OnCo
trialsTrialPositive

APHINITY

Adding pertuzumab after surgery helps women whose cancer had reached the lymph nodes, by a few percentage points, and does not help those with node-negative disease.

8-year iDFS 88.4% vs 85.8% overall (HR 0.78); node-positive 86.1% vs 81.2% (absolute 4.9%); no benefit node-negative. OS not significantly different at 8 years (HR 0.83). Led to pertuzumab's restriction to higher-risk disease.

Setting
Adjuvant HER2+ early breast cancer: pertuzumab + trastuzumab + chemotherapy vs placebo + trastuzumab + chemotherapy
Phase
Phase 3
Sponsor
Roche / BIG
Registry
Headline result
8-year iDFS HR 0.78; node-positive absolute +4.9%.
Reported
2017
Enrolled
4805
Replication
Consistent with neoadjuvant pCR data (NeoSphere, TRYPHAENA); OS benefit not shown.

Outcomes

1top
In plain words
What these results mean for people, not percentages
4,805 people took part
8-year invasive disease-free survivalprimarysurrogate endpoint
  • 88.4 vs 85.8 out of 100 alive without the cancer coming back at 8 years with Pertuzumab arm compared with Placebo arm; 2.6 more per 100.
  • Roughly one extra person helped for every 38 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 22 percent lower chance of the event at any given time (hazard ratio 0.78, likely range 0.66 to 0.92).
  • 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: Adjuvant HER2+ early breast cancer: pertuzumab + trastuzumab + chemotherapy vs placebo + trastuzumab + chemotherapy. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (HER2); 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.

4,805 participants enrolled.

8-year invasive disease-free survivalprimary
HR 0.78 (0.66–0.92)
Pertuzumab arm88.4 of 100
n = 2,400
Placebo arm85.8 of 100
n = 2,405
Source
EndpointArmnValueHR (95% CI)pSource
8-year invasive disease-free survivalprimaryPertuzumab arm2,40088.4%0.78 (0.66–0.92)link
Placebo arm2,40585.8%
Replication
Consistent with neoadjuvant pCR data (NeoSphere, TRYPHAENA); OS benefit not shown.

Connected

7top