A lot of the limitations of research in the palliative care and survivor care setting are now being met with [randomized] clinical trials.… [T]he evidence base is building, and it’s building very quickly.
—Arif H. Kamal, MD
"This year was actually a boon for the patient and survivor care section,” Arif H. Kamal, MD, said at the Best of ASCO meeting in Seattle, where he reviewed the leading abstracts and gave some of his own perspective. “What you see is a lot of the limitations of research in the palliative care and survivor care setting are now being met with [randomized] clinical trials…that are starting to match the evidence level that’s already apparent in all the other [oncology] disease groups. So the evidence base is building, and it’s building very quickly.”
Older, Less Costly Drug Controls Nausea and Vomiting
An Italian randomized noninferiority trial compared the neurokinin inhibitor aprepitant with the antidopaminergic agent metoclopramide, each combined with dexamethasone, for prevention of delayed nausea and vomiting in patients receiving cisplatin-containing chemotherapy.1 Metoclopramide, often used in the United States at lower doses to treat diabetic gastroparesis, was given at 20 mg four times daily on days 2 to 4. “As long as your patient is not older and does not have a history of Parkinson-type symptoms, you can actually get away with doses like that,” commented Dr. Kamal, who is Director of Quality and Outcomes at the Duke Cancer Institute in Durham, North Carolina.
Results showed no significant differences between the metoclopramide and aprepitant groups in the rate of complete response (lack of any vomiting and rescue medication)—82.5% vs 80.3%—or in use of breakthrough medication, quality of life, or adverse effects. Dr. Kamal estimated that a 30-day prescription of metoclopramide costs roughly $4, whereas two tablets of aprepitant cost $144 to $340.
“The major limitation to this study was that they did not use fosaprepitant [Emend] and eliminate aprepitant on days 2 and 3, although fosaprepitant still has a higher cost than metoclopramide. Even if you use fosaprepitant, the antidopaminergic medications—metoclopramide, olanzapine, and [haloperidol]—are very, very good as antiemetics and should be used commonly,” he maintained. “Metoclopramide can be considered as a first-line antiemetic, and certainly, if a patient cannot afford a neurokinin inhibitor, should be considered.”
Less Frequent Zoledronic Acid Dosing Is Just as Efficacious
The OPTIMIZE-2 randomized noninferiority trial compared the bisphosphonate zoledronic acid given every 4 weeks vs every 12 weeks to patients with bone metastases of breast cancer.2 “These are patients who had been living a long time with advanced disease and who had already received quite a bit of bisphosphonates up front,” Dr. Kamal commented.
The time to a first skeletal-related event was statistically indistinguishable between treatment groups, at a median of about 1 year. There was also no significant difference in the rate of skeletal morbidity.
As a result of the findings, “the issue of frequency of bisphosphonates or bone-modifying agents is certainly up for question,” Dr. Kamal commented. The trial had methodologic issues, such as the need to drop a placebo arm because of the low accrual and the advent of RANKL inhibitors, he noted. In fact, a similar denosumab (Xgeva)-based trial is now enrolling patients.3
DHEA With Moisturizer Relieves Vaginal Symptoms
A trial from the Alliance group tested a combination of vaginal dehydroepiandrosterone (DHEA) and a bioadhesive moisturizer for relieving vaginal symptoms in postmenopausal women treated for breast or gynecologic cancers.4 Patients were randomly assigned to lower-dose DHEA (3.25 mg) plus moisturizer, higher-dose DHEA (6.5 mg) plus moisturizer, or moisturizer alone—each applied nightly for 12 weeks. “So this was not [as-needed] use, which is very different from other trials in how they’ve been designed and certainly differently than how it may be clinically given,” Dr. Kamal pointed out.
Results showed significant improvements in some sexual function outcomes with lower-dose DHEA and in nearly all of them with the higher dose, relative to moisturizer alone. The products studied are not yet on the market, but in the meantime, “bioadhesive moisturizers, which can be found over the counter—one example is Replens—should be used in patients with sexual dysfunction who are on antihormonal treatments for breast cancer specifically and should be used daily or nightly, and for a long period of time,” Dr. Kamal recommended.
Cardiomyopathy Screening in Childhood Cancer Survivors
A randomized trial among at-risk adult survivors of pediatric malignancies from the Childhood Cancer Survivor Study assessed whether adding counseling by an advanced practice nurse to a printed survivorship care plan improved cardiomyopathy screening.5 The counseling consisted of two telephone motivational interviewing sessions plus two follow-up letters summarizing the content.
The patients studied had not had cardiomyopathy screening during the past 5 years. “So these are patients who are not getting very close follow-up support, for example, not participating in any other long-term follow-up program. So this was their major way of having contact with anything in survivorship,” Dr. Kamal noted.
At 12 months, 52% of intervention patients had undergone echocardiography compared with 22% of control patients (adjusted relative risk = 2.31). “What’s not surprising is that the piece of paper on its own has limited value,” Dr. Kamal commented. “The highlight of this is that the value is still at 52%. So you essentially are putting a lot of resources into survivorship follow-up here for an echocardiogram and you’re still only getting to about 50%, which highlights the idea that probably the actual solution to this problem is going to be multimodality and potentially even multiprofessional.”
Palliative Care for Caregivers
The randomized ENABLE III trial compared immediate vs delayed palliative care for family caregivers of patients with advanced cancer.6 In the immediate group, patients had an in-person consult with an advanced practice nurse that the caregiver was welcome to attend; thereafter, nurses conducted telephone-based sessions and follow-up with both. Patients in the delayed group were wait-listed. “This is actually the first time in the world ever that I am aware of that a family caregiver study using palliative care was actually performed and with this rigor of methodology,” Dr. Kamal noted.
Results showed that relative to wait-listed peers, caregivers in the early palliative care group had better quality of life, less depression, and lower subjective burden. However, among families in which the patient died, early palliative care did not reduce depression or grief.
“This is the first trial that shows that [palliative care] does the same thing for families and caregivers as long as they are brought in at the same time as the patient,” Dr. Kamal noted. At his facility, “as a rule we don’t do a lot of palliative care consults—certainly first visits—without having somebody else in the room, such as other caregivers.” ■
Disclosure: Dr. Kamal reported no potential conflicts of interest.
1. Roila F, Ballatori E, Ruggeri B, et al: Aprepitant versus metoclopramide, both combined with dexamethasone, for preventing cisplatin-induced delayed emesis: A randomized, double-blind study. 2014 ASCO Annual Meeting. Abstract 9503.
2. Hortobagyi GN, Lipton A, Chew HK, et al: Efficacy and safety of continued zoledronic acid every 4 weeks versus every 12 weeks in women with bone metastases from breast cancer: Results of the OPTIMIZE-2 trial. 2014 ASCO Annual Meeting. Abstract LBA9500.
3. U.S. National Institutes of Health: Prevention of symptomatic skeletal events with denosumab administered every 4 weeks versus every 12 weeks. Available at ClinicalTrials.gov/show/NCT02051218. Accessed November 17, 2014.
4. Barton DL, Sloan JA, Shuster LT, et al: Impact of vaginal dehydroepiandosterone (DHEA) on vaginal symptoms in female cancer survivors: Trial N10C1 (Alliance). 2014 ASCO Annual Meeting. Abstract 9507.
5. Hudson MM, Leisenring WM, Stratton K, et al: Increasing cardiovascular screening in at-risk adult survivors of pediatric malignancies: A randomized controlled trial. 2014 ASCO Annual Meeting. Abstract 9506.
6. Dionne-Odom JN, Azuero A, Lyons K, et al: Benefits of immediate versus delayed palliative care to informal family caregivers of persons with advanced cancer: Outcomes from the ENABLE III randomized clinical trial. 2014 ASCO Annual Meeting. Abstract LBA9513.
Discussions with patients and families about stopping non–cancer-related medications near the end of life are thorny but necessary, according to Arif H. Kamal, MD, of Duke Cancer Institute, at the Best of ASCO meeting in Seattle.
“What’s happening now is that a lot of hospices are having a...
A trial reported in 2010 found that adding palliative care to standard care at the time of lung cancer diagnosis prolonged overall survival by an average of about 2.6 months,1 Arif H. Kamal, MD, told attendees at the Best of ASCO meeting in Seattle. Dr. Kamal is Director of Quality and Outcomes at...