A multicenter, randomized trial of long-acting octreotide (LAR) in the treatment of chemotherapy-induced diarrhea (CTID)

Rosenoff, Stephen H.; Gabrail, N.; Conklin, Richard H.; Hohneker, John; Berg, William J.; Hedrick, James; Warsi, Ghulam; Benedetto, Jean-Pierre; Zhu, Weiping; Anthony, Lowell

doi:10.1200/jco.2004.22.90140.8109

Cited by 9 publications

(14 citation statements)

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“…In an open-label, randomized, multicenter study designed to assess the effects of two dose levels of octreotide LAR, 147 patients with active or prior chemotherapy-induced diarrhea and scheduled for chemotherapy were randomized to receive up to six doses of either octreotide LAR 30 or 40 mg. Both dose levels provided clinical benefit, although fewer patients in the 40-mg group than the 30-mg group experienced severe diarrhea, required intravenous fluid, and had diarrhea-related unscheduled healthcare visits 80 . Another study has shown complete resolution of diarrhea in 30 of the 32 patients treated with octreotide 81 .…”

Section: The Next 20 Yearsmentioning

confidence: 97%

From somatostatin to octreotide LAR: evolution of a somatostatin analogue

Anthony

Freda

2009

Current Medical Research and Opinion

102

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Background Acromegaly is characterized by overproduction of growth hormone (GH) by the pituitary gland. GH stimulates the synthesis of insulin-like growth factor-I (IGF-I), and the somatic growth and metabolic dysfunction that characterize acromegaly are a consequence of elevated GH and IGF-I levels. Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are rare, slow-growing neoplasms that have usually metastasized by the time of diagnosis. The majority of GEP-NETs are carcinoid tumors whose syndrome is caused by the hypersecretion of biogenic amines, peptides and polypeptides responsible for the principal symptoms of diarrhea and flushing. Methods The MEDLINE and EMBASE databases were searched for preclinical and clinical studies of octreotide (Sandostatin*), a potent synthetic somatostatin analogue, in patients with acromegaly or GEP-NETs. Objective This article reviews the 20 years of clinical experience with octreotide and the impact it has made in patients with acromegaly or GEP-NETs. Results Octreotide has proven to be an essential component in the management strategy of acromegaly and GEP-NETs over the past 20 years. The multiple beneficial effects of octreotide throughout the body, combined with its established safety profile (the most common adverse effects are injection-site pain and gastrointestinal events), have made it an appealing option for clinicians. The advent of the long-acting release (LAR) formulation of octreotide provided additional benefits to patients through monthly administration, while maintaining the efficacy and tolerability profile of the daily subcutaneous formulation. Conclusions Octreotide is a potent synthetic somatostatin analogue that has become the mainstay of medical therapy for tumor control in neuroendocrine disorders such as acromegaly and GEP-NETs. The development of octreotide LAR offered a further advancement; less frequent dosing provided valuable benefits in quality of life to patients, with equivalent efficacy and tolerability. Moreover, recent results from the PROMID study have confirmed the antiproliferative effect of octreotide LAR in patients with well-differentiated metastatic GEP-NETs of the midgut. New therapeutic uses of octreotide are currently under investigation in a variety of clinical settings.

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Section: The Next 20 Yearsmentioning

confidence: 97%

From somatostatin to octreotide LAR: evolution of a somatostatin analogue

Anthony

Freda

2009

Current Medical Research and Opinion

102

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“…Hence, there remains a need for preventative measures, and although a number of strategies for CID prevention have been previously reported, none has been adopted into routine clinical practice. Studies to date have generally been small and some have been further limited by not including an adequate or any control group (Michael et al , 2004; Rosenoff et al , 2006). Moreover, any potential agent for CID prevention must be well tolerated with a low risk of drug interactions.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, even though a possible role of intestinal alkalisation for CID prevention has been suggested, its usefulness is potentially limited by the changes it causes in the pharmacokinetics and plasma levels of irinotecan (Hamada et al , 2005). A further limiting factor for some preventative agents, despite evidence that they may have a beneficial effect on the incidence or severity of CID, is difficulty in administration, such as need for parenteral administration (Rosenoff et al , 2006; Li et al , 2009), or patient acceptability, particularly in the setting of other treatment toxicities such as nausea or mucositis, which may limit patient compliance with additional oral medication, or potential drug interactions with other medication (Michael et al , 2004). …”

Section: Discussionmentioning

confidence: 99%

“…In the STOP study, 147 patients were randomised to receive one of two dose levels (30 or 40 mg) of long-acting octreotide prior to chemotherapy with less severe diarrhoea and less need for supportive measures for management of CID observed in the higher dose level although the differences were not statistically significant (Rosenoff et al , 2006). However, the use of prophylactic long-acting octreotide was not effective in preventing chemoradiotherapy-induced diarrhoea in patients with rectal cancer (Zachariah et al , 2010).…”

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confidence: 99%

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A randomised double-blind placebo-controlled phase II study of AGI004 for control of chemotherapy-induced diarrhoea

Coyle

Lungulescu²,

Togănel

et al. 2013

Br J Cancer

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Background:AGI004 is a controlled-release transdermal patch preparation of mecamylamine. We conducted a randomised placebo-controlled phase II study of two dose levels of AGI004 in chemotherapy-induced diarrhoea (CID).Methods:Adult patients receiving chemotherapy who had experienced diarrhoea (NCI grade 1–2) during previous cycles of chemotherapy were eligible. In all, 64 patients were randomised to receive AGI004 4 mg then 8 mg per 24 h transdermal patch or placebo for two sequential cycles of chemotherapy. Patients' severity of diarrhoea was physician-assessed using NCI grade of diarrhoea and patient-assessed using information recorded in daily diaries of bowel movements.Results:Overall AGI004 doubled the odds of a response to treatment on the first day of chemotherapy based on physician assessment of NCI grade of diarrhoea compared with placebo (odds ratio=2.0, 90% confidence interval: 0.9–4.5) and there was a trend to improved response rates for AGI004 for the full treatment cycle although these results were not statistically significant. There was also evidence of significantly improved response rates based on patient assessment of diarrhoea both overall (P=0.05) and at the 8-mg dose level (P=0.02) compared with placebo.Conclusion:AGI004 demonstrated effectiveness in reducing chemotherapy-associated diarrhoea, with results suggesting response across multiple measurements of diarrhoea. Treatment was well tolerated with no drug-related adverse events. Further evaluation of this agent in the management of CID is warranted.

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“…Agents used in the management of chemotherapy-induced diarrhea are listed in Table 6. [67][68][69][70][71][72][73] …”

Section: Fluoropyrimidine-induced Diarrheamentioning

confidence: 99%