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. 2019 Dec 27;25(4):308–e625. doi: 10.1634/theoncologist.2019-0931
Title Final assessment
Number of Patients Screened 97
Number of Patients Enrolled 48
Number of Patients Evaluable for Toxicity 48
Number of Patients Evaluated for Efficacy 48
Evaluation Method RECIST 1.1
Response Assessment CR n = 12 (25%)
Response Assessment PR n = 21 (43.8%)
Response Assessment SD n = 7 (14.6%)
Response Assessment PD n = 8 (16.7%)
Response Assessment OTHER n = 0 (0%)
(Median) Duration Assessments PFS 13.94 months, CI: 0.75–51.05
(Median) Duration Assessments OS 27.43 months, CI: 5.278–49.58
Outcome Notes The median prescribed radiation dose was 56 Gy (50.4–60 Gy), with 1.8–2.3 Gy per fraction. Twelve patients had a complete response (12/48, 25%), 21 patients had a partial response (21/48, 43.8%), and the other 7 patients had stable disease (7/48, 14.6%), yielding an ORR (CR + PR) and DCR (CR + PR + SD) at 68.8% and 83.3%, respectively (Table 1).
The median follow‐up was 29.5 months (range, 3.2–68). At the time of this analysis, 24 patients had died of cancer or any other cause, 5 patients were alive with the recurrent tumor, and the remaining 19 patients had no evidence of disease progression. As shown in the Kaplan‐Meier curves, the 1‐, 2‐, and 3‐year PFS rates for all patients were 56.9%, 29.8%, and 27%, respectively. The 1‐, 2‐, and 3‐year OS rates are 78.5%, 59.7%, and 49.7%, respectively. The median PFS was 13.94 months (95% CI, 0.75–51.05) and the median OS was 27.43 months (95% CI, 5.278–49.58; Fig. 2). Analysis of the prognostic factor identified only treatment response to be a significant predictor for PFS (hazard ratio, 4.859; 95% CI, 1.610–14.669, p = .005; Table 2). No clinical characteristic was found to be associated with the OS.