Antibody-drug conjugates (ADCs) are a class of targeted biological agents that link cytotoxic drugs to monoclonal antibodies through linkers. The monoclonal antibody targets tumor cells and transports small-molecule cytotoxic drugs for specific delivery and minimal off-target side effects. September 30, 2022, 14 anti-tumor ADC drugs have been approved for marketing in the world, and four ADCs have been approved in China. With the improvement of the clinical accessibility of ADC drugs, clinicians urgently need to understand the molecular characteristics and mechanisms of ADCs, and clarify the indications for rational use of drugs. Patients' survival mainly depends on the appropriate dose and course of treatment and also on proper management of adverse reactions. In view of this, on the basis of the "Expert Consensus on the Clinical Application of Antibody-drug Conjugates for the Treatment of Malignant Tumors (2020 edition)" , Professional Committee on Clinical Research of Oncology Drugs, Chinese Anti-Cancer Association fully combines the existing clinical research evidence and the feasibility of current ADC drugs in China to update the consensus content. This consensus aims to provide a systematic overview of ADC drugs, so as to provide practical and effective suggestions and references for clinicians to apply and manage ADC drugs more accurately.
Humans ; Immunoconjugates/therapeutic use* ; Consensus ; Neoplasms/drug therapy* ; Antineoplastic Agents/adverse effects* ; Antibodies, Monoclonal/therapeutic use*

OBJECTIVETo observe the clinical efficacy and adverse effects of herceptin for advanced Chinese breast cancer patients.

METHODSThirty-one pathologically proved advanced breast cancer women were treated by herceptin. In the first week, a loading dose 4 mg/kg was administered by intravenous infusion and from the second week, a routine dose of 2 mg/kg was given every week for at least 3 months.

RESULTSThere were 2 CR, 6 PR, 7 SD, and 16 PD among 31 patients after treatment by herceptin, the response rate being 25.8%. In factors influencing the prognosis, age and general condition were factors favoring the results, and pathological type, site of metastasis, grade of her-2 over expression and prior treatment were irrelevant to the results. The adverse effects were mild but different from those of the common anticancer drugs.

CONCLUSIONHerceptin is effective and well tolerated by the Chinese breast cancer patients.

Adult ; Aged ; Antibodies, Monoclonal ; adverse effects ; therapeutic use ; Antibodies, Monoclonal, Humanized ; Breast Neoplasms ; drug therapy ; Female ; Humans ; Middle Aged ; Trastuzumab

OBJECTIVETo evaluate the efficacy and safety of ustekinumab in the therapy of plaque psoriasis.

METHODSLiteratures published up to November 2013 were collected from Cochrane library, MEDLINE, and PubMed which were related with ustekinumab for plaque psoriasis. The efficacy was estimated using relative risk of Psoriasis Area and Severity Index (PASI) 75 response rate at the week 12 endpoint in clinical trials, and adverse effects were also analyzed. Meta-analysis was carried out by using Review Manager 5.1.

RESULTSSix randomized control trials consistent with the inclusion criteria were selected and reviewed. Ustekinumab 45 mg group and 90 mg group could get better therapeutic effect compared with the placebo group (all P<0.00001). Furthermore, ustekinumab 90 mg group was more effective than ustekinumab 45 mg group (P=0.01). Adverse effects in the 6 trials were mentioned including headache, upper respiratory tract infection, nasopharyngtis, infection, serious infection, cardiovascular events, and malignant tumors. There were no statistically significant differences of these adverse effects among three groups (all P>0.05), except that infection rate in ustekinumab 45 mg group was higher than the placebo group (P=0.02).

CONCLUSIONSUstekinumab is an effective and safe therapeutic method for plaque psoriasis. However, further longer time analysis of safety is needed.

Antibodies, Monoclonal, Humanized ; adverse effects ; therapeutic use ; Humans ; Psoriasis ; drug therapy ; Randomized Controlled Trials as Topic ; Ustekinumab

Pemphigus is a life-threatening autoimmune blistering disease affecting the skin and mucosa. Patients with severe pemphigus require long-term treatment with corticosteroids and other immunosuppressive drugs, which can lead to serious adverse events. Rituximab, a monoclonal antibody directed against the CD20 antigen of B lymphocytes, has been demonstrated to be effective in recalcitrant and life-threatening pemphigus.
Antibodies, Monoclonal, Murine-Derived ; adverse effects ; therapeutic use ; Antigens, CD20 ; immunology ; Humans ; Pemphigus ; therapy ; Rituximab

Traditional replacement therapy is the main treatment method of hemophilia, while inhibitor generation makes replacement therapy ineffective. The emergence of non-factor therapy brings new hope for the treatment of patients with inhibitor. Non-factor products mainly achieve therapeutic purpose by imitating the function of coagulation factor Ⅷ, inhibiting the function of anti-tissue factor pathway inhibitors, the expression of antithrombin mRNA, and the function of activated protein C. This paper reviews the latest research progress of non-factor products in the treatment of hemophilia.
Antibodies, Monoclonal, Humanized/adverse effects* ; Factor VIII/therapeutic use* ; Hemophilia A/therapy* ; Humans

Objective: To evaluate the efficacy and influencing factors of programmed death protein 1 (PD-1) monoclonal antibody rechallenge therapy in advanced gastric cancer (GC). Methods: The clinical data of patients with advanced GC who were treated with anti-PD-1 rechallenge in Henan Cancer Hospital from January 2020 to December 2021 were collected retrospectively. The progression-free survival (PFS) was defined as the time from the first or second used of anti-PD-1 treatment to the date of disease progression or the last follow-up, named PFS(1) and PFS(2), respectively. Kaplan-Meier method and Log rank test were used for survival analysis, Cox proportional hazard model was used to analyze the influencing factors. Results: A total of 60 patients with anti-PD-1 rechallenge therapy were collected, the median follow-up time was 12.2 months. The median progression-free survival (PFS(2)) of anti-PD-1 rechallenge therapy was 2.9 months, the objective response rate (ORR) was 16.7%, and the disease control rate (DCR) was 55.0%. The median PFS(2) of the first and second anti-PD-1 identical and different rechallenge treatment was 3.5 months and 1.9 months (P=0.007) respectively. The median PFS(2) of positive PD-L1 expression in rechallenge therapy was 3.4 months, ORR was 22.7%, and DCR was 63.6%; the median PFS(2) was 4.5 months, ORR was 27.3%, and DCR was 54.5% in patients with median PFS(1)≥6 months. Multivariate analysis showed that peritoneal metastasis was independently associated with anti-PD-1 rechallenge therapy with PFS(2) (HR=2.327, 95% CI, 1.066-5.082, P=0.034). The incidence of adverse reactions in grade 1-2 and grade 3-4 of anti-PD-1 rechallenge therapy was 83.3%, and 35.0%, respectively, and the safety was controllable. Conclusion: Rechallenge therapy with anti-PD-1 is a feasible treatment in advanced GC, but the screening of suitable population for rechallenge therapy still needs prospective data analysis and verification.
Humans ; Stomach Neoplasms/pathology* ; Retrospective Studies ; Prospective Studies ; Antibodies, Monoclonal/therapeutic use* ; Immunotherapy/adverse effects*

BACKGROUND/AIMS: Infliximab has been shown to be effective and safe for treating refractory luminal and fistulizing Crohn's disease (CD). The aim of this study was to report the efficacy and adverse effect of infliximab therapy in patients with CD at our center. METHODS: Medical records of thirteen patients who were treated with infliximab for refractory luminal or fistulizing CD were reviewed. Clinical response was classified as complete response, partial response and nonresponse. RESULTS: Seven patients were treated for fistulizing CD, four patients for luminal CD, and two for both. The mean time of follow-up was 13.1 months (3.3-28.1 months). Clinical response was seen in 10/13 (77%); complete response 7/13 (54%), partial response 3/13 (23%), nonresponse 3/13 (23%). Mean time to response was 27.1 days (10-41 days). 4 of 10 responders (40%) maintained remission over 30 weeks. Those who started on immunosuppressive treatment more than 3 months before infliximab infusion achieved lower early recurrence rate (14%) compared with those less than 3 months (67%) (p=0.039). Steroid tapering was successful in 7/12 (58%). Five patients required surgical therapy; three nonresponders, one partial responder and one who recurred after initial complete response. Initial responders required less surgery than nonresponders (p=0.035). Acute infusion reactions were seen in 2/40 infusions (5%). One patient developed herpes zoster 20 weeks after infliximab infusion. During follow-up peried, no patient developed serious infection, tuberculosis or malignancy. CONCLUSIONS: Infliximab is effective and safe in clinical practice. Concurrent immunosuppressive use is associated with lower rate of early recurrence.
Adult ; Antibodies, Monoclonal/adverse effects/*therapeutic use ; Crohn Disease/*drug therapy ; Female ; Gastrointestinal Agents/adverse effects/*therapeutic use ; Humans ; Immunosuppressive Agents/therapeutic use ; Male

The aim of this study was to compare the efficacy of rituximab plus CHOP regimen and CHOP regimen on newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL), and analyze their toxicities. A total of 69 patients were enrolled from July 2003 to Dec 2006. The patients were non-randomly were divided into 2 groups: 36 received CHOP alone (CHOP group) and 33 received rituximab plus CHOP (R-CHOP group). The complete response (CR) rates, overall survival (OS) and side events of the 2 groups were compared. The results showed that the CR rate in R-CHOP group was higher than that in CHOP group (69.7% vs 47.2%, p = 0.049); especially in patients of male, Ann Arbor III - IV and IPI 3 - 5 (p = 0.017, p = 0.005 and p = 0.000). The estimated mean OS in R-CHOP group was longer than that in CHOP group (45.7 months vs 35.2 months, p = 0.145), and also in the estimated mean progression free survival (PFS) (38.5 months vs. 24.6 months, p = 0.017). The major adverse events in combination group were infusion-related responses which could be well tolerated in patients, and hematological toxicities which were similar to those in CHOP group. In conclusions, Rituximab increases the therapeutic efficacy of CHOP regimen on newly diagnosed patients with DLBCL, without a clinically significant increase in toxicity.
Adolescent ; Adult ; Aged ; Antibodies, Monoclonal ; administration & dosage ; adverse effects ; Antibodies, Monoclonal, Murine-Derived ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Cyclophosphamide ; adverse effects ; therapeutic use ; Doxorubicin ; adverse effects ; therapeutic use ; Female ; Humans ; Lymphoma, Large B-Cell, Diffuse ; drug therapy ; Male ; Middle Aged ; Prednisone ; adverse effects ; therapeutic use ; Prospective Studies ; Rituximab ; Safety ; Vincristine ; adverse effects ; therapeutic use ; Young Adult

Rituximab, a chimeric monoclonal antibody directed against CD20, has become a part of the standard therapy for patients with non-Hodgkin's lymphoma either in combination with other drugs or as a single agent. The CD20 antigen is expressed on 95% of B-cell lymphoma cells and normal B-cells but, is not found on precursor B-cells or stem cells. Rituximab is now approved for patients with diffuse large B-cell lymphoma when combined with standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisone) or patients with follicular lymphoma who have failed first line chemotherapy. The monoclonal antibody is generally well tolerated. Most of the adverse events are infusion-associated, mild to moderate non-hematological toxicities. Severe respiratory adverse events have been infrequent. Here, we report two patients with non-Hodgkin's lymphoma in whom interstitial pneumonitis developed with rituximab therapy.
Prednisolone/therapeutic use ; Methylprednisolone/therapeutic use ; Male ; Lung Diseases, Interstitial/*chemically induced/diagnosis/drug therapy ; Humans ; Antineoplastic Agents/*adverse effects ; Antibodies, Monoclonal/*adverse effects ; Aged

The risk of lymphoproliferative disorders (LPDs) has been reported to be increased in autoimmune diseases and chronic inflammatory diseases. Similar with other chronic inflammatory diseases such as rheumatoid arthritis, there is a concern about the risk of LPDs in patients with inflammatory bowel disease (IBD). Generally, in IBD patients, the risk of LPDs appears to be similar with or very slightly higher, compared to the general population. The association of therapeutic agents with the risk of LPDs is difficult to evaluate due to multiple other potentially involved factors and co-treatment with other agents. To date, data show that thiopurine is associated with a moderately increased risk of LPDs in patients with IBD. Evidence regarding the risk of LPDs in IBD patients using methotrexate is not sufficient, but the risk of LPDs seems low. The responsibility of anti-TNF-alpha agents on the risk of LPDs is difficult to determine, because most of IBD patients receiving anti-TNF-alpha agents are co-treated with thiopurines. Attention should be given to the high risk of hepatosplenic T-cell lymphoma in young male patients treated with anti-TNF-alpha agents together with thiopurines. The risk and benefit of immunosuppressive therapy for IBD should be carefully evaluated and individualized considering the risk of LPDs.
Anti-Inflammatory Agents/therapeutic use ; Antibodies, Monoclonal/therapeutic use ; Azathioprine/adverse effects/therapeutic use ; Humans ; Immunosuppressive Agents/adverse effects/therapeutic use ; Inflammatory Bowel Diseases/complications/*drug therapy ; Lymphoproliferative Disorders/chemically induced/*etiology ; Methotrexate/therapeutic use ; Risk Factors