| General information |
| Database: | DB00261 |
| Objective: | A combination of cetuximab and sorafenib in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) were assessed for potential benefit. |
| Authors: | Gilbert J, et al |
| Title: | A randomizedphase II efficacy and correlative studies of cetuximab with or without sorafenib in recurrent and/or metastatic head and neck squamous cell carcinoma. |
| Journal: | Oral Oncol. |
| Year: | 2015 |
| PMID: | 25593015 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | cetuximab+sorafenib |
| Study Type: | A randomizedphase II efficacy and correlative study |
| Key Patients Feature: | Eligible patients included those 18 years of age or older with recurrent, refractory or metastatic, incurable HNSCC of the oral cavity, oropharynx, larynx, hypopharynx, paranasal sinus, unknown primary or nasopharyngeal carcinoma World Health Organization Type 1 |
| Biomarker: | p16 expression, HPV status, plasma immunomodulatory cytokine levels |
| Biomark Analysis: | Twentyfour plasma samples were tested for 12 cytokine levels and patients with higher TGF¦Â1 levels had inferior PFS compared to lotheyr levels (1.9 vs. 4.7months; adjusted pvalue: 0.015), regardless of study arms. |
| Control Group Info: | cetuximab and sorafenib (arm B) |
| Treatment Info: | patients were treated with cetuximab 400mg/m(2) IV on day 1 followed by 250mg/m(2) IV weekly (Arm A), or cetuximab at the same dose/schedule plus sorafenib 400mg PO twiceaday (Arm B). Each cycle was 21days. |
| Primary End Point: | ORR, PFS, OS |
| Secondary End Point: | NA |
| Patients Number: | 55 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Overall response rate was 8% for both arms. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.0 vs. 3.2 months; the p16negative patients had significantly better PFS compared to the p16positive patients (3.7 vs. 1.6 months; pvalue: 0.03), regardless of study arms; patients with higher TGF¦Â1 levels had inferior PFS compared to lotheyr levels (1.9 vs. 4.7months; adjusted pvalue: 0.015), regardless of study arms. |
| Median OS A vs. C: | 9.0 vs. 5.7 months |
| Adverse Event(agent arm): | Maculopapular rash was the most common toxicity in both arms; Fatigue was the second most common toxicity in both arms. |
| Conclusions: | A subset of RM patients with p16negative tumors or lotheyr plasma TGF¦Â1 levels had longer PFS given the cetuximabbased therapy. Hotheyver, both arms showed only modest response and sorafenib given with cetuximab did not demonstrate clinical benefit. |