Summary Background The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown. The CAIRO3 study was ...designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation. Methods In this open-label, phase 3, randomised controlled trial, we recruited patients in 64 hospitals in the Netherlands. We included patients older than 18 years with previously untreated metastatic colorectal cancer, with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine, oxaliplatin, and bevacizumab (CAPOX-B), WHO performance status of 0 or 1, and adequate bone marrow, liver, and renal function. Patients were randomly assigned (1:1) to either maintenance treatment with capecitabine and bevacizumab (maintenance group) or observation (observation group). Randomisation was done centrally by minimisation, with stratification according to previous adjuvant chemotherapy, response to induction treatment, WHO performance status, serum lactate dehydrogenase concentration, and treatment centre. Both patients and investigators were aware of treatment assignment. We assessed disease status every 9 weeks. On first progression (defined as PFS1), patients in both groups were to receive the induction regimen of CAPOX-B until second progression (PFS2), which was the study's primary endpoint. All endpoints were calculated from the time of randomisation. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT00442637. Findings Between May 30, 2007, and Oct 15, 2012, we randomly assigned 558 patients to either the maintenance group (n=279) or the observation group (n=279). Median follow-up was 48 months (IQR 36–57). The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment, and was 8·5 months in the observation group and 11·7 months in the maintenance group (HR 0·67, 95% CI 0·56–0·81, p<0·0001). This difference remained significant when any treatment after PFS1 was considered. Maintenance treatment was well tolerated, although the incidence of hand-foot syndrome was increased (64 23% patients with hand-foot skin reaction during maintenance). The global quality of life did not deteriorate during maintenance treatment and was clinically not different between treatment groups. Interpretation Maintenance treatment with capecitabine plus bevacizumab after six cycles of CAPOX-B in patients with metastatic colorectal cancer is effective and does not compromise quality of life. Funding Dutch Colorectal Cancer Group (DCCG). The DCCG received financial support for the study from the Commissie Klinische Studies (CKS) of the Dutch Cancer Foundation (KWF), Roche, and Sanofi-Aventis.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Background Treatment possibilities for colorectal peritoneal metastases (PM) are increasing. It is however unclear how treatment choice and outcome are influenced by histological subtype and ...the presence of systemic metastases. Therefore, this study assessed the impact of histological subtype and systemic metastases on treatment choice and survival in patients with colorectal PM. Methods This population-based study included patients with synchronous PM originating from colorectal adenocarcinoma (AC), mucinous adenocarcinoma (MC), or signet ring cell carcinoma (SRCC). Data of patients diagnosed between 2005 and 2014 were extracted from the National Cancer Registry (IKNL) of the Netherlands. Treatment strategy and survival were analysed with logistic regression and cox proportional hazard analyses. Results In total, 5516 patients were included, of whom 71.8% had an AC, 21.2% an MC, and 7.0% had an SRCC. The use of cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) was dependent on histological subtype and the presence of systemic metastases, and increased over time, especially in AC and MC patients. The relative survival gain of CRS + HIPEC, corrected for systemic metastases, was comparable in AC, MC, and SRCC patients (hazard ratio: 0.17, 0.21, and 0.13, respectively). Compared to supportive care only, the absolute survival gain was 30, 35, and 18 months, respectively. Systemic therapy improved survival in all histological subtypes. Conclusions Histological subtype and the presence of systemic metastases strongly influenced treatment choice and survival in patients with synchronous colorectal PM. These results can be used to optimize treatment strategy for patients with synchronous colorectal PM.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
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