A multicenter phase II trial (SAKK 36/06) of single-agent everolimus (RAD001) in patients with relapsed or refractory mantle cell lymphoma

Haematologica

Volumn 97, Issue 7, 2012, Pages 1085-1091

  Renner, Christoph ^a   Zinzani, Pier Luigi ^b   Gressin, Rémy ^c   Klingbiel, Dirk ^d   Dietrich, Pierre Yves ^e   Hitz, Felicitas ^f   Bargetzi, Mario ^g   Mingrone, Walter ^h   Martinelli, Giovanni ⁱ   Trojan, Andreas ^j   Bouabdallah, Krimo ^k   Lohri, Andreas ^l   Gyan, Emmanuel ^m   Biaggi, Christine ^d   Cogliatti, Sergio ^f   Bertoni, Francesco ⁿ   Ghielmini, Michele ⁿ   Brauchli, Peter ^d   Ketterer, Nicolas ^o  

^a UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^b UNIVERSITY OF BOLOGNA   (Italy)

^c GRENOBLE UNIVERSITY HOSPITAL   (France)

^d SWISS GROUP FOR CLINICAL CANCER RESEARCH SAKK   (Switzerland)

^e GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^f CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^g CANTONAL HOSPITAL AARAU   (Switzerland)

^h KANTONSSPITAL   (Switzerland)

ⁱ EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^j OnkoZentrum Zürich   (Switzerland)

^k University Hospital   (France)

^l Kantonsspital Liestal   (Switzerland)

^m UNIVERSITY HOSPITAL OF TOURS   (France)

ⁿ ONCOLOGY INSTITUTE OF SOUTHERN SWITZERLAND   (Switzerland)

^o LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

more..

Author keywords

Everolimus; Mantle cell lymphoma; RAD001; Refractory; Relapsed

Indexed keywords

EVEROLIMUS;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BIOPSY; CANCER REGRESSION; CANCER RELAPSE; CANCER STAGING; CHROMOSOME TRANSLOCATION; CLINICAL ARTICLE; COUGHING; DIARRHEA; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; FATIGUE; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; FOLLOW UP; HEARTBURN; HUMAN; HUMAN TISSUE; MALE; MANTLE CELL LYMPHOMA; MONOTHERAPY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PAIN; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; POLYMERASE CHAIN REACTION; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; PRURITUS; RASH; SIDE EFFECT; THROMBOCYTOPENIA; WEIGHT REDUCTION;

ADULT; AGED; AGED, 80 AND OVER; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LYMPHOMA, MANTLE-CELL; MALE; MIDDLE AGED; NEOPLASM PROTEINS; NEOPLASM STAGING; PROSPECTIVE STUDIES; PROTEIN KINASE INHIBITORS; RECURRENCE; REMISSION INDUCTION; SIROLIMUS; TOR SERINE-THREONINE KINASES;

EID: 84863971730     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2011.053173     Document Type: Article

References (41)

1. Raffeld M, Jaffe ES. bcl-1, t(11;14), and mantle cell-derived lymphomas. Blood. 1991;78(2):259-63.
2. Jares P, Colomer D, Campo E. Genetic and molecular pathogenesis of mantle cell lymphoma: perspectives for new targeted therapeutics. Nat Rev Cancer. 2007;7(10):750-62.
3. Perez-Galan P, Dreyling M, Wiestner A. Mantle cell lymphoma: biology, pathogenesis, and the molecular basis of treatment in the genomic era. Blood. 2011;117(1):26-38.
4. Tsujimoto Y, Jaffe E, Cossman J, Gorham J, Nowell PC, Croce CM. Clustering of breakpoints on chromosome 11 in human B-cell neoplasms with the t(11;14) chromosome translocation. Nature. 1985;315 (6017):340-3.
5. Meeker TC, Sellers W, Harvey R, Withers D, Carey K, Xiao H, et al. Cloning of the t(11;14)(q13;q32) translocation breakpoints from two human leukemia cell lines. Leukemia. 1991;5(9):733-7.
6. Herrmann A, Hoster E, Zwingers T, Brittinger G, Engelhard M, Meusers P, et al. Improvement of overall survival in advanced stage mantle cell lymphoma. J Clin Oncol. 2009;27(4):511-8.
7. Witzig TE. Current treatment approaches for mantle-cell lymphoma. J Clin Oncol. 2005;23(26):6409-14.
8. Ghielmini M, Zucca E. How I treat mantle cell lymphoma. Blood. 2009;114(8):1469-76.
9. Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, et al. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010;95 (8):1350-7.
10. Thieblemont C, Antal D, Lacotte-Thierry L, Delwail V, Espinouse D, Michallet AS, et al. Chemotherapy with rituximab followed by high-dose therapy and autologous stem cell transplantation in patients with mantle cell lymphoma. Cancer. 2005;104(7):1434-41.
11. Romaguera JE, Fayad L, Rodriguez MA, Broglio KR, Hagemeister FB, Pro B, et al. High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. J Clin Oncol. 2005;23(28):7013-23.
12. Geisler C, Kolstad A, Laurell A, Räty R, Nordic Lymphoma Group, Mantle Cell Lymphoma Subcommittee. Mantle cell lymphoma-does primary intensive immunochemotherapy improve overall survival for younger patients? Leuk Lymphoma. 2009;50(8):1249-56.
13. Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, et al. Longterm progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivopurged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008;112(7): 2687-93.
14. Ruan J, Leonard JP. Mantle cell lymphoma: current concept in biology and treatment. Cancer Treat Res. 2006;131:141-59.
15. Williams ME, Dreyling M, Winter J, Muneer S, Leonard JP. Management of mantle cell lymphoma: key challenges and next steps. Clin Lymphoma Myeloma Leuk. 2010;10(5):336-46.
16. Kouroukis CT, Belch A, Crump M, Eisenhauer E, Gascoyne RD, Meyer R, et al. Flavopiridol in untreated or relapsed mantle-cell lymphoma: results of a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2003;21(9):1740-5.
17. Samad N, Younes A. Temsirolimus in the treatment of relapsed or refractory mantle cell lymphoma. Onco Targets Ther. 2010;3:167-78.
18. Hipp S, Ringshausen I, Oelsner M, Bogner C, Peschel C, Decker T. Inhibition of the mammalian target of rapamycin and the induction of cell cycle arrest in mantle cell lymphoma cells. Haematologica. 2005;90 (10):1433-4.
19. Grewe M, Gansauge F, Schmid RM, Adler G, Seufferlein T. Regulation of cell growth and cyclin D1 expression by the constitutively active FRAP-p70s6K pathway in human pancreatic cancer cells. Cancer Res. 1999;59(15):3581-7.
20. Mita MM, Mita A, Rowinsky EK. The molecular target of rapamycin (mTOR) as a therapeutic target against cancer. Cancer Biol Ther. 2003;2(4 Suppl 1):S169-77.
21. Rudelius M, Pittaluga S, Nishizuka S, Pham TH, Fend F, Jaffe ES, et al. Constitutive activation of Akt contributes to the pathogenesis and survival of mantle cell lymphoma. Blood. 2006;108(5):1668-76.
22. Hess G, Herbrecht R, Romaguera J, Verhoef G, Crump M, Gisselbrecht C, et al. Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2009;27(23):3822-9.
23. Lane HA, Lebwohl D. Future directions in the treatment of hormone-sensitive advanced breast cancer: the RAD001 (Everolimus)-letrozole clinical program. Semin Oncol. 2006;33(2 Suppl 7):S18-25.
24. Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebocontrolled phase III trial. Lancet. 2008;372 (9637):449-56.
25. Witzig TE, Reeder CB, LaPlant BR, Gupta M, Johnston PB, Micallef IN, et al. A phase II trial of the oral mTOR inhibitor everolimus in relapsed aggressive lymphoma. Leukemia. 2011;25(2):341-7.
26. Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17(4): 1244.
27. Hitz F, Martinelli G, Zucca E, von Moos R, Mingrone W, Simcock M, et al. A multicentre phase II trial of gemcitabine for the treatment of patients with newly diagnosed, relapsed or chemotherapy resistant mantle cell lymphoma: SAKK 36/03. Hematol Oncol. 2009;27(3):154-9.
28. Bertoni F, Conconi A, Cogliatti SB, Schmitz SF, Ghielmini M, Cerny T, et al. Immunoglobulin heavy chain genes somatic hypermutations and chromosome 11q22-23 deletion in classic mantle cell lymphoma: a study of the Swiss Group for Clinical Cancer Research. Br J Haematol. 2004;124(3):289-98.
29. Cogliatti SB, Bertoni F, Zimmermann DR, Henz S, Diss TC, Ghielmini M, et al. IgV H mutations in blastoid mantle cell lymphoma characterize a subgroup with a tendency to more favourable clinical outcome. J Pathol. 2005;206(3):320-7.
30. Dudkin L, Dilling MB, Cheshire PJ, Harwood FC, Hollingshead M, Arbuck SG, et al. Biochemical correlates of mTOR inhibition by the rapamycin ester CCI-779 and tumor growth inhibition. Clin Cancer Res. 2001;7(6):1758-64.
31. Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, et al. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol. 2005;23(23):5347-56.
32. Ansell SM, Inwards DJ, Rowland KM, Jr., Flynn PJ, Morton RF, Moore DF, Jr., et al. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer. 2008;113(3):508-14.
33. Pott C, Hoster E, Delfau-Larue MH, Beldjord K, Bottcher S, Asnafi V, et al. Molecular remission is an independent predictor of clinical outcome in patients with mantle cell lymphoma after combined immunochemotherapy: a European MCL intergroup study. Blood. 2010;115(16): 3215-23.
34. Andersen NS, Pedersen LB, Laurell A, Elonen E, Kolstad A, Boesen AM, et al. Preemptive treatment with rituximab of molecular relapse after autologous stem cell transplantation in mantle cell lymphoma. J Clin Oncol. 2009;27(26):4365-70.
35. Ghielmini M, Schmitz SF, Burki K, Pichert G, Betticher DC, Stupp R, et al. The effect of Rituximab on patients with follicular and mantle-cell lymphoma. Swiss Group for Clinical Cancer Research (SAKK). Ann Oncol. 2000;11 (Suppl 1):123-6.
36. Czuczman MS, Grillo-Lopez AJ, McLaughlin P, White CA, Saleh M, Gordon L, et al. Clearing of cells bearing the bcl-2 [t(14;18)] translocation from blood and marrow of patients treated with rituximab alone or in combination with CHOP chemotherapy. Ann Oncol. 2001;12(1):109-14.
37. Pott C, Schrader C, Gesk S, Harder L, Tiemann M, Raff T, et al. Quantitative assessment of molecular remission after high-dose therapy with autologous stem cell transplantation predicts long-term remission in mantle cell lymphoma. Blood. 2006;107(6):2271-8.
38. Ansell SM, Tang H, Kurtin PJ, Koenig PA, Inwards DJ, Shah K, et al. Temsirolimus and rituximab in patients with relapsed or refractory mantle cell lymphoma: a phase 2 study. Lancet Oncol. 2011;12(4):361-8.
39. Goy A, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, et al. Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study. Ann Oncol. 2009;20(3):520-5.
40. Witzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, et al. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011;22(7):1622-7.
41. Furman RR, Byrd JC, Flinn IW, Coutre SE, Benson Jr. DM, Brown JR, et al. Interim results from a phase I study of CAL-101, a selective oral inhibitor of phosphatidylinositol 3-kinase p110d isoform, in patients with relapsed or refractory hematologic malignancies. J Clin Oncol. 2010;28:15s (suppl; abstr 3032).