ALASCCA
A Nordic trial showing that three years of low-dose aspirin roughly halves recurrence in bowel cancers carrying a particular set of mutations, a biomarker-directed use of a drug that costs pennies.
3,508 patients were screened for tumour PIK3CA and PI3K-pathway alterations; 626 with alterations were randomised. In group A (PIK3CA exon 9 or 20 hotspot mutations, n=314) recurrence at three years was 7.7% with aspirin vs 14.1% with placebo (HR 0.49, 95% CI 0.24-0.98); in group B (other PIK3CA mutations or PIK3R1/PTEN alterations, n=312) it was 7.7% vs 16.8% (HR 0.42, 95% CI 0.21-0.83). Severe adverse events attributable to aspirin were uncommon (about 2%). ALASCCA validates a decade of observational data from the Nurses' Health Study and CALGB 89803 suggesting PIK3CA-mutant tumours are aspirin-sensitive, and creates an implementation task: routine PIK3CA testing in early colorectal cancer, which most pathology services do not currently perform.
- 7.7 vs 14.1 out of 100 reached this endpoint at 3 years with Aspirin compared with Placebo; 6.4 fewer per 100.
- On this measure the first group did worse, not better.
- Put another way, the treated group had about 51 percent lower chance of the event at any given time (hazard ratio 0.49, likely range 0.24 to 0.98).
- 7.7 vs 16.8 out of 100 reached this endpoint at 3 years with Aspirin compared with Placebo; 9.1 fewer per 100.
- On this measure the first group did worse, not better.
- Put another way, the treated group had about 58 percent lower chance of the event at any given time (hazard ratio 0.42, likely range 0.21 to 0.83).
- 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.
- These results apply to the people the trial enrolled: Resected stage I-III rectal or stage II-III colon cancer with somatic PIK3CA (exon 9/20) or other PI3K-pathway alterations: aspirin 160 mg/day for 3 years vs placebo. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PIK3CA); the result should not be assumed for people whose cancer does not have 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.
626 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Time to recurrence at 3 years, group A (PIK3CA exon 9/20)primary | Aspirin | — | 7.7% | 0.49 (0.24–0.98) | — | link |
| Placebo | — | 14.1% | ||||
| Time to recurrence at 3 years, group B (other PI3K-pathway alterations) | Aspirin | — | 7.7% | 0.42 (0.21–0.83) | — | link |
| Placebo | — | 16.8% |
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not linked directly; found by shared links- TrialAdd-Aspirin
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