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OBJECTIVE To evaluate the economics of serplulimab combined with chemotherapy regimens for the first-line treatment of extensive-stage small cell lung cancer （ES-SCLC） from the perspective of health system in China. METHODS A partitioned survival model was constructed based on the ASTRUM-005 clinical trial and related literature data， with a model simulation time frame of 10 years and a 3-week cycle， and both cost and utility values were discounted using a 5% discount rate. The quality-adjusted life year （QALY） was used as a model output indicator and the incremental cost-effectiveness ratio （ICER） was calculated to evaluate the economics of serplulimab combined with chemotherapy regimens （serplulimab group） versus chemotherapy alone regimens （chemotherapy alone group） for the first-line treatment of ES-SCLC. One-way sensitivity analysis and probabilistic sensitivity analysis were used to verify the robustness of the results of the base-case analysis and to conduct a scenario analysis for the serplulimab patient assistance program. RESULTS The results of the base-case analysis showed that compared with chemotherapy alone group， ICER of serplulimab group was 758 690.27 yuan/QALY， which was higher than 3 times China’s per capita gross domestic product （GDP） in 2022 as the willingness-to-pay （WTP） threshold. The results of the scenario analysis showed that compared with chemotherapy alone group， the ICER of serplulimab group was 172 275.74 yuan/QALY， which was below above WTP threshold. The one-way sensitivity analysis showed that the progress-free survival utility value， serplulimab price and so on had a significant impact on the model results. The results of the probabilistic sensitivity analysis showed that the probability of the serplulimab group being economic was 0 when the serplulimab patient assistance program was not considered， but 100% when the patient assistance program was considered. CONCLUSIONS At a WTP threshold of 3 times China’s per capita GDP in 2022， the serplulimab group is no cost-effectiveness compared to the chemotherapy alone group； however， this result is reversed when the patient assistance program is taken into account.
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【Objective】 To retrospectively analyze the average carboplatin dosage and calculate the area under the curve (AUC) using the Calvert formula in first-line chemotherapy in patients with epithelial ovarian cancer in The First Affiliated Hospital of Xi’an Jiaotong University so as to evaluate the effect of the AUC difference in the Chinese population on therapeutic efficacy and safety. 【Methods】 We enrolled patients who underwent first-line chemotherapy with paclitaxel and carboplatin 3-week regimen in our hospital from January 1, 2012 to January 1, 2022. According to the median of AUC, the patients were divided into high-dose group and low-dose group. The overall response rate (ORR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and the incidence of adverse events (AEs) were compared. 【Results】 A total of 153 patients were enrolled in this study and the median AUC of carboplatin was 3.981 (range 2.314-5.446). Only 10.46% patients (16/153) had an AUC above 5. There were 77 patients with the AUC0.05). The ORR in the low-dose group and the high-dose group was 59.74% and 57.89%, respectively, and the DCR was 87.01% and 85.53%, respectively. The median PFS of the two groups was 14 and 15.5 months, respectively, and the median OS was 50 and 55 months, respectively. None of the above outcomes were statistically different between the two groups (P>0.05). The two groups showed significant differences in the incidence of anemia, neutropenia, and thrombocytopenia (P<0.05). The incidence of nausea and vomiting, grade 1-2 diarrhea or constipation, and grade 1-2 fever showed significant differences (P<0.05). In addition, the incidence of dose limiting toxicity (DLT), including grade 4 thrombocytopenia and febrile neutropenia (FN), was significantly increased in the high-dose group (P<0.05). 【Conclusion】 Compared with the recommended AUC 5-6 of carboplatin abroad, the actual carboplatin dosage in the first-line chemotherapy for patients with epithelial ovarian cancer was generally insufficient in our hospital. There was no difference in therapeutic efficacy between the patients with AUC<4 and AUC≥4. However, considering the increased risk of some AEs and DLT in the high-dose group, it is not recommended to increase the carboplatin AUC blindly.
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BACKGROUND@#Human epidermal growth factor receptor 2 (HER2) is one of the driver genes of non-small cell lung cancer (NSCLC). Several studies have shown that the efficacy of pemetrexed in HER2-mutant NSCLC is controversial. The aim of this study is to investigate the efficacy of pemetrexed combined with platinum chemotherapy in patients with HER2-mutant and HER2 wild-type lung adenocarcinoma.@*METHODS@#The clinical data of 106 cases of EGFR, ALK, ROS-1, KRAS, BRAF, RET and MET-negative patients with advanced lung adenocarcinoma patients who diagnosed by histopathology in the First Affiliated Hospital of Zhengzhou University were retrospectively reviewed. The relationships between HER2 gene status, clinical characteristics and response and progression-free survival (PFS) were analyzed.@*RESULTS@#All of the 106 patients' HER2 status were determined. HER2 mutations occurred in 32 cases (30.2%), no mutations in 74 cases (69.8%). HER2 mutations were common in young, non-smoking and female patients. All patients received first-line pemetrexed and platinum-based chemotherapy. The objective response rate (ORR) and disease control rate (DCR) of patients with HER2-mutant lung adenocarcinoma were significantly higher than those without HER2 mutations (40.6% vs 14.9%, χ²=8.464, P=0.004; 93.8% vs 68.9%, χ²=6.327, P=0.012), and the difference was statistically significant. According to univariate analysis, the PFS was significantly associated with the brain metastases, maintenance chemotherapy and HER2 gene status (P0.05). Cox multivariate analysis indicated that HER2 mutation was an independent positive prognostic factor of PFS (P=0.038).@*CONCLUSIONS@#HER2-mutant lung adenocarcinoma patients with first-line pemetrexed combined with platinum chemotherapy have greater clinical benefit than HER2 wild-type patients.
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Aged , Female , Humans , Male , Middle Aged , Adenocarcinoma of Lung , Drug Therapy , Genetics , Pathology , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Disease-Free Survival , Genes, erbB-2 , Genetics , Mutation , Pemetrexed , Therapeutic Uses , Platinum , Therapeutic Uses , Retrospective Studies , Treatment OutcomeABSTRACT
Objective In patients with non -small cell lung cancer(NSCLC)undergoing radical surgery,there were still many inevitable recurrences and distant metastases,even after systemic postoperative adjuvant chemotherapy.At the same time,many patients were in the stage Ⅳ at the time of initial treatment.The aims of this study were to investigate and compare the first-line chemotherapy(First-line Chemotherapy at Recurrence Post-adjuvant Chemotherapy,FCRPC)in NSCLC patients with distant metas-tasis after adjuvant chemotherapy with initial treatment at the phase Ⅳ of NSCLC patients with first-line chemotherapy(Initial First-line Chemotherapy,IFC).Methods A total of 603 patients with distant metastatic NSCLC were collected in this study.Among them,73 of them were FCRPC and 530 of them for IFC.Statistical methods for propensity score matching were used to balance the clinical features between FCRPC and IFC groups.Chi-square test was used to compare the short-term efficacy between FCRPC and IFC groups.Survival analysis was performed using regression analysis and Kaplan-Meier analysis.Results There was no significant difference in objective response rate(ORR)and disease control rate(DCR)between FCRPC and IFC groups in NSCLC patients with dis-tant metastases(ORR rate:27.46% in the FCRPC group,24.7% in the PFC group,P=0.851 and DCR rate:78.1% in the FCRPC group,65.6% in the PFC group,P=0.140).There was also no significant difference in the median progression-free survival(9.8 months in the FCRPC group and 8.5 months in the PFC group,P=0.337)and median overall survival(20.0 months in the FCRPC group and 14.4 months in the PFC group,P=0.087).Conclusion There is no significant difference in the prognosis of first-line chemotherapy between NSCLC patients with distant metastases and with initial treatment at the stageⅣafter adjuvant chemotherapy.
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Objective: After establishing standard multi-modal therapy, prognosis of refractory and metastatic high-grade osteosarcoma remains dismal and unchanged over the last decades. Early clinical intervention to newly detected metastatic lesions is crucial and effective for better prognosis. Arsenic trioxide (ATO) is one of the oldest remedies used in traditional oriental medicine and is recently rediscovered as an immunomodulator due to its activity against other solid tumors. This study aims to evaluate the efficiency of ATO combined with first-line chemotherapy in treating pulmonary metastatic osteosarcoma patients with long-term follow-up in our institution.Methods: Osteosarcoma patients with pulmonary metastasis were intravenously administered with ATO (5-10 mg) daily combined with first-line chemotherapy for their treatment. A total of 119 patients were finally enrolled; 65 presented metastasis, and 54 relapsed with lung metastasis. Results: Two-year and five-year overall survival (OS) rates for these patients reached 52.6% and 30.9%, respectively. Only 20 cases underwent thoracotomies (16.8%). Our five-year OS was nearly similar to that of other institutions (37% in Rizzoli, Italy). We observed that combined with bone metastasis, bilateral metastasis, and >3 pulmonary nodules, incomplete resection of pulmonary lesions deteriorated the disease and significantly influenced survival as compared with all other parameters. Conclusion:Combined with conventional chemotherapy, ATO may be effective and well-tolerated as new therapeutic option for patients with nonresectable pulmonary metastatic osteosarcoma. Lung metastasectomy should be strictly selected only for populations who benefit from this treatment.
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Objective: To explore the impact of dose intensity of first-line chemotherapy on disease control rate (DCR) and overall survival (OS) of patients with metastatic colorectal cancer (mCRC). Methods: The clinical data of 37 patients with mCRC from March 2012 to December 2015 were retrospectively analyzed. All of the patients received FOLFOX regimen as first-line chemotherapy in Tianjin Medical University Cancer Institute and Hospital. The values of 80%, 75% and 85% were respectively used as the cutoff points of relative dose intensity (RDI) of oxaliplatin, 5-fluorouracil and the average RDI (ARDI). Kaplan-Meier method and log-rank test were used for univariate survival analysis and the COX proportional hazard regression model was used for multivariate survival analysis. Results: The DCRs of oxaliplatin RDI ≥80% group, 5-fluorouracil RDI ≥75% group and ARDI ≥ 85% group were respectively higher than those of oxaliplatin RDI 0.05). Kaplan-Meier univariate survival analysis showed that age, subsequent surgery, subsequent chemotherapy, first-line oxaliplatin RDI, first-line 5-fluorouracil RDI and serum carbohydrate antigen (CA) 19-9 level before chemotherapy had effects on OS of patients with mCRC (all P 0.05). COX multivariate analysis showed that subsequent surgery, subsequent chemotherapy and first-line oxaliplatin RDI were independent prognostic factors for OS (all P < 0.05) of mCRC patients. Conclusion: First-line oxaliplatin RDI is an independent prognostic factor for patients with mCRC. Patients who received first-line oxaliplatin RDI≥80% have better OS than those who received first-line oxaliplatin RDI < 80%. These findings throw light on the standardized chemotherapy for advanced colorectal cancer patients.
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Background and purpose: Docetaxel/cisplatin are widely used in chemo-naive patients with advanced non-small cell lung cancer(NSCLC),but the standard 3-weeks'project of docetaxel caused significant toxicity.We performed this study to compare the effect and toxicity of modified and standard 3-weeks'docetaxel/cisplatin as first line chemotherapy for advanced NSCLC.Methods:68 patients with stage ⅢB or Ⅳ NSCLC(proven by histology or cytology) were randomly divided into two groups,modified(A) and standard(B) chemotherapy.Group A: docetaxel 75 mg/m2,divided into 2 days,ivgtt d1 and d 8,cisplatin 25 mg/(m2?d),ivgtt d 1-d 3,q3w;Group B: docetaxel 75 mg/m2,ivgtt d 1,cisplatin was administered as Group A,q3w.The effect and toxicity were assessed after two cycles and one-year survival was followed up.Results:There was no CR in both groups.10 PR,20 SD,4 PD were found in group A,the overall response rate is 29%;whereas 11 PR,20 SD,3 PD were found in group B,the overall response rate is 32%.The one-year survival rate were 38% and 35% in group A and B,respectively.There were no significant difference about the overall response rate(P=0.793) and one-year survival rate(P=0.801) between group A and B.The rates of grade Ⅲ/Ⅳ neutropenia were 18% and 47% in group A and B respectively.The difference was statistically significant(P=0.010).Conclusions:In comparison with the standard 3-weeks'docetaxel/ cisplatin chemotherapy,the modified one has similar response rate but lower hematologic toxicity,and thus it was well tolerated.
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0.05). The adverse reaction rates of the two regimen were no statistical difference. CONCLUSION: The 2-week regimen and the 3-week regimen of L-OHP combined with 5-FU/CF have the same efficacy in MCC patients.