2000miler
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To date, I have compiled data for 347 members, which represents about 14.3% of this organization’s membership. Of these 347 members I have data for 251 cc patients for which I have a detection date, the date on which the patient was diagnosed with a tumor which was later identified as cc by additonal tests, pathology reports, etc. Many members post the dates as only a month and a year, and for these I estimate the actual date as the 15th of the month. Of these 251 patients, 146 have died (94 men and 52 women) and 105 (53 men and 52 women) are either still living or have died and I am not aware of their deaths. In survival studies, these 105 patients are treated as right-censored failures. They represent patients who drop out of studies. In those studies these patients and their times within the study are included in the analyses. In my study, I calculate these times from the last posts made by members in which the patient is still alive or from other sources such as blogs.
In order to process this data, I have downloaded the free R Statistical Program, which has a Survival Package and is used by the professionals for doing Kaplan-Meier estimates, log-rank tests, confidence intervals, Cox regression, and all the good stuff that the professionals who write the medical papers utilize.
My first try with this program was to calculate survivals for these 251 patients and compare men and women.
I used the Kaplan-Meier estimate and log-rank test, and found that the median survival time for men was 1.43 years and for women, 2.47 years. The test had a chisq of 7.5 , 1 degree of freedom, and a p=0.00603, indicating a high confidence level that the data is significant.
The Kaplan-Meier survival curves for men and women tracked together from 100% down to about 60%, after which the men’s curve continued its steep slope, while the slope of the women’s curve decreased, resulting in the greater median survival. At 30% survival, women were 1.67 years greater than men.
Bruce
Thanks Holly. I saw that you had posted elsewhere since your surgery and hadn’t mentioned it, so I was concerned.
So far I have compiled data for 329 cholangiocarcinoma.org members and have found 11 other intrahepatic cholangiocarcinoma patients in the organization who were initially denied surgery because of multiple liver mets. The multiple mets were found in one patient while undergoing a resection and the surgery was stopped because of it. Later, after receiving chemo, which did not shrink the tumors, the patient was resected anyway. Another of these 11 patients was like you, his chemo shrunk the tumors, and he had a successful resection.
I have also found 3 other patients, besides Percy, who have had a resection even though they had multiple liver mets. One of these was like Percy, in that the surgeon did the resection knowing that the liver mets were present. In the other two, the surgeons discovered the liver mets during surgery, but continued with the resections anyway.
Bruce
I changed the name of my topic where I post most of my statistical information from “Cholangiocarcinoma.org Statistics” to “Cholangiocarcinoma.org Statistics (CONTAINS SURVIVAL STATISTICS)” This is in the Geneal Discussion area and is where I post most of the statistics from my cc database. Some of my statistics appear in my other posts but I include them to answer questions or to expand on topics I’ve introduced that did not originally include statistical evidence.
Bruce
Marion – I agree that more patients will improve the statistical significance of the results I presented, but the results are still worth presenting. Statistical significance will improve as I collect more data from the discussion boards and enter it into my spreadsheet.
50 patients were used in my analysis and were divided into two subsets, 33 from the USA and 17 not from the USA.
For comparison, the following article, published in the American Journal of Surgery, discusses a study with 31 patients and the authors were still able to make statments about survival for subsets of the 31 patients, those with R0 resection, negative lymph nodes, a solitary tumor, a width of resection margin greater than 3 mm, and stages III and IV patients who received chemotherapy. I don’t have the complete article, but I bet some of these subsets had less than 17 patients.
http://www.ncbi.nlm.nih.gov/pubmed/15720985
Bruce
Based on actual death data, the median survival time after diagnosis of cholangiocarcinoma for 17 patients living outside the United States is 0.64 years (0.10 – 3.37), whereas for 33 patients living inside the United States, it is double that value, or 1.28 years (0.12 – 5.45).
The countries in my database which are included as outside the USA are Australia, Belgium, Canada, Denmark, France, Greece, India, Mexico, and the United Kingdom.
Bruce Baird
Hi Melinda,
I was adding your data to my cholangiocarcinoma database and your posts on your participation in the NIH trial really got my attention. Thank you so much for being a pioneer in this clinical trial and posting your results to the discussion boards.
Similar to you, my wife has intrahepatic cc and had a resection (72% of liver removed for a 6.4 cm tumor) with clear margins. Unlike you, however, she had a single positive lymph node and adjuvant therapy. The therapy consisted of 4 cycles (rounds) of GemCis, GemCis on both days 1 and 8 and a Neulasta shot for low WBC count on day 9, and the 3rd week off. Also, she is scheduled to have 3D radiation therapy with 5FU starting next Monday, which will be every M-F for the next five weeks.
She had an enhanced CT scan on 2/15/13, which was 0.43 years after her surgery, and it showed no signs of cc. I suspect recurrence will occur within the first year after her surgery, since that is the case for 19 out of the 24 patients (79%) in my cc database who have intrahepatic cc and have had a resection. Maybe she’ll fair better because only three of the 24 had radiation with chemo and for two of those the chemo was cut short. When, and if, this occurs, this clinical trial will definitely be a possible course of action.
Bruce
Julie – In response to your staging statement:
“We weren’t given the staging, although when I asked the oncologist last Wednesday what my Dad’s staging is now given his recurrence, he said Stage III or IV which seems quite an aggressive staging to me after looking at the NCCN guidelines.”
The accepted reference for cancer staging in the United States and elsewhere is the American Joint Cancer Committee Cancer Staging Manual, 7th edition which replaced the 6th edition and became effective 1/1/2010. I believe some doctors still use a previous version of the manual for staging, which may be the situation in your father’s case. For example, many people report that they have IHCC (intrahepatic cholangiocarcinoma), Stage IV, but there is no Stage IV for IHCC in the 7th edition, only a Stage IVA and a Stage IVB, and there is a big difference between the two of them.
From your discripitons of your father’s situation, he was initally T1N0M0 and Stage I. T1 is a solitary tumor without vascular invasion, N0 is no regional lymph node metastases, and M0 is no distant metastases. Usually, a patient is not restaged when his cancer recurs, but if they did restage your father, he would br T2bN0M0 and Stage II. T2b is multiple tumors, with or without vascular invasion.
In order to be stage III, the tumors would have to perforate the visceral peritoneum OR involve local hepatic structures by direct invasion.
To reach stage IVA, a tumor would have periductal invasion OR regional lymph node metastases would be present. My wife had a positive regional lymph node and was stage IVA, but she was resectable. Stage IVB results when distant metastases is present and usually that results in no resection.
Also, the above is just the case for IHCC. Different stagings are used for Perihilar CC (aka Hilar CC or Klatskin) and Extrahepatic CC (aka Distal or Distal Extrahepatic). Whereas the stages for IHCC are 0, I, II, III, IVA, and IVB, the stages for perihilar are 0, I, II, IIIA, IIIB, IVA, and IVB; and the stages for Extrahepatic are 0, 1A, 1B, IIA, IIB, III, and IV.
An example of how staging depends on the type of cc a patient has is illustrated by the impact of a single positive regional lymph node on staging. A positive node can cause a patient with IHCC to be stage IVA, a patient with perihilar cc to be stage IIIB, and a patient with extrahepatic cc to be stage IIB.
Bruce
Julie,
Looking at your past posts, I see that your father’s oncologist did not recommend adjuvant therapy for your father following his R0 resection.
I checked my limited database developed from about a 9% sample of previous posts to these boards and found the following regarding adjuvant therapy for intrahepatic cc patients who had R0 resections.
From May 2001 to June 2008, 5 patients had no adjuvant therapy, 2 had chemo only and 1 had both chemo and chemoradiation.
From November 2008 to Sept 2012, 1 patient had no adjuvant therapy, 7 had chemo only, and 3 had chemo and chemoradiation. Chemoradiation included radiation combined with 5FU or Xeloda pills.
So, it appears from this limited data, that oncologists started changing their tune about adjuvant therapy being helpful to R0 patients around 2008.
Since mid-2008, the only oncologist (besides your dad’s doctor) I have found who didn’t recommend adjuvant therapy for an intrahepatic cc R0 patient, was associated with Mayo Clinic in Rochester, MN. Others who did were associated with Emory University Hosp., Atlanta, GA; Sherman Health, Elgin, IL; Kaiser; Cleveland Clinic, Cleveland, OH; University of Pittsburgh Medical Center, Pittsburgh, PA; a hospital in Lebanon; Jewish Barnes, St. Louis, MO; Kings College Hospital, London, England; and Ochsner Hospital, Jefferson, LA.
Bruce
Julie – I gave some data for adjuvant therapy following resections in the following topic:
http://www.cholangiocarcinoma.org/punbb/viewtopic.php?id=9174
I’ll take a further look in my database for doctors and hospitals that prescribe adjuvant therapy and those that do not. My first impression is that doctors are tending to prescibe it more than they use to because of papers showing that it increases survival rates.
At this point we don’t know if our doctor will give my wife radiation treatments because she has unexplained temperature spikes that show up from 13 to 19 days after her first chemo treatment in a cycle. This has presented itself in each of four cycles. The doctor says that radiation can be hard on the liver. The planned radiation was to be around the surgical markers in her liver, because that is a common place where recurrence takes place. We should find out about the radiation treatments this Monday when we meet with the doctor to discuss a CT scan which my wife had today.
Bruce
The surgery dates for my group ranged from May 2001 to Sept. 2012 so all of my group would be in the Italian post 1999 group. Of the 25, 3 had neoadjuvant chemo before the resection and I don’t have information regarding if they had chemo after the resection. Of the others, 15 had adjuvant or systemic therapy, 6 had none, and 1 was not available.
My database at this time represents only 8% of the foundation’s membership. Considering that the total membership at this time is 2,339, the potential number of members falling into this classification could conceivably be over 300, although it probably won’t be that high since I have been concentrating so far, but not exclusively, on finding members with IHCC.
However, the paper by Olivier Farges, which discussed preliminary analysis of the AJCC 7th edition of TMN Staging for resectable IHCC, used a cohort of 163 patients and the median survival for the entire cohort was 36 months. His study started with 522 patients but excluded 217 of them because of no lymphadenectory, 63 because of no accurate pN staging, 63 because of no R0 resenction, and 16 for other causes. Of the 25 in my database, 15 are R0, 5 appear to be R0, 1 is R1, 2 are R2, and 1 is unknown. So the 25 member cohort should have a lower survival rate than the Farges paper. It’s not, but the 37.4 months I got was pretty close to the 36 months that Farges got.
Bruce
I figured out how to calculate the median survival time using all 25 patients with IHCC who have had resections, by substituting last post date for follow-up date. The final result increased the median survival time from 33.3 months to 37.4 months, still a lot lower than the Italians got.
Bruce
Thanks Pam and Marion. I think I read on these discussion boards that you shouldn’t take NSAIDs, including aspirin & ibuprofen, when you’re having chemo and my oncology nurse daughter said the same thing, so Margaret hasn’t taken these since she started chemo. She also won’t take Tylenol because she read that it was bad for the liver. During the second ER visit, the doctor suggested she take an ibuprofen to reduce the fever and Margaret refused.
Bruce
I just looked at the abstract and saw that the median survival time for all 72 patients was 57.1 months, which seemed high to me. My database of foundation members has 25 patients with IHCC who have had resections. I have surgery dates and death dates for nine of those, and for this group the median survival time from surgery is 33.3 months.
Usually these studies use an algorithm for calculating median survival times which include patients with a last follow-up before the end of the study, so the authors don’t know if the patient has died or not. I could probably do that with the data I have using the time between surgery and the last post, but I’ll have to explore this further.
Other than that, what do the Italians know that the Americans don’t know?
Bruce
