Method of treatment tactics optimisation in case of hodgkin's lymphoma in children and teenagers

FIELD: medicine.

SUBSTANCE: invention relates to medicine, in particular to oncology, and can be used for optimisation of treatment tactics in case of Hodgkin's lymphoma in children and teenagers. Method is realised in the following way. Such unfavourable prognostic factors as: age over 10 years, IV stage of disease, conglomerate dimensions more than 5 cm and/or value of mediastinal-thoracic index greater than 0.33, number of affected zones more than 4, symptoms of intoxication and biological activity of process. After that three risk groups are determined by the sum of detected unfavourable factors. In the first group, if 0-2 factors are detected, 2 cycles of polychemotherapy in accordance with regimen VBVP are carried out, in the second group, if 3-4 risk factors are detected - 4 cycles in alternating regimen VBVP-ABVD-VBVP-ABVD, in the third group, if 5-6 factors are detected - 6 cycles in alternating regimen VBVP-ABVD-VBVP-ABVD-VBVP-ABVD. Two weeks after carrying out polychemotherapy in all groups irradiation of all earlier affected zones is performed.

EFFECT: method allows to reduce risk of post-cytostatic and radiation complications development due to reduction of treatment loading in patients.

1 tbl, 1 dwg, 2 ex

 

The invention relates to medicine, namely to methods of treatment of oncological diseases in children and adolescents.

Cytostatics with Hodgkin's lymphoma has been used 60 years ago in the form of monotherapy Mostaganem. The first sensational reports of high efficiency four-part schema of polychemotherapy of MORR (mustargen/embihin, oncovin/vincristine, procarbazine/natulan, prednisolone) appeared 20 years later (De Vita V. et al., 1967, 1970). However, with the increasing number of patients and prolonged periods of observation were identified and serious consequences of MORR (especially in children and adolescents): reduced fertility, largely observed in males; increased risk of second tumors and leukemias, etc. In the future, it was found that these complications are caused by the use of alkylating agents and natulan, but attempts to replace them led to worse outcomes. For 40 years it was tested a huge number of different schemes of chemotherapy, but only ABVD (adriblastin, bleomycin, vinblastine, dacarbazine), proposed G.Bonadonna et al. (1975), was able to compete with MORR efficiency, and its use was accompanied by a smaller number of remote consequences. Currently, ABVD is considered the "gold standard" in the treatment of Hodgkin lymphoma in adults despite the fact that h is on the large total doses of bleomycin may in some cases result in the development of pneumosclerosis, and use antracycline - cardiomyopathies. Currently, foreign literature extensively as about the long-term effects of treatment for Hodgkin's lymphoma, and the quality of life of treated patients. Observed a clear dependence of the frequency of the remote consequences of the number of alkylating drugs and their cumulative doses. So, G.Schellong et al. (1999) found that in 65% of patients with secondary tumors total dose of cyclophosphamide in the primary treatment of HL were 2-6 g/m2, procarbazine - 3-11 g/m2. As shown by the work A.T.Meadows et al. (1989), the risk of secondary hematological malignancies is increased in proportion to the number used alkylating agents over a period of 6 months. The study authors in all children with leukemia arising after treatment of primary Hodgkin's lymphoma, during this time interval was used, at least two agents with an alkylating action. Radiotherapy induces the emergence of second tumors solid structure, with two-thirds of these tumors (both malignant and benign nature) are localized in the zone or on the border of the radiation field.

In connection with this circumstance in oncidiinae great attention is paid to two directions of optimization of medical tactics in Hodgkin's disease: the use of schemes in Altamira the future mode, to a total dose of the most "dangerous" drugs did not exceed the threshold, and the exclusion of these drugs from used schemes. Perspective by reducing the total dose is the use of the principles of the so-called risk-adapted therapy, i.e. the dependence of the number of cycles of chemotherapy from risk (decrease therapeutic stress (radiation and cytostatic) at early stages of Hodgkin's lymphoma and intensification therapy for common forms of the disease).

The prototype of the claimed invention is a famous German-Austrian risk-adapted program DAL-HD. Since 1978, this research group has spent 6 consecutive treatment protocols for Hodgkin's lymphoma in children and adolescents (the total number of initial observations exceeds 2000). It is noted that when the high performance of these protocols could reduce the number of remote consequences (in particular, second tumors, and leukemias). It should be noted that in recent versions of the Protocol when stratification of risk groups are used only information about the stage of the disease and the General symptoms, and treatment schemes remain the anthracyclines and alkylating agents. DAL-HD has been adapted for our country (research Director G.Schellong) and put into practice sotrudnikami with Germany, oncopediatrie the fir branches. Our Department began to use the Protocol DAL-HD since 1987 (in cooperation with the former GDR), i.e. before other departments. There were obtained good results, which are, however, lower than reported by participants DAL-HD (especially in numbers event free survival). The risk of second neoplasms (particularly acute myeloid leukemia) was reduced from 10.4% to 0.9%. In our material, this fact was confirmed, however, the likelihood of myelogenous leukemia still remains (when increasing the observation period), which can be explained by the use of natulan and platinum. In the Protocol DAL-HD number used alkylating agents over a period of 6 months is 2-3, the cumulative dose of cyclophosphamide was 0-4,8 g/m2, procarbazine - 3-9 g/m2that, studies have shown A.T.Meadows et al.(1989), increases the risk of second neoplasms. Despite the fact that in our study, 60 patients of groups 1 and 2 (72,3%) cytotoxic loads were significantly reduced 5-year treatment outcomes (overall survival OS for the entire cohort treated equal for 93.4% with event free survival (EFS - 80,1%) can be considered satisfactory. However, there were a large number (12%) failures in the primary treatment, which, presumably, was the cause of the decline in event-free survival. Significant "RA the Bros" in figures in survival between the groups at risk, and, as is known, an indication of the imperfection of the principles of stratification of risk groups. Given the fact that almost half of the relapses occurred in non-irradiated lymph areas, the question as to the adequacy of the staging system, and the need to use in the stratification of risk groups larger number of prognostically significant factors.

In the present invention proposes a fundamentally new approach to the treatment of children and adolescents with Hodgkin's lymphoma.

The technical result of the invention is to optimize the treatment and reduction treatment loads in patients with early forms of the disease using risk-adapted Protocol Spbl-05.

When developing the original Protocol Spbl-05, we were guided by two factors: the use of inductive chemotherapy schemes that do not contain anthracyclines and alkylating cytostatics (or reduce their use to a minimum), and the desire to optimize the system randomization at risk by taking into account a larger number of prognostic factors. Was elected circuit VBVP, which, in our opinion, was sufficient to the task. "Weak point" of this scheme was the need to use relatively large total doses of bleomycin (90 mg/m 2in patients with 3 risk groups) and the lack of efficiency in 3-risk group. In this regard, in the latest version of the Protocol in patients 2 and 3 risk groups in alternating mode used VBVP and ABVD.

Certain changes took place in the system of stratification of risk groups. The latest forecast model (RF patent for the invention №2218861 "Method of optimizing therapeutic tactics with chlamydia in children. Kalugin B.A., Lebedev S. C. date of registration 20.12.03) enables patients as follows: 1 risk group includes 65,8% of patients, 2 - 17.8% and 3 - 16,4%, while when using the principles of stratification adopted in the DAL-HD, these figures are equal to 32.5%, 39.8% and 27.7 per cent respectively. In other words, the proposed system of stratification is twice the number of patients in group 1 (65,8% vs. 32,5%) and almost twice reduces the number of patients 3 groups (16.4% of vs. 27,7%). From this it follows that a greater number of patients significantly reduced cytotoxic load.

In the Protocol used stratified randomization. Stratification of risk groups is carried out depending on the values of the prognostic index (PI), emerging with regard to 6 signs (aged 10 years, the number of affected zones 4 or more, the size of the largest conglomerate of 5 cm or more and/or MIT more of 0.333, stage IV disease, the presence of common the symptoms and biological activity). It was slightly modified and the determination of the biological stage of the disease, because according to our data a significant impact on long-term results had only the values of the ESR, albumin level and anemia.

Patients randomizers into groups of low (group 1, P=0-2), intermediate (group 2, PI=3-4) and high (group 3, PI=5-6) risk, which determines the number of cycles inductive chemotherapy: patients of the 1st group risk (0-2 unfavorable prognostic signs) is 2 cycles of chemotherapy according to the scheme VBVP, 2 risk groups (3-4 symptom) to 4 cycles in alternating mode (VBVP-ABVD-VBVP-ABVD), 3 risk groups (5 or more symptoms) to 6 cycles in alternating mode (VBVP-ABVD-VBVP-ABVD-VBVP-ABVD). To consolidate remission after 2 weeks after drug therapy with normalization of blood counts is the exposure of all previously affected areas. SOD-specific lymphatic zone depends on the completeness of remission after drug therapy: when the achievement of complete remission in the lymph area or when reducing the size of the conglomerates in the PCT 75% or more of the original tumor SOD is typically 25 Grams, while the regression of a tumor less than 75% of 30-36 Gy; SOD to the lungs and liver - 12-15 Gr.

The objective of the invention was to develop a reliable determination of the scope of the treatment program, is to avoid "pereuchivaniya" patients while maintaining high survival rates.

For a better understanding of the essence of the invention claimed below is specific information about the use of this treatment program compared to the program DAL-HD.

Significant differences in survival rates depending on the applied Protocol is not marked: OS, DFS and EFS in the group "DAL-HD" was

94,9%, 90.9% 78,4%. in the group "Spbl-05" - 94,3%and 88.6% and 85.3%, respectively (log-rank test of 0.5-0.6).

Table 1 presents the performance of 3-year survival depending on the treatment Protocol and risk groups.

As can be seen in table 1, OS 1-th risk when using Protocol DAL-HD reached 100%, in the 2nd - 96,7%, 3rd - 87,0% at relapse-free survival (DFS) 88,0%, 95.6% of and 84,6% and EFS 84.4 per cent, 81,1% and 72.7%, respectively. Overall and disease-free survival in the 1st and the 2nd groups at risk when using Protocol Spbl-05 has reached 100%, in the 3rd - scores were equal to 83.1% and 60.3 percent, respectively. EFS in the 1st, 2nd and 3rd groups was of 92.9%, 100% and 53.8%, respectively.

Survival rates in the groups with low and intermediate risk indicate the validity of the proposed principles of stratification. Undoubtedly, the increase in the number of observations will make some adjustments in therapeutic tactics, which, in our opinion, will primarily affect 3 risk groups in which the number of patients will surely need in the early escalation of therapy (MEASOR, high the dose chemotherapy with hematopoietic stem cell transplantation).

Our approach to stratification of risk groups can reduce the medical burden (as cytostatic and radiation) on the child's body, which likely will reduce the risk of developing petticoating and radiation effects (the second tumor, cardiomyopathy, reduced fertility).

To enhance the specification of our proposals here are clinical examples:

1. Elena 3., 16, Hodgkin's lymphoma with lesions of the cervical-supraclavicular, intrathoracic and parietally lymph nodes (III AA senior). In accordance with the principles of stratification Protocol DAL-HD-90, the patient identified 2-I-risk group that requires 4 cycles of chemotherapy. However, using the prognostic index Protocol Spbl-05, the girl assigned to the 1st group risk, and therefore held 2 cycles of chemotherapy according to the scheme VBVP (without the use of alkylating drugs) and consolidating the irradiation of the affected areas in SOD-25 Gr. When observed within 2.5 years after completion of the treatment program, relapse, late complications are not detected.

3. Natalia R., age 4, Hodgkin's defeat of the nasopharynx, left cervical-supraclavicular, paraaortal lymph nodes, spleen (IIIS Century Art.). The treatment program was conducted according to the Protocol DAL-HD-90 and consisted of 6 cycles of chemotherapy (2 ORR and 4 CORR) and irradiation Shea is about-supraclavicular and paraaortal zones in SOD - 36-38 Gr (3-I-risk group). The amount of alkylating drugs amounted to 3, the total dose of cyclophosphamide - 4.8 g/m2, procarbazine - 9 g/m2. After 6 years after treatment diagnosed induced by cytostatics nelimpoblastny acute leukemia. When using our principles of stratification of the patient belonged to the 2nd group risk and would have received 4 courses of chemotherapy with single-agent alkylating action (dacarbazine).

A method of optimizing therapeutic tactics with Hodgkin's lymphoma in children and adolescents, including the detection of these adverse prognostic factors as: age more than 10 years, stage IV disease, the size of the conglomerate of more than 5 cm and/or value mediastinal-thoracic index more than 0.33, the number of affected areas more than 4 symptoms of intoxication and biological activity of the process, with subsequent determination of the three risk groups according to the amount of unfavorable factors, characterized in that in the first group when identifying 0-2 factors hold 2 cycles of chemotherapy according to the scheme VBVP, in the second group, with 3-4 risk factors - 4 cycle in alternating mode VBVP-ABVD-VBVP-ABVD in which cumulative dose of dacarbazine and doxorubicin is 750 and 100 mg/m2accordingly, in the third group with 5-6 risk factors 6 cycles in alternating mode VBVP-ABVD-VBVP-ABVD-VBVP-ABVD, the ri which cumulative dose of dacarbazine and doxorubicin is 1125 and 150 mg/m 2respectively; 2 weeks after completion of chemotherapy in all groups carry out the irradiation of all previously affected areas where SOD is 25 Grams, while achieving complete remission in the lymph area or when reducing the size of the conglomerates as a result of chemotherapy on 75% or more of the original tumor, and 30-36 Gy in regression of a tumor less than 75%.



 

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