LIVER RESECTABILITY FOLLOWING MFOLFOX6 WITH BEVACIZUMAB AS THE FIRST-LINE TREATMENT OF UNRESECTABLE LIVER LIMITED METASTASES FROM COLORECTAL CANCER IN JAPANESE PATIENTS (KSCC 0802)

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Abstract

Background

There is no data concerning liver resectability following mFOLFOX6 with Bevacizumab as the first-line treatment of unresectable liver limited metastases from colorectal cancer by prospective, multi-center studyin Japan. The Kyushu Study group of Clinical Cancer (KSCC) conducted phase II trials in this setting.

Methods

Eligibility criteria included unresectable liver limited metastases from histologically confirmed advanced colorectal cancer, ECOG PS 0-1 and adequate general condition. Patients received six cycles of mFOLFOX6 (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 day 1 followed by 400 mg/m2 bolus 5-FU and a 46-h 2400 mg/m2 5-FU infusion every 2 weeks) with bevacizymab (5 mg/kg) followed by evaluating the liver resectability (UMIN000001308).

Results

Of the 40 patients enrolled from 9 September 2008 to 10 August 2010; M/F, 29/11; median age, 63 years (range 37–74); ECOG PS 0/1, 38/2. The median number of administration cycles was 6 (range, 1–7). Response for CR, PR, SD, PD and NE were 0 (0%), 12 (30.0%), 22 (55.0%), 3 (7.5%) and 3 (7.5%), respectively. An overall response rate was 30.0% (95% CI: 16.6% to 46.5%). The grade 3–4 adverse events were leukopenia (10%), neutropenia (32.5%), febrile neutropenia (5%), fatigue (2.5%), appetite loss (2.5%), diarrhea (2.5%), mucositis (2.5%), liver damage (2.5%) and ileus (2.5%). The number of cases to intent operation was 17 (42.5%), the liver resectability was 16 of 40 (40.0%). The number of R0 cases was 10 patients (25.0%, 95% CI; 12.7% to 41.2%).

Conclusions

mFOLFOX6 with Bevacizumab regimen is safe and effective for unresectable liver limited metastases from colorectal cancer, and might be to lead the high liver resectability.

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