
What Do Real-world Data Say About FGFR2 Status and PFS, OS in Cholangiocarcinoma?
The presence of FGFR2 alterations occurs almost exclusively in intrahepatic cholangiocarcinoma (iCCA) and is seen in 10% to 16% of patients. A question examined in abstracts over the past year has been whether FGFR2 alterations affect survival in those patients who receive systemic chemotherapy for iCCA.
After years of little progress on new treatments for patients with advanced
The presence of FGFR2 alterations occurs almost exclusively in intrahepatic cholangiocarcinoma (iCCA) and is seen in 10% to 16% of patients. A question examined in abstracts over the past year has been whether FGFR2 alterations affect survival in those patients who receive systemic chemotherapy for iCCA.
At the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), investigators from Memorial Sloan Kettering Cancer Center (MSKCC) & Weill Medical College
At the May 2021 ASCO annual meeting, investigators from the University of Arizona and QED Therapeutics used real-world data from the Flatiron Health-Foundation Medicine CCA for a similar analysis, involving 571 patients and 270 cancer clinics.2
The investigators said the primary point was “to compare real-world OS in patients with advanced CCA and FGFR2 fusions/rearrangements vs. those with wild-type FGFR2 from the index date of diagnosis of advanced CCA to date of death.” A secondary objective, they wrote, was to analyze OS in those patients with CCA and FGFR2 fusions/rearrangements from the start of second-line therapy to date of death.
As of May 2020, 75 of the patients had FGFR2 fusions/rearrangements; this goup was 64% female, 95% had iCCA, and 68% had stage IV disease at diagnosis. Of the 496 patients who were FGFR2-wild type, 48% were female, 74% had iCCA, and 55% were at stage IV at diagnosis. Median OS from the index data of diagnosis was numerically higher, but not statistically different, for patients with FGFR2 fusions/rearrangements vs. wild-type FGFR2 (12.1 months vs. 7.1 months).Investigators also found:
Of the 50 patients who were FGFR2+ received second-line therapy; median real-world OS from the start of second-line therapy was 8.5 months.
Investigators concluded that these real-world OS findings did not demonstrate a survival advantage for patients with CCA who were FGFR2+ vs those with wild-type FGFR2 who received therapies for advanced disease. However, the OS trend favored those patients who were FGFR2+. At the same time, they wrote, “FGFR2 status was not a significant predictor of OS after adjusting for potential prognostic covariates.”
The study is still examining OS from the start of second-line therapy inpatients with advanced CCA, comparing FGFR2+ and those with wild-type FGFR2.
References
1. Abou-Alfa GK, Bibeau K, Schultz N, et al. Effect of FGFR2 alterations on survival in patients receiving systemic chemotherapy for intrahepatic cholangiocarcinoma. J Clin Oncol. 2021;39(suppl_3). DOI: 10.1200/JCO.2021.39.3_suppl.303
2. Shroff RT, Avogadri F, Weng F, et al. Natural history of patients (pts) with advanced cholangiocarcinoma (CCA) with FGFR2 gene fusion/rearrangement or wild-type (WT) FGFR2. J Clin Oncol. 2021;39(suppl_15) abstr 4089. DOI: 10.1200/JCO.2021.39.15_suppl.4089
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