579P - A nomogram for predicting overall survival (OS) in Japanese patients (pts) with advanced colorectal cancer (aCRC) treated with irinotecan (IRI)-bas...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Cytotoxic agents
Colon and Rectal Cancer
Biological therapy
Presenter Wataru Ichikawa
Citation Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370
Authors W. Ichikawa1, K. Uehara2, K. Minamimura3, C. Tanaka4, Y. Takii5, H. Miyauchi6, S. Sadahiro7, K. Shinozaki8, K. Fukumoto9, T. Otsuji10, T. Kambara11, S. Morita12, Y. Ando13, M. Arai14, M. Sugihara15, T. Sugiyama16, Y. Ohashi17, Y. Sakata18
  • 1Division Of Medical Oncology, Showa University School of Medicine, 142-8666 - Tokyo/JP
  • 2Department Of Surgical Oncology, Nagoya University Graduate School of Medicine, Nagoya/JP
  • 3Department Of Surgery, Mitsui Memorial Hospital, Tokyo/JP
  • 4Department Of Surgery, Gifu Prefectural General Medical Center, Gifu/JP
  • 5Department Of Surgery, Niigata Cancer Center Hospital, Niigata/JP
  • 6Department Of Frontier Surgery, Chiba University Graduate School of Medicine, Chiba/JP
  • 7Department Of Surgery, Tokai University, Isehara/JP
  • 8Division Of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima/JP
  • 9Department Of Surgery, Nishijin Hospital, Kyoto/JP
  • 10Department Of Gastroenterology, Dongo Hospital, Yamatotakada/JP
  • 11Department Of Surgery, Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital, Fukuyama/JP
  • 12Department Of Biomedical Statistics And Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto/JP
  • 13Department Of Clinical Oncology And Chemotherapy, Nagoya University Hospital, Nagoya/JP
  • 14Pharmacovigilance Department, Daiichi Sankyo, Tokyo/JP
  • 15Clinical Data & Biostatistics Department, Daiichi Sankyo, Tokyo/JP
  • 16Department Of Obsterics And Gynecology, Iwate Medical University School of Medicine, Morioka/JP
  • 17Department Of Integrated Science And Engineering For Sustainable Society, Chuo University Faculty of Science and Engineering, Tokyo/JP
  • 18Ceo, Misawa City Hospital, Misawa/JP



One of the standard treatments for aCRC is IRI-based regimens, which are commonly used as second line treatment in Japan. We conducted a prospective observational study to examine the correlation between UGT1A1 genotypes and the clinical outcome of IRI-based regimens in Japanese pts with aCRC (NCT 01039506). We presented previously the results of OS, the secondary endpoint (ASCO 2015, Abst No. 3525). Furthermore, We are going to present update results of OS (ASCO 2016, Abst No. 3571). We developed a nomogram for predicting survival of pts treated with second-line IRI-based regimens after first-line oxialiplatin-based treatment.


From Oct 2009 to Mar 2012, 1,376 pts with histologically confirmed aCRC treated with IRI-based regimens were enrolled into the study. Among all enrolled pts, 747 pts were treated with the second-line IRI-based regimens after first-line oxialiplatin-based treatment. A nomogram for predicting OS was developed using multivariable Cox proportional hazards model. The discriminative ability and predictive accuracy of the nomogram were determined by concordance index (c-index) and calibration plot. The nomogram was internally validated using bootstrap resampling.


The median OS was 18.5 months (95% CI, 16.8 – 20.7). The multivariable Cox proportional hazards model included age, performance status, resection of primary tumor, location of primary tumor (right vs left), tumor burden based on longitudinal diameters of target lesions according to the RECIST criteria, diabetes and white blood cell count as predictors of OS. The resulting nomogram demonstrated good discrimination and calibration in predicting OS, with a bootstrap-corrected c-index of 0.68. The nomogram showed good separation between risk groups stratified by tertile of the total score, with median OS of 10.1, 18.6, and 29.4 months for low, middle, and high risk groups, respectively.


This proposed nomogram is well calibrated and internally validated. External validation is essential before implementing this nomogram in clinical practice.

Clinical trial identification

NCT 01039506, first released on 23/Dec/2009. The trial protocol number is TOP009-061.

Legal entity responsible for the study

Daiichi Sankyo


Daiichi Sankyo


W. Ichikawa, S. Morita, Y. Ando, T. Sugiyama, Y. Ohashi: Advisory Board members of this study. Honoraria from Daiichi Sankyo. Y. Takii: Honoraria from Daiichi Sankyo. M. Arai: Employee of Daiichi sankyo. M. Sugihara: Employee of Daiichi Sankyo. Y. Sakata: Advisory Board members of this study. Honoraria from Daiichi Sankyo, Taiho Pharmaceutical, Yakult Honsya. All other authors have declared no conflicts of interest.