| General information |
| Database: | DB00394 |
| Objective: | To assess the toxicity profile of erlotinib therapy combined with postoperative adjuvant radiation therapy in patients with advanced cutaneous squamous cell carcinoma. |
| Authors: | Heath CH, et al |
| Title: | Phase 1 study of erlotinib plus radiation therapy in patients with advanced cutaneous squamous cell carcinoma. |
| Journal: | Int J Radiat Oncol Biol Phys. |
| Year: | 2013 |
| PMID: | 23182701 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | stage III squamous cell carcinoma of the head and neck |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | erlotinib plus radiation therapy |
| Study Type: | singleinstitution, openlabel, nonrandomized, singlearm, phase Iclinical trial. |
| Key Patients Feature: | patients were older than 19 years of age and had histologically proven stage III cutaneoussquamous cell carcinoma arising from the head and neck. Immunocompromised patients andpatients with a history of radiation to the affected area were excluded. Each patient hadeither T4 disease or histologically proven regional lymph node involvement. patients wereallowed to enroll after completion of the surgical resection contingent on concurrenterlotinib and radiation therapy beginning within 8 weeks of resection. Patients with priornoncutaneous malignancies were not excluded unless they were less than two years fromtreatment |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients began erlotinib therapy 150mg a day concurrently with fractionated radiotherapy of 60- 66 Gy for 6 weeks within 8 weeks of resection. There was a mean of 26 days from surgical resection to radiotherapy start. |
| Primary End Point: | the safety and toxicity |
| Secondary End Point: | the 2year overall survival and time to recurrence. |
| Patients Number: | 15 |
| Trial Results |
| DLT_MTD: | The next most frequent toxicity was mucositis with 87% (n=13) experiencing a grade 2-3 reaction. Other grade 2-3 toxicities that were commonly reported in this study included esophagitis (40%) , fatigue(47%), nausea/vomiting (47%), dehydration(47%) , and diarrhea (20%) |
| Objective Response Rate: | NA |
| Disease Control Rate: | 0.45 |
| Median Time to Progression: | mean time to cancer recurrence was 10.5 months. |
| Median PFS A vs. C: | Two year disease free survival was 60%. |
| Median OS A vs. C: | Two year overall survival was 65% |
| Adverse Event(agent arm): | The most common toxicity attributed to erlotinib was a grade 2-3 dermatologic reaction occurring in 100% of the patients, followed by mucositis (87%). Diarrhea occurred in 20% of the patients. |
| Conclusions: | Erlotinib and radiation therapy had an acceptable toxicity profile in patients with advanced cutaneous squamous cell carcinoma. The diseasefree survival in this cohort was comparable to that in historical controls. |