Dataset Information

Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study.

ABSTRACT: To evaluate the effects of lanreotide Autogel on patient-reported outcomes and association with biochemical control, using PRIMARYS data.PRIMARYS was a 1-year, open-label study of lanreotide Autogel (Depot in USA) 120 mg every 4 weeks in 90 treatment-naïve patients with acromegaly. Symptoms were assessed using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) and health-related quality of life (HRQoL) using the AcroQoL questionnaire. Correlations between PASQ and AcroQoL scores, and between PASQ/AcroQoL and growth hormone (GH)/insulin-like growth factor-1 (IGF-1) levels were also evaluated (post hoc).Acromegaly symptoms and HRQoL significantly improved from week 12 to week 48, with modest correlations at week 48 between PASQ total score (R = -0.55, p < 0.0001) and AcroQoL global and physical scores (R = -0.67, p < 0.0001). Approximately 60% of patients achieved a minimal important difference (MID; improvement >50% of baseline standard deviation) in PASQ total score and >40% achieved a MID in AcroQoL global score (post hoc). Changes in PASQ scores were similar in biochemically controlled (GH levels ?2.5 ?g/L and normal IGF-1 levels) and uncontrolled groups, while changes in global and psychological AcroQoL scores were greater in the controlled group. There was no correlation between changes in PASQ or AcroQoL scores and changes in GH or IGF-1 levels.Primary treatment with lanreotide Autogel over 1 year was associated with rapid and sustained improvements in clinical signs and symptoms and HRQoL in patients with acromegaly. Improvements in HRQoL, but not symptoms, were greater in those achieving biochemical control (ClinicalTrials.gov: NCT00690898; EudraCT: 2007-000155-34).

SUBMITTER: Caron PJ

PROVIDER: S-EPMC4799252 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study.

Caron Philippe J PJ Bevan John S JS Petersenn Stephan S Houchard Aude A Sert Caroline C Webb Susan M SM

Pituitary 20160401 2

<h4>Purpose</h4>To evaluate the effects of lanreotide Autogel on patient-reported outcomes and association with biochemical control, using PRIMARYS data.<h4>Methods</h4>PRIMARYS was a 1-year, open-label study of lanreotide Autogel (Depot in USA) 120 mg every 4 weeks in 90 treatment-naïve patients with acromegaly. Symptoms were assessed using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) and health-related quality of life (HRQoL) using the AcroQoL questionnaire. Correlations between PA ...[more]

PMID: 26603536

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Project description:ContextMethodological shortcomings often compromise investigations into the effects of primary somatostatin-analog treatment on tumor size in acromegaly. There are also limited data for the long-acting lanreotide formulation.ObjectiveThe aim of the study was to better characterize the effects of primary lanreotide Autogel treatment on tumor size in patients with GH-secreting macroadenomas.DesignPRIMARYS was a 48-week, multicenter, open-label, single-arm study.SettingThe study was conducted at specialist endocrine centers.PatientsTreatment-naïve acromegalic patients with GH-secreting macroadenomas participated in the study.InterventionLanreotide Autogel 120 mg was administered sc every 28 days (without dose titration).Outcome measuresThe primary endpoint was the proportion of patients with clinically significant (≥20%) tumor volume reduction (TVR) at week 48/last post-baseline value available using central assessments from three readers. The null hypothesis (H0) for the primary endpoint was that the proportion with TVR was ≤55%. Secondary endpoints included: TVR at other time points, GH and IGF-1, acromegalic symptoms, quality of life (QoL), and safety.ResultsSixty-four of 90 (71.1%) patients completed the study. Clinically significant TVR at 48 weeks/last post-baseline value available was achieved by 62.9% (95% confidence interval, 52.0, 72.9) of 89 patients in the primary analysis (intention-to-treat population; H0 not rejected) and 71.9-75.3% in sensitivity (n = 89) and secondary analyses (n = 63) (H0 rejected). At 12 weeks, 54.1% had clinically significant TVR. Early and sustained improvements also occurred in GH and IGF-1, acromegalic symptoms, and QoL. No patients withdrew due to gastrointestinal intolerance.ConclusionsPrimary treatment with lanreotide Autogel, administered at 120 mg (highest available dose) without dose titration, in patients with GH-secreting macroadenomas provides early and sustained reductions in tumor volume, GH and IGF-1, and acromegalic symptoms, and improves QoL.

Project description:INTRODUCTION:Although the previous lanreotide autogel/depot syringe had been well received, feedback indicated that improvements could be made to make it more user-friendly. Additionally, the view that patients should have greater involvement in the research and development process is echoed by the International Neuroendocrine Cancer Alliance. A series of studies aimed to develop and validate a new syringe that works better for patients, caregivers and healthcare professionals (HCPs) by involving these groups at key stages in the development and testing process. METHODS:The multicentre, international, human factor studies, consisted of four formative studies and one validation study. The formative studies collected patient, caregiver and HCP feedback on the lanreotide autogel/depot syringe on the market at the time, and on newly designed prototypes. The validation study was conducted to evaluate the final syringe to confirm that it can be used effectively and safely in the intended environment, by the intended user, for the intended purpose. RESULTS:Overall, 213 individuals participated in the studies; 145 contributed to the formative studies and 68 to the validation study. The validated new-generation syringe included several important updates compared with the lanreotide autogel/depot syringe currently on the market, including the flanges, which are now larger and have a better grip; the overcap, which is white, ridged, opaque and bigger; the plunger supports and the thermoformed tray. No participant hurt themselves or others during the validation study (although several misuses were reported), and all participants succeeded in delivering a complete dose and activating the safety system. CONCLUSION:With collaboration, a new syringe was developed to meet the needs of patients, caregivers and HCPs, whilst ensuring lanreotide was delivered effectively and safely. These studies highlight the importance of involving patients, caregivers and HCPs in clinical evaluation studies to develop medical products that address their concerns and meet their needs. FUNDING:Ipsen. Plain language summary available for this article.

Project description:BACKGROUND:Lanreotide autogel is a somatostatin analog (SSA) approved for the treatment of acromegaly in 73 countries worldwide; however, it is not yet approved in China. The aim of this study was to evaluate the efficacy and safety of lanreotide autogel compared with lanreotide 40?mg prolonged release (PR) in Chinese patients with active acromegaly. METHODS:LANTERN was a phase 3, randomized, open-label, non-inferiority study. Patients with active acromegaly who had undergone surgery ?3?months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120?mg (monthly deep subcutaneous injection) or lanreotide 40?mg PR (intramuscular injection every 7, 10, or 14?days) for 32?weeks. Primary endpoint was mean change-from-baseline in age-adjusted insulin-like growth factor-1 (IGF-1) standard deviation scores (SDS) at the end-of-study. Secondary endpoints included: growth hormone (GH) levels ?2.5??g/L or???1.0??g/L, ?20% reduction in tumor volume (TV) and safety. RESULTS:In total, 128 patients were randomized and received study treatment. Lanreotide autogel was non-inferior to lanreotide 40?mg PR: treatment difference (95% CI) for IGF-1 SDS between groups was -?0.32 (-?0.74, 0.11; per protocol population) and?-?0.27 (-?0.63, 0.09; intention-to-treat [ITT] population), respectively. Reductions in IGF-1 (-?6.453 vs -?7.003) and GH levels (-?9.548??g/L vs -?13.182??g/L), and the proportion of patients with ?1 acromegaly symptom (-?20.3% vs -?32.5%) were observed from baseline to end-of-study in lanreotide autogel and lanreotide 40?mg PR groups, respectively. In the lanreotide autogel group, 45.5% (25/55) patients achieved ?20% reduction in TV compared with 50.9% (25/53) in lanreotide 40?mg PR group (ITT). Safety profiles were similar in both treatment groups. CONCLUSIONS:Lanreotide autogel was non-inferior to lanreotide 40?mg PR in Chinese patients with active acromegaly after 32?weeks of treatment. TRIAL REGISTRATION:Retrospectively registered on ClinicalTrials.gov: NCT02493517 (9 July 2015); prospectively registered on chinadrugtrials.org.cn: CTR20140698 (24 October 2014).

Dataset Information

Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study.

Publications

Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study.

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