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• W2157913687 abstract "Background: Bevacizumab-based therapy demonstrated clinical efficacy for neoadjuvant treatment of patients with colorectal liver-limited metastases (CLLM). There are no data concerning the benefit of bev maintenance therapy after induction with bev-based therapy for patients who underwent R0 liver resection. Methods: Untreated metastatic pts with histologically confirmed colorectal cancer with liver-limited mets were treated before surgery with the combination therapy mFOLFOX-6/bev for 5 cycles (cycle 1-5) followed by one cycle (cycle 6) of mFOLFOX6 alone (without bev). Postoperative chemotherapy + bev was restarted 5 weeks after surgery: patients were treated with the combination therapy mFOLFOX-6 + bevacizumab for additional 6 cycles (cycle 7-12). Immediately at the end of the post-operative phase, patients were treated with bev alone for 52 weeks (1 year). We report here an IA for the first 26 out of pre-planned 77 pts. Pts received oxaliplatin 85 mg/m2 by intravenous infusion (i.v.) on day1, i.v. LV 200 mg/m2 on day 1, followed by 5-FU 2,400 mg/m2, by continuous infusion over 46 hours + bev 5 mg/Kg i.v on day 1 q2w. Eligibility criteria included adequate organ function and ECOG PS 0-1. All pts were candidates for neoadjuvant therapy and categorized according to the following surgical criteria: i) unresectable CLLM for whom the 2 following conditions of resectability are not satisfied: preservation of 2 contiguous segments maintaining both vascularization (inflow and outflow) and biliary drainage or maintenance of at least 30% of the total hepatic parenchyma, ii) borderline resectable CLLM, where R0 surgery cannot be guaranteed, iii) “high risk” resectable CLLM defined as > 3 metastases, if the patient has a metachronous disease or 1 metastatic lesion ≥ 5 cm or multiple lesions (≥ 2) of any size, if the patient has a synchronous disease. Primary endpoint was ORR. Results: According to ITT analysis, 26 out of 27 enrolled pts were evaluable for ORR. Pts characteristics were: sex 18M/8F, median age 64.5 years [37-77], PS 0/1: 23/3. Site of primary tumor: rectum 2, colon 24. Synchronous/metachronous metastases: 24/2. Unresectable 14, borderline resectable 6, “high risk” resectable 6. ORR was 16 responders (61.5%, all PR) and 10 non-responders [38.5%: 7 SD (26.9%) and 3 withdrawals], respectively. Fourteen (53.8%) underwent R0 liver resection. Grade 3 related AEs (%) were: neutropenia 1 (3,8%) [and 2 neutropenia G4 (7.6%)], myocardial infarction 1 (3.8%), fatigue 2 (7.6%), proteinuria 1 (3.8%), hypertransaminasemia 1 (3.8%). Conclusion: IA results show high RR of mFOLFOX6/bev in CLLM treatment, resulting in high rate of R0 liver resection with good safety profile. Data should be confirmed and the role of bev maintenance clarified with study final results." @default.
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• W2157913687 date "2013-06-01" @default.
• W2157913687 modified "2023-09-23" @default.
• W2157913687 title "Interim Analysis Results of Above Phase II Study with Bevacizumab in Patients with Initially not Resectable/Borderline Resectable Colorectal Liver-Limited Metastases" @default.
• W2157913687 doi "https://doi.org/10.1093/annonc/mdt203.253" @default.
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