Immunotherapy in Switzerland

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mpbser
Posts: 854
Joined: Wed Apr 19, 2017 11:52 am

Immunotherapy in Switzerland

Postby mpbser » Fri May 03, 2019 6:11 pm

https://www.int-imm-foundation.com/en/o ... tients.htm

Has anyone heard about this? Thoughts?
Wife 4/17 Dx age 45
5/17 - Lap left
Adenocarcinoma
5 x 4 x 1 cm
low grade
T3 N2b M1a
Stage IV A
8/17 Sub-total colectomy
2nd tumor 5.5 cm T1 N0
lymph nodes: 9 of 96
CEA: 2.9 to 2.2
MSS/MSI-L
Lynch no; KRAS wild
Immunohistochemsistry Normal
Tumor DNA variants: MTOR, APC, TP53
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI shows 1 met in liver
Resection & HAI Mar 7
Folfiri & FUDR started Apr 1

Pyro70
Posts: 75
Joined: Mon Jan 21, 2019 4:25 pm

Re: Immunotherapy in Switzerland

Postby Pyro70 » Sat May 04, 2019 12:06 pm

“Data show: effective against most, perhaps all solid tumor types“

This should set off a BS alarm. Where are the clinical trials that show efficacy/safety? I see a lot of “data” intended to confuse the uneducated under publications but no clinical trial data.

Let’s say it did work, why wouldn’t your oncologist have heard about it?
Dx Jan 2017 stage IVB w/ PC age 35
FOLFOX
SEP 17 HIPEC 1, anastamosis leak
XELODA
MAR 18 HIPEC 2
JUN 18, ileo reversal and 2nd anastamosis leak

zephyr
Posts: 216
Joined: Thu Aug 18, 2016 7:31 am

Re: Immunotherapy in Switzerland

Postby zephyr » Sat May 04, 2019 5:09 pm

Pyro70 wrote:Let’s say it did work, why wouldn’t your oncologist have heard about it?


It's been my personal experience that U.S. based oncologists only know about treatments that have gone through the expensive and time consuming process of FDA approval. While that certainly prevents patients from learning about "BS" treatments, it also keeps out information about treatments that are legitimate and effective. For example, I had the YAG laser surgery in Germany. I spoke with 3 oncologists and 2 thoracic surgeons here in the U.S. and none of them knew anything about it ahead of time. Three of the five doctors tried to discourage me from going but they were all impressed with the results when I returned and all my "inoperable" tumors were gone. That said, I did a lot of research ahead of time and communicated with others who had undergone the surgery. I'm not passing judgment one way or the other on the treatment in Switzerland, only saying that's in been my experience not to discount anything just because it's not known or available in the U.S.
Nov-2009 Early stage CRC found during routine colonoscopy
2010, 2011, 2014 Follow up colonoscopies, all clear
Jun-2016 CRC found during routine follow up colonoscopy, surgery, Stage 4, KRAS, MSS, inoperable lung mets
Aug-2016-May-2018 Folfox, 5FU & Avastin, 5FU, Folfiri & Cyramza
Aug/Sep-2018 YAG laser surgeries (Germany) on both lungs, 11 nodules (9 mets) removed
Nov-2018 clean CT scan
Mar-2019 New lung nodules
April-2019 Xeloda + Avastin

Pyro70
Posts: 75
Joined: Mon Jan 21, 2019 4:25 pm

Re: Immunotherapy in Switzerland

Postby Pyro70 » Sat May 04, 2019 6:42 pm

zephyr wrote:
Pyro70 wrote:Let’s say it did work, why wouldn’t your oncologist have heard about it?


It's been my personal experience that U.S. based oncologists only know about treatments that have gone through the expensive and time consuming process of FDA approval. While that certainly prevents patients from learning about "BS" treatments, it also keeps out information about treatments that are legitimate and effective. For example, I had the YAG laser surgery in Germany. I spoke with 3 oncologists and 2 thoracic surgeons here in the U.S. and none of them knew anything about it ahead of time. Three of the five doctors tried to discourage me from going but they were all impressed with the results when I returned and all my "inoperable" tumors were gone. That said, I did a lot of research ahead of time and communicated with others who had undergone the surgery. I'm not passing judgment one way or the other on the treatment in Switzerland, only saying that's in been my experience not to discount anything just because it's not known or available in the U.S.



I’m sure if there were such an amazing cure as the Switzerland immunotherapy everyone would know about it. But I understand your point about docs only knowing their sandbox. That being said, I’m pretty sure the YAG treatment is approved by EU regulators. Switzerland treatment, not so much...

Btw. Off topic, but why YAG? Could it remove tumors that could not be treated by radiation, percutaneous ablation, or surgery?
Dx Jan 2017 stage IVB w/ PC age 35
FOLFOX
SEP 17 HIPEC 1, anastamosis leak
XELODA
MAR 18 HIPEC 2
JUN 18, ileo reversal and 2nd anastamosis leak

zephyr
Posts: 216
Joined: Thu Aug 18, 2016 7:31 am

Re: Immunotherapy in Switzerland

Postby zephyr » Sat May 04, 2019 7:49 pm

Pyro70 wrote:Btw. Off topic, but why YAG? Could it remove tumors that could not be treated by radiation, percutaneous ablation, or surgery?


Yes. That was exactly my situation: my lung tumors could not safely be treated with radiation, ablation, surgery or any other treatment available in the U.S. The YAG removed them all.
Nov-2009 Early stage CRC found during routine colonoscopy
2010, 2011, 2014 Follow up colonoscopies, all clear
Jun-2016 CRC found during routine follow up colonoscopy, surgery, Stage 4, KRAS, MSS, inoperable lung mets
Aug-2016-May-2018 Folfox, 5FU & Avastin, 5FU, Folfiri & Cyramza
Aug/Sep-2018 YAG laser surgeries (Germany) on both lungs, 11 nodules (9 mets) removed
Nov-2018 clean CT scan
Mar-2019 New lung nodules
April-2019 Xeloda + Avastin

mpbser
Posts: 854
Joined: Wed Apr 19, 2017 11:52 am

Re: Immunotherapy in Switzerland

Postby mpbser » Sun May 05, 2019 6:22 am

I believe that data to which the page referred was the data presented here: https://www.int-imm-foundation.com/en/p ... ations.htm which leads the doctors at this place to theorize: The fact that anti-tumor activity is seen in such a diverse group of tumors following OncoPherese supports the idea of a common immune inhibitory mechanism active in all solid-tumor cancers.
Wife 4/17 Dx age 45
5/17 - Lap left
Adenocarcinoma
5 x 4 x 1 cm
low grade
T3 N2b M1a
Stage IV A
8/17 Sub-total colectomy
2nd tumor 5.5 cm T1 N0
lymph nodes: 9 of 96
CEA: 2.9 to 2.2
MSS/MSI-L
Lynch no; KRAS wild
Immunohistochemsistry Normal
Tumor DNA variants: MTOR, APC, TP53
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI shows 1 met in liver
Resection & HAI Mar 7
Folfiri & FUDR started Apr 1

rp1954
Posts: 1504
Joined: Mon Jun 13, 2011 1:13 am

Re: Immunotherapy in Switzerland

Postby rp1954 » Mon May 06, 2019 11:50 am

mpbser wrote:https://www.int-imm-foundation.com/en/oncopherese/for-prospective-patients.htm
Has anyone heard about this? Thoughts?

It's entirely new to me but interesting. Since the video quoted only 35% major responses with CRC patients (+12% "responses") , I'd definitely want more specific and up-to-date information on all their CRC patients to narrow the selection (other companion markers? durability, side effects compared to dialysis, etc), and perhaps view this as a treatment component rather than a stand alone treatment. Typically one spends months accumulating information before any big moves.

What's not obvious here is how much they already use combined treatments or might gain with more recent experience on combinations, obvious or other sources. Your insurance's participation would probably be a big factor too. I would assume at least $40,000+ associated costs "per cycle" with expenses, and maybe a lot more.

Pyro70 wrote:Let’s say it did work, why wouldn’t your oncologist have heard about it?

Because it wasn't served after some pharma's filet mignon and desert service? Seriously.
It is the repeated experience on the boards that important stuff in their own journals is a mystery, where they may then give online abstracts a quick once over, yea or nay, but no insights from a paper(s) read much less research, education, experience, or likewise from their associates.

If the oncs were so expert, how come they always snickered or were surprised about metronomic 5FU-cimetidine, it was repeatedly in their journals and in the news where patients saw it. In a properly tissue targeted mode, metronomic 5FU-cimetidine has a reasonable claim of far better adjuvant OS performance than Folfox even today, without the costs, inconvenience, morbidity and disability.

Never mind drugs and supplements that were recognized or mentioned in Japan, even published in major journals "over here". Out of sight, out of mind. Some part of their belated education seems to come from us.
watchful, active researcher and caregiver for stage IVb/c CC. surgeries 4/10 sigmoid etc & 5/11 para-aortic LN cluster; 8 yrs immuno-Chemo for mCRC; now mostly IV C & no chemo
most of 2010 Life Extension recommendations and possibilities + more, some (much) higher, peaking ~2011-12, taper to almost nothing mid 2018

Pyro70
Posts: 75
Joined: Mon Jan 21, 2019 4:25 pm

Re: Immunotherapy in Switzerland

Postby Pyro70 » Mon May 06, 2019 3:40 pm

rp1954 wrote: In a properly tissue targeted mode, metronomic 5FU-cimetidine has a reasonable claim of far better adjuvant OS performance than Folfox even today, without the costs, inconvenience, morbidity and disability.




Ok you’ve said this a bunch of times. Please show us the clinical trial data that shows better performance versus FOLFOX
Dx Jan 2017 stage IVB w/ PC age 35
FOLFOX
SEP 17 HIPEC 1, anastamosis leak
XELODA
MAR 18 HIPEC 2
JUN 18, ileo reversal and 2nd anastamosis leak

Pyro70
Posts: 75
Joined: Mon Jan 21, 2019 4:25 pm

Re: Immunotherapy in Switzerland

Postby Pyro70 » Mon May 06, 2019 3:45 pm

mpbser wrote:I believe that data to which the page referred was the data presented here: https://www.int-imm-foundation.com/en/p ... ations.htm which leads the doctors at this place to theorize: The fact that anti-tumor activity is seen in such a diverse group of tumors following OncoPherese supports the idea of a common immune inhibitory mechanism active in all solid-tumor cancers.



Ok where are the prospective trials they claim are in process. Can someone find them on clinicaltrials.gov or a European equivalent? When are these trials completed? What phase are they? What endpoint are they measuring? How big are the trials?

The fact that anti-tumor activity is seen in such a diverse group of tumors following OncoPherese supports the idea of a common immune inhibitory mechanism active in all solid-tumor cancers.

We must now await prospective clinical trials at multiple clinical sites focused on multiple cancer types to determine the true response rates in individual tumor types, duration of response and true impact on survival.
Dx Jan 2017 stage IVB w/ PC age 35
FOLFOX
SEP 17 HIPEC 1, anastamosis leak
XELODA
MAR 18 HIPEC 2
JUN 18, ileo reversal and 2nd anastamosis leak

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betsydoglover
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Facebook Username: Betsy Lindh Williams
Location: Maryland - outside DC

Re: Immunotherapy in Switzerland

Postby betsydoglover » Mon May 06, 2019 6:12 pm

There is absolutely no clinical trial data to support their claims - even if there was, only 100 patients (according to them) were evaluated. It would be great if their treatment results were true, but it sounds like a scam to me.
Betsy
diag. Stage IV, 5/05, liver met
lap sigmoid colectomy, 6/05
6 cycles Xeloda/oxaliplatin/Avastin (NED after 2)
11/08 9x13mm right lower lobe lung nodule; removed via VATS 4/09
NED
6 cycles Xeloda + Avastin
Avastin only 10/09-5/11
Still NED 06/18

mpbser
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Re: Immunotherapy in Switzerland

Postby mpbser » Tue May 07, 2019 3:24 pm

I'm wary too as I don't know enough to evaluate the science they cite and am not a scientist able to assess all this. However, I do find it interesting that this immunotherapy focuses on inhibiting the cytolytic activity of tumor necrosis factor alpha (in my very basic layman's understanding, this increases the immune system's killing activity on the cancerous cells) while most immunotherapies in the US focus on putting the brakes ("checkpoint inhibition on/of the PD-L1 and PD-1 link") on cancer cells' ability to evade immune surveillance. It's a totally different angle.

Since all immunotherapies are considered experimental at this stage, I don't see a reason to dismiss this Swiss therapy out of hand. Unless, of course, someone has a better argument than "not enough research yet."
Wife 4/17 Dx age 45
5/17 - Lap left
Adenocarcinoma
5 x 4 x 1 cm
low grade
T3 N2b M1a
Stage IV A
8/17 Sub-total colectomy
2nd tumor 5.5 cm T1 N0
lymph nodes: 9 of 96
CEA: 2.9 to 2.2
MSS/MSI-L
Lynch no; KRAS wild
Immunohistochemsistry Normal
Tumor DNA variants: MTOR, APC, TP53
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI shows 1 met in liver
Resection & HAI Mar 7
Folfiri & FUDR started Apr 1

rp1954
Posts: 1504
Joined: Mon Jun 13, 2011 1:13 am

Re: Immunotherapy in Switzerland

Postby rp1954 » Tue May 07, 2019 3:30 pm

Pyro70 wrote:
rp1954 wrote: In a properly tissue targeted mode, metronomic 5FU-cimetidine has a reasonable claim of far better adjuvant OS performance than Folfox even today, without the costs, inconvenience, morbidity and disability.

Ok you’ve said this a bunch of times. Please show us the clinical trial data that shows better performance versus FOLFOX

A Big Medicine person like yourself may not like Japanese style RCTs but here goes.

There are a number of phase 2 level trials of adjuvant cimetidine, CRC stage 2s and 3s, and they produce a characteristic Y curve of improved survival. A series of stage 4 GI cancer papers showed notable but less dramatic improvements to OS.

The most notable adjuvant trial, an RCT originally run ca 1990-92 as a cimetidine treatment for oral 5FU damaged GI, showed the unusual "Y shaped" survival improvement. Tissue analysis with the sialyl Lewis markers strongly suggest CA199 and CSLEX1 as a good companion marker pair to cimetidine. The very interesting data from this trial produced at least two papers, Matsumoto(1995) and Matsumoto (2002), and a patent, US 6268156. The trial is associated with about 20 years of research and publications in Japan on cimetidine and sialyl Lewis X/A antigens. A 2007 paper summarizes more details about sialyl Lewis markers.

In Matsumoto (2002), when you add the CSLEX and CA199 tissue marked survivals, the result is ~95% OS but the trial was too small to reach formal significance on the combined markers. Either marker based result alone, CA199 in Figure 3D or CSLEX1 in Fig 3A, is probably much better than Folfox could have achieved, the combined markers almost quantitative. An important difference being metronomic oral 5FU or derivatives, perhaps at comfort levels, vs cyclical 5FU infusions at maximum tolerated doses. Further no (targetable) PSK or titrated LV was used to increase (immuno)chemo effect or comfort in the Matsumoto trial.

The caveat is no markers, no benefit or some drag.
watchful, active researcher and caregiver for stage IVb/c CC. surgeries 4/10 sigmoid etc & 5/11 para-aortic LN cluster; 8 yrs immuno-Chemo for mCRC; now mostly IV C & no chemo
most of 2010 Life Extension recommendations and possibilities + more, some (much) higher, peaking ~2011-12, taper to almost nothing mid 2018

Pyro70
Posts: 75
Joined: Mon Jan 21, 2019 4:25 pm

Re: Immunotherapy in Switzerland

Postby Pyro70 » Tue May 07, 2019 4:39 pm

rp1954 wrote:
Pyro70 wrote:
rp1954 wrote: In a properly tissue targeted mode, metronomic 5FU-cimetidine has a reasonable claim of far better adjuvant OS performance than Folfox even today, without the costs, inconvenience, morbidity and disability.

Ok you’ve said this a bunch of times. Please show us the clinical trial data that shows better performance versus FOLFOX

A Big Medicine person like yourself may not like Japanese style RCTs but here goes.

There are a number of phase 2 level trials of adjuvant cimetidine, CRC stage 2s and 3s, and they produce a characteristic Y curve of improved survival. A series of stage 4 GI cancer papers showed notable but less dramatic improvements to OS.

The most notable adjuvant trial, an RCT originally run ca 1990-92 as a cimetidine treatment for oral 5FU damaged GI, showed the unusual "Y shaped" survival improvement. Tissue analysis with the sialyl Lewis markers strongly suggest CA199 and CSLEX1 as a good companion marker pair to cimetidine. The very interesting data from this trial produced at least two papers, Matsumoto(1995) and Matsumoto (2002), and a patent, US 6268156. The trial is associated with about 20 years of research and publications in Japan on cimetidine and sialyl Lewis X/A antigens. A 2007 paper summarizes more details about sialyl Lewis markers.

In Matsumoto (2002), when you add the CSLEX and CA199 tissue marked survivals, the result is ~95% OS but the trial was too small to reach formal significance on the combined markers. Either marker based result alone, CA199 in Figure 3D or CSLEX1 in Fig 3A, is probably much better than Folfox could have achieved, the combined markers almost quantitative. An important difference being metronomic oral 5FU or derivatives, perhaps at comfort levels, vs cyclical 5FU infusions at maximum tolerated doses. Further no (targetable) PSK or titrated LV was used to increase (immuno)chemo effect or comfort in the Matsumoto trial.

The caveat is no markers, no benefit or some drag.


So what you’re saying is there has been no direct comparison RCT between your proposed protocol and FOLFOX. If there hasn’t been a direct comparison there is no basis for saying it performs better than FOLFOX. It doesn’t even matter if the results are “probably much better than what FOLFOX could have achieved”. There are simply too many variable such as patient population (eg how many BRAF patients, ratio of left to right sided, average age, comorbidities, MSI status, etc.), how to measure response (RECIST? subjectiveness of radiologists), quality of resection/surgeon skill, and a multitude of other non-controlled factors that makes an indirect comparison impossible. Youre also basing all the grandiose claims of superiority based on a total of 34! treated patients... That’s probably why the oncologist “snickered”.

Also then there is this trial:
https://ascopubs.org/doi/abs/10.1200/JC ... ppl.e15678

This trial had about twice the number of patients and found NO BENEFIT of cimetidine in perioperative adjuvant CRC treatment. Lesson learned, be careful of results from small trials and don’t believe everything you read online, especially grandiose claims not backed by strong evidence.
Dx Jan 2017 stage IVB w/ PC age 35
FOLFOX
SEP 17 HIPEC 1, anastamosis leak
XELODA
MAR 18 HIPEC 2
JUN 18, ileo reversal and 2nd anastamosis leak

rp1954
Posts: 1504
Joined: Mon Jun 13, 2011 1:13 am

Re: Immunotherapy in Switzerland

Postby rp1954 » Tue May 07, 2019 8:08 pm

Pyro70 wrote:So what you’re saying is there has been no direct comparison RCT between your proposed protocol and FOLFOX. If there hasn’t been a direct comparison there is no basis for saying it performs better than FOLFOX.

Up to 5 yrs survival wise, the sialyl Lewis marked (++) cimetidine+5FU patients were 100% alive, not so for the placebo group.
In the case of the heavily sialyl Lewis marked, 5FU+placebo treated patients, including stage 2, they were 100% dead.
The heavily marked sialyl Lewis patients likely correlate a lot with BRAF mutants. CA199 correlates with RAS/BRAF mutants.
I've never seen a Folfox trial for stages 2-3 remotely near that.

It doesn’t even matter if the results are “probably much better than what FOLFOX could have achieved”. There are simply too many variable such as patient population (eg how many BRAF patients, ratio of left to right sided, average age, comorbidities, MSI status, etc.), how to measure response (RECIST? subjectiveness of radiologists), quality of resection/surgeon skill, and a multitude of other non-controlled factors that makes an indirect comparison impossible. ...
Also then there is this trial: https://ascopubs.org/doi/abs/10.1200/JC ... ppl.e15678

I expect a carefully written paper, with lots of data presented for direct comparison, directly corresponding to the old stuff, rather creating uncertainties by omissions. This abstract so far does not increase my faith in ASCO authors and their papers' experimental design and reporting. If you can get both reports and datasets, I'm interested.

CSLEX1 is pretty rare outside of Japan. There are least 5-6 sialyl Lewis X mabs and they won't identify the same patients. Matsumoto actually compared 3 sialyl Lewis X mabs in Figure 3, CSLEX1 was best.
Only CIM treated 5 weeks perioperatively, not CIM tx'd a year after. I also would suspect that the patients were treated at surgery with more modern proton pump inhibitors, which typically interferes with cimetidine for CRC.
29% of patients treated with chemo. Normal cyclical 5FU based chemos alone can create recurs, Matusomo used continuous, less inflammatory chemo. Lots of noise.
I not sure of 800 mg BD in NZ. If that's 1600 mg, its harsh for ~50% of guys and non sialyl Lewis ++ patients.
Stage 0 - 1 patients at best dilute the results, and can ceate drag.
Stage 4 patients needed a lot more CIM tx time to do anything, and it was less OS gained than with stage 2-3 in Japan. We used CIM additively and metronomically.
They misused the markers, correct usage as a complete companion marker pair would be "AND" (both markers, ++), not "OR" (either marker, ++, +-,-+) with elevated content (>5%). Skews the results toward noise or negativity.
The paper has the normal medical (mis)use conventions by not explicitly stating "significance" or "significiantly", so that a non-significant positive result is verbally reversed into a big negative.
.................................................................................................................................CIM...............placebo
..............................5-year DFS with CIM and placebo was 65.5% and 62.2% respectively (HR 1.04, logrank p = 0.92)
and was not improved by CIM in pts with > 5% of tumour cells expressing either sLe Ag (seen in 97 of 103 tumours):
.........................................................5-year DFS was 62.1% and 56.0% with CIM and placebo respectively (HR 1.13, p = 0.69).
CIM... 5-year overall survival compared to placebo in all pts (76.9% and 76.0% respectively, HR 0.84, p = 0.59)
.................or in those with sLe Ag in > 5% of tumour cells (80.0% and 68.6% respectively, HR 0.63, p = 0.28)


Despite many discrepancies and misapplications, if you are really trying to keep patients alive, or test cimetidine against Matsumoto (2002), or even the perioperative CIM papers, CIM is still tracking with a net benefit here, just not with p=0.05 significance, a trial design issue here, one of many.

You're also basing all the grandiose claims of superiority based on a total of 34! treated patients...
This trial had about twice the number of patients and found NO BENEFIT of cimetidine in perioperative adjuvant CRC treatment. Lesson learned, be careful of results from small trials and don’t believe everything you read online, especially grandiose claims not backed by strong evidence.

There are a lot of things you don't understand about Matsumoto (2002) that make it a lot tighter than most western phase 2 trials.

That’s probably why the oncologist “snickered”.

He reflexively snickered about a cheap, obsolete, weak, generic antacid; he appeared to know absolutely nothing about the cimetidine cancer papers.
Normal CIM ignorant oncologist sim, 2010.
watchful, active researcher and caregiver for stage IVb/c CC. surgeries 4/10 sigmoid etc & 5/11 para-aortic LN cluster; 8 yrs immuno-Chemo for mCRC; now mostly IV C & no chemo
most of 2010 Life Extension recommendations and possibilities + more, some (much) higher, peaking ~2011-12, taper to almost nothing mid 2018

Pyro70
Posts: 75
Joined: Mon Jan 21, 2019 4:25 pm

Re: Immunotherapy in Switzerland

Postby Pyro70 » Tue May 07, 2019 9:57 pm

rp1954 wrote:This abstract so so far does not increase my faith in ASCO authors and their papers' experimental design and reporting.


And next you’ll be preaching about some great anti CIM conspiracy theory...

Here is the problem with all the alternative medicine BS. You only count the hits, never the misses. You’ve demonstrated a classic example here: you are picking and choosing which trials/data you’ll listen to.

https://m.youtube.com/watch?v=8T_jwq9ph8k


You also claim that Japanese trials are far superior to US trials. Well please show me where in the JSCCR guidelines CIM has been approved? Last I checked, it was not.
Dx Jan 2017 stage IVB w/ PC age 35
FOLFOX
SEP 17 HIPEC 1, anastamosis leak
XELODA
MAR 18 HIPEC 2
JUN 18, ileo reversal and 2nd anastamosis leak


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