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CLASSIC showed that six months of capecitabine and oxaliplatin after a thorough stomach cancer operation stops the cancer returning in many more people, with 68 percent free of disease at five years against 53 percent with surgery alone, and more of them alive; it made CAPOX one of the two standard adjuvant treatments in East Asia.
CLASSIC was an open-label phase 3 trial at 37 centres in South Korea, China and Taiwan that randomised 1,035 patients with stage II to IIIB gastric cancer after curative D2 gastrectomy to eight three-week cycles of capecitabine and oxaliplatin (520) or observation (515). The primary endpoint was three-year disease-free survival.
Three-year disease-free survival was 74 percent with chemotherapy against 59 percent with surgery alone (hazard ratio 0.56), and at five years 68 against 53 percent with overall survival of 78 against 69 percent (hazard ratio 0.66). Grade 3 or 4 adverse events occurred in 56 percent of treated patients, mainly nausea, neutropenia and loss of appetite. With ACTS-GC (adjuvant S-1 in Japan) the trial defines adjuvant chemotherapy after D2 gastrectomy in East Asia, which is how the corpus's gastric cancer page cites it.
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.
1,035 enrolled.
95% CI 69 to 79 · 95% CI 53 to 64
Source95% CI 63 to 73 · 95% CI 47 to 58
Source95% CI 74 to 82 · 95% CI 64 to 73
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 3 yearsprimary | Adjuvant capecitabine + oxaliplatin | 520 | 74% | 0.56 (0.44 to 0.72) | <0.0001 | link |
| Surgery alone (observation) | 515 | 59% | ||||
| Disease-free survival at 5 years | Adjuvant capecitabine + oxaliplatin | 520 | 68% | 0.58 (0.47 to 0.72) | <0.0001 | link |
| Surgery alone (observation) | 515 | 53% | ||||
| Overall survival at 5 years | Adjuvant capecitabine + oxaliplatin | 520 | 78% | 0.66 (0.51 to 0.85) | 0.0015 | link |
| Surgery alone (observation) | 515 | 69% | ||||
| Grade 3 or 4 adverse events | Adjuvant capecitabine + oxaliplatin | 496 | 56% | - | - | link |
| Surgery alone (observation) | 478 | 6% |
Confirms a survival benefit for adjuvant CAPOX after D2 gastrectomy.
Adjuvant CAPOX after D2 gastrectomy is a standard option for operable stage II to III gastric cancer, alongside S-1 in Japan.
Shares Oxaliplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Roche / Genentech, Cytotoxic chemotherapy and the tag soc-trials.
Shares Oxaliplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Roche / Genentech, Cytotoxic chemotherapy and the tag soc-trials.
Shares Capecitabine, Cytotoxic chemotherapy and the tag soc-trials.
Shares Roche / Genentech, Cytotoxic chemotherapy and the tag soc-trials.
Shares Capecitabine, Cytotoxic chemotherapy and the tag soc-trials.
Shares Oxaliplatin, Cytotoxic chemotherapy and the tag soc-trials.