#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. xitter.cf/SoniaKupfer/status/998…
#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.
Here is the trials.gov website. cancer.gov/about-cancer/trea… #CGAjc xitter.cf/SoniaKupfer/status/998…
#CGAjc If we have patients who might qualify, how best to get them into the trial? Can you provide inclusion criteria for current study?
Broad inclusion: clinical or genetic FAP, >18 yo, 5years out from cancer, Spigelman stage 1, 2, 3 duodenal disease, #CGAjc xitter.cf/SoniaKupfer/status/998…
#CGAjc If we have patients who might qualify, how best to get them into the trial? Can you provide inclusion criteria for current study?
Centers participating include: Mayo Arizona, Mayo Rochester, U Utah, MD Anderson, Cleveland Clinic, U Pitt, U Michigan, Peurto Rico. #CGAjc xitter.cf/SoniaKupfer/status/998…
#CGAjc If we have patients who might qualify, how best to get them into the trial? Can you provide inclusion criteria for current study?
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 xitter.cf/SoniaKupfer/status/998…
#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?
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 xitter.cf/SoniaKupfer/status/998…
#cgajc When do you anticipate completing the current erlotinib trial? Will be interesting to see if same efficacy but less rash. Would be ideal.
Still to be answered. Most patients have stayed on the medication (erlotinib + sulindac) for at least 6-12 months. #CGAjc xitter.cf/eve_karloski/status/99…
Eventually covered in two patients where we were considering Whipple. Insurance seemed to favor erltonib over Whipple. #CGAjc xitter.cf/DocStanich/status/9987…
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 xitter.cf/SoniaKupfer/status/998…
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 xitter.cf/DocStanich/status/9987…
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 xitter.cf/SoniaKupfer/status/998…
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 xitter.cf/J_Samadder/status/9987…
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 xitter.cf/RachelP_LGC/status/998…
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 xitter.cf/RachelP_LGC/status/998…
@J_Samadder what is the selling point for patients? Less surgery? Less endoscopy? #CGAjc
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 xitter.cf/DocStanich/status/9987…
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 xitter.cf/gcleslieb/status/99871…
.@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
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 xitter.cf/J_Samadder/status/9987…
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 xitter.cf/gcleslieb/status/99871…
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 xitter.cf/gcleslieb/status/99871…
CGA twitter journal club is happening NOW! Follow along & submit ?s using #CGAjc // #GCchat #crcsm xitter.cf/cgaigc/status/99871582…
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 xitter.cf/CGAIGC/status/99871773…
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 xitter.cf/J_Samadder/status/9987…
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 xitter.cf/DocStanich/status/9987…
#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 xitter.cf/DocStanich/status/9987…