PMID- 35318952
OWN - NLM
STAT- MEDLINE
DCOM- 20220704
LR  - 20220928
IS  - 1879-355X (Electronic)
IS  - 0360-3016 (Linking)
VI  - 113
IP  - 4
DP  - 2022 Jul 15
TI  - The Combination of Radiation Therapy and Immunotherapy Is Effective and 
      Well-Tolerated for Unresectable Biliary Tract Cancer.
PG  - 816-824
LID - S0360-3016(22)00252-8 [pii]
LID - 10.1016/j.ijrobp.2022.03.019 [doi]
AB  - PURPOSE: For unresectable biliary tract cancer (BTC), chemotherapy (CT) alone is 
      associated with poor survival and severe toxicity. Immunotherapy (IO) is 
      potentially effective for BTC, and radiation therapy (RT) may synergize with IO. 
      We investigated CT versus combined RT and anti-programmed cell death-1 (PD-1) IO 
      for unresectable BTC. METHODS AND MATERIALS: We prospectively observed 117 
      participants with unresectable BTC either at initial diagnosis or at first 
      recurrence at a single center who chose 1 of 2 treatment options between August 
      2018 and October 2020. The options were (1) external beam RT combined with 
      anti-PD-1 IO (RT/IO) or (2) CT alone. In the RT/IO group, camrelizumab (200 mg 
      intravenously every 3 weeks) was initiated within 7 days after the completion of 
      RT and continued until progression or intolerable side effects were noted. The 
      median dose per fraction was 55 Gy/25 fractions (range, 50-60 Gy/20-25 
      fractions). In the CT group, cisplatin and gemcitabine were delivered 
      intravenously every 3 weeks for 8 cycles. We analyzed the adverse events (AEs), 
      overall survival (OS), and disease-free survival (DFS), and performed subgroup 
      analysis according to tumor mutational burden (TMB) and microsatellite status in 
      the combination group. RESULTS: Thirty-nine and 78 participants received RT/IO 
      and CT, respectively. The crude rate of severe AEs (grade >/=3 AEs) was higher in 
      the CT group (79.4% vs 7.7%, P < .001). The OS and DFS after RT/IO were longer 
      than that after CT (median OS: 17.0 vs 11.5 months, P = .01; median DFS: 12.5 vs 
      7.9 months, P = .008). Participants with low TMB or microsatellite stability had 
      a shorter median OS (13.6 vs 25.7 months, P = .03) and median DFS (9.8 vs 19.3 
      months, P = .012) than participants with high TMB or microsatellite instability. 
      CONCLUSIONS: RT combined with anti-PD-1 IO may be well tolerated and associated 
      with an improved response rate, DFS, and OS compared with CT alone in patients 
      with unresectable BTC.
CI  - Copyright (c) 2022 Elsevier Inc. All rights reserved.
FAU - Chen, Yong
AU  - Chen Y
AD  - Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China.
FAU - Wei, Mengchao
AU  - Wei M
AD  - Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China.
FAU - Shen, Shunli
AU  - Shen S
AD  - Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China.
FAU - Chen, Shuling
AU  - Chen S
AD  - Division of Interventional Ultrasound, The First Affiliated Hospital of Sun 
      Yat-sen University, Guangzhou, China.
FAU - Li, Dongming
AU  - Li D
AD  - Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China.
FAU - Wang, Yan
AU  - Wang Y
AD  - Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China.
FAU - Kuang, Ming
AU  - Kuang M
AD  - Department of Liver Surgery, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China; Division of Interventional Ultrasound, The First 
      Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Institute of 
      Precision Medicine, The First Affiliated Hospital of Sun Yat-sen University, 
      Guangzhou, China; Cancer Center, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China.
FAU - Peng, Zhenwei
AU  - Peng Z
AD  - Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen 
      University, Guangzhou, China; Institute of Precision Medicine, The First 
      Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Cancer Center, 
      The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. 
      Electronic address: pzhenw@mail.sysu.edu.cn.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220319
PL  - United States
TA  - Int J Radiat Oncol Biol Phys
JT  - International journal of radiation oncology, biology, physics
JID - 7603616
RN  - Q20Q21Q62J (Cisplatin)
SB  - IM
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - *Biliary Tract Neoplasms/drug therapy/metabolism
MH  - Cisplatin
MH  - Disease-Free Survival
MH  - *Gastrointestinal Neoplasms/etiology
MH  - Humans
MH  - Immunotherapy/adverse effects
MH  - Treatment Outcome
EDAT- 2022/03/24 06:00
MHDA- 2022/07/06 06:00
CRDT- 2022/03/23 08:40
PHST- 2021/07/27 00:00 [received]
PHST- 2022/03/08 00:00 [revised]
PHST- 2022/03/13 00:00 [accepted]
PHST- 2022/03/24 06:00 [pubmed]
PHST- 2022/07/06 06:00 [medline]
PHST- 2022/03/23 08:40 [entrez]
AID - S0360-3016(22)00252-8 [pii]
AID - 10.1016/j.ijrobp.2022.03.019 [doi]
PST - ppublish
SO  - Int J Radiat Oncol Biol Phys. 2022 Jul 15;113(4):816-824. doi: 
      10.1016/j.ijrobp.2022.03.019. Epub 2022 Mar 19.