Rajini Katipamula¹, Aminah Jatoi¹, Nathan R. Foster², Francis Nichols³, Joseph Rubin¹, Matthew Callister⁴, Leonard Gunderson⁴ and Steven Alberts¹

¹Department of Oncology, Mayo Clinic, Rochester, Minnesota. ²Division of Biostatistics, Mayo Clinic, Rochester, Minnesota. ³Division of Thoracic Surgery, Mayo Clinic, Rochester, Minnesota. ⁴Department of Radiation Oncology, Mayo Clinic, Scottsdale, Arizona.

Abstract

Purpose: This brief report describes a planned, interim, 6-patient toxicity analysis that confirms the safety of pemetrexed, carboplatin, radiation with subsequent surgery, as prescribed in the North Central Cancer Treatment Group trial N044E, in patients with locally advanced esophageal cancer.

Methods: Six patients with locally advanced, potentially resectable esophageal cancer received pemetrexed 500 mg/m² and carboplatin AUC = 6 on days 1 and 22 with 5040 centigray of concomitant radiation in 28 fractions over 5.5 weeks followed by esophagectomy as a prelude to a phase II multi-institutional trial.

Results: Only 1 of the 6 patients experienced a grade 4 adverse event (neutropenia). This patient also experienced a grade 3 depression. Of the remaining 5 patients, three experienced at least one grade 3 adverse event (neutropenia, nausea/vomiting, and esophagitis). There were no deaths. Incidentally, one patient manifested a complete pathologic response, three a partial pathologic response, and one stable disease.

Conclusion: These preliminary observations on safety suggest that this regimen can be further studied in this clinical setting.