The Lynx Group
Cholangiocarcinoma News

Welcome to the Inaugural Issue of CCA News

August 2020, Vol 1, No 1
Milind M. Javle, MD
Department of Gastrointestinal Medical Oncology
Division of Cancer Medicine
The University of Texas
M.D. Anderson Cancer Center
Houston, TX

It is my great pleasure to launch the inaugural issue of CCA News, an important new publication highlighting the latest research and development in cholangiocarcinoma (CCA). I am proud that we now have a focused publication on biliary tract cancers and am humbled to serve as the first editor-in-chief.

This journal will review the latest clinical research in CCA and biliary tract cancers based on the peer-reviewed literature, oncology meetings, and updates on developments in new drugs.

Readers will be educated on ongoing and completed pivotal clinical trials related to CCA and biliary tract cancers, including reviews of the latest basic and translational research related to these types of cancer, with an aim to develop an understanding of the pathophysiology of these complex diseases. We welcome contributions that demonstrate the value of a multidisciplinary approach and will address any controversies in the field.

We will provide a forum for a wide-ranging discussion on these topics among academia, research, industry, and patient advocacy groups, including the Cholangiocarcinoma Foundation. Varied formats will be considered for publication, including full-length review articles, summaries of FDA approvals and in-depth reviews of new drugs introduced into the market, as well as highlights of conference proceedings, case studies, best practice articles, and supportive care guidelines. We will use a debate format to discuss controversial topics in CCA and biliary tract cancers.

The past year has been truly historic with the COVID-19 outbreak. However, the resilience of the CCA community has been inspirational. On April 17, 2020, the FDA granted accelerated approval to pemigatinib (Pemazyre; Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic CCA with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangements, as detected by an FDA-approved test. This is the first drug to be approved by the FDA for the treatment of CCA associated with FGFR2 fusion, and this approval represents a remarkable breakthrough for patients with this type of cancer. In this inaugural issue, we include an in-depth review of this important development in drug therapy for this patient population.

In this issue, we also present the highlights of research and new findings related to CCA and biliary tract cancers that were presented at the 2020 annual meetings of the American Society of Clinical Oncology, the American Association for Cancer Research, as well as the Cholangiocarcinoma Foundation.

Finally, in this issue we discuss the implications of the recent inclusion of the new targeted drug ivosidenib (Tibsovo) in the National Comprehensive Cancer Network’s hepatobiliary cancers guidelines, which was published on June 1, 2020.

CCA News will be published 4 times annually, starting with 3 issues in 2020.

On behalf of the authors, reviewers, volunteers, and study sponsors, I welcome the readership of CCA News and look forward to working with you to make this publication a success. We hope to hear from you soon, and we welcome your feedback!

If you have any questions, suggestions, or concerns, please address them to me at This email address is being protected from spambots. You need JavaScript enabled to view it..

Yours sincerely,
Milind M. Javle, MD

Related Items

Takeaways from the 2020 Cholangiocarcinoma Summit
By Milind M. Javle, MD
December 2020, Vol 1, No 3
In this last issue for the year, we are highlighting the proceedings of the Second Annual Cholangiocarcinoma (CCA) Summit, which was conducted on October 22-23, 2020. This summit attracted a wide, multidisciplinary audience and was very interactive, despite being a virtual event. An important focus for this meeting was the emergence of molecular targets in CCA and early successes seen with precision medicine in this disease. Many of the key presentations from the summit are included in the current issue and are highlighted below.
Managing Cholangiocarcinoma in the Setting of COVID-19: Unique Challenges and Opportunities
By Ghassan K. Abou-Alfa, MD, MBA; Bruce Lin, MD; Farshid Dayyani, MD, PhD; Richard Kim, MD; Rachna T. Shroff, MD, MS; Melinda Bachini; Milind M. Javle, MD
December 2020, Special Issue: Managing CCA in the Setting of COVID-19
The first confirmed case in the United States of the 2019 novel coronavirus (COVID-19) was reported on January 21, 2020, and as of November 27, 2020, there were >63 million confirmed cases and >1.5 million deaths globally. Despite the global impact, certain populations have been identified as having a higher risk of developing severe COVID-19 infection, including patients with cancer. Various studies have shown that patients with cancer experience particularly poor outcomes after COVID-19 infection. As a result of the pandemic, care delivery has been disrupted to some degree based on the need for prioritization and limitations on resources. Therefore, healthcare providers and patients have been continually reassessing the balance between the benefits and risks of anticancer interventions in the context of the added risk of COVID-19 infection.
Important Advances in Cholangiocarcinoma Management
By Milind M. Javle, MD
October 2020, Vol 1, No 2
While the COVID-19 pandemic rages throughout the world, patients, providers, and healthcare advocates are learning to survive in an alternative (virtual) world that is likely to change the face of medicine forever. Cholangiocarcinoma (CCA) is a complex disease that requires multidisciplinary care. Virtual clinic visits and online tumor boards and symposia represent just a few of the countless innovations introduced over the past year.
Hot Topics on Cholangiocarcinoma and Biliary Tract Cancer Presented at ASCO 2020
By Milind M. Javle, MD
August 2020, Vol 1, No 1
Several hot topics were presented at the recent ASCO 2020 annual meeting about cholangiocarcinoma (CCA), which I would briefly discuss here. First, it was very exciting to see 3 important studies regarding immunotherapy for CCA, which may represent a step forward in the development of CCA therapies.
Top 10 Abstracts from ASCO 2020 with Milind Javle
By Milind M. Javle, MD
Treatment options for cholangiocarcinoma continue to evolve. Milind Javle, MD, from MD Anderson Cancer Center, discusses some interesting abstracts from the ASCO 2020 meeting.
Using FGFR Inhibitors in Clinical Practice
By Milind M. Javle, MD; Angela Lamarca, MD, PhD, MSc; Vaibhav Sahai, MBBS, MS
Dr Angela Lamarca discusses the use of FGFR inhibitors in daily practice. Their use will depend largely on data from currently ongoing second- and first-line clinical trials. She suggests that consideration should be given to their use in combination with chemotherapy and/or as maintenance therapy after first-line chemotherapy. Dr Milind Javle summarizes the field, suggesting that a time may come when patients with CCA are never treated with chemotherapy at all. Pemigatinib was FDA approved as second-line therapy in cholangiocarcinoma in May 2020.
Toxicities Associated with FGFR Inhibitors
By Milind M. Javle, MD; Angela Lamarca, MD, PhD, MSc; Vaibhav Sahai, MBBS, MS
Dr Vaibhav Sahai reviews the toxicities that have been encountered in clinical trials with FGFR inhibitors. He suggests that most of these adverse events are class effects and include hyperphosphatemia (which is relatively easy to manage with dietary restrictions and phosphate-binding agents), nail and hair changes, stomatitis, and retinal epithelial changes. In contrast, Dr Angela LaMarca considers the adverse events associated with chemotherapy, including myelosuppression, nausea, vomiting, diarrhea, and others. Dr Milind Javle suggests that the toxicities encountered with chemotherapy are significantly worse than those with FGFR inhibitors.
Effective Targeted Therapies in CCA: IDH1 and FGFR
By Milind M. Javle, MD; Angela Lamarca, MD, PhD, MSc; Vaibhav Sahai, MBBS, MS
Dr Angela Lamarca reviews the current clinical trials with FGFR inhibitors, particularly those with patients with FGFR2 fusion and other genetic aberrations. Dr Vaibhav Sahai highlights those FGFR inhibitors that are nonselective and those that are selective for FGFR1-4, and discusses the clinical trial results with the selective inhibitors, including pemigatinib and infigratinib. He remarks that the response rates and progression-free survival in these trials have been remarkable, far better than what is seen with chemotherapy.
Managing CCA Patients While Waiting for Molecular Biomarker Testing Results
By Milind M. Javle, MD; Angela Lamarca, MD, PhD, MSc; Vaibhav Sahai, MBBS, MS
Dr Vaibhav Sahai and Dr Angela Lamarca consider options for managing patients with CCA while awaiting results from biomarker testing, which can take 3 to 6 weeks. They discuss starting these patients on first-line chemotherapy and then switching appropriate patients to second-line targeted therapy, and also speak to the increased utility of next-generation sequencing in CCA.
The Use of Molecular Biomarker Testing in Patients with CCA
By Milind M. Javle, MD; Vaibhav Sahai, MBBS, MS
Dr Vaibhav Sahai discusses different approaches to molecular biomarker testing, including when to order the tests in the course of the disease, use of institutional and commercial testing facilities, and what platforms exist for testing.

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