SWOG S1815
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.
Overview
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.
- Median 14 vs 13.6 months with Gemcitabine + cisplatin + nab-paclitaxel compared with Gemcitabine + cisplatin; about 0.4 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 9 percent lower chance of the event at any given time (hazard ratio 0.91, likely range 0.72 to 1.14).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- Median 7.5 vs 6.3 months with Gemcitabine + cisplatin + nab-paclitaxel compared with Gemcitabine + cisplatin; about 1.2 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 11 percent lower chance of the event at any given time (hazard ratio 0.89, likely range 0.71 to 1.12).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- These results apply to the people the trial enrolled: Newly diagnosed advanced biliary tract cancer (intrahepatic, extrahepatic, gallbladder): gemcitabine, cisplatin and nab-paclitaxel versus gemcitabine and cisplatin, randomised 2:1. People in a different situation may not see the same effect.
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 |
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