Lindsay Fischer is the Associate Editor at ONN. She joined MJH life sciences in 2021 after graduating from Rutgers University with majors in both English and Spanish and a minor in creative writing. When she is not writing, or researching the latest oncology nursing news, Lindsay is an amateur backpacker and rollerblader. Email Lindsay at lfischer@mjhlifesciences.com

The approval of futibatinib (Lytgobi) for patients with unresectable, locally advanced or metastatic intrahepatic 

positive cholangiocarcinoma represents a new, great option for patients who usually face a poor prognosis, according to Osheka Hansel, APRN.

Futibatinib’s approval was supported by findings from the phase 2 FOENIX*-CCA2 trial (NCT02052778). This open-label trial demonstrated that the targeted therapy produced an objective response rate of 42% in this patient population (n = 103). Moreover, the median duration of response was 9.7 months, and 72% of responses endured for 6 months or longer.

Futibatinib is an oral medication which is given twice daily. According to Hansel, the ability to provide treatment in the outpatient setting is another advantage, with less time spent in the hospital setting correlating to improvements in patient quality of life.

“This is an encouraging targeted therapy for qualified patients who typically have limited treatment options,” Hansel, who is an advanced practice nurse at the Florida Cancer Specialists & Research Institute, and a researcher with the Sarah Cannon Research Institute, said in an interview with 

®. “There are currently many clinical trials investigating how 

 inhibitors alone and in complement with standard of care systemic chemotherapy can impact patient overall survival. So, I think it’s wonderful. With oral therapy such as futibatinib, patients are not tethered to an institution for infusions, giving them more freedom and better quality of life.”

Expanding on the what the approval represents for patients with unresectable cholangiocarcinoma, Hansel discussed what best practices in adverse event (AE) management will likely entail, and where research must continue to go in order to provide the best care for this patient population.

What does this approval mean for patients with 

 During the phase 1 and 2 clinical trials of futibatinib, investigators saw the best overall response in patients with cholangiocarcinoma, specifically intrahepatic cholangiocarcinoma. Patients with unresectable disease typically have a very poor prognosis, due to limited treatment options. Futibatinib is targeted therapy specifically for patients with an 

 mutation. For patients, this is a highly selective second-line treatment option that has shown positive results in increasing overall response and survival.

For patients diagnosed with cholangiocarcinoma, the only curative and most favorable treatment option is resection. But if it’s unresectable, systemic chemotherapy is the only treatment option, which is not ideal due to the high potential for adverse effects. To have futibatinib approved as oral therapy, [with] 75% partial response rates in phase I trial, and median progression free survival of 8.9 months, is excellent.

mutation to qualify for futibatinib, they have to first be treated with platinum therapy; first line [treatment] with gemcitabine and cisplatin and consideration for FOLFOX in the second line.

Please discuss the safety profile of futibatinib. What will best practices look like with bedside nursing?

The most common adverse effects [AEs] of the medication include elevated phosphate levels as well as other electrolyte abnormalities. Gastrointestinal AEs, such as nausea, vomiting, and diarrhea, and poor appetite [can also occur]. Hematologic AEs were also seen—including anemia and thrombocytopenia.

Dermatologic AEs include dry skin, palmar-plantar erythrodysesthesia (hand-foot syndrome) which causes redness, swelling, and pain in the palms and the soles of the feet. [Patients] can also have dry eyes, fatigue, and urinary tract infections.

As a bedside nurse, best practice would be to assess your patients with each contact, asking open-ending questions—keeping in mind the most common AEs. Ask them about their eating habits and whether there are any changes. Assess for weight loss. Are the patient’s labs appropriate? Patient questionnaires listing common AEs may also be beneficial. Does the patient have the pharmaceutical medications at home to manage their symptoms? Discuss findings with the provider.

Education is always key prior to and continually while the patient is being treated. I recommend encouraging the patient to use lubricant after showers and throughout the day to prevent the cracking and the hands and the feet. For dry mouth and to help to prevent that poor appetite, they can suck on hard candies or something sour. 

The adverse effects of futibatinib are all things that are manageable, either with lifestyle changes, dose modification/reduction, or discontinuation. Overall, the medication is well tolerated allowing patients to maintain quality of life.

Are there any problems that you have observed in integrating this drug into clinical use? How have you handled that as an institution?

Personally, I have not observed problems integrating this drug into clinic use. Financial barriers typically inhibit clinic use with newer medication. In my experience, they typically come at a higher cost to patients. However, there are usually financial assists available through the manufacturer. Many manufactures provide representatives that can review the financing options with providers. Also, with this being a new medication, some providers may not know it’s available or they may be apprehensive about trying something new.

What questions do you have going forward about safely caring for patients with this drug?

Some of the AEs are directly correlated with the type of medication that it is— an FGFR inhibitor. As treatment progresses patients are going to experience increased phosphate levels and electrolyte abnormalities, I’m interested to see how future research will seek to mitigate these reactions.

FDA approves Taiho's Lytgobi (futibatinib) tables for previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma. News release. Taiho Oncology, Inc. September 30, 2022. Accessed December 1, 2022. https://prn.to/3y2s7W8

Lytgobi. Prescribing information. Taiho Oncology, Inc; 2022. Accessed December 1, 2022. https://bit.ly/3BXxase

Articles

Osheka Hansel, APRN, discusses the recent approval of futibatinib (Lytgobi) for patients with unresectable, locally advanced or metastatic intrahepatic FGFR2-positive cholangiocarcinoma.

Futibatinib Approval Ushers in Targeted Therapy Option for Patients With Unresectable, Intrahepatic FGFR2-Positive Cholangiocarcinoma

Debi Fischer is a nurse at the University of Miami surgical oncology step down unit. Prior to that she worked in orthopedics and neurology for many years. In addition to her nursing experience, she has earned a master’s degree in social work. Becoming a Licensed Clinical Social Worker was a long-sought-after goal which she finally attained. She is a caregiver for her family and her dogs as well.

Pain management is essential in cancer care, especially in surgical oncology settings. Oncology RNs may administer narcotic pain killers to their patients on either a prn (“pro re nata” or as needed basis) or a scheduled basis. Unfortunately, this also opens the door to nurse abuse of high-risk medications, and other issues. Although the popular Netflix series 

 has brought attention to a specific nurse intending to cause harm, there are statistics which suggest that innappropriate handling of high-risk medications is a relevant problem for many institutions.

The rate of substance abuse in the United States is 6% to 8%.

According to the American Nurses Association, this figure has held true for the past 3 decades, and the percentage rate is comparative to the substance abuse rate in the country overall.

However, the general population does not typically have access to the same medications that nurses have access to.

RNs must chart on the electronic medication administration record, MAR, that the medication was given to their patient. However, it is possible to pretend to give an intravenous (IV) push medicine by trading it for saline or sterile water. The liquid pain medication can be extracted with a needle and compatible flushes and vials are readily available in the hospital. This scenario happens despite the advent of the computerized drug dispensers, known as the Pyxis or Omnicell. 

Drug diversion is defined as when a drug, in this case a narcotic, does not reach the patient. It is then used by the nurse, or may even be sold by the health care professional. Drug diversion includes drug theft, or tampering (adulteration or substitution). 

 Moreover, it is a felony that can result in a nurse’s criminal prosecution and loss of license.

What happens when a nurse tampers with narcotics? First of all, the patient suffers. Their pain is not controlled. The patients on the floor or unit experience what is described as “inadequate care from impaired health care workers.”

 Patients may also be at risk of infections from contaminated syringes.”

 The hospital or health care setting does not escape unscathed neither. They can accrue fines and may lose Medicare funding. The nurse with substance abuse disorder may also experience hardship as he or she could find themselves facing both legal and medical consequences of their addiction.

I work in surgical oncology and sometimes a dose is ordered that is less than what is dispensed. There are cameras in the med room to document what has transpired. Despite this safeguard, drug diversion continues.

 When a nurse signs off on a waste that was not witnessed, a note in the system can be added and an incident report can be created as a prompt for patient safety concerns not as a punitive measure.

 One potential solution to this problem may lay with pharmacy—if wider dose ranges are available it may become more difficult to make excuses for differences between ordered and administered doses.

 Having a designated bin where all witnessed narcotic waste is discarded is another potential strategy. In any case, unapproved Environmental Protection Agency methods of disposing drugs—such as discarding meds down a sink or in a sharps container—must be avoided.

I am in Florida, and there is a mandatory reporting law in this state for nurses with substance abuse problems. Different states have individual reporting requirements, so these processes can depend on where you are employed, but in Florida, hospital or medical facilities should report nurses suspected of experiencing substance abuse disorder to the Department of Health or Intervention Project for Nurses (IPN). The IPN was created in 1983 with the purpose of protecting the public by helping nurses with substance abuse disorders. The IPN gives them the tools to cope with substance abuse.

The IPN is contracted by the Florida Department of Health to help nurses through “state-wide education, support and monitoring to nurses with impairing conditions such as substance use disorders.”

 Florida statute 456.076 is the legal basis for this project.

, streaming on Netflix, based on the book by Charles Graeber tells the story of convicted serial killer Charles Cullen, RN.6He repeatedly took out Digoxin and Insulin and spiked IV bags with these high-risk medications. Cullen would also take out medication and then cancel the removal before closing the Pyxis. A nurse on the unit, one of his coworkers and friends, risked her safety to pull all his Pyxis and Cerner records—which showed his documentation—to bring him to justice. He is now serving multiple life sentences.

These issues and the buzz around this series, 

, suggest that inappropriate handling of high-risk medications is an issue which is not going away soon. This has been the topic of the day in many nurses’ stations nationwide. The oncology nurse should be aware of the issues regarding impairment to effectively function in the healthcare setting.

Pavlovich-Danis SJ. The nurse with substance use disorder: moving past the “impaired” nurse label. June 18,2019

https://cedirect.continuingeducation.com/Aspx/CourseContent.aspx?uniqueid=38817892&topicid=601&page=1&IsAnthology=1

Webster A. Drug and alcohol rehab for nurses near you. American Addition Centers. September 14, 2022. Accessed December 5, 2022. 

Alunni-Kinkle S. Identifying substance use disorder in nursing. 

. 2015;46(12):53-54. doi:10.1097/01.NUMA.0000473512.38679.ca

Nyhaus, J. Drug diversion in healthcare: prevention and detection for nurses. 

About us. IPN: Intervention Project for Nurses. March 2022. Accessed November 28, 2022. 

Nicholson A.‘The Good Nurse’ review: Bad medicine. 

. October 27, 2022. Accessed November 28, 2022. https://nyti.ms/3VMSzMS



Sometimes nurses inappropriately handle high-risk medications. It is important that other nurses, especially those who work in pain management, hold colleagues accountable to promote patient safety. 

Opinion: The Good Nurse Brings Safe Narcotic Handling to the Forefront of Nursing Minds

Adjuvant pembrolizumab (Keytruda) was associated with better quality of life (QOL) outcomes compared with ipilimumab (Yervoy) or high-dose interferon α 2b (HDI) in patients with resected melanoma, according to a secondary analysis of the randomized SWOG S1404 trial (NCT02506153).

, showed that patient-reported outcomes collected at cycle 3 of treatment using the Functional Assessment of Cancer Therapy Biological Response Modifiers Trial Outcome Index (FACT-BRM TOI) score were 9.6 points higher with pembrolizumab than comparators (95% CI, 7.9-11.3; 

 < .001). Investigators hypothesized that a difference of 5.0 points would signal clinically meaningful difference in QOL with pembrolizumab.

In the linear-mixed models, pembrolizumab surpassed ipilimumab and HDI by over 5 points through cycle 7, and in the post hoc analysis, the FACT-BRM TOI scores favored the pembrolizumab arm against both the ipilimumab (difference, 6.0 points; 95% CI, 4.1-7.8;

 < .001) and HDI arms (difference, 17.0 points; 95% CI, 14.6-19.4;

“We found that QOL end points for patients randomized to receive treatment with pembrolizumab were superior than those of patients randomized to treatment with ipilimumab/HDI,” wrote Joseph Unger, PhD, MS, associate professor, biostatistician, and health services researcher with the Cancer Prevention Program and Public Health Sciences Division of Fred Hutch Cancer Center, and coinvestigators, in the study.

Immune checkpoint blockade has repeatedly demonstrated its benefit in the adjuvant setting for high-risk melanoma; in 2015, ipilimumab outperformed placebo in prolonging recurrence-free survival (RFS), although patients in the experimental arm experienced worse QOL and patient-reported symptoms were higher for diarrhea, and insomnia.

In the KEYNOTE-054 trial (NCT02362594), pembrolizumab also extended RFS compared with placebo; but again was associated with detriments to QOL. However, in both trials, the worse QOL outcomes were deemed clinically insignificant and therefore supported widespread adoption of immune checkpoint inhibitor adjuvant therapy in melanoma.

The CheckMate 238 trial (NCT02388906) found that the PD-1 inhibitor nivolumab (Opdivo), elicited superior RFS than the CTLA-4 inhibitor, ipilimumab; however, the differences in QOL outcomes between the 2 immune checkpoint inhibitors were not considered meaningful.

“An important issue in the adjuvant treatment of patients with high-risk melanoma is how patients weigh the benefits of RFS, overall survival, and QOL,” study authors noted. “Adjuvant high-dose interferon improves RFS for this patient population but is known to be associated with major grade 3 to 4 toxic effects and impaired QOL. Ipilimumab, a cytotoxic T-lymphocyte antigen 4–blocking antibody, has been shown to provide longer RFS in resectable high-risk melanoma, but to result in potentially dose-limiting toxic effects.”

The S1404 trial was a randomized, phase 3 clinical trial, which was conducted across 211 community and academic sites in the US, Canada, and Ireland. The trial enrolled patients with high-risk melanoma to assess the clinical efficacy of pembrolizumab in this setting.

Patients were enrolled between December 2015 to October 2017 and randomly assigned 1:1 to adjuvant treatment with either pembrolizumab or standard of care (ipilimumab/DHI). The QOL analysis captured responses from 832 evaluable patients. Previous reports form the trial showed that pembrolizumab resulted in a significantly longer RFS than standard of care with a 23% reduction in risk of relapse (HR, 0.77; 99.62% CI, 0.59-0.99; 

Patients were assessed for QOL at baseline, and again at cycles 1, 3, 5, 7, and 9. QOL outcomes was assessed via the FACT-BRM TOI ,FACT-General, Functional Assessment of Chronic Illness Therapy–Diarrhea, and the European QOL 5-Dimension 3-Level scales. However, the FACT-BRM TOI scores at the end of cycle 3 were the primary comparison point.

At cycle 3, 267 (32.1%) were receiving standard of care treatment and 565 (67.9%) were receiving pembrolizumab. The rates of FACT-BRM TOI compliance were similar (ipilimumab/HDI, 96.0% vs pembrolizumab, 98.3%; 

Overall, adverse events (AEs) occurred in over 90% of patients in the intention-to-treat population—including 91% (n = 585) of patients receiving pembrolizumab, 95% of patients receiving ipilimumab (n = 401), and 99% (n = 143) of patients receiving HDI. The rates of grade 3 or worse AEs in these 3 groups were 17%, 43%, and 66%, respectively.

Fatigue (59%) and maculo-papular rash (29%) represented the 2 most common AEs linked to pembrolizumab, fatigue (51%) and nausea (48%) were most common with ipilimumab, and fatigue (88%) and aminotransferase increase (70%) were most prevalent with HDI.

Unger JM, Darke A, Othus M, et al. Effectiveness of adjuvant pembrolizumab vs high-dose interferon or ipilimumab for quality-of-life outcomes in patients with resected melanoma: a secondary analysis of the SWOG S1404 randomized clinical trial. 

 Published online November 23, 2022. doi:10.1001/jamaoncol.2022.5486

Adjuvant pembrolizumab demonstrated significantly better quality of life outcomes for patients with resected melanoma vs standard care. 

Adjuvant Pembrolizumab Offers Patients With Resected Melanoma Better QOL Outcomes Than Ipilimumab, High-Dose Interferon 

Zimberelimab (GLS-010) exhibited promising responses and a manageable safety profile in patients with PD-L1–positive, recurrent or metastatic cervical cancer who had progressed after first- or subsequent-line, platinum-containing chemotherapy, according to findings presented at the 2022 SITC Annual Meeting (NCT03972722).

The phase 2 findings showed that patients treated with the fully human anti–PD-1 monoclonal antibody (n = 90) achieved an overall response rate (ORR) of 27.8% (95% CI, 18.85%-38.22%) per independent review committee (IRC), including a complete response rate of 5.6%, a partial response rate at 22.2%, and a stable disease rate of 26.7%. The disease control rate (DCR) was 54.4% (95% CI, 43.60%-64.98%).

“In this pivotal registration phase 2 study, zimberelimab exhibited encouraging therapeutic activity and a manageable safety profile in [patients with] PD-L1–positive recurrent or metastatic cervical cancer,” lead study author, Xiaohua Wu, MD, of Fudan University Shanghai Cancer Center, in Shanghai, China, and colleagues, wrote in the poster presentation of the data.

Zimberelimab previously displayed acceptable safety and preliminary efficacy in a phase 1 study. The phase 2 trial evaluated the agent in patients with PD-L1–positive, recurrent or metastatic cervical cancer who progressed after first- or subsequent-line platinum-containing chemotherapy. Moreover, patients were required to have an ECOG performance status of 0 or 1, at least 1 measurable lesion per RECIST v1.1 criteria, and adequate organ function.

The study used a Simon’s 2-stage design. Stage 1 enrolled 45 patients who received at least 1 prior line of chemotherapy. Investigators initiated stage 2 (N = 105) after at least 3 patients experienced a CR or PR in Stage 1. All patients received 240 mg of intravenous zimberelimab once every 2 weeks. Treatment continued for 24 months or until disease progression or intolerable toxicity.

Fifteen patients in stage 2 were not eligible for efficacy in the full analysis set because they did not receive prior platinum-based chemotherapy. All 105 patients were evaluable for safety.

At the April 29, 2022, data cutoff and at a median follow-up of 16.9 months, 83 patients had discontinued treatment with zimberelimab, and 22 were still on treatment. Reasons for discontinuation included disease progression (n = 56), adverse effects (AEs; 14), investigator’s judgement (n = 5), patient withdrawal (n = 4), death (n = 2), poor compliance (n = 1), or study drug suspension for more than 4 weeks (n = 1).

ORR per IRC assessment served as the primary end point of the trial. Secondary objectives included investigator-assessed ORR, plus DCR, duration of response (DOR), progression-free survival (PFS), overall survival (OS), and time to response (TTR).

The median age of patients evaluable for efficacy from stage 2 was 51 years (range, 31- 75). The majority of patients had an ECOG performance status 1 (62.2%), had previous surgery (71.1%), prior radiotherapy (95.6%), and prior chemotherapy (100%). Moreover, 57.8% of patients received 1 prior line of chemotherapy, 32.2% had previously received 2 lines of chemotherapy, and 10.0% of patients were given at least 3 prior lines of chemotherapy.

Most patients presented with squamous carcinoma (87.8%). Other histologies included adenomatous carcinoma (10%) and adenosquamous carcinoma (2.2%). Finally, 18.9% of patients had stage IB disease, 21.1% had stage IIA, 23.3% had stage IIB, 2.2% had stage IIIA, 11.1% had stage IIIB, 12.2% had stage IIIC, and 7.8% had stage IV.

Additional data showed the median PFS was 3.7 months (95% CI, 1.94-5.55) and the median OS was 16.8 months (95% CI, 11.50–not estimable). The median TTR was 1.9 months (95% CI, 1.84-3.65). The median DOR was not reached, and the 12-month DOR rate was 78% (95% CI, 55%-90%).

Any-grade treatment-emergent AEs (TEAEs) occurred in 97.1% of patients, including grade 3 or higher TEAEs in 41.9% of patients. Any-grade treatment-related AEs (TRAEs) were reported in 78.1% of patients, and 24.8% of patients experienced at least 1 TRAE of grade 3 or higher. Any-grade Immune-related AEs (irAEs) and grade 3 or higher irAEs were reported in 45.7% and 10.5% of patients, respectively. The rates serious AEs and treatment-related serious AEs were 28.6% and 15.2%, respectively.

The most common TRAEs of any grade were hypothyroidism (26.7%), anemia (19.0%), hyperthyroidism (12.4%), elevated aspartate aminotransferase (10.5%), elevated alanine aminotransferase (10.5%), and decreased white blood cell count (10.5%). Grade 3 or higher TRAEs included anemia (7.6%) and decreased white blood cell count (0.7%).

“The trial is still ongoing, and we are looking forward to further results,” Wu and study authors concluded.

Wu X, Xia L G, Wang C, et al. Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, open-label, single-arm, phase II study. Presented at: 2022 SITC Annual Meeting; November 8-12, 2022; Boston, MA. Abstract 673.

Zimberelimab demonstrated encouraging efficacy with a tolerable safety profile in patients with PD-L1–positive recurrent or metastatic cervical cancer who had progressed after first- or subsequent-line, platinum-containing chemotherapy.

Zimberelimab Monotherapy Proves Safe, Effective in PD-L1–Positive Cervical Cancer 

All checkpoint inhibitor-naïve patients with Merkel cell carcinoma demonstrated an objective response with the combination of nivolumab (Opdivo) and ipilimumab (Yervoy), according to data from a phase 2 trial (NCT03071406). Notably, the addition of stereotactic body radiation therapy (SBRT) did not impact the objective response rate (ORR), which was 100% (95% CI, 82%-100%).

Among all 24 patients who did not receive prior treatment with a checkpoint inhibitor, 13 received nivolumab/ipilimumab alone and 11 were administered nivolumab/ipilimumab with SBRT. Data presented at the 2022 ESMO Congress showed that 41% of all checkpoint inhibitor–naïve patients achieved a complete response (CR) and 59% had a partial response (PR). Nine percent of patients experienced disease progression following an initial response.

In patients who received prior treatment with a checkpoint inhibitor (n = 26), nivolumab/ipilimumab with or without SBRT produced an ORR of 31% (95% CI, 15%-52%), with a CR rate of 15% and a PR rate of 15%. Additionally, 1 patient had stable disease, 65% of patients experienced progressive disease, and 50% of responders progressed following an initial response. Those given nivolumab/ipilimumab alone and a prior checkpoint inhibitor (n = 12) achieved an ORR of 42% (95% CI, 16%-71%), and those who received nivolumab/ipilimumab plus SBRT and a prior checkpoint inhibitor had an ORR of 21% (95% CI, 6%-51%).

“[The] addition of SBRT did not improve the efficacy of nivolumab/ipilimumab,” Sungjune Kim, MD, PhD, the director of Radiation Oncology Translational Research and an associate member of the Department of Radiation Oncology and Department of Immunology at Moffitt Cancer Center, wrote in a presentation of the data.

The open-label, randomized, phase 2 trial investigated the combination of nivolumab and ipilimumab with or without SBRT in patients aged at least 18 years with recurrent or metastatic MCC who had at least 2 distinct lesions to assess response in the non-irradiated lesion. Patients were also required to have an ECOG performance status of 0 to 1. Patients could not have active brain metastases. Patients were stratified based on prior immunotherapy.

Patients in arm A (n = 25) received 240 mg of nivolumab every 2 weeks plus 1 mg/kg of ipilimumab every 6 weeks. Those in arm B (n = 25) received the same nivolumab/ipilimumab regimen plus 24 Gy/3 fx of SBRT at week 2. Treatment continued until disease progression, unacceptable toxicity, or withdrawn consent.

ORR served as the trial’s primary end point. Secondary end points included overall survival (OS), progression-free survival (PFS), local control, and exploratory biomarkers.

Among all enrolled patients (n = 50), the median age was 73 years (interquartile range, 67-81), 78% of patients were male, and all patients were White. Patients either had an ECOG performance status of 0 (46%) or 1 (54%). Patients had stage IIIB (24%) or IV (76%) disease. Forty-eight percent of patients were naïve to checkpoint inhibitors and 90% were chemotherapy naïve.

Additional data showed that the median duration of response (DOR) was not evaluable (NE; 95% CI, 34-NE) in all patients who were naïve to checkpoint inhibitors. For those with prior exposure to checkpoint inhibitors, the median DOR was 11 months (95% CI, 5-NE). In arm A, the median DORs in the checkpoint inhibitor–naïve and–exposed populations were NE (95% CI, 34-NE) and 15 months (95% CI, 7-NE), respectively. In arm B, the median DOR in these populations were NE and 5 months (95% CI, 3-NE), respectively.

The median PFS was NE among checkpoint inhibitor–naïve patients in both arms. Those with prior checkpoint inhibitor treatment in arms A and B experienced a median PFS of 4.2 months and 2.7 months, respectively. The median OS was NE for both arms among patients without prior checkpoint inhibitor exposure. Those in arm A with prior checkpoint inhibitor treatment achieved a median OS of 14.9 months compared with 9.7 months for those in arm B.

Regarding safety, 54% of all patients experienced at least 1 grade 1/2 treatment-related adverse effect (TRAE). The rates of grade 1/2 TRAEs in arm A and arm B were 44% and 64%, respectively. Grade 3 TRAEs occurred in 26% of all patients, including 28% of those in arm A and 24% of those in arm B. Grade 4 TRAEs were reported in 10% of all patients, including 12% of those in arm A and 8% of those in arm B.

Overall, 8 patients discontinued treatment due to toxicity.

Kim S, Wuthrick E, Blakaj DM, et al. Combined nivolumab and ipilimumab with or without stereotactic body radiation therapy for advanced Merkel cell carcinoma. 

. 2022;33(suppl 7):S1409-S1410. doi:10.1016/j.annonc.2022.08.041

All 24 patients with Merkel cell carcinoma who received nivolumab plus ipilimumab responded to treatment, and 41% achieved complete responses. 

Nivolumab/Ipilimumab Induces Stark Overall Response Rate in Checkpoint Inhibitor–Naïve Merkel Cell Carcinoma

Combining enzalutamide with salvage radiation therapy helped delay prostate-specific antigen progression in patients with PSA-recurrent, high-risk prostate cancer.

Enzalutamide Inspires Meaningful Delay in PSA Progression For Patients With PSA-Recurrent High-Risk Prostate Cancer

The FDA has approved olutasidenib capsules to treat patients with relapsed or refractory acute myeloid leukemia with identified an IDH1-mutation. The label comes with a boxed warning for differentiation syndrome, and a warning for hepatotoxicity. 

Olutasidenib Approved for IDH1-Mutated Acute Myeloid Leukemia 

Nurse investigators created an enteral nutrition standardized pathway for pediatric patients about undergoing hematopoietic stem cell transplantation. 

Enteral Nutrition Pathway for Pediatric Patients Highlights Challenges in Combatting Malnutrition During HSCT 

Trastuzumab and pertuzumab with a chemotherapy regimen of fluorouracil, leucovorin, oxaliplatin, and docetaxel increased response, and high-grade toxicity, in patients with HER2-positive gastric or gastroesophageal junction cancer.

Benefit-Risk Profile of Trastuzumab/Pertuzumab With FLOT Regimen Comes Into Question in HER2-positive Gastric Cancer

Podcasts

For this episode of “The Vitals,” Aliènne Salleroli, MS, BSN, RN, OCN, discusses her research on equity, diversity, and inclusion in oncology nurse leadership.

Equity, Diversity, and Inclusion in Oncology Nursing Leadership

Private Medicare beneficiaries face high access barriers and increased mortality rates following oncologic resection than patients with traditional Medicare plans. 

Private Medicare Plans Lead to Worse Oncologic Surgery Outcomes vs Traditional Medicare

In November 2022, HER2-directed therapies made headlines in breast cancer as did innovations to help individuals who are often overlooked in oncology care. 

Oncology Nursing News Top Stories: November 2022

Pembrolizumab plus physician’s choice of chemotherapy bested placebo plus chemotherapy in improving overall survival rates in patients with HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma, regardless of PD-L1 expression.

Pembrolizumab Combination Delivers Overall Survival Benefit in HER2-Negative Gastric/GEJ Adenocarcinoma

An observational study of 2450 patients with stage III colon cancer identified key factors that may increase a patient’s risk of oxaliplatin-induced peripheral neuropathy. 


Fewer Cycles of Oxaliplatin Treatment May Reduce Incidence of Severe Neuropathy for Patients With Stage III Colon Cancer

Videos

Certified Nurse Practitioner Kimberly Spickes shares the educational and supportive resources she recommends for patients with newly-diagnosed advanced endometrial cancer.

Resources for Patients With Endometrial Cancer

Nurse Practitioners Kathleen Lutz and Kimberly Halla describe the conversations they have with patients with advanced endometrial cancer before and after diagnosis and the common questions they hear.

Conversations with Patients With Advanced Endometrial Cancer Before and After Diagnosis

In light of findings from the phase 3 DREAMM-3 trial, manufacturers have elected to withdraw belantamab mafodotin-blmf from the United States market.  

Belantamab Mafodotin Will No Longer Be Available For Multiple Myeloma

Disease-free survival in patients with metastatic breast cancer did not differ between treatment with everolimus or placebo.

Everolimus Fails to Show DFS Benefit in Aromatase Inhibitor–Resistant Metastatic Breast Cancer 

Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

Combining ponatinib with reduced-intensity chemotherapy elicited a high rate of minimal residual disease (MRD)-negative complete remissions and no new safety signals in patients with Philadelphia chromosome–positive acute lymphoblastic leukemia.

Ponatinib Outperforms Imatinib in Newly Diagnosed Philadelphia Chromosome+ Acute Lymphoblastic Leukemia  

Combining the doxorubicin analogue camsirubicin with pegfilgrastim yielded encouraging clinical activity in patients with advanced soft tissue sarcoma. 

Top Medical News

Futibatinib Approval Ushers in Targeted Therapy Option for Patients With Unresectable, Intrahepatic FGFR2-Positive Cholangiocarcinoma

Opinion: The Good Nurse Brings Safe Narcotic Handling to the Forefront of Nursing Minds

Adjuvant Pembrolizumab Offers Patients With Resected Melanoma Better QOL Outcomes Than Ipilimumab, High-Dose Interferon

Zimberelimab Monotherapy Proves Safe, Effective in PD-L1–Positive Cervical Cancer

Nivolumab/Ipilimumab Induces Stark Overall Response Rate in Checkpoint Inhibitor–Naïve Merkel Cell Carcinoma

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