This article highlights the importance of biosimilars, as a cost-cutting strategy, in the delivery of state-of-the-art health care in developing countries, at a fraction of what a reference biological agent would cost.
Central nervous system (CNS) relapse is uncommon in patients with acute myeloid leukemia (AML) with the use of high-dose cytarabine containing chemotherapy regimens. The clinical and molecular features associated with a higher risk of CNS relapse are not well defined. We assessed the incidence and outcome of CNS relapses among 1245 patients with relapsed/refractory AML referred to our institution between 2000 and 2014. CNS leukemia relapse was observed in 51 patients (4.1%). Using a multivariate regression model and after adjusting for age, FLT3-ITD mutation (OR = 2.33; P = .02) and elevated LDH (>1000 IU/L, OR = 1.99; P = .04) were independent predictive factors for CNS relapse. Patients under 64 years of age with 0, 1, or 2 baseline adverse features had a probability of 3.8%, 7.0%–8.0%, and 13.9% for developing CNS disease, respectively. Our study identifies patients with AML at higher risk for CNS relapse in whom prophylactic CNS therapy may be warranted.
We reviewed 216 consecutive patients with MDS and abnormal karyotype treated with hypomethylating agents between 4/04 and 10/12. Median follow-up was 17 months. Using IWG criteria, best responses were complete response (CR) in 79 patients (37%), partial response (PR) in 4 (2%), and hematologic improvement (HI) in 10 (5%). Cytogenetic response (CyR) was achieved in 78 patients (36%): complete (CCyR) in 62 (29%) and partial in 16 (7%). CyR was achieved in 48 of 79 patients (61%) with CR, 1 of 14 (7%) with PR/HI, and in 29 of the 123 (24%) with no morphologic response. Median overall survival (OS) and leukemia-free survival (LFS) for patients with and without CCyR were 21 and 13 months (p=0.007), and 16 and 9 months (p=0.001), respectively. By multivariate analysis, the achievement of CCyR was predictive for better OS (HR=2.1; p<0.001). In conclusion, CyR occurs at a rate of 36% (complete in 29%) in patients with MDS treated with HMA and is not always associated with morphological response. The achievement of CCyR is associated with survival improvement and constitutes a major predictive factor for outcome particularly in patients without morphologic response. Therefore, the achievement of CCyR should be considered a milestone in the management of patients with MDS.
e14636 Background: The number of new OV CT have been increasing along with the evolution of cancer immunotherapy. The OVs induce direct oncolysis and enhances the host innate and adaptive immunity. There are ongoing efforts to improve the anticancer efficacy of OVs with combinational strategies. However, there has been no direct comparison of OV CTs to evaluate their different dose levels, administration routes, frequencies, and the types of OVs and combinations. Methods: A random-effect meta-analysis was performed to evaluate pooled best ORR of all the existing OV phase II and III trials from publications and presented abstracts from ASCO, AACR, and ASGCT from 1/1/2016 to 12/4/2016. MeSH term “oncolytic” was used in PubMed. The inclusion criteria were: phase II or III, solid tumor, reported ORR. We evaluated the best ORR among different viruses, DNA vs. RNA, intratumoral (IT) vs. intravenous (IV) / intra-arterial (IA), and single vs. combination. Results: From 79 publications and 176 presented abstracts identified, 6 published studies and 12 presented abstracts were selected and pooled (n=875). The best ORRs were: DNA OV 23% (15 ~ 34%) vs. RNA OV 31% (13 ~ 58%), IT 36% (23 ~ 51%) vs. IV/IA 16% (10 ~ 25%), and single agent 22% (16 ~ 31%) vs. combinations 35% (17 ~ 58%). The combination OV CTs were either with chemotherapy (n= 144), chemoradiation (n= 23), or immunotherapy (n= 69). Each OV’s ORR is summarized in the table below. Direct comparison of the secondary endpoints: clinical outcome and adverse events will be presented with the poster. In general, the OV CTs had good overall safety profile and most adverse events were less than grade 3. Conclusions: The antitumor effect of OVs against solid tumors is evident and consistent in many trials. The largest data currently available is with herpes virus and coxsackie virus appears to have the best ORR possibly due to the combination with immunotherapy. The above results confirm the promising clinical activity of novel oncolytic viral vectors both alone and in combination. [Table: see text]
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