Both studies were presented as the European Society for Medical Oncology (ESMO) 2021 Congress.
The PEACE-1 trial investigated the benefit of adding abiraterone acetate-prednisone (AAP) with or without local radiotherapy to standard of care androgen-deprivation therapy (ADT) plus or minus docetaxel in 1,173 men with de novo metastatic CSPC. The addition of docetaxel became the new standard of care after the start of the study.
The addition of AAP improved median overall survival (OS) both in the overall population (5.7 years vs. 4.7 years; hazard ratio: 0.82; P=0.030) and in the subpopulation receiving ADT with docetaxel (median OS not reached vs. 4.4 years; HR, 0.75; P=0.017), reported Dr. Karim Fizazi of Institut Gustave Roussy in Villejuif, France.
"This benefit translates to a median lifetime gain of more than 1.5 years for men with high-volume metastases," he noted.
Among men who developed castration-resistant disease in the ADT plus docetaxel standard-of-care control arm, 84% then received at least one life-prolonging therapy and 81% received a next-generation ASI. "This clearly suggests that early use of these agents is better than deferred use," Dr. Fizazi said.
Side effects were "as expected, with no apparent synergistic side effects from the addition of AAP-based therapy," he noted.
"These results will change the standard of care," Dr. Maria De Santis of Charite Universitaetsmedizin, in Berlin, said in a conference statement.
"In an earlier analysis of PEACE-1, the addition of AAP to ADT plus docetaxel significantly prolonged radiographic progression-free survival but here, an obvious improvement in OS has been demonstrated, which extends the advances recently made in metastatic CSPC," said Dr. De Santis.
"In patients with metastatic CSPC, we already knew that early treatment intensification improved survival significantly, but the question was if doublets or triplet therapy should be used. This has now been answered in the PEACE-1 study," she added.
Similarly promising results were also evident in the STAMPEDE trial of 1,174 men with non-metastatic CSPC, which tested AAP-based therapy, with or without enzalutamide, added to ADT compared with ADT alone.
"In what is clearly good news for patients," AAP plus ADT significantly improved the primary endpoint of metastasis-free survival (HR, 0.53; P<0.0001) and there is a six-year improvement in metastasis-free survival from 69% to 82%, reported Dr. Gerhardt Attard of the Institute of Cancer Research, in London, U.K.
AAP plus ADT also led to an improvement in OS (HR, 0.60; P<0.0001), with six-year OS improving from 77% to 86%, he noted. Adding enzalutamide to AAP increased toxicity but had no discernible effect on efficacy, Dr. Attard said.
Based on the findings, APP-based therapy "should be considered the new standard of care" in this patient group, he concluded.
"For patients with high-risk, locally advanced disease - the so-called M0 CSPC setting - we have been eagerly awaiting OS data for several years," Dr. De Santis said in the news release.
"Until now it was unclear if the major failure-free survival improvements would translate into an OS benefit. This is a completely new patient (sub)group that has not been included in other published trials. With the clinically relevant improvements in survival seen in STAMPEDE, I expect this kind of treatment intensification to be implemented as a standard of care," she added.
The PEACE-1 trial was funded by Janssen Pharmaceutical NV, Ipsen, Sanofi and PHRC. The STAMPEDE trial was funded by Cancer Research UK, Medical Research Council, Astellas and Janssen. Several authors reported financial relationships with Janssen and other pharmaceutical companies.
SOURCE: https://bit.ly/3nNaaXt ESMO 2021 Congress, presented September 19, 2021.
By Megan Brooks
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