nanoknife IRE for pancreatic cancer

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RE: nanoknife IRE for pancreatic cancer

by denver88 on Thu May 24, 2018 02:50 PM

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You are taking the proper steps on pursuing treatment by asking questions.  One thing we know on this message board is that one size doesn't fit all, all situations are unique, and there are alternative scientific treatments.  We also know that treatment can work with success.  The nonoknife comments are encouraging and that is great and this procedure gets better and more effective all the time.  My suggestion is to pursue a second (and third if you feel required) at another clinic.  I'm sure you have recommendations from folks on this forum.  I pursued second opinions and please don't feel it will in any way affect your treatment or relationship with your current doctors.  MD Anderson in Houston, Mayo Clinic, Memorial Sloan Kettering in NY, and UCSF San Francisco are the institutions I looked into because of their ratings.  Also the Hospitals of the University of Pennsylvania-Penn Presbyterian, Philadelphia is noted for cancer treatment.  Do pursue second and third opinions if uncomfortable with current treatment.  Do research hospitals that specialize in IRE/nanoknife if you go that direction and be sure to ask about the surgeons experience with your particular situation.  Take care

RE: nanoknife IRE for pancreatic cancer

by johndnc on Thu May 24, 2018 04:03 PM

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My wife had nanoknife surgery last October at Norton Hospital in Louisville, KY for stage T1a pancreatic cancer located in between the bile duct and the dorsal pancreatic duct.  Dr. Robert Martin performed the surgery.  The surgery was more rigorous than we expected, and my wife's recovery longer and more tortuous than we expected, even though we had been told the nanoknife procedure was as rigorous as the Whipple proceedure.  As of several weeks ago, we found that a new site of adenocarcinoma has appeared in the pancreas head, and we are declining further procedures.

From my research, the nanoknife is about the only surgical proceedure that will deal effectively with a tumor wrapped around an artery.  Examine the after effects and prognosis carefully with the surgeon where ever you have it done.

Probably the most important question to ask is, "How many of these procedures have you done and what has been your success rate?  What has been your mortality experience?"

My first choice was Dr. Martin at Louisville, second choice, M. D. Anderson, Houston, and third choice, U. Maryland.

Hope this helps and our prayers are with you and your mother.

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Sun May 27, 2018 12:51 PM

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2018 ASCO Annual Meeting, Installment Part 1
EGFR BATs Immunotherapy & FFX/Proton Therapy for LAPC

Everyone,
          Today, I will be reviewing abstracts from the 2018 ASCO Annual Meeting, which begins June 01, 2018.  There are at least 40 relevant abstracts.  So, over a period of several days or weeks, I will cover the “best” research, which may be less than 10 studies.  If you can’t wait, the abstracts can be found here for awhile.  After a few weeks they will likely be removed from ASCO’s website:
http://abstracts.asco.org/214/CatAbstView_214_101_AA.html
http://jaxelection.altervista.org/pancreatic/Abstracts2018AS
          The order in which I present the abstracts does NOT signify their importance.  I am merely beginning randomly within the pancreatic series.
          Note that the two abstracts below name related Clinical Trials.  Those studies meet the definition of PRUDENT clinical trials, since the patient receives a responsible backbone therapy even if the experimental agents do not work.  An IMPRUDENT trial has no backbone chemotherapy.
         PhilipJax

Abstract 4108: Targeting advanced pancreatic cancer with activated t cells armed with anti-CD3 x anti-EGFR bispecific antibody
          In 4 sequential clinical trials several US institutions treated 9 locally-advanced and metastatic patients using immuno agent EGFR BATs as a means to activate T cells.  The immunotherapy followed the well known but substandard FOLFOX6 regimen.  Details here:
https://clinicaltrials.gov/show/NCT01420874
          For this unusual research the outcomes were rather dramatic:
1. The median Overall Survival was 31.0 months, a success achieved withOUT surgical resection.
2. Three of 9 patients (33%) suffered disease progression, but developed Complete Responses when later treated with standard chemotherapy.  In one case the subsequent chemo agent was merely Capecitabine – that patient has been off therapy for 1 year, and alive 40.8 months after the start of the initial EGFR BATs infusion.
          Researchers speculate that EGFR “BATs infusions may enhance tumor responses to subsequent chemotherapy.”
          This research is difficult to extrapolate to a larger patient population, due to the very small size of the research group.  However, the results are impressive.
          A related clinical trial is available at University of Virginia, Charlottesville.  Enrollment is limited to 22 subjects, who receive “standard of care” chemotherapy, then EGFR BATs infusions.  Prior chemotherapy is acceptable and wanted; so, patients need NOT be chemotherapy naïve.  “Standard of Care” is likely FOLFIRINOX or Nab-Paclitaxel/Gemcitabine, better than the earlier FOLFOX6.
          However, there are eligibility restrictions.  Study the details at the link below.  If interested, act quickly.  Undertaking this trial does not prevent you from undertaking subsequent therapies (except perhaps immunotherapy trials).  See
https://clinicaltrials.gov/show/NCT03269526

Abstract 4116: Potentially curative combination of TGF-b1 inhibitor losartan and FOLFIRINOX (FFX) for locally advanced pancreatic cancer (LAPC): R0 resection rates and preliminary survival data from a prospective phase II study
          This research at Massachusetts General Hospital, begun in 2013, sought to determine whether the following therapy might produce high R0 resection rates among locally-advanced (not metastatic) patients.  The investigation consisted of the following complex regimen:
          49 patients, whose median tumor size was 41mm (range 18-68mm), received 8 cycles of FOLFIRINOX (FFX) plus Losartan, a TGF-b1 inhibitor.  If the tumor was resectable after chemotherapy, patients received short-course chemoradiation (CRT) in 5 fractions totaling 25G GyE, consisting of Proton Therapy plus Capecitabine (which is an oral form of 5FU).  If the tumor still abutted blood vessels, patients received CRT to 50.4 Gy with a vascular boost to 58.8 Gy.
          Note that Losartan, a blood pressure medication, is expected to enlarge tumor-related blood vessels, allowing more FFX to reach the tumor.
          R0 is the most thorough resection.  And Proton (particle) radiation is not the same as the common photon (X-ray) radiation.  Proton Therapy inflicts far less “collateral damage” to adjacent healthy organs.  Massachusetts General’s $200M Proton facility has been a longtime world leader in the use of Proton Therapy against pancreatic cancer.
          The research results are the following:
1. Of 49 patients, 39 (80%) underwent attempted surgery; 34 (69%) were resected, and 30 patients (61%) experienced R0 resection (a good R0 resection rate).
2. For the 49 patients the overall Progression Free Survival (mPFS) was 17.5 months and Overall Survival (mOS) 31.4 months.  But, among the resected patients mPFS was 21.3 months and mOS was 33.0 months.
          The Result 2 survival numbers so NOT represent the benefit of Losartan/FFX and chemoradiation alone, since the numbers also include the survival benefit of resection.
          So, the best gauge of Losartan/FFX plus CRT is Result 1, the resection rate.  However, it may be possible to achieve a 61% resection rate using Irreversible Electroporation (IRE) during one intraoperative procedure without the use of radiation.
          Finally, researchers have an ongoing multi-center Phase II trial of this therapy regimen.  Enrollment is limited to 50 participants.  See:
http://clinicaltrials.gov/show/NCT01821729
         Stay tuned. More abstracts to come.

 

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Mon May 28, 2018 12:43 AM

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2018 ASCO Annual Meeting, Installment Part 2
Modest Indoximod Benefit & Pamrevlumab (FG-3019) Increases Resectability

Everyone,
          This installment reviews two immunotherapy agents.
          For a comprehensive discussion of all pancreatic cancer topics visit my website at
https://pancreatic.altervista.org/  " target="_blank" rel="nofollow">https://pancreatic.altervista.org/  
          Stay tuned.  More abstracts will follow in the days to come.
         PhilipJax

Abstract 4015: Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer
         
Researchers at 10 US institutions used Indoximod (an IDO pathway inhibitor) to facilitate anti-tumor immunity in metastatic patients.  All trial subjects were treatment naïve.
          Oral Indoximod was added to Gemcitabine + Nab-Paclitaxel for 104 research subjects, producing the following results:
1. The Overall Response Rate was 46.2%, including one Complete Response.  A Complete response is a complete absence of disease evidence (but not necessarily a cure).
2. The Overall Survival was 10.9 months, slightly longer than the historical 8.5 months attributable to Gemcitabine+Nab-Paclitaxel.
         The trial has been operational since 2014 and appears to have exceeded its enrollment of 98. But a few openings may be available. However, patients must have had no previous radiotherapy, surgery, chemotherapy or investigational therapy.

Abstract 4016: Effect of anti-CTGF human recombinant monoclonal antibody pamrevlumab on resectability and resection rate when combined with gemcitabine/nab-paclitaxel in phase 1/2 clinical study for the treatment of locally advanced pancreatic cancer patients
          Researchers at 8 US institutions tested whether Pamrevlumab, an anti-CTGF antibody, might increase resectability among Locally-Advanced patients who were also treatment naïve.  37 patients were randomized 2:1 to Arm PGN (Pamrevlumab + Gemcitabine/Nab-Paclitaxel) or to Arm GN (Gemcitabine/Nab-Paclitaxel).
          That is, approximately 24 subjects in Arm PGN and 13 subjects in Arm GN.  If resection took place, no adjuvant chemotherapy was given, although 2nd line therapy was undertaken if needed.  The results:
1. For Arm PGN compared to Arm GN more patients were eligible for surgery (70.8% vs 15.4%) and were resected (33.3% vs 7.7%).  Not all those eligible for surgery were eventually resected.
2. Overall Survival was greater in patients eligible for surgery vs not eligible (27.73 vs 18.40 months) and in patients resected vs not resected (Not yet known vs 18.56 months).
3. Progression Free Survival showed a similar trend: Surgery-eligible vs not eligible (16.39 vs 10.09 months) and resected vs not (16.39 vs 10.38 months).
          Although the research group was small and thus unreliable, Pamrevlumab may be a worthwhile addition to neoadjuvant therapy for Locally Advanced patients.  This recommendation does not apply to metastatic patients.  The trial details can be found at
https://clinicaltrials.gov/show/NCT02210559
          Pamrevlumab (then named FG-3019) did well in a different trial which tested Locally Advanced AND metastatic patients.  See
http://jaxelection.altervista.org/pancreatic/PamrevlumabData
          Unfortunately, no Pamrevlumab trial is currently open.  This may be a drug to obtain under Compassionate Use or under the newly-enacted Right To Try Act, passed by Congress on May 22, 2018 (whose implementation will take a while).
          Manufacturer FibroGen can be reached at 1.415.978.1200 (San Francisco), Gustavo Lorente (glorente@fibrogen.com) and
http://www.fibrogen.com/about-us/contact-us/  
          Find out more about Right To Try and review a comprehensive list of other topics at my website:
https://pancreatic.altervista.org/

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Mon May 28, 2018 06:58 PM

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2018 ASCO Annual Meeting, Installment Part 3
Merged Gem+NabP+FFX Regimen & PARP Inhibitor for DDR Defects

Everyone,
          This installment reviews two abstracts which can be downloaded here.
http://jaxelection.altervista.org/pancreatic/Abstracts2018AS
          For a comprehensive discussion of all pancreatic cancer topics visit my website at
https://pancreatic.altervista.org/ 
          Stay tuned.  More abstracts will follow in the days to come.
         PhilipJax

Abstract 4109: Sequential treatment with Nab-paclitaxel plus Gemcitabine and Folfirinox in metastatic pancreatic adenocarcinoma: GABRINOX phase II results
         
French researchers at multiple centers treated 58 metastatic patients using two merged regimens in sequence (one AG cycle followed by 2 FFX cycles), creating a combined 1st line therapy.  AG is Nab-Paclitaxel + Gemcitabine and FFX is FOLFIRINOX.  The combined series was labeled GABRINOX.  The metastatic patients were chemotherapy naïve.
          The research results are notable:
1. The Overall Response Rate was 63.2%, including 2 Complete Responses and 34 Partial Responses.  A Complete response is a complete absence of disease evidence (but not necessarily a cure).
2. The Progression Free Survival was 9.6 months, and the Overall Survival was 17.8 months, twice the 8.5-month OS usually attributed to AG (Nab-Paclitaxel + Gemcitabine).
          Details of the trial can be learned at
http://clinicaltrials.gov/show/NCT01964287

Abstract 4128: DNA repair deficiency, genomic instability and immune profiling in a phase 1 study of locally advanced pancreatic cancer patients treated with veliparib, gemcitabine and radiotherapy
          In a Phase 1 trial (started in 2013) researchers at Cedars-Sinai Medical Center hoped to learn whether Locally-Advanced patients with certain genetic defects, specifically DNA Damage Repair defects (DDR), might benefit from Veliparib, a PARP inhibitor.  PARP is Poly(ADP-ribose) Polymerase.
          Veliparib (ABT-888) has been considered helpful in treating BRCA1/2-mutated pancreatic cancer.  BRCA and “BRCAness” may be present in 10-25% of pancreatic victims.
          A group of Locally-Advanced 34 patients was tested for DDR defects, using a process called Next Generation Sequencing, and half of the 34 were found to harbor such defects.  All subjects received Veliparib, Gemcitabine and Radiotherapy, followed by “standard chemotherapy”.
          The results:
1. For the 34 patients overall, median Progression Free Survival (PFS) and Overall Survival (OS) were 10 months and 15 months, respectively.
2. However, when DDR-defect patients were compared to no-defect patients, the PFS and OS were significantly higher, 17 vs 8 months and 22 vs 12 months, respectively.  There is a survival benefit to PARP inhibitors.
          The lesson: The patient should be tested for DDR deficiency, and in defect cases a PARP inhibitor might be considered.  The Cedar-Sinai trial is closed.  But details can be found here:
https://clinicaltrials.gov/show/NCT01908478
          A Veliparib trial is available at 5 centers in the east and mid-west US, plus Canada and Israel.  However, it is randomized, so half the patients do not receive the PARP inhibitor.  It and the other therapy elements (Gemcitabine and especially Cisplatin) are meant to manage BRCA defects.  See:
https://clinicaltrials.gov/show/NCT01585805
         Note however, that two other PARP inhibitors (Olaparib, and Rucaparib) are considered by the medical literature to be more potent thanVeliparib. So, if BRCA is present, you may do well to add one of those PARP inhibitors to your treatment regimen, as well as Cisplatin or Oxaliplatin, if that is tolerable.

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Tue May 29, 2018 02:27 PM

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2018 ASCO Annual Meeting, Installment Part 4
Microsatellite Instability (MSI) and Mismatch Repair Deficiency (dMMR)
Elder Resection, Radiation & Ascites

Everyone,
          This is likely the last installment of my abstract review for the 2108 ASCO Annual Meeting, June 1-5 2018.  The abstracts can be downloaded here.
http://jaxelection.altervista.org/pancreatic/Abstracts2018AS  
          For a comprehensive discussion of all pancreatic cancer topics visit my website at
https://pancreatic.altervista.org/ " target="_blank" rel="nofollow">https://pancreatic.altervista.org/
         PhilipJax

Abstract e16254: Universal screening for mismatch repair deficiency in pancreatic cancer
          Researchers at Stanford University Medical Center now recommend dMMR testing for all pancreatic cancer patients.  Patients with Lynch Syndrome have microsatellite instability.
          Microsatellite instability (MSI) and mismatch repair deficiency (dMMR) are rare, but play a contributing role in pancreatic cancer.  And dMMR may be treated to some extent by recently approved anti-PD1/PDL1 checkpoint therapy, specifically Pembrolizumab.
          Stanford found that 8% of SCREENED patients (15 of 184 screened patients) had abnormal/equivocal MMR stains (these are not certain dMMR diagnoses, but suspect).  Five of these 15 patients had metastatic disease and were treated with Pembrolizumab, an anti-PD1/PDL1 checkpoint inhibitor.  The result:
          Four of the 5 patients (80%) are alive after a median follow-up time of 14 months, with 3 patients still on treatment.
          In a related article, page 2, leading oncologist Tanios Bekaii-Saab describes the cure of a pancreatic dMMR patient using Pembrolizumab.
http://jaxelection.altervista.org/pancreatic/CheckpointInCRC

Abstract e16227: Perioperative outcomes in elderly patients undergoing pancreatic resection for pancreatic adenocarcinoma: A systematic review and meta-analysis
          Australian researchers reviewed 10 studies to learn how well elderly patients (≥70yr, ≥75yr, ≥80yr) endured pancreatic resection compared to their younger counterparts (<70yr, <75yr, <80yr).  The findings:
1. Older patient had significantly larger tumors. Nonetheless, they were less likely to undergo portal vein resection (p = 0.005) and had lesser intraoperative blood loss.
2. There was no difference in the depth of tumor or nodal stage between the groups.
3. Postoperative complications were higher in the older group.  Nevertheless, there was no difference in postoperative pancreatic fistula, length of hospital stay or postoperative mortality.
          Conclusion: “Pancreatic resection . . . can be performed safely on elderly patients with acceptable risks in experienced centers by expert surgeons.”

Abstract e16257: The role of radiation therapy to the primary site in locally advanced and metastatic pancreatic cancer ( 2004-2015 National Cancer Data Base (NCDB) review)
          Researchers at SUNY Upstate Medical University (Syracuse, NY) used the National Cancer Data Base, a review of 83,526 cases, to determine whether radiation therapy aided Locally-Advanced and metastatic patients.  The research findings:
1. For Locally-Advanced disease the one-year Overall Survival (OS) was 35.8 % for patients who received chemotherapy (CT) alone vs. 43.8% for patients who received both CT and radiation therapy (RT), an 8% difference.
2. But, for metastatic patients one-year OS was 26.3% for chemotherapy only and less, 24.2%, for those receiving both CT and RT.
         Radiation treatment, when added to chemotherapy, increases one-year Overall Survival by about 8% in locally advanced pancreatic cancer, but not in metastatic pancreatic cancer.

Abstract e16242: Portal hypertension and ascites in pancreatic cancer
          Researchers at Cedars-Sinai Medical Center performed careful statistical analysis of 325 patient records and found “an association . . . between” “any form of” “radiation therapy and [the] development of ascites.”
         Ascites is a recognized complication of pancreatic cancer. There are no guidelines for a standardized approach to its treatment but commonly used therapies include diuretics, paracenteses, and drains.

          For a comprehensive discussion of all pancreatic cancer topics visit my website at
https://pancreatic.altervista.org/ " target="_blank" rel="nofollow">https://pancreatic.altervista.org/

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Wed May 30, 2018 06:02 PM

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Right To Try Act
Get Experimental Drugs Outside Clinical Trials

          On May 22, 2018 Congress passed (and on May 30 the President signed) legislation which allows an “eligible patient” (one suffering from a “life-threatening disease or condition”) to access “unapproved medical products,” specifically an “eligible investigational drug.”
          The Right To Try Act (RTT Act) makes it easier for people to access experimental treatments outside of a clinical trial.  Not all details are yet known.  However, the following is certain:
1. The patient must have “exhausted approved treatment options” “as certified by a physician” and must be “unable to participate in a clinical trial involving the eligible investigational drug.”
2. The “eligible investigational drug” must be the focus of a completed Phase 1 (or later) clinical trial.
3. It is not certain what TYPE of medical intervention constitutes an ELIGIBLE investigational drug.
          It is not known for example whether Stem Cell infusion, Irreversible Electroporation or TT Fields might be considered a “drug.”  The answer will be found in existing Congressional acts, since the drug must be “the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act.”
          Some of the promising Emerging Agents, listed on the EndPC website, will likely be available outside clinical trials.  Review details on those Emerging Agents here:
https://pancreatic.altervista.org/
          When there is additional information about the Right To Try Act, it will be posted at EndPC.
          The RTT Act can be downloaded here:
http://jaxelection.altervista.org/pancreatic/RightToTry_115s

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Fri Jun 01, 2018 09:46 AM

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Right To Try Act, Update 1
No Mandate on Drug Manufacturers

          An update.  The Right To Try Act does NOT mandate manufacturer cooperation.  The Act states: “It is the sense of the Senate that . . . [the Act] does not establish any new mandates, directives, or additional regulations.”
          Neither FDA’s current “expanded access” program nor the new Right To Try Act mandate cooperation from drug companies.  However, the new Act does offer some slight advantages:
1. Right To Try bypasses FDA’s approval process for "compassionate use" of experimental drugs.  Patients now need only the approval of their physician and the drug manufacturer.  Time and red tape are saved.  Compassionate Use is explained here:
https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAcc
2. The new law protects doctors and companies from the legal risks of allowing unapproved treatments, unless they intentionally harm a patient.
          Critics are correct that, in many respects, the Act is dangerous.  Many Phase 1 drugs (the likely choice by patients under this Act) do not succeed in later phases – some are later found to be harmful.
          In addition, when a patient selects a treatment under this Act, he could easily forsake a better therapy, one which has benefits proven by more thorough research.  So time and opportunity are lost – meanwhile the disease progresses.
          The above assessment is early.  Time may reveal better features of this law.  But, it is certain that drug manufacturers are NOT compelled to participate.
         A better law would have allowed patients to use drugs which have been FDA-approved for other applications. For example, some drugs, approved for lung cancer or ovarian cancer, are not FDA-approved for pancreatic cancer. Yet some emerging pancreatic chemo regimes might employ those lung/ovarian drugs, but the costs are not covered by insurance because they lack FDA approval for the pancreatic application.

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Wed Jun 06, 2018 02:07 AM

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2018 ASCO Annual Meeting, Installment Part 5
BREAKTHROUGH: mFOLFIRINOX After Surgery
likely Nab-P+Gem Before

Everyone:
          This posting applies to patients who are resectable at the time of diagnosis, unfortunately not metastatic victims.
          News reports call it a “breakthrough.”  Oncologists say it “changes clinical practice.”
          Abstract LBA4001 was a late release on June 04 at the 2018 ASCO Annual Meeting. 
          In the report French and Canadian researchers describe the test.  At 3 to 12 weeks following surgical resection 493 patients were randomly assigned to receive either Gemcitabine or modified FOLFIRINOX (mFOLFIRINOX) for 6 months – to determine which therapy performed better.  Such post-surgery therapy is called adjuvant chemotherapy.  And Gemcitabine monotherapy has been a frequent adjuvant choice, because the patient is weakened by surgery.
          The patient outcome was dramatic.
1. At a median follow-up of 33.6 months, median overall survival was much longer in the mFOLFIRINOX group (54.4 vs 35.0 months), as was the median disease-free survival (21.6 vs 12.8 months).  Of course most of the survival time is due to the surgical resection itself.
2. mFOLFIRINOX also markedly extended the time until metastases appeared (30.4 months for mFOLFIRINOX vs 17.0 months for Gemcitabine).
3. The 3-year disease-free survival was also superior in the mFOLFIRINOX group compared with the Gemcitabine group (39.7% vs 21.4%).
4. The 3-year overall survival was 63.4% vs 48.6% in favor of FOLFIRINOX, and 3-year cancer specific survival was 66.2% vs 51.2%.
5. Grade 3/4 adverse events were more common in the mFOLFIRINOX group than in the gemcitabine group (76% vs 53%), including 12% with grade 4 events in each group, but the side effects were manageable.  Commentary on Abstract LBA4001 is available here:
http://jaxelection.altervista.org/pancreatic/AdjuventFOLFIRI

          What Chemo Sequence, The Difficult Neoadjuvant Decision.  This is fine performance for mFOLFIRINOX.  The next question is: What should be the NEOADJUVANT chemotherapy (therapy BEFORE surgery) for initially resectable patients?  The Surgery-First vs Neoadjuvant-First debate has determined (to large extent) that newly-arrived resectable patient should begin with neoadjuvant chemotherapy, rather than go directly to surgery (see previous posts on the debate).
          Many oncologists typically start with FOLFIRINOX, if the patient is strong.  But now the neoadjuvant therapy will likely have to be Nab-Paclitaxel + Gemcitabine (+ Cisplatin for BRCA defect patients).
          Be sure to study the full range of other topics at my website:
https://pancreatic.altervista.org/
         PhilipJax

RE: nanoknife IRE for pancreatic cancer

by PhilipJax on Sat Jun 23, 2018 10:03 PM

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ESMO World Congress Meeting, June 2018
Peritoneal Metastases
Third Line Therapy & Napabucasin

Everyone,
          The June 2018 meeting of the European Society for Medical Oncology (ESMO) offers at least three research reports of immediate value.  The abstracts are downloadable here:
http://jaxelection.altervista.org/pancreatic/ESMO2018Posters

P-147: Use of gemcitabine and nab-paclitaxel as a third-line treatment following failure of first line gemcitabine for advanced pancreatic adenocarcinoma
          In this study of 20 metastatic patients Australian researchers found that a Third Line Therapy of Nab-Paclitaxel + Gemcitabine was effective even though the patients began their therapy with a First Line Gemcitabine-based regimen.
         The patients gained an extra 6 months of survival on average (median Overall Survival) AFTER re-initiating Nab-Paclitaxel + Gemcitabine.

P-184: CanStem111P trial: A Phase 3 Study of napabucasin (NAPA) plus nab-paclitaxel (nPTX) with gemcitabine (Gem) in adult patients with metastatic pancreatic adenocarcinoma (mPDAC) - Trial in progress
          In this report American researchers remind us of Napabucasin’s Phase 3 clinical trial for metastatic therapy-naïve patients, of the 189 trial sites worldwide, and of Napabucasin’s performance in its preceding Phase 1b trial.
          In that earlier trial Progression Free Survival and Overall Survival were modest at 7.06 and 9.59 months, respectively, for 59 metastatic patients.
          However, the Response Rate was better: 56% (28/50), with 2 complete and 26 partial responses.  A Complete Response (although not a cure) is an exceedingly rare event.  More details on the ongoing Phase 3 trial are available here:
https://clinicaltrials.gov/show/NCT02993731

P-137: Intraperitoneal chemotherapy for pancreatic cancer with peritoneal metastases: A single center retrospective analysis of 25 patients
          Peritoneal metastases were treated by Japanese researchers by injecting Paclitaxel into the abdominal cavity in a process called Intraperitoneal Chemotherapy.  Of the 25 patients 8 were therapy-naïve.
          The Progression Free Survival and Overall Survival ranged from 3.1 to 11.5 months and 11.9 to 18.4 months, respectively, depending on three factors: (1) whether the patient was therapy-naïve, (2) whether there were non-peritoneal metastases, and (2) the systemic chemo regimen chosen for each patient.
          These factors make it difficult to sort out the role of intraperitoneal therapy in longevity.  However, the research’s most prominent findings were: For 11 patients peritoneal metastases disappeared completely.  And 5 of the 11 patients achieved surgical resection of the primary tumor – a surgery rarely undertaken if peritoneal metastases are present.
          There are two types of Intraperitoneal chemotherapy.  The first type is infused through a port in the abdomen and is administered in either the hospital or an outpatient (clinic) setting.  The second type, referred to as Hyperthermic Intraperitoneal Chemotherapy (HIPEC), is administered in the operating room after surgical resection of the primary tumor.
          Infusions can last from 30 minutes to 3 hours.  The cytotoxic agent is slowly absorbed into the peritoneal cavity, with about 90% being absorbed within 4 hours.  Generally, the cytotoxic agent (in this case Paclitaxel) is unable to penetrate tumors greater than 1cm in diameter.  The injection process is described here:
https://www.oncolink.org/cancer-treatment/chemotherapy/overv
          The following journal articles describe actual patient treatment and its outcomes.  The physician needs to be very experienced in this procedure, or the patient may suffer as a result.  Paul H Sugarbaker is the American leader in this therapy:
http://jaxelection.altervista.org/pancreatic/IntraPeritoneal
http://jaxelection.altervista.org/pancreatic/HIPACPancreatic
http://jaxelection.altervista.org/pancreatic/CRS_Sugarbaker2
          Be sure to study all new developments and care strategies at the EndPC website:
https://pancreatic.altervista.org/ 
         PhilipJax

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