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In the field of urological male germline tumors, multiple clinical trials have confirmed the excellent clinical efficacy
of immune checkpoint inhibitors (ICIs) in urothelial carcinoma (UC), renal cell carcinoma (RCC) and prostate cancer (PCa).
。 However, due to the particularity of the mechanism of action of immunotherapy, clinicians need to have a more complete and in-depth understanding of the selection of treatment indications, the specification of medication regimens, the evaluation of efficacy and the management of related adverse reactions to ensure that patients maximize the benefits of clinical efficacy and quality of life in immunotherapy
.
Therefore, the Urology Health Promotion Branch of the China Medical Promotion Association and the Urology Professional Committee of the Chinese Research Hospital Association formulated this consensus on diagnosis and treatment safety, hoping to escort
the clinical application of immunotherapy in the population of urogenital tumors 。 The consensus focuses on the guarantee of conditions, patient management, selection of the indicated population, efficacy evaluation, monitoring and management of related adverse reactions, and the treatment of complications/unexpected events.
Clinical implementation of the operation
>>>>
Contraindications to immunotherapy
Absolute contraindications: contraindicated
in patients with hypersensitivity to the active ingredient or any excipient.
Relative contraindications: (1) Hepatic insufficiency: it is not recommended for moderate/severe patients, and mild patients should be used with caution under the guidance of a doctor; (2) Renal insufficiency: severe patients are not recommended, mild/moderate patients should be used with caution under the guidance of a doctor; (3) Children and elderly patients ≥ 70 years old should be used
with caution under the guidance of a doctor.
>>>>
Safety assessment before and during treatment
ICI-related side effects can affect multiple organs
of the body.
Therefore, patients should undergo a comprehensive and systematic pre-medication baseline assessment, combined disease status monitoring assessment, concomitant drug and drug interaction evaluation, and graded evaluation
of related toxic and side effects after medication.
Table 1 Immunotherapy baseline evaluation table Note: CT: computed tomography; BNP: type B natriuretic peptide; TSH: thyroid-stimulating hormone; T4: thyroxine; ACTH: adrenocorticotropic hormone
.
The consensus recommends that
special attention should be paid to the baseline status and treatment changes of each important organ of patients before clinical application and during medication.
It is recommended to pay special attention to the time point differences of immunorelated toxicity in different organs, adjust the safety evaluation interval time nodes according to different affected organs during follow-up, and evaluate the functional status of each organ through the tumor MDT team if necessary, so as to maximize the safe use
of immunotherapy.
>>>>
Efficacy assessment
Evaluation criteria for immunotherapy efficacy: The principles of tumor evaluation before and during immunotherapy are based on the efficacy evaluation criteria (irRECIST)
for immune-related solid tumors.
For baseline assessment, the definition, localization, and quantification of target and non-target lesions, measurable and non-measurable lesions, and total tumor burden should be clarified and documented
in accordance with the Criteria for the Evaluation of Immune Efficacy of Solid Tumors (iRECIST).
Table 2 Immunotherapy baseline assessment table Note: PD: disease progression; SLD: the sum of the length and diameter of the target lesion; iUPD: progress to be confirmed; irPD: progression
of immune-related diseases.
Quality of life assessment: It is recommended to conduct a quality of life assessment every 3~4 weeks, and the commonly used assessment scales include cancer treatment function assessment - Disease-Related Symptom Scale (FKSI-DRS), European Organization for Cancer Research and Treatment of Cancer Patients Quality of Life Measurement Table (EORTCQLQ-C30), European five-dimensional health scale level 3 version (EQ-5D-3L), etc
.
The consensus recommends that patients with urogenital tumors receiving immunotherapy need to assess tumor baseline and treatment response according to iRECIST criteria, tumor control and quality of life improvement are equally important, and all experts recommend that
routine assessment
of patients' quality of life should be completed regularly during treatment.
Management of adverse immunoreactions
>>>>
Adverse reaction assessment
Common adverse immunotherapy adverse reactions include kidney, skin/mucous membrane, endocrine/metabolic, gastrointestinal/liver, lung, heart, nerve/muscle and blood-related adverse reactions, the degree of which can be evaluated according to international practice using the Common Adverse Reaction Efficacy Evaluation Standard (CTCAE) version 5.
0, and its clinical manifestations and treatment are detailed in the original text
.
The consensus recommended that immunotherapy-related toxicity reactions focus on prevention, and consensus experts unanimously agreed that it is strongly recommended
to do a good job in the pre-treatment baseline assessment and regular monitoring of various related treatments during treatment, so as to detect abnormalities as soon as possible and deal with
them in time 。 Most consensus experts believe that, in principle, once grade 2 or above toxicity occurs, patients should be advised to suspend the use of immunotherapy drugs; All consensus experts agreed that once a grade 4 toxicity occurs, even if it is completely recovered after treatment, in principle, it is recommended to permanently stop immunotherapy without special circumstances; Most experts emphasize that in the event of grade 3~4 toxicity, personalized treatment plans
should be given to the corresponding clinical department of the affected organ system or through MDT.
>>>>
Adverse reaction monitoring
General principle: Through clinical manifestations, imaging examinations, laboratory tests, etc.
, regularly monitor the change process of adverse reactions, the patient's disease remission/progression and complications
.
Specifically, it includes the following: (1) General situation: clinical symptoms and adverse events should be evaluated
at each follow-up.
(2) Imaging examination: during immunotherapy, repeat chest, abdomen and pelvic CT every 4~6 weeks; Brain MRI is repeated every six months to 1 year, and patients with bone metastases are recommended to undergo full-body bone scans
every six months.
(3) General hematology test: during immunotherapy, re-examination once in 2~3 weeks, followed by re-examination every 6~12 weeks (blood routine, biochemistry, etc.
).
(4) Skin/mucous membrane: Skin and mucous membrane examination
are performed at each ward round or outpatient visit.
(5) Pancreas: if there are no symptoms, routine monitoring is not required; If symptomatic, prompt imaging of
blood, urine amylase, and pancreas.
(6) Thyroid: During immunotherapy, thyroid function tests (TFTs) are reviewed every 4~6 weeks, and then every 12 weeks
.
(7) Adrenal glands and pituitary glands: During immunotherapy, 2~3 weeks to recheck morning plasma cortisol, adrenocorticotropic hormone (ACTH), TFTs, followed up every 6~12 weeks
.
(8) Lung: During immunotherapy, recheck blood oxygen saturation every 4~6 weeks, and routine lung imaging examination
.
(9) Cardiovascular: During immunotherapy, review ECG/myocardial enzymatic indexes every
2~4 weeks.
(10) Rheumatoid / skeletal muscle: if asymptomatic, no routine monitoring is required; If there is a medical history, perform joint examinations/functional evaluations
occasionally.
>>>>
Immunotherapy in special populations
Patients with autoimmune diseases: these patients require close monitoring while receiving immunotherapy; Before initiating immunotherapy, reduce the dose
of prednisone.
Patients with autoimmune neurological disease or life-threatening conditions, as well as those whose condition cannot be controlled by immunosuppressive drugs, are not candidates for immunotherapy
.
Patients with a history of viral hepatitis: patients with hepatitis B and C can safely use immunotherapy within the scope of ensuring the safety of liver function, but should be used
with caution if severe liver function damage occurs.
Patients who have undergone hematopoietic stem cell/organ transplantation: these patients are potential to avoid immunotherapy, but there have been reports of graft-versus-host disease (GVHD) or transplant organ failure from immunotherapy, so the risks
of treatment should be discussed with the patient and transplant surgeon before initiating immunotherapy.
Pregnant patients: immunotherapy in these patients may disrupt immune tolerance, leading to an increased
risk of miscarriage, stillbirth, and neonatal death.
Patients who switch immunotherapy: these patients may increase the incidence
of irAEs.
Ill-appearing patients: these patients have limited benefit from immunotherapy and should be used
with caution.
Elderly patients: At present, there is no clear limit on the age of clinical trials, and it is necessary to choose
carefully according to the toxicity of different immunotherapy drugs.
People living with HIV: Patients with a history of HIV may be a potential demographic for immunotherapy, but immunotherapy increases the risk of
inflammatory cytokine syndrome caused by Castleman's disease and Kaposi's sarcoma-associated herpes.
Immunization patients: live vaccination
during immunotherapy is not recommended.
Patients with common diseases such as hypertension and diabetes: clinical data are limited, and chronic diseases need to be standardized and used
with caution.
The consensus recommends that special populations that
determine the physiological/pathological immunosuppressive state need to be particularly cautious when receiving immunotherapy due to the special mechanism of immune checkpoint inhibitor immunotherapy, and fully evaluate the suitability for immunotherapy through the tumor MDT team when facing special populations with the above characteristics.
Immunotherapy
is administered under close surveillance.
References: Urology Health Promotion Branch of China Association for the Promotion of Medical Medicine, Urology Professional Committee of Chinese Research Hospital Association.
Safety consensus of PD-1/PD-L1 immune checkpoint inhibitors in clinical application of urogenital tumors[J].
Modern Journal of Urology,2022,27(1):7-15.
Editor: Mumu WangReview: LR Executive: Xiaoyuan
