| General information |
| Database: | DB00436 |
| Objective: | Conventional chemotherapeutic agents are of limited benefit in patients with recurrent or metastatic cancer of the esophagus or gastroesophageal junction (GEJ). They report results from a phase II trial in this population using gefitinib, an oral epidermal growth factor receptor inhibitor. |
| Authors: | Adelstein DJ, et al |
| Title: | a phase II trial of gefitinib for recurrent or metastatic cancer of the esophagus or gastroesophageal junction. |
| Journal: | Invest New Drugs. |
| Year: | 2011 |
| PMID: | 21863238 |
| Trial Design |
| Clinical Trial Id: | IRUSIRES0115 |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | squamous cell carcinoma or adenocarcinomaof the esophagus or gastroesophageal junction |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | open labelphase II study |
| Key Patients Feature: | Eligibility for this trial required a histologically confirmeddiagnosis of squamous cell carcinoma or adenocarcinomaof the esophagus or gastroesophageal junction, and diseasewhich was either metastatic, or recurrent and incurable afterinitial definitive therapy. Patients could not have receivedmore than one prior chemotherapy regimen whether givenfor metastatic disease or as part of their initial definitivetreatment. An Eastern Cooperative Oncology Group performance status of 0 to 1 was required, as was adequatehematologic, renal, and hepatic function to tolerate theproposed treatment. Response to therapy was the primaryendpoint, and measurable disease was required for patiententry. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | No more than one prior chemotherapy regimen was permitted. Treatment consisted of gefitinib 250 mg daily for a minimum of 8 weeks. |
| Primary End Point: | Response to therapy |
| Secondary End Point: | NA |
| Patients Number: | 18 |
| Trial Results |
| DLT_MTD: | Toxicity was modest, although most experienced grade 12 diarrhea and/or skin rash |
| Objective Response Rate: | There were 4 partial responders (7%) and 10 patients with stabledisease (17%). The clinical benefit (partial response andstable disease) lasted for a median 6.1 months. |
| Disease Control Rate: | 0.24 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 5.5 months |
| Adverse Event(agent arm): | Toxicity was modest, although most experienced grade 1-2 diarrhea and/or skin rash. There were 4 partial responders (7%) and 10 patients with stable disease (17%). |
| Conclusions: | Gefitinib was well tolerated but of limited efficacy in patients with recurrent or metastatic esophageal or GEJ cancer. Further study of this or similar agents will require better patient selection. |