Perjeta and recurrence rates

First, welcome Countrygirl80 to our community. Not sure that this is helpful, but here is a link to some of our content on Perjeta. Hoping the rest of your TCH-P chemo goes smoothly. It must be very difficult to be managing all this with a baby! Hang in there, and we are thinking of you!

Hi Countrygirl80:

The accelerated FDA approval of pertuzumab (Perjeta) in the neoadjuvant setting was based on improvements in pathologic complete response (pCR), the primary endpoint of the Neosphere trial (see also, results from the neoadjuvant TRYPHAENA trial). In May-June 2016, some additional results from the Neosphere trial at 5-year follow-up were published, with some important caveats:

Gianni (2016) (Neosphere): http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)00163-7/fulltext

"[S]econdary endpoints reported here are 5-year progression-free survival (analysed in the intention-to-treat population) and disease-free survival (analysed in patients who had surgery). Secondary and exploratory analyses were not powered for formal statistical hypothesis testing, and therefore results are for descriptive purposes only."

It seems that the trial was not powered statistically to detect differences in progression-free survival ("PFS") or disease-free survival ("DFS") between groups, and indeed the observed Confidence Intervals ("CIs") were large and overlapping ("Progression-free survival and disease-free survival at 5-year follow-up show large and overlapping CIs . . .")

Elsewhere, the lead author stated that the results show a trend, but were not statistically significant.

The results of the Phase 3 APHINITY trial (NCT01358877; Adjuvant Pertuzumab and Herceptin in Initial Therapy in Breast Cancer) in the adjuvant setting, including its primary endpoint of Invasive Disease-Free Survival (IDFS) Duration, are thus eagerly awaited:

Clinicaltrials.gov entry: https://clinicaltrials.gov/ct2/show/study/NCT01358877?view=results

BarredOwl