KNOXVILLE, Tenn. (Ivanhoe Newswire) – Four thousand women in the U.S. will die and another 12 thousand will be diagnosed with cervical cancer this year alone. While there’s no cure, researchers are excited about a new therapy that could improve and even extend the lives of patients with recurring or advanced disease.
For Lisa McDevitt there’s nothing better than hitting the road in her limited edition “warriors in pink” mustang.
“I actually had a woman follow me home and she wanted to know how much and I was like it’s not for sale,” Lisa McDevitt, cervical cancer patient, told Ivanhoe.
It’s Lisa’s reward for successfully battling and beating cervical cancer twice. Her doctor at the time said she wouldn’t survive round two.
“She said you will be dead within six years. I really was just ready to die,” Lisa said.
That’s when Dr. Larry Kilgore asked her to join a clinical trial. It’s for patients with advanced or recurrent cervical cancer. Researchers are testing a new therapy that combines the biologic drug Avastin with chemo.
“So, the chemotherapy kills the cancer cells and the biologic agent stops blood vessel growth so tumors can’t grow. It’s a real, real advance,” Larry C. Kilgore, MD, Professor of Gynecologic Oncology and Division Director at the University of Tennessee Medical Center, Knoxville, told Ivanhoe.
Results from the phase 3 trial showed patients who received Avastin and chemo lived an average of 17 months, compared to about 13 months for those treated with chemo alone. As for Lisa, it’s been two years since her last chemo.
“Yes, she is disease free. We will have to follow her to see, but so far so good,” Dr. Kilgore said.
While Avastin is FDA approved for the treatment of some cancers, including colorectal and lung cancer, it’s not currently approved for cervical cancer. You can still get the treatment, but your insurance company may not cover it and this treatment can cost thousands of dollars per month.
Larry C. Kilgore, MD, Professor of Gynecologic Oncology and Division Director at the University of Tennessee Medical Center, Knoxville, talks about a current study seeking better treatments for patients with cervical cancer.
Cervical cancer affects thousands of women; correct?
Dr. Kilgore: Well, cervix cancer is one of the most common killers of women from cancer in the world. In the U.S. we are blessed with better screening for the last 50 years. So, we have decreased the death rates from cervical cancer, but there are still about 15,000 new cases a year in the U.S. and about 4,000 deaths per year; so it’s still a problem.
How are treatments improving or changing since you have gotten into the business?
Dr. Kilgore: We have improved surgery for cervical cancer in the early stages and our adjuvant chemotherapy and radiation has improved the lives of many women with cervical cancer. Unfortunately, those that have advanced disease are our biggest problem area and that is where we are trying to make strides.
Where does this study come in?
Dr. Kilgore: That is exactly where this study comes in. GOG-240, as it is called, is an NCI National Trial that started just a few years ago. It is trying to improve our cure rates and survival rates in patients who have advanced disease and patients who have recurrent disease, which is always a problem in any cancer.
What was your role in this study?
Dr. Kilgore: Well, as head of GYN/Oncology here at the University of Tennessee, we participated as an institution in national trials, GOG trials. So, I was the principal investigator here for this institution.
So, you started when the study started a couple of years?
Dr. Kilgore: Right. I came here actually from the University of Alabama at Birmingham, where I had been on the faculty there for 25 years. One of my charges was to bring advanced clinical trials to the University of Tennessee and this region of patients. GOG-240 had just opened in 2009, so we had an opportunity to enroll patients right off the bat.
Why do you think it was important to bring it here?
Dr. Kilgore: Cancer patients need clinical trials and we need participation in clinical trials to improve our survival and cure rates, and in this particular trial, give patients an opportunity for new treatments that were only available on the GOG trial; that specifically is what happened here.
You got some pretty interesting results with this trial, correct?
Dr. Kilgore: Yes, the trial was designed to compare two different chemotherapy regimens; that was its main objective. A secondary objective was to evaluate the response rate by adding a biologic agent called Avastin to those chemotherapy regimens. Patients were randomized between those two different treatments of chemotherapy and then once they were randomized to which chemo they got, they were randomized to either receive or not receive the biologic agent Avastin. So, there were four opportunities for these patients. It was randomized because we did not know how effective it would be.
What kind of biological agent is it?
Dr. Kilgore: In contrast to chemotherapy, the biologic agents do things like stimulate the immune system, or in this particular case the biologic agent Avastin is designed to block blood vessel growth to tumors. So, the chemotherapy kills the cancer cells and the biologic agent stops blood vessel growth so tumors cannot grow. It is a real advance.
The patients who received this, they got about 15 mg per kg of body weight; correct?
Dr. Kilgore: That is correct.
Was that mixed with the traditional or standard chemotherapy?
Dr. Kilgore: They received their chemotherapy every 21 days, and the days they received their chemotherapy they also received the biologic agent.
What were the results of this after 3 years?
Dr. Kilgore: The results were just recently released. The clinical trial is ongoing because we are waiting for the maturation of the data, but an interim investigation for safety noted a significant response rate or improved progression-free survival for those patients who had received the biologic agent. It was so noteworthy that the National Cancer Institute put out an alert to practicing physicians and patients that the addition of Avastin to the chemotherapy regimen improved survival.
How much did it improve?
Dr. Kilgore: It is a statistical analysis; so we look at what is called median survival. Those that did not receive it had a median survival of 13 months or so. Those that had received the Avastin had a median survival of 17 months. That may not sound like a lot, but it improved median survival by nearly half a year. We do not know the overall survival impact yet because it is too early to tell, but it will obviously follow that. In cancer trials, that is a big difference.
How could this change treatment?
Dr. Kilgore: It will change treatment because this trial decided which of those two chemotherapy regimens is better to choose and we also have the data that when the biologic agent is added, their median progression-free survival is improved. I think now clinicians and payers will have data to make decisions about implementation of these trials, results, costs and how it should best be managed, which is important as we move forward in healthcare.
How does it move forward? Because they put out this alert, does that mean physicians can try to implement this immediately with certain patients?
Dr. Kilgore: Well, yes. Those physicians who have been alerted and treat cervical cancer patients similar to the patients in this trial now have the opportunity to introduce the biologic agent in addition to their treatment. Hopefully, our payers will follow suit and approve these biologic agents. They are expensive, but now that we have data saying it improves survival, hopefully clinicians will have the opportunity to use these drugs.
What is the cost and would it be covered by insurance if it could become more widespread?
Dr. Kilgore: Avastin is approved for some lung cancers and notably colon cancer; these are FDA approved areas. We use it extensively in ovary cancer, especially in recurrent ovary cancer where there is also improved survival with this. It has not been FDA approved for cervix cancer, but now that we have this clinical data from the trial which is a great advance, the FDA will look upon this more favorably and hopefully it will be approved. However, the insurance companies do not have to wait for FDA approval. They can approve it based on the data before the FDA releases a statement; so hopefully it will be covered in that regard.
Until that time comes, will it be off label?
Dr. Kilgore: Yes, it will be off label until that time.
Any negatives seen in this trial? What kind of side effects did patients see?
Dr. Kilgore: Fortunately, the only side effects on the trial were those that were already known for Avastin, and they are actually fairly low risk side effects. Let me say it this way, the biologic agent is safe. Side effects are low percentage. There can be some significant ones, but they were typical for what we had already seen in previous trials for colon cancer and lung cancer; nothing new.
What were the specifics?
Dr. Kilgore: The side effects from the chemotherapy are typically nausea, hair loss, effects on the blood counts of white blood cells, and so forth. Avastin can cause an increase in blood pressure, and we saw some of that in the trial, and also a little protein in the urine, but no major adverse effects.
So what is next for the trial? Is it still recruiting or how long is it set to continue?
Dr. Kilgore: The trial is close to new accrual, but we are waiting on the data to be more mature and look at not only just progress-free survival, which is out first statistical landmark, but also overall survival and we have not yet heard that data yet. It will be about another year or so before we will see that.
Can you tell us a little bit about Lisa’s experience with the trial?
Dr. Kilgore: Our patient Lisa was a wonderful woman, very brave and courageous. She was diagnosed with cervical cancer about 6 years ago. She was treated in Indiana with surgery because she had early stage disease and that was successful. She enjoyed 5 years of being disease free then almost on the anniversary of her 5 year survival she had a recurrence of her cancer. She recurred actually in the lymph nodes in her neck and that is how it was discovered. We saw Lisa shortly after that time and told her about the clinical trial. She needed to be treated with chemotherapy and had an opportunity to be treated with chemotherapy on this clinical trial. She is a wonderful patient and fortunately she randomized to receive one of the four arms that had the biologic agent. We did not choose that and she did not choose that. The trial design randomly assigns patients, so she happened to land on one of the arms that had the biologic Avastin. She is very fortunate and is doing great.
When did her treatments start and stop?
Dr. Kilgore: Her treatments started last year with the chemotherapy initially and she received the agent Cisplatin and Taxol, which are chemotherapy drugs, and then the biologic Avastin. She completed that last year.
Does she fall in that range of the median improvement?
Dr. Kilgore: Yes, she is disease free. She is among those in the statistical analysis whose progression-free survival is good and she has not recurred, so she is disease free and hopefully cured. Hopefully we will never see cancer in her again. We will have to follow her to see, but so far so good.
Once you found the recurrence, what stage was she?
Dr. Kilgore: The stage does not change. She was initially a stage 1, and in cervix cancer that is her state forevermore. She is actually described as a stage 1 cancer with recurrence and she recurred in her neck 5 years out from her initial diagnosis.
Seeing people come in who have recurrence or are diagnosed with cervical cancer and then you have a new drug to help them, how does that make you feel?
Dr. Kilgore: We are always apprehensive when patients recur with any cancer because most patients will not achieve a cure once the cancer recurs, especially in cervix cancer. We used to have very limited opportunities for treatments. We had chemotherapy, but responses rates of chemotherapy alone were in the 15% to 20% range, and so we needed improved survival and improved opportunities. Avastin appears to give us some new weapon for cervix cancer recurrence, so we are delighted about that.
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.