Effect of 5-FU Bolus on Survival in Patients with Metastatic Colorectal Cancer Treated with Combination Chemotherapy Restricted; Files Only

Yang, Chenyue (Spring 2019)

Permanent URL: https://etd.library.emory.edu/concern/etds/k643b2042?locale=en
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Abstract

Background: The standard treatment for metastatic colorectal cancer (CRC) include the use of FOLFOX chemotherapy in combination with 5-fluorouacil (5-FU) bolus. However, the use of 5-FU bolus has been associated with toxicity effects in other cancers. The primary objective of this study is to compare the progression-free survival (PFS) of CRC patients receiving 5-FU bolus to PFS of CRC patients omitting 5-FU bolus. Secondary objectives include comparing overall survival (OS), toxicity events, dose reductions due to toxicity, and genetic mutations between two patient groups.

 

Methods: The dataset included 110 metastatic CRC patients, with 74 in the with-bolus group, and 36 in the no-bolus group. Kaplan-Meier plots were used to examine the PFS and OS of the patients, and log-rank tests were used to compare survival pattern between two treatment groups. Univariate analysis was done on PFS and OS, and variables that were significant in univariate analysis were included in multivariate Cox proportional hazard models. Forward selection was used to choose the best model, and residual analysis was performed.  

 

Results: Overall, 66.36% of patients died, and 74.55% had disease progression during the study period. 72.22% of patients died, and 69.44% had disease progression in no-bolus group. 63.51% of patients died, and 77.03% had disease progression in with-bolus group. Among 110 patients, percentage of patients censored were 25.45% for PFS and 33.64% for OS. The log-rank test p-value between two treatment groups was 0.1988 (>0.05) for PFS, and 0.2856 (>0.05) for OS. After adjusting for diabetes status, the hazard of disease progression for no-bolus group is 1.581 (0.958, 2.612) times the hazard of disease progression for with-bolus group (p = 0.073).

 

Conclusion: The unadjusted hazard of disease progression and death are not significantly different between no-bolus group and with-bolus group. However, after adjusting for diabetes status, the effect of using bolus is beneficial under a = 0.1, but not under a = 0.05. Given the relatively small sample size of this study, further consideration is needed before omitting the bolus from metastatic CRC treatments.

Table of Contents

I. INTRODUCTION............................................................................. 1-4

1.1 disease background ......................................................................  1-2

1.2 current treatments .....................................................................  2

1.3 current situation .........................................................................  3

1.4 purpose statement ........................................................................  4

 

II. METHODS ......................................................................................  4-11

2.1 study design and patient enrolment......................................... 4-5

2.2 variables........................................................................................ 5-7

2.3 statistical analysis...................................................................... 7-11

 

III. RESULTS .......................................................................................  11-17

3.1 descriptive statistics................................................................... 11-12

3.2 survival analysis for pfs ............................................................  12-14

3.3 survival analysis for os ..............................................................  15-16

3.4 additional results ........................................................................  16-17

 

IV. CONCLUSION ..............................................................................  17

 

V. DISCUSSION ..................................................................................  17-19

 

VI. REFERENCES ..............................................................................  20-21

 

VII. TABLES AND FIGURES ............................................................  22-36

 

VIII. APPENDIX .................................................................................  37-40

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