| General information |
| Database: | DB00314 |
| Objective: | The objectives of this randomized, phase II trial were to evaluate the efficacy and safety of cetuximab maintenance therapy following definitive RT with concomitant cetuximab in patients with oropharyngeal cancer. |
| Authors: | Mes¨ªa R, et al |
| Title: | Adjuvant therapy with cetuximab for locally advanced squamous cell carcinoma of the oropharynx: results from a randomized, phase II prospective trial. |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23041591 |
| 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: | 4 |
| Therapeutic Combination Content: | cetuximab maintenance therapy following definitive RT with concomitant cetuximab |
| Study Type: | prospective, multicenter, randomized, openphase II pilot study |
| Key Patients Feature: | previously untreated patients between18 and 80 years old, with histologically proven, stage III-IV, nonmetastatic, squamous cell carcinoma of the oropharynx were includedin this trial. Otherinclusion criteria included Karnofsky performance score >60% and anadequate nutritional status at inclusion. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:Cetuximab combined with radiotherapy (RT) B:concomitant cetuximab |
| Treatment Info: | patients were randomly assigned to the treatment with accelerated concomitant boost RT (69.9 Gy) + cetuximab or the same treatment with the addition of 12 consecutive weeks of cetuximab maintenance therapy. |
| Primary End Point: | LRC rate at 1 year. |
| Secondary End Point: | LRC rates at 2 and 3 years, specific diseasefree survival (SDFS), eventfree survival (EFS), overall survival (OS) and the safety and toxic effect. |
| Patients Number: | 91 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Ttheylve weeks of cetuximab maintenance therapy after concomitant cetuximab + RT in locally advanced oropharyngeal carcinoma is feasible and improves clinical outcomes measured at 1 year. This improvement is not maintained after the second year suggesting that epidermal growth factor receptor blockade is not sufficient to completely eliminate the minimal residual disease |
| Disease Control Rate: | LRC of 73% for group A and 83% for group B (LRC at this point includes initial CR, PR that finally were confirmed as CR, and partial cervical responses salvaged with the neck dissection). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 33.6 months (10.8-51.2) for group A and 39.9 months (19.6¡ªnot reached) for group B (Pvalue = 0.44) |
| Adverse Event(agent arm): | most adverse events were grade 1-2 and mainly included skin rash, mucositis, odynophagia and asthenia. |
| Conclusions: | Ttheylve weeks of cetuximab maintenance therapy after concomitant cetuximab + RT in locally advanced oropharyngeal carcinoma is feasible and improves clinical outcomes measured at 1 year. This improvement is not maintained after the second year suggesting that epidermal growth factor receptor blockade is not sufficient to completely eliminate the minimal residual disease. |