Entry Detail
| General information | |
| Database: | DB00387 |
| Objective: | They aimed to investigate the efficacy and tolerability of sorafenib combined with cisplatin and 5fluorouracil (5FU) in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). |
| Authors: | Xue C, et al |
| Title: | Phase II study of sorafenib in combination with cisplatin and 5fluorouracil to treat recurrent or metastatic nasopharyngeal carcinoma. |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23172635 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced nasopharyngeal carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | sorafenib + cisplatin and 5fluorouracil |
| Study Type: | Phase II study |
| Key Patients Feature: | Patients enrolled in this study had histologically confirmed NPC that wasmetastatic or locally recurrent at diagnosis or after previous curativetreatment. Disease was measurable as defined by RECIST [28]. Patientsmust not have received prior treatments for recurrent or newly diagnosedmetastatic disease; however, chemotherapy or radiation as part of the initialcurative therapy was permitted. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | The regimen was sorafenib 400 mg orally b.i.d., cisplatin 80 mg/m(2) i.v. day 1, and 5FU 1000 mg/m(2)/day CIV for 4 days, repeated every 21 days. After a maximum of six cycles of chemotherapy, patients received maintenance of sorafenib. |
| Primary End Point: | ORR, including the percentage of complete response (CR) and partial response (PR). |
| Secondary End Point: | toxicity (particularly hand-foot skin reaction, HFSR), disease control rate (DCR, the proportion of CR, PR, and SD), PFS, and OS. |
| Patients Number: | 54 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | The objective response rate reached 77.8%, including 1 complete response and 41 partial responses |
| Disease Control Rate: | 0.908 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7.2 months (95% CI 6.8-8.4 months) |
| Median OS A vs. C: | 11.8 months (95% CI 10.6-18.7 months). |
| Adverse Event(agent arm): | Major toxic effects included hand-foot skin reaction, myelosuppression, and gastrointestinal (GI) reaction. The incidence of hemorrhage was 22.2%, and one patient with liver metastases died of GI bleeding. |
| Conclusions: | Combination of sorafenib, cisplatin (80 mg/m(2)) and 5FU (3000 mg/m(2)) was tolerable and feasible in recurrent or metastatic NPC. Further randomized trials to compare sorafenib plus cisplatin and 5FU with standard dose of cisplatin plus 5FU in NPC are warranted. |