Pasireotide treatment significantly reduces tumor volume in patients with Cushing's disease: results from a Phase 3 study.

Lacroix A, Gu F, Schopohl J, Kandra A, Pedroncelli AM, Jin L, Pivonello R

Pituitary1 Jun 2020Cited by 20 (Europe PMC)

PMID31875276PMCIDPMC7181422DOI10.1007/s11102-019-01021-2PepBankPUB-31875276

Summary

PurposeIn the multinational, randomized, double-blind, Phase 3 B2305 study of patients with Cushing's disease (CD; ClinicalTrials.gov identifier NCT00434148), pasireotide substantially decreased urinary-free cortisol (UFC) levels, decreased mean corticotroph tumor volume, and improved clinical signs of disease. The current post hoc analysis further assesses the effects of pasireotide on corticotroph pituitary tumor volume.MethodsPatients enrolled in the B2305 study had persistent or recurrent CD or newly diagnosed CD but were not surgical candidates. Enrollees were randomized to receive subcutaneous pasireotide, either 600-μg or 900-μg twice daily. Tumor volume was assessed independently at months 6 and 12 by 2 blinded radiologists and compared with baseline value and UFC response.ResultsOf 162 patients enrolled in the trial, 53 had measurable tumor volume data and were included in the post hoc analysis. Reductions in tumor volume were both dose and time dependent. Tumor volume reduction was more frequently observed at month 6 in the 900-μg group (75%) than in the 600-μg group (44%). Similarly, at month 12 (n = 32), tumor volume reduction was observed more frequently in the 900-µg group (89%) than in the 600-µg group (50%). Control of UFC levels was not required for reduction of tumor volume. No relationship was noted between baseline tumor size and change in tumor size.ConclusionsMeasurable decreases in pituitary tumor volume were observed in a large proportion of patients with CD and measurable tumor volume who were enrolled in the trial and treated with subcutaneous pasireotide; this decrease was not correlated with UFC control. CLINICALTRIALS.Gov identifierNCT00434148.

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

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Cushing's disease, tumor reduction at month 6 occurred in 75% with pasireotide 900 μg versus 44% with 600 μg twice daily.
In plain wordsIn Cushing's disease, tumor shrinkage at month 6 occurred more frequently with pasireotide 900 μg than 600 μg twice daily.
Peptide
Pasireotide
Outcome
IncreaseTumor reduction frequency at month 6
Study
n = 53
Comparator
Pasireotide 600 μg twice daily
Outcome group
Tumor growth · Endocrine and hormones
Studied dose
900 μg twice daily · subcutaneousAs given in this study (human).
Measurements
Tumor volume reduction at month 6
75%
900-μg twice daily group
Tumor volume reduction at month 6
44%
600-μg twice daily group
Source sentences
Summary
Tumor volume reduction was more frequently observed at month 6 in the 900-μg group (75%) than in the 600-μg group (44%).
3 context sentences(design, population, supporting numbers)
Summary · context
Patients enrolled in the B2305 study had persistent or recurrent CD or newly diagnosed CD but were not surgical candidates.
Summary · context
Enrollees were randomized to receive subcutaneous pasireotide, either 600-μg or 900-μg twice daily.
Summary · context
Tumor volume was assessed independently at months 6 and 12 by 2 blinded radiologists and compared with baseline value and UFC response.
Show in the study text Report a problemFND-3187527602
02HumanRandomized controlled trialEfficacy outcome
In Cushing's disease, tumor reduction at month 12 occurred in 89% with pasireotide 900 µg versus 50% with 600 µg twice daily.
In plain wordsIn Cushing's disease, tumor shrinkage at month 12 occurred more frequently with pasireotide 900 µg than 600 µg twice daily.
Peptide
Pasireotide
Outcome
IncreaseTumor reduction frequency at month 12
Study
n = 32
Comparator
Pasireotide 600 μg twice daily
Outcome group
Tumor growth · Endocrine and hormones
Studied dose
900 μg twice daily · subcutaneousAs given in this study (human).
Measurements
Tumor volume reduction at month 12
89%
900-µg twice daily group
Tumor volume reduction at month 12
50%
600-µg twice daily group
Source sentences
Summary
Similarly, at month 12 (n = 32), tumor volume reduction was observed more frequently in the 900-µg group (89%) than in the 600-µg group (50%).
3 context sentences(design, population, supporting numbers)
Summary · context
Patients enrolled in the B2305 study had persistent or recurrent CD or newly diagnosed CD but were not surgical candidates.
Summary · context
Enrollees were randomized to receive subcutaneous pasireotide, either 600-μg or 900-μg twice daily.
Summary · context
Tumor volume was assessed independently at months 6 and 12 by 2 blinded radiologists and compared with baseline value and UFC response.
Show in the study text Report a problemFND-3187527603
03HumanNon-randomized trialEfficacy outcome
In Cushing's disease patients with measurable tumors, tumor volume reductions during pasireotide treatment were dose and time dependent.
In plain wordsIn Cushing's disease patients with measurable tumors, tumor shrinkage during pasireotide treatment depended on dose and time.
Peptide
Pasireotide
Outcome
DecreaseDose- and time-dependent tumor volume reduction
Study
n = 53
Outcome group
Tumor growth · Endocrine and hormones
Studied dose
600 or 900 μg twice daily · subcutaneousAs given in this study (human).
Source sentences
Summary
Reductions in tumor volume were both dose and time dependent.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients enrolled in the B2305 study had persistent or recurrent CD or newly diagnosed CD but were not surgical candidates.
Summary · context
Enrollees were randomized to receive subcutaneous pasireotide, either 600-μg or 900-μg twice daily.
Summary · context
Tumor volume was assessed independently at months 6 and 12 by 2 blinded radiologists and compared with baseline value and UFC response.
Show in the study text Report a problemFND-3187527601
04HumanObservational studyOther
In pasireotide-treated Cushing's disease patients, tumor volume reduction did not require urinary free cortisol control.
In plain wordsIn pasireotide-treated Cushing's disease patients, tumors could shrink without urinary cortisol control.
Peptide
Pasireotide
Outcome
Not applicableTumor reduction relationship with UFC control
Study
n: not reported in source
Outcome group
Tumor growth · Endocrine and hormones
Studied dose
600 or 900 μg twice daily · subcutaneousAs given in this study (human).
Source sentences
Summary
Control of UFC levels was not required for reduction of tumor volume.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients enrolled in the B2305 study had persistent or recurrent CD or newly diagnosed CD but were not surgical candidates.
Summary · context
Enrollees were randomized to receive subcutaneous pasireotide, either 600-μg or 900-μg twice daily.
Summary · context
Tumor volume was assessed independently at months 6 and 12 by 2 blinded radiologists and compared with baseline value and UFC response.
Show in the study text Report a problemFND-3187527604
05HumanObservational studyOther
In pasireotide-treated Cushing's disease patients, baseline tumor size had no observed relationship with tumor size change.
In plain wordsIn pasireotide-treated Cushing's disease patients, baseline tumor size was not linked to tumor size change.
Peptide
Pasireotide
Outcome
No significant changeBaseline tumor size association
Study
n: not reported in source
Outcome group
Tumor growth · Endocrine and hormones
Studied dose
600 or 900 μg twice daily · subcutaneousAs given in this study (human).
Source sentences
Summary
No relationship was noted between baseline tumor size and change in tumor size.
3 context sentences(design, population, supporting numbers)
Summary · context
Patients enrolled in the B2305 study had persistent or recurrent CD or newly diagnosed CD but were not surgical candidates.
Summary · context
Enrollees were randomized to receive subcutaneous pasireotide, either 600-μg or 900-μg twice daily.
Summary · context
Tumor volume was assessed independently at months 6 and 12 by 2 blinded radiologists and compared with baseline value and UFC response.
Show in the study text Report a problemFND-3187527605

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00434148

Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease

Novartis Pharmaceuticalsn = 162Dec 2006 to May 2014

Cushing's Disease

Trial page ClinicalTrials.govUpdated 8 Mar 2016

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

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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