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3. Long-Term Outcomes and Genetic Predictors of Response to Metastasis-Directed Therapy Versus Observation in Oligometastatic Prostate Cancer: Analysis of STOMP and ORIOLE Trials

Author

Deek, MP, Van der Eecken, K, Sutera, P, Deek, RA, Fonteyne, V, Mendes, AA, Decaestecker, K, Kiess, AP, Lumen, N, Phillips, R, De Bruycker, A, Mishra, M, Rana, Z, Molitoris, J, Lambert, B, Delrue, L, Wang, H, Lowe, K, Verbeke, S, Van Dorpe, J, Bultijnck, R, Villeirs, G, De Man, K, Ameye, F, Song, DY, DeWeese, T, Paller, CJ, Feng, FY, Wyatt, A, Pienta, KJ, Diehn, M, Bentzen, SM, Joniau, S, Vanhaverbeke, F, De Meerleer, G, Antonarakis, ES, Lotan, TL, Berlin, A, Siva, S, Ost, P, Tran, PT, Deek, MP, Van der Eecken, K, Sutera, P, Deek, RA, Fonteyne, V, Mendes, AA, Decaestecker, K, Kiess, AP, Lumen, N, Phillips, R, De Bruycker, A, Mishra, M, Rana, Z, Molitoris, J, Lambert, B, Delrue, L, Wang, H, Lowe, K, Verbeke, S, Van Dorpe, J, Bultijnck, R, Villeirs, G, De Man, K, Ameye, F, Song, DY, DeWeese, T, Paller, CJ, Feng, FY, Wyatt, A, Pienta, KJ, Diehn, M, Bentzen, SM, Joniau, S, Vanhaverbeke, F, De Meerleer, G, Antonarakis, ES, Lotan, TL, Berlin, A, Siva, S, Ost, P, and Tran, PT

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The initial STOMP and ORIOLE trial reports suggested that metastasis-directed therapy (MDT) in oligometastatic castration-sensitive prostate cancer (omCSPC) was associated with improved treatment outcomes. Here, we present long-term outcomes of MDT in omCSPC by pooling STOMP and ORIOLE and assess the ability of a high-risk mutational signature to risk stratify outcomes after MDT. The primary end point was progression-free survival (PFS) calculated using the Kaplan-Meier method. High-risk mutations were defined as pathogenic somatic mutations within ATM, BRCA1/2, Rb1, or TP53. The median follow-up for the whole group was 52.5 months. Median PFS was prolonged with MDT compared with observation (pooled hazard ratio [HR], 0.44; 95% CI, 0.29 to 0.66; P value < .001), with the largest benefit of MDT in patients with a high-risk mutation (HR high-risk, 0.05; HR no high-risk, 0.42; P value for interaction: .12). Within the MDT cohort, the PFS was 13.4 months in those without a high-risk mutation, compared with 7.5 months in those with a high-risk mutation (HR, 0.53; 95% CI, 0.25 to 1.11; P = .09). Long-term outcomes from the only two randomized trials in omCSPC suggest a sustained clinical benefit to MDT over observation. A high-risk mutational signature may help risk stratify treatment outcomes after MDT.

Published
2022

5. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma

Author

Epstein JI(1), Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA, Grading Committee.Al-Hussain T, Algaba F, Aron M, Berman D, Berney D, Brimo F, Cao D, Cheville J, Clouston D, Colecchia M, Comperat E, da Cunha IW, De Marzo A, Ertoy D, Fine S, Foster C, Grignon D, Gupta N, Gupta R, Kench J, Kristiansen G, Kunju L, Leite KR, Loda M, Lopez-Beltran A, Lotan T, Lucia M, Magi-Galluzzi C, Montironi R, McKenney J, Merrimen J, Netto G, Orozco R, Paner G, Parwani A, Pizov G, Reuter V, Ro J, Samaratunga H, Schultz L, Shanks J, Sesterhenn I, Shen S, Simko J, Suzigan S, Suryavanshi M, Tan PH, Takahashi H, Tomlins S, Trpkov K, Troncoso P, True L, Tsuzuki T, van der Kwast T, Varma M, Warren A, Wheeler T, Yang X, Zhou M, Kantoff P, Eisenberger M, Stadler W, Andriole G, Klein E, Benson M, Montorsi F, Crawford D, Loeb S, Catto J, Schaeffer E, Nacey JN, DeWeese T, Sandler H, Zietman A, Pollack A, Rodrigues G, Epstein, JI(1), Egevad, L, Amin, Mb, Delahunt, B, Srigley, Jr, Humphrey, Pa, Grading Committee., Al-Hussain T, Algaba, F, Aron, M, Berman, D, Berney, D, Brimo, F, Cao, D, Cheville, J, Clouston, D, Colecchia, M, Comperat, E, da Cunha, Iw, De Marzo, A, Ertoy, D, Fine, S, Foster, C, Grignon, D, Gupta, N, Gupta, R, Kench, J, Kristiansen, G, Kunju, L, Leite, Kr, Loda, M, Lopez-Beltran, A, Lotan, T, Lucia, M, Magi-Galluzzi, C, Montironi, R, Mckenney, J, Merrimen, J, Netto, G, Orozco, R, Paner, G, Parwani, A, Pizov, G, Reuter, V, Ro, J, Samaratunga, H, Schultz, L, Shanks, J, Sesterhenn, I, Shen, S, Simko, J, Suzigan, S, Suryavanshi, M, Tan, Ph, Takahashi, H, Tomlins, S, Trpkov, K, Troncoso, P, True, L, Tsuzuki, T, van der Kwast, T, Varma, M, Warren, A, Wheeler, T, Yang, X, Zhou, M, Kantoff, P, Eisenberger, M, Stadler, W, Andriole, G, Klein, E, Benson, M, Montorsi, F, Crawford, D, Loeb, S, Catto, J, Schaeffer, E, Nacey, Jn, Deweese, T, Sandler, H, Zietman, A, Pollack, A, and Rodrigues, G

Subjects
Gleason grading system, Pathology, medicine.medical_specialty, Neoplasm Grading, business.industry, Prostatectomy, medicine.medical_treatment, 030204 cardiovascular system & hematology, urologic and male genital diseases, medicine.disease, Gleason Score 6, Pathology and Forensic Medicine, PI-RADS, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, 030220 oncology & carcinogenesis, Medicine, Mucinous carcinoma, Surgery, Anatomy, business, Grading (education)
Abstract

In November, 2014, 65 prostate cancer pathology experts, along with 17 clinicians including urologists, radiation oncologists, and medical oncologists from 19 different countries gathered in a consensus conference to update the grading of prostate cancer, last revised in 2005. The major conclusions were: (1) Cribriform glands should be assigned a Gleason pattern 4, regardless of morphology; (2) Glomeruloid glands should be assigned a Gleason pattern 4, regardless of morphology; (3) Grading of mucinous carcinoma of the prostate should be based on its underlying growth pattern rather than grading them all as pattern 4; and (4) Intraductal carcinoma of the prostate without invasive carcinoma should not be assigned a Gleason grade and a comment as to its invariable association with aggressive prostate cancer should be made. Regarding morphologies of Gleason patterns, there was clear consensus on: (1) Gleason pattern 4 includes cribriform, fused, and poorly formed glands; (2) The term hypernephromatoid cancer should not be used; (3) For a diagnosis of Gleason pattern 4, it needs to be seen at 10x lens magnification; (4) Occasional/seemingly poorly formed or fused glands between well-formed glands is insufficient for a diagnosis of pattern 4; (5) In cases with borderline morphology between Gleason pattern 3 and pattern 4 and crush artifacts, the lower grade should be favored; (6) Branched glands are allowed in Gleason pattern 3; (7) Small solid cylinders represent Gleason pattern 5; (8) Solid medium to large nests with rosette-like spaces should be considered to represent Gleason pattern 5; and (9) Presence of unequivocal comedonecrosis, even if focal is indicative of Gleason pattern 5. It was recognized by both pathologists and clinicians that despite the above changes, there were deficiencies with the Gleason system. The Gleason grading system ranges from 2 to 10, yet 6 is the lowest score currently assigned. When patients are told that they have a Gleason score 6 out of 10, it implies that their prognosis is intermediate and contributes to their fear of having a more aggressive cancer. Also, in the literature and for therapeutic purposes, various scores have been incorrectly grouped together with the assumption that they have a similar prognosis. For example, many classification systems consider Gleason score 7 as a single score without distinguishing 3+4 versus 4+3, despite studies showing significantly worse prognosis for the latter. The basis for a new grading system was proposed in 2013 by one of the authors (J.I.E.) based on data from Johns Hopkins Hospital resulting in 5 prognostically distinct Grade Groups. This new system was validated in a multi-institutional study of over 20,000 radical prostatectomy specimens, over 16,000 needle biopsy specimens, and over 5,000 biopsies followed by radiation therapy. There was broad (90%) consensus for the adoption of this new prostate cancer Grading system in the 2014 consensus conference based on: (1) the new classification provided more accurate stratification of tumors than the current system; (2) the classification simplified the number of grading categories from Gleason scores 2 to 10, with even more permutations based on different pattern combinations, to Grade Groups 1 to 5; (3) the lowest grade is 1 not 6 as in Gleason, with the potential to reduce overtreatment of indolent cancer; and (4) the current modified Gleason grading, which forms the basis for the new grade groups, bears little resemblance to the original Gleason system. The new grades would, for the foreseeable future, be used in conjunction with the Gleason system [ie. Gleason score 3+3=6 (Grade Group 1)]. The new grading system and the terminology Grade Groups 1-5 have also been accepted by the World Health Organization for the 2016 edition of Pathology and Genetics: Tumours of the Urinary System and Male Genital Organs.

Published
2016
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7. OC-0505: Interim results of a randomized trial of observation versus SABR for oligometastatic prostate cancer

Author

Tran, P., primary, Radwan, N., additional, Phillips, R., additional, Ross, A., additional, Rowe, S., additional, Gorin, M., additional, Antonarakis, E., additional, DeVille, C., additional, Greco, S., additional, Denmeade, S., additional, Paller, C., additional, Song, D., additional, Diehn, M., additional, Wang, H., additional, Carducci, M., additional, Pienta, K., additional, Pomper, M., additional, DeWeese, T., additional, Dicker, A., additional, and Eisenberger, M., additional

Published
2018
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8. Targeting Twist1-Hoxa9 to sensitize prostate cancer to PARP inhibition

Author

Malek, R., primary, Gajula, R., additional, Williams, R., additional, Nghiem, B., additional, Simons, B., additional, Wang, H., additional, Taparra, K., additional, Barbhuiya, M., additional, Deweese, T., additional, Pienta, K., additional, Hurley, P., additional, Morrissey, C., additional, and Tran, P., additional

Published
2017
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13. Very-high-risk Localized Prostate Cancer - Outcomes Following Definitive Radiation

Author

Narang, A., primary, Robertson, S.P., additional, Ram, A.N., additional, He, P., additional, Sundi, D., additional, Griffith, E., additional, Singh, H., additional, DeWeese, T., additional, Honig, S., additional, McNutt, T.R., additional, Ross, A.E., additional, Bivalacqua, T.J., additional, Schaeffer, E.M., additional, Partin, A.W., additional, DeWeese, T.L., additional, Song, D., additional, and Tran, P.T., additional

Published
2014
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24. Tissue Biomarkers for Prostate Cancer Radiation Therapy

Author

T. Tran, P., primary, K. Hales, R., additional, Zeng, J., additional, Aziz, K., additional, Salih, T., additional, P. Gajula, R., additional, Chettiar, S., additional, Gandhi, N., additional, T. Wild, A., additional, Kumar, R., additional, M. Herman, J., additional, Y. Song, D., additional, and L. DeWeese, T., additional

Published
2012
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44. A randomized, placebo-controlled trial of celecoxib in men prior to receiving prostatectomy for clinically localized adenocarcinoma of the prostate: Evaluation of drug-specific biomarker modulation

Author

Carducci, M. A., primary, Walczak, J. R., additional, Heath, E., additional, Nelson, W. G., additional, DeMarzo, A. M., additional, Zahurak, M., additional, Dannenberg, A. J., additional, Parnes, H., additional, DeWeese, T. L., additional, and Partin, A. W., additional

Published
2007
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