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StephN · 12-14-2012, 02:06 PM

Phil -

Paula, that was a heartfelt and honest appeal. BRAVO!

I certainly agree that T-DM1 should have had approval. If someone in the FDA decided the agency made a mistake in approving the single arm trial, then THEY should live with that. But then other drugs will come to them with single arm trials, and some of those may not be as good as our special drug conjugate.

The person who I spoke with has a long and deep abiding interest in metastatic breast cancer. She was at the FIRST San Antonio symposium, and goes to other meetings as well. From what I could gather, patient advocacy IS our best route at this time, and you are right that we need more people to speak up.

I did hear several "thought leader" type doctors speak from various podiums during the conference on the "fog of trials" which they think should have better designs and clearer effective parameters. The frustration with slow acceleration in getting good drugs to human trials and beyond is spoken more freely each year I attend the conference.

12-14-2012, 02:06 PM	#55
StephN Senior Member Join Date: Nov 2004 Location: Misty woods of WA State Posts: 4,128	Re: Meeting Up in San Antonio NEXT WEEK! Phil - Paula, that was a heartfelt and honest appeal. BRAVO! I certainly agree that T-DM1 should have had approval. If someone in the FDA decided the agency made a mistake in approving the single arm trial, then THEY should live with that. But then other drugs will come to them with single arm trials, and some of those may not be as good as our special drug conjugate. The person who I spoke with has a long and deep abiding interest in metastatic breast cancer. She was at the FIRST San Antonio symposium, and goes to other meetings as well. From what I could gather, patient advocacy IS our best route at this time, and you are right that we need more people to speak up. I did hear several "thought leader" type doctors speak from various podiums during the conference on the "fog of trials" which they think should have better designs and clearer effective parameters. The frustration with slow acceleration in getting good drugs to human trials and beyond is spoken more freely each year I attend the conference. __________________ "When I hear music, I fear no danger. I am invulnerable. I see no foe. I am related to the earliest times, and to the latest." H.D. Thoreau Live in the moment. MY STORY SO FAR ~~~~ Found suspicious lump 9/2000 Lumpectomy, then node dissection and port placement Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR - Adriamycin 12 weekly, taxotere 4 rounds 36 rads - very little burning 3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED! 2003 & 2004 no active disease - 3 weekly Herceptin + Zometa Jan 2005 two mets to brain - Gamma Knife on Jan 18 All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying Continue as NED while on Herceptin & quarterly Zometa Fall-2006 - off Zometa - watching one small brain spot (scar?) 2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava 2008 - Brain and body still NED! Port removed and scans in Dec. Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011 STILL NED everywhere in Feb 2014 - on wing & prayer 7/14 - Started twice yearly Zometa for my bones Jan. 2015 checkup still shows NED 2015 Neuropathy in feet - otherwise all OK - still NED. Same news for 2016 and all of 2017. Nov of 2017 - had small skin cancer removed from my face. Will have Zometa end of Jan. 2018.