BACKGROUND Owing to the absence of specific symptoms in early-stage gastric cancer,most patients are diagnosed at intermediate or advanced stages.As a result,treatment often shifts from surgery to other therapies,with...BACKGROUND Owing to the absence of specific symptoms in early-stage gastric cancer,most patients are diagnosed at intermediate or advanced stages.As a result,treatment often shifts from surgery to other therapies,with chemotherapy and targeted therapies being the primary options for advanced gastric cancer treatment.A total of 116 patients with advanced gastric cancer,admitted from January 2021 to December 2023,were selected and divided into two groups of 58 each using the random number table method.The control group received FOLFOX4 chemothe-rapy(oxaliplatin+calcium+folinate+5-fluorouracil)combined with intravenous sindilizumab.The observation group received the same treatment as the control group,supplemented by oral administration of Senqi Shiyiwei granules.Both groups underwent treatment cycles of 3 weeks,with a minimum of two cycles.The therapeutic efficacy,immune mechanisms,and treatment-related toxicity and side effects were compared between the groups.The objective remission rate in the observation group(55.17%)was higher than that of the control group(36.21%)(P<0.05).After two treatment cycle,CD3+,CD4+,and CD4+/CD8+levels were higher in the observation group compared to the control group,while CD8+,regulatory T cells,and natural killer cells were lower(P<0.05).Additionally,the incidence of leukopenia,nausea,and vomiting was lower in observed group(P<0.05).No significant differences were observed in the incidence of other adverse reactions(P>0.05).CONCLUSION Adjuvant therapy with Shenqixian granules may enhance the efficacy of simudizumab combined with FOLFOX4 chemotherapy in advanced gastric cancer and the immune function by increasing immune cell counts,making it a valuable option in clinical treatment.展开更多
Objective: To determine the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) and efficacy of sorafenib in combination with FOLFOX4(oxaliplatin/leucovorin(LV)/5-fluorouracil) as first-line treatment fo...Objective: To determine the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) and efficacy of sorafenib in combination with FOLFOX4(oxaliplatin/leucovorin(LV)/5-fluorouracil) as first-line treatment for advanced gastric cancer, we performed a phase I dose-finding study in nine evaluable patients with unresectable locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Methods: According to modified Fibonacci method, the design of this study was to guide elevation of the sorafenib dosage to the next level(from 200 mg twice daily to 400 mg twice daily and then, if tolerated, 600 mg twice daily). If the patient achieved complete response(CR), partial response(PR) or stable disease(SD) after eight cycles of treatment, combination chemotherapy was scheduled to be discontinued and sorafenib monotherapy continued at the original dose until either disease progression or unacceptable toxicity. Results: In sorafenib 200 mg twice daily group, DLT was observed in 1 of 6 patients, and in 400 mg twice daily group, it was observed in 2 of 3 patients. Seven of 9(77.8%) evaluable patients achieved PR, with a median overall survival(OS) of 11.8 [95% confidence interval(CI): 8.9-14.7] months. Common adverse effects include hand-foot syndrome, leukopenia, neutropenia, anorexia, and nausea.Conclusions: Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 was proven effective and safe for the treatment of advanced gastric cancer, and could be an appropriate dosage for subsequent phase II clinical studies.展开更多
Objective: To evaluate the therapeutic as well as side effects of hydroxycamptothecin (HCPT) plus FOLFOX4 regimen as salvage therapy for patients with advanced gastric cancer. Methods: A total of 19 patients with adva...Objective: To evaluate the therapeutic as well as side effects of hydroxycamptothecin (HCPT) plus FOLFOX4 regimen as salvage therapy for patients with advanced gastric cancer. Methods: A total of 19 patients with advanced gastric cancer received HCPT plus FOLFOX4 as salvage therapy, in detail, Oxaliplatin 85 mg/m2 was given intravenously on day 1, CF 200 mg/m2, 5-Fu 400 mg/m2 given in bolus immediately after CF, days 1-2; 5-Fu 600 mg/m2 given continuously after bolus for 22 h on day 1, day 2, HCPT given intravenously at dosage of 10 mg/m2 on days 1-2. Therapeutic effects were evaluated at least after two cycles of treatment. Results: 17 cases among the 19 patients were valid for response evaluation, with CR 1 , PR 6, SD 4, PD 6. The response rate was 41.2%. For the 12 patients with liver metastasis, response rate of the liver foci was 50%. The main toxicities were bone marrow suppression, nausea and vomiting, and peripheral neuropathy; there were no chemotherapy-related deaths. Conclusion: The combination regimen with HCPT plus FOFLOX4 regimen was effective as salvage therapy for patients with advanced gastric cancer, with particularly high response rate for liver metastasis, and the side effects were tolerable and manageable.展开更多
文摘BACKGROUND Owing to the absence of specific symptoms in early-stage gastric cancer,most patients are diagnosed at intermediate or advanced stages.As a result,treatment often shifts from surgery to other therapies,with chemotherapy and targeted therapies being the primary options for advanced gastric cancer treatment.A total of 116 patients with advanced gastric cancer,admitted from January 2021 to December 2023,were selected and divided into two groups of 58 each using the random number table method.The control group received FOLFOX4 chemothe-rapy(oxaliplatin+calcium+folinate+5-fluorouracil)combined with intravenous sindilizumab.The observation group received the same treatment as the control group,supplemented by oral administration of Senqi Shiyiwei granules.Both groups underwent treatment cycles of 3 weeks,with a minimum of two cycles.The therapeutic efficacy,immune mechanisms,and treatment-related toxicity and side effects were compared between the groups.The objective remission rate in the observation group(55.17%)was higher than that of the control group(36.21%)(P<0.05).After two treatment cycle,CD3+,CD4+,and CD4+/CD8+levels were higher in the observation group compared to the control group,while CD8+,regulatory T cells,and natural killer cells were lower(P<0.05).Additionally,the incidence of leukopenia,nausea,and vomiting was lower in observed group(P<0.05).No significant differences were observed in the incidence of other adverse reactions(P>0.05).CONCLUSION Adjuvant therapy with Shenqixian granules may enhance the efficacy of simudizumab combined with FOLFOX4 chemotherapy in advanced gastric cancer and the immune function by increasing immune cell counts,making it a valuable option in clinical treatment.
基金supported by the Chinese National Major Project for New Drug Innovation(2008ZX09312,2012ZX09303012)Bayer Health Care Ltd.for partial financial support and Content Ed Net(Shanghai)Co.,Ltd.for editorial support
文摘Objective: To determine the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) and efficacy of sorafenib in combination with FOLFOX4(oxaliplatin/leucovorin(LV)/5-fluorouracil) as first-line treatment for advanced gastric cancer, we performed a phase I dose-finding study in nine evaluable patients with unresectable locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Methods: According to modified Fibonacci method, the design of this study was to guide elevation of the sorafenib dosage to the next level(from 200 mg twice daily to 400 mg twice daily and then, if tolerated, 600 mg twice daily). If the patient achieved complete response(CR), partial response(PR) or stable disease(SD) after eight cycles of treatment, combination chemotherapy was scheduled to be discontinued and sorafenib monotherapy continued at the original dose until either disease progression or unacceptable toxicity. Results: In sorafenib 200 mg twice daily group, DLT was observed in 1 of 6 patients, and in 400 mg twice daily group, it was observed in 2 of 3 patients. Seven of 9(77.8%) evaluable patients achieved PR, with a median overall survival(OS) of 11.8 [95% confidence interval(CI): 8.9-14.7] months. Common adverse effects include hand-foot syndrome, leukopenia, neutropenia, anorexia, and nausea.Conclusions: Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 was proven effective and safe for the treatment of advanced gastric cancer, and could be an appropriate dosage for subsequent phase II clinical studies.
文摘Objective: To evaluate the therapeutic as well as side effects of hydroxycamptothecin (HCPT) plus FOLFOX4 regimen as salvage therapy for patients with advanced gastric cancer. Methods: A total of 19 patients with advanced gastric cancer received HCPT plus FOLFOX4 as salvage therapy, in detail, Oxaliplatin 85 mg/m2 was given intravenously on day 1, CF 200 mg/m2, 5-Fu 400 mg/m2 given in bolus immediately after CF, days 1-2; 5-Fu 600 mg/m2 given continuously after bolus for 22 h on day 1, day 2, HCPT given intravenously at dosage of 10 mg/m2 on days 1-2. Therapeutic effects were evaluated at least after two cycles of treatment. Results: 17 cases among the 19 patients were valid for response evaluation, with CR 1 , PR 6, SD 4, PD 6. The response rate was 41.2%. For the 12 patients with liver metastasis, response rate of the liver foci was 50%. The main toxicities were bone marrow suppression, nausea and vomiting, and peripheral neuropathy; there were no chemotherapy-related deaths. Conclusion: The combination regimen with HCPT plus FOFLOX4 regimen was effective as salvage therapy for patients with advanced gastric cancer, with particularly high response rate for liver metastasis, and the side effects were tolerable and manageable.