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  • br Adverse Events of Chemotherapy br The treatment

    2020-08-06


    3.3. Adverse Events of Chemotherapy
    The treatment-related AEs are summarized in Table 2. All grade hematologic AEs occurred in 17 patients, 9 of which had CIRS-G score 3 or 4. The most common grade 4 hematologic AEs was neutro-penia (N = 16, 10.5%). Two patients had grade 4 anemia, and each of their CIRS-G score was 3 or 4. In univariate and multivariate analysis for factors associated with hematologic toxicity, CIRS-G categories and TRS did not have a significant association. In univariate and multivariate analysis for factors associated with non-hematologic toxicity, CIRS-G categories and TRS did not have a significant associ-ation with non-hematologic toxicity. A comorbidity heat map shows the association of comorbidities and hematologic toxicities (Fig. 3A). The heat maps showed the trend that patients with hema-tologic toxicity had more severe comorbidities for vascular disease and genitourinary disease than patients with no hematologic toxicity. Another comorbidity heat map showed the association of comorbidities and non-hematologic toxicities (Fig. 3B). However, the heat map showed that there was no difference between patients with and without non-hematologic toxicity.
    3.4. Overall Survival
    The median follow-up duration of all surviving patients was 22.3 months (range 2.9–127.2). The median OS of all patients was 25.1 months (95% CI: 21.2–27.6). In univariate and multivariate analysis for prognostic factors associated with OS (Table 3), ECOG PS of 2 or higher, poorly differentiated histology, age at diagnosis, and colon pri-mary site were significant worse prognostic factors of OS. In univariate analysis of CIRS-G categories for OS, no categories were found to be as-sociated with OS.
    In analysis according to primary site, the median OS for patients with colon cancer was 23.7 month (95% CI: 17.3–25.9) and for patients with rectal cancer was 35.6 months (95% CI: 27.1–49.5). In univariate analy-sis for prognostic factors associated with OS of patients with colon can-cer, ECOG PS of 2 or higher, poorly differentiated histology, number of
    CIRS-G 4 categories and age at diagnosis were associated with worse OS, while prior surgery and endocrine comorbidity were favorable prognostic factors (Table 4). In multivariate analysis, ECOG PS 2 or higher, poorly differentiated histology, number of CIRS-G 4 categories, no prior surgery, and peritoneal Salvinorin A were adverse prognostic fac-tors. For patients with rectal cancer In univariate analysis of patients with rectal cancer, poorly differentiated histology, respiratory disease, and renal disease, were worse prognostic factors for OS (Table 5). In multivariate analysis for rectal cancer, poorly differentiated histology and TRS ≥2 were worse prognostic factors for OS. According to TRS group, a comorbidity heat map shows the association of comorbidities and survival (Fig. 4). The high TRS risk patients had more comorbidities for respiratory, lower GI, renal and endocrine/metabolic and breast dis-ease and psychiatric illness than low TRS risk patients. Survival of low TRS risk patients was significantly longer than that of high TRS risk pa-tients (median survival: 49.5 Salvinorin A months vs. 27.5 months, HR = 4.32, 95% CI:1.32–14.12, p = 0.009) (Fig. 5).
    3.5. Unplanned Hospitalization
    During treatment, 32 patients(21%) had an unplanned hospitaliza-tion. In univariate analysis for prognostic factors associated with un-planned hospitalization, age at diagnosis was a worse prognostic factor (OR = 1.43, 95%CI: 1.04–1.96, p = 0.026). In multivariate
    Table 3
    Univariate (A) and multivariate (B) Cox regression analysis for OS of all patients.
    Variables
    Primary site (ref = Colon)
    Histology Differentiation
    (ref = Well/Moderate)
    differentiation
    Liver metastasis (ref = No)
    Lung metastasis (ref = No)
    Prior Operation (ref = No)
    increase
    Age at Diagnosis, per 5 years old
    increase
    CIRS-G severity index
    HEMATOPOIETIC (ref = 0)
    GENITOURINARY (ref = 0)
    MUSCULOSKELETAL (ref = 0)
    Variables Level
    (ref = well/moderate)
    Age, per 5 years old increase
    Table 4
    Univariate (A) and multivariate (B) Cox regression analysis for OS of patients with colon cancer.
    Variables
    Histology Differentiation
    (ref = Well/Moderate)
    differentiation
    Liver metastasis (ref = No)
    Lung metastasis (ref = No)
    Prior Operation (ref = No)
    increase
    Age at Diagnosis, per 5 years old
    increase
    CIRS-G severity index
    HEMATOPOIETIC (ref = 0)
    GENITOURINARY (ref = 0)
    Variables Level
    Peritoneum metastasis Yes
    (ref = well/moderate)
    Prior operation Yes
    analysis, ECOG PS of 2 or higher (OR = 2.91, 95%CI: 1.01–8.39, p = 0.048) and age at diagnosis (OR = 1.48 per 5-year-old increase, 95% CI: 1.07–2.05, p = 0.018) were worse prognostic factors associated with unplanned hospitalization. No patients with rectal cancer had an unplanned hospitalization. A comorbidity heat map showed the associ-ation of 14 comorbidities and unplanned hospitalization (Fig. 6). There was no difference in severity and number of comorbidities between pa-tients with and without unplanned hospitalization.