Hospitals that install HAI pump?

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mpbser
Posts: 746
Joined: Wed Apr 19, 2017 11:52 am

Re: Hospitals that install HAI pump?

Postby mpbser » Wed Jan 02, 2019 8:03 am

OK, so I cleared up some of the confusion about the HAI pump issues I have discussed in this thread. There was a bit of misinformation in the New York Times article. I had to deduce the information that I came up with from various conversations here, on Facebook, and from medical literature that someone emailed to me.

Apparently, Medtronic started making pumps with catheters decades ago. The SynchroMed EL (programmable) and IsoMed (constant flow) pumps appear to have been designed to infuse drugs to many parts of the body, not just the spine. I have heard of people who have CC-liver cancer who have had Medtronic's SynchroMed EL pump implanted. These pumps are not compatible with MRIs as they were designed and tested for under 2 and 1.5 Tesla. The majority of MRI machines these days are 3 Tesla. The SynchroMed EL pump seems to be an old, discontinued model, as the website only shows SynchroMed II which is only FDA approved for use in the spine and does not have a catheter. It appears that the IsoMed pump is also no longer in production. Hence, Medtronic does not currently make pumps with catheters and thus the need for adaptation of SynchroMed II with Codman catheter. I would like to know exactly who is making the adaptation. There is nothing on Medtronic's website about it. Searching the google today to see what I can find.
Wife 4/17 Dx age 45
5/17 - Lap left hemi
Adenocarcinoma
5 x 4 x 1 cm
low grade
T3 N2b M1a
Stage IV A
lymph nodes: 9 of 54
8/17 Sub-total colectomy
2nd tumor 5.5 cm T1 N0
CEA: 1.4, 2.1, 1.5, 1.9, 1.9, 2.1, 2.1, 2.4, 1.7, 2.0, 2.9, 2.2
MSS/MSI-L
Lynch no; KRAS wild
Immunohistochemsistry: Normal MLH1, MSH2, MSH6, and PMS2
Tumor DNA variants: MTOR, APC, TP53
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI shows met
Resection & HAI Mar 7

mpbser
Posts: 746
Joined: Wed Apr 19, 2017 11:52 am

Re: Hospitals that install HAI pump?

Postby mpbser » Wed Jan 02, 2019 8:13 am

chadwick, If the trial is the only way to get a pump at MSK right now, then you would not be a candidate. I can't imagine that there is any other way to get a pump these days given the production issues I just mentioned in my most recent comment and as discussed in this thread. The criteria for the trial include: History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinicalyl or radiographically confirmed extrahepatic disease (or) Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of metastatic disease that has been resected is allowed, provided there is no recurrence in that area prior to protocol consent) [copied from the link I provided previously, repeated here: https://clinicaltrials.gov/ct2/show/NCT ... eny&rank=1 typo and all]. Because you have extrahepatic disease, you do not qualify at this time.
Wife 4/17 Dx age 45
5/17 - Lap left hemi
Adenocarcinoma
5 x 4 x 1 cm
low grade
T3 N2b M1a
Stage IV A
lymph nodes: 9 of 54
8/17 Sub-total colectomy
2nd tumor 5.5 cm T1 N0
CEA: 1.4, 2.1, 1.5, 1.9, 1.9, 2.1, 2.1, 2.4, 1.7, 2.0, 2.9, 2.2
MSS/MSI-L
Lynch no; KRAS wild
Immunohistochemsistry: Normal MLH1, MSH2, MSH6, and PMS2
Tumor DNA variants: MTOR, APC, TP53
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI shows met
Resection & HAI Mar 7

mpbser
Posts: 746
Joined: Wed Apr 19, 2017 11:52 am

Re: Hospitals that install HAI pump?

Postby mpbser » Wed Jan 02, 2019 9:03 am

Dr. K apparently is making this adaptation "in house" so to speak. I gleaned this from https://www.cancernetwork.com/news/halt ... s/page/0/2:

"the company, Cerenovus, [was] telling me that they can give [the catheters] to me, and so I have catheters to connect to the Medtronic pump. But when they first told me this, they literally were closing my program and everyone else’s because they told us that we were getting neither the catheters nor the pumps. Now, with the catheters, we are not closed down, but we do have problems."
Wife 4/17 Dx age 45
5/17 - Lap left hemi
Adenocarcinoma
5 x 4 x 1 cm
low grade
T3 N2b M1a
Stage IV A
lymph nodes: 9 of 54
8/17 Sub-total colectomy
2nd tumor 5.5 cm T1 N0
CEA: 1.4, 2.1, 1.5, 1.9, 1.9, 2.1, 2.1, 2.4, 1.7, 2.0, 2.9, 2.2
MSS/MSI-L
Lynch no; KRAS wild
Immunohistochemsistry: Normal MLH1, MSH2, MSH6, and PMS2
Tumor DNA variants: MTOR, APC, TP53
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI shows met
Resection & HAI Mar 7

User avatar
juliej
Posts: 2923
Joined: Thu Aug 05, 2010 12:59 pm

Re: Hospitals that install HAI pump?

Postby juliej » Thu Jan 03, 2019 5:30 pm

chadwick1 wrote:
juliej wrote:Chadwick, I'm confused why your liver was resected but they didn't implant the pump at the same time. I had a met in each of my lungs and still got the pump. Hopefully your liver will stay clear in your next scans, but if you have a recurrence, get a consultation with Dr. Kemeny about the pump.

Hi Julie, thanks, that’s really interesting to hear! I’m not sure but looking at your sig I wonder if perhaps the protocol has changed since then? I’m seeing a different onc at MSK and we were a bit skeptical at first when she said I wouldn’t be a good candidate, but we asked Kingham about it too and he said the same thing: the lung met would mean systemic chemo and that would be a contra-indication for the pump. I won’t pretend to fully understand why medically but they both were pretty unequivocal. Certainly if this scan or another shows more liver recurrence I’ll be bringing it back up!

Yes, definitely bring it back up if the situation arises. I don't think Dr. Kemeny has changed her protocol whatsoever. You have to have systemic chemo anyway with the HAI pump. 5FU goes in the pump of course, but HAI patients also take a systemic chemo like Xeloda or Irinotecan. So that would take care of any lung met. Might be a difference in the way Kingham does things though. Or maybe Dr. Kemeny is just more aggressive in her treatment. In any case, good luck with everything!
Stage IV, liver/lung mets 8/4/2010
Xelox+Avastin 8/18/10 to 10/21/11
LAR, liver resec, HAI pump 11/11
Double lung surgery + ileo reversal 2/12
Adjuvant Xeloda 3-9/12
VATS rt. lung 12/21/12 - benign granuloma!
NED 3/17/12 to 2/1/2019, CEA<1

SGNYC
Posts: 34
Joined: Mon Sep 03, 2018 9:20 pm

Re: Hospitals that install HAI pump?

Postby SGNYC » Thu Jan 03, 2019 5:58 pm

Hi,

Just to offer some further info re the MSK approach when there is a lung Met. They don’t generally put in the pump if any lung Mets exist. DH had a single small liver met and a single small lung Met and we of course asked about HAI pump. The oncology team discussed it and didn’t feel my husband needed it at this point bc it was a single small and resectable Met (and as it turned out, by the time surgery rolled around the liver Met was just scar tissue! Yay!) but secondarily would not recommend it with the lung Met as many hai pump patients with Mets to both liver/lung experienced less efficacy from chemo (not just hai pump delivered but also systemic) as it relates to the lung Met.

We did not push bc this was a secondary conversation for my husband as the main point was he had a single small Met that was responding to neoadjuvant and it was not necessary at this point in time. I got the feeling if we really felt strongly we could have made it happen, but we’re there to get their expert treatment! I don’t know how it would have been handled had we wanted it (ie trial/insurance etc).

Hope this is helpful
Wife to DH, 44
DX July 18 - RC at Rectosigmoid
Adenocarcinoma, Mod diff
T3N1M1
Stage IV (but MSK said not a true Stage IV at Dx)
Pos nodes: 1/18
1 Liver Met and 1 Lung Met - liver Met dead tissue at surgery, hence MSK M1 status
Baseline CEA value of 25, now 4.7 - normal per MSK
LAR (Robotic)/Liver resect(dead tissue), VATS lung - clear margins
Temp Ileo- Reversal Feb 19
Folfox - 5 Rounds Neoadj, 3 rounds Adj, then discontinued Oxali and 4 rounds just 5FU
NED Feb 2019 - clear contrast CT, clear contrast MRI

chadwick1
Posts: 23
Joined: Sat Oct 13, 2018 9:04 am

Re: Hospitals that install HAI pump?

Postby chadwick1 » Fri Jan 04, 2019 3:58 pm

SGNYC, that sounds very similar to my situation and what I heard from the docs. In any case my only known liver met is already out with clear margins, so if anything recurs there I'll cross that bridge when I come to it. Plus there’s still a chance the lung lesion could be benign! (Not counting on it though. The waiting is hard!) I hope you and your DH are doing well.
DX 6/2017, 37yo father of two
Stage IIIb rectal cancer (T3N1bM0) no genetic indicators, normal CEA
7/2017 radiation + 5FU
10/2017 LAR w/ temp loop ileo. clear margins, 2/33 nodes
11/2017-3/2018 FOLFOX, 9 rounds
2/2018 clear CT
4/2018 ileo reversal
10/2018 CT shows suspicious mass in liver (1.7 cm), and in lung (0.6 cm)
MRI confirms 1 liver met, Stage IV
11/2018 liver resection, clear margins
1/2019 CT: lung node shrank to 0.3 cm

SGNYC
Posts: 34
Joined: Mon Sep 03, 2018 9:20 pm

Re: Hospitals that install HAI pump?

Postby SGNYC » Fri Jan 04, 2019 11:16 pm

Hi Chadwick,

Very similar to my DH, who is also early onset. Are you NY based?

I’ll be keeping you in my thoughts. I’m very hopeful it’s not a lung Met but I have full faith in the excellent care at MSK to get both our families through hurdles.
Wife to DH, 44
DX July 18 - RC at Rectosigmoid
Adenocarcinoma, Mod diff
T3N1M1
Stage IV (but MSK said not a true Stage IV at Dx)
Pos nodes: 1/18
1 Liver Met and 1 Lung Met - liver Met dead tissue at surgery, hence MSK M1 status
Baseline CEA value of 25, now 4.7 - normal per MSK
LAR (Robotic)/Liver resect(dead tissue), VATS lung - clear margins
Temp Ileo- Reversal Feb 19
Folfox - 5 Rounds Neoadj, 3 rounds Adj, then discontinued Oxali and 4 rounds just 5FU
NED Feb 2019 - clear contrast CT, clear contrast MRI

chadwick1
Posts: 23
Joined: Sat Oct 13, 2018 9:04 am

Re: Hospitals that install HAI pump?

Postby chadwick1 » Sat Jan 05, 2019 10:00 pm

Upstate NY, but we gladly make the drive down to go to MSK. Thanks so much—I agree!
DX 6/2017, 37yo father of two
Stage IIIb rectal cancer (T3N1bM0) no genetic indicators, normal CEA
7/2017 radiation + 5FU
10/2017 LAR w/ temp loop ileo. clear margins, 2/33 nodes
11/2017-3/2018 FOLFOX, 9 rounds
2/2018 clear CT
4/2018 ileo reversal
10/2018 CT shows suspicious mass in liver (1.7 cm), and in lung (0.6 cm)
MRI confirms 1 liver met, Stage IV
11/2018 liver resection, clear margins
1/2019 CT: lung node shrank to 0.3 cm

mpbser
Posts: 746
Joined: Wed Apr 19, 2017 11:52 am

Re: Hospitals that install HAI pump?

Postby mpbser » Tue Jan 08, 2019 7:21 am

OK, so I got clarification from a physician heavily involved in HAI pumps at Spectrum Health in Grand Rapids. I think he is a liver oncological surgeon. His facility is using the Medtronic SynchroMed II with Codman catheter. MSK is the only place conducting a trial on this new adaptation and everyone else (including this surgeon) is implanting them off-label. These same Medtronic pumps were used for HAI in years past, so Medtronic is not new to the pump business. (Not many years for the particular model currently available, just a few years.) MSK just wants to get FDA-approval for the combination so they can use in further studies. "I don’t think anyone has any true safety concerns, it’s more of a formality," says this surgeon.
Wife 4/17 Dx age 45
5/17 - Lap left hemi
Adenocarcinoma
5 x 4 x 1 cm
low grade
T3 N2b M1a
Stage IV A
lymph nodes: 9 of 54
8/17 Sub-total colectomy
2nd tumor 5.5 cm T1 N0
CEA: 1.4, 2.1, 1.5, 1.9, 1.9, 2.1, 2.1, 2.4, 1.7, 2.0, 2.9, 2.2
MSS/MSI-L
Lynch no; KRAS wild
Immunohistochemsistry: Normal MLH1, MSH2, MSH6, and PMS2
Tumor DNA variants: MTOR, APC, TP53
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI shows met
Resection & HAI Mar 7

User avatar
juliej
Posts: 2923
Joined: Thu Aug 05, 2010 12:59 pm

Re: Hospitals that install HAI pump?

Postby juliej » Wed Jan 09, 2019 7:55 pm

mpbser wrote:OK, so I got clarification from a physician heavily involved in HAI pumps at Spectrum Health in Grand Rapids. I think he is a liver oncological surgeon. His facility is using the Medtronic SynchroMed II with Codman catheter. MSK is the only place conducting a trial on this new adaptation and everyone else (including this surgeon) is implanting them off-label. These same Medtronic pumps were used for HAI in years past, so Medtronic is not new to the pump business. (Not many years for the particular model currently available, just a few years.) MSK just wants to get FDA-approval for the combination so they can use in further studies. "I don’t think anyone has any true safety concerns, it’s more of a formality," says this surgeon.

Yes, that is exactly the situation. However, (a bit of insider information) there is a hush-hush possibility involving an investor group who might purchase the rights to Cerenovus's Codman HAI pump and continue manufacturing it. Apparently, Cerenovus blamed manufacturing issues for the termination, but the reality is that it didn't make enough profit for them. Plus the feeling is they wanted out of the pump business completely anyway. So... we shall see what happens!
Stage IV, liver/lung mets 8/4/2010
Xelox+Avastin 8/18/10 to 10/21/11
LAR, liver resec, HAI pump 11/11
Double lung surgery + ileo reversal 2/12
Adjuvant Xeloda 3-9/12
VATS rt. lung 12/21/12 - benign granuloma!
NED 3/17/12 to 2/1/2019, CEA<1

mpbser
Posts: 746
Joined: Wed Apr 19, 2017 11:52 am

Re: Hospitals that install HAI pump?

Postby mpbser » Thu Jan 10, 2019 8:00 am

Thanks, Julie! I heard rumblings about this in more vague terms somewhere else. My husband would definitely opt for a Codman pump but is really on the fence about this Medtronic/Codman catheter adaptation. Between the need to visit MSK every two weeks and it being in experimental trial at this stage, he does not want to make such a commitment and take such a risk. Fingers crossed that the deal happens and the production resumes!!!
Wife 4/17 Dx age 45
5/17 - Lap left hemi
Adenocarcinoma
5 x 4 x 1 cm
low grade
T3 N2b M1a
Stage IV A
lymph nodes: 9 of 54
8/17 Sub-total colectomy
2nd tumor 5.5 cm T1 N0
CEA: 1.4, 2.1, 1.5, 1.9, 1.9, 2.1, 2.1, 2.4, 1.7, 2.0, 2.9, 2.2
MSS/MSI-L
Lynch no; KRAS wild
Immunohistochemsistry: Normal MLH1, MSH2, MSH6, and PMS2
Tumor DNA variants: MTOR, APC, TP53
1/18 Liver left hepatectomy seg 4
5/18 CT clear
12/18 MRI shows met
Resection & HAI Mar 7


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