Abstract | Objectives: To retrospectively compare the efficacy of AA and ENZ in the treatment of patients with mCRPC in the post-docetaxel setting in terms of biochemical, radiological and clinical progression free survival (i.e. bPFS, rPFS and cPFS, respectively) and OS in 58 consecutive patients in a single institution. We also evaluated the toxicity of both agents.
Methods: A retrospective cohort study using the data collected from patients’ charts in the Department of Oncology and Radiotherapy in Split. A total of 58 consecutive mCRPC patients (n=58) treated with AA (1000 mg/day, 1h before or 2h after meal) plus P (2x5 mg) (n=27) and ENZ (160 mg per day) (n=31) from October 2015 until May 2018 in the post-docetaxel setting were included in this study.
Results: Despite the numerical difference in mOS, bPFS, rPFS, cPFS, in this relatively small number of patients, there was no statistically significant difference found between the two groups of patients.
In comparison to the most significant randomised control trials for AA + P (COU-AA 301) and ENZ (AFFIRM), the results of our patients' treatment with these agents regarding mOS were even better. Namely, in the COU-AA 301 study, mOS was 14.8 months (40) while in our mCRPC patients treated with AA+P mOS was not reached. In the AFFIRM trial, mOS was 18.4 months (41) whereas in our mCRPC patients treated with ENZ mOS was 24 months. In other observed parameters such as bPFS or rPFS we achieved comparable results to the COU-AA 301 trial and the AFFIRM study (40,41).
Regarding the observed toxicity in our patients, the incidence of certain side effects (among other typical side effects for each drug) did not differ significantly from those observed in the randomized trials mentioned above.
Conclusion: In conclusion, AA + P and ENZ represent an effective form of treatment for patients with mCRPC. Both drugs prolong survival, time to biochemical and radiological progression for patients at this stage of disease with acceptable toxicity profiles for both agents. |
Abstract (croatian) | Ciljevi: Retrospektivno usporediti djelotvornost AA i ENZ u liječenju pacijenata s mCRPC nakon progresije pod docetakselom u smislu biokemijskog, radiološkog i kliničkog preživljavanja bez progresije (tj. BPFS, rPFS i cPFS) i OS u 58 uzastopnih pacijenata u jednoj ustanovi. Također smo procijenili toksičnost oba lijeka.
Metode: Retrospektivna kohortna studija pomoću podataka prikupljenih iz povijesti bolesti bolesnika u Klinici za onkologiju i radioterapiju u Splitu. Sveukupno 58 bolesnika s mCRPC (n = 58) koji su liječeni s AA (1000 mg / dan, 1h prije ili 2h nakon obroka) plus P (2x5 mg) (n = 27) i ENZ (160 mg dnevno) (n = 31) od listopada 2015. do svibnja 2018. nakon progresije pod docetakselom uključeni su u ovu studiju.
Rezultati: Unatoč brojčanim razlikama u mOS, bPFS, rPFS, cPFS, s relativno malim brojem pacijenata, nije pronađena statistički značajna razlika između dviju skupina bolesnika.
U usporedbi s najznačajnijim randomiziranim studijama za AA + P (COU-AA 301) i ENZ (AFFIRM), rezultati našeg liječenja bolesnika s navedenim lijekovima u medijanu OS bili su još bolji. Naime, u studiji COU-AA 301, mOS je iznosio 14,8 mjeseci (40) dok kod naših mCRPC bolesnika liječenih AA + P mOS nije postignut. U ispitivanju AFFIRM, mOS je iznosio 18,4 mjeseci (41), dok je kod naših mCRPC bolesnika liječenih ENZ mOS iznosio 24 mjeseca. U drugim promatranim parametrima kao što su bPFS ili rPFS postigli smo usporedive rezultate s ispitivanjem COU-AA 301 i AFFIRM (40,41).
Što se tiče promatrane toksičnosti kod naših bolesnika, učestalost određenih nuspojava (među ostalim tipičnim nuspojavama za svaki lijek) nije se značajno razlikovala od onih promatranih u gore spomenutim randomiziranim istraživanjima.
Zaključak: AA + P i ENZ predstavljaju učinkovit oblik liječenja bolesnika s mCRPC. Oba lijeka produljuju preživljavanje, vrijeme do biokemijske i radiološke progresije pacijenata u ovoj fazi bolesti s prihvatljivim profilom toksičnosti za oba lijeka. |