With the FDA approval of two new PARP inhibitor drugs since last year’s Ovarian Cancer National Conference, it’s no surprise the topic was of great interest at this year’s meeting in Chicago, and a standing-room-only crowd was on hand July 8 to hear the latest news on this practice-changing class of drugs.

“There is a dizzying amount of data with respect to how effective they are, how tolerable they are, and when it’s best to use them,” noted John Moroney, MD, the expert on hand to lead the discussion.

Three of these oral agents have been FDA-approved for specific indications in ovarian cancer: olaparib (Lynparza) in December, 2014, rucaparib (Rubraca) in December, 2016, and niraparib (Zejula) in March, 2017. These drugs continue to be the topic of investigation for expanded use in ovarian cancer, and Moroney mentioned two other PARP inhibitors in development: veliparib and talazoparib.

As just one indication of the impact of these agents on the research landscape, Moroney said that when he went on clinicaltrials.gov that morning, there were 57 active trials involving PARPs. That’s a big number, but it includes some smaller trials. Moroney, who is an associate professor of obstetrics and gynecology specializing in gynecologic cancers at University of Chicago Medicine, added that the majority of the phase III trials in patients with ovarian cancer are for those who respond to platinum chemotherapy.

Inhibitors of the enzyme poly ADP ribose polymerase (PARP), work specifically in women with 

 mutations. Encouragingly, PARP inhibitors are also proving valuable for some patients who don’t have 

The first approved PARP inhibitor, olaparib, is indicated for women with germline 

-mutated advanced ovarian cancer who have had three or more lines of chemotherapy. The trial that led to the drug’s approval reported an objective response rate of 34%, and 55% of patients were free of progression at 6 months.

Rubraca is approved for the treatment of 

-positive advanced ovarian cancer after at least two lines of chemotherapy. With this drug, 

-positive status can be due either to a germline mutation or a mutation in the tumor itself, known as a somatic mutation. The FDA also approved a companion diagnostic to detect deleterious 

 mutations in tumor tissue. Rubraca’s approval was based on data from 106 patients across 2 trials; in a pooled analysis of the data, the objective response rate was 54%.

The latest approved addition to the PARP class of drugs is niraparib. This drug can be prescribed as maintenance treatment following a partial or complete response to the patient’s most recent platinum chemotherapy, and it can be used in women who do not harbor BRCA mutations.

With PARP inhibitors now established as an efficacious ovarian cancer treatment option for many women, Moroney discussed some of the questions patients may have about them, including what side effects to look out for and when is the best time to use them. There is also interest in whether they may be used in combination with other drugs.

Moroney said that when PARPs first came to market, it was assumed the oral agents would be nothing like chemotherapy in terms of adverse events: “With more experience, we’ve learned that by and large, they are significantly more tolerable than many of the first-line chemotherapies,” but he cautioned that there are still some side effects.

He highlighted three gastrointestinal side effects — nausea, constipation, and abdominal pain – observed with all three FDA-approved PARPs, but few are the serious grade 3 or 4 adverse events that can result in treatment disruption or hospitalization. He did say, however, that when grade 2 toxicities persist over time for any drug, they can be very distressing for patients and deserve more attention.

Similar to the way chemotherapy can affect hemoglobin and platelets, Moroney explained that all of the PARP inhibitors can have some hematologic toxicities, principally involving decreased hemoglobin. Fatigue is another frequently reported side effect, which, Moroney acknowledged, “is much underappreciated by most oncologists, including me.” All of the agents can cause some fatigue, he said, but less than 10% of patients have had to stop the medication as a result.

Moroney said the answer to this question is not yet clear. PARP inhibitors were initially studied in the platinum-sensitive and platinum-resistant setting, but studies are being conducted of the agents as primary treatment. There are no FDA approvals in the primary setting yet, but Moroney anticipates that findings from these studies will help to determine whether PARPs are an option as primary treatment, with some expected to report results in approximately 18 months.

Researchers are now investigating the agents in combination, including trials testing olaparib combined with cediranib maleate in platinum-sensitive and platinum-resistant ovarian cancer. He explained that cediranib is similar to Avastin in that it is an anti-angiogenesis drug that keeps new blood vessels that feed the tumor from forming.

In updated findings from a small phase 3 trial studying the combination that was reported at the annual meeting of the American Society of Clinical Oncology in June, 2017, adding cediranib to olaparib showed a superior median progression-free survival of 23.7 months, compared with 5.7 months with single-agent olaparib in 23 women with recurrent platinum-sensitive ovarian cancer, but without a known BRCA germline mutation. The 24 women in the study with a 

 mutation did not derive the same benefit. “In this trial, patients who were non—

-mutated, actually did better than those who were,” Moroney noted.

PARP-immunotherapy combinations are also being explored, including one phase I/II study that is currently recruiting patients that is examining olaparib with the monoclonal antibody tremelimumab in BRCA 1 and BRCA 2 carriers with recurrent ovarian cancer (NCT02571725).

Articles

The treatment landscape of ovarian cancer continues to change with the recent approvals of new agents.

Moving Forward with PARP Inhibitors in Ovarian Cancer

Participating in clinical trials, even early-phase ones, offers the best hope for better treatments for patients with ovarian cancer. However, efforts are urgently needed at every level to ensure that more of these research opportunities are available.

“Every single major advance in ovarian cancer has come through a clinical trial,” Carol L. Brown, MD, FACS, said in her presentation July 8, 2017 at the 20

 Annual Ovarian National Conference in Chicago.

The critical importance of expanding the universe of clinical trials in gynecologic cancers was a recurring theme at the meeting. Speaking earlier that day, John Moroney, MD, of University of Chicago Medicine, stressed that continued progress depends on an expansion of clinical trials focused on gynecologic cancers.

“This is not ‘FAKE NEWS’,” said Moroney, during his presentation. He and Brown both described a crisis in available clinical trials for women with gynecologic cancers and pointed to statistics showing a 90% reduction in patient enrollment in gynecologic cancer clinical trials from 2011-2016.

Why Should Patients Participate in a Clinical Trial?

Brown, a gynecologic oncologist and associate cancer center director for diversity and outreach at Memorial Sloan Kettering Cancer Center, noted that researchers already have a pretty good idea that a drug being tested in a phase 1 trial will provide some benefit to patients. With the dramatic advances now in cancer science, “Rarely is there a phase I trial that’s not going to benefit you at all. That’s important for patients to understand.”

The goal of phase I studies, she explained, is to determine a drug’s safety, its maximum tolerated dose and how the treatment is processed in the body. Phase I studies are small, however, usually between 20 and 40 patients will be given the new treatment.

Onto phase II trials, where Brown told her audience a lot of advances are being made. “The whole field is changing. Phase II trials are larger, they are happening more rapidly, and we’re working very hard to make them more accessible.”

While phase I trials are still mostly conducted at a specialized center, the base for phase II trials — the next stage in proving the anticancer effects of the drug in a larger population – has broadened. “You used to have to go to a cancer center for a phase II trial; it was unheard for phase 2 trials to be done in the community. That’s no longer true.”

“Researchers have realized that if we want to get people to participate, we have to take the trials to them. We can’t expect everyone to travel to the big cancer centers.”

Often seen as the “gold standard” of clinical trials, phase III studies today typically compare two treatments that researchers already know work well, Brown explained. They are looking to see if they work equally well, as well as at associated quality-of-life side effects like neuropathy and hormonal changes, even cost. Phase III findings are what the Food and Drug Administration look to when deciding whether a drug should be approved.

“Participating in a clinical trial gives you access to new drugs and interventions before they are widely available; if the treatment is a success, you are among the first to benefit,” Brown said. Yes, you are also contributing to the larger good and helping other women diagnosed in the future, she continued, but even with a phase I trial, “there’s something in it for you.”

Trial participants also will get health care and closer observation by leading physicians in the field of gynecologic cancer research. “When you participate in a clinical trial, you are getting extra CT scans and calls from the doctor or nurse to see how you are doing.”

Advocating for More Gynecologic Cancer Clinical Trials

Brown cited an array of practice-changing advances in ovarian cancer that are the result of clinical trials, including discovery of less toxic drugs like paclitaxel and carboplatin and the availability of targeted therapies in ovarian cancer, such as the oral PARP inhibitors rucaparib (Rubraca) and olaparib (Lynparza).

She noted that in the last three years, four new drugs have been approved for ovarian cancer; that’s compared with four over the previously 15 years: “Things are looking up, things are accelerating, it’s going to happen.”

This optimism is tempered, however, by disturbing trends that show a reduction in gynecologic cancer—focused trials. Brown cited reductions in federal research funding, a move toward smaller biomarker-driven studies, and reorganization of oncology cooperative group research as contributing factors: “Gynecologic cancer is unique and need its own set of resources.”

She urged the audience to advocate aggressively for trial funding and increasing awareness of the importance of gynecologic cancer trials by contacting their elected representatives. The Society of Gynecologic Oncology’s Legislative/Congressional Ambassadors Program is making increased support for the National Cancer Institute a priority and working to expand and integrate its network to educate patients and advocates on how to communicate with Congress.

“We need you to partner with us in this very important effort,” Brown concluded. “Now is the time for action, awareness, and funding. Together we have a powerful voice."

For women with ovarian cancer, the message is clear: participating in clinical trials, even early-phase ones, offers the best hope for better treatments, but efforts are urgently needed at every level to ensure that more of these research opportunities are available.

Clinical Trials are the Best Hope for Ovarian Cancer

Oncology nurses have a unique opportunity to attend “summer school” in August, earn 10.25 Contact Hours, and learn the latest information about new treatments and side effects across the full range of tumor types from nationally recognized experts at the 1st Annual School of Nursing Oncology

The SONO conference, to be held August 5 to 6, 2017, in Nashville, Tennessee, is a CME/ CE-certified activity sponsored by Physicians’ Education Resource

 SONO program co-chair Laura S. Wood, RN, MSN, OCN, explained that one of the attractions of this meeting for the practicing oncology nurse is its broad coverage of cancer and treatment options. “So much is changing for our patients and for ourselves as clinicians—the meeting offers a great opportunity to get a comprehensive update.”

“The treatment options and the diagnosis and management of cancer from early to advanced disease and survivorship is constantly evolving,” continued Wood, who is the renal cancer research coordinator at Cleveland Clinic Taussig Cancer Institute. She added that it’s especially helpful that the conference will cover all of the solid tumor malignancies as well as hematologic cancers, in one, 2-day conference.

At the conference, Wood will be giving 2 presentations, 1 focused on genitourinary cancers, where she said the biggest change has been in bladder cancer where patients have many more treatment options than they did even 1 year ago.

Immunotherapies have expanded rapidly in the clinic, following on recent FDA approvals across many tumor types; thus, not surprisingly, information to help nurses educate and manage patients on these therapies will be a focus of the SONO meeting that will include a session dedicated to clinical applications in the management of toxicities associated with immunotherapy.

Nurses are very good at managing chemotherapy and educating patients and families on chemotherapy and chemotherapy-related side effects,” said Wood.

“Immunotherapies represent a paradigm shift, and we have found in our clinical practice, that how patients with a given disease tolerate a therapy varies.” Wood stressed that for patients to stay on these therapies, communication with their healthcare team is crucial.

“Patients need to know what to watch for, and they need to clearly understand the importance of early and ongoing communication. That goes for the patient and the healthcare team.”

In her presentation, program co-chair Grace Cherry, RN, MSN, NP, will focus on melanoma, the setting where immunotherapies were first deployed. Cherry, an oncology nurse practitioner with the UCLA Melanoma Program, will focus on the mechanism of action with melanoma therapies, as well as melanoma staging.

“It’s an opportunity to show how melanoma is an immunogenic tumor,” Cherry said, adding that with immunotherapies being seen more and more in practice, helping nurses understand the agents’ significant clinical experience thus far in the melanoma setting can be very useful to the oncology nurse in the clinic.

Wood is also giving a presentation on best practices for communicating with patients about adhering to their treatment regimens. Although adherence to oral oncolytics garners a lot of attention, she will also stress the importance of patients adhering to their supportive therapies. She explained that if patients don’t understand the importance of following guidance on antidiarrheal regimens or steroids, for example, “they’re going to experience side effects that will interfere with their treatment, their quality of life, and their overall wellness.”

“If the healthcare provider isn’t well-versed on tracking that and questioning that, they’re going to miss an important piece of the overall management of that patient...Are patients taking the right dose, the right formulation, at the right time?”

Such careful monitoring and communication certainly applies to one of the more prevalent side effects that patients experience—chemotherapy-induced nausea and vomiting (CINV).

This will be the focus of a presentation by program co-chair Beth Eaby-Sandy, MSN, CRNP, OCN, thoracic oncology nurse practitioner at the Abramson Cancer Center at the Hospital of the University of Pennsylvania.

“CINV is probably the most rapidly changed supportive care topic in oncology in the past 2 years,” said Eaby-Sandy. “Several new drugs have been approved with new routes of administration with a longer half-life.

To learn more about the 1st Annual School of Nursing OncologyTM, view the agenda, and to register, visit 

. The meeting will be held at the Loews Vanderbilt Hotel in Nashville. Physicians’ Education Resource®, LLC is approved by the California Board of Registered Nursing, Provider #16669 for 10.25 Contact Hours. Program content is reviewed by the Oncology Nursing Certification Corporation (ONCC) and is acceptable for recertification points.

“The most important thing for oncology nurses is knowing which drugs cause what level of CINV and also, the newer treatment options and how to individually tailor antiemesis prophylaxis to each patient.”

Eaby-Sandy also will be presenting on side effect management in another growing class of cancer drugs: targeted agents for lung cancer. She plans to review both the MASCC and NCCN guidelines for managing toxicities associated with these agents, in particular, rash, along with some of the less common but concerning ones.

The SONO conference will have an interactive component, Cherry noted, adding that she is really looking forward to collaborating with other practitioners at the meeting:

“Our goal is to provide practical and meaningful information nurses can immediately deploy back home in their clinics...We hope nurses will leave here more confident in their interactions with patients and family members."

In August, Physician's Education Resource®, LLC will be sponsoring the 1st Annual School of Nursing OncologyTM (SONO) where nurses can earn 10.25 Contact Hours. 

School of Nursing Oncology to Offer Comprehensive Update on New Treatments in One Meeting

Advanced cancer exacts an overwhelming emotional toll, and a brief but novel psychological intervention involving individual therapy sessions delivered by trained therapists has been shown to alleviate patients’ distress and help them to manage the profound and practical problems that come with this diagnosis.

The intervention, known as CALM, yielded a clinically meaningful 52% reduction in depressive symptoms after 3 months among participants who had the intervention, compared with a 33% reduction in a control group receiving usual care, reported Gary Rodin, MD, the study’s lead author, presenting the findings of this randomized controlled trial during a presscast at the 2017 ASCO Annual Meeting. 

At 6 months of follow-up, the benefit was even greater, with a 65% reduction in depressive symptoms in those receiving the CALM intervention versus 35% in the control group. Additionally, CALM participants who were not depressed at baseline were less likely to become depressed at 3 months, compared with usual care controls (13% vs 30%, respectively).

 problems these patients face, which are many, including, ‘How do I manage my pain and my symptoms?,’ but also the 

 problems and issues that people face: ‘What is the meaning of my life having a terminal diagnosis?’” explained Rodin, who heads the Department of Supportive Care at the Princess Margaret Cancer Centre in Toronto, Canada where the trial was conducted.

Although these issues and challenges are predictable and known to cause a lot of distress, he said, “There hasn’t been a routine or systematic approach to help people with these problems.”

CALM is a novel psychotherapy intervention designed to fill that void. Rodin said the program was evaluated in 305 patients with advanced cancer evenly randomized to either CALM (n = 151) or usual care (n = 154). The Patient Health Questionnaire-9 was used to measure depressive symptoms.

Usual care participants received routine oncology treatment and follow-up, as well as clinic-based distress screening. About one-third of the control group received some specialized psychosocial oncology care, but less than 10% received structured or semi-structured psychotherapy.

Patients in the CALM group had 3 to 6 psychotherapy sessions delivered by trained therapists to support reflection in 4 broad domains. The first domain emphasizes symptom management and communication with healthcare providers, including treatment decisions. Second, are the changes in self-concept, which Rodin elaborated involves how patients feel about themselves, having a disease that affects every aspect of their physical being, as well how their relationships change, for example, the need to depend on others. The third domain centers on spirituality and patients’ sense of meaning and purpose in life.“That’s something we all need to think about,” Rodin noted, “but having a disease with a prognosis of 12 to 18 months heightens that dilemma.” Finally, the intervention is aimed at helping patients deal with their fears and concerns about the future.

“What we found is that we had a significant effect on the primary outcome [depressive symptoms],” Rodin reported, “and these effects were actually strengthened at 6 months. We also found that not only did CALM treat depression, it also had a preventive effect, so that participants who were not depressed at baseline were less likely to be depressed at 3 months.”

A number of additional secondary outcomes favored the study intervention, Rodin added, including:

Talking and feeling understood about the impact of cancer

Managing feelings about cancer and the future

Communicating with the healthcare team and with the family

Dealing with changes in relationships as a result of cancer

Rodin said that he and his research colleagues have found the results of the intervention to be generalizable: “We’ve now trained people in more than 20 countries—in Europe, the Middle East, Asia, and South America.” The group is now in the process of establishing a global network to train health professionals, including oncologists, doctors, nurses, psychologists, and psychiatrists to deliver CALM and evaluate its effectiveness and feasibility.

ASCO Expert Don S. Dizon, MD, FACP, said these data, “add much more importance to the concept of paying attention to patients’ symptoms beyond cancer-specific outcomes—that we can do things to improve their quality of life; patients who are facing advanced disease still need our help.”

 Rodin G, Lo C, Rydall A, et al. Managing cancer and living meaningfully (CALM): a randomized controlled trial of a psychological intervention for patients with advanced cancer

The novel psychological intervention, called CALM, has been shown to alleviate the distress of patients with advanced cancer.

Easing Depression, Distress in Patients With Advanced Cancer Through Brief Therapy Sessions

Patients receiving treatment for metastatic cancer who used a web-based tool to report their symptoms either while at home or during clinic visits lived on average 5 months longer than their counterparts who had standard symptom monitoring, according to findings of a randomized trial reported at the 2017 ASCO Annual Meeting and published simultaneously online in 

Those who used the tool also were able to stay on their chemotherapy longer, had fewer visits to the emergency department (ED), and experienced better quality of life and physical function, reported lead author Ethan M. Basch, MD, MSc, FASCO, at an ASCO press conference June 4.

“Compared to standard care, patients who self-reported symptoms experienced multiple, statistically significant, clinical benefits,” said Basch, MD, MSc, FASCO, professor of medicine at the Lineberger Comprehensive Cancer Center of the University of North Carolina, who was practicing at Memorial Sloan Kettering Cancer Center (MSK) when the study was conducted.

Providing a rationale for the study, Basch said that between visits, patients are often hesitant to call the office, until problems become severe. Even at clinic visits, with many competing topics and limited time, symptoms are often not fully communicated between patients and their doctors and nurses.

“We hypothesized that having patients report their own symptoms—using an online system with the information conveyed to their clinicians&mdash;would prompt clinicians to intervene earlier, therefore, improving symptom control and downstream outcomes.”

The trial enrolled 766 patients between September 2007 and January 2011 who were being treated with chemotherapy for metastatic solid tumors (breast, lung, genitourinary, or gynecologic) at MSK. Patients in the intervention arm reported on 12 common symptoms, including appetite loss, dyspnea, fatigue, hot flashes, nausea, and pain, and were asked to grade each on a 5-point grading scale based on the Common Terminology Criteria for Adverse Events. Each symptom could be reported either as “none,” or graded from 1 (mild) to 4 (disabling). Short descriptions were included alongside each of the choices to help patients accurately rate their symptoms.

Participants in the self-report intervention arm (n = 441) completed online questionnaires in 1 of 2 ways. They could respond at home between visits, which generated an automated e-mail alert to nurses any time a severe or worsening symptom was reported by the patient; weekly e-mails were sent to participants reminding them to complete the questionnaire. Patients also could complete the symptom survey at terminals in the waiting room before their clinic visit for immediate dispatch to their oncology team prior to the appointment.

Usual care control participants (n = 325) discussed symptoms during clinic visits and were encouraged to telephone the office between visits if any worrying symptoms arose.

Thirty-one percent of patients who self-reported their symptoms using the web tool had better quality of life and physical function compared with those receiving standard care. Basch noted that, interestingly, patients who were not especially computer-savvy experienced the greatest quality-of-life benefit with this approach. Additionally, investigators reported a 7% reduction in ED visits, and patients were able to remain on potentially life-prolonging chemotherapy for an average of 2 months longer.

Among the most notable study findings, however, according to Basch, is the 5-month increase in median overall survival (OS). Median OS for patients in the self-reporting arm was 31.2 months versus 26.0 months in the standard care cohort (P = .03), which, he said, equated to an almost 20% increase in survival time for these patients. Looking at this finding in the context of 5-year survival, he added, “At 5 years, 8% more patients were alive in the self-reporting group,” (41% vs 33%, respectively).

Basch posited 3 potential drivers to explain the success of the intervention. One obvious benefit is that the system enables better management of chemotherapy adverse effects, which allows patients to stay on their treatment longer. The system also yielded more responsive care, he said, “by alerting clinicians in real time about symptoms as they emerged, prompting them to take early action and manage problems before they became complications.”

Finally, Basch said, “By controlling symptoms better, this system kept patients more physically functional and kept them from becoming deconditioned or immobile, which we know from multiple prior studies has a strong association with better survival.”

The findings are being confirmed in a larger clinical trial being conducted in community practices across the United States, using an updated, more user-friendly online tool that works on both personal computers and mobile devices to make it even easier for patients to communicate with their care team. Basch said the focus now is on how best to integrate these tools into oncology practice and that researchers are building similar ones to enhance understanding of symptoms of patients participating in drug development trials.

ASCO expert Harold J. Burstein, MD, PhD, FASCO, remarked on the significance of the trial, which was chosen to be part of an ASCO plenary session because of its strong potential to influence and improve patient care: “If this were a drug that had a survival advantage of this magnitude, it would be retail priced at hundreds of thousands of dollars.”

“We don’t have the kind of resources typically to invest in this kind of electronic communication, nursing care, and other things that made this a reality for these investigators,” Burstein continued. “A big challenge for our clinicians is going to be: How do we implement such systems, how do we integrate them into electronic health recordkeeping we are currently using, and how do we provide the medical team power in the way of doctors, nurses, and other supportive providers to make this work?”

Still, he said, “That’s a good challenge and a good problem to have. I know that as these data have been circulated, it has been immensely gratifying to the oncology community to see that the kind of things we really believe in—patient-focused care, paying attention to their symptoms, and intervening early&mdash;is really helping these patients to consume fewer healthcare resources in terms of ER visits, feel better, and now&mdash;we have proof&mdash;helping them to live longer.”

Basch EM, Deal AM, Dueck AC, et al. Overall survival results of a randomized trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. 

Basch EM, Deal AM, Dueck AC, et al. Overall survival results of a randomized trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment [published online first June 4, 2017]. 

According to findings reported at ASCO 2017, patients receiving treatment for metastatic cancer who used a web-based tool to report their symptoms lived on average 5 months longer.

Online Tool Allows Patients to Report Symptoms in Real Time, Improving Survival

Although studies show that patients with cancer would prefer to be cared for at home at the end of life, the majority still die in the hospital, many in intensive care. Despite this fact, much of the knowledge about supporting their families is drawn from research in the outpatient and hospice setting, leaving a gap in bereavement support for these caregivers.

Knowing that parents of critically ill infants in the neonatal intensive care unit (NICU) receive a specific set of nursing-based supports, a team of nurses at UC Irvine Health in Huntington Beach, California, set out to find out whether lessons from the NICU can be applied in the inpatient oncology setting, and they developed an evidence-based protocol modeled on the NICU experience.

“The perinatal and OB world has had a protocol to follow in large centers to support parents who have lost a child,” based on a decades-long awareness that parents need nurses’ support during the time of a child’s death, noted lead author Deborah Boyle, MSN, RN, AOCNS, presenting the research at the 42nd Annual ONS Congress.

Boyle said that this support involves a number of interventions; for example, their chart is flagged and a plaque is placed outside the mother’s room acknowledging the loss, so that anyone who enters the room does so with sensitivity. In addition, nurses help to fill memory boxes to send home with the parents that include mementos from the baby, such as footprints, handprints, locks of hair, and clothing/blankets.

“The protocol they use is very prescriptive in terms of the range of interventions that should be provided to these acutely grieving parents,” Boyle explained. “Parents are asked if they want to have time alone holding the baby; do you want pictures of the baby; do you want to help us bathe the child, dress the child?” Parents will have different comfort levels for the nature of the interventions, Boyle added, but this approach offers a range of supportive options.

For years, Boyle had an interest in translating best practice from this model to the adult oncology setting. When working at a hospital in Virginia earlier in her nursing career, she joined a social worker in running a group for families entitled “Good Grief”: “We asked the families what the nurses did for them at the time of death and what they would have wanted, if they had another chance to enact this experience?” The literature lacked evidence specifically focused on the nurse’s role in the acute care setting, she noted.

Based on hospice nursing literature and her own experience as a family caregiver in a hospice situation, Boyle and colleagues developed a 13-item survey for patients’ families to find out what families wanted and to help guide a new bereavement protocol for adult oncology inpatients.

Specially trained staff nurses interviewed individuals who had a family member die at their hospital, and interviews were also conducted with non-native English speakers (Korean, Vietnamese, and Spanish). Questions were framed around whether a nursing intervention was employed, and if not, would the families have wanted it, for example:

Did the nursing staff offer you physical support (eg, hold your hand, embrace and sit with you)?

Did the nurses ask if you wanted them in the room with you and your loved one or whether you wanted privacy?

Did they encourage you to spend time with your loved one and say goodbye before they died?

Did they explain to you what was happening during the dying process to help you understand what you were seeing?

Did they respect your wishes and needs (eg, cultural and religious beliefs)?

Did they voice concern over your wellbeing, such as encouraging you to take care of yourself?

Did they offer you a chance to sit alone with, and care for, your loved one after they died, (ie, help the nurses care for your loved one’s body)?

Did they send you a card to let you know they were thinking of you? 

Nurses who had contact with patients at the end of life received the same survey. Boyle reported that a comparison of the results revealed “a discrepancy between what the families desired and what interventions the nurses considered helpful.”

“The nurses underestimated the importance of having us offer to pray with them, to ask them if they wanted to help with the final care of their loved one’s body, and they underestimated the importance of sending a sympathy card.”

Acute Family Bereavement Support Protocol

These findings set the stage for the team’s Acute Family Bereavement Support Protocol for acute care nurses at the bedside, including:

Offering families a menu of support options (eg, desire for privacy, helping with the final nursing care after the loved one dies)

A script to help the nurse share advice with family members about how to say goodbye

Creating a memory keepsake, including, for example, taking a photograph of the patient’s hands

Performing a post-death “honoring ceremony” (including essential oils)

Helping to gather the patient’s belongings and escorting the family out of the hospital

Establishing a process for signing and sending a sympathy card 1 month later 

The timing for implementing the interventions was at the discretion of the nurse, depending on the patient’s status; social work and spiritual services also were consulted. Relatively simple steps, Boyle said, like protecting privacy by keeping the door shut, ensuring enough chairs are in the room, and providing a parking pass the day the patient died, also were part of the intervention.

“There are many, many options for supporting families,” Boyle stressed.

Study authors reported in their abstract that the project is in the pilot phase of implementation. The research team plans to call 20 family members for their evaluation of the intervention, but that, “preliminary results have been overwhelmingly positive.”

What kind of nursing interventions do grieving families want in the acute care setting? Answers may be found in the neonatal intensive care unit.

Lessons From the NICU: Nursing Support for Cancer Caregivers in the Hospital

Evidence continues to mount on the benefits of a healthier lifestyle for cancer survivors, and findings of a new prospective study suggest that one such intervention—eating tree nuts like almonds, walnuts, and pecans&mdash;can improve overall survival and reduce the risk of recurrence in patients with colon cancer.

Researchers performed a prospective observational study of a subset of 826 patients participating in the randomized CALGB 89803 trial examining adjuvant combination chemotherapy in patients with stage III colon cancer. Among the 19% of patients in the subset who reported consuming 2 or more ounces of nuts per week, risk of disease recurrence was 42% lower and the risk of death was 57% lower.

“We observed that nut intake was associated with significant improvement in disease-free survival and overall survival in this patient population of stage III colon cancer patients,” said Temidayo Fadelu, MD, presenting the findings during a presscast May 17 in advance of the 2017 ASCO Annual Meeting. “This study adds to the evidence that dietary and lifestyle modification can, in fact, yield protective benefits in colon cancer survivors.”

Fadelu did note, however, that a secondary analysis found that this association was only limited to tree nuts and not observed with consumption of peanuts or peanut butter. He hypothesized that this is due to the fact that peanuts are technically legumes with a different biochemical composition than the other tree nuts.

Fadelu, a clinical fellow in medicine at Dana Farber Cancer Institute, explained that nut intake was chosen for examination in this observational study, not only because of their known association with lower cardiovascular mortality, but also their link to a lower incidence of obesity, type 2 diabetes, metabolic syndrome, insulin resistance—conditions that are associated with a higher risk of recurrence and death from colon cancer.

Participants in this study filled out a food frequency questionnaire 6 months after completing chemotherapy for their colon cancer. They were asked about dietary intake and, specifically, their consumption and frequency of eating tree nuts (almonds, walnuts, hazelnuts, cashews, and pecans), peanuts, and peanut butter.

The study’s primary endpoint was disease-free survival from the time the participants completed the questionnaire to disease recurrence. The overall CALGB clinical trial began in 1999, and the median follow-up for this part of the study was 7 years.

Fadelu reported that the benefits of tree nuts held even after adjusting for several factors associated with colon cancer recurrence, such as patients' total calorie intake, age, sex, number of lymph nodes, baseline performance status, BMI, physical activity, aspirin use, and glycemic load.

“The odds of surviving colon cancer, if it is not metastatic, are quite high,” said ASCO President Daniel F. Hayes, MD, FACP, FASCO, commenting on the study’s findings during the presscast. “Healthy people live healthier. I know that sounds pretty self-evident, but one cannot assume, ‘I have colon cancer, it doesn’t matter anymore.’”

Rather, he stressed, colon cancer survivors—after receiving standard of care treatment for their disease&mdash;can benefit from healthier living, “and it might even increase the chances of [their] colon cancer not coming back, as well as the other benefits that come with a healthy lifestyle.”

Hayes also noted that because these findings are from a prospective rather than retrospective study, it enhances their significance. That, he said, “takes a lot of the biases out of the classic retrospective observational trials where patients are asked, ‘Do you remember what you did several years ago?’ This was in real time, so it makes these findings even more compelling.”

Fadelu said that researchers want to explore the potential positive impact of nut consumption on other stages of colon cancer, especially stage IV, and that a randomized, controlled, clinical trial is needed to better understand nuts’ protective effect in this population.

Fadelu T, Niedzwiecki D, Zhang S, et al. Nut consumption and survival in stage III colon cancer patients: Results from CALGB 89803 (Alliance). 

Eating tree nuts may improve overall survival and reduce the risk of recurrence in patients with colon cancer. 

Eating Nuts May Reduce Recurrence Risk in Colon Cancer Survivors

Interest in complementary approaches to manage cancer-related symptoms continues to grow among oncology practitioners and their patients. With this in mind, a group of nurses at Froedtert Hospital in Milwaukee designed a project to see how one approach, aromatherapy, might be effectively used for symptom relief in patients in the hospital’s hematology/oncology department who are undergoing blood and marrow transplant.

Essential oils are low cost and have minimal side effects. The aim of this initial project, begun in August 2016, was to incorporate them into the repertoire of options available to help patients at Froedtert manage treatment-related side effects. “Right now, we’re just documenting age, gender, what oils the patients used, and what symptom they used them for…Our hope is to develop a nursing research study in the future,” the nurses explained during a poster presentation at the 2017 ONS Congress.

After conducting an extensive literature review, and based on guidance from Froedthert’s Clinical Cancer Center’s Wellness Store, 5 essential oils were chosen for the intervention. Each was explained in a short handout, “Patient’s Guide to Aromatherapy and Essential Oils,” that was included in patients’ admission folders:

Lavender: trouble sleeping, anxiety, pain

Peppermint: nausea, vomiting, heartburn or reflux, fatigue

The patient handout also included general information on aromatherapy and essential oils and how to use them safely and for the optimum effect.

Staff education was another part of the intervention, and the nurses stressed that the oils are strictly for inhalation: “We don’t recommend ingesting or applying to the skin. We typically put a few drops on a piece of gauze in a medicine cup at the bedside; if patients want to tape it to their gown, they can do that as well.”

Aromatherapy was chosen for this intervention, they noted, because it is becoming increasingly popular and patients are bringing the oils in anyway. “They were bringing in diffusers which we know isn’t necessarily good,” the nurses remarked, because these diffusers can be routes for bacteria and infection.

“The most popular oils are lavender and peppermint, and mostly patients use these for calm and relaxation, and some nausea,” the nurses noted in their presentation. “If patients are really nauseous [for example]—and we’ve thrown everything at them but the kitchen sink&mdash;we say, ‘Why don’t you try ginger?’”

Thus far, they have found the aromatherapy was used equally by men and women in the unit, and the symptom patients sought to relieve most was nausea.

Overall, the authors note in their study abstract, “The use of essential oils has been well received by patients and staff.” They noted that since the project began, other nursing areas throughout the health system have expressed interest in using them in their practice, and this project can be used as a framework to other units.

A group of nurses at Froedtert Hospital developed a study to evaluate the use of aromatherapy to relieve symptoms in patients undergoing blood and marrow transplant. 

The Nose Knows: Using Aromatherapy to Relieve Symptoms in Patients Undergoing BMT

The FDA has approved co-packaging of the oral medications ribociclib (Kisqali) and letrozole (Femara) that are used to treat HR-positive, HER2-negative advanced breast cancer in postmenopausal women.

With the new Kisqali® Femara® Co-Pack, patients can obtain a full 28-day cycle of the 2 medicines in 1 package with 1 prescription and 1 copay, and the cost will be the same as that for Kisqali alone, according to Novartis, which manufactures both medications.

“Providing physicians a convenient one-package prescribing option for their patients underscores our commitment to deliver innovative treatment solutions to the metastatic breast cancer community,” said Bill Hinshaw, executive vice president and US head of Novartis Oncology, in a statement announcing the approval.

The company noted that ribociclib, which helps to slow cancer progression by inhibiting the cyclin-dependent kinase 4 and 6 (CDK 4/6) proteins, can continue to be prescribed separately along with another aromatase inhibitor (AI).

 was approved by the FDA March 13 for use in combination with an AI for this population of women, based on findings for the phase III MONALEESA-2 trial. In that study, the combination reduced the risk of progression or death by 44% compared with letrozole alone in the first-line setting for HR+/HER2- advanced breast cancer (HR, 0.556; 95% CI, 0.43-0.72; 

 Additionally, 53% of patients with measurable disease who received the ribociclib-letrozole combination experienced a reduction in tumor burden of at least 30%.

“This is a significant result for women with this serious form of breast cancer," according to MONALEESA-2 principal investigator Gabriel N. Hortobagyi, MD, professor of medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center.

In the trial, ribociclib did add to treatment-associated toxicity, as 59.3% of patients who received the CDK 4/6 inhibitor developed grade 3/4 neutropenia, as compared with 0.9% of patients who received placebo. Grade 3/4 leukopenia occurred in 21% of the ribociclib arm and 0.6% of the placebo group. Hematologic adverse events were uncomplicated and resolved without incident in most cases.

The most common nonhematologic adverse events (all grades) were nausea (51.5% with ribociclib vs 28.5% with placebo), infections (50.3% vs 42.4%), fatigue (36.5% vs 30.0%), and diarrhea (35% vs 22.1%). The events were grade 1/2 severity in most cases.

MONALEESA-2 represents a paradigm shift for the management of HR+/HER2- advanced breast cancer, because at some point, all breast cancers will become resistant to endocrine therapy alone.

The CDK 4/6 inhibitor also proved effective in a subgroup of patients in this trial of women aged ≥65 years. The novel regimen was well tolerated among a MONALEESA-2 elderly subgroup, with a safety profile similar to that of the overall study population. Despite a higher rate of patients with an ECOG performance status of 1, the elderly population also had dose interruption and reduction rates consistent with the overall trial results, reported Lowell L. Hart, MD, of Florida Cancer Specialists, at the 2017 Miami Breast Cancer Conference.

The new co-pack is available in 3 ribociclib dosages (600 mg, 400 mg, or 200 mg), and each co-pack will also contain letrozole at the 2.5 mg dose. Novartis announced that the co-pack will be available domestically later this month at both specialty and retail pharmacies, and does not change the indication for either medicine.

The FDA has approved the co-packaging of oral medication ribociclib and letrozole, used to treat HR-positive, HER2-negative advanced breast cancer in postmenopausal women.

FDA Approves Co-Packaging of Ribociclib With Letrozole to Treat MBC

Oral mucositis is one of the most debilitating side effects of many anticancer therapies, and positive results from the use of low level laser therapy (LLLT) inspired a team of nurses at UPMC Shadyside in Pittsburgh to develop an intervention to help a group of colleagues not only learn how to deploy the laser treatment, but also to better assess mucositis and educate patients on the importance of oral hygiene and other prophylaxis.

Erin Bartell BSN, CCRN, BMTCN, who practices in the stem cell transplant unit at UPMC Shadyside, reported the project’s findings in a podium presentation at the 42nd ONS Annual Congress.

After seeing evidence of how LLLT—which was being used routinely in the hospital’s radiation oncology department&mdash;improved quality of life for patients with head and neck cancer, physicians sought to have the treatment available for inpatients. However, the machines are expensive and practitioners need training to use them.

Bartell explained that their project was made possible because a beloved former staff member and oncology patient at the hospital, Barbara King, who was passionate about alleviating the pain of oral mucositis (OM) for patients like herself, secured a grant for the purchase of 2 additional LLLT machines.

Patients who have OM may have to suspend or delay treatment, need opioid analgesia, and require enteral/parenteral nutrition. If left untreated, OM ulcerations can lead to life-threatening infections in patients who immunocompromised, such as those undergoing hematopoietic stem cell transplant; it was a group of these inpatients at UPMC Shadyside, being treated with Busulfan, who received the patient education and the LLLT for this study.

For the intervention, 11 “super users” were selected to be trained on LLLT so they could treat patients at the bedside. In addition to training on its use from THOR, the device manufacturer, these nurses also received education to improve their OM assessment and patient education skills.

Patient Education to Prevent Oral Mucositis

“Because most of our nursing staff has about 2 years or less experience, it was really important for them to understand the risk factors for oral mucositis,” Bartell noted. Additionally, “they don’t necessarily understand the severe impact oral mucositis can have on a patient’s life, so we wanted them to understand that [this adverse event] can modify, delay, or even suspend treatment.”

Nurses received education on the chemotherapy doses and regimens, such as Busulfan, posing the highest risk for the OM, along with patient factors to look out for, such as poor oral hygiene. Thus, patients were encouraged to practice proper oral care, with nurses assisting them on oral hygiene techniques as needed. Patient education also emphasized that patients avoid irritants like alcohol, including high-alcohol mouthwash, and tobacco; other patient counseling points recommend use of sodium bicarbonate—based toothpaste, a soft toothbrush, a normal saline swish, and to stay hydrated. Biotene is also available at their hospital for patients experiencing dry mouth.

Importantly, the nurses also instructed patients to report any changes in their oral health, particularly pain, Bartell said.

“A lot of patients are a little embarrassed about talking about this,” Bartell said. “It’s really important for nurses to educate patients and really get [the patients] motivated about doing their own oral care—3 times a day after every meal and before bed.”

To provide an objective way for the nurses to document their data, the researchers added an e-record treatment form that pops up as part of the e-charting, Bartell said, where nurses could easily enter information on the appearance of the oral cavity, location of any ulceration or abnormalities using the NCI-CTCAE Grading Scale, results of a pain assessment, their patient education, and the treatment given.

How Low Level Laser Therapy Works to Treat Oral Mucositis

Bartell said that the THOR LLLT system is actually very simple to use, involving both an extraoral and intraoral probe. When it’s the patient’s first encounter with the device, the nurses provided extensive education: “We really wanted them to understand why they were receiving the treatment and if they had any questions,” said Bartell.

After the patient is in a comfortable position, and aided by flashlights that are available in every room of patients on the study, the nurse conducts a thorough oral and pain assessment. Nurses and patients wear protective goggles for the procedure.

The extraoral probe is positioned close to the cheek but without touching it to target the buccal area. After both cheeks are done, the nurse then holds the probe in front of the patient’s mouth with their tongue out to target the bilateral sides of the tongue and behind the lips, which, Bartell noted, is a common location for mucositis. The intraoral probe is then angled toward the soft palate. “If the patient develops ulcerations during the hospital stay, we then target those areas specifically with the intraoral probe.”

Lauren M. Green