br oxaliplatin related neuropathy among patients with metast
oxaliplatin-related neuropathy among patients with metastatic CRC receiving first-line FOLFOX (5-FU, leucovorin, and oxaliplatin) chemotherapy. Another trial (NCT00364013) evaluated the impact of panitumumab addition on the outcomes of patients with meta-static CRC receiving first-line FOLFOX chemotherapy. Another trial (NCT00115765) evaluated the impact of panitumumab addition on the outcomes of patients with metastatic CRC receiving first-line chemotherapy/bevacizumab combination. The last trial (NCT00384176) evaluated a cediranib/FOLFOX combination regimen versus a bevacizumab/FOLFOX combination regimen.
For 3 of the included trials (NCT00272051, NCT00305188, and NCT00384176), only control arm datasets were available in the PDS platform, and they AUY922 (NVP-AUY922) were included in the pooled analysis. For the other 2 studies (NCT00115765 and NCT00364013), both experimental and control arms were available in the PDS platform, and they were included in the pooled analysis. Table 1 provides a summary of the different cohorts included in the current pooled analysis.
Where available, the following data were collected from each of the included datasets: age at diagnosis, gender, race, body mass index, Eastern Cooperative Oncology Group (ECOG) performance status, primary tumor location, number of sites with metastatic disease, chemotherapy regimen, diabetes mellitus, and hypertension. Incidence, grade, and time to start of all cardiac toxicities and specifically of arrhythmias and ischemic episodes were also collected. Cardiac toxicities were graded in different studies according to Common Terminology Criteria of Adverse Events.
According to the available protocols of all included studies, all participants have adequate organ function (including liver, renal, bone marrow, and cardiac function) in addition to satisfactory performance status. Patients with prior clinically significant cardiac disease (including arrhythmias and cardiac ischemia) were excluded.
Different 5-FU-based Regimens Evaluated in the Current Descriptive statistics were first conducted (including frequencies Pooled Analysis and percentages) of different baseline characteristics. The c2 test was
The first 2 trials evaluated the impact of xaliproden in the also used to examine the differences in frequencies of cardiac adverse reduction (NCT00272051) or prevention (NCT00305188) of events according to the type of chemotherapy regimen.
Table 2 Baseline Characteristics of Included Patients in the Cohort (3223 Patients)
Parameter N (%)
Primary tumor site
Number of organs with distant metastases
Any cardiac toxicity
To evaluate factors predicting the development of all cardiac toxicities; arrhythmias and ischemic events, univariate logistic regression analysis was conducted. Subsequently, factors with P <
.05 in univariate analysis were included in multivariate logistic regression analysis. SPSS statistical software (IBM, Armonk, NY) version 20.0 was used in all statistical procedures.
Table 2 Continued
Parameter N (%)
Abbreviations: BMI ¼ body mass index; ECOG ¼ Eastern Cooperative Oncology Group performance status; SD ¼ standard deviation.
A total of 3223 patients were included in the pooled analysis. The mean age at diagnosis was 60.7 years (SD, 11.06 years), and the mean body mass index was 26.29 (SD, 5.05). Of the participants, 59.7% were men, 90.8% were of Caucasian race, and 57.3% had an ECOG score of 0. Other baseline characteristics, including primary tumor site, number of sites with metastases, and chemotherapy regimens, are illustrated in Table 2.