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Proposal 1393

Title of the 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

University of Pittsburgh

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

Study ROCHE-BO17920: 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

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.