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2014 ; 25
(9
): 1794-1799
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
A phase I/II study of lenalidomide in combination with sunitinib in patients with
advanced or metastatic renal cell carcinoma
#MMPMID24914044
Rini B
; Redman B
; Garcia JA
; Burris HA 3rd
; Li S
; Fandi A
; Beck R
; Jungnelius U
; Infante JR
Ann Oncol
2014[Sep]; 25
(9
): 1794-1799
PMID24914044
show ga
BACKGROUND: This phase I/II study was conducted to determine the maximum
tolerated dose (MTD), safety, and efficacy of lenalidomide plus sunitinib in
metastatic renal cell carcinoma (RCC) patients. PATIENTS AND METHODS: Patients
with histologically confirmed, metastatic RCC were treated with 10 mg/day
lenalidomide plus 37.5 mg/day sunitinib, orally in 21-day cycles. Doses were
escalated to determine the MTD in phase I, with additional patients planned at
this dose in phase II. Primary end points were MTD and response rate. RESULTS:
Sixteen patients received a median of 2, 3, and 5 cycles in cohort 1
[lenalidomide 10 mg (days 1-21) and sunitinib 37.5 mg (days 1-21)], cohort 2
[lenalidomide 10 mg (days 1-21) and sunitinib 37.5 mg (days 1-14)], and cohort 3
[lenalidomide 15 mg (days 1-21) and sunitinib 37.5 mg (days 1-14)], respectively.
Median treatment durations were 41, 63, and 97 days for lenalidomide; and 41, 57,
and 97.5 days for sunitinib. The MTD was found to be continuous dosing of
lenalidomide 10 mg/day plus sunitinib 37.5 mg/day for 14 of 21 days.
Dose-limiting toxicities included neutropenia, leukopenia, thrombocytopenia,
asthenia, atrial fibrillation, and increased transaminases. The most frequent
grade 3-4 treatment-emergent adverse events were hematologic, including
neutropenia and leukopenia. One patient achieved partial response, and seven had
stable disease of which three were confirmed at subsequent tumor assessments. B
cells and several T-cell subsets were modulated versus baseline. CONCLUSION: The
dose schedules of lenalidomide and sunitinib evaluated in this study were not
well tolerated; cumulative toxicity precluded enrollment at the MTD.
|Adult
[MESH]
|Aged
[MESH]
|Angiogenesis Inhibitors/adverse effects/*therapeutic use
[MESH]
|Antineoplastic Agents/adverse effects/therapeutic use
[MESH]
|Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
[MESH]
|Carcinoma, Renal Cell/*drug therapy
[MESH]
|Drug Administration Schedule
[MESH]
|Female
[MESH]
|Humans
[MESH]
|Indoles/adverse effects/*therapeutic use
[MESH]
|Kidney Neoplasms/*drug therapy
[MESH]
|Lenalidomide
[MESH]
|Male
[MESH]
|Maximum Tolerated Dose
[MESH]
|Middle Aged
[MESH]
|Pyrroles/adverse effects/*therapeutic use
[MESH]
|Sunitinib
[MESH]
|Thalidomide/adverse effects/*analogs & derivatives/therapeutic use
[MESH]