The researchers investigated the use of oxaliplatin (OXP) in combination with protracted-infusion (PI) fluorouracil (5-FU) and radiation in patients with esophageal cancer.
The findings of the trial were reported in the latest issue of the Journal of Clinical Oncology.
A total of 38 therapeutically naÔve esophageal carcinoma patients were included in the study. Of these, 22 were noninvasively staged as IV and 16 were noninvasively staged as II and III.
Initial doses and schedules for cycle 1 consisted of OXP 85 mg/m2 on days 1, 15, and 29, and PI 5-FU 180 mg/m2 for 24 hours for 35 days. This was in addition to external-beam radiation therapy (XRT), 1.8 Gy in 28 fractions, starting on day 8.
Some 36 patients completed cycle 1.
Eligible patients could undergo an operation or begin cycle 2 without XRT.
Postoperative patients were eligible for cycle 2.
It was found that 29 patients started cycle 2, and 24 patients completed cycle 2.
Stage IV patients were allowed 3 cycles in the absence of disease progression.
|81% of patients no longer had esophageal cancer after cycle 1.
| Journal of Clinical Oncology |
OXP and 5-FU increases were based on dose-limiting toxicity encountered in cohorts of 3 consecutive patients.
The team found that combined-modality therapy was well tolerated, but dose-limiting toxicity prevented OXP and 5-FU escalation.
No grade 4 hematologic toxicity was noted.
A total of eleven grade 3 and two grade 4 clinical toxicities were noted in 8 patients.
After cycle 1, 81% of patients had no cancer in the esophageal mucosa.
Some 13 patients underwent an operation with intent to resect the esophagus. Of these, 38% of the patients exhibited pathologic complete responses.
Dr Nikhil I. Khushalani, of the Roswell Park Cancer Institute, Buffalo, said on behalf of fellow authors, "OXP 85 mg/m2 on days 1, 15, and 29, administered with PI 5-FU and XRT is safe, tolerable, and seems effective against primary esophageal carcinoma."
"The role of OXP in multimodality regimens against esophageal carcinoma deserves further evaluation," it was concluded.