A real-world study of camrelizumab in the treatment of advanced lung cancer patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21056-e21056
Author(s):  
Kangsheng Gu ◽  
Minghong Bi ◽  
Dong Zhao ◽  
Huaidong Cheng ◽  
Genhe Wang ◽  
...  

e21056 Background: Camrelizumab, as a humanized antibody against PD-1, has shown high efficiency and survival benefits in clinical studies on lung cancer treatment. This study aims to observe the efficacy and safety of Camrelizumab in the treatment of advanced lung cancer in the real world. Methods: This is a prospective, open, multi-center observational study that includes patients with advanced lung cancer who are older than 18 years of age, regardless of gender, with an ECOG score of 0-2. Results: As of November 18, 2020, a total of 253 patients have been enrolled. Males accounted for 187 cases (74.2%). The ECOG PS score was 0 in 44 cases (17.3%), 1 in 162 cases (64.0%), and 2 in 47 cases (18.6%). There were 181 patients (71.5%) of stage IV, 96 patients (37.9%) of adenocarcinoma, and 98% of patients did not undergo PD-L1 testing. A history of radiotherapy accounted for 31.2%, and a history of surgery on the primary lesion accounted for 20.2%. Camrelizumab accounted for 29.6% of the first-line treatment, 27.2% of the second-line treatment, and 43.1% of the third-line and above. Camrelizumab monotherapy accounted for 20.1%, camrelizumab combined with chemotherapy accounted for 56.3%, combined anti-angiogenesis therapy accounted for 22.1%, and combined anti-angiogenesis + chemotherapy accounted for 1.5%. Among the 199 patients with evaluable efficacy, 4 were CR, 46 were PR, 116 were SD, and 33 were PD. The ORR reached 25.1% and the DCR reached 83.4%. The overall adverse event rate was 33.7%, the major adverse event RCCEP rate was 22.6%, appetite loss was 5%, and fatigue was 3.5%. There were 4 cases (2%) of RCCEP with adverse events greater than or equal to grade 3. Conclusions: In this real-world study of lung cancer, most of the patients enrolled were patients with poor PS score and late stage, but the efficacy and safety of camrelizumab in patients with advanced lung cancer were still confirmed. The dominant population and combination therapy are still under study. Clinical trial information: ChiCTR2000034595.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16008-e16008
Author(s):  
Guoping Sun ◽  
Dong Qian ◽  
Dong Zhao ◽  
Hui Liang ◽  
Huaidong Cheng ◽  
...  

e16008 Background: Camrelizumab, a fully humanized monoclonal antibody against PD-1, has been approved in the treatment of advanced esophageal squamous carcinoma in China. The purpose of this study was to observe the efficacy and safety of Camrelizumab in the treatment of esophageal cancer in the real world. Methods: This is an open-label, prospective, multicenter, observational study. Eligible patients (pts) who received Camrelizumab had esophageal cancer; age≥18, ECOG PS of 0-2; and measurable disease. Results: As of November 30, 2020, a total of 229 patients were enrolled, of which 192 were male (83.8%). The ECOG PS score was 0 in 48 cases (21.0%), 1 in 149 cases (65.0%), and 2 in 32 cases (14.0%). Among the 134 patients of stage IV patients (58.5%), 174 patients had metastases (76.0%), and 99% of patients did not undergo PD-L1 testing. A history of radiotherapy accounted for 57.6%, and a history of surgery on the primary lesion accounted for 42%. Camrelizumab accounted for 26.2% of the first-line treatment, 33.6% of the second-line treatment, and 35.4% of the third-line and above. Camrelizumab combined with chemotherapy accounted for 40%, combined with anti-angiogenesis therapy accounted for 38.0%, combined with anti-angiogenesis + chemotherapy accounted for 9.0%, and combined radiotherapy accounted for 6.2%. Among 145 patients with evaluable efficacy, 5 cases of CR, 14 cases of PR, 97 cases of SD, and 29 cases of PD. The ORR reached 13.1% and the DCR reached 80.0%. The overall adverse event rate was 42.8%, the major adverse event RCCEP rate was 11.7%, pneumonia was 8.3%, and fatigue was 4.1%. Adverse events greater than or equal to grade 3 included 1 case of RCCEP, 3 cases of bleeding, 1 case of diarrhea, and 1 case of fever. Conclusions: In this real-world study of esophageal cancer, most of the patients enrolled were patients with poor PS score and late stage, but the efficacy and safety of Camrelizumab in patients with advanced esophageal cancer were still confirmed. The dominant population and combination therapy are still under study. Clinical trial information: ChiCTR1900027275.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15652-e15652
Author(s):  
Jifeng Feng ◽  
Lei Qian

e15652 Background: Anlotinib is an novel small molecule multi-target tyrosine kinase inhibitor, which has been approved as a third-line therapy for patients with advanced NSCLC by CFDA in May 2018, and also approved as third-line therapy for patients with advanced SCLC in China in 2019. The objective of this study was to assess the efficacy of Anlotinib for patients with advanced lung cancer in the real world. Methods: We reviewed the patients who were diagnosed as advanced lung cancer and had received anlotinib in Jiangsu Caner Hospital from May 2018 to Sep 2019. The primary endpoint was progression-free survival (PFS) and the secondary endpoint was objective response rate (ORR), disease control rate (DCR) and safety. Results: A total of 465 patients were included in our study, containing 384 cases of NSCLC and 81 cases of SCLC. Among patients with NSCLC, 85 cases received anlotinib alone or anlotinib based therapy as first-line and second-line treatment, whereas 299 cases received anlotinib alone or anlotinib based therapy as third-line or later treatment. There were no significant differences in PFS, ORR and DCR between cohort of 1st /2nd line treatment and those with 3rd /later treatment. However, patients received combination therapy (including anlotinib combined with PD1 inhibitors such as Nivolumab, pembrolizumab, or chemotherapy such as platinum, docetaxel, pemetrexed, paclitaxel, tegafur, etc.) showed a significant longer PFS and higher ORR and DCR (P < 0.001, table). In patients with SCLC, 44 cases received anlotinib alone or anlotinib based therapy as first-line and second-line treatment. There were no significant differences in PFS, ORR and DCR between cohort of anlotinib monotherapy and other combination therapies (P > 0.05, table). No additional safety profile was observed. Conclusions: Anlotinib shows similar effect in patients with NSCLC and SCLC in real world. Anlotinib provides more significant benefits when combining with PD1 inhibitor or chemotherapy comparing with monotherapy in patients with advanced NSCLC. [Table: see text]


2021 ◽  
Author(s):  
Meiling Sun ◽  
Huaijun Ji ◽  
Ning Xu ◽  
Peng Jiang ◽  
Tao Qu ◽  
...  

Abstract BackgroundThis study was designed to investigate the clinical application, efficacy, and safety of immune checkpoint inhibitors (ICIs) in the treatment of lung cancer in the real world. MethodsA retrospective, observational analysis was conducted on patients treated with ICIs in four tertiary hospitals in the region from January 2015 to March 2021, to evaluate the clinical efficacy of ICI single-agent or combined chemotherapy and anti-vascular drugs in the first-line or second-line treatment of patients with advanced lung cancer. ResultsThree hundred and fifteen patients were enrolled in this study. The objective response rate (ORR) and disease control rate (DCR) were 36.5% (115/315) and 94.0% (296/315), respectively, the median progression-free survival (PFS) was 10.8 months, and the median overall survival (OS) was not reached. A total of 165 patients received ICI as the first-line treatment, the median treatment cycle was 8 cycles (2-20 cycles), the short-term efficacy ORR was 41.2%, DCR was 94.5%, and the median PFS was 12.0 months. 150 patients received ICI treatment as second-line treatment, the median treatment cycle was five cycles (2-10 cycles), the short-term efficacy ORR was 31.3%, DCR was 93.3%, and the median PFS was 10.0 months. There were no statistically significant differences in ORR, DCR, or median PFS with ICI as the first-line treatment compared with the second-line treatment(P>0.05). The results of subgroup analysis showed that Karnofsky performance status (KPS) score, EGFR mutation status, and number of treatment lines were not correlated with median PFS((P>0.05). However, there were statistically significant differences in programmed death-ligand 1(PD-L1) expression, pathological types, hormone interference, and antibiotic (Abx) treatment among all groups (P< 0.05). In terms of safety, the overall incidence of adverse reactions in 315 patients was 62.5%, and the incidence of immune-related adverse events(irAEs) was 13.7%. Grade 1-2 and 3-4 incidence of adverse events were 34.9% and 27.65%, respectively. There were four patients who experienced fatal irAEs, two cases were liver damage leading to liver failure, one case was immune related pneumonia, and one case was immune related myocarditis. ConclusionIn the real world, immunotherapy has a good effect on patients with advanced lung cancer and significantly improves ORR and PFS.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21051-e21051
Author(s):  
Yueyin Pan ◽  
Fengshou Jiang ◽  
Yingying Du ◽  
Yong Wang ◽  
Hu Liu ◽  
...  

e21051 Background: Camrelizumab combined with chemotherapy has shown a higher efficiency and survival benefit in clinical studies of the first-line treatment of lung cancer. This study aims to observe the clinical efficacy and safety of camrelizumab combined with chemotherapy and sequential apatinib in the second-line treatment of patients with advanced non-small cell lung cancer in a real environment. Methods: This is a prospective, open, multi-center observational study that includes advanced lung cancer that is older than 18 years old, regardless of gender, with an ECOG score of 0-1, and recurrence or failure after first-line platinum-based dual-drug chemotherapy patient. Results: As of January 25, 2021, a total of 18 patients were enrolled, of which 12 were female (66.67%), 11 patients had an ECOG PS score of 1 point (61.11%), and 15 patients were stage IV (83.33%), patients, 5 patients with tissue poorly differentiation (27.78%), 55.56% of the patients had undergone immunohistochemical testing, and 66.67% of the patients had become positive for the gene. A history of radiotherapy accounted for 11.11%, and a history of surgery on the primary lesion accounted for 27.78%. Previous first-line chemotherapy options were pemetrexed combined with cisplatin (22.22%), pemetrexed combined with lobaplatin (22.22%), pemetrexed combined with carboplatin (11.11%), bevacizumab combined with Platinum dual-drug regimen (38.89%); Among the 10 patients with evaluable efficacy, 0 had CR, 2 had PR, 6 had SD, and 2 had PD. The ORR reached 20.00% and the DCR reached 80.00%. The overall incidence of adverse reactions is low, and the medication process is safe and controllable. Conclusions: In this second-line clinical study of lung cancer, most of the patients enrolled were patients with poor PS scores and later stages, but the effectiveness and safety of carrelizumab in patients with advanced lung cancer were still confirmed. The dominant population and the combined treatment plan are still being studied. Clinical trial information: ChiCTR2000034597.


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