BACKGROUND & AIMS: The effect of octreotide plus interferon-alpha versus octreotide monotherapy on the primary study end points of time to treatment failure (progression, death, stop of study treatment) and long-term survival was investigated in patients with progressive metastatic neuroendocrine foregut (mainly pancreatic) and midgut tumors. METHODS:One hundred nine of 125 registered patients were randomized starting in January 1995, and 105 patients (51 monotherapy, 54 combination treatment) were finally analyzed in March 2000. Tumor growth was assessed at 3-month intervals by computed tomography or magnetic resonance imaging. Long-term survival was studied up to April 2004 in all analyzed patients and in 9 patients not randomized because of stable disease. RESULTS:Partial tumor regression occurred in 2.9%, 1.9%, and 5.7% and stabilization of tumor growth in 44.8%, 27.6%, and 15.2% at 3, 6, and 12 months, respectively, with no significant differences between both treatment arms. In March 2000, 9.5% of patients were in treatment. Time to treatment failure and long-term survival did not differ significantly between the 2 groups, with a median survival of 32 and 54 months for the octreotide and the combination groups, respectively. Survival was longer in patients not randomized because of stable disease (median, 68 months) and in those with low nuclear Ki-67. A trend toward longer survival was shown for patients with slow spontaneous tumor growth before randomization. Patients responding to treatment lived longer than unresponsive patients. CONCLUSIONS: Combination treatment was not superior to monotherapy concerning progression-free and long-term survival. Patients responding to treatment and those with slow spontaneous tumor growth had a survival advantage.
RCT Entities:
BACKGROUND & AIMS: The effect of octreotide plus interferon-alpha versus octreotide monotherapy on the primary study end points of time to treatment failure (progression, death, stop of study treatment) and long-term survival was investigated in patients with progressive metastatic neuroendocrine foregut (mainly pancreatic) and midgut tumors. METHODS: One hundred nine of 125 registered patients were randomized starting in January 1995, and 105 patients (51 monotherapy, 54 combination treatment) were finally analyzed in March 2000. Tumor growth was assessed at 3-month intervals by computed tomography or magnetic resonance imaging. Long-term survival was studied up to April 2004 in all analyzed patients and in 9 patients not randomized because of stable disease. RESULTS: Partial tumor regression occurred in 2.9%, 1.9%, and 5.7% and stabilization of tumor growth in 44.8%, 27.6%, and 15.2% at 3, 6, and 12 months, respectively, with no significant differences between both treatment arms. In March 2000, 9.5% of patients were in treatment. Time to treatment failure and long-term survival did not differ significantly between the 2 groups, with a median survival of 32 and 54 months for the octreotide and the combination groups, respectively. Survival was longer in patients not randomized because of stable disease (median, 68 months) and in those with low nuclear Ki-67. A trend toward longer survival was shown for patients with slow spontaneous tumor growth before randomization. Patients responding to treatment lived longer than unresponsive patients. CONCLUSIONS: Combination treatment was not superior to monotherapy concerning progression-free and long-term survival. Patients responding to treatment and those with slow spontaneous tumor growth had a survival advantage.
Authors: Bruno Kovic; Xuejing Jin; Sean Alexander Kennedy; Mathieu Hylands; Michal Pedziwiatr; Akira Kuriyama; Huda Gomaa; Yung Lee; Morihiro Katsura; Masafumi Tada; Brian Y Hong; Sung Min Cho; Patrick Jiho Hong; Ashley M Yu; Yasmin Sivji; Augustin Toma; Li Xie; Ludwig Tsoi; Marcin Waligora; Manya Prasad; Neera Bhatnagar; Lehana Thabane; Michael Brundage; Gordon Guyatt; Feng Xie Journal: JAMA Intern Med Date: 2018-12-01 Impact factor: 21.873
Authors: Zhi Rong Qian; Tingting Li; Monica Ter-Minassian; Juhong Yang; Jennifer A Chan; Lauren K Brais; Yohei Masugi; Arunthathi Thiaglingam; Nichole Brooks; Reiko Nishihara; Mireille Bonnemarie; Atsuhiro Masuda; Kentaro Inamura; Sun A Kim; Kosuke Mima; Yasutaka Sukawa; Ruoxu Dou; Xihong Lin; David C Christiani; Fabien Schmidlin; Charles S Fuchs; Umar Mahmood; Shuji Ogino; Matthew H Kulke Journal: Pancreas Date: 2016-11 Impact factor: 3.327