GB 16386-1996 Judgment criteria and treatment principles for radiation-induced tumors
Some standard content:
National Standard of the People's Republic of China
Diagnostic criteria and principles of management of radiogenic neoplasms1 Subject content and scope of application
GB16386—1996
This standard specifies the criteria and principles of management of radiogenic neoplasms. Radioactive neoplasms refer to malignant tumors that occur after exposure to ionizing radiation and have a certain degree of etiological connection with the exposure. This standard is applicable to the etiological judgment of radioactive neoplasms that occur after occupational exposure. Malignant tumors that occur after non-occupational exposure can also be judged with reference to this standard. Malignant tumors that occur after voluntary medical exposure are not within the scope of application of this standard. 2 Basis for judgment
2.1 There is a history of exposure to a certain dose of certain radiation and exposure dose data. 2.2· The following specific types of primary malignant tumors occur after a certain latent period of exposure and are clinically confirmed. 2.2.1 Lung cancer that occurs after exposure to ammonia. 2.2.2 Leukemia (except chronic lymphocytic leukemia), thyroid tumor and breast cancer (female) after exposure to X-ray or radiation.
2.2.3 Bone malignant tumor after exposure to radium-226α radiation. 2.3 According to the patient's gender, age at exposure, onset latency and exposure dose, calculate the probability of causation (PC) of the malignant tumor caused by the exposure according to the methods listed in Chapter 3 and Appendix A. 2.4 PC ≥ 50% can be judged as a radioactive tumor. 3 Calculation of the probability of causation of radiation-induced malignant tumors 3.1 To calculate the probability of causation (PC), the relevant medical departments and professional dose monitoring departments need to provide the following information: 3.1.1 The patient's name, gender, age, tumor diagnosis (including cytological type), cancer diagnosis basis, diagnosis date and diagnosis unit. 3.1.2 The absorbed dose of the target organ when the person was exposed to the relevant radiation, the type of radiation received, the irradiation conditions, the start time of irradiation and the duration of irradiation obtained from the personal dose file or relevant records. When there is occupational exposure to chemical carcinogens, the type, exposure level and exposure time of the carcinogens should be explained.
3.2 Based on the above information, use the calculation method and parameters provided in Appendix A to calculate the PC of the cancer caused by previous radiation. 3.3 When diagnosing a certain occupational cancer caused by occupational exposure to combined chemical carcinogens, the PC of the combined exposure can be calculated using the respective risk factors according to the additive model.
4 Judgment of occupational radiation tumors
4.1 Radioactive tumors caused by occupational radiation can be diagnosed as occupational radiation tumors. 4.2 When occupational radiation is combined with occupational chemical carcinogen exposure, the relative contribution of radiation-induced cancer to the increased risk is greater than 1/2, and the total cause probability PC ≥ 50% is also diagnosed as occupational radiation tumors. 4.3 The diagnosis of occupational radiation tumors shall be conducted by the radiation disease diagnosis team of the province, city or autonomous region or its entrusted unit. Approved by the State Bureau of Technical Supervision on May 23, 1996 338.
Implemented on December 1, 1996
5 Principles for the treatment of radiation tumors
GB16386—1996
According to the type, type and development stage of the malignant tumor, the same methods as for similar general tumors should be adopted for active treatment and management. 339
A1 Calculation method of etiology probability
GB16386-1996
Appendix A
Calculation method of etiology probability, calculation parameters and calculation examples (supplement)
The etiology probability PC represents the possibility that a tumor suffered by an individual is caused by a certain dose of radiation received in the past. It is the ratio of the increase in tumor probability after a certain dose of radiation to the total probability of cancer. It is calculated using the relative risk increase value R of cancer: PC = R/(1 + R)
R=F×TXK
(1)
F-F(D): is the irradiation factor, which is a function of the absorbed dose D. For external irradiation, the average target organ absorbed dose cGy(rad) is taken. For chronic irradiation, the annual average target organ absorbed dose over the years during the irradiation period should be provided. Thyroid cancer and breast cancer conform to the linear dose-effect model, so FD; leukemia conforms to the linear square model, F=D+D/116. The hydrogen daughter F is expressed in WLM, and the annual cumulative WLM values are given. 1WLM=170WL·h=3.5×10-3J·hm-3. When the oxygen daughters are also exposed to low-LET radiation, such as radiation exposure in mines, the low-LET radiation dose can be converted to WLM according to 6cGy=1WLM and then added to the cumulative WLM of the hydrogen daughters, and PC is calculated according to the total WLM.
T-T(Y): is the latent period correction factor, which is the possibility of being diagnosed after Y years of exposure. For lung tumors, thyroid and breast cancer, when diagnosed 0-4 years after exposure, T=0, 5-9 years are 0.074, 0.259, 0.500, 0.741, 0.926 respectively, and more than 10 years is T=1.0. The T(Y) of chronic myeloid leukemia is given by A2.2. The T value of acute leukemia is related to the age of exposure, A, and T(At,Y) is given in A2.3.
K=K(A1,S): is the relative risk increase coefficient for the occurrence of the tumor when the age is A, and the sex is S (male m, female 1). When F-1,T=1, K=R. A2.1 gives the K(A,S) values for thyroid tumors and breast cancer (female). The K value of leukemia also depends on the age at diagnosis, Az, and is calculated from the formula K=E/I. E=E(A,S) is the increased probability of cancer when the sex S is exposed to F=1 at age A, and I=I(Az,S) is the baseline incidence of the cancer when the sex S is diagnosed at age A2. E(A,S) and I(A2,S) are given in A2.2 and A2.3. K for oxygen-induced lung cancer takes a constant value of 0.015WLM-1. When receiving multiple exposures, such as two exposures with doses of D1 and D2, the interaction model is used, and the total relative risk increase is the sum of the relative risk increases of each, that is,
R(Di,D,) = R(D) + R(D2)
(3)
This method is also used to calculate the PC of chronic occupational radiation carcinogens: in units of years, take one exposure equivalent to the annual cumulative dose each year, add up the R values obtained in previous years, and use formula (1) to calculate the PC of all exposures. When the exposure D is combined with the chemical factor Z, the total R value is also calculated according to the additive model R(D,Z) = R(D) + R(Z)
(4)
The risk increase coefficient of the compounded chemical carcinogen (Z) cannot be given in the appendix of this standard and needs to be provided through other means.
When compounding voluntary exposure, the carcinogenic contribution of voluntary exposure should be deducted, and the PC of involuntary exposure under compound voluntary exposure is given by the method of handling two exposures in reference material A2.7 (1). The parameters for calculating PC listed in Tables A1 to A4 include common age groups and time groups. If the given limits are exceeded, the parameters for all age groups and time groups can be obtained from the reference materials listed in A2.7. A2 Parameters and calculation examples for calculating the probability of etiology A2.1 Parameters and calculation examples for calculating the probability of etiology of thyroid cancer and breast cancer. 340
Age of exposure
GB16386-1996
Table A1 Parameters K(A,,S) for calculating PC of thyroid cancer and breast tumor [Thyroid cancer is taken from reference (1) given in A2.7, breast tumor is taken from reference (2)] Thyroid cancer
Breast cancer
0.011 748
0.009 370
0.004 261
0. 002 664
Age of exposure
GB 16386—1996
Continued Table A1
Thyroid cancer
0. 007 86
0. 007 63
0. 007 52
Breast tumor
0.001 936
0.001 866
0. 001 711
0.001 262
Calculation example 1: Male (m), 25 years old, thyroid gland was irradiated with 25cGyY line, 33 years old, 8 years later, diagnosed with thyroid tumor. Calculate the probability of the cause from the irradiation.
F(D)=F(25)25 (Linear dose model)T(Y)=T(8)0.741(From A1)
K(A,S)=K(25, male)=0.0139 (From Table A1)RF×T×K=25×0.741×0.013 9=0.26PCR/(1+R)=0.26/(1+0.26)0.206=20.6% Calculation Example 2. A female (f) was engaged in radiation work between the ages of 35 and 38. The breast doses received over the years were 4.2, 4.2, 2.0, and 2.0 cGy. She was diagnosed with breast cancer 12 years after she started working at the age of 47. Calculate the probability of the cause being from occupational radiation. Age, years
Dose, cGy
T(12)1.000
T(11)=1.000
T(10)=1.000
T(9)=0.926
R(total)=0.0413+0.0394+0.0174+0.01460.113PC=R/(1+R)=0.113/(1+0.113)0.102=10.2%A2.2 Parameters and calculation example for calculating the probability of the cause of chronic myeloid leukemia. 342
K(A,S)
K(35,f)-0. 009 833
K(36,f)=0.009370
K(37,f)=0.008 702
(38,f)=0.007885
R(FXTXK)
GB16386-1996
Table A2 Parameters T(Y), E(A1,S), I(A2,S) for calculating chronic myeloid leukemia [Taken from reference (1) given in A2.7] T(Y)
0. 046 10
0. 047 20
0. 045 60
0. 040 20
0. 034 70
0. 022 40
0. 018 40
0. 017 20
0. 016 20
0. 015 20
0. 014 40
E(Ar,S)
I(A2,s)
0. 007 71
GB 16386—1996
Continued Table A2bzxZ.net
E(Ar,S)
I(A2,S)
Calculation Example 3: Male, at the age of 30, the bone marrow was irradiated with 10 cGy of X-rays, and at the age of 45, that is, 15 Chronic myeloid leukemia was diagnosed years later. Calculate the probability of causation from radiation exposure.
F(D)=F(10)=10+10°/116=10.86(linear square model)T(Y)=T(15)=0.024(from Table A2)
E(A,S)=E(30,m)=1.05(from Table A2)
I(A2,S)=I(45,m)一1.16(from Table A2)K(At,A2,S)E/I-1.05/1.16=0.905R=F×TXK=10.86×0.024×0.905=0.236PC=R/(1+R)=0.236/(1+0.236)=0.191--19.1%A2.3 Parameters and calculation examples for calculating the probability of the cause of acute leukemia. 344
0. 009 10
0. 004 66
0. 004 20
0. 001 92
0. 001 47
0. 000 972
GB16386-1996
Parameters T(A1,Y) for calculating PC of acute leukemia Table A3
[Taken from reference (1) given in A2.7] A
0. 002 97
0. 001 74
0. 009 12
0. 006 72
0. 005 01
0. 001 41 | | tt | 003 44
0. 002 22
0. 002 12
0. 007 46
0. 004 36
0. 004 06
16386—1996
Continuation Table A3
0. 007 31
0. 006 32
0. 004 77
0. 007 11
0. 008 94
0. 007 27
0. 007 31
0. 004 25
0.000 260
0. 004 26
0. 006 15
0. 004 89
0.004 37
0.000 204
0. 009 90
0 006 02
0. 005 71 | | tt | 0.006 71
0. 009 44 | |tt | 002 50. 000 001 70. 000 00110.000597
0. 000 106 0. 000 076 2 0. 000 054 30.000459
0. 009 60
0. 008 97
0. 003 11
0. 004 47
:t0. 014 7
0.000 588
0. 007 91
GB16386-1996
Table A4 Parameters for calculating PC of acute leukemia E(Ai,S), I(A2,S) [taken from reference material given in A2.7 (1)] E(AS)
I(A,S)References given in 7 (1)]T(Y)
0. 046 10
0. 047 20
0. 045 60
0. 040 20
0. 034 70
0. 022 40
0. 018 40
0. 017 20
0. 016 20
0. 015 20
0. 014 40
E(Ar,S)
I(A2,s)
0. 007 71
GB 16386—1996
Continued Table A2
E(Ar,S)
I(A2,S)
Calculation Example 3: A male, whose bone marrow was irradiated with 10 cGy of X-rays at the age of 30, was diagnosed with chronic myeloid leukemia at the age of 45, i.e., 15 years later. Calculate the probability of the cause being from the irradiation.
F(D)=F(10)=10+10°/116=10.86(linear square model)T(Y)=T(15)=0.024(from Table A2)
E(A,S)=E(30,m)=1.05(from Table A2)
I(A2,S)=I(45,m)一1.16(from Table A2)K(At,A2,S)E/I-1.05/1.16=0.905R=F×TXK=10.86×0.024×0.905=0.236PC=R/(1+R)=0.236/(1+0.236)=0.191--19.1%A2.3 Parameters and calculation examples for calculating the probability of the cause of acute leukemia. 344
0. 009 10
0. 004 66
0. 004 20
0. 001 92
0. 001 47
0. 000 972
GB16386-1996
Parameters T(A1,Y) for calculating PC of acute leukemia Table A3
[Taken from reference (1) given in A2.7] A
0. 002 97
0. 001 74
0. 009 12
0. 006 72
0. 005 01
0. 001 41 | | tt | 003 44
0. 002 22
0. 002 12
0. 007 46
0. 004 36
0. 004 06
16386—1996
Continuation Table A3
0. 007 31
0. 006 32
0. 004 77
0. 007 11
0. 008 94
0. 007 27
0. 007 31
0. 004 25
0.000 260
0. 004 26
0. 006 15
0. 004 89
0.004 37
0.000 204
0. 009 90
0 006 02
0. 005 71 | | tt | 0.006 71
0. 009 44 | |tt | 002 50. 000 001 70. 000 00110.000597
0. 000 106 0. 000 076 2 0. 000 054 30.000459
0. 009 60
0. 008 97
0. 003 11
0. 004 47
:t0. 014 7
0.000 588
0. 007 91
GB16386-1996
Table A4 Parameters for calculating PC of acute leukemia E(Ai,S), I(A2,S) [taken from reference material given in A2.7 (1)] E(AS)
I(A,S)References given in 7 (1)]T(Y)
0. 046 10
0. 047 20
0. 045 60
0. 040 20
0. 034 70
0. 022 40
0. 018 40
0. 017 20
0. 016 20
0. 015 20
0. 014 40
E(Ar,S)
I(A2,s)
0. 007 71
GB 16386—1996
Continued Table A2
E(Ar,S)
I(A2,S)
Calculation Example 3: A male, whose bone marrow was irradiated with 10 cGy of X-rays at the age of 30, was diagnosed with chronic myeloid leukemia at the age of 45, i.e., 15 years later. Calculate the probability of the cause being from the irradiation.
F(D)=F(10)=10+10°/116=10.86(linear square model)T(Y)=T(15)=0.024(from Table A2)
E(A,S)=E(30,m)=1.05(from Table A2)
I(A2,S)=I(45,m)一1.16(from Table A2)K(At,A2,S)E/I-1.05/1.16=0.905R=F×TXK=10.86×0.024×0.905=0.236PC=R/(1+R)=0.236/(1+0.236)=0.191--19.1%A2.3 Parameters and calculation examples for calculating the probability of the cause of acute leukemia. 344
0. 009 10
0. 004 66
0. 004 20
0. 001 92
0. 001 47
0. 000 972
GB16386-1996
Parameters T(A1,Y) for calculating PC of acute leukemia Table A3
[Taken from reference (1) given in A2.7] A
0. 002 97
0. 001 74
0. 009 12
0. 006 72
0. 005 01
0. 001 41 | | tt | 003 44
0. 002 22
0. 002 12
0. 007 46
0. 004 36
0. 004 06
16386—1996
Continuation Table A3
0. 007 31
0. 006 32
0. 004 77
0. 007 11
0. 008 94
0. 007 27
0. 007 31
0. 004 25
0.000 260
0. 004 26
0. 006 15
0. 004 89
0.004 37
0.000 204
0. 009 90
0 006 02
0. 005 71 | | tt | 0.006 71
0. 009 44 | |tt | 002 50. 000 001 70. 000 00110.000597
0. 000 106 0. 000 076 2 0. 000 054 30.000459
0. 009 60
0. 008 97
0. 003 11
0. 004 47
:t0. 014 7
0.000 588
0. 007 91
GB16386-1996
Table A4 Parameters for calculating PC of acute leukemia E(Ai,S), I(A2,S) [taken from reference material given in A2.7 (1)] E(AS)
I(A,S)004 36 | |tt | 008 94
0. 007 27
0. 007 31
0. 004 25
0.000 260
0. 004 26
0. 006 15
0. 004 89
0. 004 37 | |tt | 40. 000 071 70. 000 053 90. 000 040 1 0. 000 029 60.00238
0. 000 981
0.000 769
0. 007 27
0. 006 92
0. 006 27
0. 005 72
0. 006 71
0. 009 44
GB16386-1996
Continued Table A3
0. 000 021 60. 000 015 60. 000 011 10. 000 007 80. 000 005 4 0. 000 003 70. 000 002 50. 000 001 70. 000 00110.000597
0. 000 106 0. 000 076 2 0. 000 054 30.000459
0. 009 60
0. 008 97
0. 003 11
0. 004 47
:t0. 014 7
0.000 588
0. 007 91
GB16386-1996
Table A4 Parameters for calculating PC of acute leukemia E(Ai,S), I(A2,S) [taken from reference (1) given in A2.7] E(AS)
I(A,S)004 36 | |tt | 008 94
0. 007 27
0. 007 31
0. 004 25
0.000 260
0. 004 26
0. 006 15
0. 004 89
0. 004 37 | |tt | 40. 000 071 70. 000 053 90. 000 040 1 0. 000 029 60.00238
0. 000 981
0.000 769
0. 007 27
0. 006 92
0. 006 27
0. 005 72
0. 006 71
0. 009 44
GB16386-1996
Continued Table A3
0. 000 021 60. 000 015 60. 000 011 10. 000 007 80. 000 005 4 0. 000 003 70. 000 002 50. 000 001 70. 000 00110.000597
0. 000 106 0. 000 076 2 0. 000 054 30.000459
0. 009 60
0. 008 97
0. 003 11
0. 004 47
:t0. 014 7
0.000 588
0. 007 91
GB16386-1996
Table A4 Parameters for calculating PC of acute leukemia E(Ai,S), I(A2,S) [taken from reference (1) given in A2.7] E(AS)
I(A,S)
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