Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma

被引：8

作者：

Shah, Jatin ^{[1
]}

Shacham, Sharon ^{[1
]}

Kauffman, Michael ^{[1
]}

Daniele, Patrick ^{[2
]}

Tomaras, Dimitrios ^{[2
]}

Tremblay, Gabriel ^{[2
]}

Casasnovas, Rene-Olivier ^{[3
]}

Maerevoet, Marie ^{[4
]}

Zijlstra, Josee ^{[5
]}

Follows, George ^{[6
]}

Vermaat, Joost S. P. ^{[7
]}

Kalakonda, Nagesh ^{[8
]}

Goy, Andre Henri ^{[9
]}

Choquet, Sylvain ^{[10
]}

Van den Neste, Eric ^{[11
]}

Hill, Brian T. ^{[12
]}

Thieblemont, Catherine ^{[13
]}

Cavallo, Federica ^{[14
]}

de la Cruz, Fatima ^{[15
]}

Kuruvilla, John ^{[16
]}

Hamad, Nada ^{[17
]}

Bouabdallah, Reda ^{[18
]}

Jager, Ulrich ^{[19
]}

Caimi, Paolo ^{[20
]}

Gurion, Ronit ^{[21
]}

Warzocha, Krzysztof ^{[22
]}

Bakhshi, Sameer ^{[23
]}

Sancho, Juan Manuel ^{[24
]}

Schuster, Michael ^{[25
]}

Egyed, Miklos ^{[26
]}

Offner, Fritz ^{[27
]}

Vasilakopoulos, Theodoros P. ^{[28
]}

Samal, Priyanka ^{[29
]}

Nagy, Agnes ^{[30
]}

Ku, Matthew ^{[31
]}

Canales Albendea, Miguel Angel ^{[32
]}

机构：

[1] Karyopharm Therapeut Inc, Newton, MA 02459 USA

[2] Purple Squirrel Econ, Hlth Econ, Montreal, PQ H3J 1M1, Canada

[3] CHU Dijon Bourgogne, Clin Hematol, F-21079 Dijon, France

[4] Inst Jules Bordet, Hematol, B-1000 Brussels, Belgium

[5] Amsterdam UMC, Dept Hematol, NL-1105 AZ Amsterdam, Netherlands

[6] Addenbrookes Hosp, Haematol, Cambridge CB2 0QQ, England

[7] Leiden Univ, Hematol, Med Ctr, NL-2333 ZA Leiden, Netherlands

[8] Univ Liverpool, Inst Translat Med, Liverpool L3 9TA, Merseyside, England

[9] Hackensack Univ, John Theurer Canc Ctr, Med Ctr, Hackensack, NJ 07601 USA

[10] Hop La Pitie Salpetriere, Serv Hematol Clin, F-75013 Paris, France

[11] Catholic Univ Louvain, Fac Med & Med Dent, B-1348 Ottignies, Belgium

[12] Cleveland Clin, Hematol & Med Oncol, Cleveland, OH 44106 USA

[13] Hop St Louis, Hematooncol, F-75010 Paris, France

[14] Univ Turin, Div Ematol, I-10138 Turin, Italy

[15] Hosp Univ Virgen del Rocio, Fac Especialista Area Hematol, Seville 41013, Spain

[16] Univ Hlth Network Res, Canc Clin Res Unit, Toronto, ON, Canada

[17] St Vincents Hosp, Haematol Clin Trials Unit, Melbourne, Vic 3065, Australia

[18] Inst Paoli Calmettes, Hematol, F-13009 Marseille, France

[19] Med Univ Vienna, Dept Clin Hematol & Hemostaseol, A-1090 Vienna, Austria

[20] Cleveland Med Ctr, Dept Med, Cleveland, OH 44106 USA

[21] Tel Aviv Univ, Hematol, IL-69978 Tel Aviv, Israel

[22] Inst Hematol & Blood Transfus, PL-02776 Warsaw, Poland

[23] Inst Rotary Canc Hosp, Dept Med Oncol, New Delhi 110029, India

[24] Germans Trias i Pujol Hosp, Dept Clin Hematol, Barcelona 08916, Spain

[25] SUNY Stony Brook, Hematol, Stony Brook, NY 11794 USA

[26] Som Cty Kaposi Mor Hosp, Dept Haematol, H-7400 Kaposvar, Hungary

[27] Ghent Univ Hosp, Dept Clin Hematol, B-9000 Ghent, Belgium

[28] Natl & Kapodistrian Univ Athens, Fac Med, Athens 10679, Greece

[29] SUM Hosp, Dept Clin Hematol, Kolkata 751003, India

[30] Semmelweis Univ, Hematol, H-1085 Budapest, Hungary

[31] St Vincents Hosp, Dept Haematol, Melbourne, Vic 3065, Australia

[32] Hosp Univ La Paz, Serv Hematol, Madrid 28046, Spain

来源：

FUTURE ONCOLOGY | 2021年 / 17卷 / 11期

关键词：

diffuse large B-cell lymphoma; disutility of adverse events; EQ-5D-5L; FACT-Lym; health-related quality of life; health state utility; health utility; patient reported outcomes; selinexor; NON-HODGKIN-LYMPHOMA; PATIENT-REPORTED OUTCOMES; CANCER CLINICAL-TRIALS; MARALEUCEL LISO-CEL; CHOP CHEMOTHERAPY; DRUG DEVELOPMENT; ELDERLY-PATIENTS; PLUS RITUXIMAB; OPEN-LABEL; TRANSPLANTATION;

D O I：

10.2217/fon-2020-0946

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Aim: Evaluate health-related quality of life (HRQoL) and health utility impact of single-agent selinexor in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma. Patients & methods: Functional Assessment of Cancer Therapy (FACT) - Lymphoma and EuroQoL five-dimensions five-levels data collected in the single-arm Phase IIb trial SADAL (NCT02227251) were analyzed with mixed-effects models. Results: Treatment responders maintained higher FACT - Lymphoma (p <= 0.05), FACT - General (p < 0.05) and EuroQoL five-dimensions five-levels index scores (p < 0.001) beginning in cycle 3. The estimated difference in health state utilities for treatment response and progressive disease was both statistically significant and clinically meaningful (mean difference: 0.07; p = 0.001). Conclusion: In patients with relapsed/refractory diffuse large B-cell lymphoma, objective response to selinexor was associated with HRQoL maintenance, reduction in disease-related HRQoL decrements and higher health utilities. Lay abstract This work examined quality of life (QoL) among patients with relapsed/refractory diffuse large B-cell lymphoma with two to five prior therapies who received single-agent selinexor in the SADAL clinical trial. Analysis of patient-reported Functional Assessment of Cancer Therapy - Lymphoma and EuroQoL five-dimensions five-levels data showed that patients who had objective clinical response to selinexor maintained their QoL over the course of treatment. Grade >= 3 adverse events and serious adverse events were not associated with clinically meaningful negative QoL impacts.

引用

页码：1295 / 1310

页数：16

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