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PhilipJax's Message Board Messages

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Tad187 & Everyone,
          When you STUDY the Decision Guide, you will find that Robert CG Martin of the University of Louisville is the world leader in IRE clinical practice research.  You will find his instruction guides linked at my website.
          Knowledge and skill make a difference.  The IRE probes must be positioned within 5mm of requisite distance for proper effect.  And, few practitioners have the desired 3D positioning radiology.  You are fortunate that you are in the US healthcare system.
          Be sure to study everything the Decision Guide has to offer, which includes two years of past CancerCompass postings.  Several days of hard work will save months of wasted wheel-spinning and lost opportunities.
         PhilipJax

2020 Gastrointestinal Cancers Symposium
Installments, Part 4

Everyone,
          This is likely the final installment of abstract reviews from the 2020 GI Cancers Symposium, held January 23-25, 2020 in San Francisco.  There are at least 50 relevant abstracts; so, over a period of several days or weeks, I will cover the “best”.  If you can’t wait, the abstracts are found here:
http://pancreatic.altervista.org/downloads/GI20PancreaticCan
          The order in which I present the abstracts does NOT signify their importance.  I am merely beginning with the first abstract meeting my search criteria.
          Be sure to study my Decision Guide, downloadable at
PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/PJaxDecisionAlg " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/PJaxDecisionAlg
or use Google to find the file: PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">PJaxDecisionAlgorithm.pdf
         PhilipJax

Abstract 716: A phase I/II study combining a TMZ-CD40L/4-1BBL-armed oncolytic adenovirus and nabpaclitaxel/ gemcitabine chemotherapy in advanced pancreatic cancer: An interim report
          American and Swedish researchers provide an interim report on the use of LOAd703, an immunotherapy, as a supplement to Gemcitabine / Nab-Paclitaxel.  In Phase 1/2b trial NCT02705196 the adenovirus LOAd703 was injected into the primary pancreatic tumor or metastasis of 13 advanced patients using image guidance.  Three subjects received low-dose LOAd703, and the remaining 10 received higher doses.
          The research is incomplete.  However, the results thus far are the following:
1. Of the 10 higher-dose patients 6 (60%) experienced Partial Responses, a very good outcome.  “Only 1 patient has had progressive disease.”  The median Overall Survival is not yet known, but the Response Rate portends a good outcome.
2. “Circulating MDSCs decreased in 8 of 13 subjects, while effector memory T-cells increased in 10 of 13” patients.  MDSCs are Myeloid-Derived Suppressor Cells.
          NCT02705196 is ongoing at Baylor University facilities in Houston, and is limited to a total of 43 patients who have not undergone prior immunotherapy.  The eligibility criterion (not eligible for a complete surgical resection”) IMPLIES that patients must be Stage 3 or 4.  So, if you are borderline resectable or locally-advanced, you might inquire.  ECOG performance status can be 0, 1 or 2, so somewhat feeble patients are eligible.  Check the trial description for more eligibility details.
          The clinical trial description is found here:
https://clinicaltrials.gov/ct2/show/NCT02705196

Abstract 702: Multicenter phase I/II study of intravenous gemcitabine + nab-paclitaxel combined with intraperitoneal paclitaxel for pancreatic ductal adenocarcinoma patients with peritoneal metastasis
          For the past two years leading research and treatment centers have been moving toward direct treatment of metastases, at least when there are few of them.  In this Phase 1-2 research 7 Japanese centers evaluated the treatment of peritoneal metastases which present “an extremely poor prognosis.”
          A total of 46 chemotherapy-naïve patients (no prior chemotherapy) received a combination of intravenous Gemcitabine and Nab-Paclitaxel, plus intraperitoneal Paclitaxel during a median treatment period of 6 months.
          The researchers reported the following outcomes:
1.The response rate and disease control rate were 45.7% and 95.7%, respectively (implying 50.0% Stable Disease – all are very good performance values).
2. “The median survival time was 12.8 months, and the 1-year survival rate was 52.2%.
3. “Ascites disappeared in 40.0%, and cytology turned negative in 67.4%.  Median CA19-9 decrease ratio was 84.4%
(“negative cytology” means that no cancer cells were identified).
4. “Finally, conversion surgery was performed in 8 (17.4%) patients, and those who received conversion surgery survived significantly longer than those who did not (not reached vs. 11.7 months
.”  “Not reached” means that more time must pass before researchers know; however, the value will exceed 11.7 months.
          Although this pancreatic research is incomplete, these researchers have published reports on intraperitoneal therapy for other primary tumors, such as gastric cancer.  See this report:
http://pancreatic.altervista.org/downloads/IntraperitonealPa
         In the USA theUniversity of Pennsylvania’s Abramson Cancer Center (and others) may be receptive to undertaking this intraperitoneal therapy.

691: The surgical outcomes of borderline resectable or locally advanced pancreatic cancer
          In this abstract Japanese surgeons reveal how they achieved “curative resection” in 67 (83%) of 81 borderline and locally-advanced patients, and how the 7-hour procedure achieved R0 resection in 96% of the 67 cases.  Their tactics achieve a 3-year after-surgery survival rate of 70.3%, with the same success in borderline resectable (contact with the main artery) and locally advanced cases.
          The surgeons describe their successful decision guide as the following:
1. “If a tumor is in contact with the superior mesenteric artery (SMA), we select the mesenteric approach.
2. “If a tumor is in contact with the common hepatic artery (CHA) and/or celiac artery (CA), we open the lesser omentum and then dissect from the cranial side of pancreas to the diaphragm leg to judge the resectability before dividing the stomach.
3. “When arterial plexus infiltration is observed during surgery, we abandoned curative surgery or we performed combined resection of CHA and reconstruction if possible.”
          The procedures are explained in the following 425-page surgery manual.  You should download it, rather then load it into your browser:
Pancreatic Cancer With Special Focus on Topical Issues and Surgical Techniques (2018)
http://pancreatic.altervista.org/downloads/PancreaticCancerS

693: Phase Ib study of gemcitabine, nab-paclitaxel, and ficlatuzumab in patients with advanced pancreatic cancer
            At two major US institutions researchers added Ficlatuzumab to standard care Gemcitabine plus Nab-Paclitaxel, as part of Phase 1b clinical trial NCT03316599.  The test subjects were 24 previously-untreated metastatic patients.  The results were the following:
1. Of the 24 patients 7 (29%) patients had partial response, 15 (63%) had stable disease, and 2 (8%) could not be evaluated.
2. “Median progression-free survival was 8 months (range, 3-16 months), 4 patients are still on study treatment.”
          These are all good results.  However, the sample size was too small to assure reliable application to the larger metastatic population.  A much larger scale trial will be needed. 
          Trial NCT03316599 is no longer recruiting.  But, it is reasonable to expect a Phase 2 trial, although none has been announced as yet.
         Ficlatuzumab, the experimental agent, was rather harsh, causingnine (38%) of the 24 patients to discontinue treatment prior to disease progression. Theprimary toxicities were hypoalbuminemia and edema.

685: The role of neoadjuvant chemotherapy in elderly patients with borderline or locally advanced pancreatic cancer: Is it safe and feasible?
          Sometimes Borderline (BL) and Locally-Advanced (LA) patients may be rendered resectable by means of Neoadjuvant Therapy (NAT), often employing either FOLFIRINOX (FFX) or Gemcitabine plus Nab-Paclitaxel (GnP).
          To determine whether elderly BL and LA patients might benefit from NAT, University of Colorado researchers reviewed the records of 230 consecutive BL and LA patients who underwent NAT at its cancer center.  214 cases were eligible for analysis and divided into three groups: <70, 70-74, >75 years of age.
          The researchers found the following:
1. “Resection rates were not statistically different between three groups (<70: 62%; 70-74: 70%; >75 years: 56%) . . . Neoadjuvant therapy . . . is a good option for fit and elderly patients >75 years.
2. “There was a slight trend towards worse survival in the two older groups.
3. “FOLFIRINOX group was superior to GnP group in all three age groups (Median Survival Time: <70: 25.6 vs 18.2 months; 70-74: 33.2 vs 16.1months; >75 years: not reached vs 16.1 months)”

690: Tumor downsizing following neoadjuvant therapy for borderline-resectable pancreatic adenocarcinoma
          Researchers associated with the Florida Hospital Cancer Institute sought to determine the effect of Neoadjuvant Therapy (NAT) on tumor downsizing.  To do so they reviewed the cases of 97 consecutive nonmetastatic unresectable patients, 40 of which undertook NAT.
          The Orlando researchers found the following:
1. Among the 40 NAT patients 90% experienced an average tumor downsizing of 8%.
2. There were no differences in rates of tumor downsizing between FOLFIRINOX or Gemcitabine/Nab-Paclitaxel-treated patients.
3. “Both regimens achieving a similar rate of R0 resections, a mean 61%.
4. “The type of chemotherapy regimen used did not affect the ratio of positive lymph nodes harvested.”
          This concludes my review of the ASCO 2020 GI conference, unless other news develops.  Some of the GI 2020 abstracts are worth greater attention, principally:
Abstract 716 LOAd703 Tumor Injection (clinical trial currently available)
Abstract 702 Intraperitoneal Chemotherapy (clinical trial not required)
Abstracts 664 & 672 Neoadjuvant vs Surgery First (clinical trial not required)
Abstract 681 Upper Abdominal Perfusion (clinical trial not required)
Abstract 754 Ipilimumab/Nivolumab For BRCA (clinical trial not required)
Abstract 682 Node Resection (clinical trial not required)
          The ASCO annual meeting takes place in mid-2020.  I expect to review the related abstracts at that time.
          It is important that you study my downloadable Decision Guide.  Within a few days of hard work you will understand how to approach this terrible disease, based on your disease stage – and learn what therapies work and which ones don’t.  The Guide is downloadable at
PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/PJaxDecisionAlg " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/PJaxDecisionAlg
          If the link doesn’t work, do a Google search for the file: PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">PJaxDecisionAlgorithm.pdf
         PhilipJax

Mkk2018,
          It would be helpful, if you would answer the questions I pose, because others read these posts.  We must not mislead them.  
          Perhaps we could begin with the first question: Please be so kind as to give links to the trial reports that you cite, the Phase 1 & 2 trial reports showing good performance for “SBRT in combination with immuno+parp” in metastatic cases. Thanks.

         PhilipJax

Mkk2018,
          You may have misunderstood my 5 examples of non-standard therapies.  They were not meant as suggestions for you.  They are example of therapies found by recent users of the Guide and ASCO abstracts, as alternatives to standard of care.
         PhilipJax

Mkk2018,
          Thanks.  Please give links to the trial reports that you cite, the Phase 1 & 2 trial reports showing good performance for “SBRT in combination with immuno+parp” in metastatic cases (or BRCA cases, if you wish).
          Also, I do not understand your following two statements.  I hope you will take a moment to clarify:
1. but not everyone follows under those guidelines:” The Decision Guide addresses all disease stages and multiple lines of therapy, and the posts on past ASCO symposia address literally scores of research abstracts.  Virtually every case is addressed.
2. If you have information to support this:” Please tell me what you mean by “information to support this”?  Support what?
         PhilipJax

2020 Gastrointestinal Cancers Symposium
Installments, Part 3

Everyone,
          This installment continues my review of abstracts from the 2020 GI Cancers Symposium, held January 23-25, 2020 in San Francisco.  There are at least 50 relevant abstracts; so, over a period of several days or weeks, I will cover the “best”.  If you can’t wait, the abstracts are found here:
http://pancreatic.altervista.org/downloads/GI20PancreaticCan
          The order in which I present the abstracts does NOT signify their importance.  I am merely beginning with the first abstract meeting my search criteria.
          Be sure to study my Decision Guide, downloadable at
PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/PJaxDecisionAlg " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/PJaxDecisionAlg
or use Google to find the file: PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">PJaxDecisionAlgorithm.pdf
         PhilipJax

Abstract 672: Neoadjuvant therapy (NAT) and its role for pancreatic adenocarcinoma (PC) in the current era: Institutional experience.
          Like a study reported in Installment Part 1, this research sought to resolve whether Neoadjuvant Therapy (NAT) is better than upfront surgery for resectable patients.  This time researchers at 3 Philadelphia institutions used their own experiences with 352 patients, rather than the National Cancer Database.  NAT was used for 225 (64%) patient, while 109 patients (31%) had upfront surgery.
          The NAT regimen consisted of chemotherapy (CTx) plus radiation for 48%, CTx alone for 8% and radiotherapy alone for 44% of pts.  Of those receiving CTx, 24% received triple agent therapy (perhaps FFX) while 51% and 25% received dual and single agent therapy, respectively.
          The researchers reported the following outcomes:
1. Surgical resection after NAT occurred in 79 of 225 patients (35%) with median overall survival of 26.3 months vs 19.7 months for those who had upfront surgery.
2. For NAT survival rates at year 1, 3, and 5 years were 94%, 34%, and 8%, but for upfront surgery 76%, 17%, and 11%.
          Researchers concluded: “Use of NAT is prevalent, yet only 35% of patients make it to surgical resection.  Survival was improved for patients who underwent resection following NAT versus upfront, although the difference was not statistically significant.”
         The conclusion is a caution: NAT had a debatable benefit for the 35% who make it to surgery, but the remaining 65% (nearly twice as many) might have done better to undergo upfront surgery immediately upon diagnosis. So, the resectable patient, if he selects NAT, would be wise to insist on very early CT and CA19-9 monitoring. If dramatic NAT improvement is not seen, the resectable patient might opt for immediate surgery.

Abstract 673: First-line drug selection versus sequential treatment in advanced pancreatic cancer: Does it really matter?  Multi-institutional Canadian perspective.
          Researchers from three Canadian institutions undertook a retrospective study of 231 advanced patients to determine the better induction (initial) chemotherapy: FOLFIRINOX (FFX) or Gemcitabine+NabPaclitaxel (GN).  The research findings:
1. “The median PFS (Progression Free Survival) of FFX was 5.5 months vs 5.1 with GN.
2. “The median OS (Overall Survival) with FFX was 9.3 months vs 10.2 with GN . . . There (sic, perhaps meaning They) were not statically significant.
3. “Patients who received first-line FFX or GN had similar PFS and OS even though (the) FFX group was younger with better PS (Performance Status).”
         Finally, it was observed that initial-FFX patients, because they are younger with good Performance Status, are more likely to continue to third-line and fourth-line therapies.

Abstract 681: Survival and quality of life after isolated upper abdominal perfusion [UAP] with chemofiltration (UAP-F) for stage III and IV pancreatic cancer
          German researchers performed UAP-F on 79 Stage 3 and 142 Stage 4 patients, to determine feasibility, safety, overall survival and quality of life.  Perfusion is the pumping of chemo agents into an organ.  In this case the agents were Cisplatin, Adriamycin and Mitomycin.  Chemofiltration is a simultaneous detoxification, process which removes excess Chemotherapy from the blood to reduce toxicity.
          The goal of UAP-F is to replace low-dose systemic chemotherapy with high-dose “regional” chemotherapy, thereby allowing increased toxicity at the tumor site but lower toxicity overall.  In this case the perfusion time was 15 minutes followed by 30 – 45 minutes of chemofiltration.  According to investigators, the research findings were:
1. “Median [overall] survival was 12.1 months and 8.7 months in stage III and IV respectively,” which is similar to harsher systemic therapies.
2. “One-year survival was 49.4% and 37% for stage III and IV, and 3-years survival 21.7% and 7.7% for stage III and IV respectively.”
3. “Resolution of ascites was achieved within two therapies in 33/36 cases with UAP-F.”

Abstract 682: Extent of lymph node resection and effect on pancreatic cancer overall survival
          To determine the impact of lymph node metastases on longevity researchers at Cedars-Sinai and Memorial Sloan Kettering examined the records of nearly 14,000 patients in the National Cancer Database, Stage 1-3 patients who underwent “curative resection.”
          As expected, they found that an “increased number of positive Lymph Nodes was associated with reduced Overall Survival.”  Consequently, the researchers urge “adequate nodal sampling” for resectable patients, noting that “if >16 Lymph Nodes were examined, patients had a 1.5-fold likelihood of better Overall Survival,” producing “an increase in Overall Survival of 2.8 months.”
          In a week or so the next 2020 GI Symposium installment will be posted.
          Be sure to study my downloadable Decision Guide.  Within a few days of hard work you will understand how to approach this terrible disease, based on your disease stage – and learn what therapies work and which ones don’t.  The Guide is downloadable at
PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/PJaxDecisionAlg " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/PJaxDecisionAlg
          If the link doesn’t work, do a Google search for the file: PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">PJaxDecisionAlgorithm.pdf
         PhilipJax

Mkk2018,
          Have you studied the Decision Guide and my last 2 years of posts as yet?  That means studying every line and every reference.  It takes a lot of work.  But, there are rewards: If there is an answer, that is where it will be found.
          I prepared the Guide and created the CancerCompass posts (taking scores of hours of work) to answer such questions as yours.  The best answer is within those two sources.
          For example, using those sources (1) a patient recently pursued a peritoneal metastases therapy; (2) another added Cisplatin to a common combination; (3) others have taken advantage of the new willingness to treat metastases when they are few; (4) another has enrolled in the hard-to-enter BATs trial, and (5) another is investigating hepatic arterial 5FU infusion combined with systemic chemotherapy. 
          You do not have to limit yourself to BRCA targeting.
         PhilipJax

RE: nanoknife IRE for pancreatic cancer

by PhilipJax - February 20 at 11:56 AM

Mkk2018 & Others:
          My replies are delayed by the forum for several days because they contain weblinks.
          Immunotherapy plus radiation.  Don’t head that way, unless there is at least a Phase 1 trial indicating effectiveness.  The selection of one path often obviates another path.  This is a swiftly moving parade.  One misstep, and you cannot go back and take a path previously forsaken.
          Radiation is a focal therapy, not a systemic one, somewhat irrational for systemic, metastatic disease.  So, seek proof via a completed, reported clinical trial (that is, a human trial, not an animal study).
          Study the Pancreatic Cancer Decision Guide thoroughly, available top-right on the following web page:
https://pancreatic.altervista.org/ 
          And study thoroughly my posts for the past 2 years, including 2 years of ASCO symposia reviews.
         PhilipJax

Everyone:
          The link to the Pancreatic Cancer Decision Guide has not copied well in the previous postings.  If the link immediately below does not work, there may be two other options:
http://jaxelection.altervista.org/pancreatic/ PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/ PJaxDecisionAlg
1. If the above link fails, add PJaxDecisionAlgorithm.pdf to the end of the following link:
http://jaxelection.altervista.org/pancreatic/
2, And, if that approach fails, Google the term “PJaxDecisionAlgorithm.pdf ” which may get you the downloadable file.
         PhilipJax

Mkk2018 & Others:
          Don’t head that way, unless there is at least a Phase 1 trial indicating effectiveness.  The selection of one path often obviates another path.  This is a swiftly moving parade.  One misstep, and you cannot go back and take a path previously forsaken.
          Radiation is a focal therapy, not a systemic one, somewhat irrational for metastatic disease.  Nevertheless, seek proof via a completed, reported clinical trial.
          Study my Decision Guide thoroughly, available top-right on the following web page:
https://pancreatic.altervista.org/ 
          And study thoroughly my posts for the past 2 years, including the ASCO symposia reviews.
         PhilipJax

Everyone
          The link to the Pancreatic Cancer Decision Guide has not copied well in the previous postings.  If the link immediately below does not work, there may be two other means:
http://jaxelection.altervista.org/pancreatic/ PJaxDecisionAlgorithm.pdf " target="_blank" rel="nofollow">http://jaxelection.altervista.org/pancreatic/ PJaxDecisionAlg
          If the above link fails, add PJaxDecisionAlgorithm.pdf to the end of the following link:
http://jaxelection.altervista.org/pancreatic/
          And, if that approach fails, Google the term “PJaxDecisionAlgorithm.pdf ” which may get you the downloadable file, hopefully.
         PhilipJax

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