Nedaplatin concurrent with three-dimensional conformal radiotherapy for treatment of locally advanced esophageal carcinoma

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.

A phase Ⅱ study of paclitaxel and nedaplatin as front-line chemotherapy in Chinese patients with metastatic esophageal squamous cell carcinoma

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.

Nedaplatin/Gemcitabine Versus Carboplatin/Gemcitabine in Treatment of Advanced Non-small Cell Lung Cancer: A Randomized Clinical Trial

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=0.298, 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=0.222） 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.

Nedaplatin-induced syndrome of inappropriate secretion of antidiuretic hormone:A case report and review of the literature

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.

Successful treatment for esophageal carcinoma with lung metastasis by induction chemotherapy followed by salvage esophagectomy: Report of a case

We here report a case of a 51-year-old man with lung metastasis from esophageal carcinoma that was initially treated by combination chemotherapy consisting of fluorouracil and nedaplatin. Because metastatic disease disappeared, salvage esophagectomy was performed. Although chest wall recurrence developed at the thoracotomy wound, prolonged survival of 48 months was achieved by local tumor resection and additional chemotherapy. This combination chemotherapy is regarded as a promising and considerable treatment for metastatic esophageal carcinoma.

Concurrent chemoradiotherapy using gemcitabine and nedaplatin in recurrent or locally advanced head and neck squamous cell carcinoma

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.

Clinical observation of nedaplatin concurrent with radiotherapy for mid-advanced nasopharyngeal carcinoma and esophageal carcinoma

Objective: The aim of our study was to evaluate the short-term efficacy and the toxic reaction of nedaplatin concurrent with radiotherapy for mid-advanced nasopharyngeal carcinoma and esophageal carcinoma. Methods: Thirty-four patients were confirmed diagnosis with cancer by pathologic results. All patients were given 6MV X-ray for radiotherapy, Dt 66-70 Gy/33-35 f/6-7 w, concurrently administrated nedaplatin (30 mg/m2) once a week (6 times). Results: A total 34 patients were enrolled, of whom 33 patients were available for objective response, 1 patient of esophageal cancer quit for allergic reaction. The response rate (RR) of nedaplatin-contained therapy for nasopharyngeal carcinoma and esophageal carcinoma were 90.0% and 76.9%, respectively. The major toxic reaction was bone marrow suppression observed in 25 patients (73.5%), in which grade III aleukocytosis was observed in 3 patients (8.8%), grade III + IV thrombocytopenia in 3 patients (8.8%). And 6 patients (17.6%) showed gastrointestinal tract reaction. There were 4 patients with radiation esophagitis in the 13 patients with esophageal carcinoma. Conclusion: Nedaplatin can increase the therapeutic effect of radiation. Its incidence rate of bone marrow suppression is high, but the gastrointestinal tract reaction and renal toxicity is low and mild.

The early efficacy of the nedaplatin and megestrol combine chemoradiotherapy to the advanced cervical cancers

Objective： The aim of this study was to investigate the early outcome of the nedaplatin and megestrol combine chemoradiotherapy to the advanced cervical cancer. Methods： Forty-two cases with cervical cancer （FIGO lib to IVa） were divided randomly into two groups, radiotherapy alone （RT group： 21 cases） and radiation combines chemotherapy （nedaplatin and megestrol） （RT ＋ C group： 21 cases）. There was no difference of radiotherapy between the two groups, the RT ＋ C group accepted nedaplatin injection during the radiation weekly, according to 30 mg/m^2 ,these regimen were given for 4-5 weeks. This group was received an oral medicine megestro1160 mg every day during the treatment. Results： The RT ＋ C group： the complete remission rate was 80.9% （17/21）, the partial remission rate was 19.1% （4/21）, the effective rate was 100%. The RT group： the complete remission rate was 38.1% （8/21） and partial remission rate was 32.9% （9/21）, the effective rate was 81.0%. The total effective rate and complete remission rate of RT ＋ C group were higher than RT group. There was significant difference between the two groups. The 1-year survival rates respectively were 100% （21/21） in RT ＋ C group, 80.9% （17/21） in RT group. There was statistically significant difference between the two groups （x^2 = 4.42 〉 3.84, P 〈 0.05）. Conclusion： The nedaplatin and megestrol combine chemoradiotherapy can improve the early outcome of the advanced cervical cancer, and the adverse effects was raised, but that can be endured.

Short-term effects of nedaplatin plus futraful chemotherapy in treatment of advanced esophageal carcinoma

Objective:To observe the efficacy and the side effects of nedaplatin with futraful in the treatment of advanced esophageal carcinoma.Methods:Observing group NDP/FT-207 regimen:given nedaplatin 80-100 mg/m2 on day 1 and futraful 500-600 mg/m2 on day 1 to 5;control group:DDP/5-Fu regimen received cisplatin 80-100 mg/m2 on day 1 and 5-Fluorouracil 500-750 mg/m2 on day 1 to 5.In both groups per 28 days was a cycle, 2-3 cycles were one course.Results:Response and toxicity could be assessed in all the 78 patients, 42 patients were in observing group, the other 36 patients were in control group.The response rate of patients treated by NDP/FT-207 and DDP/5-Fu were 57.1%(24/42) and 50%(18/36) respectively.The two groups have no significant difference.The toxicities as gastrointestinal disorders and myelosuppression in observing group was lighter than those in control group.Conclusion:The combination of NDP and FT-207 is a safer and effective regimen.

17 cases of advanced non-small cell lung cancer treated with paclitaxel liposome plus nedaplatin

Objective： The aim of this study was to evaluate the recent efficacy and adverse reactions of paclitaxel liposome plus nedaplatin in the treatment of advanced non-small cell lung cancer （NSCLC）. Methods： Seventeen cases of NSCLC treated with paclitaxel liposome and nedaplatin for 2 to 6 cycles, by infusing paclitaxel liposome 135 mg/m^2 for 3 h on d 1 and nedaplatin 80 mg/m^2 as infusion on d2. Results： Among 17 patients being evaluated for response to treatment, 1 achieved complete response （CR）, 4 achieved partial response （PR）, 3 achieved stable disease （SD）, 9 achieved progress disease （PD）. The main adverse reaction was haematological toxicities, especially leukopenia and thrombocytopenia. The non-hae- matological toxicities included nausea, vomiting, mild hepatic dysfunction, alopecia and so on. Conclusion： Paclitaxel lipo- some plus nedaplatin was effective and well tolerated for treating patients with advanced NSCLCo

Phase II clinical trial using camrelizumab combined with apatinib and chemotherapy as the first-line treatment of advanced esophageal squamous cell carcinoma

Background:Effective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma(ESCC).The incorporation of an immune checkpoint inhibitor and a molecular anti-angiogenic agent into the commonly adopted chemotherapy may produce synergistic effects.Therefore,we aimed to investigate the efficacy and safety of camrelizumab plus apatinib combined with chemotherapy as the first-line treatment of advanced ESCC.Methods:In this single-arm prospective phase II trial,patients with unresectable locally advanced or recurrent/metastatic ESCC received camrelizumab 200 mg,liposomal paclitaxel 150 mg/m2,and nedaplatin 50 mg/m2 on day 1,and apatinib 250 mg on days 1-14.The treatments were repeated every 14 days for up to 9 cycles,followed by maintenance therapy with camrelizumab and apatinib.The primary endpoint was objective response rate(ORR)according to the Response Evaluation Criteria in Solid Tumors(version 1.1).Secondary endpoints included disease control rate(DCR),progression-free survival(PFS),overall survival(OS),and safety.Results:We enrolled 30 patients between August 7,2018 and February 23,2019.The median follow-up was 24.98 months(95%confidence interval[CI]:23.05-26.16 months).The centrally assessed ORR was 80.0%(95%CI:61.4%-92.3%),with a median duration of response of 9.77 months(range:1.54 to 24.82+months).The DCR reached 96.7%(95%CI:82.8%-99.9%).The median PFS was 6.85 months(95%CI:4.46-14.20 months),and the median OS was 19.43 months(95%CI:9.93 months–not reached).The most common grade 3-4 treatmentrelated adverse events(AEs)were leukopenia(83.3%),neutropenia(60.0%),and increased aspartate aminotransferase level(26.7%).Treatment-related serious AEs included febrile neutropenia,leukopenia,and anorexia in one patient(3.3%),and single cases of increased blood bilirubin level(3.3%)and toxic epidermal necrolysis(3.3%).No treatment-related deaths occurred.Conclusions:Camrelizumab plus apatinib combined with liposomal paclitaxel and nedaplatin as first-line treatment demonstrated feasible anti-tumor activity and manageable safety in patients with advanced ESCC.Randomized trials to evaluate this new combination strategy are warranted.Trial registration:This trial was registered on July 27,2018,at ClinicalTrials.gov(identifier:NCT03603756).