I am newly diagnosed with squamous cancer on my tonsil and several nearby lymph nodes, and confirmed HPV positive. Radiation + Cisplatin simultaneously are the treatment being recommended to me. I am also being told about a nationwide Clinical Study RTOG 1016 that is focused on HPV positive patients, comparing results with Cisplatin & Radiation treatment vs. Cetuximab & Radiation treatment.

I am looking for any data on general effectiveness of Cetuximab & Radiation for this cancer, independent of the HPV factor. I have to make a decision within the next 2-3 days about participating. It sounds like it may have less risk of longer term side effects compared to cisplatin, but I've also read a few terrible exceptions on this bulletin board. Any pointers to data on Cetuximab's effectiveness compared to Cisplatin would be appreciated.

OCF is one of the funders of this clinical trial with Dr. Gillison at the James Cancer Center and 100 participating clinical institutions co funded by the NCI. You are asking a question that there is no real answer for - hence the clinical trial. The HOPE is that eliminating cisplatin will eliminate some of the long term QOL issues for people, but if Erbitux will work as well is an unknown. As a side note, OCF's part of this trial is to collect patient data on 100 iPads at the different institutions, (data filled out directly by the patient at various stages during treatment) about QOL issues during the treatment process, so that by itself can be improved regardless of which arm of the trial you are in.

Cisplatin is the known. Everything else is a crap shoot. All I can say is that at this stage of clinical trial, there has to be high expectation from previous data/experience that the alternate to the long term known, would work at least as well, or the trial would not have been approved. No individual's experience alone (there have been good and bad experiences on the same drugs) is an indicator of what will happen to the overwhelming majority of individuals on a particular protocol.

Thanks Brian - this is helpful context. Your statement about "high expectation from previous data/experience ... would work at least as well or the trial would not have been approved" is logical to me as well, but I was hoping as a patient to get a glimpse of what some of that specific data/experience to understand it for myself. I'm looking for more detail on the known success to date with all throat cancer patients with Erbitux, and why they think it may be even better for HPV.

I'm also wondering if insurance companies may have an issue covering Erbitux or related treatments from a "clinical study" that is not the current standard of care.

Six years ago when I had the "3 Big Bag Method" of Cisplatin it's effects on me during Tx were horrible uncontrollable nausea but then again I was a bad patient who didn't listen to anyone and I hadn't even found this site. After my 3rd bag I remember discussing my hearing problems with my MO and I will never forget when he said "I wish you had told me sooner as I would have switched you to Carboplatin which is just as effective as Cis but without the nasty side effects." Since then I have talked to many MO's and none disputed that statement and when asked why Mos' just didn't start off with Carbo instead of Cis I was told "well there aren't any studies proving that."

Those of us that had the 3 Big Bag Method know all to well about it's side effects both during and post Tx and after years of reading poster's Erbitux experiences I conclude overall their effects during Tx can be just as bad as Cis but do not produce any long term effects. Also within the last few years we have seen more Mo's use a 6 bag method with Cis and posters tell us that their side effects are less than one gets with 3 bags.

My question is what has happened to Carbo and why was there never a study to compare Carbo to Cis.

Also does this study compare Cis with 3 or 6 bags to Erbitux?

Regarding the insurance companies, the hospitals are being paid by the clinical trial per patient, so perhaps the charges would not be any more than the current standard of care. Erbitux is significantly more expensive than Cisplatin, but maybe the trial payments will even that out. I don't think the expectations from the trial are that the cure rate end point would be any better, as radiation is the big gun in all this, but that the collateral morbidity and QOL issues will be less. You have to remember that chemo in oral cancer is not curative, and is an adjunct to radiation. The mechanism of action of Erbitux which is a monoclonal antibody, and Cisplatin which is a systemic poison could not be more different.

David, someone has to fund millions for the study. Carbo has been out like Cisplatin for a long time and the manufacturer isn't going to invest any more into it. Erbitux is still a growing product/market so there is money from the companies involved in its sales and manufacture to put up the funds for the clinical trial. As to Carbo being equal to Cisplatin, there is no clinical trial that shows that it works equally well. Hence it is a fall back drug, not a first choice drug.

Jett,
are or were you a smoker?
what is the tumor classification (T1, T2, etc.)
Maria

If you choose the Erbitux route make sure to get the Qiagen test, which is intended to weed out the 40 percent of colorectal cancer patients who have a Kras gene mutation that makes them unresponsive to Erbitux. Little known fact that is often overlooked is that around 5% of head and neck cancer patients have this same issue and our regulatory community feels that this percentage is too low to be an issue...of course it sucks for the 5% who go through the side effects for nothing.

http://www.ncbi.nlm.nih.gov/pubmed/22281752

Excerpt:K-RAS mutations, occurring in about 40% of colorectal cancers and associated with lack of benefit from epidermal growth factor receptor (EGFR) antibodies in this disease, are found in <5% of SCCHN patients, making routine testing for K-RAS mutations unwarranted at this time.

Jett

I wasn't in a clinical trial, but my regular insurance covered Erbitux & radiation with no questions since it is FDA approved for head and neck cancer. They still have not figured out a way to determine if you will be one of the lucky ones for whom Erbitux works, or get the short straw as I did. For colon cancer, they can tell which patients it will not work for by testing the KRAS gene.
Ironically, my quality of life (QOL) issues were much much worse with the Erbitux than with the carboplatin my RO switched me to after the cancer came back. Since the Erbitux wasn't inhibiting the tumor growth, it just prevented my facial and neck radiation dermatitis from healing by suppressing the Epidermal growth factor that would have given me new skin. If you do gamble on Erbitux, look for an acne rash as that indicates it's working. Skin peeling off your face is not the same and probably indicates its not working. I did not have any problems at all with the carboplatin.
It's a tough choice, and I did have a choice between Erbitux and cisplatin my first time around-so I feel for you. As Brian noted, the trial is to see if Erbitux works as well as cisplatin but as far as I know, Cisplatin works on everybody while Erbitux does not. I did not know that when I made my choice.
Charm

Eric has a good point.

The Bonner data is one source the trial is based on compared radiation + cetuximab vs. radiation alone. It showed a greater advantage to 'HPV profile' patients. One of this was that it showed that Cetuximab was more likely to help if EFGR expression was low-moderate (correlated with never-smoker/light smokers). That is why I asked about your smoking status. It is also possible to get staining done for EFGR expression, but I don't think this is commonly done.

My husband had a very similar protocol to the RTOG 1016 cetuximab arm, and did very well on it.

Hi Maria - I have never been a smoker, my PET scan indicated it had not spread beyond several lymph nodes under my right jaw. I don't know the T1/T2 designations yet. Indication from medical oncologist is that I have the positive attributes that are desirable for successful treatment.

Charm2017 - thanks for the comments. I had read some of your specific previous postings on your personal experience, and they definitely got my attention that Erbitux is not without its own risks.

I have a copy of the Bonner study from NE Jounal of Medicine that I'm reading up on.

Eric - thanks for the Qiagen test recommendation - good to know about.

If I choose to join the study, and if I'm accepted, it is a random selection whether I'd get Erbitux option or the standard cisplatin treatment. I have to make this decision sometime tomorrow so thank everyone so much for the timely comments!