Entry Detail
| General information | |
| Database: | DB00885 |
| Objective: | To assess the efficacy and toxicity of sunitinib monotherapy in palliative squamous cell carcinoma of the head and neck (SCCHN). |
| Authors: | Machiels JP, et al |
| Title: | Phase II study of sunitinib in recurrent or metastatic squamous cell carcinoma of the head and neck: GORTEC 200601. |
| Journal: | J Clin Oncol. |
| Year: | 2010 |
| PMID: | 19917865 |
| Trial Design | |
| Clinical Trial Id: | NCT00408252. |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced squamous cell carcinoma of the head and neck |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, multicenter, phase II study |
| Key Patients Feature: | Eligible patients were required to have histologically or cytologically proven recurrent squamous cell carcinoma of the head and neck, Eastern Cooperative Oncology Group performance status 0 to 2, disease not amenable to curative treatment, and one or more measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were treated with sunitinib 37.5 mg/d given continuously until PD or unacceptable toxicity. |
| Primary End Point: | the rate of disease control, defined as stable disease (SD) or partial response (PR) at 6 to 8 weeks after treatment initiation (twostage design, Simon). |
| Secondary End Point: | NA |
| Patients Number: | 38 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 60 days (95% CI, 39 to 81 days) |
| Median OS A vs. C: | 102 days (95% CI, 81 to 123 days) |
| Adverse Event(agent arm): | The most frequent grade 1 to 2 toxicities were as follows: anemia (58%), fatigue (42%), hypertension (42%), mucositis (37%), anorexia (34%), thrombocytopenia (29%), diarrhea (26%), skin rash (21%), and tumor bleeding (18%). The main grade 3 to 4 toxicities were fatigue (32%), anorexia (16%), thrombocytopenia (13%), diarrhea (8%), and left ventricular ejection fraction decrease (5%). |
| Conclusions: | Sunitinib demonstrated modest activity in palliative SSCHN. The severity of some of the complications highlights the importance of improved patient selection for future studies with sunitinib in head and neck cancer. Sunitinib should not be used outside clinical trials in SSCHN. |