The DOI matches its Crossref record; 35 of the 35 references it cites were found in a registry or an index.
Circulating Tumor Cell Biomarker Panel As an Individual-Level Surrogate for Survival in Metastatic Castration-Resistant Prostate Cancer
Open accessAbstract
Purpose: Trials in castration-resistant prostate cancer (CRPC) need new clinical end points that are valid surrogates for survival. We evaluated circulating tumor cell (CTC) enumeration as a surrogate outcome measure. Patients and Methods: Examining CTCs alone and in combination with other biomarkers as a surrogate for overall survival was a secondary objective of COU-AA-301, a multinational, randomized, double-blind phase III trial of abiraterone acetate plus prednisone versus prednisone alone in patients with metastatic CRPC previously treated with docetaxel. The biomarkers were measured at baseline and 4, 8, and 12 weeks, with 12 weeks being the primary measure of interest. The Prentice criteria were applied to test candidate biomarkers as surrogates for overall survival at the individual-patient level. Results: A biomarker panel using CTC count and lactate dehydrogenase (LDH) level was shown to satisfy the four Prentice criteria for individual-level surrogacy. Twelve-week surrogate biomarker data were available for 711 patients. The abiraterone acetate plus prednisone and prednisone-alone groups demonstrated a significant survival difference (P = .034); surrogate distribution at 12 weeks differed by treatment (P < .001); the discriminatory power of the surrogate to predict mortality was high (weighted c-index, 0.81); and adding the surrogate to the model eliminated the treatment effect on survival. Overall, 2-year survival of patients with CTCs < 5 (low risk) versus patients with CTCs ≥ 5 cells/7.5 mL of blood and LDH > 250 U/L (high risk) at 12 weeks was 46% and 2%, respectively. Conclusion: A biomarker panel containing CTC number and LDH level was shown to be a surrogate for survival at the individual-patient level in this trial of abiraterone acetate plus prednisone versus prednisone alone for patients with metastatic CRPC. Additional trials are ongoing to validate the findings.
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Cites
Proportional hazards tests and diagnostics based on weighted residuals
GRAMBSCH, P. M., & THERNEAU, T. M. (1994) · Biometrika · doi:10.1093/biomet/81.3.515 · Cited by 5,885
Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer
Kantoff, P. W., Higano, C. S., Shore, N. D., Berger, E. R., Small, E. J., Penson, D. F., Redfern, C. H., Ferrari, A. C., Dreicer, R., Sims, R. B., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1001294 · Cited by 5,572
Circulating Tumor Cells, Disease Progression, and Survival in Metastatic Breast Cancer
Cristofanilli, M., Budd, G. T., Ellis, M. J., Stopeck, A., Matera, J., Miller, M. C., Reuben, J. M., Doyle, G. V., Allard, W. J., Terstappen, L. W. M. M., et al. (2004) · New England Journal of Medicine · doi:10.1056/nejmoa040766 · Cited by 4,593
Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
Scher, H. I., Fizazi, K., Saad, F., Taplin, M.-E., Sternberg, C. N., Miller, K., de Wit, R., Mulders, P., Chi, K. N., Shore, N. D., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1207506 · Cited by 4,586
Self-citationAbiraterone and Increased Survival in Metastatic Prostate Cancer
de Bono, J. S., Logothetis, C. J., Molina, A., Fizazi, K., North, S., Chu, L., Chi, K. N., Jones, R. J., Goodman, O. B., Saad, F., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1014618 · Cited by 4,407 · cited 2×
“98), which mirrored the previously reported survival benefit shown in the overall intent-to-treat population.(2,3) This finding satisfied Prentice(25) criterion one and provided the framework for evaluating a surrogate end point for survival.”
MethodResultSelf-citationAlpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer
Parker, C., Nilsson, S., Heinrich, D., Helle, S. I., O'Sullivan, J. M., Fosså, S. D., Chodacki, A., Wiechno, P., Logue, J., Seke, M., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1213755 · Cited by 3,408
de Bono, J. S., Oudard, S., Ozguroglu, M., Hansen, S., Machiels, J.-P., Kocak, I., Gravis, G., Bodrogi, I., Mackenzie, M. J., Shen, L., et al. (2010) · The Lancet · doi:10.1016/s0140-6736(10)61389-x · Cited by 3,318
Self-citationAbiraterone in Metastatic Prostate Cancer without Previous Chemotherapy
Ryan, C. J., Smith, M. R., de Bono, J. S., Molina, A., Logothetis, C. J., de Souza, P., Fizazi, K., Mainwaring, P., Piulats, J. M., Ng, S., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1209096 · Cited by 2,796
Self-citationScher, H. I., Halabi, S., Tannock, I., Morris, M., Sternberg, C. N., Carducci, M. A., Eisenberger, M. A., Higano, C., Bubley, G. J., Dreicer, R., et al. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.12.4487 · Cited by 2,241
Self-citationde Bono, J. S., Scher, H. I., Montgomery, R. B., Parker, C., Miller, M. C., Tissing, H., Doyle, G. V., Terstappen, L. W. W. M., Pienta, K. J., & Raghavan, D. (2008) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-08-0872 · Cited by 2,182
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Cited by
DNA-Repair Defects and Olaparib in Metastatic Prostate Cancer
Mateo, J., Carreira, S., Sandhu, S., Miranda, S., Mossop, H., Perez-Lopez, R., Nava Rodrigues, D., Robinson, D., Omlin, A., Tunariu, N., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1506859 · Cited by 2,185
Self-citationClinical Applications of Circulating Tumor Cells and Circulating Tumor DNA as Liquid Biopsy
Alix-Panabières, C., & Pantel, K. (2016) · Cancer Discovery · doi:10.1158/2159-8290.cd-15-1483 · Cited by 1,394
Sartor, O., & de Bono, J. S. (2018) · New England Journal of Medicine · doi:10.1056/nejmra1701695 · Cited by 546
Ignatiadis, M., Lee, M., & Jeffrey, S. S. (2015) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-14-1190 · Cited by 355
Petrelli, F., Cabiddu, M., Coinu, A., Borgonovo, K., Ghilardi, M., Lonati, V., & Barni, S. (2015) · Acta Oncologica · doi:10.3109/0284186x.2015.1043026 · Cited by 323
Metadata
- Authors
- Scher, H. I., Heller, G., Molina, A., Attard, G., Danila, D. C., Jia, X., Peng, W., Sandhu, S. K., Olmos, D., Riisnaes, R., McCormack, R., Burzykowski, T., Kheoh, T., Fleisher, M., Buyse, M., & de Bono, J. S.
- Venue
- Journal of Clinical Oncology
- Published
- 2015-04-20
- Volume
- 33
- Issue
- 12
- Pages
- 1348-1355
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2129128353
- Cited by
- 379
- References
- 35
- FWCI
- 49.00
- Type
- journal article
- Language
- en
- Open access
- green
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- Scher, H. I., Heller, G., Molina, A., Attard, G., Danila, D. C., Jia, X., Peng, W., Sandhu, S. K., Olmos, D., Riisnaes, R., McCormack, R., Burzykowski, T., Kheoh, T., Fleisher, M., Buyse, M., & de Bono, J. S. (2015). Circulating Tumor Cell Biomarker Panel As an Individual-Level Surrogate for Survival in Metastatic Castration-Resistant Prostate Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2014.55.3487
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