Background: Pegvisomant (PEGV) is widely used, alone or with somatostatin analogs (SSA), for GH-secreting pituitary tumors poorly controlled by SSAs alone. No information is available on specific indications for or relative efficacies of PEGV + SSA versus PEGV monotherapy. Aim of our study was to characterize real-life clinical use of PEGV vs. PEGV + SSA for SSA-resistant acromegaly (patient selection, long-term outcomes, adverse event rates, doses required to achieve control). Methods: A retrospective analysis of data collected in 2005-2010 in five hospital-based endocrinology centers in Rome was performed. Sixty-two adult acromegaly patients treated >= 6 months with PEGV (Group 1, n = 35) or PEGV + SSA (Group 2, n = 27) after unsuccessful maximal-dose SSA monotherapy (>= 12 months) were enroled. Groups were compared in terms of clinical/biochemical characteristics at diagnosis and before PEGV or PEGV + SSA was started (baseline) and end-of-follow-up outcomes (IGF-I levels, adverse event rates, final PEGV doses). Results: Group 2 showed higher IGF-I and GH levels and sleep apnea rates, higher rates residual tumor tissue at baseline, more substantial responses to SSA monotherapy and worse outcomes (IGF-I normalization rates, final IGF-I levels). Tumor growth and hepatotoxicity events were rare in both groups. Final daily PEGV doses were similar and significantly increased with treatment duration in both groups. Conclusions: PEGV and PEGV + SSA are safe, effective solutions for managing SSA-refractory acromegaly. PEGV + SSA tends to be used for more aggressive disease associated with detectable tumor tissue. With both regimens, ongoing monitoring of responses is important since PEGV doses needed to maintain IGF-I control are likely to increase over time.

Long-term treatment of somatostatin analog-refractory growth hormone-secreting pituitary tumors with pegvisomant alone or combined with long-acting somatostatin analogs: a retrospective analysis of clinical practice and outcomes / Antonio, Bianchi; Ferdinando, Valentini; Raffaella, Iuorio; Maurizio, Poggi; Roberto, Baldelli; Marina, Passeri; Antonella, Giampietro; Linda, Tartaglione; Sabrina, Chiloiro; Marialuisa, Appetecchia; Gargiulo, Patrizia; Andrea, Fabbri; Toscano, Vincenzo; Alfredo, Pontecorvi; Laura De, Marinis. - In: JOURNAL OF EXPERIMENTAL & CLINICAL CANCER RESEARCH. - ISSN 1756-9966. - 32:1(2013), p. 40. [10.1186/1756-9966-32-40]

Long-term treatment of somatostatin analog-refractory growth hormone-secreting pituitary tumors with pegvisomant alone or combined with long-acting somatostatin analogs: a retrospective analysis of clinical practice and outcomes

GARGIULO, Patrizia;TOSCANO, Vincenzo;
2013

Abstract

Background: Pegvisomant (PEGV) is widely used, alone or with somatostatin analogs (SSA), for GH-secreting pituitary tumors poorly controlled by SSAs alone. No information is available on specific indications for or relative efficacies of PEGV + SSA versus PEGV monotherapy. Aim of our study was to characterize real-life clinical use of PEGV vs. PEGV + SSA for SSA-resistant acromegaly (patient selection, long-term outcomes, adverse event rates, doses required to achieve control). Methods: A retrospective analysis of data collected in 2005-2010 in five hospital-based endocrinology centers in Rome was performed. Sixty-two adult acromegaly patients treated >= 6 months with PEGV (Group 1, n = 35) or PEGV + SSA (Group 2, n = 27) after unsuccessful maximal-dose SSA monotherapy (>= 12 months) were enroled. Groups were compared in terms of clinical/biochemical characteristics at diagnosis and before PEGV or PEGV + SSA was started (baseline) and end-of-follow-up outcomes (IGF-I levels, adverse event rates, final PEGV doses). Results: Group 2 showed higher IGF-I and GH levels and sleep apnea rates, higher rates residual tumor tissue at baseline, more substantial responses to SSA monotherapy and worse outcomes (IGF-I normalization rates, final IGF-I levels). Tumor growth and hepatotoxicity events were rare in both groups. Final daily PEGV doses were similar and significantly increased with treatment duration in both groups. Conclusions: PEGV and PEGV + SSA are safe, effective solutions for managing SSA-refractory acromegaly. PEGV + SSA tends to be used for more aggressive disease associated with detectable tumor tissue. With both regimens, ongoing monitoring of responses is important since PEGV doses needed to maintain IGF-I control are likely to increase over time.
2013
01 Pubblicazione su rivista::01a Articolo in rivista
Long-term treatment of somatostatin analog-refractory growth hormone-secreting pituitary tumors with pegvisomant alone or combined with long-acting somatostatin analogs: a retrospective analysis of clinical practice and outcomes / Antonio, Bianchi; Ferdinando, Valentini; Raffaella, Iuorio; Maurizio, Poggi; Roberto, Baldelli; Marina, Passeri; Antonella, Giampietro; Linda, Tartaglione; Sabrina, Chiloiro; Marialuisa, Appetecchia; Gargiulo, Patrizia; Andrea, Fabbri; Toscano, Vincenzo; Alfredo, Pontecorvi; Laura De, Marinis. - In: JOURNAL OF EXPERIMENTAL & CLINICAL CANCER RESEARCH. - ISSN 1756-9966. - 32:1(2013), p. 40. [10.1186/1756-9966-32-40]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/673242
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