quality of life

Quality of Life and Efficacy of Triplet IxaRd Therapy in Relapsed/Refractory Multiple Myeloma: Results of a Multi-Center Pilot Real-World Study

AUTOIMMUNE THROMBOCYTOPENIA ,

TI Ionova1,2, OYu Vinogradova3,4,5, YuB Kochkareva3, EE Markova3, KD Kaplanov6, MN Shirokova6,7, TV Shelekhova8, AN Levanov8, AV Kopylova9, OYu Li10, TA Mitina11, OA Rukavitsyn12, PI Simashova12, LV Anchukova13, EN Babich14, SA Volkova15, DB Dasheeva16, MV Demchenkova17, SK Dubov18, TV Esenina19, LE Ivanova17, TL Kravchuk20, EV Rimashevskaya21, MT Savinova22, NO Saraeva23, NM Porfirieva1, TP Nikitina1,2, VV Ptushkin3

1 Multinational Center for Quality of Life Research, 1 Artilleriiskaya ul., Saint Petersburg, Russian Federation, 191014

2 Saint Petersburg State University Hospital, 154 Fontanki nab., Saint Petersburg, Russian Federation, 198103

3 Moscow Municipal Center for Hematology, SP Botkin City Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284

4 NI Pirogov Russian National Research Medical University, 1 Ostrovityanova ul., Moscow, Russian Federation, 117997

5 Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, 1 Samory Mashela ul., Moscow, Russian Federation, 117997

6 SP Botkin City Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284

7 Volgograd Regional Clinical Oncology Dispensary, 78 Zemlyachki ul., Volgograd, Russian Federation, 400138

8 VI Razumovskii Saratov State Medical University, 112 Bolshaya Kazach’ya ul., Saratov, Russian Federation, 410012

9 Lipetsk Municipal Hospital No. 3 “Svobodnyi sokol”, 10 Ushinskogo ul., Lipetsk, Russian Federation, 398007

10 Sakhalin Regional Clinical Hospital, 430 Mira pr-t, Yuzhno-Sakhalinsk, Russian Federation, 693004

11 MF Vladimirskii Moscow Regional Research Clinical Institute, 61/2 Shchepkina ul., Moscow, Russian Federation, 129110

12 NN Burdenko Main Military Clinical Hospital, 3 Gospital’naya pl., Moscow, Russian Federation, 105094

13 Vologda Regional Clinical Hospital, 17 Lechebnaya ul., Vologda, Russian Federation, 160002

14 Yugry District Clinical Hospital, 40 Kalinina ul., Khanty-Mansiisk, Russian Federation, 628011

15 Privolzhsky Research Medical University, 10/1 Minina i Pozharskogo pl., Nizhny Novgorod, Russian Federation, 603005

16 Zabaikalsky Krai Oncology Dispensary, 104 Leningradskaya ul., Chita, Russian Federation, 672027

17 Irkutsk Regional Cancer Center, 32 Frunze ul., Irkutsk, Russian Federation, 664035

18 Krai Clinical Hospital No. 2, 55 Russkaya ul., Vladivostok, Russian Federation, 690105

19 Amurskaya Regional Clinical Hospital, 26 Voronkova ul., Blagoveshchensk, Russian Federation, 675000

20 Tomsk National Research Medical Center, 5 Kooperativnyi per., Tomsk, Russian Federation, 634009

21 Russian Medical Academy of Postgraduate Education, 38 Smolnaya ul., Moscow, Russian Federation, 125445

22 Municipal Clinical Hospital No. 16, 121 Gagarina ul., Kazan, Russian Federation, 420039

23 Irkutsk Regional Clinical Hospital, 100 Yubileinyi mikroraion, Irkutsk, Russian Federation, 664049

For correspondence: Tatyana Pavlovna Nikitina, MD, PhD, 1 Artilleriiskaya ul., Saint Petersburg, Russian Federation, 191014; Tel.: +7(962)710-17-12; e-mail: qolife@mail.ru

For citation: Ionova TI, Vinogradova OYu, Kochkareva YuB, et al. Quality of Life and Efficacy of Triplet IxaRd Therapy in Relapsed/Refractory Multiple Myeloma: Results of a Multi-Center Pilot Real-World Study. Clinical oncohematology. 2022;15(3):240–52. (In Russ).

DOI: 10.21320/2500-2139-2022-15-3-240-252

ABSTRACT

Aim. To study quality of life (QoL) indicators and symptom profile as well as treatment satisfaction of patients with relapsed/refractory multiple myeloma (r/r MM) on triplet therapy based on ixazomib combined with lenalidomide and dexamethasone (IxaRd); to assess efficacy and safety of IxaRd protocol in real-world clinical practice.

Materials & Methods. The study enrolled 40 patients with confirmed r/r MM diagnosis, aged > 18 years, at 18 Russian health care institutions. They received at least one line of prior therapy and were IxaRd-eligible. Clinical and QoL indicators were assessed according to the RAND SF-36, and symptoms were evaluated using the ESAS-R questionnaire prior to IxaRd therapy and in 1, 3, 6, 9, 12, 15, and 18 months after its start. Besides, patients filled out checklists for assessment of treatment satisfaction at all time-points after therapy onset. The analysis of clinical IxaRd efficacy included assessment of treatment response by IMWG 2011 criteria, as well as response duration, overall survival (OS), and progression-free survival (PFS). The analysis of IxaRd safety was based on reporting adverse events (AEs), including severe ones (SAEs). To analyze patient-reported QoL and symptom changes during follow-up, GEE was used. To determine clinically meaningful changes, an effect size was calculated.

Results. The study included 40 r/r MM patients (mean age 63 ± 9 years, 65 % women). Median disease duration before IxaRd therapy onset was 55 months (range 2–99 months). 60 % of patients had IIIA/IIIB Durie-Salmon stage. With the median IxaRd duration of 7.5 months, clinical benefit rate was 71.8 %. Complete response was reported in 7.7 % of patients, stringent complete response in 2.6 % of patients, very good partial response in 5.1 % of patients, partial response in 30.8 % of patients, and minor response was achieved in 25.6 % of patients. Stable disease was reported in 15.4 % of patients, and disease progression was identified in 10.3 % patients, including immunochemical relapse in 1 patient. The median response duration was 16.3 months (95% confidence interval [95% CI] 15.4–17.3 months), the median PFS was 10.6 months (95% CI 6.3–16.3 months). The median OS was not reached; the 1-year OS after IxaRd therapy onset was 85.2 % (95% CI 71–99 %). AEs on IxaRd therapy were reported in 55 % of patients, SAEs were reported in 3 (7.5 %) patients. Positive QoL changes were observed on IxaRd therapy. QoL improvement was meaningful in terms of physical functioning, role-physical functioning, general health, vitality, and mental health, compared to baseline. Moreover, a considerable decrease of pain, fatigue, and nausea was revealed. On the whole, 87.5 % of patients were satisfied with the triplet IxaRd therapy.

Conclusion. The results of the present pilot study demonstrate efficacy and safety of the triplet IxaRd therapy (all per os) in real-world clinical practice from r/r MM patients’ and physicians’ perspective. Our data testify to the importance of patients’ feedback in the evaluation of therapy efficacy.

Keywords: multiple myeloma, relapsed/refractory, ixazomib, quality of life, real-world clinical practice.

Received: March 16, 2022

Accepted: June 6, 2022

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Current Quality-of-Life Aspects in Patients with Classical Ph-Negative Myeloproliferative Neoplasms in the Russian Federation: Results and Discussion of the National Observational Program MPN-QoL-2020

AUTOIMMUNE THROMBOCYTOPENIA , , ,

TI Ionova1,2,3,*, EA Andreevskaya4,*, EN Babich5,*, NB Bulieva6,7,*, OYu Vinogradova8,9,10,*, EM Volodicheva11,*, SV Voloshin12,13,14,*, NN Glonina15,*, SK Dubov16,*, NB Esef’eva17,*, AYu Zaritskey18,*, EE Zinina19,*, MO Ivanova20,*, TYu Klitochenko21,*, AV Kopylova22,*, AD Kulagin23,*, GB Kuchma24,25,*, OYu Li26,*, EG Lomaia18,*, AL Melikyan27,*, VYa Melnichenko3,*, SN Menshakova28,*, NV Minaeva29,*, TA Mitina30,*, EV Morozova23,*,TP Nikitina1,2,*, OE Ochirova31,*, AS Polyakov13,*, TI Pospelova32,*, AV Proidakov33,*, OA Rukavitsyn34,*, GSh Safuanova35,36,*, IN Subortseva27,*, MS Fominykh37,*, MV Frolova38,*, TV Shelekhova39,*, DG Sherstnev39,*, TV Shneider40,*, VA Shuvaev12,41,*, ZK Abdulkhalikova23,†, LV Anchukova38,†, IA Apanaskevich15,†, AN Arnautova22,†, MV Barabanshchikova23,†, NV Berlina34,†, AP Bityukov34,†, EA Gilyazitdinova27,†, VI Gilmanshina36,†, EK Egorova27,†, EV Efremova12,†, EB Zhalsanova31,†, EN Kabanova19,†, OB Kalashnikova20,†, AE Kersilova41,†, TI Kolosheinova27,†, PM Kondratovskii16,†, EV Koroleva28,†, AN Kotelnikova34,†, NA Lazareva16,†, NS Lazorko18,†, EV Lyyurova33,†, AS Lyamkina32,†, YuN Maslova20,†, ES Mileeva12,†, NE Mochkin3,†, EK Nekhai16,†, YaA Noskov13,†, ES Osipova29,†, MM Pankrashkina8,†, EV Potanina16,†, OD Rudenko25,†, TYu Rozhenkova36,†, EI Sbityakova18,†, NT Siordiya18,†, AV Talko16,†, EI Usacheva42,†, YuB Chernykh30,†, TV Chitanava18,†, KS Shashkina27,†, DI Shikhbabaeva8,†, KS Yurovskaya23,†

1 Saint Petersburg State University Hospital, 154 Fontanki nab., Saint Petersburg, Russian Federation, 198103

2 Multinational Center for Quality of Life Research, 1 Artilleriiskaya ul., Saint Petersburg, Russian Federation, 191014

3 NI Pirogov National Medical and Surgical Center, 70 Nizhnyaya Pervomaiskaya ul., Moscow, Russian Federation, 105203

4 Krai Clinical Hospital No. 1, 7 Kokhanskogo ul., Chita, Russian Federation, 672038

5 Yugry District Clinical Hospital, 40 Kalinina ul., Khanty-Mansiisk, Russian Federation, 628011

6 I Kant Baltic Federal University, 14 Aleksandra Nevskogo ul., Kaliningrad, Russian Federation, 236041

7 Clinical Hospital of Kaliningrad Region, 74 Klinicheskaya ul., Kaliningrad, Russian Federation, 236016

8 Moscow Municipal Center for Hematology, SP Botkin City Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284

9 NI Pirogov Russian National Research Medical University, 1 Ostrovityanova ul., Moscow, Russian Federation, 117997

10 Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, 1 Samory Mashela ul., Moscow, Russian Federation, 117997

11 Tula Regional Clinical Hospital, 1A korp. 1 Yablochkova ul., Tula, Russian Federation, 300053

12 Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya ul., Saint Petersburg, Russian Federation, 191024

13 SM Kirov Military Medical Academy, 6 Akademika Lebedeva ul., Saint Petersburg, Russian Federation, 194044

14 II Mechnikov North-Western State Medical University, 47 Piskarevskii pr-t, Saint Petersburg, Russian Federation, 195067

15 SI Sergeev Krai Clinical Hospital No. 1, 9 Krasnodarskaya ul., Khabarovsk, Russian Federation, 680009

16 Krai Center of Hematology, Krai Clinical Hospital No. 2, 55 Russkaya ul., Vladivostok, Russian Federation, 690105

17 Ulyanovsk Regional Clinical Hospital, 7 III Internatsionala ul., Ulyanovsk, Russian Federation, 432017

18 VA Almazov National Medical Research Center, 2 Akkuratova ul., Saint Petersburg, Russian Federation, 197341

19 Surgut District Clinical Hospital, 14 Energetikov ul., Surgut, Russian Federation, 628408

20 Clinical and Diagnostic Center, IP Pavlov First Saint Petersburg State Medical University, 6/8 L’va Tolstogo ul., Saint Petersburg, Russian Federation, 197022

21 Volgograd Regional Clinical Oncology Dispensary, 78 Zemlyachki ul., Volgograd, Russian Federation, 400138

22 Lipetsk Municipal Hospital No. 3 “Svobodnyi sokol”, 10 Ushinskogo ul., Lipetsk, Russian Federation, 398007

23 RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University, 12 Rentgena ul., Saint Petersburg, Russian Federation, 197022

24 Orenburg State Medical University, 6 Sovetskaya ul., Orenburg, Russian Federation, 460000

25 Orenburg Regional Clinical Hospital, 23 Aksakova ul., Orenburg, Russian Federation, 460018

26 Sakhalin Regional Clinical Hospital, 430 Mira pr-t, Yuzhno-Sakhalinsk, Russian Federation, 693004

27 National Research Center for Hematology, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167

28 Regional Clinical Hospital, 105 Peterburgskoe sh., Tver, Russian Federation, 170036

29 Kirov Research Institute of Hematology and Transfusiology, 72 Krasnoarmeiskaya ul., Kirov, Russian Federation, 610027

30 MF Vladimirskii Moscow Regional Research Clinical Institute, 61/2 Shchepkina ul., Moscow, Russian Federation, 129110

31 NA Semashko Republican Clinical Hospital, 12 Pavlova ul., Ulan-Ude, Russian Federation, 670031

32 Novosibirsk State Medical University, 52 Krasnyi pr-t, Novosibirsk, Russian Federation, 630091

33 Komi Republican Oncology Dispensary, 46 Nyuvchimskoe sh., Syktyvkar, Republic of Komi, Russian Federation, 167904

34 NN Burdenko Main Military Clinical Hospital, 3 Gospital’naya pl., Moscow, Russian Federation, 105229

35 Bashkir State Medical University, 3 Lenina ul., Ufa, Republic of Bashkortostan, Russian Federation, 450008

36 GG Kuvatov Republican Clinical Hospital, 132 Dostoevskogo ul., Ufa, Republic of Bashkortostan, Russian Federation, 450005

37 Multispecialty Clinic “Skandinaviya”, AVA-PETER, 55A Liteinyi pr-t, Saint Petersburg, Russian Federation, 191014

38 Vologda Regional Clinical Hospital, 17 Lechebnaya ul., Vologda, Russian Federation, 160002

39 VI Razumovskii Saratov State Medical University, 6/9 53rd Strelkovoi Divizii ul., Saratov, Russian Federation, 410028

40 Leningrad Regional Clinical Hospital, 45 korp. 2A Lunacharskogo pr-t, Saint Petersburg, Russian Federation, 194291

41 VV Veresaev Municipal Clinical Hospital, 10 Lobnenskaya ul., Moscow, Russian Federation, 127644

42 SM Clinic, 19 korp. 1 Udarnikov pr-t, Saint Petersburg, Russian Federation, 195279

* Coordinators and members of Expert Panel.

† Program participants.

For correspondence: Tatyana Pavlovna Nikitina, MD, PhD, 1 Artilleriiskaya ul., Saint Petersburg, Russian Federation, 191014; e-mail: qolife@mail.ru

For citation: Ionova TI, Andreevskaya EA, Babich EN, et al. Current Quality-of-Life Aspects in Patients with Classical Ph-Negative Myeloproliferative Neoplasms in the Russian Federation: Results and Discussion of the National Observational Program MPN-QoL-2020. Clinical oncohematology. 2022;15(2):176–97. (In Russ).

DOI: 10.21320/2500-2139-2022-15-2-176-197

ABSTRACT

Background. The National Observational Program MPN-QoL-2020 was aimed at collecting the data on QoL (quality of life) characteristics and symptoms as well as patient- and physician-related disease and treatment perceptions in classical Ph-negative myeloproliferative neoplasms (MPN) in the Russian Federation.

Aim. Using new standardized forms, to analyze the quality of life among patients with various MPNs, to characterize ubiquitous symptoms and their effect on quality of life among the myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET) patients as well as to describe the perceptions of disease- and therapy-associated problems as reported by patients and hematologists treating them.

Materials & Methods. The study enrolled 1100 patients with Ph-negative MPNs (355 MF, 408 PV, and 337 ET patients at the mean age of 58 ± 14 years, 61 % women). The study also involved 100 hematologists (mean age of 42 ± 12 years, 85 % women) from 37 health and preventive facilities in 8 Federal districts of the Russian Federation. The patients contributed to the study by one-time completing a special MPN10 form for MPN symptom assessment, a special QoL questionnaire HM-PRO for hematological malignancy patients, as well as a patient checklist. The task of hematologists consisted in one-time filling out of a physician checklist and completing the medical records of all the enrolled MPN patients.

Results. For the first time in the Russian Federation, the real clinical practice yielded the data on the quality of life in Ph-negative MPN patients, symptom profiles in different MPNs, and the extent of their effect on everyday life. QoL impairments mostly relate to physical and emotional functioning of MPN patients and to feeding and drinking regime, but rarely to social functioning. More than 1/3 of patients with Ph-negative MPNs reported on considerable QoL impairments. Absolute majority of patients complain of weakness: 92.6 % in MF, 83.7 % in PV, and 82 % in ET. The profiles of relevant symptoms and their intensity differ in various MPNs. The study identified the symptoms which need most to be corrected, both in the view of patients and physicians. There were established differences between patient- and doctor-reported evaluations of the attitude to the disease and treatment as well as the aspects for improvement in physician-patient relationship.

Conclusion. The National Observational Program MPN-QoL-2020 has resulted in characterization of QoL impairments in MPN patients in Russia. It determined the spectrum of particular disease and treatment challenges specific to these patients. Moreover, their unmet needs were updated. The outcomes of MPN-QoL-2020 can serve as a basis for the guidelines for QoL improvement/maintenance in Ph-negative MPNs and for activities aimed at raising MPN patients’ awareness about the disease and its treatment.

Keywords: classical Ph-negative myeloproliferative neoplasms, polycythemia vera, essential thrombocythemia, primary myelofibrosis, quality of life, MPN10 form.

Received: October 12, 2021

Accepted: February 10, 2022

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The Efficacy of Brentuximab Vedotin in Relapsed/Refractory Classical Hodgkin’s Lymphoma and Quality of Life: Results of a Multi-Center Observational Prospective Study in the Context of Real Clinical Practice

AUTOIMMUNE THROMBOCYTOPENIA , ,

TI Ionova1,2, AA Amdiev3, MI Andrievskikh4, EA Baryakh5, EV Vasilev6, MV Volkov7, EM Volodicheva8, VV Ivanov9, OV Kaverina10, KD Kaplanov11, TYu Klitochenko12, VI Kurakin13, DG Lazareva10, OG Larionova7, KV Lepik14, IB Lysenko15, VYa Melnichenko16, RI Minullina17, OV Mironov18, EN Misyurina5, NB Mikhailova14, NE Mochkin16, TP Nikitina1,2, TS Petrova17, NM Porfireva1, OA Rukavitsyn19, AA Samoilova16, RN Safin17, PI Simashova19, EG Smirnova16, NA Trenina13, NV Fadeeva4, GN Khusainova17, VL Chang18, TV Shelekhova20, DG Sherstnev20

1 Multinational Center for Quality of Life Research, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014

2 NI Pirogov Clinic for High Medical Technology, Saint Petersburg State University, 154 Fontanki emb., Saint Petersburg, Russian Federation, 198103

3 VM Efetov Crimea Republican Clinical Oncology Dispensary, 49A Bespalova str., Simferopol, Russian Federation, 295007

4 Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine, 42 Blyukhera str., Chelyabinsk, Russian Federation, 454087

5 Municipal Clinical Hospital No. 52, 5 Marshala Katukova str., Moscow, Russian Federation, 123181

6 Krasnoyarsk Krai Clinical Hospital, 3A Partizana Zheleznyaka str., Krasnoyarsk, Russian Federation, 660022

7 Primorsky Krai Oncology Dispensary, 59 Russkaya str., Vladivistok, Russian Federation, 690105

8 Tula Regional Clinical Hospital, 1A bld. 1 Yablochkova str., Tula, Russian Federation, 300053

9 VA Almazov National Medical Research Center, 2 Akkuratova str., Saint Petersburg, Russian Federation, 197341

10 Altai Krai Oncology Dispensary, 110 Zmeinogorskii passage, Barnaul, Russian Federation, 656045

11 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-d, Moscow, Russian Federation, 125284

12 Volgograd Regional Clinical Oncology Dispensary, 78 Zemlyachki str., Volgograd, Russian Federation, 400138

13 Clinical Oncology Dispensary, 9 bld. 1 Zavertyaeva str., Omsk, Russian Federation, 644013

14 RM Gorbacheva Scientific Research Institute of Pediatric Oncology, Hematology and Transplantation; IP Pavlov First Saint Petersburg State Medical University, 6/8 L’va Tolstogo str., Saint Petersburg, Russian Federation, 197022

15 National Medical Cancer Research Center, 63 bld. 8 14th line str., Rostov-on-Don, Russian Federation, 344037

16 NI Pirogov Russian National Medical Center of Surgery, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203

17 Tatarstan Republican Clinical Oncology Dispensary, 29 bld. A Sibirskii passage, Kazan, Russian Federation, 420029

18 Tambov Regional Clinical Oncology Dispensary, 29B Moskovskaya str., Tambov, Russian Federation, 392000

19 NN Burdenko Central Military Clinical Hospital, 3 Gospital’naya sq., Moscow, Russian Federation, 105229

20 VI Razumovskii Saratov State Medical University, 6/9 53rd Strelkovoi Divizii str., Saratov, Russian Federation, 410028

For correspondence: Tatyana Pavlovna Nikitina, MD, PhD, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014; e-mail: qolife@mail.ru

For citation: Ionova TI, Amdiev AA, Andrievskikh MI, et al. The Efficacy of Brentuximab Vedotin in Relapsed/Refractory Classical Hodgkin’s Lymphoma and Quality of Life: Results of a Multi-Center Observational Prospective Study in the Context of Real Clinical Practice. Clinical oncohematology. 2022;15(1):42–53. (In Russ).

DOI: 10.21320/2500-2139-2022-15-1-42-53

ABSTRACT

Aim. To study the quality of life and symptoms, to assess the clinical effect and treatment safety in relapsed/refractory classical Hodgkin’s lymphoma (r/r cHL) patients treated with brentuximab vedotin (BV) as ≥ 3rd-line therapy in the context of real clinical practice.

Materials & Methods. The study enrolled 62 r/r cHL patients after the second- and subsequent-line chemotherapies, who are either ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) at the time of their enrollment into the study or after the failure of high-dose chemotherapy (HDCT) with auto-HSCT. The median age was 31 years; 46.8 % of patients were women. The patients received BV 1.8 mg/kg intravenously every 3 weeks. Clinical parameters, quality of life, and symptoms were assessed prior to BV therapy and in 3, 6, 9, 12, and 15 months after therapy onset. The RAND SF-36 form was used to assess the quality of life, and the ESAS-R tool was applied to report on symptoms.

Results. Objective response was observed in 68.3 % of patients, 40 % out of them showed complete response. The median progression-free survival was 10.6 months (95% confidence interval 7.4–12.9 months). Safety profile corresponded to the published data. Adverse events of grade 3/4 were identified in 1.6 % of patients. In the period of 15 months after therapy onset, quality of life improvement or stabilization was reported based on all the scales of RAND SF-36 (GEE, p < 0.001), and symptom abatement was proved based on ESAS-R total score (GEE, p < 0.001).

Conclusion. In the context of real clinical practice, BV appeared to be effective in r/r cHL patients either after the second- or subsequent-line chemotherapies or after the failure of HDCT with auto-HSCT. The study demonstrated that BV was well tolerated by the patients. BV therapy contributes to the improvement of r/r cHL patients’ quality of life. Positive changes in quality of life and symptoms on BV therapy testify to its patient-assessed efficacy.

Keywords: classical Hodgkin’s lymphoma, relapsed/refractory form, brentuximab vedotin, quality of life, real clinical practice.

Received: June 29, 2021

Accepted: November 19, 2021

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Quality of Life of Hematologists in the Russian Federation According to the RAND SF-36 Questionnaire

AUTOIMMUNE THROMBOCYTOPENIA

NN Tsyba1, TI Ionova2,3, OV Lazareva1, TP Nikitina2,3, NM Porfir’eva3, AN Petrova1, TTs Garmaeva1,4, AG Turkina1

1 National Research Center for Hematology, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167

2 NI Pirogov Clinic for High Medical Technology, Saint Petersburg State University, 13-15 Kadetskaya line, Saint Petersburg, Russian Federation, 199004

3 Multinational Center for Quality of Life Research, 1 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014

4 RUDN University, 6 Miklukho-Maklaya str., Moscow, Russian Federation, 117198

For correspondence: Nikolai Nikolaevich Tsyba, MD, PhD, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167; Tel.: +7(495)612-15-10; e-mail: tsyba2007@yandex.ru; Olga Veniaminovna Lazareva, MD, PhD, 4 Novyi Zykovskii pr-d, Moscow, Russian Federation, 125167; e-mail: stakhino@gmail.com

For citation: Tsyba NN, Ionova TI, Lazareva OV, et al. Quality of Life of Hematologists in the Russian Federation According to the RAND SF-36 Questionnaire. Clinical oncohematology. 2020;13(4):411–9. (In Russ).

DOI: 10.21320/2500-2139-2020-13-4-411-419

ABSTRACT

Medical profession is notable for its enormous social value and associated with no less responsibility. At the same time, society’s requirements for doctors constantly increase. The regulation of medical activities in various disciplines becomes more and more stringent. The aim of the present article was to study the quality of life of 104 hematologists working in different regions of the Russian Federation. For this purpose, the Russian-language version of RAND SF-36 health survey questionnaire was used. Young doctors aged 35–44 years showed lowest scores on mental health inventory which may indicate negative emotional status and a low level of positive emotions. Compared to relatively healthy respondents, hematologists show a low level of emotional role functioning that may also indicate negative emotional status which in turn negatively affects the quality of health care delivery and appears to be a contributing factor in burnout syndrome. Compared to relatively healthy respondents, hematologists show higher pain scores which may indicate a specific attitude of doctors to pain due to their professional approach. Similar quality of life indicators indirectly suggest that hematologists in different regions of the Russian Federation regard their professional activities as a priority, and it affects their quality of life. Both the results obtained and the literature review prove the relevance of the study of human resources and development of programs aimed at continuity of personnel in the health care system. The quality of life of doctors in different disciplines should become the object of comprehensive sociological, clinical, and sanitation studies which will permit to design a program to improve the quality of life of the medical professionals.

Keywords: quality of life, hematologist, doctors’ quality of life, RAND SF-36 questionnaire.

Received: May 18, 2020

Accepted: September 4, 2020

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Correction of Anemia and Evaluation of Efficacy of Red Blood Cell Transfusion in Patients with Oncohematological Diseases

ANEMIAS , , , , , , ,

NA Romanenko1, AV Chechetkin1, LYu Zhiguleva1, GV Grishina1, SV Bondarchuk2, SS Bessmel’tsev1

1 Russian Research Institute of Hematology and Transfusiology, 16 2-ya Sovetskaya str., Saint Petersburg, Russian Federation, 191024

2 SM Kirov Military Medical Academy, 6 Akademika Lebedeva str., Saint Petersburg, Russian Federation, 194044

For correspondence: Nikolai Aleksandrovich Romanenko, MD, PhD, 16 2-ya Sovetskaya str., Saint Petersburg, Russian Federation, 191024; Tel.: 8(812)717-58-57; Fax: 8(812)717-67-80; е-mail: rom-nik@yandex.ru

For citation: Romanenko NA, Chechetkin AV, Zhiguleva LYu, et al. Correction of Anemia and Evaluation of Efficacy of Red Blood Cell Transfusion in Patients with Oncohematological Diseases. Clinical oncohematology. 2018;11(3):265–72.

DOI: 10.21320/2500-2139-2018-11-3-265-272

ABSTRACT

Aim. To study the quality of life (QL) of patients with oncohematological diseases and anemia with respect to hemoglobin level and to evaluate the efficacy of red blood cell transfusion (RBCT).

Materials & Methods. QL of patients (n = 326) was studied using FACT-An questionnaire. RBCT efficacy was evaluated in two groups. The first group included patients (n = 28; 13 men and 15 women) with oncohematological diseases and chronic anemia aged 23–80 (median 65) years, the second (control) group included patients (n = 12; 11 men and 1 woman) after severe blood loss after injury (acute anemia) aged 25–43 (median 36) years. The baseline levels of hemoglobin (Hb) and hematocrit (Ht) were < 80 g/L and < 25 % in all patients, respectively. The target levels of Hb and Ht were > 80 g/L and > 25 %, respectively.

Results. The association between the severity of anemia and QL was shown. The lowest QL was observed in patients with grade III–IV anemia (Hb < 80 g/L). Each patient in both groups received 1–8 units of blood cells (median 2) during the hospital stay. After RBCT the levels of Hb and Ht increased from 64.1 ± 2.7 g/L to 90.2 ± 1.7 g/L and from 20.1 ± 0.8 % to 28.9 ± 0.7 %, respectively. The levels of Hb and Ht in the second (control) group increased from 65.9 ± 3.0 g/L to 88.3 ± 3.2 g/L and from 19.6 ± 0.9 % to 26.7 ± 1.4 %, respectively. Venous blood oxygen saturation (SvO2) increased in the first group from 42.0 ± 3.3 % to 57.6 ± 4.1 %, and in the second group from 51.3 ± 1.9 % to 69.0 ± 1.3 %. However, after RBCT the SvO2 level reached > 60 % only in 67.9 % of patients in the first group and in all the patients (100 %) in the second group. In 32.1 % of patients with various forms of hematologic cancer and chronic anemia tissue hypoxia was still observed after RBCT despite increased Hb > 80 g/L and Ht > 25 %. Therefore, it was proposed to raise the target Hb and Ht threshold levels for patients with low SvO2.

Conclusion. The effect of the severity of anemia on QL was demonstrated. The patients with Hb < 80 g/L were shown to have low quality of life. SvO2 determination in anemia patients proved to be of great importance for RBCT efficacy evaluation. In patients with low SvO2 (< 60 %) RBCT should be continued until the target levels of Hb 100 g/L and Ht 33 % are reached.

Keywords: anemia, chronic anemia, red blood cell transfusions, hemoglobin concentration, hematocrit, venous blood oxygen saturation, quality of life, FACT-An questionnaire.

Received: March 10, 2018

Accepted: May 30, 2018

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Dasatinib in First- and Second-Line Therapy of Chronic Myeloid Leukemia: Efficacy, Safety and Quality of Life

MYELOID TUMORS , , , , ,

TI Ionova1,2, NB Bulieva3, OYu Vinogradova4,5,6, TA Gritsenko7, LK Kozlova8, GB Kuchma8, EG Lomaia9, ER Machyulaitene10, TP Nikitina1,2, NV Novitskaya4, AYu Rodionova2, EI Usacheva11, TV Shneider12

1 Saint Petersburg Multifield Medical Center under the Ministry of Health of Russia, 154 Nabereznaya Reki Fontanki, Saint Petersburg, Russian Federation, 198103

2 Multinational Center for Quality of Life Research, 1 Artilleriiskaya str., office 152, Saint Petersburg, Russian Federation, 191014

3 I Kant Baltic Federal University, 14 A Nevskogo str., Kaliningrad, Russian Federation, 236041

4 SP Botkin Municipal Clinical Hospital, 5 2-i Botkinskii pr-zd, Moscow, Russian Federation, 125284

5 Dmitrii Rogachev Federal Scientific Clinical Centre of Pediatric Hematology, Oncology and Immunology under the Ministry of Health of the Russian Federation, 1 Samory Mashela str., Moscow, Russian Federation, 117198

6 NI Pirogov Russian National Research Medical University under the Ministry of Health of the Russian Federation, 1 Ostrovityanova str., Moscow, Russian Federation, 117997

7 Samara State Medical University under the Ministry of Health of the Russian Federation, 89 Chapaevskaya str., Samara, Russian Federation, 443099

8 Orenburg State Medical University, 6 Sovetskaya str., Orenburg, Russian Federation, 460000

9 Federal Almazov North-West Medical Research Centre, 2 Akkuratova str., Saint Petersburg, Russian Federation, 197341

10 Outpatient Department, Academician IP Pavlov First St. Petersburg State Medical University, 6/8 L’va Tolstogo str., Saint Petersburg, Russian Federation, 197022

11 RM Gorbacheva Scientific Research Institute of Pediatric Hematology and Transplantation; Pavlov First Saint Petersburg State Medical University, 6/8 L’va Tolstogo str., Saint Petersburg, Russian Federation, 197022

12 Leningrad District Clinical Hospital, 43/49 Lunacharskogo pr-t, Saint Petersburg, Russian Federation, 194291

For correspondence: Tat’yana Ivanovna Ionova, DSci, 1 office 152 Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014; Tel: +7(812)579-61-38; e-mail: qlife@rambler.ru

For citation: Ionova TI, Bulieva NB, Vinogradova OYu, et al. Dasatinib in First- and Second-Line Therapy of Chronic Myeloid Leukemia: Efficacy, Safety and Quality of Life. Clinical oncohematology. 2017;10(2):206–17 (In Russ).

DOI: 10.21320/2500-2139-2017-10-2-206-217

ABSTRACT

Background & Aims. The article presents results of two observational, prospective, multicenter studies “Quality of Life, Symptom Profile, and Adherence to Treatment in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia Receiving Dasatinib” (2012–2015) and “Quality of Life and Symptom Profile in Imatinib-Resistant or Intolerant Patients with Chronic Myeloid Leukemia” (2011–2014).

Methods. Data of 107 patients with chronic myeloid leukemia in chronic phase were involved in the real-world analysis — 32 newly diagnosed patients on first-line treatment with dasatinib or after yearly switch to dasatinib after imatinib treatment failure and 75 imatinib-resistant or intolerant patients on second-line treatment with dasatinib. Treatment effectiveness and safety of dasatinib were assessed during first and second-line dasatinib treatment using clinical outcomes as well as quality of life and symptom profile assessment.

Results. The real-world data obtained during observational study in limited population of CML patients conform the results of clinical trials devoted to evaluation of treatment efficacy and safety of dasatinib treatment in first and second-line treatment and demonstrate the importance of patient-reported outcomes. Patient’s quality of life improved within 12 months of the first-line dasatinib therapy according to the following scales: role physical functioning, pain, vitality, social functioning and role emotional functioning. The most pronounced and clinically significant improvement was observed for the role emotional functioning (51.1 vs. 68.9). During the second-line dasatinib treatment, stabilization of quality of life parameters was registered for the following scales: vitality, social functioning, mental health, and pain. Significant improvement of the Integral Quality of Life Index was observed (p < 0.05). Positive dynamics of relevant symptoms was registered. The symptom severity decreased during both the first and second-line therapy.

Conclusion. Quality of life and symptom assessment in CML patients contribute to a better disease control in accordance with the principles of risk-adaptive therapy.

Keywords: quality of life, chronic myeloid leukemia, dasatinib, therapy effectiveness, therapy safety, routine clinical practice.

Received: November 10, 2016

Accepted: February 10, 2017

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Malignant Lymphoproliferative Disorders with Anemia: Changes of Quality of Life in Patients Treated with Donor Red Blood Cell Transfusions and Recombinant Erythropoietin

LYMPHOID TUMORS , , , , , , , ,

S.S. Bessmeltsev1, N.A. Romanenko1, N.A. Potikhonova1, S.A. Tiranova1, M.N. Zenina1, A.E. Romanenko2, L.Yu. Zhiguleva1, K.M. Abdulkadyrov1

1 Russian Scientific Research Institute of Hematology and Transfusiology under the Federal Medico-Biological Agency, 16 2-ya Sovetskaya str., Saint Petersburg, Russian Federation, 191024

2 St. Olga Children Hospital, 2 Zemledelcheskaya str., Saint Petersburg, Russian Federation, 194156

For correspondence: Stanislav Semenovich Bessmel’tsev, DSci, Professor, 16 2-ya Sovetskaya str., Saint Petersburg, Russian Federation, 191024; Tel.: +7(812)717-58-57; e-mail: RNIIHT@mail.ru

For citation: Bessmel’tsev SS, Romanenko NA, Potikhonova NA, et al. Malignant Lymphoproliferative Disorders with Anemia: Changes of Quality of Life in Patients Treated with Donor Red Blood Cell Transfusions and Recombinant Erythropoietin. Clinical oncohematology. 2015;8(4):368–378 (In Russ).

DOI: 10.21320/2500-2139-2015-8-4-368-378

ABSTRACT

Aim. To evaluate the quality of life of anemic patients with malignant lymphoproliferative disorders after red blood cells transfusion and administration of human recombinant erythropoietin agents.

Methods. The efficacy was assessed based on evaluation of clinical data, lab test findings and quality of life (QoL) parameters using the FACT-An questionnaire. Red blood cells transfusions (RBCsT) were prescribed to anemic patients with malignant lymphoproliferative disorders (LPD) (n = 54) with initial Hb levels of 7.0 ± 0.16 g/dl. After red blood cells transfusion (Me = 3 Units) the Hb level increased up to 9.31 ± 0.12 g/dl. Human recombinant erythropoietin agents (EPO) were prescribed to LPD patients (n = 77) with initial Hb levels of 8.84 ± 0.14 g/dl.

Results. A positive response with a ³ 2.0 g/dl increase of Hb levels was observed in 52 (67.5 %) of 77 patients. The Hb level in responsive patients increased up to 12.31 ± 0.24 g/dl. Statistically significant QoL changes were observe according to «Physical well-being», «Emotional well-being», «Functional well-being», and «Anemia» scales. After EPO-therapy, significant changes were found according to «Physical well-being» and «Anemia» scales. A comparative analysis of QoL in both groups of patients demonstrated maximum changes according to the «Physical well-being» scale (from 12.9 ± 0.7 to 11.0 ± 0.8 points after RBCsT, p < 0.001; from 11.6 ± 0.7 to 9.6 ± 0.7 points on EPO, p < 0.02) and the «Anemia» scale (from 41.1 ± 2.0 to 34.2 ± 2.2 points after RBCsT, p < 0.001; from 34.5 ± 1.7 to 30.1 ± 1.6 points on EPO; p < 0.001).

Conclusion. Therefore, RBCsT and EPO therapy may significantly increase the Hb levels and improve QoL. However, the QoL of LPD patients on EPO proved to be better than that after RBCsT, because it had been possible to achieve normal and stable Hb levels.

Keywords: anemia, malignant lymphoproliferative disorders, erythropoietin, recombinant erythropoietin, donor’s red blood cells, red blood cell transfusions, quality of life, FACT-An questionnaire, «Anemia» scale.

Received: May 13, 2015

Accepted: October 12, 2015

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Quality of Life of Patients with Lymphomas at Different Time-Points after High-Dose Chemotherapy with Autologous Hematopoietic Stem Cell Transplantation

QUALITY OF LIFE , , ,

N.E. Mochkin1, D.A. Fedorenko1, V.Ya. Mel’nichenko1, T.I. Ionova2, T.P. Nikitina1,2, K.A. Kurbatova2, A.A. Novik1

1 N.I. Pirogov National Medical and Surgical Center under the Ministry of Health of the Russian Federation, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203

2 International Quality of Life Research Center, 1 office 152, Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014

For correspondence: N.E. Mochkin, PhD, assistant, 70 Nizhnyaya Pervomaiskaya str., Moscow, Russian Federation, 105203; Tel: +7(495)603-72-17; e-mail: nickmed@yandex.ru

For citation: Mochkin N.E., Fedorenko D.A., Mel’nichenko V.Ya., Ionova T.I., Nikitina T.P., Kurbatova K.A., Novik A.A. Quality of Life of Patients with Lymphomas at Different Time-Points after HighDose Chemotherapy with Autologous Hematopoietic Stem Cell Transplantation. Klin. Onkogematol. 2014; 7(4): 577–582 (In Russ.).

 

ABSTRACT

The article presents results of monitoring of quality of life of 103 patients with lymphomas (non-Hodgkin’s lymphomas, n = 36; Hodgkin’s lymphomas, n = 67) at different stages after high-dose chemotherapy with autologic hematopoietic stem cell transplantation (HDC + HSCT). The majority of patients experienced improvement or stabilization of their quality of life 1 year after the HDC + aHSCT. At that, the response associated with the quality of life and clinical response to the treatment did not coincide in all cases. Obtained results confirm the importance of a comprehensive approach to assessment of the efficacy of the treatment and may be use as a principle marker of patient’s recovery at different time points after the transplantation.

Keywords: quality of life, lymphomas, high-dose chemotherapy, autologic hematopoietic stem cell transplantation.

Accepted: September 16, 2014

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Value of Patient-Reported Outcomes in Oncohematology

QUALITY OF LIFE , , ,

T.I. Ionova1, S. Salek2, Е. Оliva3

1 International Quality of Life Research Center, 1 office 152, Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014

2 Cardiff University, Pharmacoeconomics Department, Redwood Building King Edward VII Avenue Cardiff, CF10 3NB, UK

3 Hematology Division, Azienda Ospedaliera B-M-M, Via Melacrino, 89100 Regio Calabria, Italy

For correspondence: T.I. Ionova, DSci, Professor, 1 office 152, Artilleriiskaya str., Saint Petersburg, Russian Federation, 191014; Tel: +7(812)579-61-38; e-mail: tation16@gmail.com

For citation: Ionova T.I., Salek S., Oliva E. Value of Patient-Reported Outcomes in Oncohematology. Klin. Onkogematol. 2014; 7(4): 573–576 (In Russ.).

ABSTRACT

One of priorities of modern medical science is the patient-oriented care. This approach presupposes that patient management should be based not only on analysis of clinical and lab test findings but also on reports made by the patient himself. These reports permit to perform a thorough analysis of patient’s problems and to obtain more data on the treatment effectiveness. Quality of life (QoL) and symptoms are key factors in patient-reported outcomes (PRO). The past decade has been characterized by increased attention paid by the medical community to patient’s own sensations throughout the treatment. The importance of this principle is confirmed by the fact that “Quality of Life in Hematology” was declared as the 2012–2013 theme of the year by the European Hematology Association. Partient-reported outcomes permit to obtain information that cannot be obtained from other sources. It is especially important when new treatment methods are selected and when new approaches to palliative care are developed.

Keywords: patient-reported outcomes, quality of life, symptoms, clinical practice.

Accepted: September 15, 2014

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REFERENCES

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Quality of life in adolescent and young adult Hodgkin’s lymphoma survivors

CLINICAL PRESENTATION, DIAGNOSIS, AND MANAGEMENT OF LYMPHOID MALIGNANCIES , , , , ,

Ye.G. Arshanskaya1,2, S.V. Semochkin2,3, and A.G. Rumyantsev2,3

1 S.P. Botkin City Clinical Hospital, Moscow, Russian Federation

2 Federal Clinical-and-Research Center of Pediatric Hematology, Oncology, and Immunology n.a. Dmitriy Rogachev, Moscow, Russian Federation

3 N.I. Pirogov Russian National Research Medical University, RF Ministry of Health, Moscow, Russian Federation

ABSTRACT

Background. Deterioration of quality of life (QoL) and late complications of antitumor therapy for Hodgkin’s lymphoma (HL) are the important medical issues, since they mostly relate to young patients with a high life-expectancy.

Objective. The study was to compare QoL of HL survivors versus healthy young adults.

Methods. 56 (22 males and 34 females) HL survivors with a median age of 27.5 (range 22–41) were evaluated. For the purpose of comparison, 94 (44 males and 50 females) healthy subjects with a median age of 28.0 (range 22–46) were enrolled into the study of QoL. All HL survivors were treated in our hospital according to the modified pediatric protocol DAL-HD-90 in 1997–2007. QoL was assessed using the Short Form 36 (SF-36) which enabled generating 8 separate scales and 2 final scores (0 = worst possible health, 100 = best possible health). All survivors were in complete remission of HL for ³ 5 years.

Results. The HL survivors had the lower scores than the normal controls according to all scales and SF-36. Statistically significant differences were found in: general health — 53.4 (95 %CI 47.8–59.1) vs. 72.3 (68.8–75.8; p < 0,001), vitality — 54.7 (50.4–59.1) vs. 72.2 (69.3–75.2; p < 0.001), and mental health — 57.4 (53.5–61.4) vs. 71.7 (68.6–74.8; p < 0.001). The patients at the age ³ 18.5 years (ROC-curves; p = 0.047) at the time of HL diagnosis had poorer QoL when compared to younger patients with respect to: general health — 48.3 (41.3–55.2) vs. 60.9 (51.6–70.2; p = 0.027): vitality — 50.3 (44.7–55.9) vs. 61.1 (51.6–70.2; p = 0.013). The patients with the unfavorable events including relapse (n = 6) and second malignancy (n = 2) showed the lowest scores of QoL, especially in physical role performance [34.4 (2.6–71.3) vs. 79.7 (77.8–89.6; p = 0.002)] and emotional role performance [25.0 (7.5–57.5) vs. 77.8 (67.1–88.4; p < 0.001)]. Duration of remission, age at the QoL evaluation, gender, therapy intensity (2, 4, or 6 cycles of primary chemotherapy plus radiotherapy), Ann-Arbor stages, bulky disease, current married status, and education levels showed no significant influence on the QoL parameters.

Conclusion. Long-term HL survivors had poorer physical and mental QoL than the general population of young adults. The age at the time of LH diagnosis ³ 18.5 years was associated with significantly reduced QoL. The relapsed HL and second malignancies were mostly associated with the deterioration of physical and emotional role functioning that may indicate uncertainty of patients about future well-being.

Keywords: Hodgkin’s lymphoma, quality of life, adolescents, young adults, DAL-HD-90, SF-36

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