PMID- 33457010
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220419
IS  - 2078-6891 (Print)
IS  - 2219-679X (Electronic)
IS  - 2078-6891 (Linking)
VI  - 11
IP  - 6
DP  - 2020 Dec
TI  - Chemoradiotherapy for patients with locally advanced or unresectable 
      extra-hepatic biliary cancer.
PG  - 1408-1420
LID - 10.21037/jgo-20-245 [doi]
AB  - BACKGROUND: Although surgical resection is the preferred curative-intent 
      treatment option for patients with non-metastatic, extra-hepatic biliary cancer 
      (EBC), radiotherapy (RT) or chemoradiotherapy (CRT) may be utilized in select 
      cases when surgical resection is not feasible. The purpose of this study is to 
      report the efficacy and adverse events (AEs) associated with CRT for patients 
      with locally advanced and unresectable EBC. METHODS: This was a retrospective 
      cohort study of patients with EBC, including extra-hepatic cholangiocarcinoma or 
      gallbladder cancer, deemed inoperable who received RT between 1998 and 2018. The 
      median RT dose was 50.4 Gy in 28 fractions and 94% received concurrent 
      5-fluorouracil. The Kaplan-Meier method was used to estimate overall survival 
      (OS) and progression-free survival (PFS) from the start of RT. The cumulative 
      incidence of local progression (LP), locoregional progression (LRP), and distant 
      metastasis (DM) were reported with death as a competing risk. Cox proportional 
      hazards regression models were used to assess for correlation between patient and 
      treatment characteristics and outcomes. RESULTS: Forty-eight patients were 
      included for analysis. The median OS was 12.0 months [95% confidence interval 
      (CI): 2.3-73.2 months]. The 2-, 3-, and 5-year OS were 33% (95% CI: 22-50%), 20% 
      (95% CI: 11-36%), and 7% (95% CI: 2-20%), respectively. The 2-year PFS, LP, LRP, 
      and DM were 21% (95% CI: 12-36%), 27% (95% CI: 17-44%), 31% (95% CI: 20-48%), and 
      33% (95% CI: 22-50%), respectively. On univariate analysis, biologically 
      effective dose (BED) >59.5 Gy(10) was associated with improved OS [hazard ratio 
      (HR): 0.40, 95% CI: 0.18-0.92, P=0.03] and PFS (HR: 0.37, 95% CI: 0.16-0.84, 
      P=0.02) and primary tumor size (per 1 cm increase) was associated with worsened 
      PFS (HR: 1.29, 95% CI: 1.02-1.63, P=0.04). BED >59.5 Gy(10) remained associated 
      with PFS on multivariate analysis (HR: 0.34, 95% CI: 0.15-0.78, P=0.01). 
      Treatment-related grade 3+ acute and late gastrointestinal AEs occurred in 13% 
      and 17% of patients, respectively. CONCLUSIONS: RT is associated with 3- and 
      5-year survival in a subset of patients with unresectable EBC. Further 
      exploration of the role of RT as part of a multi-modality curative treatment 
      strategy is warranted.
CI  - 2020 Journal of Gastrointestinal Oncology. All rights reserved.
FAU - Jethwa, Krishan R
AU  - Jethwa KR
AD  - Department of Therapeutic Radiology, Yale University School of Medicine, New 
      Haven, CT, USA.
AD  - Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA.
FAU - Sannapaneni, Shilpa
AU  - Sannapaneni S
AD  - Department of Internal Medicine, Texas Health Presbyterian Hospital, Dallas, TX, 
      USA.
FAU - Mullikin, Trey C
AU  - Mullikin TC
AD  - Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA.
FAU - Harmsen, William S
AU  - Harmsen WS
AD  - Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, 
      USA.
FAU - Petersen, Molly M
AU  - Petersen MM
AD  - Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, 
      USA.
FAU - Antharam, Phanindra
AU  - Antharam P
AD  - Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA.
FAU - Laughlin, Brady
AU  - Laughlin B
AD  - Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ, USA.
FAU - Mahipal, Amit
AU  - Mahipal A
AD  - Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
FAU - Halfdanarson, Thorvardur R
AU  - Halfdanarson TR
AD  - Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
FAU - Merrell, Kenneth W
AU  - Merrell KW
AD  - Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA.
FAU - Neben-Wittich, Michelle
AU  - Neben-Wittich M
AD  - Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA.
FAU - Sio, Terence T
AU  - Sio TT
AD  - Department of Radiation Oncology, Mayo Clinic, Phoenix, AZ, USA.
FAU - Haddock, Michael G
AU  - Haddock MG
AD  - Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA.
FAU - Hallemeier, Christopher L
AU  - Hallemeier CL
AD  - Department of Radiation Oncology, Mayo Clinic, Rochester, MN, USA.
LA  - eng
GR  - UL1 TR001863/TR/NCATS NIH HHS/United States
PT  - Journal Article
PL  - China
TA  - J Gastrointest Oncol
JT  - Journal of gastrointestinal oncology
JID - 101557751
PMC - PMC7807283
OTO - NOTNLM
OT  - Radiotherapy (RT)
OT  - biliary cancer
OT  - cholangiocarcinoma
COIS- Conflicts of Interest: All authors have completed the ICMJE uniform disclosure 
      form (available at http://dx.doi.org/10.21037/jgo-20-245). KRJ reports that he 
      receives honoraria from RadOncQuestions.com, LLC. The other authors have no 
      conflicts of interest to declare.
EDAT- 2021/01/19 06:00
MHDA- 2021/01/19 06:01
PMCR- 2020/12/01
CRDT- 2021/01/18 05:31
PHST- 2021/01/18 05:31 [entrez]
PHST- 2021/01/19 06:00 [pubmed]
PHST- 2021/01/19 06:01 [medline]
PHST- 2020/12/01 00:00 [pmc-release]
AID - jgo-11-06-1408 [pii]
AID - 10.21037/jgo-20-245 [doi]
PST - ppublish
SO  - J Gastrointest Oncol. 2020 Dec;11(6):1408-1420. doi: 10.21037/jgo-20-245.