Pre-Op Regimen Tolerable for Esophageal Adenocarcinoma
But fails to meet objective of achieving pathologic complete response of 40 percent
MONDAY, Oct. 24 (HealthDay News) -- Use of neoadjuvant oxaliplatin, protracted-infusion fluorouracil (PI-FU), and external-beam radiation therapy (EBRT) is tolerable for esophageal adenocarcinoma, but fails to achieve the predefined pathologic complete response (pCR) rate, according to a study published online Oct. 24 in the Journal of Clinical Oncology.
Lawrence P. Leichman, M.D., from the Comprehensive Cancer Center in Palm Springs, Calif., and colleagues carried out a phase II trial to achieve a pCR rate of 40 percent, combined with exploratory analyses of intratumoral molecular. A total of 93 patients with stage II or III esophageal adenocarcinoma received oxaliplatin on days one, 15, and 29; PI-FU on days eight through 43; and EBRT for five days a week. They underwent surgery 28 to 42 days after neoadjuvant therapy, after which time chemotherapy was planned. mRNA expression in the tumors and genetic polymorphisms in genes involved in drug metabolism and DNA repair were analyzed.
The investigators found that there were two deaths which were attributable to preoperative therapy, and two attributable to surgery. Grade 3 toxicities were recorded for 47.3 percent of patients, and grade 4 toxicities for 19.4 percent. A total of 84.9 percent of patients underwent surgery and 67.7 had potentially curative resections. Confirmed pCR was seen in 28.0 percent of patients. Estimates of median and three-year overall survival were 28.3 months and 45.1 percent, respectively, after a median follow-up of 39.2 months. Expression of intratumoral ERCC-1 was inversely associated with progression-free and overall survival.
"Because the regimen failed to meet the primary end point, it does not define a new standard," the authors write.
Several authors disclosed financial ties to Sanofi Aventis and Response Genetics, both of which partially funded the study.