| General information |
| Database: | DB00277 |
| Objective: | Normal tissues tolerance limits the use of reirradiation and stereotactic body radiotherapy (SBRT) could offer precise irradiation while sparing healthy tissues. After completion of a feasibility study, results of a multicentric study (Lille, Nancy & Nice) using SBRT with cetuximab are reported. The aim of the study was to deliver non toxic short course SBRT (2weeks) in order to get the same local control as the one demonstrated with longer protocols. |
| Authors: | Lartigau EF, et al |
| Title: | Multi institutionalphase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer. |
| Journal: | Radiother Oncol. |
| Year: | 2013 |
| PMID: | 24262821 |
| 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 cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | SBRT+ cetuximab |
| Study Type: | a multi institutionalphase II study |
| Key Patients Feature: | Patients with inoperable recurrent, or new primary tumor in a previously irradiated area, were included (WHO<3).All recurrences or new primaries were inoperable and occurred in a previously irradiated area (size 65 mm). All patients had previous radiotherapy, 85% previous surgery and 48% previous chemotherapy. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Reirradiation (RT) dose was 36Gy in six fractions of 6Gy to the 85% isodose line covering 95% of the PTV with 5 injections of concomitant cetuximab (CT). |
| Primary End Point: | PFS, TTP, OS, CR, PR |
| Secondary End Point: | NA |
| Patients Number: | 60 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | At 3months, response rate was 58.4% (95% CI: 43.272.4%); complete response was observed in 24 patients (49.0%), partial response in 10 (20.4%). |
| Disease Control Rate: | at 3 months, disease control rate was 91.7% (95% CI: 80.097.7%); stable disease in 11 (22.5%) and progressive disease in 4 patients (8.2%). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The median progression free survival was 7.1 months (95% CI: 5.5-8.9). |
| Median OS A vs. C: | median survival was 11.8 months with a oneyear OS rate of 47.5% (95% CI: 30.8-62.4) |
| Adverse Event(agent arm): | Cutaneous toxicity was observed for 41 patients. There was one toxic death from hemorrhage and denutrition. |
| Conclusions: | These results suggest that short SBRT with cetuximab is an effective salvage treatment with good response rate in this poor prognosis population with previously irradiated HNC. Treatment is feasible and, with appropriate care to limiting critical structure, acute toxicities are acceptable. This combination may be the reference treatment is this population. |