64 to 1.12; P = .24). AML transformation was significantly (P = .036) reduced at 1 year (from 33% with BSC to 22% with decitabine). Multivariate analyses indicated that patients with short MDS duration had worse outcomes. Best responses with decitabine versus BSC, respectively, were as follows: complete response (13% v 0%), partial response (6% v 0%), hematologic improvement (15% v 2%), stable disease (14% v 22%), progressive disease (29% v 68%), hypoplasia (14% v 0%), and inevaluable (8% v 8%). Grade 3 to 4 febrile neutropenia occurred in 25% of patients on decitabine versus 7% of patients on BSC; grade 3 to 4 infections occurred in 57% and 52% of patients on decitabine and BSC, respectively. Decitabine treatment was associated with improvements in patient-reported quality-of-life (QOL) parameters. Conclusion Decitabine administered in 6-week cycles is active in older patients with higher-risk MDS, resulting in improvements of OS and AMLFS (nonsignificant), of PFS and AML transformation (significant), and of QOL. Short MDS duration was an independent adverse prognosticator.

Low Dose Decitabine Versus Best Supportive Care in Elderly Patients with Intermediate or High Risk MDS Not Eligible for Intensive Chemotherapy: Final Results of the Randomized Phase III Study (06011) of the EORTC Leukemia and German MDS Study Groups

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 226-226 ◽  
Author(s):  
Pierre WijerMans ◽  
Stefan Suciu ◽  
Liliana Baila ◽  
Uwe Platzbecker ◽  
Aristoteles Giagounidis ◽  
...  
Keyword(s):  
High Risk ◽  
Supportive Care ◽  
Disease Progression ◽  
Low Dose ◽  
Phase Iii ◽  
Intensive Chemotherapy ◽  
Free Survival ◽  
Phase Iii Study ◽  
The Difference ◽  
Grade 3

Abstract Introduction: In 2002 the EORTC and the German MDS Study Group initiated a randomized phase III study comparing low dose Decitabine to supportive care in patients (pts) of 60 years or older with primary or secondary MDS or CMML. MDS patients with either 11–20% BM blasts or ≤ 10% blasts and poor cytogenetics could be included. Pts with a BM blast count between 21–30% without signs of disease progression for at least one month were also candidates for the study. Methods: Patients were centrally randomized; stratification factors were cytogenetics risk group, IPSS, MDS (primary vs secondary) and study centre, The treatment schedule was 15 mg/m2 Decitabine i.v. over 4 hours every 8 hours for the first 3 three consecutive days, of every 6 week-cycle, for a maximum of 8 cycles. Results were evaluated every 2nd cycle. When a complete remission was reached at least another 2 courses were given. The primary endpoint of the study was Overall Survival. AML free survival, Progression Free Survival (PFS), response rate, toxicity and QoL were secondary endpoints. A total of 185 deaths were required to detect a hazard ratio (HR) of 0.66 (alpha=5%, beta=20%). Intent-to-treat analysis was used. Results: Between 10.2002 and 5.2007 a total of 233 pts (149 male and 84 female) were recruited from 40 centres. The median age was 70 (60–90 years); RAEB-t was diagnosed in 32% of the pts. Most pts had an IPSS Intermediate-2 (55%) or high risk (38%). Poor risk cytogenetics was found in 46% of the patients. Prior therapy for MDS (not being intensive chemotherapy) was given in 20% of pts. The randomized groups were well balanced regarding stratification factors, age and FAB classification. The median follow up was 2.5 years. Time to Off Study was 180 (Decitabine) vs 112 days (SC arm). The median number of cycles given to the patients was 4 with 40%getting no more than 2 cycles. In a significant number of pts, subsequent treatment, consisting of transplant (10%) or induction chemotherapy (11%), was given. The distribution of best response in Decitabine vs SC arm was CR (13% vs 0%), PR (6% vs 0%), HI (15% vs 2%), SD (14% vs 22%), PD (29% vs 68%), hypoplasia (14% vs 0%), inevaluable (8% vs 8%). The 18 pts on Decitabine with a HI showed the following responses: 3-lineage (n=7), 2-lineage (n=5) and 1-lineage (n=6). The median time to response (CR/PR/HI) was 0.32 yrs and the response duration was 0.72 years. Median OS was 0.84 (Decitabine) vs 0.71 years (SC arm), estimated HR was 0.88, 95% CI 0.66–1.17, p=0.38 (logrank 2-sided). The PFS was significantly (p=0.004) longer in Decitabine vs SC arm: median was 0.55 vs 0.25 years, HR=0.68 (95% CI 0.52–0.88). Time to AML or Death was not significantly improved (p=0.24): median was 0.73 vs 0.51 years (HR=0.85, 95% CI 0.64–1.12). Toxicity. The toxicity was mainly cytopenia related toxicity that was either disease related or hematotoxicity; CTC grade 3–4 febrile neutropenia was 26% (Decitabine) vs 7% (SC arm) and Grade 3–4 infection was 59% vs 47%. Differences in non hematologic toxicities were mainly gastrointestinal: grade 1–2 nausea (28% vs 16%) and grade 1–2 vomiting (16% vs 9%). During the study period, 29 (Decitabine) vs 25 (SC arm) patients died: due to either progression to MDS/AML (7 vs 20), toxicity (9 vs 0), progression and/or toxicity (10 vs 1), other reasons (3 vs 4). Conclusions. Decitabine was found to be an effective drug in these high risk MDS patients with a overall RR of 34%, (similar to earlier studies), leading to a significant PFS improvement as compared to SC arm. The difference Decitabine vs SC arm regarding time to AML or Death was not significant. Due to shorter treatment duration (not being continued beyond 8 cycles) and maybe also due to subsequent treatments administered after disease progression, the difference regarding OS was lower (HR=0.88) and not statistically significant.

A Retrospective Comparison of Matched Elderly Patients Treated with Laromustine (Cloretazine®) or Best Supportive Care or Low Dose Ara-C in the LRF AML14 Trial

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2960-2960 ◽  
Author(s):  
Robert Hills ◽  
Susan O’Brien ◽  
Verena Karsten ◽  
Alan K. Burnett ◽  
Francis Giles
Keyword(s):  
High Risk ◽  
Supportive Care ◽  
Low Dose ◽  
De Novo ◽  
Performance Status ◽  
Single Agent ◽  
Best Supportive Care ◽  
Cell Counts ◽  
Retrospective Comparison ◽  
De Novo Aml

Abstract Background : A substantial proportion of older patients with AML are considered unlikely to benefit from an intensive treatment approach. They often receive either best supportive care (BSC), low dose treatment such as Low Dose Ara-C (LDAC), or clinical trials of novel agents. In one of the few randomised studies where patients were prospectively considered likely to be unfit for intensive therapy, LDAC was superior to BSC with 18% v 1% patients achieving CR. No patients with high risk cytogenetics (Grimwade 1998), achieved CR (Burnett 2007). Laromustine (Cloretazine®) is a novel sulfonylhydrazine alkylating agent which preferentially targets the O6 position of guanine resulting in DNA cross-links. Laromustine has previously shown clinical activity in patients with de novo AML and high risk MDS (Giles et al. JCO 2007). A confirmatory phase II study of single agent laromustine was conducted in previously untreated patients ≥ 60 years old with de novo AML, prospectively considered likely to be unfit for intensive chemotherapy. Patients had at least one poor risk factor, defined by age ≥70, performance status 2, unfavorable cytogenetics, or cardiac, pulmonary or hepatic dysfunction. Eighty-five patients received induction therapy with 600 mg/m2 laromustine. Second induction cycles were administered in 14 patients after partial response or hematologic improvement. Eighteen patients received at least one consolidation cycle of cytarabine 400 mg/m2/day CIV for 5 days. Methods: A retrospective non-randomised comparison was performed between the 85 patients treated with laromustine, and 121 patients satisfying the same entry criteria, treated in the AML 14 trial with either BSC or LDAC. Outcomes were compared using Mantel-Haenszel and logrank methods for unadjusted comparisons, and regression methods for adjusted analyses. Results : Patients in AML14 were slightly older than those treated with laromustine (median age 75 v 73), and tended to have higher white blood cell counts; by contrast, there were significantly fewer cardiac or respiratory comorbidities reported in the AML14 population. Other important risk factors such as performance status and cytogenetics were similar between the groups. Responses overall (CR/CRp) were seen in 33% (28/85) of patients treated with laromustine, compared with 2% (1/60) and 23% (14/61) in patients treated with BSC and LDAC (p<0.0001, p=0.2, respectively). In particular, 1 patient with −5/del(5q), and 3 patients with −7/del(7q) cytogenetics experienced a CR with laromustine; patients in AML 14 with adverse cytogenetics saw no remissions. Survival was significantly improved in the laromustine group compared to BSC (1 year survival 20% v 8%, unadjusted HR 0.58 [0.40–0.84] p=0.004), and roughly comparable to that of LDAC (1 year survival 20% v 25%, HR 1.04 [0.73–1.49] p=0.8). Analyses adjusted for differences in baseline demographics, and using propensity scores gave consistent figures. Conclusions: Retrospective comparison of unrandomised data has significant limitations even though care has been taken to match for factors known to be predictive for survival. Laromustine was able to achieve a higher CR rate than LDAC or BSC, and produced remissions in groups where no remissions have previously been seen with LDAC or BSC. Laromustine gave significantly better survival than BSC, and demonstrated similar survival to LDAC.

Communication of prognostic information between oncologists and patients with advanced lung cancer.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 29-29
Author(s):  
Dilip Sankar Babu ◽  
Nicholas Gerbino ◽  
Kevin Fiscella ◽  
Cleveland Shields ◽  
Jennifer J. Griggs ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Life Expectancy ◽  
Supportive Care ◽  
Statistical Data ◽  
Best Supportive Care ◽  
Metastatic Lung Cancer ◽  
Office Visits ◽  
Prognostic Information ◽  
Management Options ◽  
Metastatic Lung

29 Background: A critical domain of patient-provider communication is helping cancer patients understand their prognosis, as well as the efficacy of treatment options. In this qualitative study, we explored the ways oncology providers approached prognostic discussions during initial office visits with patients with metastatic lung cancer. Methods: Transcripts of initial visits between unannounced standardized patients portraying metastatic non-small cell lung cancer and their oncologists were recorded at multiple practice sites in community and academic settings, as part of a large NIH-funded study. Thematic analysis was conducted on a subset of these recorded visits from one study site. In this secondary analysis, three coders (one medical oncologist, one palliative care physician and one research assistant) reviewed transcripts independently to extract quotes related to prognosis, meeting regularly to review selected quotes and to decide on codes. This process repeated until saturation of themes was achieved (n = 15). Results: Discussions of prognosis were found in all 15 transcripts reviewed. Three main themes were identified: (1) Vagueness, in which best-case/worst-case scenarios were presented without an estimate of life expectancy; (2) Statistical Reliance, in which complex statistical data were presented to the patient; and (3) Emotional Support, in which the discussion was infused with emotional reassurance which was contextually appropriate. A fourth identified theme was (4) Minimizing of Supportive Care, as discussions of management options did not always elaborate on best supportive care. Conclusions: Our qualitative analysis of initial office visits among simulated patients with metastatic lung cancer revealed that providers often frame prognostic information in vague terms without a realistic estimate of life expectancy, sometimes give patients complex statistical data, and tend to accompany their discussions with emotional reassurance. Best supportive care is not always fully explained when management options are reviewed. More work is needed to determine optimal ways to convey prognostic and management information during clinic visits for patients with advanced cancer.

Phase II–III Study of Gemtuzumab Ozogamicin Monotherapy versus Best Supportive Care in Older Patients with Newly Diagnosed AML Unfit for Intensive Chemotherapy: First Results of the EORTC-GIMEMA AML-19 Trial

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 762-762 ◽  
Author(s):  
Sergio Amadori ◽  
Stefan Suciu ◽  
Dominik Selleslag ◽  
Giuliana Alimena ◽  
Liliana Baila ◽  
...  
Keyword(s):  
Supportive Care ◽  
Phase Ii ◽  
Older Patients ◽  
Phase Ii Study ◽  
Best Supportive Care ◽  
Gemtuzumab Ozogamicin ◽  
Phase Iii ◽  
Intensive Chemotherapy ◽  
Grade 3 ◽  
To Receive

Abstract Treatment of AML in the elderly remains challenging. In particular, few therapeutic options exist for patients (pts) who are not considered medically fit for intensive chemotherapy. Gemtuzumab ozogamicin (GO), a humanized anti-CD33 monoclonal antibody conjugated to calicheamicin, has demonstrated single agent efficacy in older patients with relapsed AML. In a previous trial we reported a complete response rate of 17% when the licensed dose/schedule of GO was used as frontline monotherapy for older unfit pts with AML, but excess hematologic and liver toxicity suggested changes in both dosing and scheduling to improve feasibility. The AML-19 study was designed as a sequential phase II–III trial in pts of age 61 or over with untreated AML, who could not be considered candidates for, or must have declined, conventional intensive chemotherapy. The primary objective of the phase II study was to investigate whether any of two different schedules of lower dose GO monotherapy (total delivered dose 9 mg/m2 in 2 or 3 fractions over one week) is sufficiently effective and tolerable frontline therapy to continue phase III comparison with best supportive care (BSC). Pts had to have adequate renal and hepatic function, and the WBC count had to be less than 30,000/cmm at the time of registration. Two-thirds of the pts were randomly assigned to receive a single induction course of either GO 3 mg/m2 iv on days 1, 3 and 5 (arm A), or GO 6 mg/m2 iv on day 1 and 3 mg/m2 on day 8 (arm B); the remaining third was assigned to the BSC arm. Randomization was stratified by age, performance status (PS), initial WBC, CD33 expression on marrow blasts, and Institution. Pts with no evidence of objective disease progression were eligible to receive continuation treatment with monthly outpatient infusions of GO at 2 mg/m2 for a maximum of 8 months. Primary end-point of the phase II study was clinical benefit rate (CBR) defined as the number of pts either achieving a remission (CR, CRp, PR) or maintaining a stable disease (SD) in each experimental arm. The arm associated with the highest CBR would be selected for phase III assessment, providing that it is at least 48% (Simon design). Between 06/2004 and 12/2006, 56 pts were randomized in the two experimental arms (arm A 29; arm B 27). The two arms were comparable in terms of age (arm A: median 77 yrs; arm B: median 78 yrs), PS >2 (arm A: 7%; arm B: 4%), secondary AML (arm A: 45%; arm B: 37%), and CD33 expression on ≥20% marrow blasts (arm A: 86%; arm B: 85%). In arm A, 6 pts achieved CR, 2 PR, and 3 maintained SD for an overall CBR of 38% (90% CI, 23%–55%); in arm B, 5 pts achieved CR, 1 CRp, and 11 maintained SD for an overall CBR of 63% (90% CI, 45%–78%). Most toxicities were <grade 3 in both arms and included nausea/vomiting, diarrhea, fatigue, stomatitis and transient elevations of serum transaminases and bilirubin. The rate of grade ≥3 infection was slightly higher in arm B (48% vs 31%), as was the incidence of severe bleeding (11% vs 0%). All-cause early mortality (<6 wks) occurred in 17% of pts in arm A (2 infection, 3 AML) and in 11% of pts in arm B (1 infection, 1 AML, 1 infection+AML). In summary, lower dose GO is a tolerable and active primary therapy for older AML pts who are considered unsuitable for intensive chemotherapy. The day 1+8 schedule (arm B) is associated with a more favourable efficacy profile, meeting the statistical criteria to be selected as the preferred regimen for phase III comparison with BSC. Accrual to the phase III trial is ongoing.

Chemotherapy for Acute Myeloid Leukemia Can Compensate Other Adverse Prognostic Factors in Elderly: A Retrospective Longitudinal Cohort Study in a Local Community, Japan

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3582-3582
Author(s):  
Osamu Imataki ◽  
Hiroaki Ohnishi ◽  
Yasunori Kawachi ◽  
Makoto Ide ◽  
Makiko Uemura ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Prognostic Factors ◽  
Supportive Care ◽  
Myeloid Leukemia ◽  
Local Community ◽  
Best Supportive Care ◽  
Intensive Chemotherapy ◽  
Elderly Aml ◽  
Intensive Regimen ◽  
Acute Myeloid

Abstract Abstract 3582 Background: Japan is one of the prominent aging countries, in where incidence and mortality of malignancy in elderly is increasing which is recognized as a concerned national health care issue. Among various types of cancer, incidence and prevalence of elderly acute myeloid leukemia (AML) is increasing as well, and in the most cases those patients have concomitant diseases. Thus far, the treatment for AML in elderly has been generally realized to reduce the dose intensity due to impaired organ function and comorbidity. However, the utility of dose reduction in elderly AML has not been well understood. Thereby, we performed a retrospective population cohort study of AML in a local community in Japan in order to investigate practical risk factor based on general patient population including more than 65 to 75 years old. Patients and method: We reviewed medical charts and medical records of AML patients diagnosed at seven institutions in Kagawa prefecture between January 1, 2006 and December 31, 2010. We collected patients' characteristics, background, and clinical information including laboratory data, adverse events and outcome. Induction therapy regimen was practically decided by each treating physician based on available clinical data and local standards of care, but not on karyotype. We categorized chemotherapy regimens for non-APL patients into 3 groups; intensive chemotherapy, less-intensive chemotherapy, or best supportive care. Results: A total of 213 patients (127 males and 86 females) were diagnosed with AML. With an average population during study periods in Kagawa, the incidence of AML is 4.26 per 100,000 per year. The male to female ratio was 1.48. The median age was 70 years (average 67, range 24∼95). There were 16 APL patients and 197 non-APL patients in this cohort. The 5-year overall survival (OS) rate was 21.1%. In patients who are likely to meet criteria usually applied in clinical studies (i.e., de novo AML with PS 0 to 2 and no renal dysfunction), the 5-year OS rate was 31.5%. Among 197 non-APL patients median age was 70 years (range 24∼95) consists of 119 males and 78 females. The chromosomal karyotype is known to be the strongest prognostic predictor, and each study group advocates the different classification. We classified our cohort according to 5 different karyotype classifications (NCCN, BSCH, MRC-AML10, SWOG and CALGB). On the whole, 4.4∼5.9% of the patients were classified as having favorable risk karyotypes, and 17.7∼29.1% of the patients had unfavorable risk karyotypes. In terms of treatment intensity, 51.8% patients (102/197) received intensive induction chemotherapy. A majority (71.6 %) of patients ≤ 64 years were treated with intensive chemotherapy, while approximately half (46.0%) of patients aged 65 to 74 years, and only 35.6% of patients ≥ 75 years received intensive chemotherapy as induction therapy (P < 0.001). A complete remission (CR) rate in patients treated was 67.6% (69/102) with intensive regimen, 30.4% (17/56) with less-intensive regimen, and 0.0% (0/39) with best supportive care (P < 0.001). Eight week mortality was 6.9% (7/102), 19.6% (11/56), and 41.0% (16/39), respectively (P < 0.001). In non-APL patients, the 5-year OS rate was 10.6%. Subsequent analysis by age group showed that the 5-year OS rate declined with age; the 5-year OS rate and the median survival of non-APL patients ≤ 64 years, 65∼74 years, and ≥ 75 years were 41.5% and 19 months, 14.1% and 10 months, and 8.9% and 7 months, respectively (P = 0.003). Multivariate analysis revealed aging older than 65 year-old, best supportive care, poor PS more than 3, antecedent hematological disease, and unfavorable risk karyotypes were independent adverse prognostic factors associated with OS. Discussion: This analysis provides virtual data from an unselected AML population in a Japanese cohort. Our data can be applied for realistic risk assessment for AML patients including elderly. The present result indicates all prognostic factors has comparable impact on survival, therefore chemotherapy can compensate other adverse prognostic factors even in an elderly patient with poor PS. In aggregates, we conclude it is the best way to adapt as intensive chemotherapy as possible to improve outcomes in the treatment of elderly AML. In further investigation, the external validity of the risk assessment based on identified prognostic predictors from our cohort should be reevaluated for a third party cohort from other countries. Disclosures: No relevant conflicts of interest to declare.

Acute Myeloid Leukemia: Low Peripheral Blast Count May Predict Better Outcome with Best Supportive Care Than with Intensive Chemotherapy in Older Patients

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3550-3550
Author(s):  
Duncan J Murray ◽  
Jhansi Muddana ◽  
Anton Borg ◽  
Beth D Harrison
Keyword(s):  
Supportive Care ◽  
Clinical Assessment ◽  
Older Patients ◽  
Myeloid Leukemia ◽  
Treatment Decisions ◽  
Best Supportive Care ◽  
Intensive Chemotherapy ◽  
Risk Patients ◽  
Blast Count ◽  
Related Mortality

Abstract Abstract 3550 Introduction: Older patients diagnosed with acute myeloid leukemia (AML) present the clinician with particularly difficult treatment decisions. A number of attempts have been made to develop algorithms to assist clinician decision making but these are not widely used. The United Kingdom Medical Research Council AML14 Trial failed to recruit to a randomization between intensive and non-intensive treatment approaches, suggesting that clinicians preferred to use clinical judgement when selecting patients for intensive chemotherapy despite the lack of evidence on how this should be done. Methods: Several published scoring systems were evaluated and two applied retrospectively to 54 consecutive patients older than 60 years old presenting with AML between January 2009 and December 2010 to three collaborating Hematology departments. In addition, the role of the peripheral blast count (less than versus equal to or more than 0.1×109/L), as a marker of degree of proliferation, in predicting outcome was assessed. Treatment decisions for all patients had been based on clinical assessment by a senior physician and discussion by a multidisciplinary team rather than on application of a scoring system. Patients received palliative care only (2), best supportive care (16), non-intensive (9) and intensive (27) chemotherapy. Results: Median overall survival was 5.5 months. A significant difference in survival (12.0 versus 3.2 months, p<0.005 log-rank test) was seen, irrespective of treatment received, between those with low (<6.9, equivalent to predicted treatment related mortality (TRM) of 3%) versus high (>6.9, equivalent to predicted TRM of 20%) scores using the AML Treatment-Related Mortality (AML-TRM) score (Walter RB et al, 2011, J.Clin Oncol. 29:4417), which was developed to predict risk of early death following induction chemotherapy in older patients. Despite the use of clinical assessment only, 65% of low risk patients by AML-TRM had received intensive chemotherapy; 70% of high risk patients had not received intensive chemotherapy. By contrast, the Hematopoetic cell transplantation - specific comorbidity index (HCT-CI) (Sorror ML et al, 2005, Blood 106:2912), developed to assess fitness for transplantation in younger patients, did not predict outcome in this patient group. A peripheral blast count of less than versus equal to or more than 0.1×109/L was found to predict outcome for patients who received best supportive care (Table 1). Four patients with peripheral blast counts equal to or more than 0.1×109/L who received non-intensive chemotherapy also showed poor survival (median 2.0 months). Conclusions: The previously validated AML-TRM score is a strong predictor of outcome in older patients with AML irrespective of treatment received. However, it is not clearly better than a treatment decision based on clinical assessment by an experienced physician. The peripheral blast count was a single parameter which could be used to influence treatment decisions. In this series, patients with peripheral blast counts less than 0.1×109/L, correlating with less proliferative disease, did at least as well with best supportive care as with intensive chemotherapy. These patients should be offered best supportive care unless a clear curative plan, including for example an allogeneic stem cell transplant after intensive chemotherapy, can be made. However, patients with a peripheral blast count equal to or more than 0.1×109/L did very badly with best supportive care only or with non-intensive chemotherapy and should be offered intensive chemotherapy where possible. Disclosures: No relevant conflicts of interest to declare.

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