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Research ArticleOriginal Article
Open Access

Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study

Xingyun Chen, Shuo Li, Chuntao Gao, Wei Wang, Haorui Li, Yuxiao Liu, Rui Liu and Jihui Hao
Cancer Biology & Medicine January 2025, 22 (1) 67-76; DOI: https://doi.org/10.20892/j.issn.2095-3941.2024.0287
Xingyun Chen
1Department of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, China
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Shuo Li
1Department of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, China
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Chuntao Gao
1Department of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, China
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Wei Wang
2Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, China
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Haorui Li
1Department of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, China
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Yuxiao Liu
1Department of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, China
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Rui Liu
3Department of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin Key Laboratory of Digestive Cancer, Tianjin 300060, China
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  • For correspondence: liurui9003{at}163.com haojihui{at}tjmuch.com
Jihui Hao
1Department of Pancreatic Cancer, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, China
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  • ORCID record for Jihui Hao
  • For correspondence: liurui9003{at}163.com haojihui{at}tjmuch.com
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    Figure 1

    Kaplan-Meier survival curves showing time to failure (TTF) survival according to CEA (A) D-dimer (B).

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    Figure 2

    Kaplan-Meier survival curves showing overall survival (OS) according to D-dimer (A), CEA (B), and CA19-9 (C).

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    Table 1

    Patient and disease characteristics

    No. of patientsPercentage
    Age (mean 67 years)
     < 671748.6
     ≥ 671851.4
    Gender
     Female1851.4
     Male1748.6
    Symptom
     Yes3085.7
     No514.3
    Weight loss
     Yes1542.9
     No2057.1
    Neoadjuvant chemotherapy
     Yes1131.4
     No2468.6
    Type of surgery
     DP1440
     DP + adrenalectomy1234.3
     DP + other925.7
    T
     T112.9
     T21851.4
     T31645.7
    N
     N01851.4
     N11542.9
     N225.7
    Perineural invasion
     Yes2674.3
     No925.7
    AJCC stage
     I925.7
     II2468.6
     III25.7
    IORT dose (Gy)
     1212.9
     152777.1
     20720.0
    Applicator diameter (cm)
     2411.5
     31645.7
     41337.1
     525.7
    Pre-operative CA19-9 (U/mL)
     < 371542.9
     ≥ 372057.1
    Pre-operative CEA (ng/mL)
     < 52468.6
     ≥ 51131.4
    D-dimer (ng/mL)
     < 5001028.6
     ≥ 5002571.4
    Adjuvant chemotherapy
     Yes3188.6
     No411.4
    Adjuvant chemotherapy
     Gemcitabine38.6
     S1514.3
     Gemcitabine + S1822.9
     Gemcitabine + albumin-bound paclitaxel925.7
     Albumin-bound paclitaxel + S125.7
     FOLFIRINOX411.4

    DP, distal pancreatectomy; AJCC, American Joint Committee on Cancer; IORT, intraoperative radiation therapy; CA19-9, carbohydrate antigen 19-9; CEA, carcinoembryonic antigen; S1, tegafur, gimeracil and oteracil potassium capsules; FOLFIRINOX, fluorouracil + leucovorin + irinotecan + oxaliplatin.

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      Table 2

      Univariate analysis of associations of patient, tumor, treatment, and pathologic characteristics with survival

      VariableTime to failure survivalOverall survival
      95% CIP value95% CIP value
      TNM stage4.906–18.4270.2167.128–41.2060.007*
      IORT dose ≤ 15 (vs. > 15)2.382–12.8180.5300.001–56.1590.984
      D-dimer < 500 (vs. ≥ 500)4.906–18.4270.005*10.267–38.0670.016*
      CEA < 5 (vs. ≥ 5)4.906–18.4270.036*7.790–20.6100.002*
      CA19-9 < 37 (vs. ≥ 37)0.715–16.2190.11210.520–18.9460.001*
      • ↵*P < 0.05 was considered statistically significant. CI, confidence interval.

      • View popup
      Table 3

      Multivariate analysis of associations of patient, tumor, treatment, and pathologic characteristics with survival

      VariableTime to failure survivalOverall survival
      HR95% CIP valueHR95% CIP value
      TNM stage1.3930.59–3.2890.4490.1250.006–2.3840.350
      IORT dose ≤ 15 (vs. > 15)0.3890.139–2.1570.5472.1200.473–9.5090.326
      D-dimer < 500 (vs. ≥ 500)0.2190.070–0.6820.009*0.2300.070–0.7630.016*
      CEA < 5 (vs. ≥ 5)0.3840.159–0.9280.034*0.2810.109–0.7250.009*
      CA19-9 < 37 (vs. ≥ 37)0.6660.282–1.5690.3520.2340.079–0.6920.009*
      • ↵*P < 0.05 was considered statistically significant. HR, hazard ratio; CI, confidence interval.

      • View popup
      Table 4

      Postoperative complications

      VariableNo. (%)
      Pancreatic fistula33 (94.2)
       A30 (85.7)
       B2 (5.7)
       C1 (2.9)
      Delayed gastric emptying7 (20.0)
       A3 (8.6)
       B4 (11.4)
      Intra-abdominal abscess1 (2.9)
      Multiple organ failure1 (2.9)
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    Cancer Biology & Medicine: 22 (1)
    Cancer Biology & Medicine
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    15 Jan 2025
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    Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study
    Xingyun Chen, Shuo Li, Chuntao Gao, Wei Wang, Haorui Li, Yuxiao Liu, Rui Liu, Jihui Hao
    Cancer Biology & Medicine Jan 2025, 22 (1) 67-76; DOI: 10.20892/j.issn.2095-3941.2024.0287

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    Safety and efficacy of intraoperative radiation therapy using a low-energy X-ray source for resectable pancreatic cancer: an interim evaluation of an ongoing prospective phase II study
    Xingyun Chen, Shuo Li, Chuntao Gao, Wei Wang, Haorui Li, Yuxiao Liu, Rui Liu, Jihui Hao
    Cancer Biology & Medicine Jan 2025, 22 (1) 67-76; DOI: 10.20892/j.issn.2095-3941.2024.0287
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    Subjects

    • Hepatobiliary and pancreatic cancer

    Keywords

    • Resectable pancreatic cancer
    • intraoperative radiation
    • survival
    • complications
    • benefit group

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