Guidelines for clinical application of new anti-tumor drugs (2020 edition), covering 9 major cancerous tumors and 83 drugs

In order to further standardize the clinical application of new anti-tumor drugs, improve the level of rational use of cancer drugs, ensure the quality of medical care and medical safety, and safeguard the health rights and interests of cancer patients, on December 29, 2020, the National Health and Health Commission issued the Guidelines for the Clinical Application of New Anti-Tumor Drugs (2020 edition).
Principles, the clinical application of anti-tumor drugs needs to consider the three major factors of drug accessability, patient's willingness to treat and disease prognostication.
the clinical application of anti-tumor drugs is reasonable, based on the following two aspects: whether there are signs of anti-tumor drug application, the choice of varieties and the appropriate drug administration program.
I. Basic Principle 1. The use of anti-tumor drugs can only be referred to after the diagnosis of pathological histology using malignant tumors that have been confirmed by tissue or cytological pathology, or that have been diagnosed with special molecular pathology.
patients who have been clinically diagnosed based solely on their clinical symptoms, signs and imaging results do not have the signs of anti-tumor drug therapy.
, however, for certain tumors that are difficult to obtain a pathological diagnosis, such as pancreatic cancer, the diagnosis may be carried out in accordance with relevant national guidelines or norms.
feature of the use of modern anti-tumor drugs after target testing is the emergence of a number of drugs targeting molecular abnormalities - that is, targeted drugs.
most representative drug is tyrosine kinase inhibitor for abnormal signaling path of the skin growth factor.
, depending on whether targeted testing is required, commonly used small molecule target drugs and large molecule monoclonal antibody drugs can be divided into two broad categories (Table 1).
Table 1 Commonly used small-molecule targeted drugs and large-molecule monoclonal antibody drug diseases need to detect target drugs do not need to detect target drug lung cancer gyfyniolotini ektinifadinida tynosinichtniol Ni'a laitini seredini amedini beva berva beads mono-recombinant human vascular endopenitropheit inhibition suanthinavuliu mono-resistance to paboliju mono-resistance to the degree of valiu mono-anti-Carelli pearl monoanti. Atiliju single anti-ivemos liver cancer Sorafinirig finilunvatrinicarelliju single anti-esophageal cancer Carelli pearl single anti-paboliju single anti-gastric cancer qutoju single anti-apatinavuliu single anti gastrointestinal mesothelioma imatini tini pancreatic neuroendocrine tumor Shonithini Iwimos. Cymdeithan anti-bevasone anti-rigofeni-quinine leukemia i matinida santini lodini i boutini lymphoma litosi mono-vibtosi mono-cydabenamine i bheitini bod zomixindili monoanti-carelliju monoantiju monoanti-zebutinido myeloma boron tsami to nadamine salidam. Shazomidaretoiu mono-anti-bone marrow proliferatone disease reed cantini kidney cancer ivemossolafynisunitini achtinimpani cympanympani lunvatini rotini paboliju single anti-navuliyu mono-anti-ometrobe single anti-Ionitoni monoanti-anti-lapatini cinnaini. Lisidabenamine melanoma imatiniwimofynida lafynitone methini paboliju single anti-tripri single anti-nodule sclerosis-related cytocytoplasmic cell tumor ivemos nodule sclerosis-related nephrovascular smooth fibroids ivemos bone cytoblastoma smouldering anti-adenoidal carcinoma antrotini transparent cell sarcoma Tini other advanced soft tissue sarcoma atrotini nasopharyngeal cancer nitojuda monoantithroid anti-thyroid cancer sorafini head neck squamous cell carcinoma sitoxysydd anti-navuliyu monoantitor ovarian cancer Olapalinilapali: the EGFR mutation and APK fusion patients need to be excluded.
PD-L1 expression before using The Paboli Pearl Monoantigen.
for drugs with a clear target, the principle of target testing must be followed.
equipment, diagnostic reagents and testing methods used for testing shall be approved by the State Drug Administration, especially those that have been accompanied by diagnostic verification.
may not be used blindly without the relevant examination.
3. Strict adherence to the drug instruction manual for the clinical application of anti-tumor drugs is the legal basis for the clinical application of anti-tumor drugs, and the prescribed certificate of adaptation has been approved by the State Drug Administration.
of anti-tumor drugs should follow the drug instruction manual, can not be used at will over-adaptation certificate.
In the course of the clinical application of anti-tumor drugs, if new high-level evidence-based medical evidence is found but not reflected in the drug instruction manual, medical institutions and medical personnel may give timely feedback to the drug manufacturers, and suggest that they take the initiative to declare to the state drug regulatory department and update the corresponding drug instructions in a timely manner to ensure the scientificity, authority and effective guidance of the drug instructions.
, especially those with conditions for rapid approval of drugs on the market, should ensure the estration of the drug instructions.
value of patient treatment Modern clinical oncology attaches great importance to the therapeutic value of patients with malignant tumors.
the core idea is to enable patients to live longer and have a better quality of life at the same cost of treatment.
in the clinical application of anti-tumor drugs, full consideration should be given to the cost-effect ratio of anti-tumor drugs, giving preference to drugs with high drug evaluation and cost-effect ratio.
5. The rational use of drugs under special circumstances With the rapid development of clinical practice of cancer treatment, the current market of anti-tumor drugs can not fully meet the drug demand of cancer patients, drug instructions often lag behind clinical practice, some use with high-level evidence-based medical evidence can not be clearly defined in the drug description.
under special circumstances such as the lack of better treatment methods, medical institutions shall formulate corresponding management systems and technical norms to strictly regulate the use of drugs that are not clear in the drug specification but have evidence-based medical evidence.
special circumstances, the right to use anti-tumor drugs should be limited to physicians with senior professional and technical title authorized by the third-level hospital, fully follow the principle of informed consent of patients, and should do a good job of drug monitoring and follow-up observation.
In exceptional cases, evidence-based medical evidence for anti-tumor drugs is adopted on the basis of: the use indicated in the drug specifications of other countries or regions, the international authoritative associations or organizations issued norms of diagnosis and treatment, clinical guidelines, national academic associations issued by the National Health Council approved norms of diagnosis and treatment, clinical guidelines and clinical pathways.
. Attention to drug-related adverse reactions anti-tumor drugs related toxic side effects have a higher rate, but also prone to rare toxic side effects, so anti-tumor drug adverse reactions report is particularly important.
medical institutions shall establish a system for monitoring and reporting adverse drug reactions and drug damage incidents and report them to relevant departments in accordance with the relevant provisions of the State.
medical institutions should incorporate reports of adverse reactions of anti-tumor drugs into the medical quality assessment system, and regularly analyze and report on the dynamics and trends of adverse reactions of anti-tumor drugs.
clinicians and clinicians should closely follow the patient's drug-related toxicity and promptly report adverse reactions, especially serious and newly discovered adverse reactions.
II, the new anti-tumor drug guidelines involved in the new anti-tumor drugs mainly include: Part II of the clinical application of drug clinical application guidelines for systemic tumors respiratory tumor medication I, gyfytini Gefitinib preparations and specifications: tablets: 250 mg adaptation certificate: the topical growth factor (EGFR) gene with sensitive mutations of local late stage or metastasis non-small cell lung cancer (NSCLC).
point of rational drug use: 1. Before taking the drug, it must be clear that there is an EGFR sensitive mutation detected by the EGFR gene testing method approved by the State Drug Administration.
2. Tumor tissue and blood can be used for EGFR gene mutation detection, but tissue testing is preferred.
3. When the drug is insulable due to drug toxicity during treatment, it may be replaced between the same generation of drugs, or between the same generation of drugs if the disease progresses.
4. In patients where imaging shows slow progress during treatment but clinical symptoms do not worsen, the original drug may continue to be used, patients with local progression may continue to use the original drug plus local treatment, and for patients with rapid progress, it is recommended to switch to other treatment options.
(This standard also applies to other EGFR tyrosine kinase inhibitors, ALK tyrosine kinase inhibitors and ROS1 tyrosine kinase inhibitors) 5. Attention must be paid to common skin mucosa reactions and diarrhea during drug use;
. Avoid using in union with CYP3A4 strong inducers or strong inhibitors.
taking wahfalin should regularly monitor the original time of coagulation enzymes or changes in INR.
drugs that significantly and consistently raise the pH of the stomach fluid may reduce the blood concentration of gifetinib, thereby reducing the efficacy of gifetinib.
. In some acute cases of tumor, such as brain metastasis coma or respiratory failure, non-smoking lung adenocarcinoma patients may be considered for use with full knowledge.
once the condition is in remission, tissue or blood tests for EGFR mutations must be performed.
(This standard also applies to other EGFR tyrosine kinase inhibitors) II, Elotini Erlotinib preparations and specifications: tablets: 150mg adaptation certificate: EGFR gene with sensitive mutations of local late stage or metastasis NSCLC.
point of rational drug use: 1. Before taking the drug, it must be clear that there is an EGFR sensitive mutation detected by the EGFR gene testing method approved by the State Drug Administration.
2. Tumor tissue and blood can be used for EGFR gene mutation detection, but tissue testing is preferred.
3. Patients with NSCLC with mutations in the EGFR gene with brain metastasis may consider using erotinib.
4. Attention must be paid to common skin mucosa reactions and diarrhea during medication.
special attention should be paid to the occurrence of interstitia pneumonia, abnormal liver function and eye symptoms.
. Avoid using in union with CYP3A4 strong inhibitors or strong inducers.
avoids the use of erlotini and drugs that significantly and continuously raise the pH of the stomach fluid.
6. Smoking can lead to reduced exposure to erlotini, and patients are advised to quit smoking.
. In the United States, Erlotini was approved to be used in the first-line treatment of locally advanced, incapactionable or metastatic pancreatic cancer in a joint manner with Gisithambin, and this adaptation certificate has not yet been approved in China and can be used in full communication with the patient.
usage is l00mg, once per person.
, Ektini Icotinib preparations and specifications: tablets: 125 mg adaptation certificate: EGFR gene has sensitive mutations of local late stage or metastasis NSCLC.
point of rational drug use: 1. Before taking the drug, it must be clear that there is an EGFR sensitive mutation detected by the EGFR gene testing method approved by the State Drug Administration.
2. Tumor tissue and blood can be used for EGFR gene mutation detection, but tissue testing is preferred.
patients with mutations in the EGFR gene with brain metastasis can choose ektinib first.
. Adverse reactions are mainly common I, II. degree rash and diarrhea, should pay special attention to the occurrence of interstitity pneumonia.
5. Ektinib is mainly metabolized by CYP2C19 and CYP3A4 of the CYP450 system, which have obvious inhibitory effects on CYP2C9 and CYP3A4, and should pay attention to potential drug interactions when combined with the metabolase inducer and substrate drug.
IV, Afatinib Afatinib preparations and specifications: tablets: 30 mg, 40 mg adaptive certificate: 1. Local late stage or metastasis NSCLC with sensitive mutations of the EGFR gene, has not been treated with EGFR tyrosine kinase inhibitors (EGFR-TKI).
2. NSCLC of the local late stage or metastasis scaly histological type of disease progression during or after platinum chemotherapy.
Points for Rational Drug Use: 1. For patients with advanced NSCLC who are treated with EGFR gene-sensitive mutations, the EGFR gene-sensitive mutations detected by the EGFR gene testing method approved by the State Drug Administration must be clearly identified before administration.
tumor tissue and blood can be used for EGFR gene mutation detection, but tissue testing is preferred.
2. Although the drug instructions indicate that aphatinib does not require genetic testing for second-line treatment of patients with advanced pulmonary squamous cell carcinoma that progresses during or after platinum chemotherapy, it is still not recommended for patients with EGFR gene mutations that are negative.
. For patients with EGFR gene mutations, priority is given to the use of afatinib.
. The recommended dose is 40 mg, once a day, according to the patient's tolerance dose adjustment, dose adjustment program see Table 2.
Table 2 Afatini recommended dose adjustment program CTCAEa (4.0 version) drug-related adverse events Afatini recommended dosage of 1 to 2 levels without interruption b does not interrupt b does not adjust dose level 2 (extended c or insatiable) or ≥3 level interruption until it is restored to 0/1 level b to reduce the amount of 10 mg recurring continue to da National Cancer Institute (NCI) adverse event generic term 3.0 version.
b diarrhea occurs, anti-diarrhea drugs (e.g. loperdamine) should be used immediately and should continue to be used in cases of persistent diarrhea until the diarrhea stops.
c diarrhea > 48 hours and/or rash > 7 days.
d If the patient is not able to withstand 20 mg per day, consider permanently deactiving this product.
30 mg as the recommended dose for patients rated as poorly toered by clinicians.
6. Afadinini should not be taken in the same way as food, at least 3 hours after eating or at least 1 hour before eating.
. During drug use, attention must be paid to diarrhea, skin-related adverse reactions, interstitity pneumonia and other adverse events.
. If P-glycoprotein (P-gp) inhibitors are required, staggered doses should be used to maximize the interval between those given with afatinin.
P-gp inhibitors should be given between 6 hours after afatinib is given (P-gp inhibitors are given twice a day) or 12 hours (P-gp inhibitors are given once a day).
. Afatinib is not metabolized through the CYP enzyme system, and in-body test studies have shown no significant effect on the exposure of aphatinib when used in association with CYP inhibitors or inducers.
10. This product contains lactose and should not be taken in patients with rare hereditary semi-lactose insulation, lactase deficiency, or poor glucose-semi-lactose absorption.
, Dacotini Dacomitinib preparations and specifications