| General information |
| Database: | DB00257 |
| Objective: | Salvage options for unresectable locally recurrent, previously irradiated squamous cell carcinoma of the head and neck (rSCCHN) are limited. Although the addition of reirradiation may improve outcomes compared to chemotherapy alone, significant toxicities limit salvage reirradiation strategies, leading to suboptimal outcomes. They therefore designed a phase 2 protocol to evaluate the efficacy of stereotactic body radiation therapy (SBRT) plus cetuximab for rSCCHN. |
| Authors: | Vargo JA, et al |
| Title: | A prospectivephase 2 trial of reirradiation with stereotactic body radiation therapy plus cetuximab in patients with previously irradiated recurrent squamous cell carcinoma of the head and neck. |
| Journal: | Int J Radiat Oncol Biol Phys |
| Year: | 2014 |
| PMID: | 25680594 |
| Trial Design |
| Clinical Trial Id: | NCT01104922 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced squamous cell carcinoma of the head and neck |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | cetuximab+stereostactic body radiation(SBRT) |
| Study Type: | A prospectivephase II trial |
| Key Patients Feature: | patients >18 years of age with inoperable locoregionally confined irradiated squamous cell carcinoma of the head and neck (rSCCHN) within a previously irradiated field receiving more than and equal to 60 Gy, with a Zubrod performance status of 0 to 2, and normal hepatic and renal function |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received concurrent cetuximab (400 mg/m(2) on day 7 and then 250 mg/m(2) on days 0 and +8) plus SBRT (4044 Gy in 5 fractions on alternating days over 12 weeks). |
| Primary End Point: | 1year locoregional progression free survival and toxicity. |
| Secondary End Point: | NA |
| Patients Number: | 50 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The 1year local PFS rate was 60% (95% confidence interval [CI]: 44%75%), locoregional PFS was 37% (95% CI: 23%53%), distant PFS was 71% (95% CI: 54%85%), and PFS was 33% (95% CI: 20%49%). |
| Median OS A vs. C: | The median overall survival was 10 months (95% CI: 716), with a 1year overall survival of 40% (95% CI: 26%54%). At last followup, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression. |
| Adverse Event(agent arm): | Acute and late grade 3 toxicity was observed in 6% of patients respectively. |
| Conclusions: | SBRT with concurrent cetuximab appears to be a safe salvage treatment for rSCCHN of short overall treatment time. |