nanoknife IRE for pancreatic cancer

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RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Thu Apr 20, 2017 02:47 AM

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Preventing Death Due To Cachexia-Anorexia

Everyone,
          The National Cancer Institute estimates that 20% to 40% of cancer deaths are attributable to the wasting syndrome known as cachexia, which causes loss of appetite, lean body mass, body wasting, and which can lead to multiple organ failure.
          Identifying pre-cachexia is of crucial importance for effective intervention.
          Please study the following journal articles to learn how to treat this deadly condition.  Then, check the medical records to learn whether these measures are being used.  (The good care manager always gathers the latest records and keeps them on hand.).
          If the oncologist is not utilizing the anti-cachexia therapies, get one who will, and very quickly.  Dithering also kills; this is a battle against time.
          PhilipJax
>> http://jaxelection.altervista.org/pancreatic/CachexiaTreatme
>> http://jaxelection.altervista.org/pancreatic/Cachexia2014The
>> http://jaxelection.altervista.org/pancreatic/Nutrition2015Ge
>> http://jaxelection.altervista.org/pancreatic/Supplements2016
>> http://jaxelection.altervista.org/pancreatic/Cachexia2015Mec
>> http://www.cancernetwork.com/oncology-journal/evolving-appro , Italy
>> http://www.cancernetwork.com/oncology-journal/early-engageme

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Fri Apr 21, 2017 11:11 AM

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New 2017 NCCN Guidelines for Pancreatic Adenocarcinoma

Everyone,
          NCCN has released its 2017 pancreatic clinical practice guidelines.  Every care manager should study the document carefully (and study the last two years of posts on this site).  The link is here.
http://jaxelection.altervista.org/pancreatic/NCCN1.2017Pancr
          The following is a list of NCCN features by page number:
> Pg-4, the new Evidence Block system
> Pg-42, The ranking of chemo regimens using Evidence Blocks.  Focus on the far-left column: Efficacy.
> Pg-46, Staging code.  Your overall-condition and biopsy reports should use this coding.
> Pg-47, Details of the disease and therapies.
> Pg-98, Indications for specific therapies.
> Pg-2, Oncology leaders who authored this guideline.
> Pg-6, Physician decision tree.  With the exception of IRE, your physicians should be following this decision tool.  Nearly half of treating physicians ignore these guidelines.  See
http://jaxelection.altervista.org/pancreatic/9_Pancreatic201
http://jaxelection.altervista.org/pancreatic/7_MDAnderson201
         PhilipJax

RE: nanoknife IRE for pancreatic cancer

by cdaley2 on Fri Apr 21, 2017 02:23 PM

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Philip - this a an extremely important document, thank you so much for sending it along. It is shocking how much information some doctors hold back (or don't know). Chris

RE: nanoknife IRE for pancreatic cancer

by tallysis on Sat Apr 22, 2017 04:11 AM

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I see not a mention of IRE! Am I missing something?

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Wed Apr 26, 2017 04:10 AM

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For “Advanced” & Metastatic Patients

Everyone,
          Two items:
1. ASCO has released its guidelines for treating metastatic disease.  It is not so significant as the NCCN guidelines.  So, study both, which are available here:
http://jaxelection.altervista.org/pancreatic/ASCO_Metastatic
http://jaxelection.altervista.org/pancreatic/NCCN1.2017Pancr
2. Published today: the results of a small (so less reliable) study of 24 “advanced” patients show good performance when cisplatin is added to standard gemcitabine/nab-paclitaxel.  17 of 24 patients (71%) experienced tumor-size reductions of at least 30%.  Two had complete responses, which is a very desirable and rare event.  And, median overall survival was 16.5 months.  See
http://jaxelection.altervista.org/pancreatic/AddCisplatinToGem+NabPaclitaxel2017.doc
          There are several ongoing clinical trials which utilize the 3-drug combination.  See
Stage 4, non-randomized: https://clinicaltrials.gov/show/NCT02754726
Stage 3 or 4, non-randomized: https://clinicaltrials.gov/show/NCT02227940
“Advanced” and Stage 4, non-randomized: https://clinicaltrials.gov/show/NCT02495896
Resectable & potentially-resectable: https://clinicaltrials.gov/show/NCT02550327
Resectable & potentially-resectable: https://clinicaltrials.gov/show/NCT01726582
          Usually, in non-randomized studies all patients get the experimental agents.  Also, be cautions about trials which include immuno agents.  On occasion, some have accelerated the disease greatly.  See
http://jaxelection.altervista.org/pancreatic/HyperprogressOn
          In the last trial NCT01726582 the principal investigator is Douglas B. Evans, M.D., FACS, who may be the same highly-skilled surgical oncologist who once served at MD Anderson.
          PhilipJax

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Wed Apr 26, 2017 12:20 PM

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Cisplatin Added to Gemcitabine / Nab-Paclitaxel

Everyone,
          In my post immediately above I failed to say that one does not have to be a clinical trial participant in order to receive the 3-drug Cisplatin/Gemcitabine/Nab-Paclitaxel regimen.
          The regimen appears to aid those affected by BRCA mutations (which is many pancreatic victims)
          Assuming that the disease has not progressed on a Gemcitabine regimen, all the patient needs is a willing oncologist skilled in managing related adverse events – and the regimen protocol, which is described in the trial record and at the end of this doc file:
https://clinicaltrials.gov/show/NCT01893801
http://jaxelection.altervista.org/pancreatic/AddCisplatinToGem+NabPaclitaxel2017.doc
          This may not be an approved regimen, so insurance may not cover it, although a clever provider may be able to manage the coverage.
          PhilipJax

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Thu May 11, 2017 12:59 PM

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Part 1: CPI-613

Everyone:
          Part 1.  The following is a new development.  The metastatic patient is naïve to think that the prevailing chemo regimes will save him.  More is needed.  The upcoming CPI-613 study meets the definition of a prudent trial: A standard acceptable chemo regimen, plus an experimental agent which has a positive track record (that way, if the experimental drug fails, the patient still receives an acceptable therapy).
          Reported this week: The new agent CPI-613, when used in combination with modified FOLFIRINOX, did well in a small trial of metastatic patients (single institution study, enrollment of 20 patients).  Of 18 patients 3 (17%) experienced Complete Response, and 8 (44%) experienced Partial Response, for an objective response rate of 61%.  See
http://jaxelection.altervista.org/pancreatic/CPI-613+FOLFIRINOX2017.doc 
          A Complete Response (the disease is not detectable) is a very welcome but very rare development.  The 3 eventually relapsed.  But 2 patients remain stable to date, and now utilize the regimen as something of “maintenance” therapy.
          Be cautious, however.  As similar studies have shown, encouraging results from Phase 1 studies rarely translate to significant survival benefits in Phase 3 trials.  Recently, only polychemotherapy regimens have shown some efficacy in large randomized trials (that is, FOLFIRINOX and Gemcitabine plus Nab-Paclitaxel).
          A Phase 3 CPI-613 trial will begin “soon” with a “large cohort” of metastatic patients.
          PhilipJax

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Thu May 11, 2017 01:02 PM

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Part 2: Radiation Dose, Better Surgery At High-Volume Centers
Enhanced Recovery Protocol, RenovoCath

Everyone:
          Part 2.  Other new developments.
1. Radiation after surgery.  An analysis of 514 patients in the US and Europe, suggests that radiation following surgery extends life, depending upon the radiation dose.  A dose less than 45 Gy produced an average survival of 13 months; 45 to 50, Gy 21 months; 50 to 55 Gy, 22 months, and 55 Gy or more, 28 months.
http://jaxelection.altervista.org/pancreatic/RadiationPostSu
          There can be serious drawbacks with such photon (X-ray) radiation – damage to the spinal cord and to non-target organs resulting in ulcers or other damage which may cause fatal delays in other therapy and which may prevent future Irreversible Electroporation (IRE).
          However, particle radiation (proton therapy and IORT) minimize the damage to healthy organs.  The Proton Therapy leaders are probably Massachusetts General and the University of Florida’s Proton Therapy Institute in Jacksonville.  And, IORT is performed during surgery, avoiding the usual 10-week delay, and is available only at a few facilities.  IORT (Intraoperative radiotherapy) is explained in this journal article:
http://jaxelection.altervista.org/pancreatic/IORT2017Germany
2. Better surgery at academic hospitals.  Patients, who traveled to academic centers for treatment, survived longer, because they were more likely to receive a complete resection and lymph node dissection.
          Foolishly, only 25% of patients undertake the travel.  Patients also received better care, with fewer complications, at high-volume centers.  So, if convenience is the reason to avoid travel, medical complications and death are far less convenient.  Life-taking diseases like this should be treated at one of the 5 leading cancer centers as ranked by US News.  Local community hospitals (even if they call themselves “cancer centers”) are for broken bones and stitches.  See
http://jaxelection.altervista.org/pancreatic/BetterSurgeryAt
3. Enhanced Recovery After Surgery (ERAS) protocols.  ERAS methods reduce the length of hospital stay, significantly reduce costs, and decrease the incidence of surgical complications and postsurgical readmissions.
          Yet, many hospitals do NOT practice ERAS methods.  So, it is up to you to ensure that ERAS is implemented.  Why suffer needlessly.  Make ERAS part of your discussions with the surgeon.  Why would the hospital object, since it costs the facility less?  Study the following
http://jaxelection.altervista.org/pancreatic/ERAS2014Impleme
http://jaxelection.altervista.org/pancreatic/ERAS2016Pancrea
http://jaxelection.altervista.org/pancreatic/ERAS2015Pancrea
4. RenovoCath.  This device is a catheter which delivers chemo agents via the peripheral vascular system near the tumor.  This trial, which delivered Gemcitabine, was imaginative in concept, but did not do well.  Twenty Stage III patients began the study, which had a 60% dropout rate (12 of 20 dropped out).  For the remaining 8, there was zero Objective Response Rate, since Complete and Partial Responses were both zero.  See
http://renovorx.com/wp-content/uploads/2016/07/Pancreas-Club
         PhilipJax

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Thu Jun 01, 2017 03:00 AM

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PEGPH20 Returns With Good Performance

Everyone:
          After a setback reported in an early Phase 2 article, a new Phase 2 report, to be published 04Jun2017, shows good performance, but only for patients with high levels of Hyaluronic Acid (HA).  See the report here:
http://jaxelection.altervista.org/pancreatic/PEGPH20Phase2Re
          49 patients received PEGPH20 in addition to Nab-Paclitaxel + Gemcitabine; and 35 received only Nab-Paclitaxel + Gemcitabine.  The PEGPH20 recipients experienced a Median Progression Free Survival of 9.2 months (vs 5.2 months) and Median Overall Survival of 11.5 months (vs 8.5 months).  PEGPH20 lowers the pressure in tissue surrounding the tumor, allowing more chemo agents to enter.
          There are several trials offering PEGPH20.  Some are randomized, meaning that some experimental patients do not receive the new agent (unless the project allows a latter cross-over to the experimental agent).  You will be admitted to the trial only is you have high HA and thus highly-responsive to PEGPH20.
          Study the eligibility criteria here:
>> Unresectable Stage III or Stage IV, non-randomized, plus Gemcitabine, Nab-paclitaxel, Rivaroxaban:
https://clinicaltrials.gov/show/NCT02921022
>> Stage IV, randomized FOLFIRINOX+PEGPH20:
https://clinicaltrials.gov/show/NCT01959139
>> Borderline resectable, non-randomized, plus Gemicitabine+Nab-Paclitaxel:
https://clinicaltrials.gov/show/NCT02487277
>> Stage IV, randomized, plus Gemicitabine+Nab-Paclitaxel:
https://clinicaltrials.gov/show/NCT02715804
>> Stage IV, non-randomized, Gemcitabine+Radiotherapy:
https://clinicaltrials.gov/show/NCT02910882
>> Gastric adenocarcinoma, PEGPH20 combined with Pembrolizumab, non-randomized:
https://clinicaltrials.gov/show/NCT02563548
          Most (not all) of these are prudent trial choices, since most provide acceptable standard therapies even if the experimental agent fails or if you don’t receive it.
         PhilipJax

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Sun Jun 04, 2017 02:11 AM

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Update: AM0010 Immunotherapy performs well

Everyone,
          This is a June 2107 update of data presented at the January Gastrointestinal Cancers Symposium.
          For a metastatic patients (who have few options) a new Phase 3 trial may offer help to some.
          As reported June 03 at the 2017 ASCO conference, a Phase 1b randomized trial of the immuno-drug AM0010, combined with the FOLFOX regimen, produced some hopeful results.
          Unfortunately, patient enrollment was very small at 21 and thus less reliable.  All subjects suffered from “advanced” disease and had failed an average of 2 prior therapies (ranging from 1 to 5 failed therapies):
>> 2 patients (10%) experienced Complete Response, a complete absence of disease
>> 1 patient (5%) experienced Partial Response
>> 12 patients (63%) experienced Stable Disease
>> Progression Free Survival was 3.5 months, and Overall Survival was 10.0 months.
          A Complete Response is a nearly unheard-of event, especially for “advanced” disease with no prior surgery.  It is not known why some patients did so well and others gained nothing.  The report is here,
http://jaxelection.altervista.org/pancreatic/AM0010+FOLFOX_2017GastrointestinalCancersSymposium.doc  
          and Phase 1b trial details can be found at
https://clinicaltrials.gov/show/NCT02009449
          The new Phase 3 trial of AM0010 + FOLFOX has distinct features:
** Only metastatic patients are eligible; the enrollment is 566, and the trial is randomized, meaning that about half will receive only FOLFOX, not AM0010; see
https://clinicaltrials.gov/ct2/show/NCT02923921
** Patients must have failed a prior “gemcitabine-containing regimen”;
** FOLFOX is an infrequent therapy; there may be better regimens.  See
http://jaxelection.altervista.org/pancreatic/Transcript_Rese
** Most of the 11 US treatment sites are not major cancer centers.
          Finally, there are some disturbing concerns about immunotherapy in general.  Immunotherapy tends to be unsuccessful with pancreatic cancer.  See page-3 of
http://jaxelection.altervista.org/pancreatic/Interview_Immun
          Some immuno agents (for example IMM-101) may benefit metastatic patients but may harm locally-advanced-patients.  See Table 3 of
http://jaxelection.altervista.org/pancreatic/IMM-101+Gem_bjc2016271a.pdf
          And, in an alarming development, some immuno agents unpredictably cause “hyperprogression” of the disease.  Specifically cited in the literature are Nivolumab (Opdivo) and Pembrolizumab See
http://jaxelection.altervista.org/pancreatic/HyperprogressOn
http://jaxelection.altervista.org/pancreatic/ImmunotherapySi
         PhilipJax

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