Correction to Maintenance therapy with vinflunine plus best supportive care versus best supportive care alone in patients with advanced urothelial carcinoma with a response after first-line chemotherapy (MAJA; SOGUG 2011/02): a multicentre, randomised, controlled, open-label, phase 2 trial (The Lancet Oncology (2017) 18(5) (672–681a), (S1470204517302425)(10.1016/S1470-2045(17)30242-5));Maintenance therapy with vinflunine plus best supportive care versus best supportive care alone in patients with advanced urothelial carcinoma with a response after first-line chemotherapy (MAJA; SOGUG 2011/02): a multicentre, randomised, controlled, open-label, phase 2 trial

The Lancet Oncology

Volumn 18, Issue 5, 2017, Pages 672-681

  García Donas, Jesus ^a   Font, Albert ^b   Pérez Valderrama, Begoña ^c   Virizuela, José Antonio ^d   Climent, Miquel Ángel ^e   Hernando Polo, Susana ^f   Arranz, José Ángel ^g   del Mar Llorente, Maria ^h   Lainez, Nuria ⁱ   Villa Guzmán, José Carlos ^j   Mellado, Begoña ^k   del Alba, Aránzazu González ^l   Castellano, Daniel ^m   Gallardo, Enrique ⁿ   Anido, Urbano ^o   del Muro, Xavier García ^p   Domènech, Montserrat ^q   Puente, Javier ^r   Morales Barrera, Rafael ^s   Pérez Gracia, Jose Luis ^t   Bellmunt, Joaquim ^u   more..

^a Facultad HM Hospitales de Ciencias de la Salud de la UCJC   (Spain)

^b HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^c HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

^d HOSPITAL UNIVERSITARIO VIRGEN MACARENA   (Spain)

^e INSTITUTO VALENCIANO DE ONCOLOGÍA   (Spain)

^f HOSPITAL UNIVERSITARIO FUNDACIÓN ALCORCÓN   (Spain)

^g HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^h HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE   (Spain)

ⁱ Instituto de Investigación Sanitaria de Navarra   (Spain)

^j HOSPITAL GENERAL UNIVERSITARIO DE CIUDAD REAL   (Spain)

^k HOSPITAL CLÍNIC   (Spain)

^l HOSPITAL UNIVERSITARIO SON ESPASES   (Spain)

^m HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

ⁿ PARC TAULÍ HOSPITAL UNIVERSITARI   (Spain)

^o HOSPITAL CLÍNICO UNIVERSITARIO   (Spain)

^p UNIVERSITY OF BARCELONA   (Spain)

^q Althaia   (Spain)

^r HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^s VALL D HEBRON UNIVERSITY HOSPITAL   (Spain)

^t UNIVERSITY CLINIC OF NAVARRA   (Spain)

^u HOSPITAL DEL MAR   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; GEMCITABINE; VINFLUNINE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; VINBLASTINE;

ABDOMINAL PAIN; ACUTE GASTROENTERITIS; ACUTE PANCREATITIS; ADULT; AGED; ANOREXIA; ARTICLE; ASTHENIA; BACKACHE; BONE PAIN; BRAIN ISCHEMIA; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CONSTIPATION; CONTROLLED STUDY; CREATININE CLEARANCE; DIARRHEA; DISEASE CONTROL; DISEASE COURSE; DRUG EFFICACY; DRUG RESPONSE; DRUG WITHDRAWAL; DYSESTHESIA; DYSPNEA; EDEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; FOLLOW UP; GASTROINTESTINAL DISEASE; HEMATURIA; HERNIA INCARCERATION; HUMAN; INFECTION; INTESTINE OBSTRUCTION; ISCHEMIC COLITIS; LIVER METASTASIS; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; MYOSITIS; NAUSEA; NEUTROPENIA; ORAL MUCOSITIS; PARALYTIC ILEUS; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY FAILURE; SENSORY NEUROPATHY; SEPTIC SHOCK; SPAIN; THORAX PAIN; THROMBOCYTOPENIA; THRUSH; TRANSITIONAL CELL CARCINOMA; VERY ELDERLY; VOMITING; ADVERSE EFFECTS; ANALOGS AND DERIVATIVES; CARCINOMA, TRANSITIONAL CELL; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; INTENTION TO TREAT ANALYSIS; MAINTENANCE CHEMOTHERAPY; MIDDLE AGED; PATHOLOGY; SECONDARY; UROLOGIC NEOPLASMS;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ASTHENIA; CARBOPLATIN; CARCINOMA, TRANSITIONAL CELL; CISPLATIN; CONSTIPATION; DEOXYCYTIDINE; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; FATIGUE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INTENTION TO TREAT ANALYSIS; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; NEUTROPENIA; UROLOGIC NEOPLASMS; VINBLASTINE;

EID: 85017106999     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(18)30951-3     Document Type: Erratum

References (38)

1. 1 Siegel, RL, Miller, KD, Jemal, A, Cancer statistics, 2016. CA Cancer J Clin 66 (2016), 7–30.
2. 2 von der Maase, H, Sengelov, L, Roberts, JT, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol 23 (2005), 4602–4608.
3. 3 Roberts, JT, von der Maase, H, Sengelov, L, et al. Long-term survival results of a randomized trial comparing gemcitabine/cisplatin and methotrexate/vinblastine/doxorubicin/cisplatin in patients with locally advanced and metastatic bladder cancer. Ann Oncol 17:suppl 5 (2006), v118–v122.
4. 4 Bellmunt, J, von der Maase, H, Mead, GM, et al. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine and gemcitabine/cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy: EORTC Intergroup Study 30987. J Clin Oncol 30 (2012), 1107–1113.
5. 5 García, J, Santomé, L, Anido, U, et al. Metastatic bladder cancer: second-line treatment and recommendations of the Genitourinary Tumor Division of the Galician Oncologic Society (SOG-GU). Curr Oncol Rep, 18, 2016, 72.
6. 6 von der Maase, H, Hansen, SW, Roberts, JT, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 18 (2000), 3068–3077.
7. 7 Albers, P, Siener, R, Hartlein, M, et al. Gemcitabine monotherapy as second-line treatment in cisplatin-refractory transitional cell carcinoma—prognostic factors for response and improvement of quality of life. Onkologie 25 (2002), 47–52.
8. 8 Vaughn, DJ, Manola, J, Dreicer, R, See, W, Levitt, R, Wilding, G, Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896): a trial of the Eastern Cooperative Oncology Group. Cancer 95 (2002), 1022–1027.
9. 9 Bellmunt, J, Cos, J, Cleries, R, et al. Feasibility trial of methotrexate-paclitaxel as a second line therapy in advanced urothelial cancer. Cancer Invest 20 (2002), 673–685.
10. 10 Lin, CC, Hsu, CH, Huang, CY, Cheng, AL, Vogelzang, NJ, Pu, YS, Phase II trial of weekly paclitaxel, cisplatin plus infusional high dose 5-fluorouracil and leucovorin for metastatic urothelial carcinoma. J Urol 177 (2007), 84–89.
11. 11 Fechner, G, Siener, R, Reimann, M, Kobalz, L, Albers, P, Randomised phase II trial of gemcitabine and paclitaxel second-line chemotherapy in patients with transitional cell carcinoma (AUO Trial AB 20/99). Int J Clin Pract 60 (2006), 27–31.
12. 12 Sternberg, CN, Calabrò, F, Pizzocaro, G, Marini, L, Schnetzer, S, Sella, A, Chemotherapy with an every-2-week regimen of gemcitabine and paclitaxel in patients with transitional cell carcinoma who have received prior cisplatin-based therapy. Cancer 92 (2001), 2993–2998.
13. 13 Kruczynski, A, Hill, BT, Vinflunine, the latest vinca alkaloid in clinical development. A review of its preclinical anticancer properties. Crit Rev Oncol Hematol 40 (2001), 159–173.
14. 14 Braguer, D, Barret, JM, McDaid, H, Kruczynski, A, Antitumor activity of vinflunine: effector pathways and potential for synergies. Semin Oncol 35:suppl 3 (2008), S13–S21.
15. 15 Culine, S, Theodore, C, De Santis, M, et al. A phase II study of vinflunine in bladder cancer patients progressing after first-line platinum-containing regimen. Br J Cancer 94 (2006), 1395–1401.
16. 16 Vaughn, DJ, Srinivas, S, Stadler, WM, et al. Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma: results of a large phase 2 study. Cancer 115 (2009), 4110–4117.
17. 17 Bellmunt, J, Théodore, C, Demkov, T, et al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol 27 (2009), 4454–4461.
18. 18 Bellmunt, J, Fougeray, R, Rosenberg, JE, et al. Long-term survival results of a randomized phase III trial of vinflunine plus best supportive care versus best supportive care alone in advanced urothelial carcinoma patients after failure of platinum-based chemotherapy. Ann Oncol 24 (2013), 1466–1472.
19. 19 European Medicines Agency. Javlor vinflunine. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000983/WC500039606.pdf, 2012 (accessed Feb 5, 2017).
20. 20 Powles, T, Eder, JP, Fine, GD, et al. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature 515 (2014), 558–562.
21. 21 Bellmunt, J, De Wit, R, Vaughn, DJ, et al., for the KEYNOTE-045 investigators. Pembrolizumab as second-line therapy for advanced urothelial cancer. N Engl J Med 376 (2017), 1015–1026.
22. 22 Genentech. Safety data sheet: Tecentriq® vials (1,200 mg/20 ml). http://www.gene.com/download/pdf/TECENTRIQ(R)Vials1200mgper20mlSDS2.pdf, June 14, 2016 (accessed Feb 2, 2017).
23. 23 Rosenberg, JE, Hoffman-Censits, J, Powles, T, et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet 387 (2016), 1909–1920.
24. 24 Paz-Ares, LG, de Marinis, F, Dediu, M, et al. PARAMOUNT: final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol 31 (2013), 2895–2902.
25. 25 Bellmunt, J, Choueiri, TK, Fougeray, R, et al. Prognostic factors in patients with advanced transitional cell carcinoma of the urothelial tract experiencing treatment failure with platinum-containing regimens. J Clin Oncol 28 (2010), 1850–1855.
26. 26 Zhao, L, Wang, J, Li, H, Che, J, Cao, B, Meta-analysis comparing maintenance strategies with continuous therapy and complete chemotherapy-free interval strategies in the treatment of metastatic colorectal cancer. Oncotarget 7 (2016), 33418–33428.
27. 27 Kulkarni, S, Vella, ET, Coakley, N, et al. The use of systemic treatment in the maintenance of patients with non-small cell lung cancer: a systematic review. J Thorac Oncol 11 (2016), 989–1002.
28. 28 Ismaili, N, Amzerin, M, Flechon, A, Chemotherapy in advanced bladder cancer: current status and future. J Hematol Oncol, 4, 2011, 35.
29. 29 Hoffman-Censits, J, Wong, YN, Perioperative and maintenance therapy after first-line therapy as paradigms for drug discovery in urothelial carcinoma. Clin Genitourin Cancer 13 (2015), 302–308.
30. 30 Lehmann, J, Retz, M, Siemer, S, Schreier, U, Zwergel, U, Stockle, M, Long-term survival under maintenance gemcitabine chemotherapy for metastatic transitional cell carcinoma. Int J Urol 13 (2006), 1035–1036.
31. 31 Kalogirou, C, Svistunov, A, Krebs, M, et al. Maintenance monotherapy with gemcitabine following cisplatin-based primary combination chemotherapy in surgically treated advanced urothelial carcinoma: a matched-pair single institution analysis. Mol Clin Oncol 4 (2016), 636–642.
32. 32 Muto, S, Abe, H, Noguchi, T, et al. Maintenance monotherapy with gemcitabine after standard platinum-based chemotherapy in patients with advanced urothelial cancer. Int J Urol 22 (2015), 490–494.
33. 33 Mitsuzuka, K, Yamashita, S, Namiki, S, et al. Low-dose maintenance gemcitabine-carboplatin chemotherapy could be an alternative to continuous standard chemotherapy for patients with metastatic urothelial carcinoma. Int J Urol 21 (2014), 1114–1119.
34. 34 Pécuchet, N, Bigot, F, Gachet, J, et al. Triple combination of bevacizumab, gemcitabine and platinum salt in metastatic collecting duct carcinoma. Ann Oncol 24 (2013), 2963–2967.
35. 35 Grivas, PD, Daignault, S, Tagawa, ST, et al. Double-blind, randomized, phase 2 trial of maintenance sunitinib versus placebo after response to chemotherapy in patients with advanced urothelial carcinoma. Cancer 120 (2014), 692–701.
36. 36 Philips, GK, Halabi, S, Sanford, BL, Bajorin, D, Small, EJ, A phase II trial of cisplatin (C), gemcitabine (G) and gefitinib for advanced urothelial tract carcinoma: results of Cancer and Leukemia Group B (CALGB) 90102. Ann Oncol 20 (2009), 1074–1079.
37. 37 Powles, T, Huddart, RA, Elliott, T, et al. Phase III, double-blind, randomized trial that compared maintenance lapatinib versus placebo after first-line chemotherapy in patients with human epidermal growth factor receptor 1/2-positive metastatic bladder cancer. J Clin Oncol 35 (2017), 48–55.
38. 38 Castellano, D, Puente, J, de Velasco, G, et al. Safety and effectiveness of vinflunine in patients with metastatic transitional cell carcinoma of the urothelial tract after failure of one platinum-based systemic therapy in clinical practice. BMC Cancer, 14, 2014, 779.