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Prognostic influence of body mass index and body weight gain in colorectal cancer patients treated with adjuvant chemotherapy: data from The AVANT study
Proposal
1393
Title of Proposed Research
Prognostic influence of body mass index and body weight gain in colorectal cancer patients treated with adjuvant chemotherapy: data from The AVANT study
Lead Researcher
Sae-Won Han
Affiliation
Department of Internal Medicine, Seoul National University Hospital
Funding Source
none
Potential Conflicts of Interest
None
Data Sharing Agreement Date
18 May 2016
Lay Summary
Colorectal cancer is one of the leading causes of cancer incidence and death worldwide. Although colorectal cancer mortality is declining in the developed countries, its incidence and mortality are increasing in other countries probably due to westernization of lifestyle. Many epidemiology studies have shown that obesity increases the risk of developing colorectal cancer, however, there has been conflicting data on the prognostic impact of obesity in colorectal cancer patients. In addition, very limited data regarding body weight change after colorectal cancer treatment and its impact on treatment outcome is available. Although body weight gain during the period of adjuvant chemotherapy is frequently observed in daily practice, its frequency and prognostic implication has not been studied in detail. Recently, our research team has published an article titled “Prognostic influence of body mass index and body weight gain during adjuvant FOLFOX chemotherapy in Korean colorectal cancer patients” in BMC Cancer. 2015 Oct 14;15:690. Our study results revealed that body weight gain during the adjuvant chemotherapy treatment period has a negative prognostic influence in overweight and obese patients. We want to validate our finding using the database of AVANT study. According to study outcome, patients may be advised to maintain their body weight during adjuvant chemotherapy period.
Study Data Provided
[{ "PostingID": 2546, "Title": "ROCHE-BO17920", "Description": "A Randomized, Three Arm Multinational Phase III Study to Investigate Bevacizumab (q3w or q2w) in Combination With Either Intermittent Capecitabine Plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regimen Alone as Adjuvant Chemotherapy in Colon Carcinoma: The AVANT Study" }]
Statistical Analysis Plan
DFS will be calculated from the date of operation to the first date of documented recurrence or the date of death from any cause. Data from patients who were free of recurrence will be censored at the date of the last follow-up visit for DFS. Categorical variables will be compared using chi-square test or Fisher's exact test. Trend will be analyzed using linear-by-linear association test. DFS will be calculated using the Kaplan-Meier method and comparisons will be made using the log-rank tests. Hazard ratios (HR) will be calculated using the Cox proportional hazard model. Two-sided p-values of less than 0.05 will be considered statistically significant. Statistical analysis will be performed using SPSS software for Windows, version 18.0 (SPSS, Chicago, IL, USA).
Publication Citation
Lee, DW., Cho, S., Shin, A. et al. Body mass index and body weight change during adjuvant chemotherapy in colon cancer patients: results from the AVANT trial. Sci Rep 10, 19467 (2020).
https://doi.org/10.1038/s41598-020-76643-9
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