In this podcast, we’ll discuss several studies related to patient care and quality of life highlighted at ASCO’s 2014 Annual Meeting, including new research on fertility preservation, caregiving, end of life care, and bone health. In addition, one study discussed focuses on radiation therapy for head and neck cancers.
ASCO: You're listening to a podcast from Cancer.Net. This cancer information website is produced by the American Society of Clinical Oncology known as ASCO, the world's leading professional organization for doctors that care for people with cancer. In today's podcast, we'll discuss several studies related to patient care and quality of life highlighted at ASCO's 2014 Annual Meeting, including new research on fertility preservation, caregiving, end of life care, and bone health. In addition, one study discussed focuses on radiation therapy for head and neck cancers.
This podcast will be led by Dr. Patricia Ganz, who is a professor at the University of California, Los Angeles, and the Director of Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center. Dr. Ganz is also a member of ASCO's Cancer Communications Committee. The ASCO Annual Meeting is the premiere educational and scientific event where physicians, researchers, and other healthcare professionals gather to discuss the latest in cancer care and treatment. This Cancer.Net podcast helps put new research findings in the context and explains what this news means for patients. ASCO would like to thank Dr. Ganz for summarizing these studies.
Dr. Ganz: Hello. This is Dr. Patricia Ganz. I'm a medical oncologist in UCLA and I'm going to be speaking to you about some of the ASCO abstracts that focus on quality of life and patient care. I was asked to actually define what quality of life is for you before moving ahead with this. And I wanted to recall the World Health Organization definition of health from the late 1940s. When they described health as being not just the absence of disease, but the promotion of physical, emotional, and social wellbeing. And those of us who have worked over the last 20 or 30 years to try and incorporate measures of quality of life in cancer clinical trials, have used this definition as an anchor to really say that there are dimensions of the outcomes of treatment in the physical, emotional, and social domains that are important to patients, and that we should be considering them in addition to survival and disease-free survival.
So the abstracts that I'm going to be discussing briefly today really touch on these issues. Although, they are not actually what we would call quality of life studies with the exception of one because they do not include patient or participant reported outcomes. But rather, they talk about medical outcomes that would be important to patients. So among the things that are crossing - the abstracts that I'm going to discuss - really relate to the tailoring of treatments. And we've learned a lot about how we're targeting and personalizing cancer treatments for patients by looking at the specific genetic and genomic features of the tumor to give the best drug to the right person at the right time. Well similarly, we need to think about how to tailor our treatments based on the patient population.
And the first abstract that I'd like to discuss is the one by Halle Moore as the first author which was a Phase III prevention of early menopause study—conducted by the Southwest Oncology Group—where a drug that shuts down ovarian function was used in early stage estrogen receptor negative women, who were less than 50 years of age and were menstruating, to see if this, in fact, could protect the ovaries against the toxic effects of chemotherapy. And this has been an important question because if we think about younger women who we treat with curative intent for breast cancer, if we are hoping to have them go on and have a good quality survivorship, for many of them, they will want to have the possibility of having children in the future. And we know that many of the chemotherapy regiments that we give affect their future fertility.
So this study was conducted over a fairly long period of time. They started enrolling in 2004 and the study completed enrollment with 257 patients in 2011. And they're now reporting their first results. And what was important in this study is that in looking at whether women were continuing to menstruate two years after the start of chemotherapy, the women who had been given the gonadotropin releasing hormone medication, which is goserelin, 8% of those who took that medication had loss of ovarian function at two years. Where 22% of the women who received chemotherapy had loss of function.
In addition, there were pregnancies in both groups of women. Slightly more among those who had the medication studied in this trial. And interestingly enough, this is a very small trial, the women who received this medication actually had a better disease-free survival. So it did not harm their outcomes in terms of taking medication and preserving their fertility. So this is an important study in the sense that we can now offer this kind of protection against ovarian function failure in young women and preserve the opportunity for pregnancy and fertility in the future. So this is an important survivorship issue.
And the second study that I wanted to talk about was not a randomized study, but it was a study looking at individuals with human papillomavirus in associated oropharyngeal cancer. These are cancers that are increasingly common because of the prevalence of this viral infection and the fact that it does cause cancers in a number of places in the body. And this was an observational study where they looked at the ability to reduce the dose of radiation given after induction chemotherapy to these patients against standard therapy.
But the patients who had good responses and shrinkage of the tumor prior to the start of radiation therapy were able to receive a lower dose of the radiation, and in fact, this did not compromise their survival. They survived as well. And we know that by reducing the dose of radiation in this setting, we can also reduce the complications from the treatment. And again, this is the issue of tailoring the therapy, not treating everyone with a one size fits all protocol and taking advantage of the fact that patients with this type of cancer of the mouth have a better prognosis and therefore, we can reduce or tailor the therapy for these individuals.
Now, I'd like to talk about three more trials that are being reported. And these are all randomized control trials which is the highest level of evidence that we have. And in two of these trials we're seeing, again, the issue of do we need to treat everyone in the same way, can we tailor the therapy somewhat? The first one that I want to talk about is managing comorbidities in oncology. This was a large, randomized trial where patients with advanced and life-threatening illness—49% of them who had cancer—were approached to participate in a study where they were either going to discontinue or continue their statin medication. As many of you know, statins are a commonly used medication for lowering cholesterol and reducing the risk of serious cardiac events.
And so the issue always comes up when somebody has advanced cancer or other life-limiting illnesses, do we continue all of the medications that the patient has been on before while we're often adding new medications to control their pain or other symptoms? And people are often wary of rocking the boat by changing these medications, but again, with somebody with advancing disease and serious illness, having to take medications that may not be helpful may add to more difficulties for them. So the important findings from this study were that the rate of death after stopping the medications did not differ between those who continued or discontinued—according to the randomization—and there was a slightly longer time to death for those who discontinued, but it wasn't statistically significant.
Quality of life was better among those discontinuing the statins and that was statistically significant, and that was a patient reported piece of information. And there were fewer symptoms associated with discontinuing the medication also that was not statistically significant. So overall, what this study tells us when there are medications—and in this case in particular, a statin—that are no longer contributing benefit to the care of an individual, that they can be safely discontinued without fear. And I think having this type of high-level evidence should promote greater simplification of medication regimens and treatments for individuals in this situation.
Now the next study, which also looks at reducing therapy—and again in a way tailoring it, not continuing to expose patients to treatment if it's not necessary—was a study looking at whether one should continue to give the medication zoledronic acid which is used to build up the bones in women who have metastatic breast cancer to the bones. The question here was, do we need to continue giving this medication by an infusion once every month once a woman's condition has stabilized and/or in this case in the randomized trial, has completed 1 year of monthly therapy? So this was a very well conducted randomized control trial. It was double blind and that patients did not know or the doctors did not know who was receiving the monthly or the every three months therapy.
And again, patients received either the therapy every four weeks or every 12 weeks for a year after having—had stable disease with the monthly therapy. And the primary endpoint for this trial was to see if there was equivalent stabilization of the skeletal exams meeting bone fractures or the need for radiation or bone pain. And 403 women were randomized in this trial and the average age of the women was 59 years and there was good balance between the 2 arms. And importantly, what was found was that there was absolutely no difference if you gave the zoledronic acid every 4 weeks or every 12 weeks. And this was important because of obviously the inconvenience of having to come in for treatment more frequently, but more importantly, some of the morbid complications of this treatment which includes osteonecrosis or damage to the jaw bone was reduced to those women who took the therapy every 12 weeks versus every four weeks.
In addition, the adverse events associated with the every four weeks treatment were greater than in the every 12 weeks, 9.6% in the every four weeks and 7.9% in the every 12 weeks. So the conclusion then from this study was giving this therapy every 12 weeks, instead of every 4 weeks was not inferior. There were fewer complications both in terms of kidney complications which is another toxicity and jawbone injury that's giving it every 12 weeks. So again, very important for patient care, both in terms of convenience and side effects to be able to give it less frequently.
And the final study that I'd like to talk about is one that I think is very important. It's focusing on supporting caregivers of individuals who have advanced cancer. This is again another high-quality randomized controlled trial being conducted at multiple sites with lead author from the University of Alabama, Birmingham is Dr. Dionne‐Odom. And this study recruited family caregivers of individuals with advanced cancer and asked them if they would be willing to participate in a randomized clinical trial. Where they would either initially receive phone calls and support from an advanced practitioners or have the same phone-based support occur 12 weeks later.
In this particular study, they did a classical quality of life study where they actually ask the caregiver to rate their own personal quality of life, their depression, and their sense of burden associated with caregiving for their loved one who had cancer. And these data were collected at entry into the study, and then at every 6 weeks up to 24 weeks, and then every 12 weeks thereafter until death or study completion. The findings from the study were that the caregivers who received this kind of support from the nurses with phone calls in the immediate group had lower levels of depression, lower levels of subjective burden, and had trends towards better quality of life, in comparison to the other group who had this support initiated later.
And again, I think this goes very strongly with other data that we have emerging, that giving this kind of support to the patient at the time of diagnosis of advanced cancer is also beneficial. So it does make some sense that the caregiver can feel better and potentially do a better job taking care of their loved one, if they do get this kind of additional support. So from this perspective, we're learning that even though an individual may have advanced cancer, they and their families may benefit substantially from the early integration of palliative and supportive care into their treatment plan when it may be many months to years before death, but it would help them manage their care during that time and be able to enjoy and benefit from the symptom relief and psychological support that is received in this type of program.
So in summary then, I think we're seeing emerging data in many different disease sites and with many different patient populations about studies that have been conducted to try and tailor our treatments, to reduce the burden and toxicity of treatment, as well as to enhance wellbeing among our patients. And with these kinds of studies, if we begin to incorporate them into the practice of oncology, we can expect the quality of care for all patients to improve over time. Thank you very much.
ASCO: Thank you Dr. Ganz. More information from ASCO's 2014 Annual Meeting can be found at www.cancer.net, including additional podcasts covering other highlighted research from this event.
Cancer.Net is supported by the Conquer Cancer Foundation which is working to create a world free from the fear of cancer by funding breakthrough research, sharing knowledge with physicians and patients worldwide, and supporting initiatives to ensure that all people have access to high quality cancer care. Thank you for listening to this Cancer.Net podcast.