| General information |
| Database: | DB00379 |
| Objective: | The present study aimed to evaluate efficacy and adverse effects of Nimotuzumab combined with docetaxelcisplatinfluorouracil regimen in the treatment of advanced oral carcinoma. |
| Authors: | Meng J, et al |
| Title: | Efficacy of nimotuzumab combined with docetaxelcisplatinfluorouracil regimen in treatment of advanced oral carcinoma. |
| Journal: | Cell Biochem Biophys. |
| Year: | 2014 |
| PMID: | 23733674 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | nimotuzumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced oral cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | nimotuzumab combined with docetaxelcisplatinfluorouracil regimen |
| Study Type: | single center |
| Key Patients Feature: | (1)histopathological diagnosis confirmed by surgical biopsy, (2) all cases classified as stage IIIA-IV according to TNMInternational Classification (UICC 2002) [10], (3) ECOGscore of C2 with an estimated survival of greater than3 months, (4) the longest diameter of measurable lesionof C20 mm, (5) hemoglobin C90 g/L, WBC C3 9 109/L, ALT and AST1.5 9 ULN, total bilirubin1.5 9 ULN, and serum creatinine 1.5 9 ULN. There were ten maleand seven female patients with the age ranging from 54 to89 (median age of 61) years. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Nimotuzumab combined with docetaxelcisplatinfluorouracil regimen (test group); control group (docetaxelcisplatinfluorouracil regimen alone) |
| Treatment Info: | The treatment was given as follows: Nimotuzumab 200 mg, given as intravenous infusion once a week for 6 weeks; docetaxel and cisplatin, 75 mg/m(2) each, on day 1 only; 5fluorouracil, 750 mg/m(2) infused continually for 8 h, used from day 1 to 5; the total cycle was for 21 days. Another eight patients comprised control group (docetaxelcisplatinfluorouracil regimen alone). |
| Primary End Point: | efficacy and adverse effects |
| Secondary End Point: | NA |
| Patients Number: | 9 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Another eight patients comprised control group (docetaxelcisplatinfluorouracil regimen alone). Study patients from both groups were evaluated for objective response. The response rate was significantly (p = 0.044) higher in test group (88.9 vs. 37.5 % in control group). The disease control rate also tended to be higher in test group (100 vs. 62.5 % in control group; p = 0.083). |
| Disease Control Rate: | The disease control rate tended to be higher in test group (100 vs. 62.5 % in control group; p = 0.083). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The major adverse effects were bone marrow suppression, nausea, vomiting, and alopecia. The incidence of adverse effects was similar between both study groups. |
| Conclusions: | In conclusion, Nimotuzumab combined with docetaxelcisplatinfluorouracil regimen is effective and safe in the treatment of advanced oral carcinoma. |