Salvage radiotherapy: a new standard of care

Salvage radiotherapy: a new standard of care

Nieprzeczytany postautor: franki31 » 04 mar 2021, 14:25

Ciekawy artykuł z "Nature" z tezą, że raczej korzystniejsze dla pacjenta jest powstrzymanie się od radioterapii adjuwantowej (z ryzykiem wszelkich możliwych zdarzeń niepożądanych) na rzecz późniejszej radioterapii ratującej.



Salvage radiotherapy: a new standard of care

Adjuvant radiotherapy following radical prostatectomy (RP) has been shown to reduce the risk of disease recurrence in men with high-risk prostate cancer. Nonetheless, this strategy represents overtreatment for some, who would not otherwise have disease recurrence after RP.

Paul Sargos, a lead investigator on the GETUG–AFU 17 study explains: “Three randomized trials from the 1990s compared the efficacy of adjuvant radiotherapy, to that of observation after RP. These studies, which included patients with pathological high-risk features, indicated better long-term biochemical and/or clinical tumour control, albeit with higher rates of genitourinary, sexual and gastrointestinal toxicities,” adding that: “Interestingly, despite the positivity of these data, and, despite only retrospective evidence favouring an observation policy, observation followed by salvage radiotherapy at biochemical failure has been widely adopted in daily practice, predominantly by urologists and by some radiation oncologists.”

Now, data from three randomized controlled trials indicate no evidence of an improvement in 5-year event-free survival (EFS) with the adjuvant approach over early salvage radiotherapy.

Investigators in Australia and New Zealand (TROG 08.03/ANZUP RAVES), France (GETUG–AFU 17) and Canada, Denmark, Ireland, and the UK (RADICALS-RT) randomly assigned men with Gleason grade ≥6 prostate cancer with at least one risk factor for disease progression undergoing RP (1:1) to receive either adjuvant radiotherapy or salvage radiotherapy upon detection of a rising serum PSA level (either ≥0.2 ng/ml or >0.1 ng/ml and rising on three consecutive occasions). Each trial had a different primary end point: biochemical progression-free survival (bPFS), EFS and freedom from distant metastases, respectively.

In TROG 08.03/ANZUP RAVES, involving 333 patients, both groups had similar 5-year rates of bPFS (86% in the adjuvant radiotherapy group versus 87% in the early salvage group (stratified HR 1.12; Pnon-inferiority = 0.15)). This observation was accompanied by a significant increase in grade ≥2 genitourinary toxicities in those receiving adjuvant radiotherapy (70% versus 54%, OR 0.34; P = 0.0022).

Similarly, GETUG–AFU 17, involving 424 patients, revealed no significant difference in 5-year EFS (92% in the adjuvant radiotherapy group versus 90% in the early salvage group, HR 0.81, log-rank P = 0.42) also with fewer acute grade ≥2 toxicities (59% versus 22%) and late grade ≥2 adverse events (27% versus 7%; P < 0.0001). Unlike in TROG 08.03/ANZUP RAVES, patients in this trial also received a short course of hormone therapy.

These data were further confirmed in RADICALS-RT, involving 1,396 patients, which revealed similar rates of 5-year bPFS (85% in the adjuvant group versus 88% in the salvage group, HR 1.10; P = 0.56). Significant reductions in all radiation-related toxicities (diarrhoea, proctitis, cystitis, haematuria and urethral stricture, all P ≤ 0.02) were observed in the salvage group, although patient-reported outcome measures revealed only short-term (<1 year of randomization) reductions in self-reported urinary or bowel function.

These data provide robust evidence that men undergoing RP can safely be spared adjuvant radiotherapy and the associated risk of adverse events.
These conclusions are elegantly summarized in ARTISTIC, a prospectively planned, collaborative meta-analysis, which confirms a 1% difference in 5-year EFS between groups (89% with adjuvant, versus 88% with early salvage radiotherapy).

Sargos summarizes: “These three studies, added to the ARTISTIC meta-analysis results, are an important step forward and support the use of early salvage as opposed to adjuvant radiotherapy after RP for many patients. This is a practice changing conclusion!

When asked about future directions, Chris Parker, a lead investigator on RADICALS-RT highlights: “Although the trial started 13 years ago, the results in terms of freedom from metastases and overall survival remain immature, with insufficient events currently accrued for analysis. We plan to continue follow-up monitoring in order to analyse these end points in due course.”
This article is modified from the original in Nat. Rev. Clin. Oncol.

(https://doi.org/10.1038/s41571-020-00443-3).
https://www.nature.com/articles/s41585-020-00392-7
franki31
 
Posty: 56
Rejestracja: 23 sty 2016, 13:11
Blog: Wyświetl blog (0)

Re: Salvage radiotherapy: a new standard of care

Nieprzeczytany postautor: aqq » 04 mar 2021, 15:44

We wszystkich badaniach włączano chorych z pT3a, a w jednym z nich również

We did a randomised controlled trial enrolling patients with at least one risk factor
- pathological T-stage 3 or 4,
- Gleason score of 7–10,
- positive margins, or
- preoperative PSA ≥10 ng/mL)
for biochemical progression after radical prostatectomy,
*)

czyli chorych, których nie kwalifikowalibyśmy w ogóle. Rozumiem, że chodzi Ci o wyłącznie o te wytłuszczone cechy ryzyka?
Dlatego wyniki są jakie są. Czyli za dobre?







_________________________
*) Ten "jeden z nich", to badanie kliniczne RADICALS-RT a cytat pochodzi z poniższej publikacji:


Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial
https://pubmed.ncbi.nlm.nih.gov/33002429/

Linki do publikacji na temat pozostałych 2 badań klinicznych porównujących adjuvant RT z early salvage RT:

Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial
https://pubmed.ncbi.nlm.nih.gov/33002437/

Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial
https://pubmed.ncbi.nlm.nih.gov/33002438/

-zb
A. de Saint-Exupery "Jeśli nie chcesz mieć swego udziału w klęskach, nie będziesz go miał również w zwycięstwach."
Awatar użytkownika
aqq
 
Posty: 545
Rejestracja: 03 sie 2012, 20:29
Lokalizacja: Kraków Szpital Uniwersytecki, Zamość Nu-Med
Blog: Wyświetl blog (0)

Re: Salvage radiotherapy: a new standard of care

Nieprzeczytany postautor: leonardo556 » 04 mar 2021, 22:37

Z powodu takich informacji warto czytać nasze forum. W moim przypadku niczego to nie zmienia oprócz uspokojenia sumienia, że wcześniejsza radioterapia byłaby bardziej korzystna. Skutki uboczne radioterapii są znaczące dlatego na pewno nie warto robić jej zbyt wcześnie.

Leonardo
ur. 1956 PSA 5,2 Gleason 7, sierpień 2013
RP Da Vinci 9 październik 2013 , pT3a pN0 (0/13) R0, Gleason: 4(75%) + 3(25%) = 7
PSA - 0,003 - 28.11.2013, 28.11.2014
PSA - 0.008, 0.012, 0.018 odpowiednio styczeń, lipiec, październik 2015
PSA - 0.044 22 luty, 0,038 13 lipiec 2016, 0,103 23 listopad 2016, 0,476 14 lipiec 2017, 0,55 październik 2017
wycięcie 50 węzłów Da Vinci , UICC: pT3a pN1 (1/63) R0, PSA 0,31 październik 2017, PSA 0,7 marzec 2018
IMRT TrueBeam, 22x2,6 Gy = 57,2 Gy, maj 2018 + bikalutamid 50 mg (kwiecień ,maj, czerwiec)
PSA - 0,341 - 0,310 - 0,234 - 0,212 - 0,188 - 0,154 (15.03.2019) - 0,142 (31.07.2019) - 0,148 (19.12.2019)
0,248 (19.02.2020) - 0,337 (21.04.2020) - 0,466 (03.07.2020) - 0,518 (27.07.2020) - 0,947 (10.11.2020)
IMRT Truebem 3x5=15 Gy - naświetlanie prewencyjne ginekomastii - 12.11.2020, bikalutamid 50 mg
PSA - 1,04 (12.20) - 0,127 (04.21) - 0,126 (06.21) - 0,159 (08.21), bikalutamid 100 mg, 0,08 (10.21)
PSA - 0,063 (12.21) 0,081 (01.22) 0,054 (03.22) 0,069 (04.22) 0,102 (07.22) 0,141 (10.22) bikalutamid stop
PSA - 0,874 (05.12.22), 1.1 (30.12.22) bikalutamid 150 mg start
PSA - 0,326 (02.02.23), 0,202 (8.05.23), 0,228 (29.07.23), 0,338 (14.09.23), 0,755 (4.12.23) bikalutamid stop darolutamid start
PSA - 0,411 (12.02.24)
leonardo556
 
Posty: 476
Rejestracja: 17 paź 2013, 18:21
Blog: Wyświetl blog (0)


Wróć do O CZYM POWINNIŚMY WIEDZIEĆ PRZED, W TRAKCIE I PO LECZENIU

Kto jest online

Użytkownicy przeglądający to forum: Obecnie na forum nie ma żadnego zarejestrowanego użytkownika i 18 gości

logo zenbox