KNOXVILLE, Tenn. (Ivanhoe Newswire) - It's the leading cause of cancer deaths in both men and women, higher than colon, breast, and prostate cancer. Each year, lung cancer strikes more than 222,000 people. It will kill 160,000, but adding something to chemotherapy could help beat the disease.
"It keeps my mind at peace because I know that I'm not alone," Kimberly Thomas, who has small cell carcinoma, told Ivanhoe.
Kimberly has small cell carcinoma, a very aggressive form of lung cancer, but something new could help her overcome it.
University of Tennessee Medical Center's Dr. Wahid Hanna is helping investigate how adding immune-boosting antibodies to chemotherapy drugs could help patients like Kim.
"If you have a cell that is requiring oxygen and you interfere with the nutrition, you interfere with the way it gets the cells to grow, that's it it'll die," Wahid T. Hanna, MD, Professor of Medicine at The University of Tennessee Medical Center, told Ivanhoe.
The antibody attaches itself to cancer cells, making the cancer vulnerable to being destroyed by a patient's own immune system.
After six rounds of the chemotherapy, combined with the antibody, the tumor in Kimberly's lung has shrunk by more than half.
"It makes me feel ecstatic that there's hope," Kimberly said.
Kimberly and her daughter Victoria hope the tumor will eventually disappear so they can enjoy more quality time together.
"We have definitely gotten closer and it's kind of a blessing," Victoria Marlow, Kimberly's daughter, told Ivanhoe.
After patients complete the combination treatment, they can choose to continue taking the antibody without the chemotherapy. Patients from around the US and around the world are being recruited to take part in the phase two study.
BACKGROUND: Lung cancer is the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not carry out the functions of normal lung cells and do not develop into healthy lung tissue. As they grow, the abnormal cells can form tumors and interfere with the functioning of the lung, which provides oxygen to the body via the blood. Lung cancer is the leading cause of cancer deaths in the United States among men and women. Lung cancer claims more lives each year than colon, prostate, ovarian, and breast cancers combined. (Source: www.lungcancer.org; http://www.mayoclinic.com)
SYMPTOMS: In its early stages, lung cancer normally has no symptoms. When symptoms start to appear, they may include:
Chronic, hacking, raspy coughing, sometimes with blood-streaked mucus
Recurring respiratory infections, including bronchitis or pneumonia
Bone fractures not related to accidental injury
Neurological symptoms, such as unsteady gait or memory loss
TREATMENT: Surgery, radiation, chemotherapy, and targeted treatments—alone or in combination—are used to treat lung cancer. Each of these types of treatments may cause different side effects. The body's reaction to these treatments depends on a number of factors such as length of treatment, dosage prescribed, and a person's health history. (Source:www.lungcancer.org)
NEW TECHNOLOGY: Research for small cell lung cancer (SLCL) is now focusing on adding immune boosting antibodies to chemotherapy drugs. Clinical trials funded by IummunoGen, Inc., a biopharmaceutical company that develops anticancer therapeutics, are testing the safety and efficacy of the combination treatment (IMGN901, carboplatin and etoposide) in patients with solid tumors and extensive stage small cell lung cancer. In the dose-finding evaluation, enrollment was open to any patients with any type of advanced solid tumors treated with etoposide and carboplatin. All patients received etoposide at its standard dose. Two different doses of carboplatin were each evaluated with etoposide. A total of 33 patients received one of the five dose combinations. Thirteen had SCLC. Three of the 13 patients with SCLC enrolled had chemotherapy-naïve disease. Two of these three patients had an objective response. All of the 10 patients with previously treated SCLC had received prior platinum-based therapy, and seven of these patients had platinum-resistant/refractory disease. Four of these ten patients had a PR, including two of the patients with platinum-resistant/refractory disease. Out of the 33 patients enrolled, ten had an objective response, and 24 had disease control (objective response or stable disease). For enrollment information go to:http://clinicaltrials.gov/ct2/show/study/NCT01237678?term=small+cell+lung+ca&recr=Open&rank=6&show_locs=Y#locn)
Wahid T. Hanna, MD, Professor of Medicine, Chief of Hematology/Oncology Division at the University of Tennessee Medical Center, talks about a new lung cancer antibody trial.
What is small cell lung cancer? Is it different than the lung cancer people usually hear about?
Dr. Hanna: Well lung cancer consists of two big groups; the small cell and the non- small cell. The small cell is very different than the others. The non-small cell consists of several types: adenocarcinoma, squamous cell carcinoma, or bronchi-alveolar carcinoma. The small cell is a group of cancer cells that responds best to chemotherapy. It is the most aggressive and it moves fast. Because it can spread to other areas in the body so quickly, chemotherapy is the treatment of choice for small cell cancer. In fact, part of the routine when we have small cell is to do a brain scan to see whether that has spread already to the brain because in something like 10% to 20% of the cases whenever they were discovered, it already has spread to the brain.
Is it the most common type?
Dr. Hanna: It is not the most common type, but it is the type that will respond the best to chemotherapy.
Who is more at risk for this type of lung cancer?
Dr. Hanna: Just like any other lung cancer, smokers.
So, what have treatments been like? Have chemotherapies been effective to this point?
Dr. Hanna: Chemotherapy is more effective in small cell than the rest. We have even improved in the other types of lung cancer. Now, we have targeted treatment that can help us to modify the treatment to suit a particular patient, but they respond usually well with 60% to 70% response rate, but the cure rate is not high. So, usually whenever I have a new patient, I tell them that this is the most aggressive, but it responds the best. There is a chance to put you in remission for a year and a half to two, but there is a small chance of 5% to 10% for those people to go into long term disease free survival. So that is one big difference because in the other type of lung cancer, the non-small cell, I usually do not talk about cure if the patient has extensive disease. I am talking about how long we can control the disease and how long I can prolong life if they can and if they respond well.
What is the 5-year survival rate for someone with small cell?
Dr. Hanna: It can be anything between 1-1/2 to 2 or if they are cured, they can live.
Unlike other cancers, lung cancers can actually be cured?
Dr. Hanna: A small percentage.
Dr. Hanna: Correct.
Is the aggressiveness of the cancer a concern because if it keeps spreading, then you are at more danger of dying?
Dr. Hanna: True. Of course, if a patient has a brain metastases or involvement of the brain, that adds another dimension. When you give chemotherapy to any patient, there is a blood brain barrier that prevents the chemotherapy from going to the brain. So, that is why the treatment would be radiation treatment, but if you finish the radiation treatment you cannot go back and give more radiation. So, once you have finished the radiation treatment that is it. Any progression in the brain, you cannot do much. You can do a few things, but it is not the most ideal. It is not the most effective. You may get some chemotherapy to go to the brain, but it is not. So that can limit your success.
Where does it usually spread to? Is there a certain organ or part of the body that small cell lung cancer attacks when it does spread?
Dr. Hanna: Not necessarily. It can go to the bones, the liver, the brain, the lymph nodes in between the lungs, and other lymph nodes in the body. However, these are the main sites of spread.
So how has it proven to progress in the first 2 phases?
Dr. Hanna: We are presently in Phase 2 of this study which is to determine how tolerable it is to combine the study drug with standard treatment and to look at and compare time to progression of disease and long-term survival rates. Well, we are trying a standard type treatment versus standard plus extra. In this particular trial, we are using the standard treatment, which are two drugs called etoposide and carboplatin. We are adding the study drug, which are monoclonal antibodies. It is an antibody that can attach to a certain part of the cancer cell. Hopefully one of those days once we finish the study and we have all the information, we will know whether it has an added benefit, survival benefit, or even a prolongation of the response.
What were the results? Was there a percentage difference?
Dr. Hanna: It did improve the situation, but you need to do it in phase 3, which is the real test because you have real patients and usually this is on the national level. Then you can have the numbers to support it. If we see that the patients that were on the study getting the clinical trial drug, which is the monoclonal antibody in addition to the chemotherapy and they did much better that is it; maybe that is something that needs to be added to the standard treatment and become the standard treatment. Then once we have that, maybe we will discover something else and say how about if you add drug X to the chemotherapy and monoclonal antibody; can we do better?
Describe again what the antibody does in addition to the chemo? How does it fight the cancer?
Dr. Hanna: Well, it depends. When you have a cold, your body produces antibodies to kill the bacteria, right? When you have cancer, you failed the body surveillance. So, the body does not reject that, but you are forming antibodies that have been raised against this particular cell and with a different mechanism or an antibody that works on a vital portion of the cell metabolism that will block it. So, it varies. It is an antibody that interferes with the survival of the cancer cell.
Does it kill or does it mimic it so that the immune system attacks it and then attacks the cancer as well?
Dr. Hanna: Well, if you are interfering with the metabolism; if you have a cell that is requiring oxygen and interfere with the nutrition, interfere with the way that they get the cell to grow, well that's it. It will die. So, it is an antibody that interferes somehow, somewhere in the cell cycle with the cell cycle; prevent it from maturing. If that happens, then the cell will die.
So, the study has been here at UT Medical Center for 6 months correct? Phase 3 study?
Dr. Hanna: No, we are now in the Phase 2 part of the study.
What have you seen in that time?
Dr. Hanna: Well, actually I only have 1 patient in this study.
Is that Kimberly?
Dr. Hanna: That is Kimberly.
When she came in, how progressed had she been?
Dr. Hanna: Well, she had advanced disease and on top of that psychologically she was not well once she knew that she has the disease because she is an oncology nurse. She is taking care of patients with cancer and so that, with that background, she was just devastated psychologically, emotionally plus physically with the disease itself.
So, what was her treatment like? How often did she have to come in for it?
Dr. Hanna: Well, the treatment is given for three days and repeated every three weeks and then the monoclonal antibody is given on day one and day eight. She has been getting the treatment and so far she has been doing really great.
Have you been able to track if there has been any kind of regression of the cancer?
Dr. Hanna: We are doing tests or scans every 2 cycles. So, far in each step of the way, we have seen improvement. So, we are continuing and she should be ready to receive the reevaluation test after the 6 cycles of chemotherapy very soon.
She is still going through this?
Dr. Hanna: Yes. She just had the chemotherapy just last week, this is number six. That will be the last chemotherapy. Then, if she has done well after that and she could be allowed to continue on the monoclonal antibody, just alone for as long as she wants.
So how promising do you think this is to help people with this form of cancer?
Dr. Hanna: It is quite promising, but obviously I am excited about this. This is new, but I am excited about any clinical trial because I am hoping that we will learn something and actually we do learn something; even the negative results from a clinical trial that teach us how to look for the next clinical trial and that is it. It is just; it is excitement all the way. So, I am definitely excited. I am hoping that this study will make a difference and hopefully that will be a step forward in the future for a better, brighter future.
Are you still enrolling and how many do you plan to enroll?
Dr. Hanna: There is no limit. We have to enroll in every institution until they reach the maximum number for the study. We will still have room, but small cell is not as common as the non-small cell. Then, you have to have somebody in good performance status to start with to be eligible for the study. That is criteria you have to fulfill before you put somebody on clinical trial.
Kimberly was stage IV, correct?
Dr. Hanna: Yes.
So, this is still recruiting nationwide then?
Dr. Hanna: Yes.
Are you really hoping more people will enroll in this one and others?
Dr. Hanna: Yes, in any clinical trial.
Do people think placebo means they are just going to get no treatment or is it the standard treatment that they are getting when it is a placebo.
Dr. Hanna: Right. That is very important. Placebo is given with an understanding that they are still getting the standard treatment plus the placebo and the other group is getting the standard treatment plus the study drug. So, they are not deprived from the right treatment. The standard treatment will be given to everybody. However, this study is NOT a placebo study. Half of the patients are randomized to receive the standard treatment alone and half will be treated with both the standard treatment and the addition of the study drug. Therefore, the patients on this study know exactly what they are receiving.
FOR MORE INFORMATION, PLEASE CONTACT:
Randi Ray, RN, BSN, OCN Clinical Trials Specialist The University of Tennessee Medical Center Cancer Institute (865) 305-9773
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