| General information |
| Database: | DB00437 |
| Objective: | Concurrent chemoradiotherapy (CCRT) for locoregionally advanced esophageal or gastroesophageal junction cancer produces high locoregional control rates but suboptimal distant metastatic control (DMC) and overall survival. Thisphase II study added gefitinib (G) to our previously tested CCRT regimen in an effort to improve these outcomes. |
| Authors: | Rodriguez CP, et al |
| Title: | a phase II study of perioperative concurrent chemotherapy, gefitinib, and hyperfractionated radiation followed by maintenance gefitinib in locoregionally advanced esophagus and gastroesophageal junction cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2010 |
| PMID: | 20009775 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | advanced esophagus and gastroesophageal junction cancer. |
| Therapy Type: | com |
| Therapeutic Combination Type: | 6 |
| Therapeutic Combination Content: | perioperative concurrent chemotherapy, gefitinib, and hyperfractionated radiation followed by maintenance gefitinib |
| Study Type: | a phase II study |
| Key Patients Feature: | Eligibility required T3, N1, or M1a esophageal or gastroesophageal junction squamous cell or adenocarcinoma staged by esophageal ultrasound and positron emission tomography/computed tomography. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Fourday continuous intravenous infusions of cisplatin (20 mg/m/d) and fluorouracil (1000 mg/m/d) began on day 1 of preoperative radiation (30 Gy and 1.5 Gy bid). Surgery followed in 4 to 6 weeks, and an identical course of CCRT 6 to 10 weeks postoperatively. G 250 mg/d was given with preoperative CCRT for 4 weeks and restarted with postoperative therapy for 2 years. Results were retrospectively compared with our historical series of 93 patients given CCRT without G. |
| Primary End Point: | toxicity, overall survival, DMC and locoregional control. |
| Secondary End Point: | NA |
| Patients Number: | 80 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | distant metastatic control (40% versus 32%, p = 0.33), and locoregional control (76% versus 77%, p = 0.74). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | overall survival (42% versus 28%, p = 0.06) |
| Adverse Event(agent arm): | G did not increase toxicity except for development of rash in 42 (53%) and diarrhea |
| Conclusions: | Although G did not worsen CCRT toxicity, maintenance therapy proved difficult. This contemporary cohort of patients enjoyed superior survival, which does not solely reflect a decrease in DMC and merits further investigation. |