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Development and Validation

Masami Minagawa, MD, PhD; Junji Yamamoto, MD, PhD; Tomoo Kosuge, MD, PhD; Yutaka Matsuyama, PhD; Shin-ichi Miyagawa, MD, PhD; Masatoshi Makuuchi, MD, PhD

Arch Surg. 2007;142(3):269-276.

Hypothesis  Although several staging systems for colorectal liver metastasis have been proposed, simple and generally accepted staging systems are not available for this disease. We hypothesized that more detailed analysis of primary colorectal cancer may make it possible to develop a simple staging system and that its stratification ability may be demonstrated by validation against data from unrelated patients.

Design  Retrospective analysis of prospectively documented data, development of a stage, and validation against an unrelated cohort.

Setting  Four tertiary referral centers.

Patients  Twenty-two clinicopathologic factors were examined in 369 consecutive patients who underwent curative resection for liver metastasis from colorectal cancer (original cohort). Using the independent prognostic factors, a simplified staging system was developed and was validated by data from 229 unrelated patients (validation cohort).

Main Outcome Measures  Kaplan-Meier survival curve analyses between different prognostic groups in the cohorts.

Results  Multivariate analysis revealed several independent prognostic variables, including hepatic lymph node metastasis (relative risk 4.39), 4 or more colorectal lymph node metastases (RR 1.50), carcinoembryonic antigen level of 50 ng/mL or higher (RR 1.29), and multiple hepatic metastases (RR 1.27). Patients with hepatic lymph node metastasis were assigned to stage 4, and the remaining patients were divided according to number of factors: none, stage 1; 1, stage 2; 2 or 3, stage 3. In the original cohort, median survival in stages 1, 2, 3, and 4 was 7.2, 3.5, 2.0, and 1.3 years, respectively. In the validation cohort, these values were 9.6, 4.1, 2.8, and 1.6 years, respectively.

Conclusions  The proposed simplified staging system was easy to use, was highly predictive of patient outcome, and permitted categorization of patients into treatment groups. Although we validated this staging system, further validation and improvements are needed.

Author Affiliations: Departments of Hepato-Biliary-Pancreatic Surgery and Artificial Organ and Transplantation, Graduate School of Medicine (Drs Minagawa and Makuuchi), and Department of Biostatistics, School of Health Science and Nursing (Dr Matsuyama), University of Tokyo, and Department of Gastrointestinal Surgery, Cancer Institute Hospital (Dr Yamamoto), and Department of Surgery, National Cancer Center (Dr Kosuge), Tokyo, Japan; and First Department of Surgery, Shinshu University, Matsumoto, Japan (Dr Miyagawa).

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