Transformative solutions in nursing are ones that are sustainable, according to Linda Laskowski-Jones, MS, APRN, ACNS-BC, CEN, NEA-BC, FAAN. To come up with a transformative solution, leaders need to engage their employees and see how new strategies affect their working environment.

“Transformation oftentimes [is a] term bantered about and used freely in healthcare institutions today across the board but without understanding what it means, what it looks like, and how much time it takes—because it's not a short walk,” Laskowski-Jones said. She added, “as an oncology nurse, I think you can advocate best through helping to enable others to grow and when you do that you grow yourself and you also learn to take risks in your profession.”

®, Laskowski-Jones, who is editor-in-chief of 

 and president of the Delaware Emergency Nurses Association, and who has spent nearly 4 decades working in trauma and emergency nursing, as well as served as a manager, director and vice president in her hospital’s trauma and emergency departments, discussed how meeting problems with transformative solutions can help improve the working conditions of nurses across a unit.

Understanding the problem: Nursing Shortages

In her presentation, Laskowski-Jones highlighted that, although there are 4.3 million nurses in the US, because of new roles, more jobs, retirements, better staffing ratios, and RN’s leaving the profession, 11 million more nurses are needed to avoid shortages. Moreover, RN employment is projected to be the occupation requiring the most growth through 2026.

The effect of the COVID-19 pandemic on the nursing landscape paired with outside pressures as well as internal elements such as workloads, expectations, and patient factors, have left the field needing transformative solutions to address the causes of turnover along with burnout. Based on geography and specialty, the average turnover of nursing staff ranges from 8.8% to 37% and the American Nurses Association declared the nursing shortage a national crisis on September 1, 2021, to the Department of Health and Human Services.

In speaking about the nursing shortage, Laskowski-Jones noted that the “great resignation” had already begun in 2019, before the COVID-19 pandemic. “In 2019 there was this uptake of resignations across the board in all professions—not just in healthcare…. hospitals were starting to ratchet down on staffing. They were trying to cut corners and reduce resource utilization, [even though] we had organizations saying: we expect high patient experience scores.”

Laskowski-Jones noted that hospitals were being held to higher standards as the patient experience scores are publicly reported and with that came pressure. Additionally, an increase of violence in health care, and lawsuits piled on.

Of course, in 2020, the pandemic compounded these issues, and by 2021, many nurses were burnt out.

“In 2020, we had the pandemic, and everybody was engaged because nurses rise to the challenges, we always rise to the challenges, they’re all in; they’re being battered with what they’re dealing with between the personal protective equipment needs, the complex patients, potentially being pulled to a unit where they never worked before, having to learn new skills, and dealing with devastating situations in many cases,” Laskowski-Jones said.

“[However,] 2021 was a different story,” she said. “Even with vaccines, the pandemic had not ended. The biggest thing was that there was this latent demand in the community for services [because some patient’s] cancer wasn't diagnosed or their heart disease wasn't diagnosed and now they were all coming in where they had been too afraid to even use the hospital [before].” 

With a large increase in patients coming to hospitals, nurses were working in environments that were at overcapacity and nurses “did not feel that they were being supported, they were valued, and they were starting to see shortages that weren't necessarily being addressed.”

While issues were still active, travel nurses had a large positive affect in care, but this impacted the dynamic in the hospital as travel nurses receive high contract pay which may have led some nurses who had been at institutions for a long time to feel undervalued and leave.

In her presentation, Laskowski-Jones noted that creating a healthy workplace environment is a crucial solution in beginning to rebuild the nursing field. The root causes for burnout, turnover and unhappiness must be addressed, and nurses should not be expected to be able to handle everything with a lack of support; psychological safety must be developed. Key points under that umbrella include developing non-defensive listening skills, promoting a clear vision with team alignment, innovation, respectful communication, and generating a culture across the organization of effective teamwork.

Transformative is a broad term, but it essentially refers to solutions that are sustainable, according to Laskowski-Jones. She highlighted some examples of unsustainable solutions vs sustainable ones.

“Transformation means going from this vision of what you think should be to sustainably getting there.” Laskowski-Jones gave the example, “let’s say there is a directive that when the patient comes in staff have only a specified amount of time to get a certain type of work done (eg, their admission process, or their discharge process, etc.).

In this hypothetical example, Laskowski-Jones said, someone looked at data and determined that all patients should be discharged in 6 hours. All nurses are trying to get patients discharged within a 6-hour time-frame. However, if they are struggling to do it, are exhausted, and are consequently cutting corners, that would be an unsustainable goal as currently performed.

Sustainable solutions should make work easier and more effective, Laskowski-Jones noted. This means that when new strategies are implemented, leaders should be asking employees how they feel about the change, and whether it is making things better.

Laskowski-Jones’s presentation emphasized the importance of creating a healthy work culture and assessing one’s own style and reputation to encourage positive change in the environment. Emotional intelligence is key in the workplace and establishing trust to build relationships with coworkers and teams is crucial while being mindful of short- and long-term goals that are set.

When discussing issues in the workplace, Laskowski-Jones said that she encourages nurses to come-up with solutions to the problems that they pose to her.

“If you bring me a problem,” she said, “and I don’t care what it is, you need to bring me your idea of what the solution is... If we make this change that you recommend, how is that going to affect other people?”

Lastly, Laskowski-Jones emphasized that leadership must value their staff.

“You have to show empathy,” she said. “Value is not just giving somebody a little gift… or some sort of recognition day, value is being able to have a conversation where you witnessed someone having a difficult day or a challenging patient,” she said. “It’s when a manager says ‘I was impressed with how you handled that.’ Or that must have been difficult for you, do you want to talk about it? I am here to listen, I’ve been there, and I know how hard this is.” 

Laskowski-Jones L. Finding your voice: how nurses can create a healthy work culture to enhance a thriving work environment. Presented at: ONS Bridge; September 13-15, 2022; virtual.

Articles

Linda Laskowski-Jones, MS, APRN, ACNS-BC, CEN, NEA-BC, FAAN, discusses how oncology nurse leaders can help improve working environments for their staff. 

Nurse Leaders Must Foster Change to Develop a Healthy Workplace Environment

Mirvetuximab soravtansine may induce fewer abdominal or gastrointestinal (GI) symptoms in patients with folate receptor alpha (FRα)–positive, advanced ovarian cancer, compared with chemotherapy, according to an analysis of patient-reported outcomes (PROs) from the phase 3 FORWARD-1 trial (NCT02631876) presented at the 2022 ESMO Congress.

Findings showed that among PRO-evaluable patients in the intent-to-treat (ITT) population who received mirvetuximab soravtansine (n = 142), 31.7% reported an improvement of at least 15% in OV28 abdominal/GI symptom score at week 8/9, compared with 14.0% of patients in the chemotherapy arm (n = 50; 

Additionally, among patients with FRα-high disease, 27.3% of those treated with mirvetuximab soravtansine (n = 88) experienced a symptom score improvement of at least 15%, compared with 13.3% of those treated with chemotherapy (n = 30; 

“Improved PROs were observed with mirvetuximab soravtansine treatment compared with IC chemo across multiple symptoms, including chemotherapy [adverse] effects [AEs], sexuality, hair loss, pain severity, body image, and general improvement in ovarian cancer–specific symptoms on the Functional Assessment of Cancer Therapy-Ovarian Symptom Index [FOSI],” lead study author Kathleen N. Moore, MD, MS, the associate director of Clinical Research at Stephenson Cancer Center of the College of Medicine at the University of Oklahoma, and colleagues, wrote in a poster presentation of the data.

Mirvetuximab soravtansine, a first-in-class antibody-drug conjugate consisting of a FRα-binding antibody, cleavable linker, and maytansinoid DM4 payload; previously demonstrated clinically meaningful antitumor activity with a favorable safety profile as monotherapy and in combination for patients with FRα-positive ovarian cancer.

Preplanned and exploratory analyses of PRO data collected during the FORWARD-1 trial were used to determine differences between treatment with mirvetuximab soravtansine and chemotherapy, and to inform collection of PRO data from subsequent trials evaluating mirvetuximab soravtansine.

The open-label, randomized FORWARD-1 trial evaluated mirvetuximab soravtansine vs chemotherapy investigator’s choice of chemotherapy in patients with platinum-resistant, FRα-positive advanced epithelial ovarian cancer (n = 366).

Enrolled patients were randomly assigned to 6 mg/kg of mirvetuximab soravtansine once every 3 weeks (n = 248) or investigator’s choice of chemotherapy (n = 118).

PRO assessments were completed during screening, on day 1 of cycle 1, and every 9 weeks thereafter until disease progression and at the end-of-treatment visit. The OV28 abdominal/GI symptom score assessment consisted of a 28-item ovarian cancer supplemental module developed to augment the EORTC QLQ-C30 questionnaire, which was also given.

The primary objective of the PRO analysis was minimally important difference response in abdominal/GI symptoms at week 8/9 per the OV28 abdominal/GI symptom subscale score. An increase of at least 15 points was defined as improved, and an increase of less than 15 points was not improved. Time to symptom worsening served as a secondary objective.

Among all enrolled patients, the median age in the mirvetuximab soravtansine arm and chemotherapy arm was 64 years (range, 34-89) and 64 years (range, 31-86), respectively. Most patients in both arms had epithelial ovarian cancer (83.5% and 89% in the experimental and control arms, respectively), had an ECOG performance status of 0 (56.9% and 50.8%), received 1 or 2 prior lines of therapy (64.1% and 62.7%), and had high FRα expression (59.3% and 60.2%).

Exposure to prior treatment included platinum in 100% of patients in both arms, paclitaxel in 96.0% and 95.8% of patients bevacizumab (Avastin) in 48.8% and 46.6% of patients, and PARP inhibitors in 17.7% and 16.1% of patients in the mirvetuximab soravtansine arm and chemotherapy arm, respectively.

Additional data showed that in the ITT population, the median time to symptom worsening was 3.5 months for the mirvetuximab soravtansine arm compared with 3.0 months for the chemotherapy arm (

 = .6850). Additionally, among the FRα-high population, the median time to symptom worsening was 4.0 months and 2.1 months in the mirvetuximab soravtansine and chemotherapy groups, respectively (

Compared with the chemotherapy arms, patients treated with mirvetuximab soravtansine in the ITT population had a 70% lower likelihood of deterioration of abdominal/GI symptoms (95% CI, 0.15-0.60; 

 = .0007). Those in the FRα-high subgroup treated with mirvetuximab soravtansine had an 80% lower chance of deterioration of abdominal/GI symptoms (95% CI, 0.10-0.54; 

 = .0007). Study authors noted that similar results for the likelihood of symptom deterioration with mirvetuximab soravtansine were observed on other OV28 subscales, including chemotherapy AEs, sexuality, hair loss, pain severity, and body image.

An analysis of PROs from the EORTC QLQ-C30 questionnaire also showed that mirvetuximab soravtansine demonstrated a statistically benefit in physical functioning vs chemotherapy in both the ITT and FRα-high populations. In the ITT population, the least squares (LS) mean overall change of mirvetuximab soravtansine from chemotherapy was 4.10 (standard error [SE], 1.96; 95% CI, 0.25-7.96; 

 = .0369). In the FRα-high population, the LS mean overall change of mirvetuximab soravtansine from chemotherapy was 6.03 (SE, 2.33; 95% CI, 1.42-10.63; 

An analysis of FOSI scores found that by cycle 7, 88.9% of patients in the ITT population in the chemotherapy arm declined, compared with 70.3% in the mirvetuximab soravtansine arm. Those rates were 88.1% for the chemotherapy arm and 65% for the mirvetuximab soravtansine arm in the FRα-high population.

Additionally, FOSI scores showed that the median time to symptom worsening was 2.9 months and 2.1 months for the mirvetuximab soravtansine and chemotherapy groups, respectively, in the ITT population (

 = .5423). Among those in the FRα-high subgroup, those treated with mirvetuximab soravtansine achieved a median time to symptom worsening of 3.5 months compared with 2.0 months for those given chemotherapy, per FOSI scores (

“These positive PRO findings, in conjunction with the safety profile of mirvetuximab soravtansine in recurrent ovarian cancer [and] along with significant antitumor activity, support mirvetuximab soravtansine as a potential new standard of care for patients with FRα-positive ovarian cancer,” study authors concluded.

Moore KN, Oza AM, Colombo N, et al. Analyses of patient-reported outcomes (PROs) with mirvetuximab soravtansine (MIRV) versus standard chemotherapy in the randomized phase III FORWARD I study in ovarian cancer (GOG 3011). 

. 2022;33(suppl 7):S790-S791. doi:10.1016/j.annonc.2022.07.660

An analysis of patient-reported outcomes showed that patients with advanced ovarian cancer experienced fewer abdominal or gastrointestinal toxicities with mirvetuximab soravtansine than with chemotherapy. 

Mirvetuximab Soravtansine Associated with Fewer GI Toxicities Than Chemotherapy in Advanced Ovarian Cancer

Over the past few decades, the number of advanced practice providers (APPs) in oncology has increased dramatically and the role they play expanded greatly. One reason for this is that there are more patients who need oncologists in the US than there are physicians practicing the specialty. According to the American Society of Clinical Oncology, the nation will see a shortage of more than 2200 oncologists by 2025 and an increase of 40% in demand for cancer treatment during the next 6 years.

 This growth in demand is driven not only by new patients, but by those who have completed active treatment and require follow-up care. Thanks to advanced therapies, better outcomes are being achieved and survival rates are improving. Cancer survivors—even with complex comorbidities—are living longer than ever before.

Survivorship care can readily be performed by APPs, given their wide breadth of expertise and training. A closer look at how these highly skilled professionals deliver survivorship care will provide some insight into why they areideally suited to lead these programs, meeting a critical need that will only grow in the future.

In many practices, APPs are the backbone of survivorship programs, playing a key role in their planning and execution. They are well suited to lead these programs because of their extensive education, training, and scope of practice.

They also develop strong relationships with patients and caregivers during active treatment. As trusted members of the care team, it makes sense for them to discuss the key elements of survivorship with patients, some of which—like lifestyle changes and advance care planning—can be difficult to talk about.

Many patients are under the misconception that survivorship doesn’t begin until they have finished active treatment. According to the National Cancer Institute, however, a patient is considered to be a survivor from the time of diagnosis until the end of life.

APPs can help patients understand that survivorship encompasses everything from diagnosis onward—be they undergoing treatment, in remission, or facing recurrence.

A Critical Role at All Stages of Survivorship

APPs make valuable contributions at all stages of the survivorship journey.

They manage patients during active treatment, helping them keep side effects under control so that they can adhere to treatment. They educate patients about what to look for so that side effects can be caught early and dealt with more easily. They support the psychological well-being of patients by addressing their expectations and fears. They talk with patients early on about the emotional impact of the diagnosis, teach them stress-coping skills, and refer them to mental health professionals if and when necessary.

Once active treatment ends, the focus shifts to long-term surveillance. Patients may not be cured but they may be in remission, so ongoing follow-up care is critical, from a clinical and psychological standpoint.

By this stage, a long-term care plan has been developed that spells out exactly what treatment has been given and what follow-up care is needed and when. It details intervals between office visits and the imaging, lab tests, and other surveillance that may be needed. It also includes information that helps patients and their care team recognize signs of recurrence, the emergence of a secondary cancer, and potential long-term side effects like cardiotoxicity.

The transition away from active treatment is always stressful for patients because they must adjust to many changes, including less frequent office visits, which may make them feel as if they lack support. APPs play an important role at this stage, as by now they have a good relationship with patients and their caregivers. They can thus communicate effectively about such sensitive topics as patient emotions, lifestyle changes, and advance care planning. APPs are able to recognize signs of distress during this transition and provide appropriate assistance, whether that be by getting patients into support groups, referring them to mental health professionals, or prescribing medication.

Once active treatment concludes, patients may transition to receiving most of their care from a primary care physician. A detailed survivorship plan makes the PCP intimately familiar with a patient’s condition and needs. And APPs are always available to offer advice about mutual patients.

There is always a concern that the patient may not adhere to a survivorship plan. Because they interact less frequently with the oncology care team, they may lose motivation. APPs must make sure patients understand not only the plan but the need for them to become more responsible for their own health.

This is also a time when APPs are very vigilant about checking for anxiety and depression so that they can catch the conditions before they get out of control. Primary care providers can also be brought into the discussion and intervene if need be.

A survivorship plan is key to providing high-quality, patient-centered care. It must be developed early on to ensure the best patient experience and quality of life. APPs are ideally situated to manage or lead cancer survivorship because of the close relationship they establish with patients and their caregivers. Practices also benefit from such work because it allows physicians to focus on other priorities. Integrating APPs into survivorship care is a trend that will only grow in the future owing to the tremendous benefits it offers to the practice and its patients.

Finnegan J. Another physician shortage: oncologists.Fierce Healthcare

https://www.fiercehealthcare.com/practices/another-physician-shortage-oncologists

Survivor. NCI Dictionary of Cancer Terms. National Cancer Institute. Accessed July 13, 2022. 

https://www.cancer.gov/publications/dictionaries/cancer-terms/def/survivor

Advanced practice providers are the future of survivorship care because of the tremendous value they offer to the practice and its patients. 

Advanced Practice Providers Are Uniquely Suited for Survivorship Care

Dual inhibition with letrozole (Femara) and abemaciclib (Verzenio) exhibited promising activity in recurrent patients with estrogen receptor (ER)-positive endometroid endometrial cancer, according to findings from a phase 2 study (NCT03675893) published in the 

At a median follow-up of 12.5 months, the predetermined criteria for both overall responses and progression-free survival (PFS) had been met. Among 30 enrolled patients, there were 9 total responses, for an objective response rate (ORR) of 30% (99% CI, 14.7%-49.4%). The median duration of response (DOR) was 7.4 months (95% CI, 3-nonevaluable [NE]). Thirteen patients (43.3%) had stable disease (SD), with 5 having SD of 6 months or longer.

The median PFS was 9.1 months (95% CI, 3.5-16.5) with a 6-month PFS rate of 55.6% (95% CI, 35.1%-72.0%). The median overall survival (OS) was 21.6 months (95% CI, 10.6-NE).

Among responders there were 8 confirmed partial responses and 1 unconfirmed; for the patients with the unconfirmed response measurable lesions had tumor shrinkage of –31% prior to withdraw of consent.

All patients who achieved responses had endometrioid tumors. In addition, 4 patients who responded had received prior hormonal therapy and 5 patients who achieved responses had not received prior hormonal therapy.

“A clinically important finding of our study was that activity of letrozole/abemaciclib was demonstrated in patients who had previously received hormonal therapy including prior AI [aromatase inhibitor], tamoxifen, and progestin monotherapy as well as patients who had previously received letrozole/everolimus and megestrol/tamoxifen combinations,” wrote Panagiotis A. Konstantinopoulos, MD, PhD, director of Translational research in Gynecologic Oncology at Dana-Farber Cancer Institute and associate professor of medicine at Harvard Medical School.

“These responses suggest that letrozole/abemaciclib may not be cross-resistant with other hormonal approaches and may represent a viable salvage endocrine therapy regimen for patients with ER-positive endometrioid endometrial cancer.”

Endometrioid is the most common endometrial cancer histology. This tumor type accounts for nearly 80% of endometrial cancer cases. Moreover, the disease is understood to be driven by hormones, specifically though estrogen signaling.

Following progression with chemotherapy and immunotherapy, standard of care dictates that many patients with ER-positive endometrioid endometrial cancer will receive hormonal/endocrine therapy. In some cases, patients will receive hormonal therapy upfront as it may be less toxic and therefore preferable for those with minimally symptomatic disease.

Unfortunately, investigators have noted that endocrine therapy is usually associated with modest responses, which are brief in duration. Only a small portion of patients achieve extended benefit with this treatment. Therefore, novel treatments designed for this patient population represent an unmet need in the space, according to study authors.

Investigators hypothesized that a combination regimen of the AI letrozole and the CDK4/6 inhibitor abemaciclib would induce promising responses in this population because the extensive crosstalk between estrogen receptor, PI3K and RTK/RAS/ CTNNB1 pathway is associated with the upregulation of cyclin D1. These clinical pathways are present in ER-positive endometrial cancers, and an upregulation of cyclin D1 is involved with CDK4/6 and represents a key mediator of hormonal therapy resistance.

To that end, a single-arm, 2-stage, phase 2 study was designed to see whether the CDK4/6 inhibitor, abemaciclib, could be effective in combination with letrozole. The primary objective was to determine clinical activity via ORR and the rate of patients who achieved a PFS of 6 months or greater. Secondary end points included PFS, OS, DOR, and safety.

Eligible participants needed pathologically confirmed endometrial cancer that was recurrent, metastatic, or resistance to standard therapies. All patients with endometrial cancer were permitted in the first stage of the study; however, to be eligible for the second stage, patients also needed histologically confirmed endometrioid endometrial cancer or endometrial carcinoma with an endometroid epithelial component. All enrolled patients had ER-disease (≥ 1% of tumor cell nuclei being immunoreactive by immunohistochemistry). There was no limit or prior therapies; previous hormonal therapy, including prior letrozole therapy, was permitted. The exclusion criteria included prior CDK4/6 treatment, active brain metastases, and concomitant therapy with moderate or strong CYP3A4 inducers, or strong inhibitors of CYP3A4.

A total of 30 patients were enrolled between September 18, 2019, and August 30, 2021; 28 of whom had endometrioid histology and 29 had received at least 1 prior line of chemotherapy. Participants received the recommended phase 2 dose of abemaciclib, 150 mg twice daily, and letrozole, 2.5 mg once daily—both agents were taken by mouth.

In regard to safety, the most common grade 3 or 4 treatment-related adverse events (TRAEs) were neutropenia, which occurred in 20% of patients (n = 6), and anemia, which occurred in 17% of patients (n = 5). No grade 5 toxicities TRAEs were reported.

Other notable TREAs included diarrhea, which is associated with abemaciclib and was experienced by 70% of patients (n = 21), as well as increases in creatinine, which was observed in 33% of patients (n = 10) and all instances were grade 1 or 2.

Moreover, 53% of patients (n = 16) required at least 1 abemaciclib dose reduction mostly related to diarrhea (n = 7) and fatigue (n = 6). Two patients required treatment discontinuation because of toxicities.

“Letrozole/abemaciclib met the prespecified criteria to be considered worthy of further investigation in patients with recurrent ER-positive endometrioid endometrial cancer and unlimited prior lines of therapy,” study authors concluded. “Letrozole/abemaciclib demonstrated an acceptable safety profile with only 2 patients discontinuing protocol therapy because of toxicity. There were no new safety signals or unexpected toxicities, and adverse events were comparable with those observed in previous studies.”

Konstantinopoulos PA, Lee EK, Xiong N, et al. A phase II, two-stage study of letrozole and abemaciclib in estrogen receptor-positive recurrent endometrial cancer. 

. Published online September 29, 2022. doi:10.1200/JCO.22.00628

A combination of the aromatase inhibitor letrozole and the CDK4/6 inhibitor abemaciclib may help patients with recurrent estrogen receptor–positive endometrial cancer achieve responses. 



Letrozole Plus Abemaciclib Draw Clinical Activity in ER+ Endometrial Cancer

Following treatment with single-agent neratinib (Nerlynx), patients with metastatic or recurrent 

-mutated cervical cancer achieved durable responses, according to updated findings from the phase 2 SUMMIT basket trial (NCT01953926), which were presented during the 2022 ESMO congress.

Among 22 treated patients, neratinib elicited an objective response rate (ORR) of 18.2% (95% CI, 5.2%-40.3%), which included a complete response (CR) rate of 4.5%, a partial response (PR) rate of 13.6%, and a stable disease (SD) rate of 27.3%. The clinical benefit rate (CBR) was 45.5% (95% CI, 24.4%-67.8%).

When broken down by histology, patients with adenocarcinoma (n = 18) experienced an ORR of 22.2% (95% CI, 6.4%-47.6%) with the agent, which comprised a CR rate of 5.6%, a PR rate of 16.7%, and a SD rate of 33.3%. In this group, the CBR with neratinib was 55.6% (95% CI, 30.8%-78.5%). No patients with squamous cell carcinoma (n = 4) responded to treatment with the agent.

“Neratinib led to durable responses and disease control in patients with metastatic or recurrent 

-mutant cervical cancer,” lead study author Claire F. Friedman, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, wrote in a poster featuring the data. “[The] safety profile [of the agent] was consistent with previous reports in metastatic HER2-positive or 

Patients with recurrent or metastatic cervical cancer who progress on frontline platinum-based chemotherapy regimens have a wide range of active drugs available, but response rates have not exceeded 24%. As such, there is a need for novel therapeutic options for this population. Moreover, to date, no targeted therapies have been developed for those with metastatic disease.

In February 2020, the FDA approved neratinib for use in combination with capecitabine for patients with advanced or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2–based regimens in the metastatic setting.2 In cervical cancer, and other 

-mutant cancers, the agent has showcased encouraging single-agent activity, according to prior data from SUMMIT. At the 2022 ESMO Congress, investigators shared final data from the cervical cancer cohort.

The international, open-label, multicohort, multitumor, SUMMIT basket trial enrolled patients with persistent, recurrent, or metastatic cancers with a documented 

 mutation and an ECOG performance status of 0 to 2.

Patients were excluded from the trial if they received prior treatment with a pan-HER TKI, such as lapatinib (Tykerb), afatinib (Gilotrif), dacomitinib (Vizimpro), or neratinib (Nerlynx). Moreover, patients could not have symptomatic or unstable brain metastases.

Study participants received neratinib monotherapy at 240 mg daily. The trial utilized a Simon 2-stage design. If at least 1 response was recorded in the first evaluable 7 patients, the cohort would expand to stage 2 with 18 patients. If there were at least 4 responses in stage 2, the cohort would expand further or break out.

The primary end point of the trial was ORR at the time of the first post-baseline tumor assessment, which was done at week 8. Secondary end points included confirmed ORR, duration of response (DOR), CBR, progression-free survival (PFS), safety, and biomarker analysis.

Among the 22 patients with cervical cancer, the median age was 55 years (range, 29-74). The majority of patients were White (68.2%) and had an ECOG performance status of 1 (68.2%). Moreover, 31.8% of patients had FIGO stage I disease at the time of diagnosis, 22.7% had stage II disease, 9.1% had stage III disease, and 27.3% had stage IV disease; this information was missing in 9.1% of patients. Most patients (81.8%) had adenocarcinoma.

Additionally, 59.1% of patients had a positive human papillomavirus status. Furthermore, 63.6% of patients underwent prior surgery, and 77.3% received prior radiotherapy. Prior systemic treatments included platinum-based chemotherapy (100.0%), bevacizumab (Avastin; 72.7%), and pembrolizumab (Keytruda; 18.2%).

The median duration of treatment with neratinib was 3.7 months (range, 0.5-67.5).

Additional data showed that among all patients with cervical cancer, the median DOR was 7.6 months (95% CI, 5.6-12.3) and the median PFS was 5.1 months (95% CI, 1.7-7.2). When broken down by histology, those with adenocarcinoma experienced a median DOR of 7.6 months (95% CI, 5.6-12.3) and a median PFS of 5.5 months (95% CI, 3.7-10.9). Patients with squamous cell carcinoma experienced a median PFS of 1.7 months (95% CI, 0.7-3.5).

 mutations, patients with S310F or S310Y single mutations (n = 10) achieved an ORR of 30% (95% CI, 6.7%-65.2%) with neratinib; the CBR in this group was 40.0% (95% CI, 12.2%-73.8%). The median DOR in these patients was 9.3 months (95% CI, 5.6-12.3), and the median PFS was 3.7 months (95% CI, 0.5-14.1).

Those with S310F or S310Y double mutations (n = 3) experienced an ORR of 33.3% (95% CI, 0.8%-90.6%), with a CBR of 66.7% (95% CI, 9.4%-99.2%). In this group, the median DOR was 5.9 months (95% CI, not estimable [NE]–NE) and the median PFS was 6.5 months (95% CI, 1.7-7.7). Notably, no responses were observed in patients with D769H or D769N mutations (n = 2), other kinase domain mutations (n = 2), or transmembrane domain mutations (n = 5).

Additionally, study authors noted that prior use of bevacizumab did not appear to affect the efficacy of neratinib.

The safety profile of neratinib in patients with 

-mutated cervical cancer was consistent with other reports of its single-agent use. All patients experienced at least 1 any-grade adverse effect (AE), and 45.5% of patients had at least 1 grade 3 or higher AE. Additionally, 84.6% of patients experienced at least 1 treatment-related AE (TRAE) of any grade; 22.7% had at least 1 TRAE that was grade 3 or higher.

The most common TRAEs of any grade included diarrhea (81.8%), nausea (40.9%), vomiting (22.7%), decreased appetite (18.2%), abdominal pain (18.2%), and dysgeusia (18.2%). Regarding grade 3 or higher TRAEs, 22.7% of patients experienced diarrhea and 4.5% of patients had abdominal pain. Study authors noted that instances of diarrhea were manageable with antidiarrheal prophylaxis.

“These encouraging results support further investigation of neratinib in patients with persistent, metastatic or recurrent 

-mutant cervical cancer following platinum failure,” the study authors concluded.

Friedman CF, D’Souza AA, Tinker AV, et al. Neratinib in HER2-mutant, recurrent/metastatic cervical cancer (R/M CC): updated findings from the phase 2 SUMMIT basket trial. 

. 2022;33(suppl 7):S803-S804. doi:10.1016/j.annonc.2022.07.687

Neratinib was associated with a clinical benefit rate of 45.5% among patients with metastatic or recurrent HER2-mutated cervical cancer. 

Neratinib Yields Robust Responses in Patients with HER2-Mutated Cervical Cancer

According to the American Association of Nurse Practitioners, over 36,000 new nurse practitioners (NPs) completed academic programs between 2019 and 2020, and licensed NPs reportedly increased from 325,000 in 2021 to 355,000 in 2022.

As the number of new graduates continues to rise, so will the need for preceptorship, especially in specialties such as oncology.

Preceptors help novices navigate their new role as health care providers, coaching them on such core competencies as diagnostic reasoning, clinical judgment, and critical thinking skills.

 The transition from student to NP can be very difficult, and thus the importance of highly experienced preceptors, particularly in oncology, cannot be overemphasized.

To provide care to oncology patients, NPs need highly specialized training and education, which they usually receive during postgraduate fellowships.

The preceptors’ primary goal is to help the novice bridge educational gaps and advance from entry-level competence to high-level proficiency.

They share knowledge and clinical skills, facilitate experiential learning scenarios, and encourage the development of social, critical thinking, and clinical judgment skills. Preceptors provide this for the novice NP while simultaneously providing safe, high-quality, and holistic care to patients.

Although preceptors are considered to be experts, they still need guidance themselves. According to Pleshkan et al,

 a structured preceptorship improves the process of training a novice NP. Preceptors share their knowledge with the NPs and teach them effective ways to analyze their clinical decisions and manage their workload.

Preceptors must employ the teaching strategies that are best suited to each learner’s style

 and assess the preceptees’ depth of knowledge and level of clinical expertise to facilitate a positive experience.

 In addition, an open dialogue between preceptor and novice gives both the opportunity to become acquainted with one another, clarify goals and expectations, and give/receive constructive feedback. Open dialogue has also been shown to be an effective way to build the preceptor-preceptee relationship and create mutual respect and trust as well as a positive learning environment.

Emotional Support and the Preceptorship Experience

Transitioning from new graduate to proficient NP in any specialty takes time and determination as the process can be intimidating and, at times, anxiety-inducing.

 However, having a guide who has been through the same process can make the transition a healthy and pleasant experience.5 Preceptors ensure the competence of novices. From them novices learn to provide safe, cost-effective care to patients with complex diseases.

What may at first seem like a daunting journey becomes less so thanks to the preceptor’s ongoing reassurance. Preceptors are like personal coaches: they teach learners what to do and offer emotional support throughout.

As I transition from an experienced RN to a novice oncology NP, I see that preceptors have been a critical part of my personal and professional growth. Although most preceptorships are short and not all encounters are positive, many of the connections are genuine. Several of my past preceptors have become lifelong friends and continue to be mentors of mine. Because of their willingness to share their knowledge and clinical expertise, I am confident that when my turn comes, I will be able to pass on what they taught me (plus some tips and tricks of my own) to the next generation.

Novice oncology NPs require a great deal of support as they transition to their new role.

 A structured preceptorship that caters specifically to them promotes a safe environment that is conducive to learning, builds competence, confidence, and job satisfaction and encourages intra- and interdisciplinary collaboration.

 To novice oncology NPs starting their journey in clinical practice, I say that to succeed, you must pay attention, ask questions, and maintain a flexible and positive attitude.

1. NP fact sheet. American Association of Nurse Practitioners. Updated April 2022. Accessed July 15, 2022. https://www.aanp.org/about/all-about-nps/np-fact-sheet

2. Pleshkan V, Boykins AD. Cognitive preceptorship: an emerging nurse practitioner role transition to practice model. 

.2022;39:194-205. doi:10.1016/j.profnurs.2022.02.002

3. Pleshkan V, Hussey, L. Nurse practitioners’ experience with role transition: supporting the learning curve through preceptorship. 

4. Bazzell AF, Jones T, Dains JE, Champion JD. Assessing the needs of oncology APRN preceptors. 

5. Pirschel C. Competencies create expert, accountable nurses delivering quality care. 

.April 3, 2017. Accessed July 15, 2022. https://voice.ons.org/news-and-views/core-competencies-of-oncology-nurses

6. Alencar M, Butler E, MacIntyre J, Wempe EP. Nurse practitioner fellowship: developing a program to address gaps in practice. 

7. Pearson T, Hensley T. Positive precepting: identifying NP student learning levels and needs. 

8. Thomassen A. Fellowship programs: reflections of an advanced practice nurse fellow. 

9. Kelly DE. Initiation of a new nurse preceptor program in the era of COVID-19. 

10. Bazzell AF, Dains JE. Supporting nurse practitioner preceptor development. 

Structured preceptorships promote competence, confidence, and job satisfaction in new oncology nurse practitioners. 

Supporting the Novice Oncology NP: The Benefits of Preceptorship

As the cancer treatment landscape continues to evolve, the role of front-line nurses in clinical trials remains essential, according to Anne Delengowski, RN, MSN, AOCN, CCCTM.

“I don’t know if nurses today can truly appreciate where we’ve come because they were never there, [but] I have had the honor and privilege of being there,” Delengowski, who has been an oncology nurse for 42 years, and is the director of Oncology Nursing Education at Thomas Jefferson University Hospital, said in an interview. “In the past, we had very few cancer drugs, we had minimal second-line therapies which are standard now, we didn’t have targeted therapy or immunotherapy, and we had poor symptom management.” 

Delengowski recently presented at the 2022 Oncology Nursing Society Bridge, highlighting notable improvements spanning the course of her career and the excitement that comes with being a part of a clinical trial from start to finish. In a post-presentation interview with 

®, Delengowski offered a personal perspective into how the field has changed during her career as a frontline nurse.

“When I first started as a cancer nurse, we didn’t have the antiemetics we have today, and it was awful. I did a study back then with a colleague from the school of nursing looking at anticipatory nausea and vomiting because the patients would come in vomiting prior to getting their drugs because they were anticipating it happening, [but] very rarely do you see that anymore. We [also] didn’t have growth factors; we didn’t have the colony stimulators to be able to prevent neutropenic fevers, so patients were hospitalized for most of the course of their disease. Today, all the stuff we talked about here came through clinical trials.”

She also highlighted how pain management strategies have significantly improved.

“I worked a lot in nightshift when I was in graduate school, and we didn’t have sustained release narcotics,” she said. “We used to have to wake people up in the middle of the night to give them pain medicine because if we didn’t their pain would be out of control in the morning. Once again, it was revolutionized that we have PCA [patient-controlled analgesia] pumps now, we have sustained release therapy. The nightmare of seeing patients in pain, you kind of weighed the fact if I didn’t wake them up, they’d be in a lot of pain in the morning and if I did wake them up, I interrupted their sleep, and it wasn’t good.”

Throughout her career, she shared that she has been inspired by the advances that clinical trials have brought about. She noted that patients are living longer, healthier lives, and that clinical trials are allowing providers to achieve “magical things.”

She noted, as an example, the breakthrough findings from Memorial Sloan Kettering Cancer Center where 100% of patients with rectal mismatch repair-deficient locally advanced rectal cancer achieved a complete response with dostarlimab-gxly (Jemperli).

Delengowski shared that, prior to working in clinical trials, she did not understand much about the process or have proper understanding or the extent of the behind-the-scenes work. For example, in her presentation, she explained how clinical trials must receive approval form a multidisciplinary disease group and a facilitation committee, along with a protocol review committee. In addition, there is a site initiation visit which provides the principal investigator and the team with training on all aspects of the trial, prior to its initiation.

Teamwork is also critical and research coordinators who understand the trial have been involved from the inception to guide nurses.

As part of her presentation, Delengowski outlined the different phases of clinical trials. Phase 1 trials are specifically designed to find a safe dose of a novel regimen for humans. This step determines how much a new treatment should be given (ie, oral or intravenous administration), and what the maximum-tolerated dose is.

Delengowski stressed, “A lot of times in phase 1 [trials] we don’t know what the symptoms or outcomes might be, so we need to be cognizant of the fact that anything that happens to that patient we need to document. We need to make sure we do it and we need to follow the protocol to dot the i, cross the t and do it all perfectly because if everyone chooses to do something different than it really doesn't make the trial valuable.”

“I remember giving my very first phase 1 [treatment] and I took a step back thinking ‘You want me to give this to a human being now? It’s the first time a human being has received this drug,’” she said. “I was humbled and wowed at the same time. It was wonderful for all involved, but a little frightening it was for us [as nurses] to administer.”

Phase 2 trials are larger and are designed to determine if the new treatment is effective against a certain cancer, as well as its safety profile. Phase 3 trials compare the new treatment (or new use of a treatment) against the current standard of care.

Across the trial continuum, supporting patients during the trial remains a significant part of the nurse’s role as patients can be overwhelmed throughout treatment. Delengowski highlighted that knowing where to get information for patients and helping to educate them is important for front-line nurses.

“It becomes very exciting when you know you’re part of [clinical trials],” she said. “Some frontline nurses may not exactly understand the value they bring, but [they’re] invaluable; We’re the frontline, we’re the last line, we’re the point where the person gets the medication or the therapy.”

However, phase 3 trials, which are usually randomized, can be difficult for nurses, because patients may not be happy to learn they were randomly assigned to receive the standard of care.

Delengowski explained “It's very hard when you talk up a study and the patient was randomized to standard of care. Often a frontline nurse will be confronted with [patients who say] ‘I signed on thinking I was going to get the new therapy and now I got standard of care drug.’ ”

“What I tell [patients] is in phase 3 studies we don’t know that standard care might be the best therapy. We don’t know and that’s what this is all about. I’ve been involved in phase 3 [trials], where the [experimental drug] was not better than standard of care; it was good, but not as good. It’s just part of the process and once you give that information to the patient, they feel a bit better about it.”

When looking back on all the various phases of clinical trials she has been a part of, Delengowski said it was an exciting feeling to think, “Wow, I was part of that, and we were there when it happened. Some of the trials didn’t come to fruition, but a lot of them did and when you look at that and know that you were part of it, it is so exciting…. As cancer nurses we see the patient go through from diagnosis to hopefully a long life, but in between there’s roadblocks. If they fail first-line therapy and other therapies and go onto a clinical trial, we walk that walk with them. I think that understanding that there is that next step [is important].”

Future steps in improving the clinical trial process include ensuring that inclusivity is a priority and that trials will be brought to the community. Historically, clinical trials have been performed in large academic centers which can be difficult to get to and exploring ways to bring them to patients and working with a community-based staff can be beneficial in making the clinical trials more comfortable for patients.

“[Clinical trials] give that glimmer of hope to someone that there may be other outcomes out there,” Delengowski said. “Even if it’s not something that’s going to be beneficial for that individual, which is not always the case, but it leads to phase 2 and phase 3 [trials] where there seemingly is some hope for a disease process that might not have had a whole lot of other options.”

Delengowski A. Clinical trials on the frontline: the changing landscape of clinical trials nursing. Presented at: ONS Bridge; September 13-15, 2022; virtual.

Cercek A, Lumish MA, Sinopoli JC, et al. Single agent PD-1 blockade as curative-intent treatment in mismatch repair deficient locally advanced rectal cancer. 

. 2022;40(suppl 17):LBA5. doi:10.1200/JCO.2022.40.17_suppl.LBA5

Anne Delengowski, RN, MSN, AOCN, CCCTM, discusses the evolving role of the oncology nurse in clinical trial research.

Clinical Trials Continue to Propel Field of Oncology with Nurses on The Frontline

I recently cared for a 32-year-old woman who was admitted to the Inpatient Oncology Unit 2 months after giving birth to her first child. She had been transferred to us for a higher level of care and was diagnosed with acute leukemia. The joy of having a baby quickly turned to insomnia, and she began having panic attacks about her disease as well as treatment-related nausea.

She also had a history of depression and suicidal behavior, which posed a significant challenge for her care team. Our attempts to manage the mental problems that were beginning to become manifest during her third week were unsuccessful. Eventually, the nursing staff started to feel that they had “failed” to “help her feel better” and no longer wanted to have her as a patient.

No patient assignment was conducive to caring for her and helping her cope. After many failed attempts, the woman requested alternative therapy for anxiety and insomnia and to cope with not being able to see her baby and was eventually prescribed medicinal cannabis.

Unfortunately, 30% of patients with cancer develop a mental disorder during the course of their illness.

 Those currently recognized in the literature include anxiety and mood disorders, which can have a negative impact on treatment, lead to suicidal ideation, and create additional difficulties for health care workers. Initially, the hospital stay can be prolonged.

But as time passes, patients may become dissatisfied and not adhere to treatment.

Diminished overall quality of life can lead to increased mortality.

Oncology nurses have also identified suicidal ideation as challenging to manage. Currently, there are no protocols they can follow in terms of who should be contacted, who should complete the documentation, and who should assess patients.

 Although nurses are trained to assess the psychosocial needs of patients, they need better resources to mitigate patient mental health problems.

Although oncology nurses are trained to show empathy and offer support, they lack the resources to adequately care for patients with acute mental health problems. 

Gynecologic Cancers