Clinical effects of octreotide compared to placebo in patients with gastrointestinal neuroendocrine tumours Report on a double‐blind, randomized trial

Jacobsen, M. B.; Hanssen, L. E.

doi:10.1111/j.1365-2796.1995.tb01175.x

Cited by 42 publications

(23 citation statements)

References 19 publications

(6 reference statements)

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“…Octreotide has been shown in a large study by Kvols [51] to at least halve mean 5-HIAA excretion in 77% of the patients, abolish (60%) or substantially improve (76%) flushing and diarrhoea (77%), and lead to a reduc tion in size of liver métastasés (18% partial remissions) in patients with large-volume, poor-prognosis, and metastat ic carcinoid tumour. These data have been confirmed in many studies [52,53], and, importantly, a novel slowrclease intramuscularly injectable formulation of octreo tide, Sandostatin LAR. has recently been shown to be as efficacious and well tolerated with the advantage of being administered once a month [54], Octreotide was shown to inhibit the growth of colorec tal, gastric, and pancreatic tumour cell lines and liver métastasés [55,56], It may act firstly by direct tumour cell inhibition via specific somatostatin receptors [56], sec ondly by reducing secretion of growth hormone, insulin, gastrin, insulin-like growth factor 1, epidermal growth factor, and tumour growth factor alpha which act as endo crine or paracrine stimulators of gastro-intestinal cancer cell proliferation [57], thirdly by stimulating the hepatic rcticulo-endothelial activity in the liver and thus increas ing the Kupffcr cells' ability to destroy malignant cells [58], and finally by reducing hepatic artery blood flow and neoangiogenesis [59], While high doses of octreotide are needed to see a significant antiproliferative effect in most studies, it has been shown to act additively and at higher doses synergisticallv with mitomycin C. doxorubicin, and most importantly 5-FU in vitro [60], Finally, a symptom atic benefit and significant prolongation of overall surviv al (20 vs. 11 weeks) was demonstrated in 55 advanced chemotherapy-resistant gastro-intestinal cancer patients (gastric, colorectal, and pancreas) randomized to receive octreotide 200 pg three times a day compared to 52 patients receiving best supportive care only [61],…”

Section: Horm Onal Treatmentsupporting

confidence: 55%

New Approaches to the Treatment of Gastro-lntestinal Cancer

Waters¹,

Ross²,

Popescu³

et al. 1997

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A number of new cytotoxic agents are currently being assessed for the treatment of gastro-intestinal cancers. Colorectal cancer has been successfully treated with several direct thymidylate synthase inhibitors, oral 5-fluorouracil analogues, irinotecan, and oxaliplatin, alone and in combination regimens. Upper gastro-intestinal malignancies are also proving responsive to combinations including irinotecan and the taxanes. Pancreatic cancer, while remaining relatively chemoresistant, is proving treatable with the new direct thymidylate synthase inhibitors, docetaxel, and gemcitabine, improvements in quality of life being an important outcome. New strategies of treatment delivery are also proving beneficial. Neo-adjuvant chemotherapy is well tolerated for the treatment of gastric cancer and results in tumour downstaging. Randomized trials will show wheter this translates into a survival advantage. Combination chemoradiation for oesophageal, pancreatic, and rectal cancers also appears to be an effective strategy. Biological therapies including hormonal manipulation, immunotherapy, angiogenesis inhibition, and gene-directed therapies are the subjects of intensive research at present, with many approaches being applied in early clinical trials. These have demonstrated the tolerability of many of these treatments with evidence for activity in some cases.

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Section: Horm Onal Treatmentsupporting

confidence: 55%

New Approaches to the Treatment of Gastro-lntestinal Cancer

Waters¹,

Ross²,

Popescu³

et al. 1997

Digestion

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“…All treatment strategies showed similar rates of tumour stabilisation (18-28%; Faiss et al 2003). This rate is lower than previous nonrandomised retrospective studies (24-57%; Kvols et al 1986, Oberg et al 1991, Jacobsen & Hanssen 1995, Di Bartolomeo et al 1996, Ducreux et al 2000, Welin et al 2004). These results have been replicated in a recent yet to be published randomised prospective study of patients with metastatic MNET's.…”

Section: Discussionmentioning

confidence: 60%

Midgut neuroendocrine tumours with liver metastases: results of the UKINETS study

Ahmed¹,

Turner²,

King³

et al. 2009

Endocrine-Related Cancer

252

221

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We intended to identify the prognostic factors and the results of interventions on patients with liver metastatic midgut carcinoids. Five institutions that are part of United Kingdom and Ireland neuroendocrine tumour (NET) group took part in this study. Patients were included if they had histology proven NET of midgut origin and liver metastases at the time of the study. Clinical and biochemical data were collected retrospectively from hospital charts, pathology reports, radiology reports and biochemistry records for each patient. Three hundred and sixty patients were included in the study. The median survival from date of diagnosis was 7.69 years (confidence interval (CI) 6.40-8.99) and 5.95 years (CI 5.02-6.88) from date of diagnosis of liver metastases. On univariate analysis, increasing age at diagnosis, increasing urinary hydroxyindole acetic acid levels, increasing plasma chromogranin A levels, high Ki67, high tumour volume and treatment with chemotherapy were identified as factors associated with a significantly poorer outcome. Resection of liver metastases, resection of small bowel primary, treatment with somatostatin analogue therapy and treatment with peptide receptor therapy were associated with improved prognosis. Multivariate analysis revealed that age at diagnosis (PZ0.014), Ki67 level (PZ0.039) and resection of primary (PZ0.015) were independent predictors of survival. This is the largest study to our knowledge looking specifically at the prognosis and clinical course of patients with liver metastatic midgut NETs. For the first time, we have shown that Ki67 and resection of primary are independent predictors of survival for this group of patients.

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“…That study mainly addressed the agreement between patient and staff ratings of patient HRQOL. In a study of 11 patients with endocrine GI tumours treated with a somatostatin analogue, results revealed that two domains of HRQOL, ability to relate socially and psychosocial distress, were significantly improved (12).…”

Section: Health-related Quality Of Lifementioning

confidence: 95%

Health-related Quality of Life in Patients with Endocrine Tumours of the Gastrointestinal Tract

1999

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Health-related quality of life (HRQOL) (EORTC QLQ-C30) and levels of anxiety and depression (HADS) were investigated in patients with endocrine tumours of the gastrointestinal tract treated with interferon and/or a somatostatin analogue. In addition, patient perceptions of the importance of and satisfaction with some HRQOL aspects were studied. QOL was perceived as quite good, but more than half of the patients reported diarrhoea. The levels of anxiety and depression were low. Patients perceived physical HRQOL aspects as most important for a good QOL and stated the highest satisfaction with some social aspects. Patients who reported high levels of anxiety or depression were less satisfied with several HRQOL aspects, had more health problems, and a lower level of functioning on several of the EORTC QLQ-C30 scales and single items. Neither demographic nor medical background variables seemed to have an influence on the results. The relatively high QOL could be explained by the fact that most patients had had their treatment for a long period and thus had time to adjust to the situation.

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Clinical effects of octreotide compared to placebo in patients with gastrointestinal neuroendocrine tumours Report on a double‐blind, randomized trial

Abstract: The clinical effect of octreotide on symptoms in patients with neuroendocrine tumours was demonstrated in a controlled, prospective trial.

Cited by 42 publications

References 19 publications

New Approaches to the Treatment of Gastro-lntestinal Cancer

New Approaches to the Treatment of Gastro-lntestinal Cancer

Midgut neuroendocrine tumours with liver metastases: results of the UKINETS study

Health-related Quality of Life in Patients with Endocrine Tumours of the Gastrointestinal Tract

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