The Lynx Group
Cholangiocarcinoma News

Nanoliposomal Irinotecan Combination Therapy Falls Short in Metastatic BTC

Web Exclusives — November 22, 2022

Second-line treatment options for patients with metastatic biliary tract cancer (BTC) whose tumors have been unresponsive to gemcitabine-based therapies are largely lacking. NALIRICC was an open-label, randomized, phase 2 interventional study evaluating the efficacy of nanoliposomal irinotecan (Nal-IRI) in patients with advanced, unresectable, and metastatic cholangiocarcinoma (CCA) and gallbladder cancer (GC). The primary objective of this study was to examine whether the addition of Nal-IRI to 5-fluorouracil (5-FU) plus leucovorin (LV) provided better survival outcomes compared with 5-FU plus LV alone as a second-line treatment for BTC.

Eligible patients were aged >18 years with histologically confirmed metastatic cancer (CCA or GC) who had progressed during first-line treatment with gemcitabine. Arm A participants received Nal-IRI (80 mg/m2) plus 5-FU (2400 mg/m2) and LV (400 mg/m2). Patients in arm B received 5-FU (2400 mg/m2) and LV (400 mg/m2) only. Patients were grouped by primary tumor site and response was evaluated every 6 weeks. The primary end point was progression-free survival (PFS) assessed up to 42 months after treatment. Secondary end points included overall survival (OS), overall response rate, toxicity/safety, and health-related quality of life (QOL).

A total of 100 patients were assessed across 17 study sites in Germany: 49 patients were randomly assigned to arm A (Nal-IRI) and 51 to arm B (no Nal-IRI). Of the 100 patients, 64 patients were diagnosed with intrahepatic CCA, 19 with extrahepatic CCA, and 17 with GC.

Median OS in arm A was 6.9 months compared with 8.21 months in arm B. Median PFS was comparable regardless of the inclusion of Nal-IRI: 2.76 months in arm A and 2.3 months in arm B. Significantly more patients receiving Nal-IRI reported ≥3 adverse events (AEs) compared with those who did not receive Nal-IRI (70.8% and 50%, respectively). QOL measurements were comparable in both treatment arms.

The NALIRICC trial did not meet its primary end point in that the addition of Nal-IRI to 5-FU plus LV did not improve OS or PFS. Nal-IRI was also associated with a higher rate of patients with ≥3 AEs, indicating higher toxicity. However, this study indicated that 5-FU plus LV may be a reasonable second-line alternative in patients whose cancers have progressed on standard first-line therapies.

Source: Vogel A, Wenzel P, Folprecht G, et al. Nal-IRI and 5-FU/LV compared to 5-FU/LV in patients with cholangio- and gallbladder carcinoma previously treated with gemcitabine-based therapies (NALIRICC – AIO-HEP-0116). Ann Oncol. 2022;33(suppl 7):S563-S564.

Related Items

The Impact of mFOLFOX Chemotherapy in Conjunction with Active Symptom Control on Patient QOL: The ABC-06 Trial
Web Exclusives
Preliminary analyses of patient quality-of-life data from the ABC-06 clinical trial suggest a potentially positive impact of L-folinic acid plus oxaliplatin plus 5-fluorouracil when used in conjunction with active symptom control.
Derazantinib Shows Clinical Efficacy in the Treatment of iCCA in Patients with Genetically Aberrant FGFR2
Web Exclusives
Data from the FIDES-01 clinical trial showed encouraging results for derazantinib as a second-line treatment for patients with intrahepatic cholangiocarcinoma with FGFR2 fusions, mutations, or amplification.
Real-World Evidence for Liquid Biopsy to Identify Molecular Alterations
Web Exclusives
Real-world evidence supports a role for liquid biopsy in identifying molecular alterations, offering personalized treatment options.
FGFR Inhibitor RLY-4008 Shows Promise in Treating Metastatic CCA
Web Exclusives
Early data from the ReFocus trial indicated that the highly selective FGFR2 inhibitor RLY-4008 may be an effective new treatment for cholangiocarcinoma in patients with FGFR2 fusions or rearrangements.
Tislelizumab as Part of a Conversion Therapy Regimen for Potentially Resectable Biliary Tract Cancers
Web Exclusives
A phase 2 study found that the combination of tislelizumab, lenvatinib, and gemcitabine/oxaliplatin showed promise as a conversion therapy for patients with potentially resectable locally advanced biliary tract cancer, making curative surgery a possibility for some patients.
Additional 6-Month Follow-up from the TOPAZ-1 Study Comparing Durvalumab with Placebo plus Gem/Cis in Patients with Advanced BTC
Web Exclusives
Updated overall survival (OS) and safety data from the TOPAZ-1 study revealed improved median OS for the full patient population as well as subgroup analyses and an adverse event profile consistent with previously reported data.
Immune-Related Adverse Events in the TOPAZ-1 Study of Durvalumab or Placebo plus GemCis in Advanced BTC
Web Exclusives
Analysis of the safety population in the TOPAZ-1 trial in patients with biliary tract cancer revealed that immune-related adverse events were more common in the durvalumab arm, had a variable time to onset, and were associated with improved overall survival.
CCA Summit Live from ESMO 2022
By Juan W. Valle, MB ChB, MSc, FRCP
Videos
On September 21, 2022, I presented an overview of key abstracts on biliary tract cancer (BTC) presented at the 2022 annual meeting of the European Society for Medical Oncology (ESMO 2022). In addition, I provided my perspective on the impact of the data on the management of patients with BTC.
Key Abstracts Presented at the European Society for Medical Oncology (ESMO) 2021 Annual Meeting
By Richard Kim, MD
Videos
Richard Kim, MD, from the Moffitt Cancer Center, University of South Florida College of Medicine, provides expert commentary on key abstracts and posters presented at the 2021 annual meeting of the European Society for Medical Oncology. Dr Kim will highlight new data from 11 presentations on interventional modalities for patients with cholangiocarcinoma.
Futibatinib Safe and Effective in Patients with Advanced or Metastatic Intrahepatic Cholangiocarcinoma and FGFR2 Fusions
October 2020, Vol 1, No 2
Two phase 2 studies of futibatinib, a highly selective irreversible fibroblast growth factor receptor (FGFR)1-4 inhibitor, analyzed data from the FOENIX-CCA2 clinical trial and were presented at the 2020 virtual meeting of the European Society for Medical Oncology (ESMO).

Subscribe Today!

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

I'd like to receive: