Predictors of toxicity-related hospitalization in four randomized studies of 5-fluorouracil-based chemotherapy in metastatic colorectal cancer
- 45 Downloads
To evaluate the predictors of toxicity-related hospitalization associated with various chemotherapy regimens among metastatic colorectal cancer patients
This pooled analysis includes patient-level datasets from four randomized clinical studies (NCT00272051; NCT00305188; NCT00115765; NCT00364013). Through univariate and multivariate logistic regression analyses, factors predicting the development of serious adverse events, fatal adverse events, and toxicity-related hospitalizations were determined.
A total of 2533 patients were included in the current study. A total of 1010 patients (39.9%) experienced one or more episodes of serious adverse events. These include 914 patients (36.1%) who were hospitalized at least once and 148 patients (5.8%) who suffered from a fatal adverse event. Within multivariate logistic regression analysis, older age (P < 0.001), higher ECOG score (P < 0.001), bevacizumab-containing chemotherapy (P < 0.001), and panitumumab-containing chemotherapy (P < 0.001) were predictive of hospitalization. Similarly, older age (P < 0.001), higher ECOG score (P < 0.001), and panitumumab-containing chemotherapy (P = 0.003) were predictive of fatal adverse events in multivariate logistic regression analysis. Moreover, in a multivariate Cox regression analysis, hospitalization was predictive of worse overall survival (P < 0.001) and progression-free survival (P < 0.001).
Older age, poorer performance status, and bevacizumab- and panitumumab-containing regimens are associated with a higher risk of hospitalization. Moreover, hospitalization is predictive of worse overall and progression-free survival.
Keywords5-fluorouracil Serious adverse events Fatal adverse events Hospitalization Colorectal cancer
This publication is based on research using information obtained from www.projectdatasphere.org.
Compliance with ethical standards
Informed consent was obtained from all participants included in the study.
All procedures performed were in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Conflict of interest
The authors declare that they have no conflict of interest.
- 1.Numico G, Cristofano A, Mozzicafreddo A, Cursio OE, Franco P, Courthod G, Trogu A, Malossi A, Cucchi M, Sirotovà Z, Alvaro MR, Stella A, Grasso F, Spinazzé S, Silvestris N (2015) Hospital admission of cancer patients: avoidable practice or necessary care? PLoS One 10(3):e0120827CrossRefPubMedGoogle Scholar
- 3.Russo CA, Stocks C (2006) Hospitalizations for colorectal cancer, 2006: Statistical Brief #69. 2009 Mar. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US). Available from: https://www.ncbi.nlm.nih.gov/books/NBK54563/. Accessed 10 Jan 2018
- 4.Oster G (1999) Hospitalization for 5-FU toxicity in metastatic colorectal cancer: incidence and cost. Oncology (Williston Park, NY) 13(7 Suppl 3):41Google Scholar
- 5.Devani K, Patil N, Simons-Linares CR, Patel N, Jaiswal P, Patel P, Patel S, Savani C, Sajnani K, Young M, Reddy C (2017) Trends in hospitalization and mortality of venous thromboembolism in hospitalized patients with colon cancer and their outcomes: US perspective. Clin Colorectal Cancer 16(3):e199–e204CrossRefPubMedGoogle Scholar
- 6.https://www.projectdatasphere.org/projectdatasphere/html/home. Last accessed on 7/10/2017
- 7.globocan.iarc.fr. Last accessed on 27/11/2016
- 9.Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocákova I, Ruff P, Błasińska-Morawiec M, Šmakal M, Canon JL, Rother M, Oliner KS, Tian Y, Xu F, Sidhu R (2014) Final results from PRIME: randomized phase III study of panitumumab with FOLFOX4 for first-line treatment of metastatic colorectal cancer. Ann Oncol 25(7):1346–1355CrossRefPubMedGoogle Scholar
- 10.Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, Marshall J, Cohn A, McCollum D, Stella P, Deeter R, Shahin S, Amado RG (2009) A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol 27(5):672–680CrossRefPubMedGoogle Scholar
- 11.https://www.fda.gov/safety/medwatch/howtoreport/ucm053087.htm. Last accessed on 7/10/2018