Thursday, February 04, 2016 7:08:49 PM
Initial Therapy
Tempero's presentation focused on choosing regimens for initial therapy for patients with metastatic disease. In reviewing the recent history, she called FOLFIRINOX (folinic acid [leucovorin], fluorouracil [5FU], irinotecan, oxaliplatin) a breakthrough in treatment as shown in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al: NEJM 2011;364:1817-1825). That trial compared FOLFIRINOX with gemcitabine monotherapy for patients with high performance status, and the results led to the adoption of FOLFIRINOX as a front-line standard.
“The results were nothing less than dramatic--an improvement in overall survival, with a hazard ratio of 0.57. That's a hazard ratio we would like to see in every trial that we do.”
Still, that improvement comes at some cost: “It's a tough regimen, with dominating toxicities of myelosuppression, diarrhea, and neuropathy. We are getting better at making FOLFIRINOX more tolerable by omitting the bolus 5FU, reducing doses, and using chemotherapy holidays. We're still figuring it out, and as more trials are done with FOLFIRINOX-like regimens we will finally settle into a regimen that is more tolerable.”
Nab-Paclitaxel
The next contender for standard treatment was nab-paclitaxel, as demonstrated in a trial of that plus gemcitabine versus gemcitabine alone (Von Hoff et al: NEJM 2013:309:1691-1703).
“The overall survival benefit was not as dramatic as with FOLFIRINOX, but it had a respectable hazard ratio of 0.72,” Tempero said. “A clinically meaningful hazard ratio of anything less than 0.75 has to be taken very seriously.”
But nab-paclitaxel plus gemcitabine is also not an easy regimen to take--“perhaps easier to manage than FOLFIRINOX but not a walk in the park.”
http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=1308&desktopMode=true
Never argue with a fool, for after awhile, it becomes difficult to determine which is the fool.
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