Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.
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Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. / Rinke, Anja; Müller, Hans-Helge; Schade-Brittinger, Carmen; Klose, Klaus-Jochen; Barth, Peter; Wied, Matthias; Mayer, Christina; Aminossadati, Behnaz; Pape, Ulrich-Frank; Bläker, Michael; Harder, Jan; Arnold, Christian; Gress, Thomas; Arnold, Rudolf.
In: J CLIN ONCOL, Vol. 27, No. 28, 28, 2009, p. 4656-4663.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.
AU - Rinke, Anja
AU - Müller, Hans-Helge
AU - Schade-Brittinger, Carmen
AU - Klose, Klaus-Jochen
AU - Barth, Peter
AU - Wied, Matthias
AU - Mayer, Christina
AU - Aminossadati, Behnaz
AU - Pape, Ulrich-Frank
AU - Bläker, Michael
AU - Harder, Jan
AU - Arnold, Christian
AU - Gress, Thomas
AU - Arnold, Rudolf
PY - 2009
Y1 - 2009
N2 - PURPOSE: Somatostatin analogs are indicated for symptom control in patients with gastroenteropancreatic neuroendocrine tumors (NETs). The ability of somatostatin analogs to control the growth of well-differentiated metastatic NETs is a matter of debate. We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs. The hypothesis was that octreotide LAR prolongs time to tumor progression and survival. PATIENTS AND METHODS: Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death. The primary efficacy end point was time to tumor progression. Secondary end points were survival time and tumor response. This report is based on 67 tumor progressions and 16 observed deaths in 85 patients at the time of the planned interim analysis. RESULTS: Median time to tumor progression in the octreotide LAR and placebo groups was 14.3 and 6 months, respectively (hazard ratio [HR] = 0.34; 95% CI, 0.20 to 0.59; P = .000072). After 6 months of treatment, stable disease was observed in 66.7% of patients in the octreotide LAR group and 37.2% of patients in the placebo group. Functionally active and inactive tumors responded similarly. The most favorable effect was observed in patients with low hepatic tumor load and resected primary tumor. Seven and nine deaths were observed in the octreotide LAR and placebo groups, respectively. The HR for overall survival was 0.81 (95% CI, 0.30 to 2.18). CONCLUSION: Octreotide LAR significantly lengthens time to tumor progression compared with placebo in patients with functionally active and inactive metastatic midgut NETs. Because of the low number of observed deaths, survival analysis was not confirmatory.
AB - PURPOSE: Somatostatin analogs are indicated for symptom control in patients with gastroenteropancreatic neuroendocrine tumors (NETs). The ability of somatostatin analogs to control the growth of well-differentiated metastatic NETs is a matter of debate. We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs. The hypothesis was that octreotide LAR prolongs time to tumor progression and survival. PATIENTS AND METHODS: Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death. The primary efficacy end point was time to tumor progression. Secondary end points were survival time and tumor response. This report is based on 67 tumor progressions and 16 observed deaths in 85 patients at the time of the planned interim analysis. RESULTS: Median time to tumor progression in the octreotide LAR and placebo groups was 14.3 and 6 months, respectively (hazard ratio [HR] = 0.34; 95% CI, 0.20 to 0.59; P = .000072). After 6 months of treatment, stable disease was observed in 66.7% of patients in the octreotide LAR group and 37.2% of patients in the placebo group. Functionally active and inactive tumors responded similarly. The most favorable effect was observed in patients with low hepatic tumor load and resected primary tumor. Seven and nine deaths were observed in the octreotide LAR and placebo groups, respectively. The HR for overall survival was 0.81 (95% CI, 0.30 to 2.18). CONCLUSION: Octreotide LAR significantly lengthens time to tumor progression compared with placebo in patients with functionally active and inactive metastatic midgut NETs. Because of the low number of observed deaths, survival analysis was not confirmatory.
KW - Humans
KW - Male
KW - Female
KW - Quality of Life
KW - Prospective Studies
KW - Treatment Outcome
KW - Prognosis
KW - Survival Analysis
KW - Abdominal Pain chemically induced
KW - Antineoplastic Agents, Hormonal adverse effects
KW - Diarrhea chemically induced
KW - Double-Blind Method
KW - Intestinal Neoplasms drug therapy
KW - Karnofsky Performance Status
KW - Ki-67 Antigen metabolism
KW - Liver Neoplasms metabolism
KW - Neuroendocrine Tumors drug therapy
KW - Octreotide adverse effects
KW - Placebos
KW - Humans
KW - Male
KW - Female
KW - Quality of Life
KW - Prospective Studies
KW - Treatment Outcome
KW - Prognosis
KW - Survival Analysis
KW - Abdominal Pain chemically induced
KW - Antineoplastic Agents, Hormonal adverse effects
KW - Diarrhea chemically induced
KW - Double-Blind Method
KW - Intestinal Neoplasms drug therapy
KW - Karnofsky Performance Status
KW - Ki-67 Antigen metabolism
KW - Liver Neoplasms metabolism
KW - Neuroendocrine Tumors drug therapy
KW - Octreotide adverse effects
KW - Placebos
M3 - SCORING: Zeitschriftenaufsatz
VL - 27
SP - 4656
EP - 4663
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 28
M1 - 28
ER -
