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Page 4 of 10                                 Shimizuguchi et al. Hepatoma Res 2020;6:66  I  http://dx.doi.org/10.20517/2394-5079.2020.51

                               Table 2. Patient baseline characteristics
                                Characteristic                               Value
                                Age, median (range), years                  72 (57-93)
                                sex       Male                              19
                                          Female                            5
                                ECOG performance status
                                          0                                 5
                                          1                                 16
                                          2                                 3
                                Charlson comorbidity index [9]
                                          3 to 4                            15
                                          5 or more                         9
                                Underlying liver disease
                                          HCV infection                     7
                                          HBV infection                     4
                                          Alcohol                           4
                                          Non-alcoholic steatohepatitis     5
                                          Other/none                        4
                                Previous treatment course
                                          0                                 9
                                          1 to 2                            6
                                          3 or more                         9
                               ECOG: European Oncology Study Group; HVB: hepatitis B virus; HCV: hepatitis C virus


               a comparable local control rate at 2 years 100% (86%) (P = 0.59) [Figure 2]. In the 11 patients who
               experienced non-local progression, 9 had intrahepatic recurrences as the first site of recurrence, one had
               both intrahepatic and regional lymph node recurrence, and one had lung metastasis.


               Toxicity
               One patient (4.2%) experienced a decline in CP score by 2 points 3 months after the treatment, although
               it remains unclear whether SBRT directly worsened the liver function since HCC developed rapidly after
               the treatment. Grade 2 or greater gastrointestinal toxicity was observed in three patients: One patient
               experienced Grade 3 cholangitis 3 months after the SBRT for S4/8 tumor; another patient experienced
               Grade 2 esophagitis 2 months after SBRT for S8 tumor; and the other patient with an S5/6 tumor
               experienced Grade 2 lower gastrointestinal hemorrhage. The list of SBRT treatment planning parameters,
               liver function before and after treatment, and toxicity are shown in Table 3.


               DISCUSSION
               The current study evaluated the safety and efficacy of liver SBRT in patients with combined treatment
               difficulty. An equally high local control rate with acceptable toxicity was demonstrated in patients with
               both physical and tumor adverse factors.


               The patient selection criteria of the prospective liver SBRT trials, and the patient characteristics that were
               actually included denote the group of patients in which the feasibility of SBRT has been confirmed. Existing
               prospective studies of liver SBRT mainly recruited patients with CP A diseases, or those with at least CP B
                     [6-8]
               score 7 . Additionally, most of the patients who participated in those prospective studies were categorized
               as ECOG PS 0 or 1. Thus, the safety and efficacy of liver SBRT in unfit patients has not been demonstrated
               in prospective trials. Although tumor location is not necessarily regarded as a crucial factor in liver SBRT
               eligibility, substantial attention is paid to dose constraints when the tumor is in contiguity with OAR.
               Furthermore, controversy exists in relation to the dose constraint for the digestive tube, although previous
                                                                                                 [10]
               studies encourage clinicians to reduce the dose for the digestive tube below the prescription dose .
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