AIM:To evaluate the efficacy and toxicity of nedaplatin(NDP)concurrent with radiotherapy in the treatment of locally advanced esophageal carcinoma.METHODS:Sixty-eight patients with locally advanced esophageal carcinom...AIM:To evaluate the efficacy and toxicity of nedaplatin(NDP)concurrent with radiotherapy in the treatment of locally advanced esophageal carcinoma.METHODS:Sixty-eight patients with locally advanced esophageal carcinoma were randomized into either a NDP group(n=34)or a cisplatin(DDP)group(n=34).The NDP group received NDP 80-100 mg/m2iv on day 1+leucovorin(CF)100 mg/m2iv on days 1-5+5-fluorouracil(5-FU)500 mg/m2iv on days 1-5.The DDP group received DDP 30 mg/m2iv on days 1-3+CF 100 mg/m2on days 1-5+5-FU 500 mg/m2iv on days 1-5.The treatment was repeated every 4 wk in both groups.Concurrent radiotherapy[60-66 Gy/(30-33f)/(6-7 wk)]was given during chemotherapy.RESULTS:There was no significant difference in the short-term response rate between the NDP group and DDP group(90.9%vs 81.3%,P=0.528).Although the 1-and 2-year survival rates were higher in the NDP group than in the DDP group(75.8%vs 68.8%,57.6%vs 50.0%),the difference in the overall survival rate was not statistically significant between the two groups(P=0.540).The incidences of nausea,vomiting and nephrotoxicity were significantly lower in the NDP group than in the DDP group(17.6%vs 50.0%,P=0.031;11.8%vs 47.1%,P=0.016;8.8%vs 38.2%,P=0.039).There was no significant difference in the incidence of myelosuppression,radiation-induced esophagitis or radiation-induced pneumonia between the two groups.CONCLUSION:NDP-based concurrent chemoradiotherapy is effective and well-tolerated in patients with locally advanced esophageal carcinoma.NDP-based regimen has comparable efficacy to DDP-based regimen but is associated with lower incidences of gastrointestinal and renal toxicity.展开更多
AIM:To evaluate the efficacy and safety of paclitaxelnedaplatin combination as a front-line regimen in Chinese patients with metastatic esophageal squamous cell carcinoma(ESCC).METHODS:A two-center,open-label,single-a...AIM:To evaluate the efficacy and safety of paclitaxelnedaplatin combination as a front-line regimen in Chinese patients with metastatic esophageal squamous cell carcinoma(ESCC).METHODS:A two-center,open-label,single-arm phaseⅡstudy was designed.Thirty-nine patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events.Patients received 175mg/m2of paclitaxel over a 3 h infusion on 1 d,followed by nedaplatin 80 mg/m2in a 1 h infusion on 2 d every3 wk until the documented disease progression,unac-ceptable toxicity or patient’s refusal.RESULTS:Of the 36 patients assessable for efficacy,there were 2 patients(5.1%)with complete response and 16 patients(41.0%)with partial response,giving an overall response rate of 46.1%.The median progression-free survival and median overall survival for all patients were 7.1 mo(95%CI:4.6-9.7)and 12.4 mo(95%CI:9.5-15.3),respectively.Toxicities were moderate and manageable.Grade 3/4 toxicities included neutropenia(15.4%),nausea(10.3%),anemia(7.7%),thrombocytopenia(5.1%),vomiting(5.1%)and neutropenia fever(2.6%).CONCLUSION:The combination of paclitaxel and nedaplatin is active and well tolerated as a first-line therapy for patients with metastatic ESCC.展开更多
BACKGROUND Syndrome of inappropriate secretion of antidiuretic hormone(SIADH)is relatively common in several cancers,such as small cell lung cancer.However,nedaplatin-induced SIADH is rare.We describe a case of SIADH ...BACKGROUND Syndrome of inappropriate secretion of antidiuretic hormone(SIADH)is relatively common in several cancers,such as small cell lung cancer.However,nedaplatin-induced SIADH is rare.We describe a case of SIADH mediated by nedaplatin.CASE SUMMARY A 54-year-old female with nasopharyngeal carcinoma was treated with nedaplatin and developed severe hyponatremia due to SIADH.The side effects were successfully treated by fluid restriction and sodium supplementation.CONCLUSION This case report highlights the importance of cautiously treating life-threatening hyponatremia in patients treated with nedaplatin.展开更多
BACKGROUND Patients with recurrent or locally advanced head and neck squamous cell carcinoma(HNSCC)typically have limited treatment options and poor prognosis.AIM To evaluate the efficacy and safety of two drugs with ...BACKGROUND Patients with recurrent or locally advanced head and neck squamous cell carcinoma(HNSCC)typically have limited treatment options and poor prognosis.AIM To evaluate the efficacy and safety of two drugs with potent radio-sensitization properties including gemcitabine and nedaplatin as concurrent chemoradiotherapy regimens in treating HNSCC.METHODS This single-arm prospective study enrolled patients with HNSCC to receive gemcitabine on days 1 and 8 and nedaplatin on days 1 to 3 for 21 days.Intensitymodulated radiation therapy with a conventional fraction was delivered 5 days per week.Objective response rate(ORR),disease control rate,and toxicity were observed as primary endpoints.Overall survival(OS)and progression free survival were recorded and analyzed as secondary endpoints.RESULTS A total of 24 patients with HNSCC were enrolled.During the median 22.4-mo follow-up,both ORR and disease control rate were 100%.The one-year OS was 75%,and one-year progression-free survival(PFS)was 66.7%(median PFS was 15.1 mo).Recurrent HNSCC patients had a poorer prognosis than the treatment-naïve patients,and patients who achieved complete response had better survival than those in the PR group(all P<0.05).The most common grade 1-4(100%)or grade 3-4 toxicities(75%)were hematological,and the most common grade 3-4 non-hematological toxicity was mucositis in 17(71%)patients.CONCLUSION Gemcitabine plus nedaplatin with concurrent chemoradiotherapy is a therapeutic option for HNSCC with predictable tolerability.Considering the high adverse event rate,the optimized dose and schedule must be further explored.展开更多
Objective: To evaluate the efficacy and safety of nedaplatin/gemcitabine (NG) and carboplatin/gemcitabine (CG) in the management of untreated advanced non‐small cell lung cancer (NSCLC). Methods: Sixty‐two patients ...Objective: To evaluate the efficacy and safety of nedaplatin/gemcitabine (NG) and carboplatin/gemcitabine (CG) in the management of untreated advanced non‐small cell lung cancer (NSCLC). Methods: Sixty‐two patients with previously untreated advanced NSCLC were recruited between June 2006 and November 2007. Subjects were randomly assigned to the NG arm (n=30) and the CG arm (n=32). Only patients (24 and 25 in the NG and CG arms, respectively) who completed ≥2 chemotherapy cycles were included in the data analysis. The primary outcome measure was the objective response rate (ORR). The secondary outcome measures included progression‐free survival (PFS), overall survival (OS) and adverse events. Results: There were no statistically significant differences in the efficacy measures (ORR, P=0.305; median PFS, P=0.198; median OS, P=0.961) or in the major adverse events (grade 3/4 neutropenia, P=0.666; grade 3/4 anemia, P=0.263; grade 3/4 thrombocytopenia, P=0.212) between the two treatment arms. However, there was a trend towards higher ORR (37.5% vs. 24.0%), longer PFS (6.0 vs. 5.0 months), and less adverse events in the NG arm. Conclusion: NG regimen seems to be superior over CG regimen for advance NSCLS, but further investigation is needed to validate this superiority.展开更多
目的系统评价奈达铂联合紫杉醇同步放化疗治疗中晚期宫颈癌的效果与安全性。方法在中国知网、万方数据库、维普、中国生物医学文献数据库、Medline数据库、EMbase、PubMed、Web of Science中检索有关中晚期宫颈癌应用奈达铂联合紫杉醇...目的系统评价奈达铂联合紫杉醇同步放化疗治疗中晚期宫颈癌的效果与安全性。方法在中国知网、万方数据库、维普、中国生物医学文献数据库、Medline数据库、EMbase、PubMed、Web of Science中检索有关中晚期宫颈癌应用奈达铂联合紫杉醇同步放化疗治疗的随机对照试验(RCT),检索时限截至2022年7月,两名研究员独立阅读、筛选、提取资料并评价质量后,采用RevMan 5.4软件进行meta分析。结果共纳入22项RCT试验共计1627例患者,meta分析结果显示,与单纯放疗相比,奈达铂联合紫杉醇同步放化疗可显著提高患者的近期疗效[RR=1.59,95%CI(1.44,1.74),P<0.00001]和总生存率[RR=1.29,95%CI(1.21,1.37),P<0.00001];安全性指标差异均无统计学意义(P>0.05)。结论对于中晚期宫颈癌,奈达铂联合紫杉醇同步放化疗效优安全,可作为未来中晚期宫颈癌放化疗方案的新选择。但文章仍存在诸多局限性,有待更多高质量RCTs进一步验证并丰富研究结果。展开更多
文摘AIM:To evaluate the efficacy and toxicity of nedaplatin(NDP)concurrent with radiotherapy in the treatment of locally advanced esophageal carcinoma.METHODS:Sixty-eight patients with locally advanced esophageal carcinoma were randomized into either a NDP group(n=34)or a cisplatin(DDP)group(n=34).The NDP group received NDP 80-100 mg/m2iv on day 1+leucovorin(CF)100 mg/m2iv on days 1-5+5-fluorouracil(5-FU)500 mg/m2iv on days 1-5.The DDP group received DDP 30 mg/m2iv on days 1-3+CF 100 mg/m2on days 1-5+5-FU 500 mg/m2iv on days 1-5.The treatment was repeated every 4 wk in both groups.Concurrent radiotherapy[60-66 Gy/(30-33f)/(6-7 wk)]was given during chemotherapy.RESULTS:There was no significant difference in the short-term response rate between the NDP group and DDP group(90.9%vs 81.3%,P=0.528).Although the 1-and 2-year survival rates were higher in the NDP group than in the DDP group(75.8%vs 68.8%,57.6%vs 50.0%),the difference in the overall survival rate was not statistically significant between the two groups(P=0.540).The incidences of nausea,vomiting and nephrotoxicity were significantly lower in the NDP group than in the DDP group(17.6%vs 50.0%,P=0.031;11.8%vs 47.1%,P=0.016;8.8%vs 38.2%,P=0.039).There was no significant difference in the incidence of myelosuppression,radiation-induced esophagitis or radiation-induced pneumonia between the two groups.CONCLUSION:NDP-based concurrent chemoradiotherapy is effective and well-tolerated in patients with locally advanced esophageal carcinoma.NDP-based regimen has comparable efficacy to DDP-based regimen but is associated with lower incidences of gastrointestinal and renal toxicity.
基金Supported by Natural Science Foundation of Anhui Province No.070413256XMedical Research Foundation of Anhui Provincial Health Department No.2010B001 and No.13zc012
文摘AIM:To evaluate the efficacy and safety of paclitaxelnedaplatin combination as a front-line regimen in Chinese patients with metastatic esophageal squamous cell carcinoma(ESCC).METHODS:A two-center,open-label,single-arm phaseⅡstudy was designed.Thirty-nine patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events.Patients received 175mg/m2of paclitaxel over a 3 h infusion on 1 d,followed by nedaplatin 80 mg/m2in a 1 h infusion on 2 d every3 wk until the documented disease progression,unac-ceptable toxicity or patient’s refusal.RESULTS:Of the 36 patients assessable for efficacy,there were 2 patients(5.1%)with complete response and 16 patients(41.0%)with partial response,giving an overall response rate of 46.1%.The median progression-free survival and median overall survival for all patients were 7.1 mo(95%CI:4.6-9.7)and 12.4 mo(95%CI:9.5-15.3),respectively.Toxicities were moderate and manageable.Grade 3/4 toxicities included neutropenia(15.4%),nausea(10.3%),anemia(7.7%),thrombocytopenia(5.1%),vomiting(5.1%)and neutropenia fever(2.6%).CONCLUSION:The combination of paclitaxel and nedaplatin is active and well tolerated as a first-line therapy for patients with metastatic ESCC.
文摘BACKGROUND Syndrome of inappropriate secretion of antidiuretic hormone(SIADH)is relatively common in several cancers,such as small cell lung cancer.However,nedaplatin-induced SIADH is rare.We describe a case of SIADH mediated by nedaplatin.CASE SUMMARY A 54-year-old female with nasopharyngeal carcinoma was treated with nedaplatin and developed severe hyponatremia due to SIADH.The side effects were successfully treated by fluid restriction and sodium supplementation.CONCLUSION This case report highlights the importance of cautiously treating life-threatening hyponatremia in patients treated with nedaplatin.
基金Supported by Tianjin Science and Technology Plan Project,No. 19YFZCSY00170Tianjin Union Medical center,No. 2019YJ007Beijing medical and health foundation,No. F1814B
文摘BACKGROUND Patients with recurrent or locally advanced head and neck squamous cell carcinoma(HNSCC)typically have limited treatment options and poor prognosis.AIM To evaluate the efficacy and safety of two drugs with potent radio-sensitization properties including gemcitabine and nedaplatin as concurrent chemoradiotherapy regimens in treating HNSCC.METHODS This single-arm prospective study enrolled patients with HNSCC to receive gemcitabine on days 1 and 8 and nedaplatin on days 1 to 3 for 21 days.Intensitymodulated radiation therapy with a conventional fraction was delivered 5 days per week.Objective response rate(ORR),disease control rate,and toxicity were observed as primary endpoints.Overall survival(OS)and progression free survival were recorded and analyzed as secondary endpoints.RESULTS A total of 24 patients with HNSCC were enrolled.During the median 22.4-mo follow-up,both ORR and disease control rate were 100%.The one-year OS was 75%,and one-year progression-free survival(PFS)was 66.7%(median PFS was 15.1 mo).Recurrent HNSCC patients had a poorer prognosis than the treatment-naïve patients,and patients who achieved complete response had better survival than those in the PR group(all P<0.05).The most common grade 1-4(100%)or grade 3-4 toxicities(75%)were hematological,and the most common grade 3-4 non-hematological toxicity was mucositis in 17(71%)patients.CONCLUSION Gemcitabine plus nedaplatin with concurrent chemoradiotherapy is a therapeutic option for HNSCC with predictable tolerability.Considering the high adverse event rate,the optimized dose and schedule must be further explored.
文摘Objective: To evaluate the efficacy and safety of nedaplatin/gemcitabine (NG) and carboplatin/gemcitabine (CG) in the management of untreated advanced non‐small cell lung cancer (NSCLC). Methods: Sixty‐two patients with previously untreated advanced NSCLC were recruited between June 2006 and November 2007. Subjects were randomly assigned to the NG arm (n=30) and the CG arm (n=32). Only patients (24 and 25 in the NG and CG arms, respectively) who completed ≥2 chemotherapy cycles were included in the data analysis. The primary outcome measure was the objective response rate (ORR). The secondary outcome measures included progression‐free survival (PFS), overall survival (OS) and adverse events. Results: There were no statistically significant differences in the efficacy measures (ORR, P=0.305; median PFS, P=0.198; median OS, P=0.961) or in the major adverse events (grade 3/4 neutropenia, P=0.666; grade 3/4 anemia, P=0.263; grade 3/4 thrombocytopenia, P=0.212) between the two treatment arms. However, there was a trend towards higher ORR (37.5% vs. 24.0%), longer PFS (6.0 vs. 5.0 months), and less adverse events in the NG arm. Conclusion: NG regimen seems to be superior over CG regimen for advance NSCLS, but further investigation is needed to validate this superiority.
文摘目的系统评价奈达铂联合紫杉醇同步放化疗治疗中晚期宫颈癌的效果与安全性。方法在中国知网、万方数据库、维普、中国生物医学文献数据库、Medline数据库、EMbase、PubMed、Web of Science中检索有关中晚期宫颈癌应用奈达铂联合紫杉醇同步放化疗治疗的随机对照试验(RCT),检索时限截至2022年7月,两名研究员独立阅读、筛选、提取资料并评价质量后,采用RevMan 5.4软件进行meta分析。结果共纳入22项RCT试验共计1627例患者,meta分析结果显示,与单纯放疗相比,奈达铂联合紫杉醇同步放化疗可显著提高患者的近期疗效[RR=1.59,95%CI(1.44,1.74),P<0.00001]和总生存率[RR=1.29,95%CI(1.21,1.37),P<0.00001];安全性指标差异均无统计学意义(P>0.05)。结论对于中晚期宫颈癌,奈达铂联合紫杉醇同步放化疗效优安全,可作为未来中晚期宫颈癌放化疗方案的新选择。但文章仍存在诸多局限性,有待更多高质量RCTs进一步验证并丰富研究结果。
