Advances in the Management of Patients With Biliary Cancer

September 2023, Vol 4, No 3
Milind M. Javle, MD
Hubert L. and Olive Stringer Professor
Department of Gastrointestinal Medical Oncology
Division of Cancer Medicine
The University of Texas
M.D. Anderson Cancer Center
Houston, TX
NCI Task Force: Hepatobiliary Cancers

As we approach the fall season, it is wonderful to reflect on some of the amazing research presented this year, most recently at the ASCO 2023 annual meeting. One of the major highlights of ASCO this year included the results of HER2/neu-directed novel therapies in biliary cancer. Shubham Pant, MD, MBBS, from MD Anderson Cancer Center, presented the results of the HERIZON-1 clinical trial of the bispecific antibody zanidatamab in HER2/neu-expressing biliary cancers. A total of 80 patients with immunohistochemistry test score of 2+ or 3+ biliary cancers received this agent; the overall response rate was 41.3%, with a median response duration of 12.9 months and median time to first response of 1.8 months. These impressive results were associated with tolerable adverse events (diarrhea was the most common).

The BILCAP study has established the standard for adjuvant therapy in biliary tract cancer, and the analysis of genetic alterations from the study population was eagerly awaited. It is interesting to note that although FGFR2 fusions have been associated with an improved overall survival, no such correlation was noted in this study. EGFR amplification was associated with a worse clinical outcome and may represent a therapeutic target. Circulating tumor DNA may have a role in disease monitoring after resection, as was demonstrated by Changhoon Yoo, MD, PhD, from Asan Medical Center, in a correlative analysis of the STAMP adjuvant chemotherapy trial in Korea. Vaibhav Sahai, MBBS, MS, from the University of Michigan, presented the results of the BilT-02 phase 2 trial of the poly-ADP ribose polymerase inhibitor rucaparib and the PD-1 inhibitor nivolumab as maintenance therapy following first-line platinum-based chemotherapy in advanced biliary tract cancer. Although the trial did not meet the prespecified progression-free survival end point, the favorable overall survival argues for a randomized prospective trial in this setting.

Finally, this letter would not be complete without recognizing the remarkable efforts of the Cholangiocarcinoma Foundation’s (CCF) CholangioConnect initiative. This innovative program plays a crucial role in connecting caregivers with mentors and offers support through calls, emails, and virtual meetings. Patty Maxin assumed the role of the inaugural Program Manager for CholangioConnect, and under her leadership, the program has expanded its reach to 31 countries, fostering a network of more than 1000 patients and caregivers. We extend our heartfelt congratulations to Patty and the CCF for this exceptional accomplishment!


Milind M. Javle, MD

Related Items

Annual CCF Conference Brings Together All Stakeholders
By Milind M. Javle, MD
June 2023, Vol 4, No 2
This issue of CCA News highlights the Cholangiocarcinoma Foundation (CCF) 10th Annual Conference held in April. This meeting was chaired by Dr Chiara Branconi, a Lord Kelvin Adam Smith Reader at the University of Glasgow and a medical oncologist with Beatson Cancer Centre; and Dr Laura Goff, medical director of the Vanderbilt-Ingram Cancer Center’s Hematology and Oncology Division.
Exciting New Abstracts from the ASCO GI Cancers Symposium
By Milind M. Javle, MD
March 2023, Vol 4, No 1
Dr Javle provides his perspective on important abstracts presented at the ASCO Gastrointestinal Cancers Symposium, held January 19-21, 2023, in San Francisco, CA.
Highlights from the Fourth Annual CCA Summit
By Milind M. Javle, MD
December 2022, Vol 3, No 4
We have recently concluded the 4th Annual CCA Summit, which was held on October 13-15, 2022, in Denver, Colorado.
New Standard of Care Emerging for Treatment of BTCs
By Milind M. Javle, MD
September 2022, Vol 3, No 3
On September 2, 2022, the US Food and Drug Administration approved durvalumab in combination with gemcitabine/cisplatin for advanced biliary tract cancers (BTCs) on the basis of the TOPAZ-1 study.
Rapid Trajectory of Clinical Research in Biliary Tract Cancers
By Milind M. Javle, MD
March 2022, Vol 3, No 1
The 2022 ASCO GI Cancers Symposium clearly highlighted the rapid trajectory of clinical research in biliary tract cancers. One of the most eagerly anticipated studies, TOPAZ-1, was presented by Do-Youn Oh, MD, PhD, from Seoul National University Hospital in South Korea. This phase 3 clinical trial enrolled 685 patients and investigated the addition of the PD-L1–directed agent durvalu­mab to gemcitabine and cisplatin chemotherapy backbone versus these chemotherapies alone. The results demonstrated a statistically significant improvement in overall survival (OS), overall response rate (ORR), and progression-free survival (PFS), without dose-limiting toxicities.
Hot Topics at ASCO-GI 2022
By Milind M. Javle, MD
Dr Milind Javle provides his perspectives on key presentations on cholangiocarcinoma and biliary tract cancer at the 2022 ASCO Gastrointestinal Cancers Symposium.
Cholangiocarcinoma Research Continues to Thrive
By Milind M. Javle, MD
December 2021, Vol 2, No 4
The Third CCA Summit was held on October 21-22, 2021 in New Orleans. For the majority of the cholangiocarcinoma (CCA) community, this was their first “live” meeting since the pandemic.

Subscribe Today!

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

I'd like to receive: