Dear Colleagues,
It gives me great pleasure to introduce the March issue of CCA News. Once again, we have several recent developments in cholangiocarcinoma (CCA) clinical research, and these have been reviewed by leaders in the field.
At the CCA Summit held during the 2021 ASCO Gastrointestinal Cancers Symposium, Rachna T. Shroff, MD, MS, from the University of Arizona Cancer Center, has provided a detailed overview of the 15 clinical trials and research presented at the meeting that focused on developments in biliary tract cancers and CCA. A succinct summary of her presentation at the meeting is presented in this issue.
These 15 studies include the pivotal phase 2 clinical trial of infigratinib for the treatment of advanced, chemorefractory CCA associated with FGFR2 fusions and gene rearrangements. The results of this trial indicate a new therapeutic opportunity for patients with CCA. We hope that this promising agent receives FDA approval.
The updated results of the clinical trial ClarIDHy indicate an improved overall survival with the IDH1 inhibitor, ivosidenib (Tibsovo), compared with placebo, showing a beneficial effect on patients’ quality of life.
Other novel agents presented at the meeting included silmitasertib, an oral casein kinase 2 inhibitor; zanidatamab, a dual kinase HER2/neu inhibitor; neratinib (Nerlynx); and the novel arginase inhibitor, INCB001158.
This issue also includes several presentations from the 2020 CCA Summit. Abby Siegel, MD, MS, from Merck, provided an insightful and nuanced view of the role of immune checkpoint inhibitors in CCA and biliary tract cancers. Although the efficacy signal of immunotherapy has been somewhat muted, sequencing studies have identified “immunogenic clusters” that need prospective studies. She also noted that the role of chemotherapy as an adjunct to immunotherapy may be context-dependent, with higher responses seen in bladder cancer or lung cancer compared with biliary tract cancers. In the KEYNOTE-158 trial, which involved multiple solid tumors, including biliary tract cancers, a tumor mutational burden (TMB) of ≥10 was associated with a higher response rate than seen in those with low TMB. The median TMB in biliary tract cancers tends to be low.
Flavio Rocha, MD, of Virginia Mason Medical Center, has presented the rationale for the new American Joint Committee on Cancer 8th edition staging system for CCA and the implications for clinical practice.
Neoadjuvant and perioperative strategies are gathering momentum in the management of patients with CCA, as discussed by James Harding, MD, from Memorial Sloan Kettering Cancer Center.
Two recent retrospective studies, one by Hop S. Tran Cao, MD, FACS, from M.D. Anderson Cancer Center, and another from Amit Mahipal, MBBS, MPH, from the Mayo Clinic, have reviewed the National Cancer Database. They suggest that neoadjuvant therapy is being used increasingly for node-positive disease and may result in a survival advantage over upfront surgery.
We look forward to your feedback and contributions in the upcoming issues!
Sincerely,
Milind Javle, MD Professor Department of Gastrointestinal Medical Oncology Division of Cancer Medicine The University of Texas M.D. Anderson Cancer Center Houston, TX Chair NCI Task Force: Hepatobiliary Cancers
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