Final safety results from the post-marketing survey (PMS) of bevacizumab (BV) in Japanese colorectal cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15035-e15035
Author(s):  
T. Doi ◽  
K. Shirao ◽  
H. Uetake ◽  
K. Hatake ◽  
Y. Takahashi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Observational Studies ◽  
Advanced Colorectal Cancer ◽  
Drug Reactions ◽  
Rectum Cancer ◽  
Post Marketing ◽  
Colon And Rectum ◽  
The Common ◽  
Colorectal Cancer Patients

e15035 Background: BV was approved in Apr. 2007 in Japan in patients (pts) with advanced colorectal cancer. The number of pts in Japanese clinical trials were extremely limited. Therefore, the Japanese MHLW (Ministry of Health Labor and Welfare) required Chugai to initiate a PMS in all pts after the launch as a post-approval commitment to evaluate the incidence of adverse drug reactions (ADRs) in Japanese pts. This is the first safety well controlled large cohort PMS in Asian pts. Objectives: To assess the use of BV in clinical practice and to evaluate the incidence of ADRs in Japanese pts. Methods: All pts who were treated by BV were registered before initial administration since the launch of BV in Jun. 2007. Follow-up period was 6 months. Results: Between Jun. and Nov. 2007, 2712 pts were registered from 574 institutions, and 2699 pts were eligible for the safety analysis. Pts characteristics were colon/rectum/colon and rectum cancer; 1580/1105/14, M/F; 1632/1067, median age; 61 (15–86), ECOG P.S.0/1/2/3; 2192/477/28/2, combination chemotherapy regimens with BV (FOLFOX / FOLFIRI /5-FU LV /IFL/Other); 1716/778/141/54/10, treatment lines (1st, 2nd, 3rd and more); 1238/1418/43. Of 2699 pts, ADRs were reported in 1589 pts (58.9%) with serious ADRs in 381 pts (14.1%). The common BV ADRs of interest were hypertension; 13.0%, hemorrhage; 11.3% (epitaxis;7.3%), proteinuria; 4.1%. Other ADRs were wound healing complications 1.2%, GI Perforation 0.9%, and thromboembolism (arterial/venous); 0.4 /1.3%. No Japanese-specific ADRs were observed. Conclusions: These safety results are consistent with those reported in International observational studies (BRiTE, Hedrick et al. JCO 2006;24(Jun 20 Suppl.):abstr 3536; First BEAT, Berry et al. JCO 2008;26(May 20 Suppl):abstr 4025). [Table: see text]

scholarly journals Identification of Lifestyle Behaviors Associated with Recurrence and Survival in Colorectal Cancer Patients Using Random Survival Forests

Cancers ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 2442
Author(s):  
Moniek van Zutphen ◽  
Fränzel J. B. van Duijnhoven ◽  
Evertine Wesselink ◽  
Ruud W. M. Schrauwen ◽  
Ewout A. Kouwenhoven ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Recurrence Risk ◽  
Lifestyle Behaviors ◽  
Sugary Drinks ◽  
All Cause Mortality ◽  
Random Survival Forests ◽  
Colorectal Cancer Patients ◽  
Survival Forests ◽  
Risk Of Cancer

Current lifestyle recommendations for cancer survivors are the same as those for the general public to decrease their risk of cancer. However, it is unclear which lifestyle behaviors are most important for prognosis. We aimed to identify which lifestyle behaviors were most important regarding colorectal cancer (CRC) recurrence and all-cause mortality with a data-driven method. The study consisted of 1180 newly diagnosed stage I–III CRC patients from a prospective cohort study. Lifestyle behaviors included in the current recommendations, as well as additional lifestyle behaviors related to diet, physical activity, adiposity, alcohol use, and smoking were assessed six months after diagnosis. These behaviors were simultaneously analyzed as potential predictors of recurrence or all-cause mortality with Random Survival Forests (RSFs). We observed 148 recurrences during 2.6-year median follow-up and 152 deaths during 4.8-year median follow-up. Higher intakes of sugary drinks were associated with increased recurrence risk. For all-cause mortality, fruit and vegetable, liquid fat and oil, and animal protein intake were identified as the most important lifestyle behaviors. These behaviors showed non-linear associations with all-cause mortality. Our exploratory RSF findings give new ideas on potential associations between certain lifestyle behaviors and CRC prognosis that still need to be confirmed in other cohorts of CRC survivors.

Factors determining the appreciation of treatment by advanced colorectal cancer patients

1997 ◽  
Vol 33 ◽  
pp. S60
Author(s):  
E.M. Breimer-Linckens ◽  
G. Vreugdenhil ◽  
J.J. Keuning ◽  
H.K. van Halteren ◽  
A.J.J.M. Vingerhoets
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Advanced Colorectal Cancer ◽  
Colorectal Cancer Patients

scholarly journals Targeted Plasma Metabolic Profiles and Risk of Recurrence in Stage II and III Colorectal Cancer Patients: Results from an International Cohort Consortium

Metabolites ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 129
Author(s):  
Jennifer Ose ◽  
Biljana Gigic ◽  
Stefanie Brezina ◽  
Tengda Lin ◽  
Andreas Baierl ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Multiple Testing ◽  
Tumor Stage ◽  
Stage Ii ◽  
Sphingolipid Metabolism ◽  
Risk Of Recurrence ◽  
Cox Proportional Hazard Models ◽  
Edta Plasma ◽  
Colorectal Cancer Patients

The identification of patients at high-risk for colorectal cancer (CRC) recurrence remains an unmet clinical need. The aim of this study was to investigate associations of metabolites with risk of recurrence in stage II/III CRC patients. A targeted metabolomics assay (128 metabolites measured) was performed on pre-surgery collected EDTA plasma samples from n = 440 newly diagnosed stage II/III CRC patients. Patients have been recruited from four prospective cohort studies as part of an international consortium: Metabolomic profiles throughout the continuum of CRC (MetaboCCC). Cox proportional hazard models were computed to investigate associations of metabolites with recurrence, adjusted for age, sex, tumor stage, tumor site, body mass index, and cohort; false discovery rate (FDR) was used to account for multiple testing. Sixty-nine patients (15%) had a recurrence after a median follow-up time of 20 months. We identified 13 metabolites that were nominally associated with a reduced risk of recurrence. None of the associations were statistically significant after controlling for multiple testing. Pathway topology analyses did not reveal statistically significant associations between recurrence and alterations in metabolic pathways (e.g., sphingolipid metabolism p = 0.04; pFDR = 1.00). To conclude, we did not observe statistically significant associations between metabolites and CRC recurrence using a well-established metabolomics assay. The observed results require follow-up in larger studies.

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