CLASSIC
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.
Overview
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.
- 74 vs 59 out of 100 alive without the cancer coming back at 3 years with Adjuvant capecitabine + oxaliplatin compared with Surgery alone (observation); 15 more per 100.
- Roughly one extra person helped for every 7 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 44 percent lower chance of the event at any given time (hazard ratio 0.56, likely range 0.44 to 0.72).
- 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.
- 68 vs 53 out of 100 alive without the cancer coming back at 5 years with Adjuvant capecitabine + oxaliplatin compared with Surgery alone (observation); 15 more per 100.
- Roughly one extra person helped for every 7 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 42 percent lower chance of the event at any given time (hazard ratio 0.58, likely range 0.47 to 0.72).
- 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.
- 78 vs 69 out of 100 alive at 5 years with Adjuvant capecitabine + oxaliplatin compared with Surgery alone (observation); 9 more per 100.
- Roughly one extra person helped for every 11 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 34 percent lower chance of the event at any given time (hazard ratio 0.66, likely range 0.51 to 0.85).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 56 vs 6 out of 100 reached this endpoint with Adjuvant capecitabine + oxaliplatin compared with Surgery alone (observation); 50 more per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Stage II to IIIB gastric adenocarcinoma after curative D2 gastrectomy in South Korea, China and Taiwan: eight cycles of adjuvant capecitabine and oxaliplatin (CAPOX) against surgery alone, with disease-free survival as the primary endpoint. 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.
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.
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