Validation of the 12-Gene Colon Cancer Recurrence Score in NSABP C-07 As a Predictor of Recurrence in Patients With Stage II and III Colon Cancer Treated With Fluorouracil and Leucovorin (FU/LV) and FU/LV Plus Oxaliplatin

Yothers, Greg; O’Connell, Michael J.; Lee, Mark; Lopatin, Margarita; Clark-Langone, Kim; Millward, Carl; Paik, Soonmyung; Sharif, Saima; Shak, Steven; Wolmark, Norman

doi:10.1200/jco.2012.47.3116

Cited by 153 publications

(119 citation statements)

References 31 publications

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“…In clinical practice, the patients treated were more complex because they may take other drugs affecting efficacy of chemotherapy regimens. Moreover, previous trials did not clearly indicate that if the heterogeneous group of stage III colon cancer patients, such as status of molecular profile with same benefit from FOLFOX regimen [10,11].…”

Section: Backgroundsmentioning

confidence: 97%

“Real World” Effectiveness of Different Postoperative Adjuvant Chemotherapy Regimens in Stage III Colon Cancer Patients

Jm¹,

Hy²,

Sf³

et al. 2016

Chemotherapy

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Section: Backgroundsmentioning

confidence: 97%

“Real World” Effectiveness of Different Postoperative Adjuvant Chemotherapy Regimens in Stage III Colon Cancer Patients

Jm¹,

Hy²,

Sf³

et al. 2016

Chemotherapy

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“…Yothers et al reported that the 12-gene Recurrence Score provides additional information beyond the conventional clinical and pathological factors 28 ; this score is a predictor of recurrence risk that was developed using gene expression data 29 . In clinical practice, these factors could improve decision-making regarding adjuvant chemotherapy for patients with Stage and colon cancer.…”

Section: Discussionmentioning

confidence: 99%

Prognostic Factors for Recurrence after Tegafur-uracil Plus Leucovorin Adjuvant Chemotherapy in Patients with Colorectal Cancer

Watanabe

Murakami

Ozawa

et al. 2016

Showa Univ J Med Sci

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: To evaluate prognostic factors for recurrence after tegafur-uracil plus leucovorin UFT / LV adjuvant chemotherapy in patients with colorectal cancer CRC . Consecutive patients with CRC who received UFT / LV as adjuvant chemotherapy at Showa University Hospital between June 2005 and December 2008 were included in the study, 5-year disease-free survival DFS and overall survival OS rates were estimated, and prognostic factors for recurrence were analyzed using the Cox proportional hazards model for multivariate analysis. Of 92 patients included in the study, 17 18.5 had disease recurrence. The 5-year DFS and OS rates were 82.2 and 91.9 , respectively. In the multivariate analysis, preoperative CA19-9 level 37 U / ml, emergency operation, and T4 lesions were independent signi cant prognostic factors after treatment with UFT / LV adjuvant chemotherapy. The three independent prognostic factors T4 lesions, emergency operation, and high preoperative CA19-9 levels may be useful for decision-making regarding whether patients should receive 5-fluouracil-based or L-oxaliplatin-based adjuvant chemotherapy. As this was a single-institution study with a small number of patients, our ndings need to be con rmed in larger multicenter studies..

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“…In the medical journals, a total of 767 parallel group RCTs were reported from January 2013 to December 2014: 179 in the New England Journal of Medicine, 108 in The Lancet, 108 in The Journal of the American Medical Association, 26 in Annuals of Internal Medicine, 122 in The Lancet Oncology, and 224 in the Journal of Clinical Oncology. We found five papers [5,41,22,21,40] covering four types of CBPTI plots (two papers presented STEPP. One was selected for our study).…”

Section: Literature Reviewmentioning

confidence: 99%

“…A Bland-Altman plot is recommended for this example [7]. The lack of uncertainty is a major limitation of [41] basis of the principles of visual display, Figure 3.2 shows two limitations. The readers have to read the legend to check which thickness of line belongs to which treatment group.…”

Section: Distinguishing the Outcome E↵ect For Each Treatment Groupmentioning

confidence: 99%

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Graphical Presentation of Patient-Treatment Interaction Elucidated by Continuous Biomarkers

Shen¹,

Le²,

Wilson³

et al. 2017

Methods Inf Med

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Summary Background: Biomarkers providing evidence for patient-treatment interaction are key in the development and practice of personalized medicine. Knowledge that a patient with a specific feature – as demonstrated through a biomarker – would have an advantage under a given treatment vs. a competing treatment can aid immensely in medical decision-making. Statistical strategies to establish evidence of continuous biomarkers are complex and their formal results are thus not easy to communicate. Good graphical representations would help to translate such findings for use in the clinical community. Although general guidelines on how to present figures in clinical reports are available, there remains little guidance for figures elucidating the role of continuous biomarkers in patient-treatment interaction (CBPTI). Objectives: To combat the current lack of comprehensive reviews or adequate guides on graphical presentation within this topic, our study proposes presentation principles for CBPTI plots. In order to understand current practice, we review the development of CBPTI methodology and how CBPTI plots are currently used in clinical research. Methods: The quality of a CBPTI plot is determined by how well the presentation provides key information for clinical decision-making. Several criteria for a good CBPTI plot are proposed, including general principles of visual display, use of units presenting absolute outcome measures, appropriate quantification of statistical uncertainty, correct display of benchmarks, and informative content for answering clinical questions especially on the quantitative advantage for an individual patient with regard to a specific treatment. We examined the development of CBPTI methodology from the years 2000-2014, and reviewed how CBPTI plots were currently used in clinical research in six major clinical journals from 2013-2014 using the principle of theoretical saturation. Each CBPTI plot found was assessed for appropriateness of its presentation and clinical utility. Results: In our review, a total of seven methodological papers and five clinical reports used CBPTI plots which we categorized into four types: those that distinguish the outcome effect for each treatment group; those that show the outcome differences between treatment groups (by either partitioning all individuals into subpopulations or modelling the functional form of the interaction); those that evaluate the proportion of population impact of the biomarker; and those that show the classification accuracy of the biomarker. The current practice of utilizing CBPTI plots in clinical reports suffers from methodological shortcomings: the lack of presentation of statistical uncertainty, the outcome measure scaled by relative unit instead of absolute unit, incorrect use of benchmarks, and being non-informative in answering clinical questions. Conclusions: There is considerable scope for improvement in the graphical representation of CBPTI in clinical reports. The current challenge is to develop instruments for high-quality graphical plots which not only convey quantitative concepts to readers with limited statistical knowledge, but also facilitate medical decision-making.

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Validation of the 12-Gene Colon Cancer Recurrence Score in NSABP C-07 As a Predictor of Recurrence in Patients With Stage II and III Colon Cancer Treated With Fluorouracil and Leucovorin (FU/LV) and FU/LV Plus Oxaliplatin

Cited by 153 publications

References 31 publications

“Real World” Effectiveness of Different Postoperative Adjuvant Chemotherapy Regimens in Stage III Colon Cancer Patients

“Real World” Effectiveness of Different Postoperative Adjuvant Chemotherapy Regimens in Stage III Colon Cancer Patients

Prognostic Factors for Recurrence after Tegafur-uracil Plus Leucovorin Adjuvant Chemotherapy in Patients with Colorectal Cancer

Graphical Presentation of Patient-Treatment Interaction Elucidated by Continuous Biomarkers

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