Nedaplatin

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Munetaka Takekuma - One of the best experts on this subject based on the ideXlab platform.

Satoshi Takeuchi - One of the best experts on this subject based on the ideXlab platform.

  • phase ii trial of paclitaxel and Nedaplatin in patients with advanced recurrent uterine cervical cancer a kansai clinical oncology group study
    Gynecologic Oncology, 2012
    Co-Authors: Munetaka Takekuma, Kimihiko Ito, Yasuyuki Hirashima, Hiroshi Tsubamoto, Tsutomu Tabata, Atsushi Arakawa, Yoshio Itani, Naoto Furukawa, Homare Murakoshi, Satoshi Takeuchi
    Abstract:

    Abstract Objective A multicenter phase II trial was conducted to evaluate the activity and toxicity of paclitaxel and Nedaplatin (cis-diammineglycolatoplatonum) in patients with advanced/recurrent uterine cervical cancer. Methods Patients were required to have measurable disease. Histologic confirmation of the primary diagnosis as uterine cervical cancer was mandatory. The treatment consisted of paclitaxel 175mg/m 2 over 3hours and Nedaplatin 80mg/m 2 intravenously over 1hour on day 1 every 28days until progressive disease or adverse effects prohibited further therapy. Results Fifty patients were enrolled into the study protocol from October 2007 to February 2010. 45 patients(90%) were eligible for assessment of response (RECIST version 1.0) to treatment; 31 patients (62%) received prior radiotherapy and 23 patients (46%) received prior chemotherapy. The overall response rate was 44.4% (11 complete responses and 8 partial responses) with 22.2% of patients having stable disease. Grades 3 or 4 adverse events (NCI-CTCAE ver 3) included neutropenia ( n =16, 32.7%), febrile neutropenia ( n =1, 2.0%), anemia ( n =9, 18.4%), but there was no significant thrombocytopenia. Non-hematologic toxicity was generally not serious and without a dominant pattern. The median progression-free survival was 7.5months (95% C.I., 5.7, 9.4) and overall survival was 15.7months (95% C.I., 9.4, 21.9). Conclusions Paclitaxel 175mg/m 2 and Nedaplatin 80mg/m 2 intravenously on day 1 every 28days in patients with advanced/recurrence uterine cervical cancer demonstrated easy administration, favorable antitumor activity, and the toxicity profile of this regimen would be decreased compared with cisplatin-containing combinations. Evaluation of this regimen in phase III trials is warranted.

  • phase ii trial of paclitaxel and Nedaplatin in patients with advanced recurrent uterine cervical cancer a kansai clinical oncology group study
    Journal of Clinical Oncology, 2011
    Co-Authors: Munetaka Takekuma, Kimihiko Ito, Yasuyuki Hirashima, Hiroshi Tsubamoto, Tsutomu Tabata, Atsushi Arakawa, Yoshio Itani, Naoto Furukawa, Homare Murakoshi, Satoshi Takeuchi
    Abstract:

    5102 Background: A multicenter phase II trial was conducted to evaluate the activity and toxicity of paclitaxel and Nedaplatin (cis-diammineglycolatoplatonum) in patients with advanced/recurrent ut...

Shozo Fujino - One of the best experts on this subject based on the ideXlab platform.

Dong Wang - One of the best experts on this subject based on the ideXlab platform.

  • induction chemotherapy with Nedaplatin with 5 fu followed by intensity modulated radiotherapy concurrent with chemotherapy for locoregionally advanced nasopharyngeal carcinoma
    Japanese Journal of Clinical Oncology, 2010
    Co-Authors: Jijun Zheng, Ge Wang, Gary Y Yang, Daoyuan Wang, Xizhong Luo, Chuan Chen, Zhimin Zhang, Dong Wang
    Abstract:

    OBJECTIVE This Phase II study was conducted to evaluate the activity and feasibility of a regimen of Nedaplatin and 5-fluorouracil as induction chemotherapy, followed by intensity-modulated radiotherapy concurrent with chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. METHODS Patients received neoadjuvant chemotherapy comprised two cycles of 5-fluorouracil at 700 mg/m(2)/day administered on days 1-4 as continuous intravenous infusion and Nedaplatin (100 mg/m(2) administered i.v. over 2 h) given after the administration of 5-fluorouracil on day 1, repeated every 3 weeks, followed by intensity-modulated radiotherapy concurrent with Nedaplatin. During intensity-modulated radiotherapy, Nedaplatin was administered at a dose of 100 mg/m(2) intravenous infusion on days 1, 22 and 43, given approximately 60 min before radiation. RESULTS Fifty-nine (95.8%) of the 60 patients were assessable for response. Thirty-eight cases of complete response and 14 cases of partial response were confirmed after completion of chemoradiation, with the objective response rate of 86.7% (95% CI, 78.1-95.3%). The median follow-up period was 48 months (range, 30-62 months). The 3-year progression-free survival and overall survival were 75.0% (95% CI, 63.0-87.0%) and 85.5% (95% CI, 75.9-95.1%). No patient showed Grade 3 or higher renal dysfunction. The most commonly observed late effect was xerostomia, but the severity diminished over time, and the detectable xerostomia at 24 months was 10.2%. There were no treatment-related deaths during this study. CONCLUSIONS Neoadjuvant chemotherapy with Nedaplatin and 5-fluorouracil followed by concomitant Nedaplatin and intensity-modulated radiotherapy is an effective and safe treatment for Southern China patients affected by locoregionally advanced nasopharyngeal carcinoma.

Fang Yun Xie - One of the best experts on this subject based on the ideXlab platform.

  • concurrent chemoradiotherapy with Nedaplatin versus cisplatin in stage ii ivb nasopharyngeal carcinoma an open label non inferiority randomised phase 3 trial
    Lancet Oncology, 2018
    Co-Authors: Dong Ping Chen, Pan Wang, Qing Liu, Yuanhong Gao, Fang Yun Xie, Lin Quan Tang, Ling Guo, Ying Huang, Shan Shan Guo, Qing Nan Tang
    Abstract:

    Summary Background Cisplatin-based concurrent chemoradiotherapy is currently considered to be the standard treatment regimen for patients with advanced nasopharyngeal carcinoma, but has well known side-effects such as gastrointestinal reactions, nephrotoxicity, and ototoxicity. Nedaplatin was developed to decrease the toxic effects induced by cisplatin, and in this trial we assessed whether a Nedaplatin-based concurrent chemoradiotherapy regimen was non-inferior to a cisplatin-based regimen in patients with locoregional, stage II–IVB nasopharyngeal carcinoma. Methods We did an open-label, non-inferiority, phase 3, randomised, controlled trial at two centres in China. Patients aged 18–65 years with non-keratinising stage II–IVB (T1–4N1–3 or T3–4N0) nasopharyngeal carcinoma, a Karnofsky score of at least 70, and adequate haematological, renal, and hepatic function were randomly assigned (1:1) to receive intravenously either Nedaplatin 100 mg/m 2 or cisplatin 100 mg/m 2 on days 1, 22, and 43 for three cycles concurrently with intensity-modulated radiotherapy. Randomisation was done manually using a computer-generated random number code and patients were stratified by treatment centre and clinical stage. Patients and clinicians were not masked to treatment allocation. The primary endpoint was progression-free survival at 2 years; non-inferiority was shown if the upper limit of the 95% CI for the difference in 2-year progression-free survival between the two groups did not exceed 10%. Analyses were by both intention to treat and per protocol, including all patients who received at least one complete cycle of chemotherapy. This trial is registered with ClinicalTrials.gov, number NCT01540136, and is currently in follow-up. Findings Between Jan 16, 2012, and July 16, 2014, we randomly assigned 402 patients to Nedaplatin-based (n=201) or cisplatin-based (n=201) concurrent chemoradiotherapy. In the intention-to-treat population, 2-year progression-free survival was 89·9% (95% CI 85·8–94·0) in the cisplatin group and 88·0% (83·5–94·5) in the Nedaplatin group, with a difference of 1·9% (95% CI −4·2 to 8·0; p non-inferiority =0·0048). In the per-protocol analysis (cisplatin group, n=197; Nedaplatin group, n=196), 2-year progression-free survival was 89·7% (95% CI 85·4–94·0) in the cisplatin group and 88·7% (84·2–94·5) in the Nedaplatin group, with a difference of 1·0% (95% CI −5·2 to 7·0; p non-inferiority =0·0020). A significantly higher frequency of grade 3 or 4 vomiting (35 [18%] of 198 in the cisplatin group vs 12 [6%] of 200 in the Nedaplatin group, p vs four [2%], p=0·0021), and anorexia (53 [27%] vs 26 [13%], p=0·00070) was observed in the cisplatin group compared with the Nedaplatin group. 11 (6%) patients in the Nedaplatin group had grade 3 or 4 thrombocytopenia compared with four (2%) in the cisplatin group (p=0·065). Patients in the cisplatin group had a higher frequency of any grade or grade 3 or 4 late auditory or hearing toxicities than did patients in the Nedaplatin group (grade 3 or 4: three [2%] in the Nedaplatin group vs 11 [6%] in the cisplatin group, p=0·030). No patients died from treatment-related causes. Interpretation Our findings show that Nedaplatin-based concurrent chemoradiotherapy represents an alternative doublet treatment strategy to cisplatin-based concurrent chemoradiotherapy for patients with locoregional, advanced nasopharyngeal carcinoma. Further investigations are needed to explore the potential use of this treatment as induction or adjuvant chemotherapy or in combination with other agents. Funding National Key R&D Program of China, National Natural Science Foundation of China, Sun Yat-sen University Clinical Research 5010 Program, Sci-Tech Project Foundation of Guangzhou City, National Key Basic Research Program of China, Special Support Plan of Guangdong Province, Sci-Tech Project Foundation of Guangdong Province, Health & Medical Collaborative Innovation Project of Guangzhou City, National Science & Technology Pillar Program during the Twelfth Five-year Plan Period, PhD Start-up Fund of Natural Science Foundation of Guangdong Province, Cultivation Foundation for the Junior Teachers in Sun Yat-sen University, and Fundamental Research Funds for the Central Universities.

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