Neoadjuvant Chemoradiation and Orthotopic Liver Transplantation versus Definitive Chemoradiation in Unresectable CCA

2020 Year in Review: Cholangiocarcinoma — December 19, 2020

Data reported at the ASCO 2020 GI Cancers Symposium indicate that treatment with neoadjuvant definitive chemoradiation followed by orthotopic liver transplantation was associated with better outcomes compared with definitive chemoradiation alone in patients with unresectable extrahepatic/hilar CCA.

A study compared survival outcomes associated with neoadjuvant chemoradiation and orthotopic liver transplantation (OLT) versus definitive chemoradiation (CRT) in patients with unresectable extrahepatic/hilar CCA. The results of this study were presented at the American Society of Clinical Oncology (ASCO) 2020 Gastrointestinal Cancers Symposium and are summarized here.

Eligible patients had unresectable extrahepatic/hilar CCA who were treated with CRT with or without OLT at Mayo Clinic, Tucson, AZ, between February 1998 and September 2019. CRT consisted of external beam radiation therapy (EBRT; median, 4500 cGy) and boost (median, 900 cGy) with either continuous 5-fluorouracil (dose range, 180-225 mg/m2) or capecitabine (dose range, 825-1000 mg/m2 twice daily) alone or prior to undergoing OLT. Radiation boosts were delivered with EBRT or bile duct brachytherapy.

A total of 49 patients (OLT group, N = 20; CRT group, N = 29) were enrolled in the study. In the study population, the median age was 64.3 years at diagnosis (range, 27.9-84.3 years), and 18 patients had previous diagnosis of primary sclerosing cholangitis (PSC). In the OLT cohort, patients were younger (mean age, 56.5 vs 69.0 years), more likely to have PSC and ulcerative colitis (65% vs 17%), and had a lower cancer antigen 19-9 (median, 43 vs 535; P = .003).

At the end of follow-up, 31 of 49 (63%) patients had died, of which 7 (35%) were treated with neoadjuvant CRT and OLT therapy while 24 (86%) who were treated with definitive CRT died. From the end date of radiation, median OS was 76.8 months in the OLT group compared with 15.6 months in the CRT group. The 3-year OS and 5-year OS rates were significantly higher in the OLT group (78% and 69%, respectively) compared with the CRT group (19% and 6%, respectively; HR, 7.73; 95% CI, 3.04-19.65; P <.0001). Similarly, patients who received OLT showed a better 3-year PFS than CRT (89% vs 30%, respectively) and distant metastasis-free survival at 3 years (88% vs 66%, respectively) compared with those who received CRT alone (HR, 5.74; 95% CI, 1.12-29.34; P <.02). In univariate analysis, the method of treatment (OLT vs CRT) was found to be associated with better clinical outcomes.

These results support treatment with neoadjuvant CRT followed by OLT in patients with unresectable extrahepatic/hilar CCA compared with definitive CRT alone.

Source: Laughlin BS, et al. J Clin Oncol. 2020;38(4_suppl). Abstract 494.

Related Items

KEYNOTE-966: Pembrolizumab Combined With GemCis Versus GemCis Alone in Patients With BTC
2023 Year in Review: Cholangiocarcinoma
In the KEYNOTE-966 study, pembrolizumab was added to gemcitabine/cisplatin to assess outcomes in patients with advanced biliary tract cancer.
Post-hoc Analysis of the ABC-01, -02, and -03 Trials in Patients With Advanced eCCA
2023 Year in Review: Cholangiocarcinoma
This post-hoc analysis of the ABC-01, -02, and -03 clinical trials provides reference survival data for patients with advanced extrahepatic cholangiocarcinoma treated with first-line gemcitabine/cisplatin chemotherapy.
Efficacy and Safety of Tinengotinib in Patients With Advanced Refractory/Relapsed CCA Who Previously Received an FGFR Inhibitor
2023 Year in Review: Cholangiocarcinoma
Investigators pooled data from 3 trials to evaluate tinengotinib in patients with advanced, refractory/relapsed cholangiocarcinoma who previously received an FGFR inhibitor.
KLF5 Inhibition Reduces Tumor Growth and Sensitizes to Chemotherapy-Induced Cell Death in Experimental Models of CCA
2023 Year in Review: Cholangiocarcinoma
Researchers evaluated KLF5 expression and its inhibition in cholangiocarcinoma using clustered regularly interspaced short palindromic repeats technology.
Phase 2 Trial of SHR-1316 Plus IBI310 in Patients With Advanced iCCA After Inadequate Response to First-Line Therapy
2023 Year in Review: Cholangiocarcinoma
In this ongoing phase 2 study, the efficacy of SHR-1316 plus IBI310 is being evaluated in patients with advanced intrahepatic cholangiocarcinoma after inadequate response to first-line therapy.
Examination of Patients With CCA Treated With Novel Targeted Therapies After Extended Molecular Profiling on Liquid Biopsies
2023 Year in Review: Cholangiocarcinoma
Dr Mahmood presented results from the largest multi-institutional review of efficacy outcomes following targeted agents in patients with cholangiocarcinoma.
Phase 2 Component of the BEER-BTC Study: Comparing Bevacizumab Plus Erlotinib Maintenance Versus Observation in Patients With Advanced BTC
2023 Year in Review: Cholangiocarcinoma
In the phase 2 component of the phase 2/3 BEER-BTC study, bevacizumab plus erlotinib improved outcomes in patients with advanced biliary tract cancers.
The DEBATE Trial: Neoadjuvant Durvalumab Plus GemCis Versus GemCis Alone for Patients With Localized BTC
2023 Year in Review: Cholangiocarcinoma
Researchers investigated the efficacy and safety of neoadjuvant durvalumab plus gemcitabine/cisplatin (GemCis) versus GemCis alone in patients with biliary tract cancer.
The Phase 2 ADJUBIL Study of Durvalumab Plus Tremelimumab With or Without Capecitabine in BTC
2023 Year in Review: Cholangiocarcinoma
In the ongoing phase 2 ADJUBIL study, the clinical activity of immunotherapies durvalumab and tremelimumab with or without capecitabine is being assessed in patients with resectable biliary tract cancer in the adjuvant setting.
Tucatinib and Trastuzumab in Patients With Previously Treated HER2-Positive Metastatic BTC: The SGNTUC-019 Study
2023 Year in Review: Cholangiocarcinoma
This phase 2 basket study investigated the combination of tucatinib and trastuzumab as second-line treatment for patients with HER2-positive biliary tract cancer.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: