Jewel Samadder

[Jewel Samadder @J_Samadder]

#CGAjc Thank you everyone for participating. I know we are all working together to better the lives of our hereditary cancer patients. Medical trials will be an important option to consider for our patients. https://t.co/HsRot6LFEa

[Sonia Kupfer @SoniaKupfer]

#cgajc Jewel, I wanted to congratulate you on your important work and clinical trials. We finally have a medical option for FAP patients with advanced duodenal disease. Still questions to be answered but already a game-changer.

[Jewel Samadder @J_Samadder]

Here is the https://t.co/iuFAz9XgCq website. https://t.co/r6pvYWiE1l #CGAjc https://t.co/BR0dEZzyIk

[Sonia Kupfer @SoniaKupfer]

#CGAjc If we have patients who might qualify, how best to get them into the trial? Can you provide inclusion criteria for current study?

[Jewel Samadder @J_Samadder]

Broad inclusion: clinical or genetic FAP, >18 yo, 5years out from cancer, Spigelman stage 1, 2, 3 duodenal disease, #CGAjc https://t.co/BR0dEZzyIk

[Sonia Kupfer @SoniaKupfer]

#CGAjc If we have patients who might qualify, how best to get them into the trial? Can you provide inclusion criteria for current study?

[Jewel Samadder @J_Samadder]

Centers participating include: Mayo Arizona, Mayo Rochester, U Utah, MD Anderson, Cleveland Clinic, U Pitt, U Michigan, Peurto Rico. #CGAjc https://t.co/BR0dEZzyIk

[Sonia Kupfer @SoniaKupfer]

#CGAjc If we have patients who might qualify, how best to get them into the trial? Can you provide inclusion criteria for current study?

[Jewel Samadder @J_Samadder]

Personally I think important to combine with COX inhibition (ie. sulindac). The new trial is testing if erlotinib alone is effective at a lower dose (50mg per day). The data will show the answer. #CGAjc https://t.co/aR62K36TBa

[Sonia Kupfer @SoniaKupfer]

#CGAjc Do you think erlotinib would be effective on its own or is it a combined effect with COX inhibition? Is there any way to predict who will be more likely to respond?

[Jewel Samadder @J_Samadder]

That would be ideal. We are planning to recuit 50 patients and have just started as of January 2018. 3 patients enrolled so far. Likely at least 12-18 months away from completion. #CGAjc https://t.co/FoEPxwGH4Q

[Sonia Kupfer @SoniaKupfer]

#cgajc When do you anticipate completing the current erlotinib trial? Will be interesting to see if same efficacy but less rash. Would be ideal.

[Jewel Samadder @J_Samadder]

Still to be answered. Most patients have stayed on the medication (erlotinib + sulindac) for at least 6-12 months. #CGAjc https://t.co/6gGoiQvfOc

[Jewel Samadder @J_Samadder]

Eventually covered in two patients where we were considering Whipple. Insurance seemed to favor erltonib over Whipple. #CGAjc https://t.co/HCyg6M1hya

[Jewel Samadder @J_Samadder]

idiopathic pulmonary fibrosis is a very rare complication of erlotinib. Case reportable almost. We did not see any in our trial. Would not worry about IPF in practice, rash is day to day issue. #CGAjc https://t.co/SBoeaYCp3X

[Sonia Kupfer @SoniaKupfer]

#cgajc Any concerns about pulmonary toxicity with erlotinib longer term? Someone mentioned this as a concern for polyposis indication. Don't remember this being a problem in your trial. @CGAIGC

[Jewel Samadder @J_Samadder]

At the baseline endoscopy we only sampled one polyp to confirm Spigelman stage which requires histology. Otherwise leave polyps in place for 6 months to monitor effect of the drug. #CGAjc https://t.co/ShDw3L3yt0

[Jewel Samadder @J_Samadder]

Insurance is the sticking point. I got two patients covered by sending them through Oncology who prescribed the drug. The other option is the NCI clinical trial ongoing which pays for the drugs. #CGAjc https://t.co/FBJPwEgjJn

[Sonia Kupfer @SoniaKupfer]

#CGAjc Coming to the jc a bit late but I wanted to ask Jewel about insurance coverage. I've had trouble getting coverage for erlotinib. Any advice? @CGAIGC

[Jewel Samadder @J_Samadder]

If erltotinib can regress rectal polyps, in patient with large polyp burden could decrease need for rectal/pouch revision surgery. Big win for patients. #CGAjc https://t.co/7U6PDRNKIy

[Jewel Samadder @J_Samadder]

If a drug were to shrink polyps and downstage the patient, benefit is to avoid a Whipple or need for aggressive endoscopy procedures such as EMR. These have significant morbidity. #CGAjc https://t.co/kWvwyEtLnG

[Jewel Samadder @J_Samadder]

If a drug were to shrink polyps and downstage the patient, benefit is to avoid a Whipple or need for aggressive endoscopy procedures such as EMR. These have significant morbidity. #CGAjc https://t.co/kWvwyEtLnG

[Rachel Pearlman @RachelP_LGC]

@J_Samadder what is the selling point for patients? Less surgery? Less endoscopy? #CGAjc

[Jewel Samadder @J_Samadder]

Anyone can prescribe erlotinib, as it is an oral chemotherapy. I have always used an oncology partner to prescribe/monitor these patients with me as they have the nursing resources to follow the patients. Would dose at 50 per day with sulindac.#CGAjc https://t.co/cr3u93pvix

[Jewel Samadder @J_Samadder]

Great question. Hopefully some GI docs can chime in. Problem is that endoscopic therapies including EMR, ESD, APC are all limited and potentially hazardous in causing a perforation. Chemoprevention is the future. #CGAjc https://t.co/s9UosaukFf

[Leslie Bucheit @gcleslieb]

.@J_Samadder many who do not specialize *specifically* in polyposis may be unfamiliar w/ new therapies (incl. those in trials). What are potential benefits/risks vs current, better known treatments? #CGAjc #GCchat

[Jewel Samadder @J_Samadder]

Let me ask the group what do they do with a patient with Spigelman 3 duodenal disease? Surveillance, APC therapy, EMR? Nothing works well for these patients. Consider drug therapy? #CGAjc https://t.co/YMYPdpErtZ

[Jewel Samadder @J_Samadder]

There are alot of exciting trials in FAP starting or ongoing. 1) NCI trial of low dose erltoinib running at 7 centers. 2) DFMO-Sulindac trial wrapping up, results will be ready for DDW in 2019. 3) Upcoming pharma trials also in works. #CGAjc https://t.co/DxtwYai55j

[Jewel Samadder @J_Samadder]

There are alot of exciting trials in FAP starting or ongoing. 1) NCI trial of low dose erltoinib running at 7 centers. 2) DFMO-Sulindac trial wrapping up, results will be ready for DDW in 2019. 3) Upcoming pharma trials also in works. #CGAjc https://t.co/DxtwYai55j

[Leslie Bucheit @gcleslieb]

CGA twitter journal club is happening NOW! Follow along & submit ?s using #CGAjc // #GCchat #crcsm https://t.co/BuPk6uhLGs

[Jewel Samadder @J_Samadder]

The rash does focus on sun exposed areas, thus we tell them to use sun protection. A few patients we have treated clinically with 50mg per day have had almost no rash and use steroid cream prn. #CGAjc https://t.co/yLYlEIQirm

[CGA-IGC @CGAIGC]

Was it a diffuse rash? Any predilection for an area (ie face)? Just thinking that for my young patients especially might be an issue. #CGAjc https://t.co/764BuMTHXc

[Jewel Samadder @J_Samadder]

Also remember that oncology patients on erlotinib are on nearly 5 times the dose of this drug. Current clinical trial through NCI is using a lower dose of erlotinib (50mg) to see if better tolerability. #CGAjc https://t.co/lDmDi9sDnD

[Jewel Samadder @J_Samadder]

#CGAJC. Thanks Pete for the question. Though the % of patients with a rash was high (80%), they were all Grade 1 and 2. They could be treated with steroid cream and oral clindmycyin (since the rash is believe to have a bacterial component). #CGA https://t.co/lDmDi9sDnD