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• W2949265829 abstract "Background: Diffuse large B-cell lymphoma (DLBCL) is the most spread subtype of NHL. Outcomes of standard treatment in high-risk patients are poor, especially in LMIC with limited access to expensive drugs and 2nd line treatment. Aims: We have started multicenter prospective cohort study with the aim to compare efficacy, toxicity and cost-effectiveness of treatment of high-risk DLBCL patients. Methods: Newly diagnosed patients with DLBCL non-specified, with 3 to 5 points according to IPI, age 18 years and older, without known CNS involvement were included into the study. Chemotherapy regimen (CHOP-like, R-CHOP or R-DA-EPOCH) was chosen by the investigators opinion. The patients received radiation therapy 30–36 Gy by standard indications and some CNS prophylaxis by investigator choice. Primary end-point was 2-year event-free survival (EFS). Secondary end-points were overall response (OR) rate, 2-year overall survival (OS), toxicity rates, quality of life (QOL), index of cost-effectiveness (ICE) for each couple of regimens (for the pharmaco-economy analysis). The analysis of direct costs of treatment and Quality-adjusted life years (QALY) was used for calculation of ICE. As an acceptable level of ICE was chosen amount of 20000 US dollars. Results: Four Ukrainian centers recruited 140 patients during the period since January 2014 till Decmber 2016. Final analysis was performed in July 2016. Median age was 53 years. CHOP-like regimens received 53 patients (I group), R-CHOP – 60 patients (II group), R-DA-EPOCH – 27 patients (III group). Average number of treatment cycles was (5.8 ± 1.7). Radiation therapy received 20 patients (27.0 %), CNS prophylaxis – 15 patients (20.3 %). Median FU period was 24.7 months. Groups were comparable by demographic and clinical data, except level of CNS prophylaxis, that was higher in the III group (P = 0,04). 2-year EFS was higher in the III group 86,3 ± 7,5 % vs 64,3 ± 10,4 % in the II group and 42,7 ± 11,4 in the I group (P = 0,045). OR rate didn’t differ statistically in three groups, but was higher in the III group. 2-year OS was higher in the III group as well, but not statistically significant. Number of patients, who needed further treatment was 7.4% in the III group, 35.0% - in the II group, 49.1% in the I group (p = 0.001). Anemia was less frequent in the group II (P = 0.04) as well as neutropenia (P = 0.04). Among non-hematological complication significant difference was revealed in the rate of neurotoxicity that was higher in the group III (P = 0,023) and hyperglycemia, that was higher in the group I (P = 0,05). Treatment toxicity did not influence on QOL. The cost of 6 treatment cycles of CHOEP regimen (as the most frequent among CHOP-like regimens) was 2363 US dollars, with R-CHOP - 350412 US dollars and with R-DA-EPOCH – 467178 US dollars. Average QALY was (0,8 ± 1,6) in the I group, (0,86 ± 1,55) – in the II group and (1,63 ± 1,34) – in the III group (P = 0,14). ICER-CHOPvsCHOP-like was 74850 US dollars, ICER-DA-EPOCHvsCHOP-like was 18801 US dollars, and ICER-DA-EPOCHvsR-CHOP was 5833 US. Summary/Conclusion: R-DA-EPOCH was the most effective regimen for treatmet of high-risk patients with DLBCL with acceptable toxicity level and similar QoL compare to R-CHOP and CHOP-like regimens. The pharmaco-economy analysis showed acceptable level of ICE of R-DA-EPOCH compare to R-CHOP regimen. Thus, we consider R-DA-EPOCH regimen as a satisfying option for treatment of high-risk DLBCL even for LMIC." @default.
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• W2949265829 date "2019-06-01" @default.
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• W2949265829 title "PB1812 PHARMACO-ECONOMY ANALYSIS OF THE THREATMENT WITH R-DA-EPOCH, R-CHOP, AND CHOP-LIKE REGIMENS IN HIGH-RISK PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (UKRAINIAN MULTICENTER STUDY)" @default.
• W2949265829 doi "https://doi.org/10.1097/01.hs9.0000565752.67378.2c" @default.
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