Laura Goff, MD, discusses the key takeaways from results of the phase 3 SWOG 1815 trial in newly diagnosed patients with advanced biliary tract cancers.
Laura Goff, MD, associate professor of Medicine, Hematology/Oncology, executive medical director, Vanderbilt-Ingram Cancer Center Patient Care Center, co-chair, Data and Safety Monitoring Committee, Vanderbilt-Ingram Cancer Center, discusses the key takeaways from results of the phase 3 SWOG 1815 trial (NCT03768414) in newly diagnosed patients with advanced biliary tract cancers.
In the phase 3 trial, investigators evaluated the addition of nab-paclitaxel (Abraxane) to gemcitabine and cisplatin within this patient population to evaluate the efficacy and safety of the triplet vs doublet chemotherapy. The study rapidly accrued patients, with 441 patients enrolling at institutions across the United States, Goff says, adding that it was encouraging to see how quickly the trial accrued patients in what historically has been a rare histology.
Data from SWOG 1815 presented at the 2023 Gastrointestinal Cancers Symposium showed that the triplet therapy failed to generate a statistically significant improvement in overall survival (OS) compared with doublet therapy, missing the trial’s primary end point. Patients treated with the triplet regimen (n = 294) experienced a median OS of 14.0 months (90% CI, 12.6-16.3) vs 12.7 months (90% CI, 9.5-16.6) for those treated with the doublet (n = 147; P = .65).
Although the trial’s outcome was disappointing, there were some positives to take away from these data, Goff emphasizes. For example, since doublet therapy is generally better tolerated, it can be used as backbone for novel therapeutics in future trials without sacrificing efficacy, Goff notes.
Moreover, there may be some subgroups of patients that should be considered for the triplet therapy, Goff says. However, doublet chemotherapy should remain the mainstay standard of care for previously untreated patients with advanced biliary tract cancers, Goff concludes.