Purpose. The purpose of this prospective pilot study was to
determine the efficacy of preoperative chemotherapy with six
cycles of FOLFOX 6 (without radiation therapy) followed by
radical surgery followed by six additional cycles ofFOLFOX6 for
patients with stage II/III rectal cancer.
Patients and Methods. From January 2010 to January 2014,
patients with locally advanced rectal cancer who met the
eligibility criteria were enrolled in this study. Patients received
FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin
calcium i.v. over 2 hours on day 1, then bolus, and then
continuous fluorouracil i.v. over 46 hours on days 1 and 2.
Treatment was repeated every 14 days for 6 courses followed
by radical surgery followed by additional 6 cycles of FOLFOX 6.
Results. In total, 45 patients were enrolled in this study. In
the preoperative re-evaluation, the overall response rate was
68.8% (clinical complete response was 4.4%, and the partial
response was 64.4%). There were 14 cases (31.2%) of stable
disease. No patients had progressive disease. Postoperatively,
the pathologic complete response ratewas8of45 (17.8%;95%
confidence interval [CI]: 8.9%–28.9%). The median follow-up
was 29 months (range 9–54 months). The actuarial 3-year
overall survival and disease-free survival rates for all patients
were 80.8% (standard error, 1.877; 95% CI: 69.3%–92.3%)
and 67.9% (standard error, 2.319; 95% CI: 54.3%–81.5%),
respectively.
Conclusion. Neoadjuvant chemotherapy (FOLFOX) without
radiotherapy is active and safe but cannot be considered
a standard of care until the results of prospective randomized
phase III trials are available.