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Study · Observational study · 2020

8 results

Predictive factors for responses to primary medical treatment with lanreotide autogel 120 mg in acromegaly: post hoc analyses from the PRIMARYS study.

Petersenn S, Houchard A, Sert C, Caron PJ

Pituitary1 Apr 2020Cited by 29 (Europe PMC)

PMID31879842 (opens in a new tab)PMCIDPMC7066297 (opens in a new tab)DOI10.1007/s11102-019-01020-3 (opens in a new tab)PepBankPUB-31879842
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Summary

PurposePRIMARYS (NCT00690898) was a 48-week, open-label, phase 3b study, evaluating treatment with the somatostatin receptor ligand lanreotide autogel (stable dose: 120 mg/28 days) in treatment-naïve patients with growth hormone (GH)-secreting pituitary macroadenoma. This post hoc analysis aimed to evaluate factors predictive of long-term responses.MethodsPotential predictive factors evaluated were: sex, age, and body mass index at baseline; and GH, insulin-like growth factor-1 (IGF-1), and tumor volume (TV) at baseline and week 12, using univariate regression analyses. Treatment responses were defined as hormonal control (GH ≤ 2.5 µg/L and age- and sex-normalized IGF-1), tight hormonal control (GH < 1.0 µg/L and normalized IGF-1), or ≥ 20% TV reduction (TVR). Receiver-operating-characteristic (ROC) curves were constructed using predictive factors significant in univariate analyses. Cut-off values for predicting treatment responses at 12 months were derived by maximizing the Youden index (J).ResultsAt baseline, older age, female sex, and lower IGF-1 levels were associated with an increased probability of achieving long-term hormonal control. ROC area-under-the curve (AUC) values for hormonal control were high for week-12 GH and IGF-1 levels (0.87 and 0.93, respectively); associated cut-off values were 1.19 μg/L and 110% of the upper limit of normal (ULN), respectively. Results were similar for tight hormonal control (AUC values: 0.92 [GH] and 0.87 [IGF-1]; cut-off values: 1.11 μg/L and 125% ULN, respectively). AUC and J values associated with TVR were low.ConclusionsThe use of predictive factors at baseline and week 12 of treatment could inform clinical expectations of the long-term efficacy of lanreotide autogel.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanObservational studyOther

    In lanreotide-treated acromegaly patients, older baseline age was associated with greater probability of long-term hormonal control.

    In plain wordsIn lanreotide-treated acromegaly patients, older age was linked to a greater chance of long-term hormone control.

    Peptide
    Lanreotide
    Outcome
    IncreaseBaseline age predictor of hormonal control
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    120 mg every 28 days · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    At baseline, older age, female sex, and lower IGF-1 levels were associated with an increased probability of achieving long-term hormonal control.
    1 context sentence
    Summary · context
    PRIMARYS (NCT00690898) was a 48-week, open-label, phase 3b study, evaluating treatment with the somatostatin receptor ligand lanreotide autogel (stable dose: 120 mg/28 days) in treatment-naïve patients with growth hormone (GH)-secreting pituitary macroadenoma.
  2. 02HumanObservational studyOther

    In lanreotide-treated acromegaly patients, female sex was associated with greater probability of long-term hormonal control.

    In plain wordsIn lanreotide-treated acromegaly patients, female sex was linked to a greater chance of long-term hormone control.

    Peptide
    Lanreotide
    Outcome
    IncreaseSex predictor of hormonal control
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    120 mg every 28 days · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    At baseline, older age, female sex, and lower IGF-1 levels were associated with an increased probability of achieving long-term hormonal control.
    1 context sentence
    Summary · context
    PRIMARYS (NCT00690898) was a 48-week, open-label, phase 3b study, evaluating treatment with the somatostatin receptor ligand lanreotide autogel (stable dose: 120 mg/28 days) in treatment-naïve patients with growth hormone (GH)-secreting pituitary macroadenoma.
  3. 03HumanObservational studyOther

    In lanreotide-treated acromegaly patients, lower baseline IGF-1 was associated with greater probability of long-term hormonal control.

    In plain wordsIn lanreotide-treated acromegaly patients, lower baseline IGF-1 was linked to a greater chance of long-term hormone control.

    Peptide
    Lanreotide
    Outcome
    IncreaseBaseline IGF-1 predictor of hormonal control
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    120 mg every 28 days · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    At baseline, older age, female sex, and lower IGF-1 levels were associated with an increased probability of achieving long-term hormonal control.
    1 context sentence
    Summary · context
    PRIMARYS (NCT00690898) was a 48-week, open-label, phase 3b study, evaluating treatment with the somatostatin receptor ligand lanreotide autogel (stable dose: 120 mg/28 days) in treatment-naïve patients with growth hormone (GH)-secreting pituitary macroadenoma.
  4. 04HumanObservational studyOther

    In lanreotide-treated acromegaly patients, week-12 GH predicted hormonal control with AUC 0.87 and cut-off 1.19 μg/L.

    In plain wordsIn lanreotide-treated acromegaly patients, week-12 GH predicted hormone control with AUC 0.87 and cut-off 1.19 μg/L.

    Peptide
    Lanreotide
    Outcome
    Not applicableWeek-12 GH prediction of hormonal control
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    120 mg every 28 days · 48 weeksAs given in this study (human).

    Measurements

    ROC AUC for hormonal control
    0.87
    week-12 GH
    Cut-off value for hormonal control
    1.19 μg/L
    week-12 GH

    Source sentences

    Summary
    ROC area-under-the curve (AUC) values for hormonal control were high for week-12 GH and IGF-1 levels (0.87 and 0.93, respectively); associated cut-off values were 1.19 μg/L and 110% of the upper limit of normal (ULN), respectively.
    1 context sentence
    Summary · context
    PRIMARYS (NCT00690898) was a 48-week, open-label, phase 3b study, evaluating treatment with the somatostatin receptor ligand lanreotide autogel (stable dose: 120 mg/28 days) in treatment-naïve patients with growth hormone (GH)-secreting pituitary macroadenoma.
  5. 05HumanObservational studyOther

    In lanreotide-treated acromegaly patients, week-12 IGF-1 predicted hormonal control with AUC 0.93 and cut-off 110% ULN.

    In plain wordsIn lanreotide-treated acromegaly patients, week-12 IGF-1 predicted hormone control with AUC 0.93 and cut-off 110% ULN.

    Peptide
    Lanreotide
    Outcome
    Not applicableWeek-12 IGF-1 prediction of hormonal control
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    120 mg every 28 days · 48 weeksAs given in this study (human).

    Measurements

    ROC AUC for hormonal control
    0.93
    week-12 IGF-1
    Cut-off value for hormonal control
    110 % ULN
    week-12 IGF-1

    Source sentences

    Summary
    ROC area-under-the curve (AUC) values for hormonal control were high for week-12 GH and IGF-1 levels (0.87 and 0.93, respectively); associated cut-off values were 1.19 μg/L and 110% of the upper limit of normal (ULN), respectively.
    1 context sentence
    Summary · context
    PRIMARYS (NCT00690898) was a 48-week, open-label, phase 3b study, evaluating treatment with the somatostatin receptor ligand lanreotide autogel (stable dose: 120 mg/28 days) in treatment-naïve patients with growth hormone (GH)-secreting pituitary macroadenoma.
  6. 06HumanObservational studyOther

    In lanreotide-treated acromegaly patients, week-12 GH predicted tight hormonal control with AUC 0.92 and cut-off 1.11 μg/L.

    In plain wordsIn lanreotide-treated acromegaly patients, week-12 GH predicted tight hormone control with AUC 0.92 and cut-off 1.11 μg/L.

    Peptide
    Lanreotide
    Outcome
    Not applicableWeek-12 GH prediction of tight hormonal control
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    120 mg every 28 days · 48 weeksAs given in this study (human).

    Measurements

    AUC
    0.92
    week-12 GH, tight hormonal control
    Cut-off value
    1.11 μg/L
    week-12 GH, tight hormonal control

    Source sentences

    Summary
    Results were similar for tight hormonal control (AUC values: 0.92 [GH] and 0.87 [IGF-1]; cut-off values: 1.11 μg/L and 125% ULN, respectively).
    1 context sentence
    Summary · context
    PRIMARYS (NCT00690898) was a 48-week, open-label, phase 3b study, evaluating treatment with the somatostatin receptor ligand lanreotide autogel (stable dose: 120 mg/28 days) in treatment-naïve patients with growth hormone (GH)-secreting pituitary macroadenoma.
  7. 07HumanObservational studyOther

    In lanreotide-treated acromegaly patients, week-12 IGF-1 predicted tight hormonal control with AUC 0.87 and cut-off 125% ULN.

    In plain wordsIn lanreotide-treated acromegaly patients, week-12 IGF-1 predicted tight hormone control with AUC 0.87 and cut-off 125% ULN.

    Peptide
    Lanreotide
    Outcome
    Not applicableWeek-12 IGF-1 prediction of tight hormonal control
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    120 mg every 28 days · 48 weeksAs given in this study (human).

    Measurements

    AUC
    0.87
    week-12 IGF-1, tight hormonal control
    Cut-off value
    125 % ULN
    week-12 IGF-1, tight hormonal control

    Source sentences

    Summary
    Results were similar for tight hormonal control (AUC values: 0.92 [GH] and 0.87 [IGF-1]; cut-off values: 1.11 μg/L and 125% ULN, respectively).
    1 context sentence
    Summary · context
    PRIMARYS (NCT00690898) was a 48-week, open-label, phase 3b study, evaluating treatment with the somatostatin receptor ligand lanreotide autogel (stable dose: 120 mg/28 days) in treatment-naïve patients with growth hormone (GH)-secreting pituitary macroadenoma.
  8. 08HumanObservational studyOther

    In lanreotide-treated acromegaly patients, AUC and Youden index values for predicting tumor volume reduction were low.

    In plain wordsIn lanreotide-treated acromegaly patients, AUC and Youden index values for predicting tumor volume reduction were low.

    Peptide
    Lanreotide
    Outcome
    Not applicablePrediction of tumor volume reduction
    Study

    n: not reported in source

    Outcome group
    Tumor growth · Endocrine and hormones
    Studied dose
    120 mg every 28 days · 48 weeksAs given in this study (human).

    Source sentences

    Summary
    AUC and J values associated with TVR were low.
    1 context sentence
    Summary · context
    PRIMARYS (NCT00690898) was a 48-week, open-label, phase 3b study, evaluating treatment with the somatostatin receptor ligand lanreotide autogel (stable dose: 120 mg/28 days) in treatment-naïve patients with growth hormone (GH)-secreting pituitary macroadenoma.

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

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

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