| General information |
| Database: | DB00401 |
| Objective: | In this pilot study, they investigated the safety and efficacy of concurrent erlotinib and radiotherapy as an alternative treatment modality for esophageal carcinoma patients who are intolerant to chemoradiotherapy. |
| Authors: | Zhai Y, et al |
| Title: | Concurrent erlotinib and radiotherapy for chemoradiotherapyintolerant esophageal squamous cell carcinoma patients: results of a pilot study. |
| Journal: | Dis Esophagus |
| Year: | 2013 |
| PMID: | 22862289 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | esophageal squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | Concurrent erlotinib and radiotherapy |
| Study Type: | pilot study |
| Key Patients Feature: | histologically confirmed unresectable ESCC; locally advanced, metastatic, or recurrent disease; Eastern CooperativeOncology Group (ECOG) performance status (PS)score 3; age 18 years old; life expectancy 12weeks; any stage with measurable or assessabledisease by Response Evaluation Criteria in SolidTumors (RECIST; version 1.0); need but intoleranceto concurrent chemoradiotherapy in pretreatmentevaluation due to advanced age ( 70 years old), malnutrition (who can have liquid food only or evenworse), or severe medical comorbidities; absoluteneutrophil count 1000/mL and platelets 75 000/mL; and serum creatinine and transaminases within1.5 times the upper normal limit |
| Biomarker: | epidermal growth factor receptor expression |
| Biomark Analysis: | The relationship between epidermal growth factor receptor expression and treatment outcomes could not be concluded.Valuable markers to predict the effect of erlotinib should be exploited in future studies. |
| Control Group Info: | single arm |
| Treatment Info: | Erlotinib was given orally for 60 days (150 mg per day). Radiotherapy (total dose, 60 Gy) was given at dosages of 2 Gy for a total of 30 times. IMC staining was performed to assess epidermal growth factor receptor expression. |
| Primary End Point: | The overall survival, progression free survival, and localregional relapsefree survival |
| Secondary End Point: | NA |
| Patients Number: | 18 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | In grade 1 group, complete response is 11.1%, partial response is 44.4%, stable disease is 44.4%; in grade 2, complete response is 33.3%, partial response is 66.7%, stable disease is 0; in grade 3, complete response is 0, partial response is 50%, stable disease is 50%; |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Twoyear progression free survival rate is 38.9% |
| Median OS A vs. C: | Twoyear overall survival rate is 44.4% |
| Adverse Event(agent arm): | Grade 3 esophagitis and skin rash were observed in five (27.8%) and two (11.1%) patients, respectively. Radiation pneumonitis of grades 2 and 5 was observed in one patient each. No grade 3/4 impaired liver function or hematological toxicity was observed. |
| Conclusions: | For esophageal squamous cell carcinoma patients who cannot tolerate chemoradiotherapy, concurrent erlotinib and radiotherapy are tolerable and effective. Valuable markers to predict the effect of erlotinib should be exploited in future studies. |