Apalutamide/ADT Confers 100% Recurrence-Free Survival in High-Risk Prostate Cancer

[street-air]

oncnursingnews.com/view/apa...

So if I have this right high risk patients who got RP are put on adt and apalutamide for 12 months and after two years, now with recovered tst none have had a recurrence.

am a little confused on the implications is this simply deferring the recurrence that would occur in the first 5 years after RP anyway? or is the suggestion that the doublet adt has moved some people into a long term durable remission group that would otherwise not be?

[NanoMRI]

I did not see PSA value for recurrence free determination. I rely on believe <0.010 is the correct value. And, is not the true test years after ADT has stopped?

[street-air in reply to NanoMRI]

well, exactly.

[Graham49]

P2-07 APALUTAMIDE FOR HIGH-RISK LOCALIZED PROSTATE CANCER FOLLOWING RADICAL PROSTATECTOMY IN Apa-RP: A Multicenter, Open-Label, Single-Arm Phase 2 Study

Neal Shore , Jason Hafron , Daniel Saltzstein , Gordon Brown , Laurence Belkoff , Pankaj Aggarwal , Jennifer Phillips , Amitabha Bhaumik , and Tracy McGowan

doi.org/10.1097/01.JU.00010...

Abstract

INTRODUCTION AND OBJECTIVES:

Approximately 25% of patients (pts) with high-risk localized prostate cancer (HR LPC) experience disease recurrence within 2 years following radical prostatectomy (RP). The Apa-RP study (NCT04523207) investigated adjuvant treatment with apalutamide and androgen deprivation therapy (ADT) to determine if this combination improved the biochemical recurrence (BCR)-free rate in participants with HR LPC who had undergone RP, compared with historical data from pts with RP alone.

METHODS:

In this multicenter, open-label, single-arm, Phase 2 study conducted at 27 US community urologic practices, treatment-naïve pts with HR LPC who had undergone RP were treated with apalutamide (240 mg; once daily) and ADT for 12 cycles (1 cycle=28 days). The primary endpoint was confirmed BCR-free rate at 24 months, where BCR is defined as two sequential prostate-specific antigen (PSA) levels >0.2 ng/mL. Secondary endpoints included testosterone recovery rate and safety. Modified intention-to-treat analysis set is reported.

RESULTS:

108 pts were enrolled; the median age was 66.0 (range 46.0-77.0) years. The median pre-operative PSA and testosterone at baseline were 7.6 (range 2.2-62.7) ng/dL and 340.0 (range 43.0-939.0) ng/dL, respectively. Confirmed BCR-free rate was 100% at 24 months (90% confidence interval [CI] 93.0, 100.0) (Figure 1A); unconfirmed BCR-free rate at 24 months was 98.4% (90% CI 92.2, 99.7) (Figure 1B). The serum testosterone recovery (≥150 ng/dL) event rate was 76.4% (95% CI 65.0-84.5) at 12 months following treatment completion. Treatment-emergent adverse events (TEAEs) were reported by 99.1% (n=107) of pts during the study; 22.2% (n=24) were Grade 3 -4, and 14.8% (n=16) were serious AEs. 13.0% (n=14) and 10.2% (n=11) of pts required treatment dose reduction/interruption or discontinuation due to AEs, respectively.

CONCLUSIONS:

The Apa-RP study results suggest that treatment intensification with 12 months of apalutamide+ADT could become an option for patients with HR LPC undergoing RP, based on a 100% BCR-free survival. 76% of patients had testosterone recovery (≥150 ng/dL) 12 months after treatment completion. The safety profile of apalutamide + ADT was consistent with previous reports.

[vintage42]

That is for adjuvant treatment with RP. I wonder if the Apalutamide/ADT combo works as well for recurrence -- that Erleada is better than Xtandi, Nubeqa or Abiraterone.

[Grandpa4]

agree. At 2 years I was negative without these drugs. Interested in 5 year data.

[Tony666]

it is silly to draw ANY conclusions from such a short period. Not surprising that no psa detected while on intensive adt for the first year. And in all likelihood there is still a strong adt effect in the second year (since with a year of intensive adt it usually takes at least 6 months for T to come back). No doubt sponsored by the makers of the drugs. Let’s see the impact after 5-10 years.

[j-o-h-n]

To street-fair.

Odds are: Can occur in years 1 3 5 7 or 9.

Good Luck, Good Health and Good Humor.

j-o-h-n

[Anatalya]

I don't know. I think anybody can spin numbers to make results look how they want them to look.

[Justfor_]

The title of this silly paper should have been: "Balistic missile launches against irritating sparrows". I am high risk in all accounts (GS 4+5, pT3b). 2.5 years after RP my PSA was 0.17, so not BCR according to their criteria (2 conservative 0.2 readings). Now, 5 years post RP my PSA is hovering the lowest level of detection only by taking 1/10 the normal dosage of Bicalutamide (half a tablet every 5 days).

[Izzysdad]

I, for one, appreciate the information. I don’t think every snippet of info has to be the “holy grail” of prostate cancer research. A lot of the guys on this forum are new to the trenches. Positive articles can be mentally uplifting even if the study does need a few more whiskers to be medically significant. Thanks for posting.

[Yzinger in reply to Izzysdad]

well said and agree