@HimanshuNagarMD@Rad_Nation@PBlanchardMD@TheLancet Not enough bandwidth for fourth arm (huge numbers of pts). Decision based on 94-13. Ramey et al Eur Urol 2018 sheds some light on that arm. There are no solid data on upfront PLNRT vs salvage PLNRT, but we know the benefit of upfront intensification. #radonc#jc
@HimanshuNagarMD@Rad_Nation@PBlanchardMD@TheLancet Good point. 71% in Arm 1 is at 5 yr and FFP continues to drop. Incremental benefit was observed at low and high PSA levels. Other prognostic factors and comorbidities may influence the decision. Intensification upfront reduces the chance of lifelong ADT later. #radonc#jc
@Sushilberiwal@Rad_Nation@PBlanchardMD@HimanshuNagarMD@TheLancet Great question because we all know that one size does not fit all. The PSA >0.35 is one criterion, but consider PLNRT with lower PSAs and other adverse factors such as negative margins, high grade, SVI, no or few LNs sampled, High Decipher score. #radonc#jc
@Rad_Nation@PBlanchardMD@HimanshuNagarMD@TheLancet 3) All patients benefitted from short term ADT
4) Those with PSAs above the median (0.35) benefitted most from PLNRT.
Question: Should we wait for patients to declare themselves and then give PLNRT?
Answer: No (to be continued) #Radon#JC
@Rad_Nation@PBlanchardMD@HimanshuNagarMD@TheLancet Other points:
1) Adding PLNRT to PBRT+ADT resulted in a significant benefit by the primary endpoint 5 yr FFP.
2) Forest plots in Fig 3 at 8 yr show less of a benefit for Group 3 vs 2; although arm 3 had the lowest DM and CSD rates at only median FU 8.2 yr. #radonc#jc
@Rad_Nation@the_lancet Doubling time inclusion nearly killed the study. It required 3 PSAs at 2 mo intervals (anxious pts). Also, short PSADTs were excluded (CTEP requirement), which Trock et al showed in JAMA using Hopkins data was a mistake. With exclusion accrual skyrocketed. #radonc#jc
@Rad_Nation@the_lancet Also on Endpoints: We included a more standard biochemical failure cutpoint of 0.4 and in an ad hoc analysis second salvage ADT (see Fig 4), aside from local fialure, DM, CSM, and OS. #radonc#jc
@Rad_Nation@the_lancet Endpoints: Primary endpoint was 5yr FFP mainly based on nadir+2. See Appendix in the paper for justification. Correlated with clinical failure. Included death from any cause (standard CTEP requirement). With longer FU, increased arm convergence expected. #radonc#jc
@Rad_Nation@TheLancet Yes, GETUG AFU-16 and RTOG 9601 are the main complimentary randomized trials to the SPPORT trial. The GETUG trial is the most comparable, because both SPPORT and GETUG used short term ADT. All three trials showed outcome benefits from the addition of ADT to prostate bed RT.
@Rad_Nation@TheLancet Yes, GETUG AFU-16 and RTOG 9601 are the main complimentary randomized trials to the SPPORT trial. The GETUG trial is the most comparable, because both SPPORT and GETUG used short term ADT. All three trials showed outcome benefits from the addition of ADT to prostate bed RT.