Safety of GH after treatment for childhood cancer

Santen, Hanneke M van

doi:10.1530/eje-20-0965

Cited by 4 publications

(3 citation statements)

References 5 publications

(12 reference statements)

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“…Nonetheless in this meta-analysis, we did not conduct relevant subgroup analysis due to a lack of data on the initial disease of patients with detailed types of cancers. In addition, we believe that rhGH therapy should be carried out with caution in high-risk patients and that the start of rhGH therapy should be carefully discussed (34).…”

Section: Discussionmentioning

confidence: 99%

“…Future prospective studies are also needed to confirm these results and answer more difficult questions about the appropriate period to start GH therapy after achieving complete remission, and how to deal with children with "chronic" low-grade tumor diseases and growth hormone deficiency (GHD). In addition, more research is required on the optimal dosage of rhGH therapy (34).…”

Section: Discussionmentioning

confidence: 99%

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Association Between Recombinant Growth Hormone Therapy and All-Cause Mortality and Cancer Risk in Childhood: Systematic Review and Meta-Analysis

Deng

Wang

et al. 2022

Front. Pediatr.

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ObjectivesThe safety of recombinant human growth hormone (rhGH) treatment in childhood and the role of rhGH therapy in promoting tumorigenesis and progression have been the subject of debate for decades. We aimed to systematically assess the relationship between rhGH therapy in children and adolescents and clinical outcomes, including all-cause mortality, cancer mortality, cancer incidence, and risk of the second neoplasm.MethodsLiterature retrieval, study selection, and data extraction were completed independently and in duplicate. Effect-size estimates are expressed as standardized mortality ratios (SMRs), standardized incidence ratio (SIR), and relative risk (RR) with a 95% CI.ResultsData from 24 articles, involving 254,776 persons, were meta-analyzed. Overall analyses revealed the association of rhGH therapy was not statistically significant with all-cause mortality (SMR = 1.28; 95% CI: 0.58–2.84; P = 0.547; I2 = 99.2%; Tau2 = 2.154) and cancer mortality (SMR = 2.59; 95% CI: 0.55–12.09; P = 0.228; I2 = 96.7%; Tau2 = 2.361) and also cancer incidence (SIR = 1.54; 95% CI: 0.68–3.47; P = 0.229; I2 = 97.5%; Tau2 = 2.287), yet statistical significance was observed for second neoplasm (RR = 1.77; 95% CI: 1.33–2.35; P = 0.001; I2 = 26.7%; Tau2 = 0.055). Differences in the geographic region, gender, treatment duration, mean rhGH dose, overall rhGH exposure dose, and initial disease accounted for heterogeneity in the subgroup analyses.ConclusionOur findings indicate that the rhGH therapy is not related to all-cause mortality and cancer mortality and cancer incidence, yet it seems to trigger a second tumor risk. Future prospective studies are needed to confirm our findings and answer the more challenging question regarding the optimal dose of rhGH therapy in children and adolescents.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Association Between Recombinant Growth Hormone Therapy and All-Cause Mortality and Cancer Risk in Childhood: Systematic Review and Meta-Analysis

Deng

Wang

et al. 2022

Front. Pediatr.

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“…Initially approved only for pediatric GH deficiency (GHD), rhGH treatment currently is approved, depending on the country/region, for 8 indications in children (GHD, Prader-Willi syndrome [PWS], children born small for gestational age [SGA], Turner syndrome [TS], Noonan syndrome, idiopathic short stature [ISS], chronic renal failure [CRF], and short stature homeobox-containing gene deficiency [SHOX-D]); and 3 in adults (GHD, short bowel syndrome, and HIV wasting syndrome). Various registries/postmarketing surveillance databases were developed to follow rhGH-treated pediatric patients for long-term efficacy and safety in real-world clinical settings, and, in particular, to provide information regarding potential rare serious adverse consequences of rhGH therapy, including recurrent or new malignancies in children with preexisting malignancies, development of intracranial hypertension, unmasking of (type 2) diabetes mellitus, induction of stroke, and a possible association with increased overall mortality (3)(4)(5)(6)(7).…”

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confidence: 99%

Safety and efficacy of pediatric growth hormone therapy: results from the full KIGS cohort

MB,

et al. 2023

ESPE

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Context:The Kabi/Pfizer International Growth Database (KIGS) is a large, international database (1987-2012) of children treated with recombinant human growth hormone (rhGH) in real-world settings.Objective: This work aimed to evaluate the safety and efficacy of rhGH from the full KIGS cohort. Methods: Data were collected by investigators from children with growth disorders treated with rhGH (Genotropin [somatropin]; Pfizer). Safety was evaluated in all treated patients, and efficacy in those treated for 1 year or more. A subgroup included patients treated for 5 years or more (≥ 2 years prepubertal) who had reached near-adult height (NAH). Main outcomes included adverse events (AEs), serious AEs (SAEs), and height growth.

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Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort

Maghnie

Ranke

Geffner

et al. 2022

The Journal of Clinical Endocrinology &Amp; Metabolism

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Context KIGS is a large, international database (1987-2012) of children treated with recombinant human growth hormone (rhGH) in real-world settings. Objective To evaluate the safety and efficacy of rhGH from the full KIGS cohort Design, Patients, Setting, and Intervention Data were collected by investigators from children with growth disorders treated with rhGH (Genotropin® [somatropin]; Pfizer, NY). Safety was evaluated in all treated patients, and efficacy in those treated for ≥1 year. A subgroup included patients treated for ≥5 years (≥2 years prepubertal) who had reached near-adult height (NAH). Main Outcomes Adverse events (AEs), serious AEs (SAEs), and height growth. Results The full KIGS cohort (N = 83,803 [58% male]) was treated for idiopathic GH deficiency (IGHD; 46.9%), organic GHD (10.0%), small for gestational age (SGA; 9.5%), Turner syndrome (TS; 9.2%), idiopathic short stature (ISS; 8.2%), and others (16.2%). Median rhGH treatment duration was 2.7 years and observation 3.1 years. SAEs occurred in 3.7% of patients and death in 0.4%. The most common SAEs were recurrence of craniopharyngioma (n = 151), neoplasm (n = 99), and cancer (n = 91); and scoliosis (n = 91). Median first-year delta height-SDS (Prader) in prepubertal patients was 0.66 (IGHD), 0.55 (ISS), 0.58 (TS), 0.71 (SGA). Median gains in NAH-SDS were 1.79 (IGHD), 1.37 (ISS), and 1.34 (SGA) for boys, and 2.07 (IGHD), 1.62 (ISS), 1.07 (TS), and 1.57 (SGA) for girls. Conclusion Data from KIGS, the largest and longest running international database of rhGH-treated children, show that rhGH is safe and increases short-term height gain and adult height across GHD and non-GHD conditions.

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Safety of GH after treatment for childhood cancer

Cited by 4 publications

References 5 publications

Association Between Recombinant Growth Hormone Therapy and All-Cause Mortality and Cancer Risk in Childhood: Systematic Review and Meta-Analysis

Association Between Recombinant Growth Hormone Therapy and All-Cause Mortality and Cancer Risk in Childhood: Systematic Review and Meta-Analysis

Safety and efficacy of pediatric growth hormone therapy: results from the full KIGS cohort

Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort

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