ASCO GI 2023 | SWOG 1815: gemcitabine, cisplatin, and nab-paclitaxel in biliary tract cancer
Rachna Shroff, MD, MS, University of Arizona College of Medicine, Tucson, AZ, presents findings from the Phase III SWOG 1815 trial (NCT03768414) of gemcitabine, cisplatin, and nab-paclitaxel in newly diagnosed, advanced biliary tract cancers. 441 patients were randomized to receive the investigational regimen or the standard of care (gemcitabine and cisplatin). Whilst overall survival (OS) was higher in patients receiving gemcitabine, cisplatin, and nab-paclitaxel, it was not statistically significant. OS was also marginally improved in patients with gallbladder cancer, and a number of grade 3-5 adverse events were reported. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Gastrointestinal Cancers (GI) Symposium in San Francisco, CA.
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Transcript (edited for clarity)
Billiary tract cancers to date have been treated with gemcitabine and cisplatin based regimens, and we conducted a single arm phase-two trial of gemcitabine, cisplatin, and nab-paclitaxel that had some promising efficacy with the median overall survival of 19.2 months. So, SWOG 1815 was designed to really understand what GemCis NAB-Paclitaxel did in comparison to the standard of care at the time, gemcitabine and cisplatin...
Billiary tract cancers to date have been treated with gemcitabine and cisplatin based regimens, and we conducted a single arm phase-two trial of gemcitabine, cisplatin, and nab-paclitaxel that had some promising efficacy with the median overall survival of 19.2 months. So, SWOG 1815 was designed to really understand what GemCis NAB-Paclitaxel did in comparison to the standard of care at the time, gemcitabine and cisplatin. So, the study was designed as a two to one randomization comparing the two arms with a primary endpoint of overall survival and a total of 441 patients were enrolled across the entire country through the NCTN mechanism with an NCI sponsored study that was open through SWOG.
So, the results demonstrated that the median overall survival of GemCis NAB-Paclitaxel was 14 months compared to 12.7 months. This difference was numerically improved but did not reach statistical significance. There was also numerical improvement in progression free survival, but again did not reach statistical significance.
And the overall response rate of GemCis Nab-Paclitaxel was 31% versus 22% in the GemCis arm. So, also better but not significant in terms of differences. The study though, did demonstrate some potential signals of efficacy and certain pre-specified stratification factors. So, for instance, in gallbladder cancer patients, as well as locally advanced patients, there’s perhaps some promising data that suggests better OS, better overall response. But these numbers were small, so we really need further investigation to understand that better.
The safety and toxicity did show a higher incidence of grade three to five hematologic toxicities in the triplet arm, which was not surprising. But there was not any difference in the treatment discontinuation rate. So, patients did stay on both arms about the same. So, overall, it does seem that there may be some benefit for GemCis Nab-Paclitaxel, but I think we need to better understand the patients in whom it may benefit them.
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