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      Stereotactic body radiation therapy to postpone systemic therapy escalation for castration-resistant prostate cancer: A multicenter retrospective analysis

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          Highlights

          • •

            Systemic therapies are the standard treatment for metastatic castration resistant prostate cancer.

          • •

            Systemic therapies are associated with numerous side effects.

          • •

            For oligoprogressive disease, stereotactic radiation therapy could postpone systemic treatment.

          • •

            Stereotactic Radiation Therapy is a promising approach with acceptable toxicity.

          Abstract

          Purpose

          To evaluate the oncological outcome after stereotactic body radiation therapy (SBRT) for oligoprogressive metastatic castration-resistant prostate cancer (omCRPC) patients.

          Materials-Methods

          In this retrospective, observational, multi-institutional study, omCRPC patients (≤5 metastases) underwent SBRT. Primary endpoint was systemic therapy escalation-free survival (STE-FS) after SBRT. Local relapse (LR), distant (DP) and isolated biochemical (iBP) progressions were reported with progression-free survival (PFS) and overall survival (OS). Prognostic factors for STE-FS were investigated. Toxicity was reported.

          Results

          From 01/07 to 09/19, 50 pts with omCRPC underwent SBRT. With a MFU of 23 months [3–––100], median STE-FS was 13.1 months (95 %CI 10.8 – 36.4). Median OS was not reached and PFS was 13 months (CI95% 10.1 – 20.8). Post-SBRT PSA remained stable or decreased in 19 pts (38 %). Progression events (LR, DP, iBP) were observed in 34 pts (68 %), among whom 6 relapsed in the irradiated area (local control rate: 88 %). DP and iBP were observed in 28 pts (56 %) and 4 pts (8 %) respectively. In multivariate analysis, post-SBRT biochemical response was an independent prognostic factor for STE-FS. Grade ≥ 3 toxicity occurred in 2 pts.

          Conclusion

          With excellent local control and tolerance, SBRT for omCRPC patients represents an acceptable approach to defer systemic therapeutic escalation and prevent its side effects. Accurate patient selection for SBRT requires more data with longer follow-up and higher numbers of patients pending the results of upcoming randomized trials.

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          Most cited references24

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          Increased survival with enzalutamide in prostate cancer after chemotherapy.

          Howard I Scher, Karim Fizazi, Fred Saad … (2012)
          Enzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor-signaling pathway, the major driver of prostate-cancer growth. We aimed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy. In our phase 3, double-blind, placebo-controlled trial, we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity. We randomly assigned them, in a 2:1 ratio, to receive oral enzalutamide at a dose of 160 mg per day (800 patients) or placebo (399 patients). The primary end point was overall survival. The study was stopped after a planned interim analysis at the time of 520 deaths. The median overall survival was 18.4 months (95% confidence interval [CI], 17.3 to not yet reached) in the enzalutamide group versus 13.6 months (95% CI, 11.3 to 15.8) in the placebo group (hazard ratio for death in the enzalutamide group, 0.63; 95% CI, 0.53 to 0.75; P<0.001). The superiority of enzalutamide over placebo was shown with respect to all secondary end points: the proportion of patients with a reduction in the prostate-specific antigen (PSA) level by 50% or more (54% vs. 2%, P<0.001), the soft-tissue response rate (29% vs. 4%, P<0.001), the quality-of-life response rate (43% vs. 18%, P<0.001), the time to PSA progression (8.3 vs. 3.0 months; hazard ratio, 0.25; P<0.001), radiographic progression-free survival (8.3 vs. 2.9 months; hazard ratio, 0.40; P<0.001), and the time to the first skeletal-related event (16.7 vs. 13.3 months; hazard ratio, 0.69; P<0.001). Rates of fatigue, diarrhea, and hot flashes were higher in the enzalutamide group. Seizures were reported in five patients (0.6%) receiving enzalutamide. Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy. (Funded by Medivation and Astellas Pharma Global Development; AFFIRM ClinicalTrials.gov number, NCT00974311.).
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            Enzalutamide in Metastatic Prostate Cancer before Chemotherapy

            Tomasz M. Beer, Andrew J Armstrong, Dana E Rathkopf … (2014)
            Enzalutamide is an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer in whom the disease has progressed after chemotherapy. New treatment options are needed for patients with metastatic prostate cancer who have not received chemotherapy, in whom the disease has progressed despite androgen-deprivation therapy. In this double-blind, phase 3 study, we randomly assigned 1717 patients to receive either enzalutamide (at a dose of 160 mg) or placebo once daily. The coprimary end points were radiographic progression-free survival and overall survival. The study was stopped after a planned interim analysis, conducted when 540 deaths had been reported, showed a benefit of the active treatment. The rate of radiographic progression-free survival at 12 months was 65% among patients treated with enzalutamide, as compared with 14% among patients receiving placebo (81% risk reduction; hazard ratio in the enzalutamide group, 0.19; 95% confidence interval [CI], 0.15 to 0.23; P<0.001). A total of 626 patients (72%) in the enzalutamide group, as compared with 532 patients (63%) in the placebo group, were alive at the data-cutoff date (29% reduction in the risk of death; hazard ratio, 0.71; 95% CI, 0.60 to 0.84; P<0.001). The benefit of enzalutamide was shown with respect to all secondary end points, including the time until the initiation of cytotoxic chemotherapy (hazard ratio, 0.35), the time until the first skeletal-related event (hazard ratio, 0.72), a complete or partial soft-tissue response (59% vs. 5%), the time until prostate-specific antigen (PSA) progression (hazard ratio, 0.17), and a rate of decline of at least 50% in PSA (78% vs. 3%) (P<0.001 for all comparisons). Fatigue and hypertension were the most common clinically relevant adverse events associated with enzalutamide treatment. Enzalutamide significantly decreased the risk of radiographic progression and death and delayed the initiation of chemotherapy in men with metastatic prostate cancer. (Funded by Medivation and Astellas Pharma; PREVAIL ClinicalTrials.gov number, NCT01212991.).
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              Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer

              Ian Tannock, Ronald de Wit, William R Berry … (2004)
              Mitoxantrone plus prednisone reduces pain and improves the quality of life in men with advanced, hormone-refractory prostate cancer, but it does not improve survival. We compared such treatment with docetaxel plus prednisone in men with this disease. From March 2000 through June 2002, 1006 men with metastatic hormone-refractory prostate cancer received 5 mg of prednisone twice daily and were randomly assigned to receive 12 mg of mitoxantrone per square meter of body-surface area every three weeks, 75 mg of docetaxel per square meter every three weeks, or 30 mg of docetaxel per square meter weekly for five of every six weeks. The primary end point was overall survival. Secondary end points were pain, prostate-specific antigen (PSA) levels, and the quality of life. All statistical comparisons were against mitoxantrone. As compared with the men in the mitoxantrone group, men in the group given docetaxel every three weeks had a hazard ratio for death of 0.76 (95 percent confidence interval, 0.62 to 0.94; P=0.009 by the stratified log-rank test) and those given weekly docetaxel had a hazard ratio for death of 0.91 (95 percent confidence interval, 0.75 to 1.11; P=0.36). The median survival was 16.5 months in the mitoxantrone group, 18.9 months in the group given docetaxel every 3 weeks, and 17.4 months in the group given weekly docetaxel. Among these three groups, 32 percent, 45 percent, and 48 percent of men, respectively, had at least a 50 percent decrease in the serum PSA level (P<0.001 for both comparisons with mitoxantrone); 22 percent, 35 percent (P=0.01), and 31 percent (P=0.08) had predefined reductions in pain; and 13 percent, 22 percent (P=0.009), and 23 percent (P=0.005) had improvements in the quality of life. Adverse events were also more common in the groups that received docetaxel. When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plus prednisone. Copyright 2004 Massachusetts Medical Society.
              Article 0 comments Cited 439 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                J.M. Hannoun-Levi
                Journal
                Journal ID (nlm-ta): Clin Transl Radiat Oncol
                Journal ID (iso-abbrev): Clin Transl Radiat Oncol
                Title: Clinical and Translational Radiation Oncology
                Publisher: Elsevier
                ISSN (Electronic): 2405-6308
                Publication date PMC-release: 08 December 2023
                Publication date Collection: March 2024
                Publication date (Electronic): 08 December 2023
                Volume: 45
                Electronic Location Identifier: 100710
                Affiliations
                [a ]Department of Radiotherapy, Centre Antoine Lacassagne, University Cote d'Azur, Nice, France
                [b ]Department of Radiotherapy Centre Oscar Lambret, Lille, France
                [c ]Biostatistic Unit Antoine Lacassagne Cancer Center, University of Cote d’Azur, Nice, France
                [d ]Department of Radiotherapy Centre Hospitalier Princesse Grace, Monaco
                Author notes
                Article
                Publisher Item ID: S2405-6308(23)00135-0 Publisher ID: 100710
                DOI: 10.1016/j.ctro.2023.100710
                PMC ID: 10764986
                PubMed ID: 38179575
                SO-VID: e2e04b79-3d65-46d7-9063-a746e08785f8
                Copyright © © 2023 The Author(s)
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 5 October 2023
                Date revision received : 4 December 2023
                Date accepted : 5 December 2023
                Categories
                Subject: Original Research Article

                Keywords: oligometastatic prostate cancer,stereotactic body radiation therapy,systemic therapy,castration-resistant
                Data availability:
                Keywords: oligometastatic prostate cancer, stereotactic body radiation therapy, systemic therapy, castration-resistant

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