RECORD-2: Phase II randomized study of everolimus and bevacizumab versus interferon α-2a and bevacizumab as first-line therapy in patients with metastatic renal cell carcinoma

Annals of Oncology

Volumn 26, Issue 7, 2015, Pages 1378-1384

  Ravaud, Alain ^a   Barrios, C H ^b   Alekseev, B ^c   Tay, M H ^d   Agarwala, S S ^e   Yalcin, S ^f   Lin, C C ^g   Roman, L ^h   Shkolnik, M ⁱ   Anak, O ^j   Gogov, S ^j   Pelov, D ^j   Louveau, A L ^k   Melichar, B ^l  

^a HÔPITAL SAINT ANDRÉ   (France)

^b PONTIFICAL CATHOLIC UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

^c P A Herzen Research Oncological Institute   (Russian Federation)

^d Oncocare Cancer Centre   (Singapore)

^e Health Network   (United States)

^f HACETTEPE UNIVERSITY   (Turkey)

^g NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^h Leningrad Regional Oncology Center   (United States)

ⁱ Russian Center for Research in Radiological and Surgical Technologies   (Russian Federation)

^j NOVARTIS PHARMA AG   (Switzerland)

^k Novartis Oncology   (France)

^l PALACKÝ UNIVERSITY   (Czech Republic)

more..

Author keywords

Bevacizumab; Combination targeted therapy; Everolimus; First line; Metastatic renal cell carcinoma

Indexed keywords

ALPHA2A INTERFERON; BEVACIZUMAB; EVEROLIMUS; ALPHA INTERFERON; ANTINEOPLASTIC AGENT; IFNA2 PROTEIN, HUMAN;

ADULT; AGED; ANEMIA; ARTHRALGIA; ARTICLE; ASTHENIA; BODY WEIGHT DISORDER; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIARRHEA; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG WITHDRAWAL; EPISTAXIS; FATIGUE; FEMALE; FEVER; FOLLOW UP; HEADACHE; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; KIDNEY METASTASIS; MAJOR CLINICAL STUDY; MALE; NAUSEA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PREDICTIVE VALUE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; RASH; STOMATITIS; SURVIVAL RATE; SURVIVAL TIME; CANCER STAGING; CARCINOMA, PAPILLARY; CARCINOMA, RENAL CELL; CLINICAL TRIAL; COMPARATIVE STUDY; KIDNEY NEOPLASMS; METASTASIS; MIDDLE AGED; MORTALITY; PATHOLOGY; PROGNOSIS; SECONDARY; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BEVACIZUMAB; CARCINOMA, PAPILLARY; CARCINOMA, RENAL CELL; EVEROLIMUS; FEMALE; FOLLOW-UP STUDIES; HUMANS; INTERFERON-ALPHA; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM STAGING; PROGNOSIS; SURVIVAL RATE; YOUNG ADULT;

EID: 84937900491     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdv170     Document Type: Article

References (18)

1. Escudier B, Pluzanska A, Koralewski P et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007; 370: 2103-2111.
2. Rini BI, Halabi S, Rosenberg JE et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma:CALGB 90206. J Clin Oncol 2008; 26: 5422-5428.
3. Casanovas O, Hicklin DJ, Bergers G, Hanahan D. Drug resistance by evasion of antiangiogenic targeting of VEGF signaling in late-stage pancreatic islet tumors. Cancer Cell 2005; 8: 299-309.
4. Thomas GV, Tran C, Mellinghoff IK et al. Hypoxia-inducible factor determines sensitivity to inhibitors of mTOR in kidney cancer. Nat Med 2006; 12: 122-127.
5. Hainsworth JD, Spigel DR, Burris HA, III et al. Phase II trial of bevacizumab and everolimus in patients with advanced renal cell carcinoma. J Clin Oncol 2010; 28:2131-2136.
6. Padhani AR, Ollivier L. The RECIST (Response Evaluation Criteria in Solid Tumors) criteria: implications for diagnostic radiologists. Br J Radiol 2001; 74:983-986.
7. Hong S, Shi L. Predictive power to assist phase 3 go/no go decision based on phase 2 data on a different endpoint. Stat Med 2012; 31: 831-843.
8. Rini BI, Bellmunt J, Clancy J et al. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol 2013; 32: 752-759.
9. Harshman LC, Barbeau S, McMillian A, Srinivas S. A phase II study of bevacizumab and everolimus as treatment for refractory metastatic renal cell carcinoma. Clin Genitourin Cancer 2013; 11: 100-106.
10. McDermott D, Manola J, Keith MP et al. The BEST trial (E2804): a randomized phase II study of VEGF, RAF kinase, and mTOR combination targeted therapy (CTT) with bevacizumab (bev), sorafenib (sor), and temsirolimus (tem) in advanced renal cell carcinoma (RCC). J Clin Oncol 2014; 31(suppl):abstr 345.
11. Motzer RJ, Barrios CH, Kim TM et al. Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and second-line everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol 2014; 32: 2765-2772.
12. Motzer RJ, Escudier B, Oudard S et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010; 116: 4256-4265.
13. Pavel ME, Hainsworth JD, Baudin E et al. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT 2): a randomised, placebo-controlled, phase 3 study. Lancet 2011; 378: 2005-2012.
14. Baselga J, Campone M, Piccart M et al. Everolimus in postmenopausal hormone receptor-positive advanced breast cancer. N Engl J Med 2012; 366:520-529.
15. Grunwald V, Karakiewics PI, Bavbek SE et al. An international expanded-access programme of everolimus: addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy. Eur J Cancer 2012; 48:324-332.
16. White DA, Camus P, Endo M et al. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med 2010; 182:396-403.
17. Motzer RJ, Hutson TE, Tomczak P et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007; 356: 115-124.
18. Sternberg CN, Davis ID, Mardiak J et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010; 28: 1061-1068.