Modeling 1-year Relapse-free Survival After Neoadjuvant Chemotherapy and Radical Cystectomy in Patients with Clinical T2–4N0M0 Urothelial Bladder Carcinoma: Endpoints for Phase 2 Trials

European Urology Oncology

Volumn 2, Issue 3, 2019, Pages 248-256

  Bandini, Marco ^a   Briganti, Alberto ^a   Plimack, Elizabeth R ^b   Niegisch, Günter ^c   Yu, Evan Y ^d   Bamias, Aristotelis ^e   Agarwal, Neeraj ^f   Sridhar, Srikala S ^g   Sternberg, Cora N ^h   Vaishampayan, Ulka ⁱ   Théodore, Christine ^j   Rosenberg, Jonathan E ^k   Bellmunt, Joaquim ^l   Galsky, Matthew D ^m   Montorsi, Francesco ^a   Necchi, Andrea ⁿ  

^a VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

^b FOX CHASE CANCER CENTER   (United States)

^c HEINRICH HEINE UNIVERSITY   (Germany)

^d UNIVERSITY OF WASHINGTON   (United States)

^e UNIVERSITY OF ATHENS   (Greece)

^f UNIVERSITY OF UTAH   (United States)

^g PRINCESS MARGARET HOSPITAL   (Canada)

^h SAN CAMILLO FORLANINI HOSPITAL   (Italy)

ⁱ KARMANOS CANCER INSTITUTE   (United States)

^j FOCH HOSPITAL   (France)

^k MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^l HARVARD MEDICAL SCHOOL   (United States)

^m MOUNT SINAI SCHOOL OF MEDICINE   (United States)

ⁿ NATIONAL CANCER INSTITUTE   (Italy)

more..

Author keywords

Bladder cancer; Nomogram; Perioperative chemotherapy; Relapse free survival; Urothelial carcinoma

Indexed keywords

ADULT; AGED; ARTICLE; BENCHMARKING; CANCER ADJUVANT THERAPY; CANCER PROGNOSIS; CANCER STAGING; CONTROLLED STUDY; CYSTECTOMY; DISEASE ASSOCIATION; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MODEL; MUSCLE INVASIVE BLADDER CANCER; NEOADJUVANT CHEMOTHERAPY; OUTCOME ASSESSMENT; PERIOPERATIVE PERIOD; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RECURRENCE FREE SURVIVAL; SURGICAL MARGIN; ADJUVANT CHEMOTHERAPY; BIOASSAY; BLADDER TUMOR; CLINICAL TRIAL; DISEASE FREE SURVIVAL; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; NEOADJUVANT THERAPY; NOMOGRAM; PATHOLOGY; RISK FACTOR; TRANSITIONAL CELL CARCINOMA;

AGED; CARCINOMA, TRANSITIONAL CELL; CHEMOTHERAPY, ADJUVANT; CLINICAL TRIALS, PHASE II AS TOPIC; CYSTECTOMY; DISEASE-FREE SURVIVAL; ENDPOINT DETERMINATION; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOADJUVANT THERAPY; NOMOGRAMS; RISK FACTORS; URINARY BLADDER NEOPLASMS;

EID: 85057836303     PISSN: None     EISSN: 25889311     Source Type: Journal    
DOI: 10.1016/j.euo.2018.08.009     Document Type: Article

References (26)

1. Witjes, J.A., Lebret, T., Compérat, E.M., et al. Updated 2016 EAU guidelines on muscle-invasive and metastatic bladder cancer. Eur Urol 71 (2017), 462–475, 10.1016/j.eururo.2016.06.020.
2. International Collaboration of Trialists. International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial. J Clin Oncol 29 (2011), 2171–2177, 10.1200/JCO.2010.32.3139.
3. Zargar, H., Espiritu, P.N., Fairey, A.S., et al. Multicenter assessment of neoadjuvant chemotherapy for muscle-invasive bladder cancer. Eur Urol 67 (2015), 241–249, 10.1016/j.eururo.2014.09.007.
4. Funt, S.A., Rosenberg, J.E., Systemic, perioperative management of muscle-invasive bladder cancer and future horizons. Nat Rev Clin Oncol 14 (2017), 221–234, 10.1038/nrclinonc.2016.188.
5. Sternberg, C.N., Skoneczna, I., Kerst, J.M., et al. Immediate versus deferred chemotherapy after radical cystectomy in patients with pT3–pT4 or N+ M0 urothelial carcinoma of the bladder (EORTC 30994): an intergroup, open-label, randomised phase 3 trial. Lancet Oncol 16 (2015), 76–86, 10.1016/S1470-2045(14)71160-X.
6. Burger, M., Mulders, P., Witjes, W., Use of neoadjuvant chemotherapy for muscle-invasive bladder cancer is low among major European centres: results of a feasibility questionnaire. Eur Urol 61 (2012), 1070–1071, 10.1016/j.eururo.2012.01.039.
7. Meeks, J.J., Bellmunt, J., Bochner, B.H., et al. A systematic review of neoadjuvant and adjuvant chemotherapy for muscle-invasive bladder cancer. Eur Urol 62 (2012), 523–533, 10.1016/j.eururo.2012.05.048.
8. Reardon, Z.D., Patel, S.G., Zaid, H.B., et al. Trends in the use of perioperative chemotherapy for localized and locally advanced muscle-invasive bladder cancer: a sign of changing tides. Eur Urol 67 (2015), 165–170, 10.1016/j.eururo.2014.01.009.
9. Powles, T., Necchi, A., Rosen, G., Hariharan, S., Apolo, A.B., Anti-programmed cell death 1/ligand 1 (PD-1/PD-L1) antibodies for the treatment of urothelial carcinoma: state of the art and future development. Clin Genitourin Cancer 16 (2018), 117–129, 10.1016/j.clgc.2017.11.002.
10. Karakiewicz, P.I., Shariat, S.F., Palapattu, G.S., et al. Nomogram for predicting disease recurrence after radical cystectomy for transitional cell carcinoma of the bladder. J Urol 176 (2006), 1354–1361, 10.1016/j.juro.2006.06.025.
11. Xylinas, E., Cha, E.K., Sun, M., et al. Risk stratification of pT1–3N0 patients after radical cystectomy for adjuvant chemotherapy counselling. Br J Cancer 107 (2012), 1826–1832, 10.1038/bjc.2012.464.
12. International Bladder Cancer Nomogram Consortium, Bochner, B.H., Kattan, M.W., Vora, K.C., Postoperative nomogram predicting risk of recurrence after radical cystectomy for bladder cancer. J Clin Oncol 24 (2006), 3967–3972, 10.1200/JCO.2005.05.3884.
13. Gill, R., Understanding Cox's regression model. Experientia Suppl 41 (1982), 187–199.
14. Vickers, A.J., Elkin, E.B., Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making 26 (2006), 565–574, 10.1177/0272989X06295361.
15. Spiess, P.E., Agarwal, N., Bangs, R., et al. Bladder cancer, version 5.2017, NCCN clinical practice guidelines in oncology. J Natl Compr Cancer Netw 15 (2017), 1240–1267, 10.6004/jnccn.2017.0156.
16. Bellmunt, J., Albiol, S., Kataja, V., ESMO Guidelines Working Group. Invasive bladder cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 20:Suppl 4 (2009), 79–80, 10.1093/annonc/mdp136.
17. Necchi, A., Briganti, A., Bianchi, M., et al. Preoperative pembrolizumab (pembro) before radical cystectomy (RC) for muscle-invasive urothelial bladder carcinoma (MIUC): Interim clinical and biomarker findings from the phase II PURE-01 study. Cancer Res, 78(13 Suppl), 2018, CT003.
18. Rosenblatt, R., Sherif, A., Rintala, E., et al. Pathologic downstaging is a surrogate marker for efficacy and increased survival following neoadjuvant chemotherapy and radical cystectomy for muscle-invasive urothelial bladder cancer. Eur Urol 61 (2012), 1229–1238, 10.1016/j.eururo.2011.12.010.
19. Petrelli, F., Coinu, A., Cabiddu, M., Ghilardi, M., Vavassori, I., Barni, S., Correlation of pathologic complete response with survival after neoadjuvant chemotherapy in bladder cancer treated with cystectomy: a meta-analysis. Eur Urol 65 (2014), 350–357, 10.1016/j.eururo.2013.06.049.
20. Brant, A., Kates, M., Chappidi, M.R., et al. Pathologic response in patients receiving neoadjuvant chemotherapy for muscle-invasive bladder cancer: Is therapeutic effect owing to chemotherapy or TURBT?. Urol Oncol, 35, 2017, 10.1016/j.urolonc.2016.08.005 34.e17–25.
21. Kassouf, W., Spiess, P.E., Brown, G.A., et al. P0 stage at radical cystectomy for bladder cancer is associated with improved outcome independent of traditional clinical risk factors. Eur Urol 52 (2007), 769–774, 10.1016/j.eururo.2007.03.086.
22. Sonpavde, G., Goldman, B.H., Speights, V.O., et al. Quality of pathologic response and surgery correlate with survival for patients with completely resected bladder cancer after neoadjuvant chemotherapy. Cancer 115 (2009), 4104–4109, 10.1002/cncr.24466.
23. Liu, D., Abbosh, P., Keliher, D., et al. Mutational patterns in chemotherapy resistant muscle-invasive bladder cancer. Nat Commun, 8, 2017, 2193, 10.1038/s41467-017-02320-7.
24. Jones, S., Anagnostou, V., Lytle, K., et al. Personalized genomic analyses for cancer mutation discovery and interpretation. Sci Transl Med, 7, 2015, 283ra53, 10.1126/scitranslmed.aaa7161.
25. Bhindi, B., Frank, I., Mason, R.J., et al. Oncologic outcomes for patients with residual cancer at cystectomy following neoadjuvant chemotherapy: a pathologic stage-matched analysis. Eur Urol 72 (2017), 660–664, 10.1016/j.eururo.2017.05.016.
26. Zaffuto, E., Bandini, M., Gazdovich, S., et al. Contemporary rates of adherence to international guidelines for pelvic lymph node dissection in radical cystectomy: a population-based study. World J Urol 36 (2018), 1417–1422, 10.1007/s00345-018-2306-7.