Phase II trial of gefitinib for recurrent or metastatic esophageal or gastroesophageal junction (GEJ) cancer

Abstract

4054 Background: Conventional chemotherapeutic agents are of limited benefit in patients (pts) with recurrent or metastatic cancer of the esophagus or GEJ. We report preliminary results from an ongoing phase II trial of gefitinib, an oral epidermal growth factor receptor inhibitor, in this population. Methods: Eligibility for this trial requires a histologic diagnosis of esophageal or GEJ adenocarcinoma or squamous cell carcinoma which is either metastatic, or recurrent and incurable after initial definitive therapy. Pts may not have received more than one prior chemotherapy regimen, must have an ECOG performance status of 0–1, and must sign informed consent. Treatment consists of gefitinib 250 mg daily for a minimum of 8 weeks followed by clinical reassessment. Experimental therapy is discontinued if there is objective disease progression, subjective evidence of clinical deterioration or drug intolerance. Results: Between 4/03 and 10/04, 20 pts (17 men, 3 women) with a median age of 58 (range 45–73) years were entered on this trial. There were 12 pts with GEJ and 7 with distal esophageal adenocarcinoma; and 1 with a proximal esophageal squamous cell cancer. All but 4 pts had previously received chemotherapy. Toxicity was modest with grade I diarrhea in 10 pts (50%), a grade II gefitinib rash in 1 (5%), and a grade I rash in 14 pts (70%), and grade I-II nausea in 5 pts (25%). Compliance with the medication could be assessed in 16 of the 20 pts and was excellent. Pts took an average of 98% (range 89–100%) of the prescribed pills. There have been 3 partial responders and 3 pts with stable disease (30% response/stability) with a mean duration of benefit of 4.6 (range 2.2–7.9) months. The median survival for all 20 pts is 5.5 months, but has not yet been reached for the 6 responding or stable pts. Conclusions: Gefitinib is well tolerated and active in previously treated pts with recurrent or metastatic esophageal or GEJ cancer. The disease response or stability rate with this agent is similar to that achieved for other solid tumors. This study continues to accrue pts and is supported by AstraZeneca pharmaceuticals. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca