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Adding a third chemotherapy drug, nab-paclitaxel, to gemcitabine and cisplatin did not help people with advanced bile duct or gallbladder cancer live longer in this 452-patient US trial, although the gallbladder subgroup showed a hint of slower progression that needs its own test.
SWOG S1815 (NCT03768414) randomised 452 patients with newly diagnosed locally advanced unresectable or metastatic biliary tract cancer 2:1 to gemcitabine 800 mg/m², cisplatin 25 mg/m² and nab-paclitaxel 100 mg/m² (GAP) or gemcitabine 1,000 mg/m² and cisplatin 25 mg/m² (GC), days 1 and 8 every 21 days. Of 441 eligible and analysable participants, 67 percent had intrahepatic cholangiocarcinoma, 16 percent gallbladder carcinoma and 17 percent extrahepatic cholangiocarcinoma. Median overall survival was 14.0 months with GAP and 13.6 with GC (hazard ratio 0.91, 95 percent confidence interval 0.72 to 1.14, p 0.41) and median progression-free survival 7.5 versus 6.3 months (hazard ratio 0.89, p 0.32). In exploratory subsets the benefit of GAP appeared greater in locally advanced disease (not significant) and the progression-free survival improvement was greater in gallbladder carcinoma than in cholangiocarcinoma (interaction p 0.01), but not overall survival (interaction p 0.28). The trial closes the question of taxane triplets as a general first-line standard and leaves the gallbladder signal as a hypothesis for the Indian RUGB trial and Chinese gemcitabine-nab-paclitaxel trials to pursue.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
452 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Gemcitabine + cisplatin + nab-paclitaxel | - | 14 months | 0.91 (0.72 to 1.14) | 0.41 | link |
| Gemcitabine + cisplatin | - | 13.6 months | ||||
| Progression-free survival | Gemcitabine + cisplatin + nab-paclitaxel | - | 7.5 months | 0.89 (0.71 to 1.12) | 0.32 | link |
| Gemcitabine + cisplatin | - | 6.3 months |
Shares Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer and the tag failure.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Nab-paclitaxel, Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Gemcitabine.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Biliary tract cancer (all types), Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer, Cytotoxic chemotherapy and the tag failure.