Prospective phase II study of neoadjuvant FOLFOX6 plus cetuximab in patients with
colorectal cancer and unresectable liver-only metastasis.
Author(s): Ji JH(1), Park SH, Lee J, Kim TW, Hong YS, Kim KP, Kim SY, Baek JY, Kang HJ, Shin
SJ, Shim BY, Park YS.
Affiliation(s): Author information:
(1)Division of Hematology and Oncology, Department of Medicine, Samsung Medical
Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu,
Seoul, 135-710, Korea.
Publication date & source: 2013, Cancer Chemother Pharmacol. , 72(1):223-30
PURPOSE: Liver resection may offer the only chance of cure in patients with
colorectal cancer with liver metastases. In the unresectable cases, neoadjuvant
chemotherapy could render curability if resectability could be achieved.
METHODS: Newly diagnosed K-RAS wild-type colorectal cancer patients with
unresectable liver-only metastases were treated with 5-fluorouracil, leucovorin,
and oxaliplatin (FOLFOX6) plus cetuximab every 2 weeks for a maximum of 12
cycles. Clinical response was evaluated every 6 weeks, and surgery was performed
at the physician's discretion in patients with sufficient tumor shrinkage,
followed by chemotherapy with the same regimen, to complete a total of 12 cycles.
The primary endpoint was an overall R0 resection rate.
RESULTS: Between July 2008 and December 2009, 73 patients were registered from 11
Korean centers. Among 53 (73 %) patients who showed at least partial response,
surgery with curative intent was attempted in 36 (49 %) patients.
Intention-to-treat analysis revealed a R0 resection rate of 27 % (20/73)
including 8 patients whose unresectable liver metastases were successfully
treated with radiofrequency ablation (RFA). The most common grade 3 and 4
toxicity was neutropenia (50/462 cycles, 10.7 %). Median time to progression
(TTP) was 9.8 months (range 0.5-31.8) in all patients, but we observed TTP of
14.1 months (range 1.3 to -30.8) in patients who received R0 resection and RFA +
R0 resection.
CONCLUSIONS: Neoadjuvant chemotherapy with FOLFOX6 plus cetuximab showed high
response rates and increased the resectability in colorectal patients with
non-resectable liver-only metastases.
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