Clinical Research Papers:
Development and validation of a prognostic nomogram for colorectal cancer after radical resection based on individual patient data from three large-scale phase III trials
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Abstract
Michitaka Honda1,*, Koji Oba2,*, Takashi Akiyoshi3, Hiromichi Maeda4, Kosuke Kashiwabara2, Mitsuro Kanda5, Shuhei Mayanagi6, Toru Aoyama7, Chikuma Hamada8, Sotaro Sadahiro9, Yosuke Fukunaga3, Masashi Ueno3, Junichi Sakamoto10,11, Shigetoyo Saji11 and Takaki Yoshikawa12
1Department of Minimally Invasive Surgical and Medical Oncology, Fukushima Medical University, Fukushima, Japan
2Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
3Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
4Cancer Treatment Center, Kochi Medical School Hospital, Kochi University, Nankoku, Japan
5Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan
6Department of Surgery, Keio University, Tokyo, Japan
7Department of Surgery, Yokohama City University, Yokohama, Japan
8Faculty of Engineering, Tokyo University of Science, Tokyo, Japan
9Department of Surgery, Tokai University, Isehara, Japan
10Tokai Central Hospital, Kakamigahara, Japan
11Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan
12Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan
*These authors contributed equally to this work
Correspondence to:
Michitaka Honda, email: [email protected]
Takaki Yoshikawa, email: [email protected]
Keywords: prognostic nomogram, prediction model, colorectal cancer, overall survival, disease free survival
Received: August 14, 2017 Accepted: September 21, 2017 Published: October 12, 2017
ABSTRACT
Background: Few prediction models have so far been developed and assessed for the prognosis of patients who undergo curative resection for colorectal cancer (CRC).
Materials and Methods: We prepared a clinical dataset including 5,530 patients who participated in three major randomized controlled trials as a training dataset and 2,263 consecutive patients who were treated at a cancer-specialized hospital as a validation dataset. All subjects underwent radical resection for CRC which was histologically diagnosed to be adenocarcinoma. The main outcomes that were predicted were the overall survival (OS) and disease free survival (DFS). The identification of the variables in this nomogram was based on a Cox regression analysis and the model performance was evaluated by Harrell’s c-index. The calibration plot and its slope were also studied. For the external validation assessment, risk group stratification was employed.
Results: The multivariate Cox model identified variables; sex, age, pathological T and N factor, tumor location, size, lymphnode dissection, postoperative complications and adjuvant chemotherapy. The c-index was 0.72 (95% confidence interval [CI] 0.66-0.77) for the OS and 0.74 (95% CI 0.69-0.78) for the DFS. The proposed stratification in the risk groups demonstrated a significant distinction between the Kaplan–Meier curves for OS and DFS in the external validation dataset.
Conclusions: We established a clinically reliable nomogram to predict the OS and DFS in patients with CRC using large scale and reliable independent patient data from phase III randomized controlled trials. The external validity was also confirmed on the practical dataset.
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