 magazine, recently asked its audience of patients, survivors, and caregivers to share how oncology nurses have helped them on their cancer journey. In honor of Nurses' Week, from May 6-12, take a look at what some of them had to say - and thank you for your dedication!

I’ve had so many amazing nurses just show basic kindness & respect. To have someone listen to you, hold your hand, or give you a hug during extremely emotional times makes a world of difference. I’m so grateful for their unwavering compassion. – D.D.

They are angels! Calming, caring, and they talk with me as though I'm "normal" and not sick. – B.C.

I've had support from many oncology nurses. There were patient designated nurses during my original diagnosis. And since my regional recurrence I've been working with a nurse practitioner. But the ones who boosted my spirits were the treatment nurses. – N.D.

Nurses have the ability to make treatment so much more bearable. – S.D.

After my mastectomy I was feeling very alone, my sweet nurse came into my room and spent so much time with me just talking and being there for me. I loved that she took time for me in a time when I was feeling confused and alone. – T.V.

My nurses helped me) by making sure my needs were met, both physically and emotionally. – D.K.

(My nurse) keeps track of my labs and chemotherapy appointments. She is always encouraging me and even stopped by with a new oncology nurse to do my neurology exam to show her how it’s done. – C.V.

The nurses at the chemo clinic were amazing! – M.E.

My two favorite oncology nurses are twins that work together. Seeing them at the center actually makes me feel less anxious... I’m fortunate to have them on my cancer care team. – Y.P.

Articles

In honor of Nurses' Week, from May 6-12, we’re sharing what some patients, survivors, and caregivers had to say about how oncology nurses helped them along their cancer journey.

Oncology Nursing News Honors Nurses’ Week 2021

The FDA has granted a priority review to the supplemental new drug application for ivosidenib tablets (Tibsovo) as a treatment option for patients with previously treated, 

The application is supported by data from the phase 3 ClarIDHy study (NCT02989857), in which ivosidenib led to a 63% reduction in the risk of disease progression or death vs placebo in patients with previously treated, 

The median progression-free survival (PFS) with ivosidenib was 2.7 months vs 1.4 months with placebo (HR, 0.37; 95% CI, 0.25-0.54; 1-sided 

 <.0001). The 6-month and 12-month PFS rates with the agent were 32% and 22%, respectively. No patients who were given placebo were found to be free of disease progression at either of those time points. Moreover, the 6-month disease control rate with ivosidenib was 53%, while it was 28% at 12 months.

Ivosidenib was also found to lead to a 21% reduction in the risk of death compared with placebo in these patients.

 The median OS in the investigative and control arms was 10.3 months and 7.5 months, respectively (HR, 0.79; 95% CI, 0.56-1.12; 1-sided 

 = .093). The 6-month OS rates in the investigative and control arms were 69% and 57%, respectively; these rates were not adjusted for crossover. The 12-month OS rate with ivosidenib was 43% vs 36% with placebo.

“Currently, there are no approved systemic therapies for 

-mutated cholangiocarcinoma and limited chemotherapy options are available for patients with advanced disease,” Susan Pandya, MD, vice president of Clinical Development and head of Cancer Metabolism Global Development at Servier Pharmaceuticals, stated in a press release. “The FDA’s priority review is a major milestone for patients. I’d like to acknowledge and thank all the patients, their families, and the investigators and research teams who took part in the ClarIDHy study.”

A total of 187 patients with previously treated, 

-mutated cholangiocarcinoma was enrolled to the international phase 3 ClarIDHy trial. Participants were randomized in a 2:1 fashion to receive either oral ivosidenib at a daily dose of 500 mg (n = 126) or placebo (n = 61). Patients on the control arm were permitted to crossover to the investigative arm after experiencing radiographic progression.

Inclusion criteria called for patients to be at least 18 years of age, to have 

-mutated cholangiocarcinoma, and to have previously received 1 to 2 therapies which included a gemcitabine- or 5 fluorouracil­–containing regimen. Study participants had a median age of 62 years, 92.4% had intrahepatic disease and 92.3% had metastatic disease. Just under half, or 46.7%, had received 2 prior therapies, while the rest of the patients had received 1 prior treatment. About 71% of patients had their 

 mutations confirmed by next-generation sequencing in R132C, while the rest were found to be in R132L/G/S/H. Moreover, 63.3% of patients had an ECOG performance status of 1.

The primary objective of the trial was PFS per blinded independent central review. Secondary end points comprised OS, overall response rate, PFS per local review, safety and tolerability, pharmacokinetics, pharmacodynamics, and health-related quality of life (QoL).

Ivosidenib was found to preserve physical functioning from baseline. Per the EORTC QLQ-C30 questionnaire, patients who were given placebo reported a decline from baseline at day 1 of cycle 2 (2-sided 

 = .004). Moreover, per the EORTC QLQ-BIL21 questionnaire, ivosidenib improved pain at day 1 of cycle 2 compared with placebo (2-sided 

 = .039). On day 1 of cycle 3, no differences were observed between the 2 treatment arms. Neither arm was favored on other prespecified QoL subscales like the QLQ-C30 Appetite Loss and QLQ-BIL21 Pain and Eating.

The most commonly experienced treatment-emergent toxicities on the ivosidenib and placebo arms comprised nausea (38.0% vs 28.8%, respectively), diarrhea (33.1% vs 16.9%), fatigue (28.9% vs 16.9%), abdominal pain (22.3% vs 15.3%), cough (21.7% vs 8.5%), decreased appetite (21.7% vs 18.6%), ascites (19.9% vs 15.3%), vomiting (19.9% vs 18.6%), and anemia (18.1% vs 5.1%).

Moreover, 53% of patients on the investigative arm experienced treatment-emergent adverse effects (TEAEs) that were grade 3 or higher compared with 37.3% of those on the control arm; this included those who crossed over from the placebo arm. The most frequently reported TEAEs that were grade 3 or higher were ascites, blood bilirubin increase, and anemia.

Additionally, 6.6% of those who received ivosidenib experienced TEAEs that led to discontinuation of treatment vs just under 9% of those who were given placebo. In the ivosidenib arm, 3% required dose reductions vs 0% of those on the placebo arm. Moreover, 30.1% of those on the investigative arm experienced dose interruptions vs 18.6% of those on the control arm.

In May 2019, the FDA approved ivosidenib for use in patients with 

-mutated acute myeloid leukemia (AML), specifically for those with newly diagnosed disease who were at least 75 years of age and who have comorbidities that preclude the use of intensive induction chemotherapy and for those with relapsed/refractory AML. The regulatory decision was based on data from a phase 1 trial where ivosidenib elicited a complete response (CR) of 28.6% and a CR plus CR with partial hematologic recovery rate of 42.9%.

Servier announces FDA filing acceptance and priority review for TIBSOVO (ivosidenib tablets) in IDH1-mutated cholangiocarcinoma. News release. Servier Pharmaceuticals. May 5, 2021. Accessed May 5, 2021. 

Abou-Alfa GK, Macarulla T, Javle MM, et al. Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study. 

. 2020;21(6):796-807. doi:10.1016/S1470-2045(20)30157-1

Zhu AX, Macarulla T, Javle MM, et al. Final results from ClarIDHy, a global, phase III, randomized, double-blind study of ivosidenib (IVO) versus placebo (PBO) in patients (pts) with previously treated cholangiocarcinoma (CCA) and an isocitrate dehydrogenase 1 (IDH1) mutation. 

. 2021;39(suppl 3):266. doi:10.1200/JCO.2021.39.3_suppl.266

Agios announces FDA approval of supplemental new drug application (sNDA) for TIBSOVO as monotherapy for newly diagnosed adult patients with IDH1 mutant acute myeloid leukemia (AML) not eligible for intensive chemotherapy. News release. Agios Pharmaceuticals Inc. May 2, 2019. Accessed May 5, 2021. 

This article was originally published on OncLive as, "

FDA Grants Priority Review to Ivosidenib in IDH1-Mutant Cholangiocarcinoma

The FDA has granted a priority review to the supplemental new drug application for ivosidenib tablets as a treatment option for patients with previously treated, IDH1-mutant cholangiocarcinoma.

Ivosidenib Granted Priority Review for IDH1-Mutant Cholangiocarcinoma

The Food and Drug Administration (FDA) granted an accelerated approval to pembrolizumab (Keytruda) plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

The approval was based on interim findings from the ongoing multicenter, randomized, double-blind, placebo-controlled KEYNOTE-811 trial. The trial included 264 patients with HER2-positive advanced gastric or GEJ adenocarcinoma who had not previously received systemic therapy for metastatic disease. Half the patients received 200 mg of pembrolizumab every 3 weeks in combination with trastuzumab and either fluorouracil plus cisplatin or capecitabine plus oxaliplatin.

The overall response rate, as assessed by a blinded independent review committee, was 74% in the pembrolizumab arm, and 52% in the placebo arm. Average duration of response was 10.6 months (range 1.1 months to 16.5 months) for the immunotherapy agent, compared with 9.5 months (range, 1.4 months to 15.4 months) for the placebo arm.

Researchers said that the adverse event profile observed in KEYNOTE-811 is consistent with the known safety profile of the drug.

The recommended dosing for this patient population is 200 mg of pembrolizumab every 3 weeks or 400 mg every 6 weeks.

FDA. FDA grants accelerated approval to pembrolizumab for HER2-postive gastric cancer. May 5, 2021. 

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-pembrolizumab-her2-positive-gastric-cancer?utm_medium=email&utm_source=govdelivery

The FDA granted an accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. 

FDA Approves Frontline Pembrolizumab for HER2+ Gastric, GEJ Cancer

The EGFR TKI osimertinib (Tagrisso) has shaken up the treatment paradigm of advanced non–small cell lung cancer (NSCLC), and now the agent is under exploration in earlier-stage settings in an effort to further prevent recurrence and prolong survival, according to Edward S. Kim, MD, who added that the key to reaching patients earlier is to test for biomarkers earlier.

“In the early-stage setting, it is devastating when [patients experience] recurrence. Hopefully, [with osimertinib,] we can do something about it and treat them. Too many times, because of the nihilism that has built up over the years, we are just waiting for the recurrence to occur,” Kim said. “I hope we get to a point where recurrence is less common, and we are treating more patients with earlier-stage disease. Our paradigm has changed. We will continue to study other drugs and targets in these settings, as well.”

 during an Institutional Perspectives in Cancer webinar on lung cancer, Kim, physician-in-chief of City of Hope Orange County and vice physician-in-chief of City of Hope National Medical Center, highlighted the impact of osimertinib in the treatment of patients with 

-mutant NSCLC, next steps with the agent, and the importance of early genetic testing to provide personalized care.

: How has the emergence of osimertinib impacted the management of patients with

 has really been one of the pioneering biomarker pathways in lung cancer. Osimertinib is the preferred drug because it has very strong efficacy and a [favorable] safety profile. The newer-generation drugs penetrate the brain and the central nervous system much more predictably than older-generation agents; this has changed the paradigm of how we approach patients who have initially been diagnosed with brain metastases. If they are stable, then we do not jump right to radiation. Instead, we treat them [with these drugs] if they have a mutation and watch them in case we need the radiation. [However,] it is great to see even our radiation colleagues embrace these data.

What are some areas of focus in the realm of

Throughout our investigations, we have also found other mutations in 

; some are sensitizing, some are resistant, and some we are not sure about yet. We are developing drugs [to target] these specific mutations, which is exciting. That is what we dream [to do with] cancer [treatment]: identify a marker in the tumor that is unique to an individual and finding a [targeted] therapy that [that is efficacious and] will not cause many adverse effects [AEs].

 moving into the earlier-stage setting; this [development,] indeed, follows what we have seen in the breast cancer paradigm. You have drugs that [are initially used in the] metastatic [setting], like tamoxifen, that are now moving into the earlier-stage setting. [Patients] can take [these agents] for several years and [they are effective]. We are seeing that now with osimertinib, [which is under examination] in the early-stage setting, in patients who have stage IB through IIIA [disease].

 mutations. If you find one, then after you finish the surgery and/or give chemotherapy, [you can] then treat the patient with osimertinib for 3 years; this has been shown to greatly improve disease-free survival [DFS]. We are still waiting for overall survival [OS] data [with this approach]. However, the trial [that examined this strategy] was unblinded early because of its effectiveness, and patients are still being treated.

[Treatment has] really cascaded in the direction [where] we want to reach patients earlier—especially those who have curable disease or curative intent disease. [We want to] try to keep disease away as long as possible. I am really happy that biomarkers have made it into the clinic. I urge everyone out there to test [for] biomarkers. Ensure that you are testing for these before you initiate any treatment. It does not matter if you are using smaller panels or larger panels; just ensure that you are getting that information and utilizing it to inform decisions.

Looking more closely at the use of osimertinib in the adjuvant setting, how did the agent perform in the phase 3 ADAURA trial (NCT02511106)? What does this information mean for practice?

The primary end point of ADAURA was DFS, specifically in [patients with] stage II and IIIA [disease], although the trial did enroll [those with] IB through IIIA [disease]. DFS was the first reported outcome because you get those outcomes earlier. Data were revealed early because of the effectiveness [of the agent]; this [runs] parallel to what happened with tamoxifen.

The hazard ratios for DFS were unprecedented. We had not seen that magnitude [of benefit] in lung cancer [previously], although we should; this is a curative intent population. We are asking patients to take a drug for up to 3 years and need to show that there is some benefit. Some would say we need to wait for OS and, of course, our due diligence has to be to wait for [those data].

However, you have to ask yourself, if this was a friend or family member, and they had gone through lung cancer resection, would you prescribe them osimertinib if they have an 

 mutation? My answer is a very clear yes. I do believe that DFS is an important end point, and it is one that we use quite often in earlier stages [of disease]. If you consider any patient who has had early-stage breast cancer and they get a recurrence, it is just devastating.

How are the AEs associated with osimertinib being managed? Are there any challenges to using this agent in the clinic?

What has been really helpful is that osimertinib was first approved [for use] in the advanced metastatic setting. Clinicians gathered quite a bit of experience with not only this drug, but also with drugs that were similar in class. We all remember using gefitinib [Iressa], erlotinib [Tarceva], afatinib [Gilotrif], and now, we have osimertinib. There is a comfort level [with these agents]. Again, the parallels [to what has been seen in the] breast cancer [paradigm] are there. Tamoxifen was first used in the metastatic setting and [people felt comfortable] dealing with those AEs.

On the whole, osimertinib has a very [safe] toxicity profile, when considering other classes of drugs [that are used] in the metastatic setting. Upon conducting the study and reporting out, we really did not see any new safety [signals]. As we consider primary end points and focus on the [patients with] stage II and IIIA disease, even in the total analysis of [those with] IB through IIIA [disease], we saw a benefit across the board. [Osimertinib] is [an agent] that people are comfortable with and we [have] quite a bit of experience [with its use].

Research Efforts Focus on Reducing Recurrence in Early-Stage EGFR-Mutant NSCLC

Edward S. Kim, MD, highlights the impact of osimertinib in the treatment of patients with EGFR-mutant non–small cell lung cancer, next steps with the agent, and the importance of early genetic testing to provide personalized care.

Reduce Recurrence in Early-Stage NSCLC

Ethical dilemmas are unavoidable when caring for patients with cancer, and oncology nurses are often tasked with resolving such issues, relying on professional codes and standards to help guide what is best for the patient.

“One thing about ethical issues is that there’s usually not a right or a wrong. We’ve always tried to go for the best solution for the patient and the family, as well as the care team in the situation,” said Joyce Neumann, PhD, APRN, AOCN, BMTCN, FAAN, an advanced practiced registered nurse and adjuvant ethicist at The University of Texas MD Anderson Cancer Center. Neumann recently led a presentation on ethical dilemmas in oncology nursing at the 46th Annual ONS Congress.

While end-of-life care can highlight ethical dilemmas, the challenges actually start at diagnosis, when nurses are faced with educating patients and their family members, determining goals of care, discussing clinical trial participation, and assessing patients physically, cognitively, and psychologically.

Then comes the informed consent process, preparing for possible outcomes of treatment, establishing advanced care planning and goals of care – both through treatment and potentially at the end of life.

For example, nurses may need to balance being positive and providing hope with providing realistic information and expectations to patients and their loved ones.

Neumann explained that there were 669 ethics consults at MD Anderson between September 2015 and August 2020; 29% were filed by nurses. The most common reasons for these requests were inquiring about the appropriate levels of treatment.

“Probably the most major ethical challenge that we come to is when is enough enough, and when do we transition patients from curative or aggressive care to comfort care?” Neumann said.

One major way to address these ethical dilemmas in cancer care is to promote advanced care planning – where patients’ wishes, delegation of medical decision maker, and more are clearly documented for the patient, family, and clinical staff members.

Nurses should also consider patients’ comorbidities, prognosis, religious or spiritual views, and goals to help guide the best possible care.

“We obviously need to know patient preference – I can’t stress that enough,” Neumann said. “Does the patient have capacity for their decisions and those type of questions on quality of life? What does that mean to the patient? … If the patient does not have the capacity, can the family explain to us what conversations they’ve had with the patient prior to treatment starting, [regarding] views of care?”

Knowing your patient’s beliefs and goals is key to providing ethical cancer care.

Expert Talks Ethics in Oncology Nursing

The rolling submission of a new drug application to the FDA for surufatinib for the treatment of patients with pancreatic and non-pancreatic neuroendocrine tumors has been completed.

Rolling Submission Completed for Surufatinib to Treat Advanced NETs

Nurse practitioners are more valuable than ever in the world of cancer care.

NP Fellowship Helps Prepare Providers for Oncology Career

The novel oral TKI masitinib in combination with docetaxel and prednisone resulted in improved progression-free survival compared with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer, meeting the predefined primary end point of the phase 2b/3 AB12003 trial.

Drug Combo Improves PFS in mCRPC

The FDA has granted a priority review designation to a supplemental biologics license application for nivolumab for use as an adjuvant treatment in patients with surgically resected, high-risk, muscle-invasive urothelial carcinoma.

Adjuvant Nivolumab Granted Priority Review for Muscle-Invasive Urothelial Carcinoma

Each month, we take a look back at the most popular Oncology Nursing News® stories. Here are the top 5 stories from April 2021.

Oncology Nursing News Top Stories: April 2021

Podcasts

It is well known that fear of recurrence is a major issue in the cancer community, but can genetic test results outlining risk impact those feelings?

Genetic Testing May Increase Fear of Recurrence

Factors such as being younger in age, having more comorbidities, and more prior cancer treatments all contribute to higher levels of sleep disturbance in patients with gastrointestinal cancers.

Factors Correspond With Higher Levels of Sleep Disturbance in Patients with GI Cancers

With immunotherapy options expanding for patients with a range of gastrointestinal cancers to include combination strategies with chemotherapy, their use in the treatment course should come sooner rather than later for those with high PD-L1 expression.

Immunotherapy Regimen Continues to Improve GI Treatment

In particular, patients reported improved knowledge in survivorship/surveillance and brain fog following the 6-week program.

Survivorship Rehabilitation Program Provides Education to Improve Transition Following Active Treatment 

When patients rely on lip-reading to communicate, mask mandates have major effects on their care. 

Top Medical News

Oncology Nursing News Honors Nurses’ Week 2021

Ivosidenib Granted Priority Review for IDH1-Mutant Cholangiocarcinoma

FDA Approves Frontline Pembrolizumab for HER2+ Gastric, GEJ Cancer

Reduce Recurrence in Early-Stage NSCLC

Expert Talks Ethics in Oncology Nursing

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