A Multicenter Randomized Phase II Study of Single Agent Efficacy and Optimal Combination Sequence of Everolimus and Pasireotide LAR in Advanced Thyroid Cancer.

Bauman JE, Chen Z, Zhang C, Ohr JP, Ferris RL, McGorisk GM, Brandt S, Srivatsa S, Chen AY, Steuer CE, Shin DM, Saba NF, Khuri FR, Owonikoko TK

Cancers26 May 2022Cited by 5 (Europe PMC)

PMID35681620PMCIDPMC9179856DOI10.3390/cancers14112639PepBankPUB-35681620

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Summary

PurposeAberrant mTOR pathway and somatostatin receptor signaling are implicated in thyroid cancer and offer potential therapeutic targets. We assessed the clinical efficacy of everolimus and Pasireotide long-acting release (LAR) in radioiodine-refractory differentiated thyroid cancer (DTC) and medullary thyroid cancer (MTC).Patients and methodsAdults with progressive MTC and DTC untreated or treated with no more than one systemic agent were eligible. The trial was designed to establish the most promising regimen and the optimal combination sequence. Patients were randomized to start treatment with single agent everolimus (10 mg QD; Arm A), pasireotide-LAR (60 mg intramuscular injection, Q4 weeks; Arm B), or the combination (Arm C). At initial progression (PFS1), patients on Arm A or B switched to the combination and continued until progression (PFS2). Efficacy was measured by RECIST criteria.ResultsStudy enrolled 42 patients: median age 65 years; female 17 (40.5%); White 31 (73.8%), African American 6 (14.3%), others 5 (11.9); DTC 32 (76.2%); MTC 10 (23.8%). There was no objective response by RECIST criteria across the three arms. Median and 1-year PFS1 rates were 8.3, 1.8, 8.1 months and 49.9%, 36.4%, 25.0% for Arms A, B, C, respectively. Median and 1-year PFS2 rates were 26.3, 17.5, 8.1 months and 78.4%, 70.0%, 25% for Arms A, B, C, respectively. The most frequent adverse events were anemia, stomatitis, fatigue, hyperglycemia, and hypercholesterolemia.ConclusionsThe combination of everolimus and pasireotide-LAR showed promising efficacy over single agent. The delayed combination of everolimus and pasireotide-LAR following progression on single agent everolimus appeared intriguing as a combination strategy.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

01HumanNon-randomized trialEfficacy outcome
In adults with advanced thyroid cancer, no objective RECIST response occurred in the initial pasireotide-LAR monotherapy arm.
In plain wordsIn adults with advanced thyroid cancer, initial pasireotide-LAR monotherapy produced no objective tumor response.
Peptide
Pasireotide
Outcome
Not applicableObjective response
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
60 mg Q4 weeks · intramuscularAs given in this study (human).
Source sentences
Summary
There was no objective response by RECIST criteria across the three arms.
2 context sentences(design, population, supporting numbers)
Summary · context
Adults with progressive MTC and DTC untreated or treated with no more than one systemic agent were eligible.
Summary · context
Patients were randomized to start treatment with single agent everolimus (10 mg QD; Arm A), pasireotide-LAR (60 mg intramuscular injection, Q4 weeks; Arm B), or the combination (Arm C).
Show in the study text Report a problemFND-3568162001
02HumanNon-randomized trialEfficacy outcome
In adults with advanced thyroid cancer, median initial progression-free survival in the pasireotide-LAR monotherapy arm was 1.8 months.
In plain wordsIn adults with advanced thyroid cancer, median initial progression-free survival with pasireotide-LAR monotherapy was 1.8 months.
Peptide
Pasireotide
Outcome
Not applicableMedian initial progression-free survival
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
60 mg Q4 weeks · intramuscularAs given in this study (human).
Measurements
Median PFS1
1.8 months
Arm B, pasireotide-LAR 60 mg Q4 weeks
Source sentences
Summary
Median and 1-year PFS1 rates were 8.3, 1.8, 8.1 months and 49.9%, 36.4%, 25.0% for Arms A, B, C, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Adults with progressive MTC and DTC untreated or treated with no more than one systemic agent were eligible.
Summary · context
Patients were randomized to start treatment with single agent everolimus (10 mg QD; Arm A), pasireotide-LAR (60 mg intramuscular injection, Q4 weeks; Arm B), or the combination (Arm C).
Show in the study text Report a problemFND-3568162002
03HumanNon-randomized trialEfficacy outcome
In adults with advanced thyroid cancer, the one-year initial progression-free survival rate in the pasireotide-LAR monotherapy arm was 36.4%.
In plain wordsIn adults with advanced thyroid cancer, initial progression-free survival at one year with pasireotide-LAR monotherapy was 36.4%.
Peptide
Pasireotide
Outcome
Not applicableOne-year initial progression-free survival
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
60 mg Q4 weeks · intramuscularAs given in this study (human).
Measurements
1-year PFS1 rate
36.4%
Arm B, pasireotide-LAR 60 mg Q4 weeks
Source sentences
Summary
Median and 1-year PFS1 rates were 8.3, 1.8, 8.1 months and 49.9%, 36.4%, 25.0% for Arms A, B, C, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
Adults with progressive MTC and DTC untreated or treated with no more than one systemic agent were eligible.
Summary · context
Patients were randomized to start treatment with single agent everolimus (10 mg QD; Arm A), pasireotide-LAR (60 mg intramuscular injection, Q4 weeks; Arm B), or the combination (Arm C).
Show in the study text Report a problemFND-3568162003

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Version history

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Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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