Our October 2022 print publication, which is available for download 

, features nursing voices from across the breadth of care. One of our newest features, the Oncology Drug Crash Course sheet, provides a helpful overview of an agent approved across multiple indications and details what nurses need to know about adverse effects and any handling nuances. Our Nurse’s Note highlights the importance of mental health resources for oncology nurses and our Advance Practice Provider column demonstrates the value of preceptorship for novice oncology nurse practitioners.

Contributor Debi Fischer takes a unique look at breast cancer awareness. She shows that many individuals may have misconceptions regarding the origin of the movement and argues that oncology nurses should know the history behind the pink ribbon as they may support many people affected by breast cancer.

 showed that neoadjuvant chemotherapy may play a useful role in helping bridge patients with rectal cancer to organ-sparing excision surgery, a procedure associated with better quality of life and maintained bowel function than total mesorectal excision.

5. Oncology Drug Crash Course: Olaparib (Lynparza)

Kayla Freeman, DNP, APRN, FNP-C; and La-Urshalar Brock, MSN, CNM, FNP-BC, provide an in-depth look at olaparib, including the approved indications and safety considerations, in a downloadable fact sheet.

Olaparib is a potent oral PARP inhibitor which induces synthetic lethality in 

 deficient tumor cells through the formation of double-stranded DNA breaks which cannot be accurately repaired, leading to cell death, explain the 2 nurse experts. The drug currently has approved indications in ovarian, breast, pancreatic, and prostate cancer.

4. Oncology Nurses Need Better Resources to Help Patients With Mental Health Problems

Unfortunately, 30% of patients with cancer will develop a mental disorder during the course of their illness. Although oncology nurses are trained to show empathy and offer support to their patients across the care continuum, it is often insufficient and more resources are needed to adequately care for patients with acute mental health problems, Stephanie Jackson, DNP, MSN, RN, AOCNS, BMTCN, writes.

3. Supporting the Novice Oncology NP: The Benefits of Preceptorship

The American Association of Nurse Practitioners predicts that over 36,000 nurses achieved their nurse practitioners’ certifications in 2019 and 2020, and the number of individuals continuing to earn their nurse practitioner credentials are expected to continue to grow.

In this feature, Precious Ferguson, MSN, APRN, FNP-BC, discusses the specialized training and education that novice oncology nurse practitioners need and how structuredpreceptorships help promote competence, confidence, and job satisfaction in this setting.

2. Opinion: Oncology Nurses Should Know the History of the Pink Breast Cancer Awareness Ribbon

Breast cancer awareness has been in the spotlight for many years now, but many may not know about the movement’s origins. In this opinion piece, contributor Debi Fischer, MSW, BSN, BA, LCSW, RN, offers a different perspective into breast cancer awareness month by discussing the advocacy work of Charlotte Hale, a Simi Valley housewife who is credited with handing out the first breast cancer awareness ribbons. Notably, the ribbons that she handed out were peach, not pink.

1. Neoadjuvant Chemotherapy Makes Organ-Sparing Surgery More Accessible for Patients With Rectal Cancer

For many patients with early-stage I/IIA rectal cancer, 3 months of neoadjuvant chemotherapy significantly downstage their tumors and made organ-sparing excision surgery possible—allowing these patients to maintain their quality of life and bowel function.

Articles

Each month, we take a look back at the most popular Oncology Nursing News® stories. Here are the top 5 stories from October 2022. 

Oncology Nursing News Top Stories: October 2022

In September 2022, investigators published findings on an understudied stress associated with advanced cancer care—unmet death preferences. Many adolescent or young adult patients with cancer express that they would prefer to die at home; however, when combined with caregiver capabilities and necessary symptom management, most of these patients ultimately die in the hospital setting, underscoring an unmet need for this patient population.

Other topics in supportive care include a brief snapshot of cannabinoid products in the context of cancer-related pain management. During the 2022 ONS Bridge, Karen Hande, PhD(c), DNP, ANP-BC, CNE, FAANP, ANEF, offered an overview of what cannabinoid products are and what it means for patients to be taking consumed cannabidiol (CBD) vs marijuana, to improve cannabis-related dialogue between nurses and patients.

Moreover, September saw some key clinical updates in the gynecologic and genitourinary oncology spaces. Read below to see how immunotherapy is eliciting responses in urothelial carcinoma and how real-world patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer are achieving promising response with pembrolizumab (Keytruda) plus bevacizumab (avastin).

Better End-of-Life Options Are Needed for AYA Patients With Advanced Cancer

Innovative strategies are needed to ensure that adolescents and young adults with cancer who prefer to die at home can make that choice. Most adolescent or young adults (AYA) with advanced cancer prefer to die at home, according to results of a qualitative interview study published in 

Unfortunately, the desire of many of AYA patients is not realized with up to two-thirds of AYAs passing away in the hospital setting, underscoring an unmet need regarding death preferences in this population.

Oncology Nurses: What Cannabinoid Is Your Patient Taking?

In a presentation during the 2022 ONS Bridge, Karen Hande, PhD(c), DNP, ANP-BC, CNE, FAANP, ANEF, provided an overview of what some of the popular cannabinoid products are that patients with cancer may be taking.

EphrinB2 Inhibition With PD-1/PD-L1 Immunotherapy Induces Promising Responses in Progressive Metastatic Urothelial Cancer

A combination of pembrolizumab and soluble EphB4-human serum albumin (sEphB4-HSA) may elicit superior overall survival and objective response rates in patients with platinum-refractory metastatic urothelial carcinoma than PD-1/PD-L1 therapy alone, according to findings from a phase 2 trial (NCT02717156) published in the 

Opinion: Understanding Spoon Theory Is Essential for Oncology Nurses

Thanks to advances in oncology, the number of long-term survivors is growing. However, this disease often saps patients and, by extension, nurses of their strength. The spoon theory has been widely used in chronic illnesses, but it can also be applied to cancer. In this opinion piece, Debi Fischer, MSW, BSN, BA, LCSW, RN unpacks spoon theories and explains its utility for patients with cancer.

Pembrolizumab Plus Bevacizumab and Cyclophosphamide Shows Promising Efficacy, Tolerability in Recurrent Ovarian Cancer

Real-world data presented during the 2022 ESMO congress showed that pembrolizumab combined with the anti-VEGF agent bevacizumab plus oral metronomic cyclophosphamide displayed minimal toxicity in a significant number of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Each month, we take a look back at the most popular Oncology Nursing News® stories. Here are the top 5 stories from September 2022.

Oncology Nursing News Top Stories: September 2022

On September 22 and 23, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) convened for a hearing to assess the risk-benefit ratio of 3 agents. First, data supporting the new drug application (NDA) for poziotinib tablets was evaluated against available agents. Second, confirmatory and requested post marketing data for the continued approval of indications for melphalan flufenamide (Pepaxto) and duvelisib (Copiktra), respectively, were assessed. After deliberation, the participants on each of the ODAC panels voted against indications for all 3 treatments.

In a 9 to 4 vote, ODAC voted that the benefits of poziotinib do not outweigh its risks for the treatment of patients with 

 exon 20 insertion–mutated non–small cell lung cancer (NSCLC).

In explaining his decision, mirroring many of those who also voted no, Scott Waldman, MD, PhD, of Thomas Jefferson University, in Philadelphia, Pennsylvania said, “Clearly there’s a clinical unmet need for the drug, and the drug has activity, but I don’t know that it has a meaningful improvement over other drugs that, in the real world, are available to patients right now.

Waldman added that the agent has a high level of toxicities associated with it which can be managed, but it is complicated by the fact that the dose of the drug has not been adequately optimized. “That uncertainty is going to be carried through into the potential confirmatory trial, which has an end point that is far away,” he said. “[Moreover,] these patients are at risk for toxicity and [the trial] isn’t studying the same dose that’s seeking approval right now.” Waldman is the Samuel M.V. Hamilton Professor of Medicine, a professor in the Department of Biochemistry and Molecular Biology, chair of the Department of Pharmacology & Experimental Therapeutics, and director of the MD/PhD program at Jefferson.

On February 14, 2022, the FDA accepted for review an NDA seeking the approval of poziotinib in previously treated patients with locally advanced or metastatic NSCLC with 

The NDA was based on findings from cohort 2 of the phase 2 ZENITH20 trial (NCT03318939), in which poziotinib, given at a once-daily dose of 16 mg, led to an objective response rate (ORR) of 27.8% (95% CI, 18.9%-38.2%) in this population (n = 90).

The median duration of response (DOR) was 5.1 months (95% CI, 4.2-5.5), and the median progression-free survival (PFS) was 5.5 months (95% CI, 3.9-5.8).

ODAC reviewed efficacy results that failed to show improvements over current therapy, a high rate of toxicity, inadequate dosage optimization, and delayed confirmation of benefit with the tyrosine kinase inhibitor (TKI).

In their rebuttal, the sponsor stated that the confirmatory phase 3 PINNACLE trial (NCT05378763) is ongoing. However, committee members emphasized concern that the availability of other agents, including docetaxel with or without ramucirumab (Cyramza), pembrolizumab (Keytruda)/nivolumab (Opdivo), and off-label fam-trastuzumab deruxtecan-nxki (Enhertu) could negatively affect enrollment. The sponsor acknowledged that the study has yet to enroll any patients, and primary results are not expected until 2026.

Regarding safety, all patients experienced adverse effects (AEs); 81% were treatment related and grade 3 or greater in severity (grade ≥ 3 rash, 49%; grade ≥ 3 diarrhea, 26%). Fatal AEs occurred in 10% of patients, and drug interruption and dose reduction occurred in 87% and 77% of patients, respectively.

Members in support of the approval argued that clinicians have experience and are comfortable managing the AEs associated with TKIs.

Continued Approval of Melphalan Flufenamide in Relapsed/Refractory Multiple Myeloma

In a 14 to 2 vote, ODAC voted that the benefit-risk profile of melphalan flufenamide is not favorable for the approved indicated population of patients with relapsed/refractory multiple myeloma.

Committee member Christopher Lieu, MD, said, “I voted no. Post hoc analysis really should be used for hypothesis generation as opposed to labeling and indication for use. There’s certainly a need for better drugs…but we shouldn’t be using drugs that might be harming patients. To me, the answer is simple. You have an analysis which may support the use in a specified patient population that could show a benefit, and a confirmatory study should be performed in this population, but the data do not support the use of this agent.” Lieu is an associate professor, associate director for clinical research, and codirector of Gastrointestinal Medical Oncology at the University of Colorado Cancer Center.

The agent received accelerated approval for use in combination with dexamethasone in 2021;

 however, data from the confirmatory phase 3 OCEAN trial (NCT03151811) did not meet the primary or secondary end points of improved PFS and overall survival (OS) vs pomalidomide (Pomalyst) and dexamethasone according to FDA standards.

In the meeting, committee members reviewed the benefit-risk ratio of melphalan flufenamide for patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 CD38-directed monoclonal antibody.

The regulatory agency based its concerns for continued approval on the potential detriment in OS, failure to demonstrate PFS improvement, and lack of an appropriate dose with the alkylating cytotoxic agent.

Preliminary results from the trial showed that the median OS was 19.7 months (95% CI, 15.1-25.6) with melphalan flufenamide/dexamethasone vs 25.0 months (95% CI, 18.1-31.9) with pomalidomide/dexamethasone (HR, 1.104; 95% CI, 0.846-1.441), highlighting a detriment in survival in the investigative arm vs the control arm.

Updated results showed a continued detriment in OS, with a median OS of 20.2 months (95% CI, 15.8-24.3) with melphalan flufenamide vs 24.0 months (95% CI, 19.1-28.7) with pomalidomide (HR, 1.144; 95% CI, 0.913-1.435).

Although the drug developer, Oncopeptides, showed data illustrating that the OS results could have been adversely affected by patients with a time to progression within 36 months of transplant, the FDA contended that subgroups were not prospectively included in the statistical analysis plan with control of Type I error, and subgroup analyses cannot be used to conclude a treatment benefit in a subpopulation––in this case, patients without autologous stem cell transplant (ASCT) or post-ASCT progression after 36 months.

Notably, the FDA encouraged Oncopeptides to pursue a prospective trial in this population to confirm the potential benefit therein.

Additionally, the FDA showed that the median PFS in the primary analysis was 6.9 months (95% CI, 5.1-8.5) with melphalan flufenamide/dexamethasone vs 4.9 months (95% CI, 4.2-5.9) with pomalidomide/dexamethasone, failing to demonstrate statistical superiority (HR, 0.817; 95% CI, 0.659-1.012; 

 = .0644). Oncopeptides asserted that updated findings showed that treatment with melphalan flufenamide was superior to pomalidomide regarding PFS in this population (HR, 0.792; 95% CI, 0.640-0.979; 

 = .0311). The analysis was conducted by a blinded independent review committee after determining that data from 29 patients needed to be reassessed.

However, the FDA maintained that the trial failed to demonstrate PFS benefit and further emphasized that worse OS negates any real or perceived PFS improvement.

The final point was that the fixed 40-mg dose evaluated in the trial was poorly tolerated and led to high rates of dose modification. Specifically, 78% of patients experienced at least 1 dose modification, 47% experienced at least 1 AE leading to dose reduction, and 26% experienced at least 1 AE leading to drug discontinuation.

Weight or body-sized based dosing may be more appropriate, according to the FDA. “A lower dose may be more tolerable.”

Duvelisib Loses Support for CLL/SLL Indication

In an 8 to 4 vote, ODAC voted that the final OS data submitted did not demonstrate a strong enough benefit-risk ratio to support the continued approval of duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies.

Top concerns addressed for the continued approval for the highlighted long-term OS data from the phase 3 DUO trial (NCT02004522), which showed a higher rate of deaths with duvelisib vs ofatumumab (Kesimpta), a higher rate of fatal AEs attributed to infection, and an OS detriment in the setting of PFS and ORR.

“All of us feel that this is a complex situation just by virtue of the design of the clinical trial,” Jorge A. Garcia, MD, FACP, chair of the ODAC meeting said prior to the vote. “Some of the themes of our discussion relate to our inability to use the clinical trial design to really determine the true detrimental outcome of patients receiving duvelisib and that related to the compounding effect of crossover.” Garcia is a professor of medicine and urology at Case Western Reserve University School of Medicine in Cleland, Ohio. He is also the George and Edith Richman Distinguished Scientist Chair and chair of the Solid Tumor Oncology Division at University Hospitals Seidman Cancer Center.

He added that it is hard to look at these data in the absence of the clinical data available for other PI3K inhibitors and the class effects in the diseases which are chronic in nature that have a long natural history.

Commenting on his vote no, Christopher Lieu, MD, said, “I thought these data were extremely difficult to interpret, but in agreement with [other no votes] I have concerns about this class of medication. If we are not clearly improving OS in our patients but we are increasing toxicity and treatment-associated death, I’m not sure that we are truly helping patients.”

The initial application, submitted by Secura Bio Inc, was approved in 2018 based on data DUO, which evaluated duvelisib vs ofatumumab in 319 adults with CLL or SLL after at least 1 prior therapy. In data supporting the application, the median PFS in the intention-to-treat (ITT) population was 13.3 months (95% CI, 12.1-16.8) vs 9.9 months (95% CI, 9.2, 11.3) with duvelisib and ofatumumab, respectively (HR, 0.52; 95% CI, 0.39-0.69, 

 < .0001). The ORR in the duvelisib arm (n = 160) was 73.8% (95% CI, 66.9%-80.6%) vs 45.3% (95% CI, 37.5%-53.0%) in the ofatumumab arm (n = 159).

At the time of approval, the median OS data were immature with a median of 24 months of follow-up, and the OS was not reached in either arm in the indicated population (HR, 0.82; 95% CI, 0.49-1.37).

Reports of substantial toxicity including fatal AEs led the FDA to issue a box warning to address the toxicities and a postmarketing requirement was issued to Secura Bio Inc requesting 5-year follow-up data for OS. The identified safety concerns included serious or fatal infections, diarrhea or colitis, rash, pneumonitis, hepatotoxicity, and neutropenia.

Five-year OS follow-up data from the DUO trial were submitted in June 2021 with a data cutoff of January 22, 2021.

The median OS in the ITT population was 52.3 months (95% CI, 41.8-68.0) in the duvelisib arm vs 63.3 months (95% CI, 41.2–not estimable) in the ofatumumab arm (HR, 1.09; 95% CI, 0.79-1.51). This detriment extended to the indicated population with a median OS of 43.9 months (95% CI, 32.4-56.5) among patients who received duvelisib after 2 or more prior lines of therapy (n = 95) vs 46.8 (95% CI, 28.6-74.9) among those who received ofatumumab (n = 101; HR, 1.06; 95% CI, 0.71-1.58).

The updated median PFS in the ITT duvelisib arm was 17.85 months (95% CI, 15.16-22.59) vs 9.47 months (95% CI, 9.14-11.14) in the ofatumumab arm (HR, 0.40; 95% CI, 0.27-0.59).

Safety data also signaled a higher rate of death in duvelisib-treated population vs ofatumumab-treated population. In the ITT analysis 23 deaths were reported, 13 of which were among patients with 2 or more prior lines of therapy in the duvelisib cohort. In the ofatumumab population, 5 deaths occurred overall and 4 were in the indicated population. Infection was the primary cause of death in the duvelisib arm accounting for 14 events. One patient died of infection due to ofatumumab treatment.

Following this analysis, the FDA issued a safety alert in June 2022 intended to alert patients and health care providers of the potential risk of continued use of duvelisib.

Of note, crossover upon disease progression was permitted in the DUO trial. Ninety patients (57%) crossed over from the ofatumumab arm to the duvelisib arm compared with 9 patients (6%) from duvelisib to ofatumumab upon disease progression.

A sensitivity analysis was performed and demonstrated consistent potential OS detriment with the primary analysis. Further, most subgroups also reported an OS detriment with duvelisib, but for those that did not (ie, those who were refractory or had early relapse to purine treatment) would require more substantial analysis.

Oncologic Drugs Advisory Committee (ODAC) Meeting. FDA. September 22, 2022. Accessed September 22, 2022. bit.ly/3dFRtlU

Spectrum Pharmaceuticals announces acceptance of new drug application filing for poziotinib. News release. Spectrum Pharmaceuticals; February 11, 2022. Accessed September 22, 2022. bit.ly/3gGReox

Le X, Cornelissen R, Garrassino M, et al. Poziotinib in non–small-cell lung cancer harboring 

 exon 20 insertion mutations after prior therapies: ZENITH20-2 trial. 

. 2022;40(7):710-718. doi:10.1200/JCO.21.01323

Oncologic Drugs Advisory Committee (ODAC) Meeting. FDA. September 22, 2022. Accessed September 22, 2022. bit.ly/3dFRtlU

FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma. FDA. Updated March 1, 2022. Accessed September 22, 2022. bit.ly/3OZIxEz

Oncologic Drugs Advisory Committee (ODAC) Meeting. FDA. September 23, 2022. Accessed September 23, 2022. bit.ly/3BN1SnC

Briefing document. FDA. Accessed September 23, 2022. bit.ly/3DP2jk5

Meeting of the Oncologic Drugs Advisory Committee (ODAC) day 1. FDA. April 21, 2022. Accessed September 23, 2022. bit.ly/3C9lqE2

On September 22 and 23, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) convened for a hearing to assess the risk-benefit ratio of 3 agents. 

ODAC Committee Votes Against Upholding 3 Indications in Lung and Hematologic Malignancies

In August 2022, the relationship between nutrition and cancer was put to the test: myths surrounding sugar, soy, and vegan diets, and their ability to improve or injure patient outcomes were debunked. Similarly, the American Society of Clinical Oncology (ASCO) released updated guidelines with recommendations for diet and exercise for patients undergoing active treatment.

Oncology nurse research took center stage as new findings showed that taxane-based chemotherapy caused hearing loss in the majority of patients with breast, gastrointestinal, gynecological, or lung cancer. 

® discussed the findings and implications in clinical practice in an exclusive interview with principal investigator Christine Miaskowski, PhD, RN.

Finally, nurses play a powerful role in improving the quality of care for patients. Hear from experts how nurses can help ensure that patients with ovarian cancer receive optimized treatment plans, as well as help create an inclusive environment for all they attend to in their practice.

Dispelling Nutrition Myths for Patients With Cancer

Entering the words nutrition and cancer into Google returns as many as 718 million hits. With an overabundance of opinions, it can be challenging to separate fact from fiction. Therefore, in this feature, Nicole Franklin, MS, RDN, CSO, LDN, a registered dietician with the American Oncology Network, calls out 3 commonly held myths about nutrition and cancer and uncovers the bottom line.

Audiological Assessments May Be Vital Component of Cancer Survivorship Care Following Chemotherapy

New research efforts led Christine Miaskowski, PhD, RN, show that most adult cancer survivors who undergo treatment with either a platinum-based chemotherapy, taxane alone, or a combined regimen of platinum- and taxane-based treatment, experience some degree of hearing loss. In an interview with 

 Miaskowski, a professor in the Department of Physiological Nursing and Anesthesia at UCSF School of Nursing, highlights what these findings mean for clinical practice.

Nurses Play Key Role in Facilitating Maintenance Therapy With PARP Inhibitors in Ovarian Cancer

®, Paula Anastasia, RN, MN, AOCN, a gynecologic Oncology Clinical Nurse Specialist for UCLA Health, offers a recap of her presentation at 

. She discusses ways in which nurses can help facilitate maintenance therapy with PARP inhibitors such as olaparib (Lynparza), rucaparib (Rubraca), and niraparib (Zejula), and emphasizes the value of germline testing for this patient population.

ASCO Outlines Recommend Aerobic and Resistance Exercises for Patients Undergoing Active Cancer Treatment

ASCO recently convened a panel of experts to conduct a comprehensive literature review of existing data regarding the role of diet, weight, and exercise in defining patient outcomes. The updated guidelines formally recommend aerobic and resistance exercises for patient with cancer, although they note that this is an area of research that continues to be overlooked in clinical trial designs.

1. Addressing Disparities: Practicing Inclusion for LGBTQ+ Patients With Cancer

Identifying and acknowledging disparities helps providers work together to improve access to care and treatment and reduce the cancer risks. Among individuals in the LGBTQ+ community there is less access to care because of a lack of inclusive health care, underrepresentation and exclusions in clinical trials, and lack of coverage for appropriate screenings.

In this feature, our partners at Cancer Care outline key ways that nurses can improve their care delivery and create a practice that is inclusive for marginalized communities.

To stay on top of all the latest news and features

Each month, we take a look back at the most popular Oncology Nursing News® stories. Here are the top 5 stories from August 2022.

Oncology Nursing News Top Stories: August 2022

Today, the majority of patients with diffuse large B-cell lymphoma (DLBCL) will derive most benefit from therapeutic options other than autologous stem cell transplantation (ASCT), according to a presentation from the 2022 Pan Pacific Lymphoma Conference.

“ASCT is lousy therapy in the modern era,” Jeremy S. Abramson, MD, MMSc, said during the presentation. “There are select patients who are still appropriate for ASCT, but that is a tiny minority in the modern era.”

Abramson is the director of the Lymphoma Program and the Jon and Jo Ann Hagler Chair in Lymphoma at the Massachusetts General Hospital Cancer Center and an associate professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

Salvage treatment with high-dose chemotherapy plus ASCT for patients with DLBCL who responded to their initial treatment often fails most patients, Abramson explained. Approximately 75% of patients who relapse do so within a year of receiving their frontline therapy, he noted, adding that approximately half of patients with relapsed/refractory DLBCL are not eligible for treatment with ASCT because of factors such as age or comorbidities.

Abramson cited data from the phase 3 ORCHARRD trial (NCT01014208), which compared the efficacy of ofatumumab plus cisplatin, cytarabine, and dexamethasone (DHAP) followed by ASCT with that of rituximab (Rituxan) plus DHAP followed by ASCT among patients with relapsed/refractory DLBCL. The 2-year progression-free survival (PFS) rates were 24% and 26%, respectively (HR, 1.12; 95% CI, 0.89-1.42; 

 = .33). Moreover, the 2-year event-free survival (EFS) rates were 18% and 16%, respectively HR, 1.10; 95% CI, 0.90-1.36; 

In another study, the phase 3 NCIC-CTG LY.12 trial (NCT00078949), investigators evaluated gemcitabine, dexamethasone, and cisplatin followed by ASCT vs DHAP in patients with relapsed/refractory aggressive lymphoma. Patients with B-cell lymphoma were also given rituximab. No significant differences were noted in 4-year EFS (HR, 0.99; 95% CI, 0.82-1.21; stratified log-rank 

 = .95), overall survival (OS; HR, 1.03; 95% CI, 0.83-1.28; 

 = .78), or PFS (HR, 0.99; 95% CI, 0.82-1.21; 

“More contemporary trials [such as] ORCHARRD and the NCIC-CTG LY.12 study [have shown] durable remissions in fewer than a quarter of patients.” Abramson said. “This is not good therapy.”

Abramson said that CAR T-cell therapy is a superior choice for most patients with DLBCL. CAR T-cell agents have proven especially useful in the treatment of patients with primary refractory or early relapsed disease, he said.

In the phase ZUMA-7 trial (NCT03391466), the CAR T-cell agent axicabtagene ciloleucel (axi-cel; Yescarta) was evaluated against the standard of care of chemoimmunotherapy followed by high-dose chemotherapy with ASCT in patients who responded to the chemoimmunotherapy. The trial included patients with relapsed/refractory large B-cell lymphoma who were relapsed or refractory less than 1 year after their first-line treatment. Patients were randomly assigned 1:1 to receive either axi-cel (n = 180) or the standard of care (n = 179).

At a median follow-up of 24.9 months, the median EFS in the axi-cel arm was 8.3 months (95% CI, 4.5-15.8) compared with 2.0 months (95% CI, 1.6-2.8) in the standard of care arm (HR, 0.40; 95% CI, 0.31-0.51; 

 < .001). The median PFS was 14.7 months (95% CI, 5.4-not estimable [NE]) vs 3.7 months (95% CI, 2.9-5.3) in the axi-cel and standard-of-care arms, respectively (HR, 0.49; 95% CI, 0.37-0.65). Notably, the median OS in the axi-cel arm was not reached (95% CI, 28.3-NE) vs 35.1 months (95% CI, 18.5-NE) in the standard-of-care arm (HR, 0.73; 95% CI, 0.53-1.01).

In terms of response, axi-cel was also superior to the standard of care. The overall response rate (ORR) was 83% vs 50%, respectively. Patients who received axi-cel also achieved a complete response (CR) rate of 65% compared with 32% among patients treated with the standard of care. Additionally, axi-cel was associated with improved quality of life as evaluated by patient reported outcomes.

The safety findings were mostly similar between the 2 arms; all patients in both arms experienced an adverse effect (AE) of any grade. Grade 3 or higher AEs occurred in 91% of patients and 83% of patients in the investigational and control arms, respectively. However, any grade cytokine release syndrome (CRS) was present in 92% of patients in the axi-cel arm and any grade neurologic AEs were more common in the axi-cel arm compared with the standard-of-care arm (60% vs 20%).

“With CAR T-cell [therapy] we expect some CRS and neurotoxicity; we see a fair amount of that with axi-cel,” Abramson said. “The majority of patients did develop CRS, but it was severe in only 6%. Also, [most] patients developed neurologic toxicity, [but it was] severe in only 20%. And these toxicities are almost entirely reversible.”

Another trial of a CAR T-cell agent, the phase 3 TRANSFORM trial (NCT03575351), examined the efficacy and safety of lisocabtagene maraleucel (liso-cel; Breyanzi) compared with the standard of care among patients with relapsed/refractory LBCL. Patients included in the trial had primary refractory or early relapsed disease.

At a median follow-up of 6.2 months (range, 4.4-11.5), the median EFS was 10.1 (95% CI, 6.1-NE) compared with 2.3 months (95% CI, 2.2-4.3) in the liso-cel (n = 92) and standard-of-care arms (n = 92), respectively (HR, 0.35; 95% CI, 0.23-0.53; 

 < .0001). The median PFS was 14.8 months and 5.7 months, respectively (HR, 0.41; 95% CI, 0.25-0.66). The median OS was not reached vs 16.4 months, respectively (HR, 0.51; 95% CI, 0.26-1.00).

Similar to findings from the ZUMA-7 trial, liso-cel also resulted in a higher ORR compared with the standard of care (86% vs 48%). Patients in the liso-cel arm also achieved a CRR of 66% vs 39% in the standard-of-care arm. Over half of the standard-of-care arm (54%) crossed over to be treated with liso-cel and quality of life by patient reported outcomes again favored the CAR T-cell agent.

Treatment emergent AEs (TEAEs) occurred in nearly all patients in both arms (100% vs 99%). Grade 3 or higher TEAEs were slightly more common in the liso-cel arm (92%) compared with the standard-of-care arm (87%). Any grade CRS was present in 49% of patients who received liso-cel.

“As was shown on ZUMA-7 not a single subset [of patients] favored high dose chemotherapy and ASCT over CAR T-cell [therapy] in this trial,” Abramson said. “This was an exceedingly well tolerated and entirely reversible therapy for patients who had a higher likelihood of cure with this treatment compared to standard of care.”

Despite the convincing evidence against the use of ASCT, there is still a subset of patients with DLBCL for whom the treatment can be effective, argued Craig S. Sauter, MD, the director of the Blood and Marrow Transplant Programat the Cleveland Clinic in Cleveland, Ohio.

“Value-based care has many facets, including not just end points [such as] EFS, PFS, and OS, but costs strain on limited resources within the space, patient quality of life,” Sauter said. “Financial toxicity is a real issue. Access to resources is a real issue. This will be an ongoing conversation.”

Sauter went on to explain that access to CAR T-cell therapy is limited in the United States and across the world. The cost effectiveness of CAR T-cell agents in the second line is also unclear, Sauter noted. Axi-cel was found to have an $80,000 per quality adjusted life year vs standard of care and CAR T-cell therapy in general was shown to have up to a $2 million per quality adjusted life year compared with standard of care, he said.

Additionally, Sauter noted that ASCT has been shown to provide durable remissions in patients with DLBCL with a PET-positive partial response (PR). According to data from the Center for International Blood and Marrow Transplant Research, the median PFS for patients with DLBCL who received ASCT was comparable both among patients with and without early chemoimmunotherapy failure (

Stauter also pointed out that findings recently published in 

 showed that ASCT may actually be superior to CAR T-cell therapy for patients with DLBCL who are in PR following salvage chemotherapy. The 2-year PFS rates favored ASCT (52%) over CAR T-cell therapy (42%; 

 = .06). Moreover, the 2-year OS rates were 69% and 47%, respectively (

“There may be a signal of improved durability of ASCT,” Sauter said. “But [these are] very different groups [of patients] and registry-level data that has to be taken with a grain of salt.”

Abramson JS, Sauter CS. Autologous transplantation for DLBCL. Presented at: 2022 Pan Pacific Lymphoma Conference: July 18-22, 2022; Koloa, Hawaii.

van Imhoff GW, McMillan A, Matasar MJ, et al. Ofatumumab versus rituximab salvage chemoimmunotherapy in relapsed or refractory diffuse large b-cell lymphoma: the ORCHARRD study. 

. 2017;35(5):544-551. doi:10.1200/JCO.2016.69.0198

Crump M, Kuruvilla J, Couban S, et al. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. 

. 2014;32(31):3490-3496. doi:10.1200/JCO.2013.53.9593

Locke FL, Miklos DB, Jacobson CA, et al; All ZUMA-7 Investigators and Contributing Kite Members. Axicabtagene ciloleucel as second-line therapy for large b-cell lymphoma. 

. 2022;386(7):640-654. doi:10.1056/NEJMoa2116133

Kamdar M, Solomon SR, Arnason J, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial [published correction appears in 

Shah NN, Ahn KW, Litovich C, et al. Is autologous transplant in relapsed DLBCL patients achieving only a PET+ PR appropriate in the CAR T-cell era? 

. 2021;137(20):2854-2855. doi:10.1182/blood.2021011979

Shadman M, Pasquini M, Ahn KW, et al. Autologous transplant vs chimeric antigen receptor T-cell therapy for relapsed DLBCL in partial remission. 

. 2022;139(9):1330-1339. doi:10.1182/blood.2021013289

In the modern era, the number of patients with diffuse large B-cell lymphoma who will derive benefit from autologous stem cell transplantation is small, according to Jeremy S. Abramson, MD, MMSc.

Evolution of DLBCL Treatment Options Render ASCT Unsuitable for Many Patients

Each month, we take a look back at the most popular 

Topics from July 2022 include key advances in cancer survivorship toxicity management and efforts towards targeting 

mutations in the treatment paradigm for patients with pancreatic cancer. Additionally, recently reported data showed the potential quality-of-life benefit observed with ribociclib (Kisqali) for patients with hormone receptor–positive, HER2-negative breast cancer.

Other top stories include an interview with Gretchen McNally PhD, ANP-BC, AOCNP, on the need for naloxone training for oncology nurses and advanced practice providers (APPs) and a conversation between 2 palliative care experts on why buprenorphine should be considered for the treatment of cancer-related pain.

5. Frontline Ribociclib-Related Quality of Life Favorable to Abemaciclib in HR+/HER2-Advanced Breast Cance

Ribociclib was favorable over abemaciclib (Verzenio) in reducing diarrhea, fatigue, appetite loss, and arm symptoms (such as pain or swelling in the shoulder or arm and difficulty raising the arm), according to a matched-adjusted indirect comparison using published data from individual patients treated in the MONALEESA-2 (NCT01958021) and MONARCH-3 trials (NCT02246621).

4. Targeting KRAS Mutations May Help Address Unmet Need in Pancreatic Cancer Treatment

In recent years, the identification of genetic mutations such as 

 in pancreatic cancer has shifted the treatment landscape toward targeted therapies. Despite this progress, combination chemotherapy remains the standard frontline treatment for patients with localized or advanced disease. Today, many investigators are turning their eye to 

 mutations, as these mutations are the most common genetic alterations for patients with pancreatic cancer and may represent a viable treatment landscape, according to Philip A. Philip, MD, PhD, FRCP.

3. Key Advances in Cancer Survivorship Toxicity Management

, Lidia Schapira, MD, FASCO, highlights from the 2022 ASCO Symptoms and Survivorship track anddiscusses key advances in the treatment of toxicities that may present later in cancer survivorship care. She discusses the importance of baseline measurements and health equity considerations in clinical practice and underscores the potential effect evolving technologies may have on the treatment landscape.

2. Are Oncology Nurses Underutilized in Positively Affecting the Opioid Epidemic?

a nurse practitioner in hematology at The Ohio State University Comprehensive Cancer Center– Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, discusses how oncology nurses might have the opportunity to save more lives with proper naloxone training. Responses obtained from nurses and APPs at McNally’s institution demonstrated that they would feel comfortable administering naloxone, provided they had the proper training, and would be interested in pursuing educational trainings on the agent

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

At the Annual Meeting on Supportive Care in Cancer, Mary Lynn McPherson, PharmD, BCPS, FAAHPM, and Amy A. Case, MD, FAAHPM, argued that buprenorphine should play a larger role in cancer-related pain management because of its unique pharmacology and consequent safety profile. 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.

Each month, we take a look back at the most popular Oncology Nursing News® stories. Here are the top 5 stories from July 2022.


Oncology Nursing News Top Stories: July 2022

Phase 3 findings from the POLARIX (NCT03274492) trial showed that a combination of polatuzumab vedotin-piiq (Polivy) to the regimen of rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) resulted in a 27% reduction in risk of disease progression, relapse, or death for patients compared with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

The data were presented in a poster at the 2022 Pan Pacific Lymphoma Conference.

At 2 years, the progression-free survival (PFS) rate was 76.7% (95% CI, 72.7%-80.8%) in the experimental arm compared with 70.2% (95% CI, 65.8%-74.6%) with R-CHOP, translating into an absolute difference in PFS of 6.5% (HR, 0.73; 95% CI, 0.57-0.95; 

Investigators in POLARIX administered 1.8 mg/kg of polatuzumab vedotin once per day plus 375 mg/m2 of rituximab, 750 mg/m2 of cyclophosphamide, and 50 mg/m2 of doxorubicin for six 21-day cycles (n = 440). The control arm included 439 patients assigned to R-CHOP, the current standard of care. All patients received 375 mg/m2 of once-daily rituximab for cycles 7 and 8.

In this double-blind, placebo-controlled international trial, eligible adults aged 18 to 80 years were required to have previously untreated DLBCL and an International Prognostic Index (IPI) of 2 to 5. Eligible patients also had an ECOG performance score of 0 to 2. Patients were further stratified by IPI score (2 vs 3-5), bulky disease (<7.5 cm vs ≥7.5 cm), and geographic region (Western Europe, United States, Canada, and Australia vs Asia vs rest of the world).

The primary end point was investigator-assessed PFS. Key secondary end points included event-free survival (EFS), end-of-treatment PET-CT complete response (CR) rate, disease-free survival (DFS), overall survival (OS), and safety.

Median patient age was 65.0 years (range, 19-80) in the experimental arm and 66.0 (range, 19-80) for the control. Just over half of patients in both groups were male and 44% in both groups had bulky disease. In the pola-R-CHP arm, 85% of patients had an ECOG score of 0 or 1 and 38% had an IPI score of 2 compared with 83% and 38%, respectively, in the R-CHOP arm.

Investigators found that EFS favored the pola-R-CHP arm (HR, 0.75; 95% CI, 0.58-0.96; 

 = .02). There was no significant difference between PET-CR rate at end of treatment (78.0% vs 74.0%; 

=.16). However, investigators found that DFS results (HR, 0.70; 95% CI, 0.50-0.98) suggested that responses are more durable with the experimental combination.

There was no difference in OS between the treatment arms (HR, 0.94; 95% CI, 0.65-1.37; 

 = 0.75). However, fewer patients in the pola-R-CHP arm required subsequent anti-lymphoma therapies.

The incidence of grade 3/4 adverse effects (AEs) was 57.7% in the pola-R-CHP arm vs 57.5% in the R-CHOP arm. Thirty-four percent of patients in the experimental arm experienced serious AEs compared with 30.6% with R-CHOP.

Thirteen (3.0%) patients experienced grade 5 AEs with pola-R-CHP compared with 10 (2.3%) in the control group. However, patients in the pola-R-CHP arm were less likely to require dose discontinuations (4.4% vs 5.0%) or dose reductions (9.2% vs 13.0%).

In May 2022, the European Commission approved pola-R-CHP in this patient population based on findings from POLARIX.

“The approval of Polivy plus R-CHP in the first-line setting is great news for people in the EU diagnosed with this aggressive lymphoma, giving them a greater opportunity for positive outcomes,” said Hervé Tilly, MD, PhD, POLARIX principal investigator and professor of haematology at the University of Rouen, stated in a press release at the time. “Treatment with this regimen has been shown to reduce the chance of relapse and therefore need for subsequent treatments, limiting the burden of DLBCL.”

The FDA approved polatuzumab vedotin in combination with bendamustine and a rituximab product in June 2019. The combination is indicated for adult patients with relapsed/refractory DLBCL not otherwise specified after at least 2 prior therapies.

Approval was based on data from the open-label, multicenter Study GO29365 trial (NCT02257567), of 80 patients with relapsed/refractory DLBCL who previously received at least 1 prior regimen. Investigators randomly assigned patients to polatuzumab vedotin plus bendamustine and a rituximab product (BR) or BR for six 21-day cycles.

Forty percent (95% CI, 25%-57%) of patients in the polatuzumab vedotin arm had a CR with compared with 18% (95% CI, 7%-33%) with BR alone. Best overall response rate also favored the experimental combination, at 63% vs 25%, respectively. Of the 25 patients who achieved partial or complete response with the triplet, 16 (64%) had response durations of at least 6 months and 12 (48%) had response durations of at least 12 months.

Mehta-Shah N, Tilly H, Morschhauser F, et al. Polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) versus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) therapy in patients with previously untreated diffuse large B-cell lymphoma (DLBCL): results from the phase III POLARIX study. Presented at: 2022 Pan Pacific Lymphoma Conference; July 18-22, 2022; Koloa, HI. https://bit.ly/3PJhGgJ

Roche’s Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma. News release. Roche. May 25, 2022. Accessed July 19, 2022. 

FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma. FDA. June 10, 2019. Accessed July 19, 2022. 

Phase 3 findings from the POLARIX trial showed that the addition of platuzumab vedotin to rituximab, cyclophosphamide, doxorubicin, and prednisone resulted in a 27% reduction in risk of disease progression, relapse, or death for patients with newly diagnosed diffuse large B-cell lymphoma.

By ONN Staff

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