[Phase II multicenter clinical trial of nedaplatin in the treatment of malignant tumors].
Abstract | OBJECTIVE: 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(2) on 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 adverse events of nedaplatin were myelosuppression ( leukopenia, thrombocytopenia, anemia), 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/II liver toxicity was more common in the NDP-based regimen than in DDP-based regimen (10.8% vs. 0). CONCLUSION:
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Authors | Pin Zhang, Feng-yi Feng, Ling-ying Wu, Yi Hu, Ji-wei Liu, Ya-jie Gao, Xiao-qian Guan, Ke-jun Nan, Ai-li Suo, Xiu-wen Wang, Mao-hong Zhang, Wen-dong Zhang, Chao-wu Li, Yang Zhang, Jin-bo Zhao |
Journal | Zhonghua zhong liu za zhi [Chinese journal of oncology]
(Zhonghua Zhong Liu Za Zhi)
Vol. 28
Issue 3
Pg. 230-4
(Mar 2006)
ISSN: 0253-3766 [Print] China |
PMID | 16875614
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
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Chemical References |
- Antineoplastic Agents
- Organoplatinum Compounds
- Vinblastine
- nedaplatin
- Cisplatin
- Vinorelbine
- Fluorouracil
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Topics |
- Adolescent
- Adult
- Aged
- Antineoplastic Agents
(therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy)
- Cisplatin
(administration & dosage)
- Esophageal Neoplasms
(drug therapy)
- Female
- Fluorouracil
(administration & dosage)
- Head and Neck Neoplasms
(drug therapy)
- Humans
- Leukopenia
(chemically induced)
- Lung Neoplasms
(drug therapy)
- Lymphatic Metastasis
- Male
- Middle Aged
- Nausea
(chemically induced)
- Organoplatinum Compounds
(administration & dosage, therapeutic use)
- Ovarian Neoplasms
(drug therapy)
- Vinblastine
(administration & dosage, analogs & derivatives)
- Vinorelbine
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