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Objective:To investigate the clinical effect and safety of camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy for patients with locally advanced nasopharyngeal carcinoma (NPC).Methods:A total of 24 patients with stage Ⅲ-IV A NPC were recruited prospectively to receive two cycles of camrelizumab combined with induction chemotherapy (docetaxel 75 mg/m 2+ cisplatin 25 mg/m 2 for three consecutive days) followed by concurrent chemoradiotherapy (prescription doses: 6 996 cGy in 33 fractions for PGTV and PGTV nd, 6 006 cGy in 33 fractions for PTV 1, 5 096 cGy in 28 fractions for PTV 2, and concurrent cisplatin chemotherapy with a dose of 75 mg/m 2). The short-term efficacy and adverse reactions were evaluated. Results:After induction therapy, nasopharyngeal lesions showed an objective response rate (ORR) of 91.6%, including 45.8% of complete response (CR) and 45.8% of partial response (PR); cervical lymph nodes showed an ORR of 95.8% (CR: 4.2%; PR: 91.6%). Seventeen patients accepted a reexamination under a nasopharyngoscope, and the biting biopsy result indicated that 13 patients among them had complete pathologic response. After concurrent chemoradiotherapy, nasopharyngeal lesions and cervical lymph nodes showed CR rates of 83.3% and 91.7% and PR rates of 16.7% and 8.3%, respectively. After the induction therapy, 13 patients with stage IV A NPC had ORR (PR) rates of 92.4% and 92.4%, respectively, at nasopharyngeal lesions and cervical lymph nodes. After concurrent chemoradiotherapy, the patients with stage IV A NPC had CR rates of 84.6% and 92.3% and PR rates of 15.4% and 7.7%, respectively, at nasopharyngeal lesions and cervical lymph nodes. Major adverse reactions include leukopenia, granulopenia, anemia, radioactive acute oropharyngeal mucositis and dermatitis, digestive tract reaction, fatigue, hypothyroidism, aminotransferase elevation, and reactive capillary hyperplasia. Conclusions:Camrelizumab combined with induction chemotherapy followed by concurrent chemoradiotherapy can achieve high short-term efficacy for patients with locally advanced nasopharyngeal carcinoma, without increasing the incidence of adverse reactions. Its long-term efficacy deserves further research.
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Objective To investigate the safety and efficacy of camrelizumab added to second-line therapy after drug- eluting bead transarterial chemoembolization (DTACE) combined with apatinib for unresectable hepatocellular carcinoma (HCC). Methods A retrospective analysis was performed for 89 HCC patients with camrelizumab added to second-line therapy who attended The First Affiliated Hospital of Zhengzhou University from December 2019 to December 2020. The primary endpoints were overall survival (OS) and progression-free survival (PFS) after the application of camrelizumab, and the secondary endpoints were objective remission rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs). The Kaplan-Meier method was used to plot survival curves, the Log-rank test was used for stratified analysis of subgroups based on baseline characteristics, and the influencing factors for prognosis were analyzed. Results A total of 89 patients were screened and followed up in this study. The patients were followed up to December 2021, with a median follow-up time of 16 months, a median OS time of 17.0 (95% confidence interval [ CI ]: 15.3-18.7) months, and a median PFS time of 7.0 (95% CI : 6.2-7.8) months. There were significant differences in OS and PFS between the patients with different ECOG-PS scores, liver function Child-Pugh classes, portal vein invasion, patterns of progression, times of DTACE treatment, durations of oral administration of apatinib, and durations of application of camrelizumab (all P 4 months had significant improvements in median OS [21.0 (95% CI : 19.1-22.9) months vs 14.0 (95% CI : 10.4-17.6) months, χ 2 =19.399, P 5 months had significant improvements in median OS [22.0 (95% CI : 20.2-23.8) months vs 13.0 (95% CI : 9.3-16.7) months, χ 2 =22.336, P < 0.001] and PFS [9.0 (95% CI : 7.0-11.0) months vs 5.0 (95% CI : 4.1-5.9) months, χ 2 =26.141, P < 0.001]. Post-embolization syndrome was the adverse event after DTACE and resolved after symptomatic treatment. Adverse reactions related to targeted drugs and immunotherapy all resolved after symptomatic supportive treatment, with no grade ≥4 adverse reactions, and no patients withdrew from target-free therapy due to TRAEs. Conclusion As for DTACE combined with apatinib in the treatment of unresectable HCC, camrelizumab added after progression has a marked therapeutic efficacy with safe and controllable TRAEs.
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Objective@# To investigate the clinical manifestations, pathological features, and treatment of oral and maxillofacial pyogenic granulomas induced by camrelizumab. @*Methods@# A case of pyogenic granuloma of the gums and lips caused by camrelizumab was reported along with a literature review. @*Results@# After 4 months of treatment with camrelizumab for liver cancer, the patient developed systemic reactive capillary hyperplasia (RCH), followed by multiple masses on the lower lip and gingiva. After periodontal therapy, the masses on the lower lip and the gingiva were removed, and camrelizumab administration was stopped. The pathological result was gingival pyogenic granuloma/granulomatous hemangioma. No new masses were found in the oral cavity during postoperative follow-up. A review of the literature showed that RCH is the most common adverse drug reaction to camrelizumab but it occurs infrequently in the oral cavity. At present, the etiology of RCH has not been clarified, but the research has shown that camrelizumab may trigger tissue proliferation into hemangiomas by activating vascular endothelial cells, and the combined use of camrelizumab is safer than single use. RCH is self-limiting and most cases resolve spontaneously after discontinuation of the drug. If the mass causes dysfunction, surgical excision is feasible.@*Conclusion @#Camrelizumab can cause oral and maxillofacial reactive capillary hyperplasia complicated by pyogenic granuloma.
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Objective To investigate the clinical efficacy and related adverse reactions of the combination of camrelizumab with anlotinib as the third-line therapy on advanced non-small cell lung cancer. Methods We retrospectively analyzed the clinical data of 84 patients with advanced non-small cell lung cancer after second-line treatment. According to different treatment methods, 44 patients who received camrelizumab combined with anlotinib were included in the observation group, and 40 patients who received anlotinib alone were included in the control group. The PFS, ORR, DCR and incidence of adverse reactions were analyzed and compared between the two groups. Results The median PFS of the observation group was longer than that of the control group (7.0 vs. 5.6 months, P=0.001). No statistically significant difference was observed in ORR, DCR, the incidence of adverse reactions or the incidence of adverse reactions above grade 3 between two groups (all P > 0.05). Conclusion The clinical efficacy of camrelizumab combined with anlotinib as third-line therapy on advanced non-small cell lung cancer is better than anlotinib alone, and the safety is good.
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Objective:To explore the safety and efficacy of camrelizumab salvage therapy for extrahepatic recurrent hepatocellular carcinoma with PD-L1 negativity in transplanted liver tissue.Methods:From May 2020 to December 2020, retrospective analysis was performed for 3 cases of camrelizumab salvage therapy for extrahepatic recurrent hepatocellular carcinoma recipients with PD-L1 negative in transplanted liver tissue.Three recipients with extrahepatic recurrence progressed after first/second-line targeted drug therapy.Camrelizumab was given as salvage therapy after normal tissue of ransplanted liver was confirmed as negative for PD-L1 by immunohistochemistry.The safety and efficacy of treatment were observed by monitoring the changes in the levels of alanine aminotransferase, aspartate aminotransferase and bilirubin, the occurrence of complications and the outcome of treatment before and after dosing.Results:During a follow-up period of 1.5 to 15.5 months, no recipients showed acute rejection symptoms such as sharp elevations of transaminase and bilirubin.Headache ( n=1), vomiting ( n=1) and fatigue & hypertension ( n=1) became relieved after treatment.As of February 28, 2022, there were one survivor and two deaths.The fatal causes were tumor progression ( n=1) and thoracic aortic rupture due to esophageal perforation ( n=1). The survival time of recipients was (11-15.5) months and the progression-free survival time (4-6) months. Conclusions:For extrahepatic recurrent hepatocellular carcinoma with PD-L1-negative liver transplantation in normal liver tissue, camrelizumab salvage therapy can control tumor progression to a certain extent and prolong the survival time of recipients.
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Objective:To investigate the efficacy and safety of camrelizumab combined with stereotactic body radiation therapy (SBRT) in the treatment of advanced oligometastaticnon-small cell lung cancer (NSCLC).Methods:Eighty-six patients with advanced oligometastatic NSCLC who met the inclusion and exclusion criteria from March 2020 to August 2021 in the Second People′s Hospital of Yibin were divided into the control group (43 cases) and the treatment group (43 cases) according to the random number table method, the control group was given camrelizumab combined with conventional radiotherapy, and the treatment group was given camrelizumab combined with SBRT. After 8 weeks of treatment, the efficacy of the two groups was evaluated, the occurrence of side effects in the two groups was counted, the serum tumor markers [carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCC-Ag), cytokeratin 19 fragment anti-21-1 (CYFRA21-1)] levels were detected.Results:The objective effective rate of the treatment group was significantly higher than that of the control group:: 72.09% (31/43) vs. 51.16%(22/43), the difference was statistically significant ( P<0.05); the incidence of radiation pneumonia in the treatment group was significantly lower than that in the control group: 4.65% (2/43) vs. 18.60% (8/43), the difference was statistically significant ( P<0.05), and there was no significant difference in the incidences of other side effects such as cutaneous capillary endothelial proliferation (CCEP), liver damage, hypothyroidism, and radiation esophagitisbetween the treatment group and the control group ( P>0.05); the levels of serum CEA, SCC-Ag, CYFRA21-1after treatmentin the two groups were significantly lower than those before treatment, treatment group: treatmentgroup: (8.81 ± 4.82) ng/L vs. (81.67 ± 50.88) ng/L, (1.13 ± 0.55) ng/L vs. (1.56 ± 1.03) ng/L and (2.92 ± 0.99) ng/L vs. (4.63 ± 1.39) ng/L, controlgroup: (30.49 ± 19.44) ng/L vs. (89.91 ± 50.10) ng/L, (1.56 ± 1.23) ng/L vs. (1.86 ± 1.33) ng/L and (4.01 ± 2.10) ng/L vs. (5.03 ± 3.44) ng/L. and the levels after treatment in the treatment group were significantly lower than those in the control group, and there were statistical differences ( P<0.05). Conclusions:Camrelizumab combined with SBRT treatment for patients with advanced oligometastatic NSCLC can effectively reduce the levels of serum CEA, SCC-Ag, CYFRA21-1, and significantly improve the short-term efficacy, with relatively low incidence of toxic side effects.
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Objective:To explore the clinical efficacy and safety of the camrelizumab combined with apatinib and chemotherapy as second-line or later therapy in human epidermal growth factor receptor-2 (HER-2) negative advanced gastric cancer.Methods:A total of 66 patients with HER-2 negative advanced gastric cancer and first-line treatment failure in Shandong Cancer Hospital Affiliated to Shandong First Medical University from March 2018 to September 2021 were selected. They were divided into study group ( n=22) and control group ( n=44) according to the different treatment regimens. The patients in the study group were treated with camrelizumab combined with apatinib and chemotherapy, and the patients in the control group were treated with chemotherapy alone. The short-term efficacy, progression-free survival (PFS) , overall survival (OS) and the occurrence of adverse reactions were compared, and Cox regression analysis was used to analyze the influencing factors of prognosis. Results:After at least 2-4 cycles of treatment, the ORR in the study group and the control group were 9.1% (2/22) and 0 (0/44) respectively, with no statistically significant difference ( P=0.108) . DCR in the two groups were 77.3% (17/22) and 45.5% (20/44) respectively, with a statistically significant difference ( χ2=6.03, P=0.014) . The study group didn’t reach median OS and the median OS in the control group was 11.7 months, with no statistically significant difference ( χ2=1.59, P=0.207) . The study group didn’t reach median PFS and the median PFS in the control group was 3.2 months, with a statistically significant difference ( χ2=10.13, P=0.001) . Multivariate Cox regression analysis showed that treatment method was an independent influencing factor for PFS in patients with HER-2 negative advanced gastric cancer ( HR=0.33, 95% CI: 0.15-0.75, P=0.008) . In terms of adverse reactions, there was a statistically significant difference in the incidence of elevated alanine aminotransferase between the study group and the control group [31.8% (7/22) vs. 6.8% (3/44) , χ2=5.32, P=0.021]. There were no adverse-related deaths in both groups. Conclusion:Compared with chemotherapy alone, camrelizumab combined with apatinib and chemotherapy as a second-line or later therapy in HER-2 negative advanced gastric cancer can prolong PFS and improve DCR, but the incidence of elevated alanine aminotransferase increases significantly.
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Objective:To evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel in second-line treatment of advanced esophageal squamous cell carcinoma (ESCC).Methods:Seventy-two patients with advanced or metastatic ESCC who had failed first-line treatment admitted to the Department of Oncology of the Affiliated Hospital of West Anhui Health Vocational College from May 12, 2019 to August 20, 2020 were enrolled. The patients were given camrelizumab combined with albumin paclitaxel (the experimental group, n=45) or second-line chemotherapy (docetaxel or irinotecan, the control group, n=27) according to patients′ preference. Besides, the objective response rate (ORR), disease control rate (DCR), incidence of adverse events, overall survival (OS) and progress free survival (PFS) were assessed. Results:The ORR of the experimental group and the control group were 26.7% (12/45) and 7.4% (2/27) respectively, with a statistically significant difference ( χ2=3.996, P=0.046). The DCR of the two groups were 48.9% (22/45) and 29.6% (8/27) respectively, with no statistically significant difference ( χ2=2.575, P=0.109). In terms of adverse events, the experimental group was better tolerated, and the incidence of grade 3 or above adverse events was lower [28.9% (13/45) vs. 55.6% (15/27)], which was 48% lower than that of the control group, with a statistically significant difference ( χ2=5.049, P=0.025). One patient in the control group had a treatment-related death. The median OS was 8.9 months (95% CI: 7.9-9.8) in the experimental group and 6.5 months (95% CI: 5.6-7.3) in the control group, with a statistically significant difference ( χ2=5.068, P=0.024). The median PFS was 2.2 months (95% CI: 1.6-2.7) in the experimental group and 1.8 months (95% CI: 1.5-2.0) in the control group, with a statistically significant difference ( χ2=4.799, P=0.028). Conclusion:Camrelizumab combined with albumin paclitaxel in second-line treatment of advanced ESCC patients has proven efficacy and tolerable safety, which may be a potential second-line treatment for advanced ESCC.
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OBJECTIVE：To introduce the role of clinical pharmacists in the treatment of camrelizumab-induced toxic epidermal necrolysis （TEN），and to provide reference for the therapy of similar ADR. METHODS：The clinical pharmacist participated in therapy duration of a patient with TEN caused by camrelizumab. The patient was treated with Camrelizumab for injection combined with Apatinib mesylate tablet as anti-tumor therapy，and was admitted to hospital due to extensive skin lesions. After consulting relevant literatures and analyzing the patient’s admission diagnosis [severe epidermolysis bullosa，severe drug eruption（erythema multiforme），abnormal liver function，etc.] and examination results（hypokalemia，etc.），clinical pharmacists suggested to stop above anti-tumor drugs and given Methylprednisolone sodium succinate for injection（160 mg→80 mg→60 mg， qd，ivgtt） for anti-inflammatory treatment，Imiperan cilastatin for injection （1 g，q8 h，ivgtt） for an ti-infection treatment， Potassium chloride injection（1 g，qd，ivgtt）for electrolyte regulation，Compound amino acid injection（3AA）（10.65 g，qd，ivgtt） for nutritional support treatment，Pantoprazole sodium for injection（40 mg，qd，ivgtt）for acid inhibition and stomach protection， Reduced glutathione for injection（2.4 g，qd，ivgtt）for liver protection. Before medication，the patient was given cognitive and behavioral education and medication publicity. The changes of relevant indicators were closely monitored during medication，and the patient was given medication guidance when he was discharged. RESULTS：The doctors adopted the suggestions of clinical pharmacists，and 16 days after treatment，the skin lesions of the trunk and limbs were improved，and the double eyelids were still erosive and exuded a lot of secretions. The patient requested transfer for treatment. CONCLUSIONS：Clinical pharmacists assisted physicians to improve the treatment plan of patients with TEN caused by camrelizumab，and carried out cognitive and behavioral education and medication publicity for patients to ensure the effectiveness and safety of their medication.
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Objective To evaluate the safety of programmed cell death protein 1 (PD-1) inhibitor in the treatment of primary liver cancer (liver cancer) before liver transplantation. Methods Clinical data of 7 recipients given with PD-1 inhibitor before liver transplantation for liver cancer were retrospectively analyzed. The incidence of immune-related adverse event (irAE) and clinical prognosis of the recipients were summarized. The safety of PD-1 inhibitor in recipients prior to liver transplantation for liver cancer was evaluated. Results Seven recipients were treated with PD-1 inhibitor with 1-20 courses before liver transplantation for liver cancer. The time interval from drug withdrawal to liver transplantation was 6-120 d. Five recipients suffered from irAE of different degrees, including fatigue in 3 cases, fever in 2 cases, alopecia in 2 cases, rash in 1 case, nausea in 1 case and myocarditis in 1 case, respectively. A majority of these irAE were classified as grade Ⅰ-Ⅱ. One recipient died from grade Ⅴ irAE (fatal myocarditis). One recipient developed rejection at postoperative 7 d, which were mitigated after glucocorticoid pulse therapy combined with increased dosage of tacrolimus. Conclusions PD-1 inhibitor can be applied in preoperative treatment before liver transplantation for liver cancer. Nevertheless, the incidence of irAE and postoperative rejection should be intimately monitored.
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Aim: The present study evaluated the safety and efficacy of camrelizumab (a programmed death-1 antibody) in combination with microwave ablation (MWA) in advanced non-small cell lung cancer (NSCLC). Materials and Methods: A total of 21 patients were prospectively enrolled. MWA was performed in 25 pulmonary lesions during 21 sessions. Camrelizumab was administered 5–7 days after MWA as a dose of 200 mg, which was repeated every 2 weeks until disease progression or intolerable toxicities. The primary endpoints were safety and the objective response rate (ORR). Other endpoints included progression-free survival (PFS) and overall survival (OS). Results: The technical success rate was 100%. No treatment-associated deaths were identified. Major complications, minor complications, and side effects of MWA were observed in 9, 8, and 14 patients, respectively. The main major complications included pneumothorax, pneumonia, hemorrhage, and pleural effusion. The adverse events of camrelizumab included reactive skin capillary hyperplasia (n = 9), hypothyroidism (n = 5), pneumonia (n = 4), fatigue (n = 2), leukopenia (n = 1), and neutropenia (n = 1). Grade 2 and 3 camrelizumab adverse events were identified in eight and three patients, respectively. The ORR was 33.3%, with two patients achieving complete response and five patients achieving partial response. The median PFS was 5.1 months and OS was not reached. Conclusions: Camrelizumab administration combined with MWA was safe in the treatment of advanced NSCLC, and the combination improved the ORR of camrelizumab alone compared to previous reports
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Background: Camrelizumab is a promising anti-programmed cell death-1 agent for non-small cell lung cancer (NSCLC) and induces reactive capillary hemangiomas (RCHs). Routine clinical management of this unique and prevalent toxicity has been summarized in previous studies. The objective of this study was to provide evidence of apatinib as a salvage therapy for RCHs. Materials and Methods: In this single-center, observational study, patients with NSCLC who were over 18 years of age and treated with camrelizumab were enrolled. The incidence of RCHs, onset and duration time, severity, evolution, and clinical practices, especially with apatinib, for their management and impact on quality of life, were recorded during a 6-month follow-up. Results: A total of 28 patients were included. The incidence of RCHs was 28.6% (8/28). The median onset and duration time were 6 weeks and 8 weeks, respectively. Six (21.4%) patients had mild and moderate RCHs and four (9.3%) patients achieved a rapid regression of RCHs with the application of apatinib. The impact of the RCHs on quality of life was limited and assessed with Dermatology Life Quality Index scores. No treatment-associated termination was observed. Conclusion: The combination of camrelizumab and apatinib in the treatment of NSCLC reduced the incidence of RCHs. Apatinib appeared to be a salvage therapy of RCHs, which leads to rapid regression of RCHs with no impairment on the quality of life
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With the remarkable achievements made in the treatment targeted at tumor immune checkpoints, more and more new immunotherapy drugs have been applied to the malignancies treatment. Camrelizumab (AiRuiKa) is a novel human immunoglobulin G4 (IgG4) monoclonal antibody (mAb), which can target the programmed death 1 (PD-1) and block its binding to the programmed death ligand 1 (PD-L1), so as to restore the body's immune function and achieve anti-tumor effect. The drug was officially approved by National Medical Products Administration (NMPA) on May 29, 2019 for use in patients with recurrent or refractory classical Hodgkin's lymphoma (cHL) who are treated with at least second-line systemic therapy. In addition, the drug showed good anti-tumor activity in esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), nasopharyngeal carcinoma (NPC), non-small cell lung cancer (NSCLC), and gastric cancer (GC) and gastroesophageal junction cancer (EGJC). The research progress of camrelizumab on mechanism of action, pharmacodynamics and pharmacokinetics, clinical studies, adverse reactions etc. were reviewed in present paper.