51 (edited by 2000miler Tue, 04 Jun 2013 11:59:59)

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

This post was first postesd on 6/1/13 and edited on 6/4/13 to correct for the inclusion of Klatskin and other tumor data that was contained in the SEER Bile Duct - Intrahepatic file, but was not intrahepatic cholangiocarcinoma.  This data has been eliminated in this revised analysis.  Also, some surgery cases where the surgery could not be specifically identified as a resection were included in the previous analysis.  These were mostly pre-1998 data where surgical codes were not included in SEER.  These were also eliminated in this analysis.


This is my first analysis using SEER (Surveillance Epidemiology and End Results) data.  I requested a CDROM when I submitted my application to SEER, but just received a username and password to their online data, so I just used that in this analysis.

SEER has several databases and sites containing cholangiocarcinoma data, some of which is duplication, and some of which is not.  I used the database "Incidence - SEER 18 Regs Research Data + Hurricane Katrina Impacted Louisiana Cases, Nov 2012 Sub (1973-2010 varying)" and the Site and Morphology "CS Schema v0204"  The SEER 18 database has the latest data which goes through 12/31/2010.  I found Intrahepatic CC patients in three ofther Site and Morphology sections, but the CS Schema v0204 had the most, a total of 11,789.

The survival curves below show that a single postive node substantially reduces survival for patients who have resected intrahepatic cholangiocarcinoma.

In the analysis, I eliminated those patients with mutiple cancers, patients who had non-resection surgery, and patients who died from causes other than intrahepatic cc or its complications.  A total of 355 patients were used in the analysis.  These patients were diagnosed with intrahepatic cc from 1998 - 2010, median 2006.  Their ages ranged from 17 - 84, median 59 years.

Median survival is 3.42 years for 0 positive LNs and 1.33 years for 1 positive LN.   Statistical parameters for the analysis are Chsq = 33.9, 1 degree of freedom, p = 5.78 e-09.  I wanted to do this analyis from the start using the posted Cholangiocarcinoma Foundation data, but never could find sufficient data to get a statistically significant comparison.  However,  I will add those to the plot in a later post to show comparison between those from the boards and SEER's.

Bruce Baird


https://sites.google.com/site/bbairdsr/seer3.png

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

52 (edited by 2000miler Tue, 04 Jun 2013 12:12:50)

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

EDIT [The original post was made after the original survival analysis.  The woman referred to actually had cystadenocarcinoma, not cholangiocarcinoma.  The longest surviving cholangiocarcinoma patient was a San Francisco County, CA man who died 26.6 years after his diagnosis.]


I forgot to mention that the longest surviving patient in the CS Stema v0204 intrahepatic cc section is a woman, diagnosed in January, 1977 in Alameda County, CA, who was still alive on 12/31/2010, a 33.9 years survivor.  She is not included in the analysis since there was no lymph node data for her.

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

good information Bruce.  Maybe I haven't read all of your posts, but have you done the stats for extrahepatic CC?

Survivor of cholangiocarcinoma (2009), thyroid cancer (1999), and breast cancer (1994).

My comments, suggestions, and opinions are based only on my personal experience as a cancer survivor. Please consult a physician for professional guidance.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

I haven't done the extrahepatic CC cases yet, but I should be able to do those. 

I was hoping to find SEER data to do the two components of extrahepatic cc separately.  These two components are refererred to in the 7th edition of the AJCC as perihilar (aka Klatskin) and extrahepatic (aka distal). 

CS Schema v0204 shows bile duct data as Bile Ducts Intrahepatic (11,789 patients), Bile Ducts Perihilar (13,099 patients) and Bile Ducts Distal (387 patients).  Most of the Bile Ducts Distal data is from 2010, which was the year the 7th edition of the AJCC became effective and extrahepatic cc was divided into perihilar and distal.  For 2010, bile duct data in CS Schema v0204 is divided into intrahepatic (881, 51.0%), perihilar (510, 29.5%), & distal (337, 19.5%).   The distribution for extrahepatic cc is, perihilar (60.2%) and distal (39.8%).  Using 39.8% for distal, I would have expected to see about 5,367 cases of distal bile duct cancer in CS Schema v0204, instead of the very small 387 cases that are there, so something is definitely wrong with the process in which pre-2010 cases of extrahepatic cc has been divided into perihilar and distal.

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Bruce, take a look at the articles below. Klatskin (hilar) tumors were misclassified as intrahepatic in the second edition of the ICD-O. Misclassification affected SEER data.

Impact of classification of hilar cholangiocarcinomas (Klatskin tumors) on the incidence of intra- and extrahepatic cholangiocarcinoma in the United States.
http://www.ncbi.nlm.nih.gov/pubmed/16788161

Re: Impact of Classification of Hilar Cholangiocarcinomas (Klatskin Tumors) on Incidence of Intra- and Extrahepatic Cholangiocarcinoma in the United States
http://jnci.oxfordjournals.org/content/99/5/407.1.long

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Many many thanks for this Bruce.  I know that it must take you quite some time to go through all of the data etc to produce these reports here. Thanks again for all of your work and efforts with this.

Best wishes,

Gavin

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Oh my, you guys are amazing!! I am afraid I am a statistical idiot for the most part.  I have a research thesis to do this year and it is daunting to me. 

I so admire your ability to make sense of things and explain it to those of us that are statistically-challenged.

-Randi-

Survivor of cholangiocarcinoma (2009), thyroid cancer (1999), and breast cancer (1994).

My comments, suggestions, and opinions are based only on my personal experience as a cancer survivor. Please consult a physician for professional guidance.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Eli - Thanks for the information on the Klatskin tumors being incorrectly cross-references to intrahepatic cc.  The articles were written in 2006 and 2007, so I would have thought that the problem had been corrected in the Collaborative Stage Data Collection System version 2:0204, dated 12/5/11, which I used.  Unfortunately, it hasn't been corrected.  I hadn't downloaded histology data for the intrahepatic bile duct cancer data, but I found it as one of the parameters available and downloaded it.  It refers to ICD-0-3.  There were 779 patients coded 8162/3 Klatskin and included in the intrahepatic bile duct data.

I also noticed that there were 2,200 other patients among the 11,789 I downloaded as intrahepatic bile duct cancer, which were not coded as cholangiocarcinoma.  I'll need to eliminate the Klatskin and these other patients from the analysis and revise the above plots.  Evidently bile duct cancer and cholangiocarcinoma are not the same.

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Below are histology codes and malignant tumors found in SEER which are not intrahepatic cholangiocarcinoma but are considered as intrahepatic bile duct cancers.

8000/3: Neoplasm, malignant
8001/3: Tumor cells, malignant
8010/3: Carcinoma, NOS
8012/3: Large cell carcinoma, NOS
8020/3: Carcinoma, undifferentiated type, NOS
8031/3: Giant cell carcinoma
8032/3: Spindle cell carcinoma
8033/3: Pseudosarcomatous carcinoma
8041/3: Small cell carcinoma, NOS
8046/3: Non-small cell carcinoma
8050/3: Papillary carcinoma, NOS
8070/3: Squamous cell carcinoma, NOS
8124/3: Cloacogenic carcinoma
8140/3: Adenocarcinoma, NOS
8141/3: Scirrhous adenocarcinoma
8161/3: Bile duct cystadenocarcinoma
8180/3: Combined hepatocellular ca. & cholangiocarcinoma
8240/3: Carcinoid tumor, malignant
8246/3: Neuroendocrine carcinoma
8260/3: Papillary adenocarcinoma, NOS
8310/3: Clear cell adenocarcinoma, NOS
8440/3: Cystadenocarcinoma, NOS
8453/3: Intraductal papillary-mucinous carcinoma, invasive
8470/3: Mucinous cystadenocarcinoma, NOS
8480/3: Mucinous adenocarcinoma
8481/3: Mucin-producing adenocarcinoma
8490/3: Signet ring cell carcinoma
8500/3: Infiltrating duct carcinoma, NOS
8560/3: Adenosquamous carcinoma
8800/3: Sarcoma, NOS
8980/3: Carcinosarcoma, NOS
9100/3: Choriocarcinoma
9120/3: Hemangiosarcoma

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

I couldn't find surgical margin or chemo data in SEER so I emailed them about it.  Their response, in short, was that they do not collect surgical margin data and the limited chemo data they collect are not released to the public but may be available through special request.  Radiation data is in SEER.

I was hoping to use SEER data to determine the effectiveness of adjuvant therapy for cc, but I suppose I will have to depend on posts to these discussion boards to calculate this.

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

61 (edited by PCL1029 Mon, 03 Jun 2013 15:48:34)

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Hi,  Bruce,
Well done.
One request, can you recommend some article  that I can read and understand about the "  95%confident  interval "
God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Bruce,

This is a fabulous stream of information. Thank you for your energy and determination in gathering all this information and making sense of it for the rest of us.

I will send you information on my wife to add to your database.

To all who have added comments; You are definitely a great support group and I want to say thank you as a caregiver. I look forward to reading the comments in this message stream.

Carl

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Percy - There are a lot of explanations on the web (Wikipedia, You Tube, etc.) concerning the "95% confidence interval," "null hypothesis," and p-value, but they generally involve statistical terms and numbers and are not representative of survival analysis.

The survival curves I've plotted so far are based on samples of cholangiocarcinoma.org data and the SEER data.  Both of these databases are themselves only a sample of all the cholangiocarcinoma cases in the cholangiocarcinoma universe, which would be the world for cc.org and the USA for the SEER data.  The curves are all approximate, since I'm working with a sample and not the whole universe.  If I used another sample of the same size, I would get a different curve.  If I had 100 samples, each the same size, I would get 100 different curves.  On average, 95 of these curves would lie between an upper curve and a lower curve.  This is the 95% confidence interval.  The R statistical software I use plots the 95% confidence interval for each curve and I will do that for my corrected SEER IHCC curves to better illustrate this.  I haven't shown them in the past because they clutter up the plot.

The "null hypothesis" assumes there is no relationship between two measured phenomena.  For example, in my last plot, the "null hypothesis" assumes that survival will be be the same with 0 or 1 positive node.  If this was the case, the curves would lie on top of each other, but they could be separated solely because they are two independent samples.  The question, are they separated because they are just two different samples, or are they separated because survival is dependent on positive nodes.  The answer is in the p-value, which gives the probabilitiy that they are different because they are just two independent samples.  Generally researchers would use a p-value equal to or less than 0.05 as evidence that the difference is because survival is dependent on positive nodes (>=95%) and not just different samples (<=5%)

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Thanks for that Bruce, great work you are doing here!

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

I have corrected the original post with the plot of survival for Resected SEER Intrahepatic CC Patients.  Median survival increased from 2.50 years to 3.42 year for 0 positive node patients and 1.25 to 1.33 years for 1 positive node patients.

Percy - I tried to include 95% confidence intervals for the two curves, but had trouble.  However, I do have 95% confidence intervals for the median survivals.  For the 0 positive node case, the 95% confidence interval is 2.33 - 4.50 years and for the 1 positive node case, it is 1.17 - 1.67 years.

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Hi, Bruce,

Thanks for your tremendous analytical skill. Extreme helpful.
I have just come home from ASCO; and I have to ask you to see whether one of the session presenter's opinion is valid or not.  I talked to him about the usage of the HR, the p value and  the 95% CI with regard to determine ,compare and validate the studies of, for example, of the efficacy,OS and toxicities on three studies of the SAME drug combo. GEM/CIS.(assumed the 3 studies are very similar in population, age and risk factors, stages ,and metastasis.etc. )
Here is the interesting part ;he told me after the session when I approached him and asked him," If you are sitting on the FDA committee and trying to approve  or disapprove a new  drug, what is the most important statistic tool (HR,<p value or CI )you will use  to determine your vote of approval?" He said, he will use ONLY the CI .

Bruce, will you shed some light on his comment to help me to understand his logic? I ask how about the HR and p value? He said no, He will just use the CI?

God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

67 (edited by 2000miler Tue, 04 Jun 2013 18:02:22)

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Percy - If it was survival analysis, I would have picked HR (hazard ratio).  I've read several technical papers on cholangiocarcinoma survival and CI is usually not even mentioned.  I took a quick look at the papers and found one by Yamashita, et al. "The Impact of Surgical Treatment and Poor Prognostic Factors for Patients with Intrahepatic Cholangiocarcinoma: Retrospective Analysis of 60 Patients."  Table III in it is "Multivariate analysis to determine poor prognosis factors.  Here's part of it:

Overall survival     Hazard ratio     95% CI        p-factor
n(+)                          28.3           5.4-148.0       <0.01
ly(+)                            8.5           2.3-30.5           0.01
Poorly diff.                    8.3           2.4-29.2           0.01
R1/2                             6.4           1.4-28.7           0.01

First of all confidence interval, by itself, means nothing.  It is only meaningful in that it gives you a measure of how much the Hazard ratio can vary.  Likewise, p-factor is only significant in that it tells you the calculation of Hazard ratio was statistically significant.

Now, I'm not familiar with measures of efficacy,OS and toxicities for your drug combo.  Efficacy is the capacity to produce an effect.  If that effect is a longer life, then it appears to me that Hazard ratio, CI, and p-factor would have the same role as in overall survival.

I'm probably missing something here.

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Bruce....you won't find any data re:  adjuvant therapy for cc - it has not been collected.  What will be of most interest is the data collected from the Bilcap trial presently undergoing in the UK.  This trial will prove the efficacy of  Gemcitabine (Gemzar) in adjuvant settings.  Data will be released in 2014.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

From 2011, AMMF's meeting with Cancer Research UK re BILCAP trial -

http://www.ammf.org.uk/2011/09/22/meeti … re-bilcap/

BILCAP ASCO poster from ASCO 2011 -

http://www.ammf.org.uk/wp-content/uploa … JUNE-2.pdf

Thanks to Helen at AMMF for this.

Just thought I'd post this for those interested in BILCAP who may not have heard of it.

Gavin

Any advice or comments I give are based on personal experiences and knowledge and are my opinions only, they are not to be substituted for professional medical advice. Please seek professional advice from a qualified doctor or medical professional.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Hi,  Bruce
Thanks for your insight, you may be correct, we may miss to account for the time element for the efficacy, but i agree of using the HR for survival studies;for the toxicity study, we may need the time element and the degree too.In the mean time I will just use all of available statistic tools to compare the studies.
I think what the presenter's comment is  just a simple answer due to the fact that some people were also there to ask specific questions and he just want to answer them all while the time is short.
But I will look into the statistic or going to a seminar for a day to refresh my memory.
thanks again, Bruce.

God bless.

Please know that my personal opinion is not intended nor implied to be a substitute for professional medical advice. If  provided, information are for educational purposes.Consult doctor is a MUST for changing of treatment plans.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Marion - According to the literature, the BILCAP trial is studying the effects of capecitabine (Xeloda), not Gemzar, vs. no capecitabine, for R0 & R1 resected intrahepatic cc, extrahepatic cc (Klatskin, hilar), lower common bile duct cc (distal), and muscle invasive gallbladder cancer.  As stated in their literature, the primary objective is an increase in 2-year survival from 20% to 32%.  Patients are from England and Wales.

Right now GemCis seems to be the "standard" for adjuvant therapy, even thought many oncologists are still prescribing other chemo therapies.  This "standardizaton" is most likely based on the results of ABC-02 trial which compared the results of GemCis with those of Gemzar alone for 410 patients from the United Kingdom with locally advanced or metastatic cholangiocarcinoma, gallbladder cancer, or ampullary cancer.  The results were a median overall survival of 11.7 months for the GemCis group vs. 8.1 months for the Gemzar group.  Time started from the date of randomization, not from the date of diagnosis.

Now, my SEER data plots of survival for resected IHCC & ECC (Klatskin + distal), shows that in the USA, 2-year survival is about 55% for 0 positive node, and about 30% for 1 positive node.  These results include patients who are R0, R1, and R2, may or may not have had chemo and/or radiation.  So what's the big deal about trying to improve 2-year survival from 20% to 32%.  One of my previous analyses showed that the USA leads the rest of the world in achieving increases in survival for cholangiocarcinoma patients, and maybe that is the case here.

In any case, unless the BILCAP results are much better than expected, I don't see how a USA oncologist could prescribe Xeloda over GemCis for R0 & R1 resected cholangiocarcinoma patients.

Eventually, I will gather enough cc.org board data to produce statistically significant survival plots showing the effectiveness of chemo adjuvant therapy for resected R0 patients.

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

72 (edited by 2000miler Wed, 05 Jun 2013 13:13:33)

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

The following survival plot is for resected SEER cholangiocarcinoma patients.  As for the intrahepatic cholangiocarcinoma plot,   I used the database "Incidence - SEER 18 Regs Research Data + Hurricane Katrina Impacted Louisiana Cases, Nov 2012 Sub (1973-2010 varying)" and the Site and Morphology "CS Schema v0204."   This site has data coded as BileDucts Perihilar, BileDuctsDistal, BileDuctsIntraHepat, and BiliaryOther.  Unfortunately, Klatskin data has been incorrected coded and placed in all four lists plus other unidentified locations.  However, it appears all the Klatskin data is also coded in the site ICD-O-3 Hist/behav.  There were 1362 cases of Klatskin in this site. These were duplicated in the other lists with 779 in the BilesDuctIntraHepat, 527 in the BilesDuctPerihilar (where they all should have been), 1 in BileDuctDistal, 31 in OtherBiliary, and 24 in unknown lists.  The analyzed database for ECC was Perihilar & Distal without Klatskin and the Klatskin list form ICD-O-3 Hist/behav.

Again the survival curves below show that a single postive node substantially reduces survival for patients who have resected extrahepatic  cholangiocarcinoma, although the reduction is not as much as for intrahepatic cholangiocarcinoma, 63.1% for ECC vs. 38.9% for ICC for median survivals.

Patients in the database were eliminated from the analysis based on the same criteria used for the intrahepatic cholangiocarcinoma analysis.  A total of 336 patients were used in the analysis.  These patients were diagnosed with extrahepatic cc from 1998 - 2010, median 2006.  Their ages ranged from 12 - 87, median 65 years.

Median survival is 2.25 years for 0 positive LNs and 1.42 years for 1 positive LN.   Statistical parameters for the analysis are Chsq = 17, 1 degree of freedom, p = 3.82 e-05.

The longest survivor in the database was a deceased man from Alameda County, CA with a resected Klatskin tumor, 22.8 years.  He is not included in the analsis.

Bruce Baird

https://sites.google.com/site/bbairdsr/seer2.png

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Bruce....thanks for pointing out my error, it is much appreciated.  Having said that, dear Bruce, at present there is no data reflecting survival benefit derived from post resection based adjuvant therapy.  I believe that we are close, but at this point, physicians determine such therapy individually. 
It would be interesting to see the results from your data collection based on the postings of this site re: adjuvant therapy. 
Thanks so much for providing information to the patient community at large.
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

74 (edited by 2000miler Wed, 05 Jun 2013 19:25:52)

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Marion - If you mean there are no large (phase 3) randomized studies reflecting survival benefit derived from post resection adjuvant therapy, I agree with that.

However, there are small retrospective studies, based on small to large populations, that show there is a benefit.  There are others that also say there is no benefit.  Maybe others even show a negative impact.

Just glancing at some of the papers on my desk:

1. Murakami, "Gemcitabine-based adjuvant chemotherapy improves survival after aggressive surgery for hilar cholangiocarcinoma,", 2009, 42 patients, "Five-year actuarial survival rates of patients who did or did not receive adjuvant gemcitabine-based chemotherapy were 57% and 23%, respectively (P=0.026)."

2. Shinohara, "Radiotherpy is associated with improved survival in adjuvant and palliative treatment of extrahepatic cholangiocarcinomas", 2009, 4,758 patients, "The median overall survival time was 16 months for surgery and RT and 9 months for surgery alone.

3. Nakeeb, "Radiation therapy, chemotherapy and chemoradiation in hilar cholagiocarcinoma", 2005, "A carefully controlled trial from the John Hopkins Hospital did not demonstrate any benefit for adjuvant radiation therapy. A number of phase II trials of chemotherapy have demonstrated modest response rates (20-40%)...... Neither radiation therapy nor chemotherapy alone has been proven to prolong survival in completely or partially resected patients or in unresected patients."

4. Cereda, "Adjuvant treatment in biliary tract cancer: To treat or not to treat?", 2011, "A retrospective series of 73 patients with gallbladder cancer treated between 1985 and 2004 at Mayo Clinic suggested that adjuvant CRT may obtain a statistically significant improvement in OS only for patients with lymph node involvement ..... A more recent phase III trial exploring the role of single agent adjuvant chemotherapy with either gemcitabine or 5-fluorouracil, in 304 patients with ampullary adenocarcinoma submitted to curative resection did not demonstrate a survival benefit for any of the adjuvant therapy arms when compared to surgery alone."

And there are many more.  I should look at all this in detail and try and figure out why the results vary so much.

Bruce

Please be advised that any advice or information in my posts is my personal opinion only and is not intended nor implied to be a substitute for professional medical advice.  ALWAYS seek the advice of your physician or other qualified health care provider.

Re: Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)

Bruce...phase II studies need to be followed up by large, phase III studies in order to validate the findings.  They generally are randomized and compare the investigational drug to another or, to a standard of treatment, if applicable. 
Biliary tract cancers include, gallbladder, ampulla of Vater, and pancreatic cancer, but the reality is that these are four different diseases.  We know for sure that gallbladder has a completely, different cell structure; the others have similarities but they are not the same. 
I believe that Phase II clinical studies lumping together these disease simply cannot present with accurate data.  Stratification helps but the true meaning of a study can only derive from a large amount of patients presenting with the same disease, in Phase III studies.
Having said that, there still is uncertainty re: extrahepatic vs. intrahepatic bile duct cancer.  Is it the same cancer? 
In an ideal setting we would like to see large scale, Phase III clinical trials,  extrahepatic and intrahepatic, separated.  The later is unlikely to happen, as recruitment is not feasible due to low volume of available patients.
But it could happen if more international clinical trials were conducted.  That again has been hindered by the recent decision that virtually no global clinical trials will be supported by the government - we lack the necessary funding.  This in turn will lead us to the pharma industry.  Not a question of money here, but a question of return on the investments. Oh my, I better stop here. 
Hugs,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER