CE lesson worth 1 contact hour that is intended to advanced practice nurses, registered nurses, and other healthcare professionals who care for patients with cancer.
Release Date: February 22, 2021 Expiration Date: February 22, 2022 This activity is provided free of charge.
STATEMENT OF NEED
This CE article is designed to serve as an update on cancer detection and prevention and to facilitate clinical awareness of current and new research regarding state-of-the-art care for those with or at risk for cancer.
Advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients may participate in this CE activity.
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METHOD OF PARTICIPATION
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Adding Daratumumab to Combination Therapy Improves Response Rates for Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma
The addition of daratumumab (DARA), a CD38-targeted monoclonal antibody, to lenalidomide, bortezomib, and dexamethasone (RVd) induction and consolidation followed by DARA-lenalidomide (D-R) maintenance led to a significant improvement in response rates and depth of response compared with the DARA-free regimen for transplant-eligible patients with newly diagnosed multiple myeloma, according to data presented at the 62nd American Society of Hematology Annual Meeting and Exposition, held virtually December 5 to 8, 2020.1
The results of an updated analysis of the phase 2 GRIFFIN study (NCT02874742) highlighted that D-R maintenance therapy improved patients’ depth of response while maintaining remissions.
“These results support D-RVd as a potential new standard of care for transplant-eligible [patients with] newly diagnosed multiple myeloma,” Jonathan L. Kaufman, MD, Medical Director and Section Chief of the Winship Cancer Institute Ambulatory Infusion Centers, associate professor in hematology and medical oncology at Emory University, in Atlanta, Georgia, said in his presentation of the data.
The investigators compared the updated results (after 12 months of maintenance therapy, at a median follow-up of 26.7 months) against earlier data from the primary analysis (after consolidation, at a median follow-up of 13.5 months). They found that patients’ responses to the treatments deepened over time, with response rates and depths greater for patients in the D-RVd arm at all points in time. At the end of consolidation, the stringent complete response (sCR) rate was 42.4% in the D-RVd arm (n = 99) compared with 32.0% in the RVd alone arm (n = 97; 1-sided P = .0680, which met prespecified 1-sided alpha of .10). The updated, post-maintenance data showed an sCR rate of 63.6% for the D-RVd arm versus 47.4% for the RVd alone arm (2-sided P = .0253, which met prespecified 2-sided alpha of .05).
Investigators also examined the post-maintenance minimal residual disease (MRD) negativity rate (10-5 threshold). They found that, in the intent-to-treat population, the total MRD negativity rate in the D-RVd arm was 62.5% compared with 27.2% for the RVd alone arm (P < .0001). When the analysis was limited to MRD-evaluable patients (those with both baseline and follow-up samples), the MRD negativity rate was 78.3% for the D-RVd arm (n = 83) versus 39.4% for the RVd alone arm (n = 71; P < .0001).
Moreover, the durability of MRD negativity was significantly greater in the D-RVd arm versus the RVd alone arm. The proportion of patients with MRD negativity lasting at least 6 months was 37.5% in the D-RVd arm (n = 104) compared with only 7.8% in the RVd alone arm (n = 103; P < .0001). Similarly, 28.8% and 2.9% (P < .0001) of patients were MRD negative for at least 12 months.
When patients were stratified by factors such as sex, age, disease stage, cytogenetic risk, and ECOG score, the MRD negativity results showed that all examined subgroups benefited from adding DARA to RVd treatment.
“D-RVd is now considered a treatment that is appropriate [by] NCCN [National Comprehensive Cancer Network]. Based on the data I presented, we have made this our standard of care at our center,” explained Kaufman. “It is a regimen that’s well tolerated, it’s effective, it doesn’t negatively impact the ability to collect stem cells or [for stem cells] to engraft after transplant. The goal of our induction therapy is to induce MRD negativity, and what we see here is that this regimen is very good at inducing MRD negativity.”
The primary end point of the study was the post-consolidation sCR rate, with secondary end points including MRD negativity and clinical response rates.
The investigators also stated that, at a median follow-up of 27.4 months, there was no significant difference between the arms in progression-free or overall survival.
Although there were higher rates of neutropenia and upper respiratory infections for D-RVd compared with RVd alone, these increased rates did not lead to higher rates of treatment discontinuation. Moreover, similar rates of any-grade and grade 3/4 infections were observed for D-RVd and RVd alone.
Looking ahead, the ongoing phase 3 PERSEUS study is evaluating the same 2 treatment regimens in the same patient population. However, patients in this trial will receive a subcutaneous formulation of DARA, rather than intravenous one used in GRIFFIN (NCT03710603).
Kaufman JL, Laubach JP, Sborov D, et al. Daratumumab (DARA) plus lenalidomide, bortezomib, and dexamethasone (RVd) in patients with transplant-eligible newly diagnosed multiple myeloma (NDMM): updated analysis of Griffin after 12 months of maintenance therapy. Presented at: 62nd ASH Annual Meeting and Exposition; December 5-8, 2020; Virtual. Abstract 549. Accessed December 8, 2020.
High-Dose Imetelstat Improves Overall Survival and Offers Clinical Benefits in Intermediate-2 and High-Risk Myelofibrosis
Patients with myelofibrosis who have relapsed after or are refractory to therapy with Janus kinase (JAK) inhibitors saw a dose-related trend toward better overall survival (OS), spleen response, and symptom response with the telomerase inhibitor imetelstat, according to an analysis of results of the phase 2 IMbark study (MYF2001; NCT02426086) presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, held virtually December 5 to 8, 2020.1 The randomized, single-blind study evaluated the efficacy of 2 doses of intravenous imetelstat: 4.7 mg/kg and 9.4 mg/kg, both every 3 weeks.
“No matter what clinical benefit one looks at, whether it's survival, symptom response, spleen response, progression-free survival, clinical improvement, transfusion independence, reduction in bone marrow fibrosis, or reduction in the variant allele fraction of driver mutations, there was superiority at the high dose of the active arm of this treatment with imetelstat in this patient population [with] very advanced JAK inhibitor–failure [disease],” said John Mascarenhas, MD, associate professor of medicine at the Icahn School of Medicine at Mount Sinai, in New York, New York, in a presentation of study results at ASH.
The improvement in OS was further supported by the results of an analysis comparing the IMbark patients in the high-dose arm against closely matched real-world controls treated with best available therapy.2
At ASH, Mascarenhas presented results of the intent-to-treat (ITT) analysis, which also evaluated associations between OS and spleen response, symptom response, and bone marrow fibrosis improvement, as well as the prognostic effects of pretreatment baseline characteristic factors on OS. All 107 enrolled patients (9.4 mg/kg arm, n = 59; 4.7 mg/kg arm, n = 48) were included in the ITT analysis.
The coprimary end points of spleen response and symptom response, both at week 24, were defined as a spleen volume reduction of 35% or more and a total symptom score (TSS) reduction of 50% or more, respectively. OS was a key secondary end point, and bone marrow fibrosis was assessed by a central pathologist.
At a median follow-up of 41.7 months (range, 0.2-49.2 months), median OS was 28.1 months in the 9.4 mg/kg arm (95% CI, 22.8-31.6) and 19.9 months in the 4.7 mg/kg arm (95% CI, 17.1-33.9). Similar results were observed in sensitivity analyses that accounted for confounding factors of subsequent therapies, including stem cell transplantation and dose escalation from 4.7 mg/kg to 9.4 mg/kg. At 24 months, 57.9% (95% CI, 43.6%-69.7%) of patients in the high-dose arm were alive, compared with 42.0% (95% CI, (27.4%-56.0%) in the low-dose arm.
There was also a dose-related improvement in bone marrow fibrosis, which was significantly correlated with lower risk of death. Of the 57 patients with available bone marrow data, 19 (33%) had bone marrow fibrosis improvement of at least 1 grade, and significantly more of these patients survived compared with those who had worsening bone marrow fibrosis (HR, 0.36; 95% CI, 0.13-0.96; P = .04). According to Mascarenhas, “this also trended for patients who had stability in bone marrow fibrosis over the treatment period.”
Patients who achieved symptom response at week 24 also exhibited a nonsignificant trend toward longer OS compared with those without symptom response or who had no assessment (HR, 0.79; 95% CI, 0.41-1.51). In terms of imetelstat dose, a TSS reduction of 50% or more occurred in 32.2% and 6.3% of patients in the high- and low-dose arms, respectively.
A similar trend toward longer OS was seen for patients who achieved spleen response at week 24 (HR, 0.46; 95% CI, 0.11-1.92). Regarding the effect of dose on this factor, Mascarenhas said, “If you look at patients who had even a 10% or greater reduction in spleen volume with imetelstat treatment in the 9.4 mg/kg arm, half the patients attained this versus 19% in the low-dose arm.”
Mascarenhas and his colleagues identified several baseline disease characteristic factors as prognostic for survival irrespective of treatment dose. Pretreatment high risk according to the dynamic International Prognostic Scoring System, ECOG performance status of 2, transfusion dependency, higher baseline neutrophils, and lower baseline hemoglobin and platelet values all correlated with increased risk of death.
“Myelofibrosis is a serious, life-threatening myeloproliferative neoplasm. Patients who are relapsed after or refractory to JAK inhibitor therapy have a dismal overall survival that ranges between 13 and 16 months,” Mascarenhas explained.
These data, however, suggest dose-related improvement in OS in this patient population, highlighting the need for further clinical studies. Accordingly, Mascarenhas provided a preview of the upcoming IMpact study (IMpactMF, NCT04576156), a phase 3 trial of imetelstat at 9.4 mg/kg compared with best available therapy. IMpact is expected to be open for screening and enrollment in the first quarter of 2021.
Both Patients and Nurses Prefer Subcutaneous Rituximab Administration
Nurses and other health care providers agreed with patients in their preference for a subcutaneously (SC) administered form of rituximab (rituximab and hyaluronidase human; Rituxan Hycela) over the intravenous (IV) formulation (Rituxan), according to recent research presented at the 62nd American Society of Hematology Annual Meeting and Exposition, held virtually December 5 to 8, 2020.1
“Among nursing staff, time savings, convenience, and perceived patient preference contributed to the positive experience [of giving rituximab subcutaneously],” study author Mitul Gandhi, MD, said in his presentation. Gandhi is a medical oncologist at Virginia Cancer Specialists in Gainesville, Virginia.
The SC formulation of rituximab received FDA approval in 2017 to treat follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).
The investigators surveyed 29 patients with those malignancies (13 follicular lymphoma, 12 DLBCL, and 4 CLL) between July 2017 and April 2019. The average age was 69 years, and the majority of patients had a preserved ECOG performance status and had received both the IV and SC formulations.
Sixty-nine percent of patients said they preferred SC rituximab. Common reasons cited included less time spent in the clinic (69% of respondents) and less emotional distress (41%).
Additionally, 62% of patients said that SC rituximab was very convenient, compared with 45% who responded the same about the IV formulation. SC administration was shown to be easier, too, as only 28% of respondents said it required caregiver assistance, compared with 45% of respondents regarding IV.
Similarly, of 36 nurses who completed a separate survey, 58% reported that they preferred SC rituximab administration, citing that this method saves time, is convenient, and is preferred by patients. Most nurses (80%) said that they spent 1.5 to over 2 hours administering and monitoring IV rituximab for each patient, and more than half (52%) said that 1.5 to 2 hours could be saved with each SC administration compared with IV.
Regarding nurse characteristics, the majority were younger than 65 years, had more than 1 year of clinical experience, and had familiarity with administering both the IV and SC rituximab formulations.
“In conclusion, even though our study was limited by a small sample size, the majority of surveyed patients and nurses expressed a preference for subcutaneous rituximab over intravenous rituximab, with reduced clinic time as the main motivation for this preference,” Gandhi said.
So, nurses and other clinicians should discuss patient preferences—as well as the pros and cons of each method of administration—with their patients before deciding on a rituximab formulation.
“[These] real-word data [provide] useful information regarding the administration of subcutaneous rituximab in a community oncology setting,” Gandhi said.
References are available on OncNursingNews.com.
Gandhi MD, Shapouri S, Ravelo A, Sudharshan L, Beeks A, Dawson KL. NHL patients and nurses in the US prefer subcutaneous rituximab injection versus intravenous rituximab infusion: a real-world study. Presented at: 62nd ASH Annual Meeting and Exposition; December 5-8, 2020; Virtual. Abstract 1609.
Karolina Faysman, MSN, RN, AOCNP
[SUBCUTANEOUS RITUXIMAB (RITUX-AN HYCELA)] IS usually given after a patient received at least 1 dose of intravenous rituximab (Rituxan) without a re-action. So if the patient had a first infusion of rituximab and had a reaction, they cannot proceed with [subcutaneous rituximab] until they had a second dose without a reaction. Once they can tolerate rituximab infusion, then they can move on to [subcutaneous rituximab]. With [subcutaneous] rituximab, administration comes with hyaluronidase acid, therefore the collagen and subcutaneous tissue become flexible to allow the infusion of a large volume. The injection lasts between 5 and 7.5 minutes, maybe up to 15 minutes, depending on how obese the patient is. As a matter of fact, the more obese a person is, the easier it will go in versus someone who is very thin. You can’t in-crease the rate of injection, you can’t push it in. So, nurses shouldn’t be apprehensive about injecting it too quickly and creating a subcutaneous hematoma or abscess. Upon completion of injection, there should be no bumps or visible changes in the skin.
Treatment With Rituximab Plus Ibrutinib Benefits Patients With Waldenström Macroglobulinemia for Up to 5 Years
Darlene Dobkowski, MA
Treatment with the anti-CD20 antibody rituximab (Rituxan) plus the Bruton tyrosine kinase inhibitor ibrutinib (Imbruvica) in patients with Waldenström macroglobulinemia, a slow-growing type of non-Hodgkin lymphoma, led to superior response and progression-free survival (PFS) after up to 5 years of follow-up compared with rituximab plus placebo, according to data presented at the 62nd American Society of Hematology Annual Meeting and Exposition, held virtually December 5 to 8, 2020.1
“When you add rituximab [to single-agent ibrutinib], the response rates and PFS largely act independently of the genotype,” said Christian Buske, MD, medical director of the Comprehensive Cancer Center Ulm at the Institute of Experimental Cancer Research at University Hospital Ulm in Germany, during a discussion after his virtual presentation of the data. “In addition, by adding rituximab, the time to response is shorter. And this is clinically relevant because many of the patients we are treating are really suffering from Waldenström [macroglobulinemia]. For us as clinicians, it's an advantage to see that this approach indeed works and helps the patient.”
In the phase 3 iNNOVATE trial (PCYC-1127; NCT02165397), investigators analyzed data from 150 patients with confirmed symptomatic Waldenström macroglobulinemia who were either treatment naïve or previously treated. If prior therapy involved rituximab, a minor response or better was required. All patients were randomly assigned to weekly intravenous rituximab (375 mg/m2, weeks 1-4 and 17-20) plus either once-daily ibrutinib (420 mg; 75 patients; median age, 70 years; 60% men) or placebo (75 patients; median age, 68 years; 72% men).
“The overall goal of this trial was to compare 2 chemotherapy-free approaches,” said Buske during the discussion. “Particularly in the US, rituximab single agent was the most frequently used chemotherapy-free approach before the introduction of ibrutinib.”
The trial’s primary end point was median PFS. Other end points of interest included response rates, overall survival (OS), time to next treatment, hemoglobin improvement (defined as an increase of ≥20 g/L sustained continuously for ≥8 weeks without blood transfusion or growth factors), and safety.
At a median follow-up of 50 months, median PFS was not reached in the rituximab plus ibrutinib arm, compared with 20.3 months in the rituximab monotherapy arm (HR, 0.25; 95% CI, 0.15-0.42; P < .0001). At 54 months, PFS rates were 68% and 25%, respectively. The PFS benefit of the combination over monotherapy was maintained regardless of genotype or prior treatment status and was observed across several subgroups, including sex, age at baseline, hemoglobulin, serum immunoglobulin, and International Prognostic Scoring System for Waldenström Macroglobulinemia score, which is used to stratify patients with this condition into risk groups.
The major response rate, defined as a partial response to treatment or greater, was 76% in patients assigned to rituximab plus ibrutinib vs 31% in those assigned to rituximab plus placebo (P < .0001). Overall response rates (ORRs), defined as a minor response or greater, were 92% and 44%, respectively (P < .0001). Higher ORRs were observed in the rituximab plus ibrutinib arm, regardless of prior treatment status and across genotypes. More patients who received the combination had sustained hemoglobin improvement compared with those assigned to rituximab alone (77% vs 43%; P < .0001). Median OS was not reached in either treatment arm (HR, 0.81; 95% CI, 0.328-1.990; P = .6430). At 54 months, the OS rate was 86% in the combination group compared with 84% in the monotherapy group. Crossover to single-agent ibrutinib, which was allowed in cases of confirmed disease progression, occurred in 47% of patients originally assigned to rituximab plus placebo.
Median time to next treatment was not reached in the combination arm and was 18 months in the monotherapy arm. At 54 months, subsequent treatment had not been received by 87% and 29% of patients, respectively.
The median treatment duration for the rituximab plus ibrutinib arm was 48 months. The safety profile for this group was consistent with previous reports from this study, with minimal differences in common adverse event (AE) rates during the 24 months of additional follow-up since the primary analysis. The most common grade 3 to 4 AEs in the combination arm included atrial fibrillation (16%), hypertension (15%), neutropenia (13%), and anemia (12%).
“These adverse events are quite rare, and at least when you look at dose reduction or diarrhea or hypertension, there's a tendency that these adverse events occur less frequently later on during treatment,” said Buske. “With [at least grade 3] atrial fibrillation, we see again the same phenomenon; there's a tendency that these adverse events occur less frequently with longer treatment.”
Nine of the 12 patients who developed grade 3 or 4 atrial fibrillation remained on treatment, and no other serious AEs led to patients discontinuing ibrutinib. After the study ended, 45% (n = 68) of all patients remained on rituximab plus ibrutinib.
“I think an important notion is that responses are deepening over time, that patients can achieve up to a 30% very good partial [response rate] with longer treatment,” said Buske.
Buske C, Tedeschi A, Trotman J, et al. Five-year follow-up of ibrutinib plus rituximab vs placebo plus rituximab for Waldenstrom’s macroglobulinemia: final analysis from the randomized phase 3 iNNOVATE study. Presented at: 62nd ASH Annual Meeting and Exposition; December 5-8, 2020; Virtual. Abstract 336.
Patients With Hematologic Cancers Are at Increased Risk for Adverse COVID-19 Outcomes
Patients with hematologic malignancies are at increased risk for significant morbidity and mortality from coronavirus disease 2019 (COVID-19), and the risk of adverse outcomes from the disease appears to be greatest in those who are older, have more advanced cancer, have a poorer cancer prognosis, or decide to forgo intensive COVID-19 treatment, according to updated data from the American Society of Hematology (ASH) Research Collaborative (RC) COVID-19 Registry presented at the 62nd ASH Annual Meeting and Exposition.1
Twenty percent of the 656 patients included in the registry cohort had died. Among patients who required either hospital- or intensive care unit (ICU)–level care, the mortality rate was 33%; this rate was almost doubled (65%) in those with ICU-level severity.
Additionally, COVID-19 disease severity was strongly associated with malignancy status at the time of COVID-19 diagnosis. Specifically, 69% of patients with a recent cancer diagnosis had moderate or severe COVID-19 compared with 50% of those in remission and 79% of those with relapsed or refractory cancer. Mortality rates differed based on the patient’s prognosis. Patients whose prognosis was less than 12 months at the time of their COVID-19 diagnosis had a mortality rate of 51% compared with just 13% in those whose prognosis was over 12 months. Mortality rates also differed by malignancy status at time of COVID-19 diagnosis, at 21% among patients with a recent cancer diagnosis, 13% of those in remission, and 36% of those with relapsed or refractory cancer.
The proportion of patients with moderate or severe COVID-19 increased with age. Specifically, 47% of patients under the age of 19 years had moderate or severe disease compared with 43% of those aged 19 to 39 years, 62% of those between the ages of 40 and 69 years, and 70% of those who were 70 years or older. Increased age was also linked to higher mortality rates; these rates were 5%, 6%, 18%, and 33% in patients under 19 years, 19 to 39 years, 40 to 69 years, and 70 years and older, respectively.
Twelve percent of patients—90% of which had moderate to severe COVID-19—decided to forgo ICU-level care in favor of a palliative approach. The decision to forgo ICU-level care was associated with age. Forty-two percent of reported deaths were patients who had chosen to forgo ICU care; only 4% of patients who chose to forgo ICU care recovered.In those who declined ICU-level care, the mortality rate was 73% versus 13% for those who did not decline care.
Seventy-seven percent of the patients were 40 years or older, and more than half (60%) were male. With regard to race and ethnicity, 43% were White/Caucasian, 27% were Asian, 17% were Hispanic/Latino or Latina, and 13% were Black/African American.
Fifty-seven percent of the patients had leukemia, 25% had lymphoma, and 18% had plasma cell neoplasms. Comorbidities were reported in 57% of patients, most frequently hypertension and diabetes, which represented 50% and 30% of patients, respectively. Additionally, the majority of patients (80%) had an expected prognosis of greater than 12 months prior to testing positive for COVID-19.
Of patients with reported smoking status, 31% were either current or former smokers. Eleven percent of patients did not have any reported COVID-19 symptoms. The most frequently reported symptoms included fever, cough, shortness of breath, and fatigue. In 60% of patients, symptoms lasted more than 10 days. Azithromycin and hydroxychloroquine had been given more than a third of patients.
Additional results showed no difference in COVID-19 severity by sex, race, or ethnicity. More than 70% of patients with moderate or severe disease had diabetes and/or hypertension. In the year before their COVID-19 diagnosis, more than 65% of patients with moderate or severe COVID-19 had received cytotoxic chemo-therapy, immunotherapy, targeted therapy, and/or other cancer treatment.
The decision to forgo ICU-level care was found to differ by prognosis. Of the patients whose prognosis at the time of COVID-19 diagnosis was more than 12 months, 6% decided to forgo ICU-level care versus 38% of those with an esti-mated prognosis of less than 12 months.
Patients with an estimated pre–COVID-19 prognosis of 12 months or less were more likely to have moderate or severe COVID-19 (79%) compared with those whose prog-nosis was greater than 12 months (58%).
Michelle Gagarin, RN, BSN
NURSES CARING FOR PATIENTS with hematologic malignancies now face a challenge: preventing patients from getting the coronavirus disease 2019 (COVID-19). Luckily, patients have already been following CDC-recommended guidelines, like frequent hand hygiene, avoiding large crowds, and mask wearing. These practices have been heavily engraved for those taking neutropenic precautions. Additionally, patients who have recovered from COVID-19 are no longer seen as contagious and are able to be placed on hematology/oncology units. But it is advised to treat a recovered patient with the same personal protective equipment (PPE) measures as a patient with COVID-19. Masks and goggles are part of the standard PPE, but when entering the rooms, it is recommended to use a gown and N95 mask for better protection.1
COVID-19 can be fatal or interfere with the curative treatments for patients with blood cancer. Most hematology/oncology units have strictly enforced a negative PCR swab prior to admission to inpatient. Additionally, it is vital to triage patients to divert cross-contamination of positive and negative COVID-19 patients.2 Fifty percent of these patients, including patients with multiple myeloma and acute leukemias, arrive to clinics and emergency rooms with fevers as well as a high white blood cell count.3 Nurses must assess whether patients are experiencing the adverse event of chemotherapy or COVID-19, as they are similar. Despite these screening mea-sures, cases arose of false-negative test results, a limitation of the PCR swab.2 Repeating a PCR swab for COVID-19 patients is highly advised. Overall, the greatest safety measure for these vulnerable patients is to limit their exposure to COVID-19 virus.