Table 3.

Clinical trial experience with mTOR inhibitors in lymphoma

Reference	Study	Evaluable Patients	ORR (CR + PR)
Relapsed/refractory MCL (and other lymphomas)
Everolimus [38]	Phase II, single-arm, monotherapy (10 mg/day PO)	MCL (n = 19) DLBCL (n = 47) Follicular grade 3 (n = 8) Other lymphomas (n = 3)	MCL 32% DLBCL 30% Follicular grade III 38% Other lymphomas 0%
Everolimus [39]	Phase I/II single-arm, monotherapy (5 or 10 mg/day PO)	MCL (n = 4) Other hematologic malignancies (n = 23)	MCL 0% Other 4%
Temsirolimus [40]	Phase II, single-arm, monotherapy (250 mg IV weekly)	MCL (N = 34)	38%
Temsirolimus [41]	Phase II, single-arm, monotherapy (25 mg IV weekly)	MCL (N = 27)	41%
Temsirolimus [42]	Phase III, monotherapy (175 mg IV weekly for 3 weeks, then 25 mg [n = 54] or 75 mg IV weekly [n = 54]) vs investigator-chosen chemotherapy (n = 54)	MCL (N = 162)	Temsirolimus 25 mg 6% Temsirolimus 75 mg 22% Investigator-chosen 2%
Ridaforolimus [43]	Phase II, single-arm, monotherapy (12.5 mg/day IV on days 1-5 every 2 weeks)	MCL (n = 9) Other hematologic malignancies (n = 43)	MCL 33% Others 5%
Waldenström macroglobulinemia
Everolimus [44]	Phase II, single-arm, monotherapy (10 mg/day)	WM (N = 50)	42% (PR)
Hodgkin lymphoma
Everolimus [45]	Phase II, single-arm, monotherapy (10 mg/day)	HL (N = 19)	HL 47%
GVHD
Sirolimus [46]	Retrospective chart review, sirolimus conditioning (12 mg loading dose days 1-3, then 4 mg daily) vs standard conditioning	GVHD prophylaxis after HSCT for lymphoma (N = 126)a	Overall survival: Sirolimus 66% Standard conditioning 38%

Abbreviations: CR - complete response, DLBCL - diffuse large B-cell lymphoma, GVHD - graft-versus-host disease, HL - Hodgkin's lymphoma, HSCT - hematopoietic stem cell transplant, IV - intravenously, MCL - mantle-cell lymphoma, ORR - overall response rate, PO - orally, PR - partial response, WM - Waldenström macroglobulinemia.

^aOverall survival reported as 3-year survival for patients receiving reduced intensity conditioning [46]