Nab-paclitaxel does not extend survival in biliary tract cancer; though has benefits for some

Adding nab-paclitaxel to a standard treatment of gemcitabine plus cisplatin does not significantly extend median overall survival (OS) time for patients with advanced biliary tract cancers, although it may provide a benefit for subsets of patients with locally advanced disease or gallbladder adenocarcinoma.

These results are from the phase 3 S1815 trial conducted by the SWOG Cancer Research Network. SWOG S1815 was designed as a randomized phase 3 trial to compare this nab-paclitaxel combination to the standard gemcitabine-cisplatin regimen to determine whether it would extend survival times in a larger group of patients newly diagnosed with advanced BTCs.

Of the 441 eligible patients randomized on the trial, about two-thirds had intrahepatic cholangiocarcinoma. The remaining third were almost evenly split between gallbladder adenocarcinoma and extrahepatic cholangiocarcinoma. The 441 patients were randomized 2:1 to a combination of nab-paclitaxel, gemcitabine, and cisplatin or to a standard regimen of gemcitabine and cisplatin.

The researchers found that median OS among patients on the nab-paclitaxel arm was 14 months, while median OS among patients on the standard gemcitabine-cisplatin arm was 12.7 months, a difference in OS that was not statistically significant. The objective response rate among patients overall on the investigative arm was 34 percent versus 25 percent on the control arm, and the median progression-free survival times were 8.2 months and 6.4 months, respectively.

In exploratory subset analyses, the researchers found that median OS was significantly longer on the nab-paclitaxel combination than on the standard gemcitabine-cisplatin regimen for those patients who had locally advanced disease.

Reference:

Rachna Shroff et al,NIH/National Cancer Institute, Celgene