Results of the Russian Multi-Center Cooperative Prospective-Retrospective Observational Program for Hodgkin’s Lymphoma Treatment RNWOHG-HD1

Aim. The observational program was aimed at obtaining data on classical Hodgkin’s lymphoma (cHL) incidence in the Russian Federation, therapy options, and clinical outcomes of treatment. The aim of the prospective part of the program was to standardize the approaches to therapy and to compare its outcomes with off-protocol treatment. Materials & Methods. The prospective-retrospective observational program for Hodgkin’s lymphoma treatment engaged 32 regional and federal centers. It included 218 patients, 21 out of them were included into the prospective part of the RNWOHG-HD1 (Russian North-West Oncology and Hematology Group - Hodgkin Disease Study 1) program. The median age was 36 years (range 22-87 years). cHL stages I/II were identified in 48 % of patients, III/IV stages were reported in 52 % of patients. The prospective part of the program used escalating protocol in patients with stages I/IIA and without risk factors and de-escalating protocol in patients with advanced stages. Overall (OS) and progression-free (PFS) survivals were analyzed in 160 and 152 patients, respectively. PET-CT was used to assess the response in 33 % of patients. Results. The study used the following first-line chemotherapy regimens: ABVD in 42 %, BEACOPPst in 11 %, BEACOPP-14 in 17 %, BEACOPPesc in 25 %, and EACOPP in 1 % of cases. After the completion of first-line therapy objective response rate was 91 % including 61 % of complete responses. Response structure did not significantly differ in the groups of non-intensive therapy (ABVD and BEACOPPst), intensified regimens (BEACOPP-14, BEACOPPesc, and EACOPP), and treatment according to the RNWOHG-HD1 protocol (91 %, 92 %, and 96 %, respectively; p = 0.7226). In the total cohort the 3-year OS was 97 % (95% confidence interval [95% CI] 94-99 %), PFS was 87 % (95% CI 80-92 %). The 3-year PFS did not differ in ABVD, BEACOPPst, BEACOPP-14, BEACOP-Pesc, and RNWOHG-HD1 recipients (р = 0.37). International Prognostic Score (IPS) yielded significant results in PFS prediction for patients with IPS score of 5-6, but not for those with IPS score of 1-4 (p = 0.0028). Conclusion. The observational program showed that the majority of participating centers use the risk-adapted ABVD/ BEACOPPesc approach which explains no difference in PFS being found with the use of these chemotherapy options. The study demonstrated the need for PET-CT to assess the response since the CT alone cannot distinguish between complete and partial responses in a considerable number of patients. The prospective unified program for cHL treatment may well be implemented in the Russian Federation.

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Treatment of patients with malignant lymphoproliferative diseases in the Russian Federation: analysis of the data from 75 regions

PHARMACOECONOMICS Modern pharmacoeconomics and pharmacoepidemiology ◽

10.17749/2070-4909.2018.11.4.003-015 ◽

2019 ◽

Vol 11 (4) ◽

pp. 3-15

Author(s):

G. R. Hachatryan ◽

T. S. Teptsova ◽

V. A. Lemeshko ◽

N. Z. Musina

Keyword(s):

Medical Care ◽

Russian Federation ◽

Hodgkin’S Lymphoma ◽

Hodgkin's Lymphoma ◽

High Tech ◽

Lymphoproliferative Diseases ◽

Number Of Patients ◽

Icd 10 ◽

The Russian Federation ◽

Specialized Institutions

The aimis to analyze the medical records of patients with malignant lymphoproliferative diseases (LPD) in the Russian Federation in 2016- 2017.Materials and methods. Treating physicians in 75 regions of the Russian Federation were asked to fill the survey questionnaire containing 9 types of malignant LPDs (according to the ICD-10 classification). The questions covered the epidemiology of LPD (prevalence, resistant forms, relapses and mortality), the existence of specialized institutions and beds, the costs of medical care in patients with malignant LPD, and the financial support of pharmacotherapy in these patients during their hospital stay.Results. We found that the most common malignant LPD in 2016-2017 was Hodgkin’s lymphoma (73.5 and 73.4%, respectively). The prevalence of resistant forms and recurrences of malignant LPD over this period accounted for 6.8% of the total patient population. In 2017, the number of patients who died was 7.5% less than that in 2016. There are 815 and 1,763 specialized institutions of the oncology and hematology profiles that provide medical care to children and adult patients, respectively. Among the malignant LPDs, the highest costs of drug therapy in 2016 pertained to lymphosarcoma, and in 2017 – to Hodgkin’s lymphoma. In the system of compulsory health insurance (OMC), the largest spending for both adult and pediatric patients in 2016 and 2017 was accounted for Hodgkin’s lymphoma; a similar result was obtained for the cost of therapy based on high-tech medical care.Conclusion. In 2017, the total number of patients with malignant LPD in the Russian Federation increased by 2.65% as compared to 2016, while the proportion of primary LPD decreased by 1.2%. In 2017, the total costs of drug supply in patients with malignant LPD in the RF increased by 55.35% as compared with 2016.

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Correlation of PET Scan Negativity and Higher Absolute Lymphocytes: Monocytes (ALC:AMC) Ratio As Prognostic Markers in Classical Hodgkin Lymphoma Patients Treated with ABVD Chemothearapy at a Single Center in Saudi Arabia

Blood ◽

10.1182/blood.v126.23.5004.5004 ◽

2015 ◽

Vol 126 (23) ◽

pp. 5004-5004

Author(s):

Ibraheem H Motabi ◽

Syed Ziauddin A. Zaidi ◽

Shahid Iqbal ◽

Atta Munawar Gill ◽

Imran Khan Tailor ◽

...

Keyword(s):

Hodgkin’S Lymphoma ◽

Conflicts Of Interest ◽

Prognostic Score ◽

Pet Scan ◽

Hodgkin's Lymphoma ◽

Monocyte Count ◽

Advanced Stage ◽

Bulky Disease ◽

Number Of Patients ◽

International Prognostic Score

Abstract The International Prognostic Score (IPS) is the standard stratification system for survival in patients with classical Hodgkin's lymphoma (cHL). However, the IPS only applies to patients with advanced stage disease and it does not offer risk stratification for classical Hodgkin's lymphoma patients diagnosed with limited disease [i.e., stages I and IIA, without constitutional symptoms and no bulky disease. Furthermore, early interim positron emission tomography (PET) has been shown to have a prognostic value superior to that of the IPS in patients with advanced-stage cHL in an analysis (Gallamini et al). Lymphopenia (<600/ul), monocytosis >750 per ul (Tadmore et al) and high tumor-associated macrophages (TAM) are reported to be negative prognostic factors for survival in classical Hodgkin's lymphoma (Koh et al). More recent studies suggested a prognostic role for the peripheral blood absolute lymphocyte count/absolute monocyte count (ALC/AMC) ratio at diagnosis in cHL patients treated with multitude of chemotherapies (Porrata et al, Tadmor et al). It is intriguing to investigate the significance of the ALC/AMC ratio in relation to PET negativity after treatment. Out of 164 cases of cHL treated at our center with ABVD +/- radiation therapy, we identified 70 patients who were evaluated by PET Scan. Median age was 26 years (range 14-80), 33 (47%) were stage IV, Median IPS was 3 (range1-6). We tested correlation of a high ALC/AMC ratio (>2.1) with achievement of a negative PET scan after ABVD chemotherapy. We arbitrarily chose cut-off value of >2.1 (Tadmore et al) from the multiple values reported recently, as this multicenter study had the largest number of patients. A total of 45 patients achieved a negative PET scan. Mean ALC/AMC ratio was 2.39 (range0.19-14.6). ALC/AMC ratio of >2.1 did show a trend for better OS in addition to a negative PET scan. A Spearman correlation test of a negative PET result showed a positive correlation with ALC/AMC ratio of >2.1 though it was weak. This study suggests that the ALC/AMC ratio may be a simple, inexpensive, and independent prognostic factor in cHL outcome and may have a role in the stratification of cHL patients in addition to the International Prognostic Score, TAM content and acheivement of a negative PET scan early post chemotherapy. However we plan to define our own best cut off value for ALC/AMC ratio by ROC and AUC analysis as ALC/AMC Ratio of ≥2.1 did not discriminate survival advantage very well and it may be a reason for weaker correlation with likelihood of a negative PET. Further larger studies are needed to confirm our findings. Disclosures No relevant conflicts of interest to declare.

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Prospective Evaluation of the International Prognostic Score (IPS) in All Stages of Hodgkin’s Lymphoma Treated with ABVD Plus Involved-Field Radiotherapy (IFRT).

Blood ◽

10.1182/blood.v112.11.1454.1454 ◽

2008 ◽

Vol 112 (11) ◽

pp. 1454-1454

Author(s):

Santiago Pavlovsky ◽

Claudia Corrado ◽

Miguel A Pavlovsky ◽

Virginia Prates ◽

Lucia Zoppegno ◽

...

Keyword(s):

Prognostic Factors ◽

Complete Remission ◽

Hodgkin’S Lymphoma ◽

Prognostic Score ◽

Hodgkin's Lymphoma ◽

Therapeutic Approaches ◽

Bulky Disease ◽

Number Of Patients ◽

Involved Field ◽

Involved Field Radiotherapy

Abstract Background: The prognostic score for Hodgkin’s lymphoma was defined as the number of adverse prognostic factors presented at diagnosis. Seven factors had similar independent prognostic effects. This model was validated retrospectively in advanced disease using different therapeutic approaches (D Hasenclever et al N Eng J Med339:1506–14, 1998). Methods: From December 1996 up to October 2005, the GATLA completed a risk-adapted therapy with ABVD and IFRT. Patients with stages I-IIIA without bulky disease, who achieved complete remission (CR) after three cycles of ABVD, favorable group (FG) received only IFRT 25 GY to areas of >2 cm at diagnosis. Patients with FG not in CR after three cycles of ABVD, slow responders (FGSR), all stages IIIB-IV and all bulky disease, unfavorable group (UG) received six cycles of ABVD and IFRT 30 GY at remaining areas after 3 cycles of ABVD. A total of 584 patients, completed therapy; of them 513 were evaluated with the IPS. Patients were divided in three groups according to the number of adverse prognostic factors 0–1, 2–3, and ≥ 4. Results: The number of patients, complete remission (CR) rate, event-free survival (EFS) and overall survival (OSV) at 5 years according to prognostic factors in the 513 patients were as follows: IPS # patients (%) # CR (%) % EFS % OSV 0–1 224 (44) 217 (97) 86 95 2–3 241 (47) 213 (88) 73 90 ≥4 48 (9) 40 (83) 65 72 P< 0.020 0.001 0.001 A total of 200 patients with FG had a 5 years EFS and OSV of 89% and 98% while 53 patients with FGSR had an EFS and OSV of 66% and 88% respectively (P<0.001). The IPS in FG and FGSR was 0–1 of 61% versus 49%, 2–3 of 38.5% versus 43% and ≥4 of 0.5% versus 8% respectively (p=0.003). In UG with an EFS and OSV of 72% and 87%, the incidence of IPS 0–1 was 29%, 2–3 was 54% and ≥4 was 17%. Conclusion: The IPS is an excellent tool to predict outcome. Patients with stages I-IIIA without bulky tumour who did not achieve CR after three cycles of ABVD (FGSR) had poorer IPS than FG. In spite of receiving six cycles of ABVD, those with FGSR instead of three of those with FG had statistically a poor outcome. In the PET-TC era, patients who remain positive after three cycles of ABVD will need an intensified therapy with the purpose of improving the bad prognosis.

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A Multicenter Study of a Gemcitabine-Based Regimen in Relapsed or Refractory Hodgkin’s Lymphoma Patients.

Blood ◽

10.1182/blood.v110.11.4436.4436 ◽

2007 ◽

Vol 110 (11) ◽

pp. 4436-4436

Author(s):

Patricia Validire ◽

Christophe Fermé ◽

Pauline Brice ◽

Marine Diviné ◽

Jean Gabarre ◽

...

Keyword(s):

Prognostic Factors ◽

Hodgkin’S Lymphoma ◽

Prognostic Score ◽

Cytotoxic Agents ◽

Hodgkin's Lymphoma ◽

Stage Iii ◽

Prognostic Impact ◽

First Line ◽

Starting Dose ◽

International Prognostic Score

Abstract The aim of this study was to assess the efficacy of a gemcitabine-based regimen in pretreated Hodgkin’s lymphoma (HL) patients. Relapsed or refractory HL patients treated with gemcitabine, used alone or in combination with other cytotoxic agents, were retrospectively reviewed. Fifty-five patients were included in the study. Initial characteristics before gemcitabine administration were: Ann Arbor stage III–IV: 84%; International Prognostic Score less than 3 in 20/43 cases (47%); thirty-one primary refractory patients at the end of first-line therapy (56%); median number of previous chemotherapy regimens of 3. Twenty-nine patients received gemcitabine alone with a median starting dose of 750 mg/m2 per injection (range: 180–1250 mg/m2); Gemcitabine was administered at a starting dose of 1000 mg/m2 per injection (range: 500–1250) in combination with vinorelbine in 10 patients, oxaliplatin in 13 patients, and other drugs in 3 patients, with a median of 6 injections (range: 1–18). Overall response rate was 20% with 11% of complete remission. On univariate analysis, two adverse factors at progression were significant for response to gemcitabine-based regimen: stage III–IV disease and hemoglobin level less than 10.5 g/dl. In conclusion, the two identified prognostic factors for response to gemcitabine are part of the International Prognostic Score of HL, suggesting that response to gemcitabine is mainly influenced by the specific prognostic factors of HL. Moreover, with an ORR of 29%, our results of the gemcitabine administered alone regimen are not different from those reported in the literature. In contrast, the results of the various series of HL patients treated by gemcitabine-combined regimens, mainly with cisplatin or derivatives, vinorelbine, ifosfamide, doxorubicin, and prednisone, are very different due to different patient characteristics. In heavily pretreated cases, as in our study, the ORR was 26%; inversely, in patients who had received only one or two lines of chemotherapy, the ORR varied between 64% and 82% with 9% to 54% of complete remissions. This discordance can probably be explained by the prognostic impact of previous treatment lines in the response to gemcitabine. This observation emphasizes the possible interest of using gemcitabine earlier in the treatment of Hodgkin’s lymphoma, namely at the time of first relapse or after first-line treatment in primary refractory HL patients.

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Hodgkin’s lymphoma in remission after first-line therapy: which patients need FDG–PET/CT for follow-up?

Annals of Oncology ◽

10.1093/annonc/mdp519 ◽

2010 ◽

Vol 21 (5) ◽

pp. 1053-1057 ◽

Cited By ~ 36

Author(s):

U. Petrausch ◽

P. Samaras ◽

P. Veit-Haibach ◽

A. Tschopp ◽

J.D. Soyka ◽

...

Keyword(s):

Fdg Pet ◽

Hodgkin’S Lymphoma ◽

Hodgkin's Lymphoma ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Pet Ct ◽

Fdg Pet Ct

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Comparison of the International Harmonization Project, London and Gallamini criteria in the interpretation of 18F-FDG PET/CT examinations after first-line treatment in Hodgkin’s lymphoma

Nuclear Medicine Communications ◽

10.1097/mnm.0000000000000024 ◽

2014 ◽

Vol 35 (2) ◽

pp. 169-175 ◽

Cited By ~ 6

Author(s):

Kornélia Kajáry ◽

Zsuzsa Molnár ◽

Tamás Györke ◽

Szabolcs Szakáll ◽

Péter Molnár ◽

...

Keyword(s):

Fdg Pet ◽

Hodgkin’S Lymphoma ◽

Hodgkin's Lymphoma ◽

Line Treatment ◽

First Line ◽

International Harmonization ◽

Pet Ct ◽

18F Fdg ◽

Fdg Pet Ct ◽

First Line Treatment

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A Study to Evaluate the Efficacy and Safety of the Sintilimab Plus ICE Regimen Versus ICE Regimen in the Classic Hodgkin's Lymphoma Patients (cHL) Who Have Failed the First-line Standard Chemotherapy

Case Medical Research ◽

10.31525/ct1-nct04044222 ◽

2019 ◽

Author(s):

Keyword(s):

Hodgkin’S Lymphoma ◽

Hodgkin's Lymphoma ◽

Efficacy And Safety ◽

First Line ◽

Standard Chemotherapy ◽

Line Standard

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Objectification of the Amount of Compensation for Non-Pecuniary Damage in Claims Against Medical Organizations

RUSSIAN JUSTICE ◽

10.37399/issn2072-909x.2020.6.35-44 ◽

2020 ◽

Vol 6 ◽

pp. 35-44

Author(s):

L. A. Shmarov ◽

Keyword(s):

Law Enforcement ◽

Russian Federation ◽

Medical Assistance ◽

Criminal Proceedings ◽

Enforcement Officer ◽

Number Of Patients ◽

The Russian Federation ◽

Law Enforcement Officer

Based on the analysis of citizens’ claims against medical organizations, as well as on the basis of the analysis of the courts’ consideration of such claims, significant differences were found in the amount of compensation for non-pecuniary damage under various conditions related to both the condition of the victim of medical assistance rendered with defects and on the number of patients. It was shown that it is necessary to further accumulate material in order to obtain a more objective picture of satisfied claims and unification in the Russian Federation. Similar calculations can be carried out for other situations related to the possibility of causing moral harm, for example, disseminating information defaming the honor and dignity of a citizen, or compensating moral harm caused by unlawful actions of a law enforcement officer during criminal proceedings. Using the established average values, the court can, on the basis of established factual circumstances, calculate the amount of compensation for non-pecuniary damage in a particular case.

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