| General information |
| Database: | DB00364 |
| Objective: | Elderly patients with esophageal cancer who are not candidates for chemoradiation may benefit from targeted agents; hence erlotinib combined with radiotherapy was evaluated in this trial. |
| Authors: | Iyer R, et al |
| Title: | Erlotinib and radiation therapy for elderly patients with esophageal cancer clinical and correlative results from a prospective multicenterphase 2 trial. |
| Journal: | Oncology. |
| Year: | 2013 |
| PMID: | 23860007 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| 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: | Erlotinib and radiation therapy |
| Study Type: | a prospective multicenterphase II trial |
| Key Patients Feature: | Eligible patients were required to have nonresectable¡¡therapyrefractory head and neck cancer that was clearly¡¡detectable by conventional imaging techniques (CT and¡¡MRI). Further eligibility criteria were age >18 years, lifeexpectancy >4 months, and Karnofsky performance status>60 points. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received erlotinib daily for 1 year starting on day 1 of radiotherapy [50.4 Gy days 128 (MonFri) at 1.8 Gy per fraction]. Response was assessed by endoscopy and computed tomography. |
| Primary End Point: | overall survival (OS) |
| Secondary End Point: | complete response, progression free survival (PFS) and toxicity. |
| Patients Number: | 17 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Among the 9 patients who had endoscopy after radiotherapy, there were 2 mucosal complete responses, 1 residual carcinoma in situ and 3 partial endoscopic responses. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.5 months (95% CI: 2.4-7.3) |
| Median OS A vs. C: | 7.3 months (95% confidence interval, CI: 3.8- 22.3) with 14 deaths. |
| Adverse Event(agent arm): | treatmentrelated toxicities (any grade, n more than and equal to 5) were rash (n = 13), fatigue (n = 16), diarrhea (n = 11), lymphopenia (n = 10), anorexia (n = 7) and dehydration (n = 6). There were 22 incidents of grade 3/4 toxicities. |
| Conclusions: | Erlotinib with radiotherapy is tolerable and warrants further biomarkerdriven evaluation in this population. |