目的:探讨复方苦参注射液对转移性肾癌患者免疫功能的影响。方法:将71例转移性肾癌患者随机分为两组,对照组38例,用白细胞介素-2(IL-2)和干扰素-α(IFN-α)治疗,治疗组33例,在常规治疗的基础上加用复方苦参注射液20 m L静脉滴注;于治疗...目的:探讨复方苦参注射液对转移性肾癌患者免疫功能的影响。方法:将71例转移性肾癌患者随机分为两组,对照组38例,用白细胞介素-2(IL-2)和干扰素-α(IFN-α)治疗,治疗组33例,在常规治疗的基础上加用复方苦参注射液20 m L静脉滴注;于治疗前1周、治疗后1个月分别监测患者外周血CD3+、CD4+、CD8+、CD4+/CD8+比值免疫功能指标。结果:两组治疗后CD3+、CD4+和CD4+/CD8+比值上升,CD8+细胞比例下降,与治疗前比较,差异均具有显著性(P<0.05)。治疗后治疗组各项指标变化与对照组比较,差异有统计学意义(P<0.05)。结论:在常规IL-2和IFN-α治疗的基础上联合复方苦参注射液能够进一步提高转移性肾癌患者细胞免疫功能。展开更多
Background Sunitinib has been proved an effective new option for treatment of metastatic renal cell carcinoma （mRCC）. Analysis of clinical data of 22 patients, who were exposed to sunitinib for at least 1 year, was ...Background Sunitinib has been proved an effective new option for treatment of metastatic renal cell carcinoma （mRCC）. Analysis of clinical data of 22 patients, who were exposed to sunitinib for at least 1 year, was conducted to evaluate the long-term efficacy and safety of sunitinib for the treatment of mRCC. Methods A total of 54 patients with mRCC were treated with sunitinib malate, 50 mg/d orally, on a 4-weeks-on and 2-weeks-off dosing schedule in Peking University First Hospital. Treatment continued until disease progression, unacceptable adverse events （AEs）, or death. Among them, 22 patients continued treatment for at least I year. The clinical data of these 22 patients were prospectively collected for analysis. AEs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0. Tumor response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors. Results Median progression-free survival was 19.5 months until last follow-up. The best efficacy results achieved were complete response, partial response, and stable disease for 2, 9, and 11 patients, respectively. Objective response rate was 50%. The most common AEs were hand-foot syndrome （95%） and hypertension （91%）. Other common AEs were thyroid-stimulating hormone elevation （82%）, platelet decrease （77%）, and loss of appetite （77%）. Only one patient withdrew from treatment for cardiac infarction. Another nine patients experienced dose modifications or short-term suspensions. Conclusion Long-term exposure to sunitinib malate showed encouraging efficacy in the treatment of mRCC. At the same time, the tolerability was good.展开更多
In the case presented here, everolimus was administered after first line therapy with sunitinib in a patient with metastatic renal cell carcinoma. The safety profile was excellent. The prolonged progression-free survi...In the case presented here, everolimus was administered after first line therapy with sunitinib in a patient with metastatic renal cell carcinoma. The safety profile was excellent. The prolonged progression-free survival(PFS) obtained with everolimus in this case is of peculiar interest, as it is a multiple of the median PFS obtained in with everolimus in the regulatory trial. Such finding suggests that a subset of patients with renal cell carcinma may particularly benefit from everolimus.展开更多
Background: Sorafenib and sunitinib are widely used as first-line targeted therapy for metastatic renal cell carcinoma(mRCC) in China.This study aimed to compare the efficacy, safety, and quality of life(QoL) in Chine...Background: Sorafenib and sunitinib are widely used as first-line targeted therapy for metastatic renal cell carcinoma(mRCC) in China.This study aimed to compare the efficacy, safety, and quality of life(QoL) in Chinese mRCC patients treated with sorafenib and sunitinib as first-line therapy.Methods: Clinical data of patients with mRCC who received sorafenib(400 mg twice daily; 4 weeks) or sunitinib(50 mg twice daily; on a schedule of 4 weeks on treatment followed by 2 weeks off) were retrieved. Primary outcomes were overall survival(OS), progression-free survival(PFS), adverse events(AEs), and QoL(SF-36 scores), and secondary outcomes were associations of clinical characteristics with QoL.Results: Medical records of 184 patients(110 in the sorafenib group and 74 in the sunitinib group) were reviewed.PFS and OS were comparable between the sorafenib and sunitinib groups(both P > 0.05).The occurrence rates of leukocytopenia, thrombocytopenia, and hypothyroidism were higher in the sunitinib group(36.5% vs. 10.9%,P< 0.001; 40.5% vs. 10.9%, P < 0.001; 17.6% vs. 3.6%, P = 0.001), and that of diarrhea was higher in the sorafenib group(62.7% vs. 35.2%, P < 0.001). There was no significant difference in SF-36 scores between the two groups. Multivariate analysis indicated that role-physical and bodily pain scores were associated with the occurrence rate of grade 3 or 4 AEs(P = 0.017 and 0.005).Conclusions: Sorafenib has comparable efficacy and lower toxicity profile than sunitinib as first-line therapy for mRCC. Both agents showed no significant impact on QoL of patients.展开更多
文摘目的:探讨复方苦参注射液对转移性肾癌患者免疫功能的影响。方法:将71例转移性肾癌患者随机分为两组,对照组38例,用白细胞介素-2(IL-2)和干扰素-α(IFN-α)治疗,治疗组33例,在常规治疗的基础上加用复方苦参注射液20 m L静脉滴注;于治疗前1周、治疗后1个月分别监测患者外周血CD3+、CD4+、CD8+、CD4+/CD8+比值免疫功能指标。结果:两组治疗后CD3+、CD4+和CD4+/CD8+比值上升,CD8+细胞比例下降,与治疗前比较,差异均具有显著性(P<0.05)。治疗后治疗组各项指标变化与对照组比较,差异有统计学意义(P<0.05)。结论:在常规IL-2和IFN-α治疗的基础上联合复方苦参注射液能够进一步提高转移性肾癌患者细胞免疫功能。
文摘Background Sunitinib has been proved an effective new option for treatment of metastatic renal cell carcinoma （mRCC）. Analysis of clinical data of 22 patients, who were exposed to sunitinib for at least 1 year, was conducted to evaluate the long-term efficacy and safety of sunitinib for the treatment of mRCC. Methods A total of 54 patients with mRCC were treated with sunitinib malate, 50 mg/d orally, on a 4-weeks-on and 2-weeks-off dosing schedule in Peking University First Hospital. Treatment continued until disease progression, unacceptable adverse events （AEs）, or death. Among them, 22 patients continued treatment for at least I year. The clinical data of these 22 patients were prospectively collected for analysis. AEs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0. Tumor response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors. Results Median progression-free survival was 19.5 months until last follow-up. The best efficacy results achieved were complete response, partial response, and stable disease for 2, 9, and 11 patients, respectively. Objective response rate was 50%. The most common AEs were hand-foot syndrome （95%） and hypertension （91%）. Other common AEs were thyroid-stimulating hormone elevation （82%）, platelet decrease （77%）, and loss of appetite （77%）. Only one patient withdrew from treatment for cardiac infarction. Another nine patients experienced dose modifications or short-term suspensions. Conclusion Long-term exposure to sunitinib malate showed encouraging efficacy in the treatment of mRCC. At the same time, the tolerability was good.
文摘In the case presented here, everolimus was administered after first line therapy with sunitinib in a patient with metastatic renal cell carcinoma. The safety profile was excellent. The prolonged progression-free survival(PFS) obtained with everolimus in this case is of peculiar interest, as it is a multiple of the median PFS obtained in with everolimus in the regulatory trial. Such finding suggests that a subset of patients with renal cell carcinma may particularly benefit from everolimus.
基金supported by the National Natural Science Foundation of China(Nos.81402084,81472378)the Shanghai Municipal Commission of Health and Family Planning(No.2013SY027)the Incubating Program for Clinical Research and Innovation of Renji Hospital(No.PYXJS16-008)
文摘Background: Sorafenib and sunitinib are widely used as first-line targeted therapy for metastatic renal cell carcinoma(mRCC) in China.This study aimed to compare the efficacy, safety, and quality of life(QoL) in Chinese mRCC patients treated with sorafenib and sunitinib as first-line therapy.Methods: Clinical data of patients with mRCC who received sorafenib(400 mg twice daily; 4 weeks) or sunitinib(50 mg twice daily; on a schedule of 4 weeks on treatment followed by 2 weeks off) were retrieved. Primary outcomes were overall survival(OS), progression-free survival(PFS), adverse events(AEs), and QoL(SF-36 scores), and secondary outcomes were associations of clinical characteristics with QoL.Results: Medical records of 184 patients(110 in the sorafenib group and 74 in the sunitinib group) were reviewed.PFS and OS were comparable between the sorafenib and sunitinib groups(both P > 0.05).The occurrence rates of leukocytopenia, thrombocytopenia, and hypothyroidism were higher in the sunitinib group(36.5% vs. 10.9%,P< 0.001; 40.5% vs. 10.9%, P < 0.001; 17.6% vs. 3.6%, P = 0.001), and that of diarrhea was higher in the sorafenib group(62.7% vs. 35.2%, P < 0.001). There was no significant difference in SF-36 scores between the two groups. Multivariate analysis indicated that role-physical and bodily pain scores were associated with the occurrence rate of grade 3 or 4 AEs(P = 0.017 and 0.005).Conclusions: Sorafenib has comparable efficacy and lower toxicity profile than sunitinib as first-line therapy for mRCC. Both agents showed no significant impact on QoL of patients.
