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Old 03-04-2013, 07:46 AM   #55
Joan M
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Re: T DM-1 Approved !!

Greg, I also read Gary Schwitzer.

I also think, Becky, that capecitabine + lapatinib without Herceptin was one of the first combos for metastatic women who progressed on Herceptin. That's why the combo is listed as an FDA-approved treatment. Now doctors realize that patients should stay on Herceptin, regardless of advancing.

I'm bothered by the trial design because, as Greg pointed out, a stellar OS response of 5.8 months might have been inflated because of the weak control arm of EMILIA, and I fear that women who advance fairly quickly on Kadcyla might feel that this "powerful" drug failed them. Whereas, perhaps the drug only appeared to be powerful because it was compared against a suboptimal arm. We'll get more info from MARIANNE and I guess TH3RESA, too.

Genentech deserves a lot of credit for developing the novel drug delivery system of Kadcyla, despite what in the opinion of probably many oncs was not a good trial design because of a weak control arm.

We all have Dr. Dennis Slamon to thank for his scientific ingenuity in developing Herceptin and perserverance in hounding Genentech at a time when the company was planning to get out of the cancer drug business. I believe Herceptin was the second monoclonal antibody after rituximab (Rituxan), which is also manufactured by Genentech.

Joan
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Diagnosed stage 2b in July 2003 (2.3 cm, HER2+, ER-/PR-, 7+ nodes). Treated with mastectomy (with immediate DIEP flap reconstruction), AC + T/Herceptin (off label). Cancer advanced to lung in Jan. 2007 (1 cm nodule). Started Herceptin every 3 weeks. Lung wedge resection April 2007. Cancer recurred in lung April 2008. RFA of lung in August 2008. 2nd annual brain MRI in Oct. 2008 discovered 2.6 cm cystic tumor in left frontal lobe. Craniotomy Oct. 2008 (ER-/PR-/HER2-) followed by targeted radiation (IMRT). Coughing up blood Feb. 2009. Thoractomy July 2009 to cut out fungal ball of common soil fungus (aspergillus) that grew in the RFA cavity (most likely inhaled while gardening). No cancer, only fungus. Removal of tiny melanoma from upper left arm, plus sentinel lymph node biopsy in Feb. 2016. Guardant Health liquid biopsy in Feb. 2016 showed mutations in 4 subtypes of TP53. Repeat of Guardant Health biopsy in Jana. 2021 showed 3 TP53 mutations, BRCA1 mutation and CHEK2 mutation. Invitae genetic testing showed negative for all of these. Living with MBC since 2007. Stopped Herceptin Hylecta (injection) treatment in March 2020. Recent 2021 annual CT of chest, abdomen and pelvis and annual brain MRI showed NED. Praying for NED forever!!

Last edited by Joan M; 03-04-2013 at 07:59 AM..
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