Dataset Information

A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma.

ABSTRACT: Pembrolizumab with cisplatin and 5-fluorouracil showed survival benefit but relatively high occurrence of treatment-related adverse events (TRAEs) for recurrent/metastatic oral squamous cell carcinoma (R/M OSCC). A more tolerable regime is needed. This trial enrolled 20 R/M OSCC patients with previously untreated and PD-L1 positive. Patients were administered camrelizumab with docetaxel and cisplatin every 3 weeks for six cycles, followed by camrelizumab monotherapy every 3 weeks until disease progression or intolerable toxicity. The primary endpoint was occurrence of grade ≥ 3 TRAEs, secondary endpoints included overall survival (OS), progression-free survival (PFS), and overall response rate (ORR). 45% patients experienced grade ≥ 3 TRAEs, which the most common were anemia (15%), stomatitis (15%), and neutropenia (10%). The most common potential immune-related adverse events were reactive cutaneous capillary endothelial proliferation (RCCEP; 60%), hypothyroidism (35%), and pneumonitis (15%). No treatment-related deaths occurred. The median OS, PFS, and ORR was 14.4 months, 5.35 months, and 40.0% respectively. The study also found RCCEP occurrence, lower FOXP3⁺ cells, and higher density of intratumor tertiary lymphoid structure were associated with improved efficacy. Our data suggest that camrelizumab with docetaxel/cisplatin as first-line therapy was well tolerable and had potentially favorite efficacy in PD-L1-positive patients with R/M OSCC.

SUBMITTER: Ju H

PROVIDER: S-EPMC10363852 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma.

Ju Houyu H Wei Dongliang D Wu Yunteng Y Liu Yang Y Ding Qi Q Rui Mengyu M Fan Zongyu Z Yao Yanli Y Hu Jingzhou J Ren Guoxin G

MedComm 20230722 4

Pembrolizumab with cisplatin and 5-fluorouracil showed survival benefit but relatively high occurrence of treatment-related adverse events (TRAEs) for recurrent/metastatic oral squamous cell carcinoma (R/M OSCC). A more tolerable regime is needed. This trial enrolled 20 R/M OSCC patients with previously untreated and PD-L1 positive. Patients were administered camrelizumab with docetaxel and cisplatin every 3 weeks for six cycles, followed by camrelizumab monotherapy every 3 weeks until disease p ...[more]

PMID: 37492783

Similar Datasets

Project description:PurposeTreatment of advanced pancreatic cancer with a single therapeutic at a maximal dose has been largely ineffective at increasing survival. Combination therapies are commonly studied but often limited by toxicity. We previously showed that low-dose multiagent therapy with gemcitabine, docetaxel (taxotere), capecitabine (xeloda), and cisplatin (GTX-C) was safe, well tolerated, and effective (NCT01459614). Here, we hypothesize that adding irinotecan to GTX-C may improve survival with minimal toxicity.Experimental designPatients with treatment-naïve metastatic pancreatic adenocarcinoma were treated with gemcitabine, docetaxel (taxotere), capecitabine (xeloda), cisplatin, and irinotecan (GTX-CI). Treatment consisted of capecitabine 500 mg twice daily on days 1-14 and gemcitabine 300 to 500 mg/m2, docetaxel 20 mg/m2, cisplatin 15 to 20 mg/m2, and irinotecan 20 to 60 mg/m2 on days 4 and 11 of a 21-day cycle. The primary objective was 9-month overall survival (OS). Secondary objectives included response rate (RR), disease control rate (DCR), progression-free survival (PFS), and OS.ResultsThe regimen was well tolerated. The recommended phase II dose was gemcitabine 500 mg/m2, docetaxel 20 mg/m2, capecitabine 500 mg po bid, cisplatin 20 mg/m2, and irinotecan 20 mg/m2. Median follow-up in phase II was 11.02 months (2.37-45.17). Nine-month OS rate was 57% [95% confidence interval (CI): (41-77)]. RR was 57% [95% CI: (37-75) 50% PR and 7% CR]. DCR was 87% [95% CI: (69-96)]. Median OS and PFS were 11.02 [95% CI: (8.54-21.09)] and 8.34 [95% CI: (6.34-NA)] months, respectively.ConclusionsThe addition of irinotecan to GTX-C was safe and well tolerated. While the study did not meet its primary objective, the responses were clinically meaningful using a well-tolerated regimen.SignificanceWe aimed to optimize the previously reported efficacious regimen of low-dose multiagent therapy with GTX-C for the treatment of metastatic pancreatic ductal adenocarcinoma by adding irinotecan. The primary objective was not met, but GTX-CI was well tolerated. The RR of 57%, median PFS of 8.3 months, median OS of 11 months, and 36-month OS rate of 19% suggest clinical benefit. Further optimization of this regimen is warranted.

Project description:ObjectiveThis study aimed to investigate the cost-effectiveness of adding Chinese-developed anti-PD-1 antibody camrelizumab to first-line platinum-doublet chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma (L/M NPC) from the perspective of Chinese healthcare system.DesignA Markov model consisting of four health states, progression-free survival, first progression survival, second progression survival and death, was built to simulate 3-week patient transitions over a 20-year horizon. A direct comparison between first-line camrelizumab in combination with gemcitabine plus cisplatin and gemcitabine plus cisplatin was performed by calculating transition probabilities from the CAPTAIN-1st trial. Costs and utilities were collected from the local public database and literature. One-way and probabilistic sensitivity analyses were employed to evaluate the robustness of the model.SettingThe Chinese healthcare system perspective.ParticipantsA hypothetical cohort of Chinese patients with pathologically diagnosed L/M NPC who had an Eastern Cooperative Oncology Group performance status of 0 or 1.InterventionsFirst-line camrelizumab in combination with camrelizumab and gemcitabine plus cisplatin (CGP) versus gemcitabine plus cisplatin (GP).Primary outcome measureCost, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratio (ICER).ResultsThe baseline analysis demonstrated that, compared with first-line GP, first-line CGP yields an effectiveness increase of 0.26 QALY, accompanied by an increment of US$6137.59 in healthcare cost. This results in an ICER of US$23 482.32/QALY. With the willingness-to-pay (WTP) threshold for a QALY set at US$37 654.50, first-line CGP proves to be cost-effective in 97.20% of the iterations. Deterministic sensitivity analyses indicated that the uncertainty in model parameters had no substantial effect on our results. Probability sensitivity analysis indicated that CGP was cost-effective at the assumed WTP threshold.ConclusionFor Chinese patients with L/M NPC, adding Chinese-developed anti-PD-1 antibody camrelizumab to the first-line GP chemotherapy may be cost-effective.

Project description:BackgroundThis study aims to evaluate the efficacy and safety of camrelizumab in combination with chemotherapy as a second-line treatment for patients with locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).MethodsIn this retrospective, single-center observational study, we collected medical records of patients with locally advanced, recurrent, or metastatic ESCC who received either camrelizumab combined with chemotherapy or chemotherapy alone as second-line treatment between July 1, 2019, and May 31, 2023. We evaluated short-term efficacy, including overall response rate (ORR) and disease control rate (DCR), as well as survival outcomes, including progression-free survival (PFS) and overall survival (OS). Safety was also assessed. Additionally, factors influencing OS in ESCC patients were analyzed.ResultsA total of 60 patients with locally advanced, recurrent, or metastatic ESCC were included, with 30 receiving camrelizumab combined with chemotherapy and 30 receiving chemotherapy alone as second-line treatment. There were no statistically significant differences in ORR (33.33% vs. 13.33%) and DCR (73.33% vs. 56.67%) between the combination therapy and chemotherapy-alone groups (P > 0.05). However, the median PFS was significantly longer in the combination therapy group compared to the chemotherapy group (4.7 months vs. 3.4 months, P = 0.048). Additionally, the median OS was significantly improved in the combination therapy group compared to the chemotherapy group (11.7 months vs. 6.5 months, P = 0.003). Age and history of radical surgery were significantly associated with OS in patients receiving camrelizumab combined with chemotherapy as second-line treatment (P < 0.05).ConclusionSecond-line treatment with camrelizumab combined with chemotherapy is well-tolerated and associated with favorable oncological outcomes in patients with locally advanced, recurrent, or metastatic ESCC. Furthermore, younger patients and those who have undergone radical surgery may derive greater benefit from camrelizumab combined with chemotherapy as a second-line treatment.

Project description:Programmed cell death 1 (PD-1) inhibitor revives the killing effect of immune cells to prevent tumor progression. The present study aimed to evaluate the efficacy and safety of first-line PD-1 inhibitor + chemotherapy vs. standard treatment in recurrent or metastatic (R/M) oral squamous cell carcinoma (OSCC). A total of 51 patients with R/M OSCC were reviewed and divided into the PD-1 inhibitor + chemotherapy (n=21) and standard treatment (n=30) groups based on their actual treatments. The results of the present study demonstrated that the objective response rate (52.4 vs. 36.7%, P=0.265) and disease control rate (81.0 vs. 70.0%, P=0.377) were numerically elevated in the PD-1 inhibitor + chemotherapy group compared with those in the standard treatment group; however, the results did not reach statistical significance. The progression-free survival (PFS) was numerically increased (without statistical significance) in the PD-1 inhibitor + chemotherapy group compared with that of the standard treatment group (P=0.057). Specifically, the PD-1 inhibitor + chemotherapy group and the standard treatment group exhibited a median [95% confidence interval (CI)] PFS duration of 6.7 (1.6-11.8) and 5.2 (3.4-7.0) months, respectively. In addition, the PD-1 inhibitor + chemotherapy group demonstrated increased overall survival (OS) compared with that of the standard treatment group (P=0.032). Specifically, the PD-1 inhibitor + chemotherapy group and the standard treatment group exhibited a median (95% CI) OS duration of 18.3 (11.9-24.7) and 10.3 (7.9-12.7) months, respectively. Furthermore, multivariate Cox regression analysis indicated that PD-1 inhibitor + chemotherapy was independently associated with improved PFS [hazard ratio (HR)=0.308, P=0.002] and OS (HR=0.252, P=0.003). In addition, the incidence of grade 3-5 adverse events (AEs) was relatively low in both groups and the incidence of any grade of each AE was not significantly different between groups (all P>0.050). In conclusion, the first-line PD-1 inhibitor + chemotherapy group had improved efficacy and comparable safety compared with those of the standard treatment in patients with R/M OSCC.

Dataset Information

A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma.

Publications

A pilot study of camrelizumab with docetaxel and cisplatin for the first line treatment in recurrent/metastatic oral squamous cell carcinoma.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets