STUDY DATA
From OncologySTAT
============================================================
reprint
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
J Clin Oncol. 2009 Aug 24; Epub ahead of print, A Rinke, H-H Müller, C Schade-Brittinger, K-J Klose, P Barth, M Wied, C Mayer, B Aminossadati, U-F Pape, M Bläker, J Harder, C Arnold, T Gress, R Arnold
BLOG FUTURE!?
BTW, someone told me "I have a lot of info on this blog and its hard to find data"! And he's damn right!!
Its outgrown what it started out as, and I am thinking about stopping it, or planning to take it down, or just "freeze" it better, and dramatically reduce the # of posts (have to find another hobby anyways...CLOGGING, I think!!).
Perhaps I will turn it into a "Perez Hilton type site" and find celebrity gossip, or make it up, half the time its right anyway, to post (or unusual items)....but it gets more interest on blog, but less cancer lives impacted, trade-off here? Perhaps, and what I want to really do, is to convert this to a Web Site!
A friend of mine offered to help me learn how to develop (I will have time in bed pretty soon- round II!!! baby!!!), so I believe that is the best way to manage the amount of data.......?
Meanwhile, if there is something you are interested in. or want to find out more information on, I probably have it on the blog! Go to the Goggle Search on the left hand side and use the search link to look for items only on the blog (it also lets you choose if you want to look for items from the Internet/goggle)
So, if you want to see the "Bill Moyers insurance interview" for example, enter that on the search button and it should pop up every article with Bill Moyers within the site! Click the link and it will take you there! Hopefully this helps to find what you need!
Over the year of posting, I have a found and also posted A lot of links; very good information, that I have divided, as best I could, in the blog's front page. They are divided into sections, with each link in the sections with a comment.
- For example, there are information on VEGF inhibitors-web site information on the drug (one excellent site with everything you ever wanted to know about all the class of drugs) and also, a couple of links on studies relative to POTENTIAL PROBLEMS with these drugs-- enhanced aggressiveness-- coming out of recent STUDIES! The articles are on the site!
I hope you can find what you need on this blog.
As noted, its much bigger than intended, as I have found this disease, and the information, options, treatments, Md's, therapies, studies, etc, that are available much more than I ever thought possible!
I think perhaps "blogger" is better for topics such as:
"Paris Hilton in bathing suits & 
comments on life, the bars she visits!" Now that is a worthwhile BLOG!!!! Plenty of comments on that blog! FYI, one of the most popular BLOGS is PEREZ HILTON'S Celebrity Gossip site, from the last blogger rating I received...so that tells you what sells in the Internet!
Listen, all who do read this in search of information.
I do wish you the best of luck in your search for information, as there is a lot of it in this site and others, especially the main carcinoid foundations. They have a ton of data! Also, PUB MED, Journal or Nuclear Meds, etc, are places to search once you have graduated into deeper information!
But I do have a lot in here also, and a patients perspective, with my head out the window yelling "I am mad as hell and I am not going to take it anymore"...problem is the damn screen and the suburb neighborhood does not like it so much!
But in this site, IF YOU JUST USE THE GOGGLE SEARCH, AS THE TOOL FOR INFO, YOU MAY GET AN ARTICLE YOU NEED/LOOKING FOR!
I HAVE IT SET UP RIGHT ON THE SITE!!! FOR YOU! ON LEFT SIDE AFTER COUNTER! YOU CAN ALSO USE IT TO SEARCH THE WEB!
Sooooooo, to the readers of this blog- "stay with it" and "keep fighting your fight", if you feel its right thing for you!
Remember, there are a ton of options out there, A TON, and in turn, a ton of info to HELP YOU (and confuse one), DECIDE what may work for you, and your disease! YOU just have to find the right treatment, including the PRRT out of country and PUSH it and FIND THE RIGHT MD supporting CAST. A tall order but can by Done. And watch out for those leading you down the wrong path for their own benefit, or just as bad, no path or all, or totally lost. This blog helps by pointing triggers items out! PRRT & Gallium seems like such a good option and therapy. I am going to try devote my time on that for a while, and most important, focus on PRRT insurance coverage, I need to get or am in bigger financial problem than ever! This is hard work, for no pay or adulation :) none at all to be exact, so its tough. But I love it and do it to help me and help others learn perhaps to avoid the madness I have gone through, and I get to "meet others" love to talk to other and share info, BUT, there come a time in ones life that at times it get to one. It only natural. Perhaps tomorrow will be a better day, but with tumors, edema, insurance issues, pain and more finance issues, I doubt it. Its part of the life through hell journey, though I should be used to it by now!
BTW, I will FINALLY be making the small donation from the earnings that came in this week from the GOGGLE blog advertising clicks (thanks all that supported the ads!!)!! I will post it, later this week or next!
Thanks for all who took the time to support the ads! $122 for a charities!!!!
I was going to add to get to $200, I still may but I have a expense, a PRRT expense, flight, etc including other expenses for LTC that have just about killed me in itself! I should.
What I need, is a damn Ponzi scheme!!!! I have little time left so what the heck!
Perhaps Paris will help with a contribution!
Folks have a got a investment for you all, its in the Jersey Island, all you have to do is invest $10,000 and I will pay you 10% monthly! It a no lose situation and my Friend from Nigeria that writes me daily on the amount waiting for me in a bank there in Nigeria will vouch for the safety of the deal......
THIS IS A JOKE INTERPOL!!!!!!!!!!!!!!!!!!!!!! ----------------------------------------------------------------------------------------------------------------------------------
Supplementary editorial provided by OncologySTATTAKE-HOME MESSAGE
In this prospective, randomized, placebo-controlled study of 85 patients with well-differentiated midgut neuroendocrine tumors, octreotide LAR was associated with significantly prolonged median time to progression, from 6 to 14 months, when compared with placebo. Treatment with octreotide LAR was associated with a benefit with regard to both functionally active and inactive tumors. Resection of the primary tumor and low hepatic tumor load were prognostic for improved outcomes with octreotide LAR. An OS (overall survival) benefit could not be established. The investigators suggest that octreotide LAR should be used as first-line therapy in patients with newly diagnosed, well-differentiated metastatic midgut NETs and with a low hepatic tumor load.STUDY IN CONTEXT
Available treatment options for patients with metastatic well-differentiated neuroendocrine tumors (LOW KI INDEX) (NETs) are associated with adverse events and reduced quality of life. Octreotide LAR, a somatostatin analog that is associated with few adverse events, is currently indicated for symptomatic relief in patients with functionally active NETs. The issue of whether somatostatin analogs control tumor progression is controversial. In this randomized, double-blind study, Rinke et al compared time to tumor progression and overall survival (OS) in patients with well-differentiated metastatic midgut NETs treated with octreotide LAR or placebo.
The study involved 85 treatment-naïve patients, enrolled from March 2001 to January 2008, at 18 German centers. This report includes results from a planned interim analysis performed after 67 progression events and 16 deaths occurred. Patients were randomized to receive either placebo (n = 43) or octreotide LAR 30 mg (n = 42) given intramuscularly every 28 days. Treatment was administered until disease progression. The primary endpoint was time to progression. Secondary endpoints were OS, quality of life, and clinical and biochemical response. Median time from diagnosis to randomization was 4.3 months. Functionally active tumors were defined as those associated with carcinoid syndrome or increased urinary 5-hydroxyindole acetic acid levels.
MY NOTE- 62 patients is VERY SMALL STUDY GROUP!!!!
The primary tumor was surgically removed in 56 patients (66%). The primary tumor site was unknown in 21 patients (25%), 5 of whom had carcinoid syndrome. The majority of patients (n = 73) had liver metastasis, most with hepatic tumor load <10%. n =" 81)">
In a censored analysis of the intention-to-treat population, 26 progressions and 40 tumor-related deaths occurred (hazard ratio [HR], 0.34; 95% CI, 0.20-0.59; P = .000072). The median time to tumor progression was significantly longer in the octreotide LAR group than in the placebo group (14.3 vs 6.0 months). In the per-protocol analysis, the effect of octreotide LAR on time to tumor progression was comparable in functionally active and inactive tumors (HR, 0.23; 95% CI, 0.09-0.57; vs HR, 0.25; 95% CI, 0.10-0.59). In subgroup analyses, low hepatic tumor burden and resection of the primary tumor were prognostic factors for longer time to progression. In particular, the extent of hepatic tumor burden was highly predictive for the antiproliferative effect of octreotide LAR. The median OS endpoint could not be assessed because of the low number of deaths in the study (HR, 0.81; 95% CI, 0.30-2.18; P = .77).
At 6 months after randomization, progression was reported in 10 of 42 patients (23.8%) in the octreotide LAR group and 23 of 43 patients (53.5%) in the placebo group. Stable disease was reported in 28 of 42 patients (66.7%) and 16 of 43 patients (37.2%), respectively. One partial remission was reported in each group! No complete responses were achieved. Tumor response was unknown in 6 patients. Results of a Wilcoxon-Mann-Whitney test showed that responses were significantly more favorable in the octreotide LAR group (P = .0079).
Serious adverse events occurred in 11 patients in the octreotide LAR group (25%) and 10 patients in the placebo group. Treatment was discontinued because of adverse events in 5 and 0 patients, respectively.
This study results showed that that octreotide LAR inhibits tumor growth in patients with metastatic well-differentiated midgut NETs.
Treatment with octreotide LAR in this setting significantly prolonged time to tumor progression in patients with both active and inactive tumors. Resection of the primary tumor and hepatic tumor load <10%>
The investigators suggest that octreotide LAR should be used as first-line therapy in patients with newly diagnosed, well-differentiated metastatic midgut NETs and with a low hepatic tumor load. In addition, octreotide LAR may be appropriate for patients with metastases remaining after surgery (note- why is this statement made? under what basis?)
Further study is needed to evaluate whether octreotide LAR therapy improves OS or can be used in NETs of other origins.
Supplementary editorial provided by OncologySTAT
TAKE-HOME MESSAGE
In this prospective, randomized, placebo-controlled study of 85 patients with well-differentiated midgut neuroendocrine tumors, octreotide LAR was associated with significantly prolonged median time to progression, from 6 to 14 months, when compared with placebo.
Treatment with octreotide LAR was associated with a benefit with regard to both functionally active and inactive tumors. Resection of the primary tumor and low hepatic tumor load were prognostic for improved outcomes with octreotide LAR. An OS (overall survival) benefit could not be established.
The investigators suggest that octreotide LAR should be used as first-line therapy in patients with newly diagnosed, well-differentiated metastatic midgut NETs and with a low hepatic tumor load.
STUDY IN CONTEXT
Available treatment options for patients with metastatic well-differentiated neuroendocrine tumors (LOW KI INDEX) (NETs) are associated with adverse events and reduced quality of life. Octreotide LAR, a somatostatin analog that is associated with few adverse events, is currently indicated for symptomatic relief in patients with functionally active NETs. The issue of whether somatostatin analogs control tumor progression is controversial.
In this randomized, double-blind study, Rinke et al compared time to tumor progression and overall survival (OS) in patients with well-differentiated metastatic midgut NETs treated with octreotide LAR or placebo.The study involved 85 treatment-naïve patients, enrolled from March 2001 to January 2008, at 18 German centers. This report includes results from a planned interim analysis performed after 67 progression events and 16 deaths occurred. Patients were randomized to receive either placebo (n = 43) or octreotide LAR 30 mg (n = 42) given intramuscularly every 28 days. Treatment was administered until disease progression. The primary endpoint was time to progression. Secondary endpoints were OS, quality of life, and clinical and biochemical response. Median time from diagnosis to randomization was 4.3 months. Functionally active tumors were defined as those associated with carcinoid syndrome or increased urinary 5-hydroxyindole acetic acid levels.
MY NOTE- 62 patients is VERY SMALL STUDY GROUP!!!!
The primary tumor was surgically removed in 56 patients (66%). The primary tumor site was unknown in 21 patients (25%), 5 of whom had carcinoid syndrome. The majority of patients (n = 73) had liver metastasis, most with hepatic tumor load <10%. n =" 81)">
In a censored analysis of the intention-to-treat population, 26 progressions and 40 tumor-related deaths occurred (hazard ratio [HR], 0.34; 95% CI, 0.20-0.59; P = .000072). The median time to tumor progression was significantly longer in the octreotide LAR group than in the placebo group (14.3 vs 6.0 months). In the per-protocol analysis, the effect of octreotide LAR on time to tumor progression was comparable in functionally active and inactive tumors (HR, 0.23; 95% CI, 0.09-0.57; vs HR, 0.25; 95% CI, 0.10-0.59). In subgroup analyses, low hepatic tumor burden and resection of the primary tumor were prognostic factors for longer time to progression. In particular, the extent of hepatic tumor burden was highly predictive for the antiproliferative effect of octreotide LAR. The median OS endpoint could not be assessed because of the low number of deaths in the study (HR, 0.81; 95% CI, 0.30-2.18; P = .77).
At 6 months after randomization, progression was reported in 10 of 42 patients (23.8%) in the octreotide LAR group and 23 of 43 patients (53.5%) in the placebo group. Stable disease was reported in 28 of 42 patients (66.7%) and 16 of 43 patients (37.2%), respectively. One partial remission was reported in each group! No complete responses were achieved. Tumor response was unknown in 6 patients. Results of a Wilcoxon-Mann-Whitney test showed that responses were significantly more favorable in the octreotide LAR group (P = .0079).
Serious adverse events occurred in 11 patients in the octreotide LAR group (25%) and 10 patients in the placebo group. Treatment was discontinued because of adverse events in 5 and 0 patients, respectively.
This study results showed that that octreotide LAR inhibits tumor growth in patients with metastatic well-differentiated midgut NETs.
Treatment with octreotide LAR in this setting significantly prolonged time to tumor progression in patients with both active and inactive tumors. Resection of the primary tumor and hepatic tumor load <10%>
The investigators suggest that octreotide LAR should be used as first-line therapy in patients with newly diagnosed, well-differentiated metastatic midgut NETs and with a low hepatic tumor load. In addition, octreotide LAR may be appropriate for patients with metastases remaining after surgery (note- why is this statement made? under what basis?)
Further study is needed to evaluate whether octreotide LAR therapy improves OS or can be used in NETs of other origins.
.JPG)
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