Chapter 07: Laryngeal Preservation Studies
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Description
In this chapter Dr. Goepfert describes his long-term work on laryngeal therapy and survivorship (protocol 91-11). He begins by briefly characterizing the perspective that otolaryngeal specialist brings to cancer of the head and neck. He then notes that, at the beginning of his career, most of his research was retrospective (he conducted such studies with Gilbert Fletcher on effects of radiation therapy). Then he describes the context of the Protocol 91-11 study, beginning with a landmark article that demonstrated that the survivorship rates were identical, whether a patient was treated with a laryngectomy versus intravenous chemotherapy plus radiation therapy. With the second course of treatment clearly better for the patient (as it preserved the voicebox and, thus, the ability to speak), Dr. Goepfert explains that Protocol 91-11 looked at whether chemotherapy was essential to preserve the larynx or would radiation alone suffice. He some advances in radiation therapy that presented some stumbling blocks to initiating the study (launched in 1991), and MD Anderson provided the largest percentage of patients (10%) to this nationwide study.
Identifier
GeopfertH_01_20120827_C07
Publication Date
8-27-2012
City
Houston, Texas
Interview Session
Helmuth Goepfert, MD, Oral History Interview, August 27, 2012
Topics Covered
The Interview Subject's Story - The Researcher; Overview; Definitions, Explanations, Translations; The Researcher; The Clinician; Multi-disciplinary Approaches; Discovery and Success; Professional Practice; The Professional at Work
Transcript
Tacey Ann Rosolowski, PhD:
Let me ask you a question. It may seem kind of obvious to you, but I’m trying to get a sense of what the perspective is that you bring as a person who has been trained in this particular field versus a general surgeon. When you see a cancer of the larynx or of the salivary glands, what is it that you see that a general surgeon would not see?
Helmuth Goepfert, MD:
Nowadays it is no different. No. The perspective is basically based on the basic training. Yes, laryngology is more sophisticated among otolaryngology. General surgeons don’t do benign laser surgery. General surgeons didn’t do repair of septum and plastic surgery in the head and neck area. Otolaryngology was doing it, and they do it now more than ever. So as I say, these things were new instances of a specialty or subspecialty contributing to the global aspect of it. Since then we have had only a few general surgeons that became members of this department. I think the last one was Stim Schantz. All the other ones have been otolaryngology from then on. In addition to that, this department then had the plastic surgeon, Dr. Larson, and the neurosurgeon. And even though before there was Dr. George Ehni, he was sort of a part-time member that came, a member of the Department of Head and Neck Surgery that is the beginner of neurosurgery at this institution was Milam Leavens, who died last year. Milam Leavens was a member of the Department of Head and Neck Surgery until Dr. Charles Balch created the department and brought in Ray Sawaya. Ray Sawaya has been here since the mid ‘80s too, so that’s how it separated off. Now, ophthalmology has been a different story. Way back then there was an ophthalmologist that sort of as an outsider gave consultation. The first staff member as an ophthalmologist in the Department of Head and Neck Surgery was Dr. Sue Ellen Young. Dr. Sue Ellen Young, in the ‘90s, retired to Austin and took on a private practice. We then didn’t have any member on the faculty, so to speak. We dealt mainly with Dr. Richard Ruiz as consultant from Hermann Hospital, and we eventually had Dr. Bita Esmaeli. Dr. Bita Esmaeli was hired here, and then the other ophthalmologists that exist now in otolaryngology and ophthalmology came back into head and neck surgery again. Will it ever be a separate department? God knows.
Tacey Ann Rosolowski, PhD:
Let me ask you where you’d like to go next in the interview. I wanted to ask you about the variety of subjects that you’ve done research on over the course of your career, but we can also talk about your role as the head of the department. So, which would make most sense to you right now?
Helmuth Goepfert, MD:
I don’t know. (laughs) Base your experience on that.
Tacey Ann Rosolowski, PhD:
Well, maybe we can go—
Helmuth Goepfert, MD:
Research in itself, I never ran a lab. I did, yes, sort of the clinical description of situations and sort of looked up—in those days you still went to the Index Medicus to look up the literature, not like today. You then would go to medical records and identify the ones from one databank. Hopefully somebody had a listing of that disease entity, and you reviewed it. That’s how most of my papers were produced in the early years. Then of course came the participation of radiation oncology, or radiation therapy, with Dr. Lindberg and Dr. Fletcher. We worked together again to review cases and doing reports on that, which was always a retrospective type of research. Prospective research in the sense of randomized trials and so forth, I participated very often. The only trial that I really was significantly involved in was the Laryngeal Preservation trial in ’91-’11. It took ten years to accrue not enough patients but enough to satisfy the need.
Tacey Ann Rosolowski, PhD:
Could you tell me about that? So that’s the Laryngeal Preservation Protocol 91-11? You were co-investigator and surgical leader. So, what was the aim of this study? You said it was a ten-year study, so how did it evolve and what did you discover?
Helmuth Goepfert, MD:
Okay. Let’s make a note here that this is going to be a full history of that protocol. The clinical interdisciplinary research in head and neck cancer was in those days predominantly in the hands of the RTOG—Radiation Therapy Oncology Group. It had specialties of head and neck surgery/otolaryngology, radiation oncology, and medical oncology among its members. In the early or mid ‘80s, Dr. Ki Hong and some other members who were affiliated—when Dr. Ki Hong [Waun Ki Hong, MD [Oral History Interview]] was in Boston—affiliated with the VA Hospital had published a landmark article in which they had randomized patients with larynx cancer to the then traditional treatment of laryngectomy, which was basically cut out the voice box, to a treatment that consisted of intravenous chemotherapy for several cycles followed by radiation therapy. The outcome of this study certainly showed the world that the survivorship was the same between the groups. Yes, there was a chance for the patients that went with the chemo/radiation to preserve the voice box—their normal voice—and that was significant enough, but one of the questions that remained unanswered is, was the chemotherapy, the way it was given, really significant in its contribution to the better survival of laryngeal preservation or was radiation therapy alone sufficient to achieve the same thing? That formed then the basis for this 91-11. It already had been proven that laryngectomy itself was not better, so you couldn’t offer this as an alternative treatment because every patient said, “Why do you take my voice box out if there’s something else?” It had to be defined which treatment was better, so there was an arm of chemotherapy pre-radiation and arm of chemotherapy together with radiation—concomitant—and an arm of radiation therapy alone. The formulation of that protocol and the different bodies that had to approve it is a different history because it always takes longer than you want to. But in the formulation of this protocol, one of the stumbling blocks was that the radiation oncologist recommended the standard radiotherapy be used—standard fractionation. For the time being, let’s keep it that way—standard fractionation.
Tacey Ann Rosolowski, PhD:
And that means a standard level of—?
Helmuth Goepfert, MD:
Yeah, it was a certain amount of gray every day for five days a week. Nevertheless, the water had been muddied a little bit, so to speak, around that time, when a group of radiation oncologists proposed that hyper fractionation, or any other modification of standard fractionation, could be better. And although it had not been proven on a randomized basis yet, the hoof beats were loud enough so that the surgeons—and I exclude myself—but the surgeons in the community felt that by using standard fractionation we were not doing the patient a service and became reluctant to offer patients this protocol, so it took two years to launch it. It was opened in 1991. That is why it’s called 91-11. No, wait a minute. In 1991, yeah. And I always joked that the accrual would be finished after my retirement. I made jokes about it because I felt it was ridiculous. The biggest contributor to that protocol was MD Anderson. We contributed ten percent to the total volume of patients. Out in the community it was not a beloved child. Now, the protocol was finished, and the publication was done back in 2002-2003. The last update of that was published last year. So, as I say, there is enough history of that now. That was a joint effort by RTOG and the subspecialties, and I think that they hoped that my presence in the steering committee would facilitate the accrual by patients in the community, but, as it always is, there is not enough esprit de corps among specialties in this country to make sure that something is finished before the next thing starts. That is very prevalent. It’s one of the difficulties that society has, in my opinion. We don’t use the appropriate tools to identify what works best, and this is in the economy of medicine and everything else. It’s more the voice of the one that has the strongest opinion that prevails. And I hate to tell you, that’s what’s going on in politics too. (laughs) So, as I say, that is the story of 91-11.
Tacey Ann Rosolowski, PhD:
I think I’m confused, or I missed the point.
Helmuth Goepfert, MD:
It proved that it was better to add chemotherapy than give radiation therapy alone, and of the two, the concomitant treatment of radiation together with chemotherapy gave the best results as far as the ability to preserve a normal larynx.
Tacey Ann Rosolowski, PhD:
Okay. Now, did you end up deciding to go with the hyper fractionation or did you keep it at the standard level?
Helmuth Goepfert, MD:
No, we kept it standard because the radiation oncologists—
Tacey Ann Rosolowski, PhD:
They were very uncomfortable.
Helmuth Goepfert, MD:
They were uncomfortable because they said it still has not been—we haven’t finished our studies to determine which is best.
Tacey Ann Rosolowski, PhD:
Now, where did you weigh in on that? You said you didn’t include yourself in—
Helmuth Goepfert, MD:
The radiation oncology—I did not decide on that because I said, “You radiation oncologists tell us what you think is necessary.”
Tacey Ann Rosolowski, PhD:
So you didn’t feel that you could really form an opinion about it. Okay. So, the survivorship rates, how did they—?
Helmuth Goepfert, MD:
The survivorship was about the same, a little bit—
Tacey Ann Rosolowski, PhD:
Right. But in terms of the preservation, I guess.
Helmuth Goepfert, MD:
The preservation of the larynx, definitely the group that had concomitant treatment was better. And that has been the basis for many of the existing protocols in which concomitant treatment is used nowadays.
Recommended Citation
Goepfert, Helmuth MD and Rosolowski, Tacey A. PhD, "Chapter 07: Laryngeal Preservation Studies" (2012). Interview Chapters. 1006.
https://openworks.mdanderson.org/mchv_interviewchapters/1006
Conditions Governing Access
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