I made a post on 12/23/12 about a letter from MSKCC (number two rated cancer center in the country, who is also part of the NCCN, and has a Chair on the NCCN) to the Editor of The Journal of Clinical Oncology titled, "Should Cetuxmab Replace Cisplatin for Definitive Chemotherapy In Locally Advanced Head and Neck Cancer."

http://jco.ascopubs.org/content/early/2012/11/30/JCO.2012.46.9049

"..Howver, outide clinical trials, caution is substituting C225 for CDDP in patients positive for HPV, given recent data on from the metastic setting..."

"In conclusion, there is accumulating evidence from both prospective and retrospective studies that suggests that it may be premature to substitute EGFR inhibitors for cisplatin outside of a clinical trial. Until there is level I evidence from a randomized phase III noninferiority trial that demonstrates equivalence in outcomes between these two agents, we believe CDDP remains the preferred concurrent treatment. Fortunately, RTOG 10-16 is addressing thisquestion, although results will not be available for several years."

MSKCC reported their own centers retrospective experience with Cisplatin/RT vs Erbitux/RT and found Cisplatin/RT was superior in 2-year locoregional failure(5.7% vs 39.9%, failure free survival (87.4% vs 44.5%), and overall survival (92.8 vs 66.6%).

http://www.redjournal.org/article/S0360-3016(10)00930-2/abstract

This was a letter to the editor and does not constitute evidence which all sophisticated health care systems subscribe to. If the guideline committee is ignoring this retrospective data troll, then it is not our place to try and usurp the committee recommendations.

The comments made that Erbitux not be used outside clinical trials flies in the face of the guidelines suggesting that it is not the opinion of the wider expert group.

I'm not trying to "upsurp" anything. I'm just stating what I'm reading, and adding the links to them.

In 2006 the FDA approved Erbitux for use in combination of SCCHN that cannot be removed by by surgery (unresectable). It was also approved for use alone (mono therapy) to treat patients whose head and neck cancer has spread (metastasized) despite the use of standard chemotherapy.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108609.htm

Also, Erbitux was then approved by the FDA in 2011 for use with chemotherapy to treat patients with late stage (Metatastic) head and neck cancer.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278894.htm

Accoring to these news releases by the FDA, unless they made an ammedndum since, waiver, agreement, who is upsurping who, the NCCN?

Amyway, I had Erbitux and taxotere ending last November.

thanks for the news release Paul. I note that it also states in the second paragraph:

[quote]Combined with chemotherapy, Erbitux extended the lives of those receiving the treatment combination compared with those receiving chemotherapy alone. Erbitux already is FDA-approved for certain types of colon cancer, and has been approved since 2006 for treatment of non-metastatic head and neck cancer in combination with radiation therapy (first-line) or as a single agent (following standard treatment).[/quote]

thanks for finding the date that it was FDA approved as 1st line therapy in conjunction with radiation which preceded the extended indication mentioned in the press release.

The 2006 FDA News press release being referred to in 2011 says , Erbitix was apporoved for use of in combination with radiation therapy to treat patients with SCCHNC that cannot be removed by surgery (unresectable). Erbitux was also approved for use alone (monotherapy) to treat patients whose head and neck cancer has spread (metastisized) despite the use of standard chemotherapy.

Two things they are saying here, unresectable tumors, and for use alone for metatastic cancer, despite the use of standard chemo therapy, so it's saying standard chemo should be used first.

Between the two news releases. I did not see Erbitux approval for use as first line, if it was not metatastic, and standard chemotherapy wasn't used first.

Again, thanks Paul for adding the 2006 press release to your previous post. My response was before you added this so the quote I used actually came from the 2011 press release.

the 2006 press release is (not unsurprisingly) out of date and cetuximab is no longer limited to unresectable tumours as the 2006 release suggests.

The Full US Prescribing information contains 3 indications for Head and Neck Cancer. The one relevant to Nancy is below

"Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy".

The Bonner study everyone keeps referring to is out of date too, 2010 lol. Doesn't the FDA only oversee the package insert layout format for U.S. Prescribing package inserts, and may time to time review. Someone one else in the pharmeceitcal,company is writing that, and use simlar to the MSDS's package inserts for chemicals.

I forgot the link for the US prescribing information. Once again the link may not work as it is for physicians who prescribe in the US and there may be barriers...

https://www.erbituxhcp.com/pages/squamous-cell-carcinoma-of-the-head-and-neck-scchn.aspx

PS the Bonner study is the only legitimate randomised controlled trial available which looks at the efficacy and safety of cetuximab in head and neck cancer patients and who are naive to previous treatment. It is regarded as a pivotal or landmark study and is most certainly not out of date.

sorry guys the link doesn't go where i hoped it would go. Just google cetuximab prescribing information and it should come up

The Bonner study was conducted before it was foreseen that concurrent therapy was superior to radiotherapy alone, and as such, Erbitux was not directly compared with Cisplatin. That's why they are doing the RTOG 10-16 to address this. I also doubt the first study included HPV positive breakdown also.