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

We rounded up 5 stories from the 2022 ASCO Annual Meeting that are of most value to oncology nurses.

This year’s meeting highlighted advances in ovarian clear cell carcinoma, as well as significant differences in tolerability among different approved PARP inhibitors. Investigators also took an inside look at the driving factors behind medication non-adherence in older patients who were prescribed oral therapies, the impact of ribociclib dose reductions on overall survival in patients with hormone receptor–positive, HER2-negative, advanced breast cancer, and whether or not Vitamin D has prognostic value in determining a patient’s risk of developing chemotherapy-induced peripheral neuropathy.

Real-World Data Identify Significant Differences in Tolerability Among Approved PARP Inhibitors in Ovarian Cancer

Patients with ovarian cancer treated with FDA-approved PARP inhibitors had significant differences in the incidence of clinically relevant adverse events (AEs), according to results of a real-world analysis presented at the 2022 ASCO Annual Meeting.

The findings highlight differences in tolerability, use, and dose modifications associated with olaparib (Lynparza), niraparib (Zejula), and rucaparib (Rubraca) for patients treated with ovarian cancer between January 1, 2017, and December 31, 2020.

Crude results found that clinical events of interest (CEIs) were generally stable across calendar years, but were lower with olaparib vs niraparib for most years. Furthermore, the risk of any CEI, as well as time to PARP dose decrease and PARP dose discontinuation, was significantly different with niraparib compared with olaparib and with niraparib compared with rucaparib.

In a multivariable Cox regression analysis, the adjusted hazard ratio (HR) of any CEI with niraparib vs olaparib was 1.34 (95% CI, 1.19-1.52; 

 < .001), compared to 1.13 with rucaparib vs olaparib (95% CI, 0.96-1.33; 

 = .1318) and 1.19 with niraparib vs rucaparib (95% CI, 1.01-1.40; 

 = .0385). The risk of all-cause hospital admission with niraparib vs olaparib was 1.46 (95% CI, 1.15-1.84; 

 = .0016), compared to 1.38 with rucaparib vs olaparib (95% CI, 1.03-1.86; 

 = .0301) and 1.05 with niraparib vs rucaparib (95% CI, 0.79-1.40; 

Adjusted HR for time to dose reduction with niraparib vs olaparib was 1.78 (95% CI, 1.43-2.22; 

 < .001), compared with 1.31 with rucaparib vs olaparib (95% CI, 0.97-1.75; 

 = .0744) and 1.37 with niraparib vs rucaparib (95% CI, 1.03-1.81; 

 = .0317). For treatment discontinuation, the adjusted HR was 1.73 with niraparib compared with olaparib (95% CI, 1.47-2.02; 

 < .001), 1.35 with rucaparib vs olaparib (95% CI, 1.09-1.66; 

 = .0056), and 1.28 with niraparib vs rucaparib (95% CI, 1.05-1.57; 

“Tolerability, or how well patients cope with the [adverse] effects of treatment, is a key consideration when selecting a PARP [inhibitor],” David O’Malley, MD, professor in the Department of Obstetrics and Gynecology at The Ohio State University College of Medicine and the director of the Division of Gynecologic Oncology at the OSUCCC – James, and coinvestigators, wrote in a poster of the data. “Here we expand on earlier work to further explore real-world tolerability and dose changes in patients with ovarian cancer receiving PARP therapy in the [US]; we also investigate how many patients continue PARP [inhibitor] therapy without treatment gaps.”

1. O’Malley D, Arend RC, Alam N. Real-world use, tolerability, and dose modifications of PARP inhibitors in ovarian cancer. 

 2022;40(suppl 16):5552. doi:10.1200/JCO.2022.40.16_suppl.5552

Patients With HR+/HER2- Advanced Breast Cancer May Reduce Ribociclib Dose Without Jeopardizing Outcomes

Dose modifications of ribociclib (Kisqali) did not demonstrate a negative effect on overall survival (OS) outcomes in postmenopausal patients with hormone receptor–positive, HER2-negative advanced breast cancer who received the therapy in combination with letrozole, according to a final protocol-specified OS analysis of the phase 3 MONALEESA-2 trial (NCT01958021).

Results were presented in a poster by Lowell Hart, MD, FACP, scientific director of clinical research at Florida Cancer Specialists and Research Institute during the 

A landmark analysis showed that the median OS among those who had at least 1 reduction 3 months into treatment was 63.1 months compared with 65.7 months among those with 0 reductions during that time frame (HR, 0.96; 95% CI, 0.68-1.36). Moreover, in a time-varying Cox regression analysis of OS by dose reduction, the median OS was 66.0 months (95% CI, 57.6-75.7) in the modification group and 60.6 months (95% CI, 42.5-79.2) in the standard group (HR, 0.87; 95% CI, 0.65-1.18).

OS outcomes were consistent with prior findings from the MONALEESA-3 (NCT02422615) and MONALEESA-7 trials (NCT02278120), suggesting that deviating from the recommended dose of 600 mg daily on a 3 weeks on/1 week off cycle in combination with endocrine therapy will yield a similar OS benefit. Notably, investigators determined that neither length of treatment nor timing of dose reduction changed these results.

1. Hart L, Bardia A, Beck T, et al. Impact of ribociclib dose modifications on overall survival in patients with HR+/HER2– advanced breast cancer in MONALEESA-2. 

. 2022;40 (suppl 16):1017. doi:10.1200/JCO.2022.40.16_suppl.1017

Vitamin D Insufficiency Predictive of Paclitaxel-Induced Peripheral Neuropathy in Early-Stage Breast Cancer

Baseline vitamin D insufficiency may be a prognostic factor for increased risk of chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving paclitaxel to treat early-stage breast cancer, according to a retrospective validation analysis of patients enrolled in the SWOG 0221 trial (NCT00070564).

Moreover, these findings may be especially meaningful for Black patients with breast cancer, as the results demonstrated that vitamin D insufficiency is more prevalent in this patient population.

The findings, which were presented in a poster by Lidia Schapira, MD, FASCO, professor of medicine at Stanford University School of Medicine, during the 

, showed that patients with vitamin D insufficiency demonstrated a higher risk of CIPN.

Vitamin D insufficiency was defined as 20 ng/mL with higher levels signifying vitamin D sufficient status. Overall, the rate of grade 3/4 CIPN was 21% (n = 397) among patients with sufficient status compared with 14% (n = 794) among those with vitamin D insufficiency (odds ratio [OR], 1.57; 95% CI, 1.14-1.15; 

 = .005). After adjusting for covariates, the odds ratio was 1.39 (95% CI, 0.98-1.97; 

Notably, the findings also revealed that Black patients had a higher incidence of vitamin D insufficiency, which may correlate with higher incidence of CIPN. Compared with White patients enrolled in SWOG 0221, 77% of Black patients (n = 109) had vitamin D insufficiency compared with 28% of White patients (n = 997).

The rate of grade 3/4 CIPN among Black patients with vitamin D insufficiency (n = 84) was 31%. these patients were also less likely to be taking vitamin D supplements (

 =.046). In an analysis comparing the association of vitamin D insufficiency with incidence of CIPN among Black patients vs White patients the odds ratio was 2.48 (95% CI, 1.57-3.86; 

“Chemotherapy-induced peripheral neuropathy is the major treatment-limiting and debilitating toxicity of paclitaxel,” the study authors wrote in the poster. “Prior retrospective studies suggest vitamin D insufficiency is associated with higher risk and severity of paclitaxel-induced [peripheral neuropathy].”

1. Chen CS, McCann SE, Budd GT, et al. Vitamin D insufficiency as a peripheral neuropathy risk factor in White and Black patients in SWOG 0221. 

 2022;40(suppl 16):12023. doi:10.1200/JCO.2022.40.16_suppl.12023

2. Budd G, Barlow WE, Moore HCF, et al. SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer. 

2015;33(1):58-64. doi:10.1200/JCO.2014.56.3296

Forgetfulness A Significant Barrier to Oral Adherence in Elderly Patients With Prostate Cancer

Elderly patients with advanced prostate cancer who were prescribed enzalutamide (Xtandi) reported better adherence to oral treatment than those who were prescribed abiraterone, according to findings from a prospective trial of the Meet-URO network. However, the results, which were recently presented during the 2022 ASCO meeting, showed that forgetfulness is a potential barrier to adherence with this treatment.

Non-adherence rates were assessed by comparing the number of missed pills to the number of prescribed pills though pill counting, an overall estimate was given based on the median of individual values. The percentage of missed pills per prescribed pills was 5.2% in the abiraterone cohort compared with 4.2% in the enzalutamide cohort (

 < .001). However, patients receiving enzalutamide were more likely to cite forgetfulness as their reason for non-adherence than their peers in the other cohort; the percentage of patients who cited forgetfulness as their reason was 42% (38 patients) vs 17% (4 patients), respectively (

“Physicians tend to treat elderly and frailer [patients with] mCRPC with enzalutamide,” wrote study authors in the poster. “These [patients tend to be] more adherent to treatment, however, forgetfulness is a potential barrier.”

“Despite this, [abiraterone] conferred a longer progression-free survival [PFS] in our study population,” they wrote.

1. Rescigno P, Maruzzo M, Rebuzzi SE, et al. Adherence to oral treatments in elderly advanced prostate cancer patients, the ADHERE study: a prospective trial of the MEET-URO network.

 2022;40(suppl 16):12044. doi: 10.1200/JCO.2022.40.16_suppl.12044

Frontline Bevacizumab Prolongs PFS, OS in Ovarian Clear Cell Carcinoma

The addition of bevacizumab(Avastin) to first-line chemotherapy resulted in significant improvements in progression-free survival (PFS) and overall survival (OS) compared with platinum-based chemotherapy in patients with advanced ovarian clear cell carcinoma (OCCC), according to a retrospective analysis presented at the 2022 ASCO Annual Meeting.

OCCC is a rare histological type of epithelial ovarian cancer that is typically resistant to chemotherapy, accounting for its historically poor prognosis for patients. Most patients will have early-stage disease, but about 30% have advanced disease. Seki also noted that the frequency of OCCC is more common in Asian countries, especially in Japan.

Bevacizumab has shown an impact on treating patients with epithelial ovarian cancers and was first approved in Japan in November 2013 for the treatment of patients with ovarian cancer.

 Moreover, A prior analysis in a small group of patients with OCCC showed that treatment with bevacizumab added to first-line chemotherapy led to a significant difference in PFS.

Additionally, a study of 2 potential subtypes of OCCC by gene expression signatures suggested that patients with a mesenchymal type, where angiogenesis and the PI3K-AKT and IL-6 signaling pathways were activated, may benefit more from bevacizumab than those with more epithelial expression (HR, 0.5; 

= .1978), despite higher stages of disease.

“The addition of bevacizumab to platinum-based chemotherapy improved PFS and OS in [patients with] advanced OCCC,” said Toshiyuki Seki, MD, of the Department of Obstetrics and Gynecology, Kashiwa Hospital, The Jikei University School of Medicine, Chiba, Kashiwa, Japan. “The benefit was especially significant in stage IIIA and IIIB disease.”

1. Seki T, Tate S, Nishikimi K, et al. Bevacizumab in first-line chemotherapy to improve the survival outcome for advanced ovarian clear cell carcinoma: A multicenter, retrospective analysis. 

 2022;40(suppl 16):5502. doi:10.1200/JCO.2022.40.16_suppl.5502

2. Anti-Cancer Agent “Avastin," Obtained Approval for Additional Indication of Ovarian Cancer. News release translation. Chugai Pharmaceutical Co., Ltd. November 22, 2013. Accessed June 6, 2022. https://bit.ly/3MlkMVR

3. Tate S, Nishikimi K, Matsuoka A, et al. Bevacizumab in first-line chemotherapy improves progression-free survival for advanced ovarian clear cell carcinoma. 

 2021;13(13):3177. doi:10.3390/cancers13133177

4. Tan TZ, Ye J, Yee CV, et al. Analysis of gene expression signatures identifies prognostic and functionally distinct ovarian clear cell carcinoma subtypes. 

. 2019;50:203-210. doi:10.1016/j.ebiom.2019.11.017

Articles

We rounded up 5 stories from the 2022 ASCO Annual Meeting that are of most value to oncology nurses. 

Oncology Nursing News’ Top ASCO Picks

Buprenorphine may be an effective pain management strategy for various populations of patients with cancer, according to palliative care experts Mary Lynn McPherson, PharmD, BCPS, FAAHPM; and Amy A. Case, MD, FAAHPM.

 The agent’s unique pharmacology, and clinical utility and safety data, make it a preferable choice over traditionally used opioids.

Mary Lynn McPherson, PharmD, BCPS, FAAHPM

McPherson, who is a professor at the University of Maryland, Baltimore, and executive director of the Advanced Post-Graduate Education in Palliative Care, Graduate Studies in Palliative Care, and Online Graduate Studies in Palliative Care programs, and Case, who is the chair of Supportive and Palliative Care at Roswell Park Comprehensive Cancer Center, recently participated in an invited speaker session titled “Why Consider Buprenorphine for Cancer-Related Pain?” at the 2022 Supportive Care in Cancer Annual Meeting.

The oral bioavailability associated with buprenorphine is low. Therefore, it is not swallowed as a pill. It is taken sublingually or through a patch that should be rotated to a different site and then returned to the original site every 21 days according to the package insert.

“It is a really good option [for] those with who cannot swallow,” Case said.

“Generally, we use it on the upper body and areas where there is not a large amount of subcutaneous fats,” she explained.

Moreover, buprenorphine functions differently compared with traditional μ-opioid receptor agonists, explained McPherson. The agent binds to μ, δ, κ, and opioid receptor-like 1 (ORL1). It has a very high binding affinity to the μ receptor, as well as with the δ and κ receptors, but a lower binding affinity for ORL1. However, it is a partial μ agonist and not a full μ-opioid agonist.

As a partial agonist, buprenorphine has less μ-receptor signaling, which may result in fewer opioid-related adverse events. However, this does not mean buprenorphine is not an effective analgesic. It has a higher binding affinity compared with most full μ-opioid agonists, suggesting that it is a very effective pain management option.

Several studies with large numbers of patients with cancer have documented that pain management with buprenorphine is effective, Case said. For example, in one study, 85% of patients reported their pain control to be “good” or “very good” and 48% of patients reported improvement in sleep quality.

“A lot of our patients in palliative care or supportive care in oncology have issues with sleep,” Case explained. “[Buprenorphine,] has been shown to be equivalent to other traditional used opioids [in managing this symptom].”

It has also demonstrated a benefit for neuropathic pain and successfully blocks secondary hyperalgesia from central sensitization. Its analgesic benefit is thought to be comparable to morphine, hydromorphone, oxycodone, fentanyl, and methadone.

Furthermore, its high potency and slow dissociation rate allows for effective treatment at lower doses, Lin added.

Buprenorphine has less beta-arrestin activity than traditional opioids once it binds

, Case explained. Beta-arrestin is linked with negative responses such as endocytosis, physical dependency, respiratory depression, and constipation.

In addition, buprenorphine is associated with less cognitive dysfunction than with other opioids, making it a viable choice for elderly patients. “There is less impairment [compared] with equal doses of morphine,” Case said. “Several studies have shown improved sleep, pain, quality of life in the elderly [who receive buprenorphine].”

Notably, the pharmacokinetics are not altered with age, so there are no required dose reductions for elderly patient populations, and it is the only opioid that is not associated with risk of fracture, although Case noted that there is insufficient literature on this risk.

Across all populations, buprenorphine represents a potentially safer alternative for patients at risk for dependency disorders, since it does not induce euphoria, and is therefore associated with reduce abuse liability. It is safe in patients with renal and liver impairment, although for patients with severe liver impairment, a 50% dose reduction is advised because the drug is metabolized by the liver. It is also associated with a reduced risk of respiratory depression.

Finally, because the drug is a κ antagonist, patients may have less anxiety, lytic effects, depression, or suicidal tendencies compared with traditional opioids.

 This may also limit the addictive potential.

“[There are] some papers out there showing that up buprenorphine is actually used as a treatment for depression,” Case said.

Case acknowledged that some providers may find it difficult to get insurance companies to cover buprenorphine. However, in her experience, most companies will if presented with data on the drugs’ efficacy.

In 2019, the US Department of Health and Human Services published their Pain Management Best Practices Document. The document lists the following recommendations:

Recommendation 4a: Make buprenorphine treatment for chronic pain available for specific groups of patients and include buprenorphine in third-party payer and hospital formularies.

Recommendation 4b: Encourage CMS and private payers to provide coverage and reimbursement for buprenorphine treatment, both for opioid use disorder and for chronic pain. Encourage primary use of buprenorphine rather than use only after failure of standard μ agonist opioids such as hydrocodone or fentanyl, if clinically indicated.

Recommendation 4c: Encourage clinical trials using buprenorphine for chronic pain to better understand indication, usage and dosage.

“When the insurance companies give me a hard time about, I send [the recommendations] to them and clog up their fax machines and then they cover it,” Case concluded.

McPherson ML, Case AA. Why consider buprenorphine for cancer-related pain? Presented at: 2022 Supportive Care in Cancer Annual Meeting; June 23-25, 2022; Toronto, Ontario. 

Gudin J, Fudin J. A narrative pharmacological review of buprenorphine: a unique opioid for the treatment of chronic pain. 

. 2020;9(1):41-54. doi:10.1007/s40122-019-00143-6

Pain management best practices best practices inter-agency task force report, updated gaps, inconsistencies, and recommendations. US Department of Health and Human Services. Accessed June 24, 2022. 

Mary Lynn McPherson, PharmD, BCPS, FAAHPM, and Amy A. Case, MD, FAAHPM, argue that buprenorphine should play a larger role in cancer-related pain management because of its unique pharmacology and consequent safety profile.  



Experts Make the Case for Buprenorphine Use in Cancer-Related Pain Management

Cancer survivors who experience both frontal and occipital late alopecia following cytotoxic or endocrine therapy may derive clinical benefit with oral minoxidil, according to data from a study at Memorial Sloan Kettering Cancer Center (MSK), which were presented during the 2022 ASCO Annual Meeting.

Overall, hair and follicle densities increased by approximately 20% across all tested populations, and 74% of patients showed clinical improvement. Moreover, no patients required treatment discontinuation because of adverse events (AEs).

Alopecia is a common AE with approximately 65% of patients who undergo chemotherapy experiencing some degree of alopecia.1 Furthermore, 58% of patients with cancer report that hair loss is the most traumatic component of receiving chemotherapy, and 1 in 7 patients would consider declining chemotherapy because of fear of hair loss. 

Late alopecia was defined by investigators as the incomplete hair regrowth 6 months following the completion of endocrine therapy or from the initiation of endocrine therapy. This longer-lasting AE reportedly affects between 25% to 30% of survivors.

Scalp cooling is the only known prevention technique, and treatment options include scalp directed topical steroids, compounded topical minoxidil finasteride, intralesional steroids, or systematic oral low dose minoxidil. Oral minoxidil at a dose of 10 to 100 mg daily is currently FDA approved as an antihypertensive agent, but it has been used in low doses off label to treat alopecia at a dosage of 0.25 to 5 mg daily.

Investigators at MSK assessed women with late alopecia who received oral minoxidil at a dose of 1.25 mg daily between January 2018 and May 2021.The efficacy of minoxidil was assessed via standardized photography, and responses were quantified via trichosocpy (HairMetrix).

Results from 42 trichoscopy assessments conducted before and after a median of 91 days (interquartile range, 136) on oral minoxidil showed that the median percentage change in hair density (hairs/cm2) was 20.4% (

= .008) in patients with frontal alopecia and 21.4% (

 = .004) in patients with occipital alopecia, respectively. Similarly, the changes in follicular density (follicles/cm2) were 22.5% (

 = .005), respectively. Hair shaft diameter between the 2 groups was –2.0% (

The literature shows that the most common AEs associated with this treatment include hypertrichosis, lightheadedness, and fluid retention. Prospective, controlled studies are still needed to validate these findings, study authors concluded.

Overall, results from this study demonstrate the importance of symptom management in survivorship care, according to experts.

“Treating late toxicities [is] the bread and butter of survivorship,” Lidia Schapira, MD, FASCO, Professor of Oncology at Stanford University with a specialization in survivorship, said in a discussion of the poster. “Patients are often left to manage these by themselves. The idea of helping patients understand, self-manage, and become better at handling toxicities, [starting] from the first day in the hospital, is a very important concept.”

The key moving forward will be expanding these efforts to populations that have less supportive resources currently available, Schapira added.

“Supportive services such as onco-dermatology and supportive dermatology are available at major cancer centers, and I absolutely am delighted to see our colleagues at Memorial Sloan Kettering continue to find solutions for some of these festering problems,” she said. “The question is how do we scale [these efforts] and how do we bring some of these advances in survivorship care to communities that are less well resourced?”

Kuo AM, Reingold RE, Ketosugbo KF, et al. Oral minoxidil for the treatment of late alopecia in cancer survivors. 

2022;40(suppl 16):12022. doi:10.1200/JCO.2022.40.16_suppl.12022

Results of a single-center study presented at the 2022 ASCO Annual Meeting showed that oral minoxidil may be effective in treating late alopecia. Moving forward, these efforts in survivorship care will need to be expanded to less resourced areas, experts said.  

Oral Minoxidil Demonstrates Efficacy in Treating Later Stage Alopecia in Cancer Survivors

Clinical gaps in febrile neutropenia care exist, according to Jeffrey Crawford, MD, a medical oncologistat Duke Cancer Center. However, biosimilars may play an interesting role in addressing those disparities.

In 2015, the FDA approved the first biosimilar to treat chemotherapy-induced neutropenia, filgrastim-sndz (Zarxio). This agent had similar safety and efficacy to the granulocyte colony-stimulating factor (G-CSF) reference agent, filgrastim (Neupogen). In February 2022, a second biosimilar, filgrastim-ayow (Releuko), was approved for the same indication with the same reference agent.

The FDA has also approved several drugs deemed to be similar to the reference agent pegfilgrastim (Neulasta). These series of approvals began with the approval of pegfilgrastim-bmez (Ziextenzo) in November 2019, followed by the approval of pegfilgrastim-apfg (Nyvepria) in June 2020, and pegfilgrastim-bmez (Fylnetra) in May 2022.

“We [now] have several biosimilars available in the US and around the world, [with the reference agents] filgrastim and pegfilgrastim” said Crawford, in a presentation on new and emerging agents on outcomes of febrile neutropenia during the 2022 Supportive Care in Cancer Annual Meeting.

“The potential impact of this is significant; [it represents] greater patient access, greater competition between the companies, and fostered innovation.”

Because biosimilars represent a more affordable option than their reference agent, a greater proportion of patients are eligible to receive these treatments, he explained. Moreover, manufacturers can take advantage of the latest technologies, which in turn, incentivizes investment in the development of new biologic products by originator companies, particularly because they receive budgetary relief.

The more companies in the business of producing biosimilars results in further cost reductions.

Notably, the concept of extrapolation is a powerful example of how biosimilars help increase accessibility, Crawford added. For example, when the FDA approved filgrastim-sndz based on data of a population of patients with breast cancer, they did not limit the approval to that indication. Based on that study population, the FDA was also able to approve filgrastim-sndz on the following indications: neutropenia with bone marrow transplant, neutropenia in the treatment of nonmyeloid malignancies, neutropenia in acute myeloid leukemia, severe chronic neutropenia, and peripheral blood progenitor cell mobilization.

“[A singular] study done in neutropenia and breast cancer treatment allowed the field—based on the biosimilar characteristics of the molecule—to extrapolate to all of the indications,” Crawford said. “That is a very important concept that reduces the cost of development.”

Crawford spotlighted trends in G-CSF following the introduction of biosimilars in the US between 2014 and 2019. He explained that findings from a cross-sectional study assessing insurance coverage of 119,129 patients treated with chemotherapy found that among those at high risk of febrile neutropenia, 75% to 83% of patients who were commercially insured, and 75% to 86% of patients who were insured with Medicare used G-CSFs. Investigators noted that this signified an overall increase in G-CSFs during this period.

Moreover, in the fourth quarter of 2019, filgrastim-sndz represented 55.6% of short-acting G-CSF use, pegfilgrastim using the on-body injector (Neulasta Onpro) represented 44.99% of long-acting G-CSF use, and pegfilgrastim biosimilars represented 29.8% of long-acting G-CSF use.

An economic analysis on biosimilar G-CSF adoption showed that in a future scenario where pegfilgrastim-bmez was used exclusively in place of pegfilgrastim, the savings could be reinvested to provide G-CSF prophylaxis (using pegfilgrastim-bmez) for at least 10% of patients who are at an intermediate risk of febrile neutropenia. This in turn, would reduce drug and administration costs, as well as reduce febrile neutropenia-related emergency visits and hospitalizations.

“The potential [for] savings [are] huge,” Crawford emphasized. “Biosimilars are going to have an impact on disparities, they are going to have an impact on utilization, impact on our practice, and [this will] expand from this area to all areas of therapeutic agents.”

Crawford J. New and emerging agents on outcomes of febrile neutropenia: addressing clinical gaps. Presented at: 2022 Supportive Care in Cancer Annual Meeting; June 23-June 25; Toronto, Ontario.

At the 2022 Supportive Care in Cancer Annual Meeting, Jeffrey Crawford, MD, highlighted the potential value of biosimilars in reducing gaps in care for the treatment of febrile neutropenia. 

Biosimilars May Reduce Disparities in Febrile Neutropenia Treatment

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

High overall response rates and complete metabolic response (CMR) rates were observed among patients with high-risk diffuse large B-cell lymphoma (DLBCL) who received frontline treatment with subcutaneous epcoritamab and R-CHOP, according to data from arm 1 of the phase 1/2 EPCORE NHL-2 trial (NCT04663347) presented during the 2022 EHA Congress.

 Moreover, the combination was associated with a manageable safety profile.

At a median follow-up of 6.9 months (range, 0.8-14.7), the combination regimen induced an ORR of 100% among 33 patients. Moreover, the combination resulted in a CMR rate of 77% and a partial metabolic response rate of 23%.

“Epcoritamab plus R-CHOP showed encouraging responses…[and] a manageable safety profile, [and] no new safety signals were detected,” Michael Roost Clausen, MD, PhD, of Vejle Hospital, and colleagues, wrote in a poster on the data. “These updated data support further exploration of epcoritamab plus R-CHOP in [patients with] first-line DLBCL.”

Patients with DLBCL and 3 to 5 risk factors are known to have poor outcomes with standard frontline R-CHOP (rituximab [Rituxan] plus cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone); these patients have an overall survival rate of 55% at 4 years. As such, novel therapeutic approaches are needed for this population.

Epcoritamab binds to CD3 on T cells and CD20 on B cells to elicit the T-cell–mediated killing of CD20-positive, malignant B cells. When used in combination with R-CHOP, epcoritamab-mediated T-cell cytotoxicity is maintained, according to the study investigators.

Previously, data from the dose-escalation portion of the phase 1/2 EPCORE NHL-1 trial (NCT03625037) showed that epcoritamab monotherapy had an acceptable toxicity profile with strong antitumor activity in patients with heavily pretreated B-cell non-Hodgkin lymphoma.

The agent elicited an ORR of 68% (95% CI, 45%-86%) in patients with relapsed/refractory DLBCL, which included a CR rate of 45% when given at full doses ranging from 12 mg to 60 mg. When administered at 48 mg, epcoritamab produced an ORR of 88% (95% CI, 47%-100%), with a CR rate of 38%. In patients with relapsed/refractory follicular lymphoma, epcoritamab induced an ORR of 90% (95% CI, 55%-100%), with a CR rate of 50% when given at full doses of 0.76 mg to 48 mg.

Arm 1 of the open-label, multicenter EPCORE NHL-2 trial was comprised of patients with newly diagnosed, CD20-positive DLBCL, an International Prognostic Index (IPI) score of 3 or greater, an ECOG performance status of 0 to 2, measurable disease, and acceptable organ function.

The dose-escalation portion of the trial included 10 patients. Subcutaneous epcoritamab was given at 24 mg (n = 4) or 48 mg (n = 6) given weekly for cycles 1 through 4, every 3 weeks for cycles 5 and 6, and every 4 weeks for cycle 7 and on. R-CHOP was also administered in cycles 1 through 6. The primary objectives were dose-limiting toxicities, safety, and tolerability.

A total of 23 patients were included in the dose-expansion phase of the trial. Here, patients received subcutaneous epcoritamab at 48 mg every week for cycles 1 to 4, every 3 weeks for cycles 5 and 6, and every 4 weeks for cycle 7 and on, in combination with R-CHOP for cycles 1 through 6. The primary objective of this portion of the research was antitumor activity.

Among the 33 patients evaluated, the median age was 66 years (range, 19-82), 55% were male, 48% had an ECOG performance status of 1, 79% had Ann Arbor stage IV disease, 55% had an IPI score of 3, and 85% had de novo disease. The median time from diagnosis to first dose of treatment was 26 days (range, 5-70).

At a data cutoff date of March 25, 2022, 73% of the 33 patients were still receiving treatment with the combination and 18% had discontinued the regimen. Reasons for discontinuation included disease progression (6%), toxicity (3%), or another unspecified reason (9%). Three patients had completed treatment.

The median number of epcoritamab cycles initiated was 9 (range, 1-15), and the median duration of treatment was 6.3 months (range, 0.6-11.5). Fifty-two percent of patients required a dose delay of epcoritamab because of a treatment-emergent adverse effect (TEAE). Moreover, 91% of patients completed 6 cycles of R-CHOP.

Regarding safety, the most common TEAEs included anemia (grade 1/2, 33%; grade 3, 27%), neutropenia (grade 1/2, 6%; grade 3, 9%), cytokine release syndrome (grade 1/2, 48%; grade 3, 3%), nausea (grade 1/2, 45%), injection-site reaction (grade 1/2, 42%), constipation (grade 1/2, 33%; grade 3, 3%), fatigue (grade 1/2, 36%), peripheral sensory neuropathy (grade 1/2, 33%), pyrexia (grade 1/2, 33%), peripheral edema (grade 1/2, 27%), cough (grade 1/2, 21%), diarrhea (grade 1/2, 18%; grade 3, 3%), dyspnea (grade 1/2, 18%), headache (grade 1/2, 21%), and thrombocytopenia (grade 1/2, 12%; grade 3, 9%). Forty-five percent of patients experienced grade 4 neutropenia, and 3% experienced grade 4 dyspnea.

No events of tumor lysis syndrome were reported, although 1 patient experienced grade 2 immune effector cell–associated neurotoxicity syndrome, which resolved in 4 days.

Seventeen of the 33 patients experienced CRS; 27% of patients experienced a grade 1 event, 21% experienced a grade 2 event, and 3% experienced grade 3 CRS. All these cases were resolved, with a mean of 2 days to resolution (range, 1-11). No patients discontinued treatment due to CRS. Fifteen percent of these patients received tocilizumab (Actemra).

“CRS was mostly low grade, and all cases resolved, the study authors wrote. “CRS occurrence was predictable; most cases occurred following the first full dose with a median time to onset of 2 days.”

Clausen MR, Offner F, Belada D, et al. Subcutaneous epcoritamab + R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma: phase 1/2 update. Presented at: 2022 EHA Congress; June 9-12, 2022; Vienna, Austria. Abstract P1214.

Hutchings M, Mous R, Clausen MR, et al. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. 

. 2021;398(10306):1157-1169. doi:10.1016/S0140-6736(21)00889-8

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