Phase IImulticenter clinical trial of nedaplattn in the treatment of malignant tumors

Objective To evaluate and compare the efficacy and safety of Nedaplatin （NDP）-based regimen and cisplatin （DDP）-based regimen for head and neck squamous cell carcinoma （HNSCC）, nonsmall cell lung cancer（NSCLC） ,esophageal cancer and ovary epithelial cell carcinoma. Methods Single agent group： NDP was administered at a dose of 100 mg/m^2 on D1, every 3 weeks for at least 2 cycles. Combination chemotherapy group： combined with 5-Fu.NVB.VDS ＋ 5-Fu.PTX or CTX respectively, NDP 80 mg/m^2 on D1 or DDP 30 mg/m^2on D1-3, every 3 weeks for at least 2 cycles was given. Results Of 237 patients in this trial, 37 were treated by single Nedaplatin, 139 by NDP-based regimen, 61 by DDP-based regimen in the control group. The response rate of single Nedaplatin chemotherapy for advanced NSCLC was 10.5% （2/19）, for ovary carcinoma（1/3） and HNSCC （ 1/1 ）. For NSCLC and ovary carcinoma patients who had failed in the previous DDP-based chemotherapy, the response rates by single NDP chemotherapy were still 9. 1% and 33.3%. The response rate of NDP-based combination regimen for NSCLC.ovary carcinoma.HNSCC and esophageal cancer was 33.9% （21/62）. 44.8% （13/29）. 20.0% （3/15） and 18.2% （4/22）, respectively, which was not statistically different from the rate of controlled group treated by DDP-based regimen. For chemonaive NSCLC, the effect of NDP-based combination regimen （35.7%） was significantly superior to the effect of DDP-based regimen （17.1%） （P =0.045 ）. The most common adverseevents of nedaplatin were myelosuppression （leukopenia, thrombocytopenia, aneana）, nausea and vomiting. The myelosuppression and renal toxicity of NDP-based regimen were similar to that of DDP-based regimen, but vomiting was milder than that of DDP-based regimen （54% vs. 75.4% ）, and grade Ⅰ / Ⅱliver toxicity was more common in the NDP-based regimen than in DDP-based regimen （ 10.8% vs. 0）. Conclusion Nedaplatin is effective in the treatment for HNSCC,NSCLC and ovary carcinoma. Compared with the control group treated by DDP-based regimen, nedaplatin-based combination chemotherapy has similar effect on HNSCC,NSCLC,ovary carcinoma and esophageal cancer. Gastrointestinal reaction of nedaplatin is milder than that of cisplatin but the liver function during chemotherapy must be monitored closely. Key words: Nedaplatin;  Head and neck neoplasms;  Squamous cell carcinoma;  Non-small cell lung carcinoma;  Esophageal neoplasms;  Ovarian neoplasms