Met with Oncologist and Radiologist at the first CCC this week.
In total agreement on treatment with the Oncologist and our ENT surgeon is on board, too. He wants to use Erbitux once a week before radiation. Six week in total. We can live with that. The radiologist wants to use IMRT, not just on the right side where the tonsil cancer was removed, but also on the left side. That threw us both, as the ENT said he felt with clean pathology results, only the one side needed radiation. Pet scan before surgery clean, except tonsil, and all pathology clean except right tonsil. So frustrating I just want to scream.

Thursday we go for the second opinion at The Siteman Cancer Center. We are very curious how they will approach the radiation. Because our ENT was with Siteman for 12 years, he knows they will suggest the Erbitux, but not sure about the other.

We are planning on beginning treatments at one of the CCC next week after deciding on the place and course of treatment. Does anyone know if the suggestion of radiating both sides is even necessary? That does not leave us many options down the road. But, this one Dr wants no chance of having to go down this road again! Thoughts, please?

Nancy

There could be involvement bilaterally, due to the highly lymphatic area, and musculature of the tonsil into the BOT, that can spread to both sides, more so with BOT near midlline. Most tonsils cancers are on the left side, but can be right ipsilateral or bilateral. The tumor is large at T3, and that usually has higher rate of metastases, lymph nodes involvement, but see N0, but could be microscopic, and undetectable now. I wouldn't want to go through treatment twice, I actually did. Your first shot is the best shot.

Is this a trial with Erbitux? It's really not the current recommended first time treatment, outside clinical trials. I would want to add some other chemo, in addition, like Taxotere. Cisplatin was recommended, in addition, but read something from MSKCC with disappointing findings with this combination, but there are other findings noting a higher response rate. Chemo will add 8-22% better response to treatment, depending on type.

I had bilateral IMRT 70 Gy with T1N2bM0 disease. They might do lesser to the left side, and cervical neck.

Good luck.

At the tumor meeting the Erbitux was discussed and chosen as drug of first choice for Jim. Even with the tumor so large, nothing else was affected. The surgeon even cut a deeper margin looking for cells elsewhere. Because of age and very good health, this is what was proposed. Of course, we have not had our second opinion at Siteman. I have to believe our surgeon when he says it was a clean cut and removel. The pathology looks good with no evidense of spread. Our hope is that with radiation and Erbitux, we will get rid of any micrscopic cells remaining. Am I being naive?

Nancy

Not really, sometimes that's what you have to do is put the trust and faith in your doctors, and get a 2nd opinion lol. They know better than me. I know a few that had Erbitux alone, stage 4 tonsil, and are doing fine, but that was a few years years ago, maybe a year and a half, and I don't see as many, other than for metatastic, and recurrent cancer, who did Cisplatin as first line treatment that failed, are using Erbitux. and I guess most are waiting the outcome of a comparative trials with Cisplatin vs Erbitux, and possible treatment reduction with HPV. There was a recent article, one of many, about HPV sensitivty with radiation in oral cancer news in the opening page.

Hopefully they will one day have a biomarker that tests the the EGFR like colon cancer since they found 40 percent of the population had a KRAS mutation to make Erbitux ineffective on them, so they test before administrating. There is no such test for HNC, but heard Erbitux may not work in 5% HNC patients. I believe a gene fir HNC was found recently that may show who these targeted EGFR inhibitors may work on, but that's not coming soon.

You are a funny guy, Paul! Thanks for the advise and support! I do have all of the trust and faith in our ENT Surgeon. He found the cancer and took quick action. Jim had seen several doctors before the ENT who kept telling him it was just acid reflux. This guy took one look and broke the news that the right tonsil had cancer. With all of that behind us, the treatment is next and we want to get rid of this beast. Jim is up for the challenge and would prefer the most aggressive treatment available. He is getting things in order and I will make sure he is taken care of.

Thanks again, Paul!

Sorry you have to join the group, but here you have a circle of friends who understand what you are going through. It helps immeasurably that Jim is up for the challenge. The patient's determination to lick the beast will make the long journey quite a bit smoother. Hoping for the very best for the two of you.

Thanks, Gloria!

Hi Nancy

Erbitux IS indicated for first line treatment of head and neck cancer in combination with radiation.

the FDA approved this indication some years ago and the National Comprehensive Cancer Network (NCCN) guidelines also list Erbitux as a potential treatment. The NCCN DO suggest that cisplatin is preferred and this is because there is more experience with this agent.

http://www.nccn.org/professionals/physician_gls/pdf/head-and-neck.pdf

I am unsure if the link above will work but it is intended to send you to the relevant page of the guidelines.

If it doesn't, search for NCCN guidelines, register (costs nothing), make sure you are on the home page, find "NCCN guidelines" tab at the top and hover on "NCCN guidelines for treatment of cancer by site", locate head and neck cancer and then click on the PDF. Once you have the document downloaded, scroll past the title page and find hyperlink to the table of contents (top right hand corner)on the next page. Locate cancer of the oropharynx (ORPH-1), then "see treatment of primary ...ORPH-3" . In the footnote section "principles of systemic therapy CHEM-A" will take you to the list of chemo drugs that can be used.

I am sure there is an easier way than this, and the guidelines are somewhere on this forum but I can never find them. Maybe someone can make this a bit easier???

there are many reasons why a doctor will choose Erbitux over cisplatin and you need to discuss this with your doctor so that you are fully aware of their reasoning.

Good luck

We had that discussion about the two drugs with our ENT and the first oncologist. They felt that in my husband's case, it was the drug of choice. Far fewer side effects and has proven to be highly successful with their patients. We will meet with the second opinion on Thursday. If it is the same, that is what we will do. Right now our ENT surgeon and the radiologist are in disagreement over the radiation treatments. They are having a talk and getting back to us. It would be nice if everyone was on the same page!

Thanks so much for the link! I keep on researching and reaching out for help and support. I really appreciate it!

Nancy

[quote=klo]I am sure there is an easier way than this, and the guidelines are somewhere on this forum but I can never find them. Maybe someone can make this a bit easier???[/quote]
The link to the NCCN page on the main OCF site is here, but be advised that the guidelines on that page are from 2011. I don't know how much they change from year to year.

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.

[quote]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.[/quote]

sorry Paul, missed this question

the answer is YES, the pharmaceutical company writes the prescribing information under very strict guidelines. And NO the FDA is not responsible for the layout and format of the document. The FDA is responsible to ensure that every word is scrutinised for accuracy before being approved (hopefully). This includes any changes the company wants to make, any new data to be added and any reviews. If the information is not approved, the product cannot be sold.

there are normally two types of information - one is the information for physicians which contains the approved indication and the other is for patients which contains a shortened version with less mumbo jumbo and more practical advice. Both are submitted and approved by the FDA

There are shortened versions that appear on advertising and internet sites and these may not be approved by the FDA but must be true to the already FDA approved versions. These versions should also direct you to the full version for further information.

Here is the "informationn for healthcare Professionals on FDA's New Prescribing Information for Drugs."

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084189.htm

This is a clearing house by the FDA and National Library of meds, DailyMed, for up to date drug information, lined to the above.

http://dailymed.nlm.nih.gov/dailymed/about.cfm

It does say Erbitix for first line treatment, amomgst the other reasons. I guess they snuck that in somewhere I didnt see. Anyway the it's not up to me, and just reporting what I read. Anyway, chemo can be used "off market" if I have the name correct, but don;t know the finer details. The good thing that cameoput of this is I have a new dailymed link I'm going to bed, my eyes hurt, and making too many typos.Nice chatting, and got losts of info pout there lol, although the link was highjacked.

Paul & Karen,

Please continue this discussion, if you wish, by starting it's own thread. We need to return this back to Nancy. I'm sure she has enough info on the 2 chemo approaches to go forward.

Nancy,

I was treated in 2006 by Moffitt and they recommended radiating both sides of my neck even though only 2 nodes on my left side were indicated if this helps.

Hi Nancy and welcome. My husband's BOT tumor was right to midline but he had both sides radiated. Good luck!

I am not going to get involved really in the whole Erbitux vs Cisplatin convo.

However I am going to say to the original poster. I fully believe in new trial drugs, it is the way we get new treatments, and sometimes the work for some people. However, you have a tried and true treatment that works well against the type of cancer your hubby has. As a first line of combat against cancer I would choose the known. It may be more toxic, it may make you sick, you may even have a bad reaction to it (some do - but then they generally switch you to carbo) but overall it is effective and I personally am not willing to risk my life or the life of someone I care for on a drug that is still in trials. I might if the tried and true has failed but not as a first line.

best of luck - I know the whole back and forth has probably muddied the waters.

I can say based on reading what you have written likely the reason they are suggesting Erbitux is because he has no nodal involvement that is apparent on a scan. But Erbitux is not without it's issues either. A friend who's ex had it had a horrible reaction to only a few doses and has had issues ever since.

A drug is a drug, and since we are all individuals we respond differently.

take care.

I will question, once again, all doctors involved. Still have second opinion tomorrow and am curious which treatment they suggest. We just want to start the journey and come back here and say "we beat the beast"!

Thanks, Cheryl

Nancy