Citations 2
Solitary plasmacytoma of bone (SPB): Randomized phase III trial to evaluate treatment with adjuvant systemic treatment and zoledronic acid (ZA) versus zoledronic acid after definitive radiation treatment (Alliance A061402)
Sborov, Douglas, Mahindra, Anuj, Suman, Vera J. , Manasanch, Elisabet, Kapoor, Prashant , Kovacsovics, Tibor, Rodriguez, Cesar, Parsons, Benjamin, Najera, Jose, Goldman, Lyle, Carlisle, Destin, Wen, Yujia, Dinner, Shira, Galinsky, Ilene, Kennedy, LeAnne , Omel, James, McCarthy, Philip, Usmani, Saad, Richardson, Paul G. , Suman, Vera , Sborov, Douglas W. , Manasanch, Elisabet E. , Rodriguez, Cesar, Parsons, Benjamin, Najera, Jose Eugenio, Galinsky, Ilene , Usmani, Saad Z. , Richardson, Paul Gerard Guy
No container title available | May 6, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available
Abstract Solitary plasmacytoma of bone (SPB) is a localized plasma cell neoplasm associated with a substantial risk of progression to multiple myeloma (MM), yet the role of adjuvant systemic therapy following definitive radiation therapy (RT) remains undefined. We conducted a randomized phase III trial (Alliance A061402) to evaluate whether the addition of systemic therapy with ixazomib, lenalidomide, and dexamethasone (IXA-LEN-DEX) to zoledronic acid (ZA) improves outcomes compared with ZA alone in patients with SPB and minimal (< 10%) bone marrow plasma cell involvement following RT. Patients were randomized to receive six 28-day cycles of IXA-LEN-DEX-ZA or ZA alone. The primary endpoint was time to progression (TTP) to MM. The study was closed early due to poor accrual after enrolling 11 patients (IXA-LEN-DEX-ZA, n = 5; ZA, n = 6). All patients completed RT and planned treatment without dose reductions. The combination regimen was well tolerated, with limited grade ≥ 3 toxicities, including hypophosphatemia and lymphopenia. At follow-up extending beyond 4 years, the 1- and 4-year progression rates to MM in the IXA-LEN-DEX-ZA arm were 0% and 33%, respectively, compared with 37.5% and 58.3% at 1 and 2 years in the ZA-alone arm. Although underpowered, these findings demonstrate the feasibility and tolerability of an all-oral adjuvant systemic regimen in SPB and provide prospective data supporting further investigation of systemic strategies to delay progression to MM.
PRESTO: A Phase III, Open-Label Study of Intensification of Androgen Blockade in Patients With High-Risk Biochemically Relapsed Castration-Sensitive Prostate Cancer (AFT-19)
Aggarwal, Rahul , Hillman, David W. , Xiao, Han , Picus, Joel , Taplin, Mary‐Ellen , Dorff, Tanya B. , Appleman, Leonard J. , Weckstein, Douglas, Patnaik, Akash , Bryce, Alan H. , Shevrin, Daniel H. , Mohler, James L. , Anderson, D. Mark , Tan, Alan , Halabi, Susan , Dooley, Katharine , O’Brien, Patrick, Ryan, Charles J. , Eggener, Scott E. , Dakhil, Shaker R. , Smith, Raymond E., Gartrell, Benjamin A. , Fagbemi, Seth O., Mowat, Rex B., Hashemi, Neda , Humeniuk, Michael, Ellerton, John , Olsen, Mark R., Wang, Jennifer , Pascual, Sheila, Randall, James M., Kilari, Deepak , Najera, Jose Eugenio, Rowland, Kendrith M. , Hauke, Ralph J. , Shehadeh, N. J., Curti, Brendan D. , Sheh, Bryant C., Basnet, Alina , Gross, Howard M., Hillman, David W , Xiao, Han , Picus, Joel , Dorff, Tanya , Appleman, Leonard , Patnaik, Akash , Bryce, Alan H , Shevrin, Daniel , Mohler, James , Rao, Arpit , Tagawa, Scott T , Halabi, Susan , Dooley, Katharine , O'Brien, Patrick, Chen, Ronald , Eggener, Scott , Morris, Michael J , Heller, Glenn , Anderson, Daniel, Tagawa, Scott T. , O'Brien, Patrick, Chen, Ronald C. , Morris, Michael J. , Kim, Charles , Whang, Young E. , Farber, Charles R. , King, David, Monk, Paul , Bitting, Rhonda L. , Gupta, Gopal N. , Collins, Timothy, Beer, Tomasz M. , Tate, David J. , Conway, James, Goodman, Michael Moses
Journal of Clinical Oncology | January 24, 2024 | Volume: 42 | Issue: 10 | Pages: 1114-1123
PURPOSE Patients with biochemically recurrent prostate cancer (BRPC) after radical prostatectomy and a short PSA doubling time are at risk for distant metastases. Apalutamide, an androgen receptor antagonist, and abiraterone acetate plus prednisone (AAP) prolong survival in the metastatic setting. We evaluated whether intensification of androgen-deprivation therapy (ADT) improves outcomes in BRPC. PATIENTS AND METHODS PRESTO is a randomized phase III, open-label trial in patients with BRPC and PSA doubling time ≤9 months (ClinicalTrials.gov identifier: NCT03009981 ). Patients were randomly assigned 1:1:1 to receive a finite 52-week treatment course with ADT control, ADT + apalutamide, or ADT + apalutamide + AAP. The primary end point was PSA progression-free survival (PSA-PFS), defined as serum PSA >0.2 ng/mL after treatment completion. RESULTS Five hundred three patients were enrolled. The median PSA was 1.8 ng/mL (IQR, 1.0-3.6). At the first planned interim analysis, both experimental arms significantly prolonged PSA-PFS compared with the control arm (median, 24.9 months for ADT + apalutamide v 20.3 months for ADT; hazard ratio [HR], 0.52 [95% CI, 0.35 to 0.77]; P = .00047; median, 26.0 months for ADT + apalutamide + AAP v 20.0 months for ADT; HR, 0.48 [95% CI, 0.32 to 0.71]; P = .00008). Median time to testosterone recovery did not differ across treatment arms. The most common grade ≥3 adverse event was hypertension (7.5%, 7.4%, and 18% in ADT, ADT + apalutamide, and ADT + apalutamide + AAP arms, respectively). CONCLUSION Intensified AR blockade for a finite duration prolongs PSA-PFS with a manageable safety profile, without adversely affecting time to testosterone recovery. The addition of apalutamide to ADT should be considered in patients with high-risk BRPC.