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2019 Gastrointestinal Cancers Symposium
Installments, Part 1

Everyone,
          Today, I begin reviewing abstracts from the 2019 GI Cancers Symposium which was held in San Francisco on January 17-18, 2019.  There are at least 45 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://jaxelection.altervista.org/pancreatic/2019ASCOGIAbstr
          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.
         PhilipJax

Abstract 168344: Single-shot celiac plexus radiosurgery in pancreatic cancer: Palliative and functional outcomes—Final results of a prospective clinical trial
          As a means to reduce epigastric/lower back pain Canadian and American researchers irradiated the celiac plexus of 17 patients using a single-fraction 25 Gy.  The median patient ECOG was 1, and about half suffered liver metastases.  The results:
1. Median baseline pain was reduced from 6.0 IQR to 2.3.  And, at 6 weeks “BPI pain interference” dropped from a 7.1 baseline to 0.
2. Opioid consumption decreased from 52.9 MME to 37.5 MME at 6 weeks.
          Trial information is here, although a patient does not have to participate in this trial to adopt practice.  A follow-up international trial is accruing.
http://clinicaltrials.gov/show/NCT02356406

Abstract 168385: Impact of neoadjuvant radiation on survival in patients with pancreatic cancer undergoing neoadjuvant chemotherapy followed by pancreatectomy
          Using the National Cancer Database, University of Miami researchers sought to learn whether Neoadjuvant ChemoRadiation (NACR) was superior to Neoadjuvant Chemotherapy (NAC, without radiation) for resected patients.
          The records of stage I-III patients who underwent surgical resection from 2004 to 2014 were examined, yielding 3,133 patient cases.  A total of 2,351 (75%) patients underwent NACR, and 782 (25%) underwent NAC alone, and 74% underwent pancreaticoduodenectomy.  The result:
1. The rates of margin positivity were similar: 15% for NACR and 17% for NAC.
2. Median Overall Survival and 5-year Overall Survival were similar: 25.7 months for NACR vs. 25.1 months for NAC, and 20% vs. 22%, respectively
          Researchers found that NACR is associated with lower rates of lymph node positivity.  However, they concluded: (1) that “NACR did NOT translate into a survival or margin positivity benefit compared to NAC alone”, and (2) that “no convincing data is currently available to advocate the widespread use of radiotherapy in the neoadjuvant setting.”
         Keep in mind that these were cases of resected patients who should be expected to do well.

Abstract 168476: Effect of neoadjuvant chemoradiotherapy on prognosis in resectable and borderline resectable pancreatic cancer with venous involvement
          In a somewhat contradictory study Japanese researchers sought to learn the value of NACR by analyzing the records of 181 patients, from 2006 through 2017, who preoperatively received full-dose gemcitabine (1000mg/m2) plus concurrent radiation of 54 Gy.  The NACR patients were compared to 149 patients who were candidates for upfront surgery and who served as the control group.
          It is important to note that it is uncertain whether the no-NACR group received any neoadjuvant chemotherapy whatsoever.  The research outcome:
1. Among the 181 NACR patients, 23 (13%) couldn’t undergo pancreatic resection following NACR due to distant metastasis in 10, tumor progression in 7 and poor physical status in 6. Among the 149 upfront-surgery patients (the control group), 10 (7%) couldn’t undergo pancreatic resection at laparotomy because of distant metastasis in 8 and tumor progression in 2.
2. NACR patients in general had a better prognosis than those without, acquiring a Median Overall Survival of 37.0 vs. 27.1 months.
3. Median Overall Survival differed by resectability status.  For R (Resectable) patients Overall Survival was 45.7 months with NACR therapy versus 33.8 months without.  For BR-P (Borderline Resectable Venous Involvement) patients the Overall Survival was 61.7 vs. 14.6 months.
4. For BP-A (Borderline Resectable Arterial Involvement) patients the researchers found that “NACR had no significant impact on prognosis.”
         
The research designs for Abstracts 168385 and 168476 may explain their contradictory outcomes.  In Abstract 168385 researchers considered a far greater number of cases, which tends to enhance accuracy.  And in 168476 it is possible that non-NACR patients received NO neoadjuvant therapy at all – no neoadjuvant chemotherapy – although we might assume that both groups received some post-resection therapy.
          Radiotherapy has always been controversial, although most radiation oncologists will not admit that.  More information can be found here:
https://www.cancercompass.com/message-board/message/all,6312
          The next 2109 GI Symposium installment will begin addressing new chemotherapy regimens.  And, be sure to study my website thoroughly including the downloadable Decision Guide, found at
https://pancreatic.altervista.org/

Therapy for Borderline Resectable & Locally Advanced
It is claimed that Neoadjuvant FOLFIRINOX is better than surgery

Everyone:
          This posting deals with conditions other than metastatic.
          New research challenges somewhat the standard treatment pattern.
          “Using published and institutional clinical data,” researchers in Boston and New York concluded that neoadjuvant (pre-surgery) FOLFIRINOX is a better option than surgery plus adjuvant (post-surgery) therapy for Borderline Resectable (BR) and Locally-Advanced (LA) cases.
          Their decision-analysis calculated that the median OS was best with nFOLFIRINOX (34.5 months) vs surgery plus GEM/CAPE (28.0 months) vs surgery plus Gemcitabine (22.0 months.  And, Median DFS was also better with nFOLFIRINOX: 15.0 months vs 14.0 months vs 13.0 months, respectively.  Gem/Cape means Gemcitabine plus Capecitabine, and DFS means Disease Free Survival, similar to Progression Free Survival (PFS).
          This finding diverges greatly from the optimal model of using IRE plus surgery to managed Locally-Advanced disease, followed by modified FOLFIRINOX (mFOLFIRINOX), if the patient can tolerate that adjuvant regimen (otherwise maintenance therapy Gemcitabine plus Capecitabine might be employed).  See my previous posts and my website on adjuvant mFOLFIRINOX and maintenance therapy.
          The 2018 Boston-New-York report can be found here:
http://theoncologist.alphamedpress.org/content/early/2018/12
          As mentioned earlier, the study did not considered the new paradigm which employs adjuvant mFOLFIRINOX following surgery.  See a previous post on adjuvant mFOLFIRINOX in this forum and at my website.  There you can also download and study the very useful Decision Guide.  See
https://pancreatic.altervista.org/
          The ASCO symposium on pancreatic cancer takes place in January 2019.  So, in a few weeks I will present an analysis of the more useful and favorable research.
         PhilipJax

RE: Pancreatic cancer next step?

by PhilipJax - December 21 at 7:57 PM

Where To Find The Most Info
Go https://pancreatic.altervista.org/ " target="_blank" rel="nofollow">tohttps://pancreatic.altervista.org/

Everyone:
          You would be wise to shift to the thread at
https://www.cancercompass.com/message-board/message/all,6312
          Study the past 2 years of posts and STUDY the website and Decision Guide found at
https://pancreatic.altervista.org/
         PhilipJax

Adjuvant Therapy NOT Needed
For Resected <1cm (T1a/T1b) Tumors

Everyone:
         For pancreatic cancer victims one can only hope for a tumor <1cm in size.  But, in such a case adjuvant therapy (chemotherapy or radiation following surgery) may offer no benefit.
          Using the National Cancer Data Base researchers at Emory University reviewed the records of 876 patients and found the following via statistical analysis:
1. “The median OS was significantly different for patients who received adjuvant therapy [following surgery] compared with patients who did not (70.7 months vs 46.9 months).”
2. However, “for patients with [resected] tumors measuring <1 cm (there was) no survival benefit for adjuvant therapy.”
          Of course this applies to tumors limited to the pancreas and less than (<) 1cm in the greatest dimension.  It might also be presumed that the surgical margins must be negative.
          Such T1a/T1b tumors are too rare.  Of 876 patients, whose pancreas-only tumors measured <2cm, only 30% had tumors <1cm (Stage T1a/T1b).
          The November 2018 report can be found here:
https://www.ncbi.nlm.nih.gov/pubmed/30457666
https://doi.org/10.1002/cncr.31787
         PhilipJax

Tamoxifen & Animal Studies

Andrea & Everyone:
          Caseyzson has done a fine job describing CEA testing.
          You should examine therapies beyond the pressurized CAR-T therapy which I have described in the post above.  You need to spend about 2-3 days of thorough study using my website and Decision Guide.  That will bring you up to date.
          And, of course, the pressurized CAR-T won’t be available for awhile.  The EndPC website is here:
https://pancreatic.altervista.org/
          Regarding the agent Tamoxifen, the recent press release, cited above, describes animal research.  And, animal response rarely translates to human subjects.  At my website read the section on clinical trial selection and animal research, right-side bottom.
          You will learn that in the past 20 years only about 4 trials have led to regimens used today in clinical practice.  Hundreds of trails failed, sacrificing thousands of desperate patients.  Yet, the hundreds of failures were based on successful animal studies.
          In the Phase 2 trial, linked above and reported in 2002, Tamoxifen is combined with Gemcitabine.  The resulting Response Rate is 11%, which is not great and which is approximately the Response Rate for Gemcitabine alone.
          The website and Decision Guide identify available and emerging regimens which have better NUMBERS.  And there you will learn how to use the NUMBERS to select the best therapies.
          And be sure to read my post of months ago evaluating the “Know Your Tumor” program.
          The ASCO symposia begin again in early 2019.  So, we may learn of additional new potent therapies then.
         PhilipJax

CAR-T For Liver Metastases
Good Effect When Delivered Under Pressure

Everyone:
          For Stage 4 pancreatic patients the presence of liver metastases makes them ineligible for surgical resection and possible cure.
          In a new development researchers recently presented data on immunotherapy for liver metastases: Anti-CEA CAR-T delivered using a new form of Hepatic Arterial Infusion (HAI) called Pressure-Enabled Drug Delivery (PEDD).  The event was the Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 7-11, 2018.
          The exceedingly small Phase 1b trial treated 4 pancreatic patient and one colorectal cancer patient.  These are the findings:
1. After treatment 2 of 4 (50%) pancreatic patients experienced Complete Responses (CR), no viable liver metastases as determined by PET scan.  One of the two is still alive after 19.3 months; the other did not do so well.
2. The more successful CR patient had undergone only one prior treatment regimen (FOLFIRINOX) and received a second CAR-T infusion 13 months after the first dose.  The other CR had undergone 6 prior chemo regimens.  They suffered 7 and 6 liver metastases, respectively.
3. For pancreatic patients the Median Overall Survival (OS) was 8.4 months.
4. PEDD significantly increased CAR-T more than five-fold within liver metastases, when compared with low-pressure microcatheters.  PEDD direct-delivery overpowers the high pressure within solid tumors and avoids the severely limiting side effects of systemic therapy such as neurotoxicity.  
          Unfortunately this trial NCT02850536 is no longer recruiting.  However, the next trial phase could start within a year.  Contact the trail leaders.  See
https://clinicaltrials.gov/ct2/show/NCT02850536
          The press release can be found here:
http://jaxelection.altervista.org/pancreatic/SorrentoCAR-T_S
          And, the detailed SITC poster presentation can be found here:
http://jaxelection.altervista.org/pancreatic/AntiCEA_CAR-T_H
          For more information on CAR-T therapy for pancreatic cancer download this article:
http://jaxelection.altervista.org/pancreatic/CAR-TPotentialP
          For more Pancreatic Cancer treatment information and a Decision Guide visit my website at
https://pancreatic.altervista.org/
         PhilipJax

The Meaning of Multiple Irons In The Fire
Canadian Limitations

Dear Daves,
          Your reference to “back pocket” means that you have not yet learned the meaning of “Multiple Irons in the Fire.”  The US residency must be started NOW.  And, Obamacare open enrollment begins in Novembers, so applications must be started in a few days.  More details here:
https://www.pancreatic.altervista.org/#ushealth
          Both Residency and Obamacare must be in place long before needed. 
          This is also called contingency planning, which requires that many preparations must be made even if eventually they are not used.
          If you wish to avoid wasting, skip the supplements and study the reports found here:
https://www.pancreatic.altervista.org/#anorexia
         PhilipJax

The Meaning of Multiple Irons In The Fire
Canadian Limitations

Dear Daves,
          Your reference to “back pocket” means that you have not yet learned the meaning of “Multiple Irons in the Fire.”  The US residency must be started NOW.  And, Obamacare open enrollment begins in Novembers, so applications must be started in a few days.  More details here:
https://www.pancreatic.altervista.org/#ushealth
          Both Residency and Obamacare must be in place long before needed. 
          This is also called contingency planning, which requires that many preparations must be made even if eventually they are not used.
          If you wish to avoid wasting, skip the supplements and study the reports found here:
https://www.pancreatic.altervista.org/#anorexia
         PhilipJax

Stage 4 Induction Therapy: FFX or NabP+Gem
Canadian Limitations

Dear Daves,
          FOLFIRINOX (modified FFX may be better) is usually the chosen induction (starting) therapy, because it is likely more effective than Nab-P + Gem, slightly, and the patient is stronger at the beginning.  Strike early and strike hard.
          As you’ve noted, there are good outcomes for some variants of Nab-P + Gem, those adding Cisplatin and other agents.
          However, they are not regularly used by typical physicians for induction therapy because of uncertainty.  Most of the emerging regimens have completed only early phase trials; they have not completed the Phase 3 trials required by US FDA for use in clinical practice.
          And, the group sizes are usually smaller in Phases 1 and 2, making the performance less able to be extrapolated reliably to larger patient populations.
          Of course, I would certainly consider using the Nab-P + Gem variants for induction, and most of the added agents are approved for pancreatic adenocarcinoma – it is the regimens that are not FDA approved.
          It is possible to find inventive oncologists willing to use these emerging regimens, but they will be nearly impossible to find within Canada’s system of socialized medicine.
          In the US you might find a few creative surgical oncologists who will address the few liver metastases (but not likely in Canada), so you should consider some of the Canadian work-arounds that I have posted recently.
          Also, I assume that you have also studied the Decision Guide found at my website.  It is updated almost weekly.  So download the latest edition.
https://pancreatic.altervista.org/
         PhilipJax

Uncertain Diagnosis
Letters from Hong Kong

MrT,
          Hong Kong presents a problem, because facilities are limited.  However, if insurance and financing are not limitations, you can go anywhere.
          You need not make any mention of past tests or diagnoses.  At each facility you can begin anew and cite only the symptoms.  That approach will result in fully independent diagnoses.  For the most urgent care, you can enter the facility via an Emergency Room visit.  State that you’ve relocated your residence; the symptoms became insufferable, and that you are able to pay costs.
          If MD Anderson has no record on you, start there.  Closer to your neighborhood, a Japanese facility may be suitable.  And, if you are racially Asian, an S-1 chemotherapy regimen may be especially effective.
         PhilipJax

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