Advanced practice providers (APPs) and research nurses may be the best primary points of contact for patients with relapsed follicular lymphoma receiving immune checkpoint inhibitor (ICI) therapy in a clinical trial setting, according to investigators who presented on best ICI-related adverse event (AE) practices during the 2022 Pan Pacific Lymphoma Conference.

Early identification and management of irAEs are critical to provide best care and promoted treatment continuation.

Institutions providing a multidisciplinary team, including a primary investigator, attending physician, clinical nurse, advanced practice provider (APP), and research nurse, are uniquely poised to address potential ICI-related toxicities during the clinical trial period. Cross-functional teams promote closer monitoring of signs and symptoms related to irAEs, assessment of a patient’s ability to self-report symptoms, and early and frequent education for patients about what to expect throughout the treatment cycle.

In a retrospective chart review, investigators assessed data from an investigator-initiated, open label, single-center phase 2 study (NCT02446457) conducted at The University of Texas MD Anderson Cancer Center (MD Anderson). The trial enrolled patients with stage I-III, relapsed or refractory follicular lymphoma who were age 18 years or older and had absolute neutrophil counts of at least 1.0 × 109 cells/L, platelet counts of at least 50 × 109 cells/L, and adequate renal, cardiac, and pulmonary function. Although patients needed to have received at least 1 line of prior therapy, prior ICI therapy was ground for exclusion. Other exclusion criteria included a history of autoimmune disease within the past 2 years requiring systemic therapy, history of any other malignancy within the past 5 years, uncontrolled serious illness or comorbidities, or history of HIV, active hepatitis B or C infection.

Enrolled patients received 375 mg/m2 of intravenous rituximab (Rituxan) on days 1, 8, 15, and 22, during cycle 1, and 200 mg of IV pembrolizumab (Keytruda) every 3 weeks for up to 16 cycles, beginning on day 2 of cycle 1. Providers used the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 to grade the AEs.

Overall, 30 patients with follicular lymphoma were treated on the study, 80% of whom experienced an irAE in accordance with the terminology criteria. Thirteen percent of patients experienced a grade 3 or 4 irAE, 33% (10 patients) completed 16 cycles without early discontinuation, and 20% (6 patients) discontinued treatment following the manifestation of an irAEs.

The onset time to first irAE ranged from 1 day to 207 days with a median of 35 days. In addition, 5 patients had pre-existing conditions (asthma, diarrhea, rash, hepatitis), which study authors noted could be further analyzed as an irAE risk factor.

The work-up for irAEs in this study included cultures, diagnostics imaging, and biopsies. Providers also referred their patients to other specialties for nuances diagnosis or management of certain irAEs, such as pulmonary medicine, infectious disease, dermatology, gastrointestinal endoscopy, ophthalmology, and endocrinology.

“Providers should pay close attention to signs [and] symptoms of irAEs,” the study authors wrote a poster of the findings. “Providers should consider treatment hold [or] discontinuation of checkpoint inhibitors when concerning irAEs occur.”

Corticosteroids continue to be a mainstay of treatment for various irAEs and higher grade, recurrent, or persistent irAEs may require the use of steroids. Moreover, as certain irAEs may be severe, and unfortunately difficult to diagnose, investigators recommend using the services of gastrointestinal, pulmonary, and infectious disease teams, for diagnostic testing and treatment recommendations. Further, collaboration with dermatology and ophthalmology are advised for skin or eye conditions.


Study authors explained that ICI therapies have been incorporated into the treatment landscapes for several cancer types, including non-Hodgkin lymphoma. However, the mechanism of action with these drugs results in immune system activation and can therefore result in irAEs. Common events include dermatitis, colitis, hepatitis, pneumonitis, and endocrine disorders including thyroid dysfunction. Because irAEs may develop at various timepoints throughout treatment and progress quickly, early detection and intervention is key in providing quality care to patients.

The ICI associated with more irAEs in the study was pembrolizumab, and the most common mitigation strategy was to hold or discontinue pembrolizumab and administering systemic corticosteroids. Following treatment hold, 4 patients were rechallenged with pembrolizumab (median of 28.5 days; range 14-51), but permanently discontinued treatment due to persistent immune-related diarrhea (n = 3) and pneumonitis (n = 1). Another patient was rechallenged with pembrolizumab and successfully completed all 16 cycles without irAE recurrence.

Several patients (n = 7) received corticosteroids to manage their irAEs. The median duration of time on corticosteroids was 125 days (range, 40-319). Three of these patients received topical corticosteroids only for rash, and the remaining were observed until resolution.

Notably, the study authors noted that for a small number of patients, irAEs did not present until after pembrolizumab was permanently discontinued. Nevertheless, all patients included in the study had eventual resolution of their irAEs.

The study authors acknowledged that patients enrolled at MD Anderson clinical trials have multiple avenues to contact a member of their care team, including direct phone calls, emails, texts, to research nurses and APPs, phone call to clinic teams, or emails to clinical teams through an online patient portal. Having multiple lines of communication between a patient and a research nurse/APP may be critical, they observed, as this facilitates effective communication.

“Providers should especially monitor patients for recurrence of irAEs who are undergoing a treatment rechallenge with a checkpoint inhibitor [and] be aware that irAEs can occur even once treatment is permanently discontinued, and continue to monitor for irAEs,” The authors wrote, noting that “multiple irAEs can occur in the same patient at different times.”

Dsouza S, Nastoupil L, Mims J. Diagnosis and management of immune-related adverse events in follicular lymphoma patients treated with a checkpoint inhibitor. Presented at: 2022 Pan Pacific Lymphoma Conference: July 18-22, 2022; Koloa, Hawaii.

Articles

Because immune-related adverse events can be hard to diagnose, patient education and clear avenues of communication with an oncology care team are critical, according to investigators at the 2022 Pan Pacific Lymphoma Conference.

Oncology APPs, Research Nurses Are Uniquely Poised to Tackle irAE Management in Follicular Lymphoma

Improving caregiver education, allowing time for a patient to process their diagnosis before discussing treatment, and utilizing multidisciplinary support systems are critical in improving the lived experiences of patients with relapsed or refractory diffuse-large B-cell lymphoma (DLBCL), according to investigators who presented on preferences and perceptions at the 2022 Pan Pacific Lymphoma Conference.

Results from a survey analysis revealed gaps in shared decision-making including limited treatment options in this setting, a lack of tailored materials to guide caregivers in their newfound roles, and few resources for physicians to integrate real-world experience into their workflows. Findings also showed that the shock of the diagnosis, and the short period time between diagnosis and treatment initiation, also represents barriers to shared decision-making as this overwhelming experience tends to negatively affect the quality of patient-provider discussions surrounding treatment elections.

“Real-world evidence generated from this study fills a major gap in evidence on the preferences and goals for this patient population, specifically,” study authors wrote in a poster of the data.

Additionally, the “findings from this qualitative research study suggest that there may be opportunities to further integrate aspects of patient and caregivers’ lived experiences into treatment decision-making for [relapsed or refractory] DLBLC, increase [the] use of individualized multidisciplinary support services that can support the holistic health needs of patients, [and] develop tailored educational materials for caregivers that can equip them as trusted and engaged members of the patients treatment decision-making process.”

Although shared decision-making is associated with improved patient experience, engagement, and treatment satisfaction, there are currently few resources for patients with DLBCL whose disease has relapsed. This is accentuated by the National Comprehensive Cancer Network guidelines, which recommend multiple systemic therapies for second- and third-line treatment regimens. If a patient’s disease does not response to first-line treatment, patients can undergo either an autologous or allogenic stem cell transplant, or CAR T-cell therapy, depending on their eligibility.

For patients who are not transplant eligible, available treatment options include tafasitamab-cxix (Monjuvi) plus lenalidomide (Revlimid), polatuzumab vedotin-piiq (Polivy) with or without rituximab (Rituxan) and with or without bendamustine, or gemcitabine and oxaliplatin with or without rituximab. Navigating between these choices can be overwhelming for patients and caregivers, and although literature exists regarding the real-world evidence on patient preferences for later-line therapies, most studies focus broadly on lymphoma or non-Hodgkin’s lymphoma rather than the relapsed or refractory DLBCL population specifically.

Therefore, investigators conducted a literature review to better understand the current body of evidence for treatment preferences. Using findings from the literature review, they then interviewed 14 adult patients, 8 caregivers, and 8 oncologists. All 30 interviews were transcribed.

The patients and caregivers were linked; however, no oncologists were the treating physician of any participating patient. Patients needed to either the undergoing second-line or third-line treatment or have completed it within the past 5 years. Caregivers had to be caring for patients who fit the patient inclusion criteria. Oncologists could either be community-based in a large health system, or academic setting.

Patients were queried about their attitudes and beliefs surrounding both their and their caregiver’s involvement in shared decision-making, their preferences and goals surrounding second- and third-line treatment options, and their treatment satisfaction in regard to quality of life and treatment schedules.

Caregivers were asked to share what their current practices were for shared decision-making and their attitudes or beliefs surrounding their involvement.

Most patients (71%) and 38% of caregivers shared that they felt limited in their ability to make decisions because their clinician had expressed that they were already following a well-established standard of care. Further, the shock of the diagnosis significantly affected their ability to be actively involved in treatment decision-making. Physicians echoed the sentiments of patients and caregivers in the study, noting that limited second and third line options offer limited opportunities for integrated treatment selection. In addition, 50% of patients felt that their caregivers were very important in supporting their understanding of second and third line treatment options; however, only 1 caregiver felt that had enough time between diagnosis and treatment initiation to make an informed decision.

Among clinicians, 75% responded that they routinely ask patients about support system and social needs during their initial treatment planning visit, such as transportation issues or living situations. One physician also reported having asked about specific events influencing treatment selections, such as upcoming weddings or travel. Generally, oncologists in a community-based setting were less able to provide a care team model, and therefore, as the patient’s main point of contact, felt limited in their ability to provide comprehensive care and address all the patient’s concerns.

One hundred percent of participating clinicians stated that patients should have a high degree of autonomy, yet 62% stated that a lack of patient understanding or a lack of education regarding treatment options was a major barrier in including patients in the selection process.

Patients were mixed about their specific experiences with treatment. One thing that many patients felt unprepared for was changes to treatment plans. Overall, 3 patients (21%) shared that when details of their care journey were inconsistent with what was previously communicated (ie, the route of administration), they felt overwhelmed. Four patients (29%) felt that their physicians did not address ancillary health concerns including mental health, in an adequate manner, and 2 patients shared that their care plan had been limited to the standard of care, and that other treatment options, such as novel methods to relieve treatment symptoms, were not made available to them.

Many patients (36%) also felt that their oncologist had overemphasized the efficacy of the first line therapy, leaving them unprepared for the possibility of requiring second or third line treatment. Younger patients felt that issues like fertility or major life events in their lives were not calculated into the treatment planning process.

Overall, the survey highlighted gaps which exist in the relapsed or refractory DLBCL treatment plan schema and offers direction for providers who want to provide a more integrative care delivery. Moving forward, real-world evidence studies should seek to focused on the needs and preferences of minority patients in this setting.

Vukcevic M, Yung M, Khan M, Houpt B, Schnell F. Preferences and perceptions regarding treatment decision-making for relapse or refractory diffuse large b-cell lymphoma. Presented at: 

 Pan Pacific Lymphoma Conference East: July 18-22, 2022; Koloa, Hawaii.

The ideal model for promoting effective shared decision-making involves tailored caregiver education, adequate time before treatment, and use of multidisciplinary support. 

Investigators Unveil Real-World Experiences on Shared Decision-Making in R/R DLBCL 

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

Topics from June 2022 include the evolving role of social media in bridging patients together, nurse perspectives on future directions in CAR T-cell therapy development, and the potential limitations surrounding the CDC’s newly proposed opioid prescribing guidelines. Other top stories include a conversation with Ohio End of Life Options founder and executive director, Lisa Vigil Schattinger, MSN, RN, about her personal experience with medical aid in dying and ongoing research to determine whether music can help reduce chemotherapy-induced nausea.

5. The Future of CAR T-Cell Therapy: Will Off-the-Shelf Options Soon Enter the Playing Field?

Approval of off-the-shelf CAR T-cell therapy options may provide greater accessibility and benefit to patients according to experts. In this feature, 

 speaks with Brittney Baer, BSN, RN, and Kelly Garvin, BSN, RN, OCN, about the evolution of CAR T-cell therapy options and whether off-the-shelf options may become available in the near future.

4. Does the CDC’s Proposed Opioid Prescribing Guideline Fall Short on Drug Testing?

Although the CDC has put forth a strong effort to improve its opioid guidelines, many providers still feel that more can be done. In this feature story, Jack Kain, PharmD, discusses the recent changes to clinical guidelines and what questions remain surrounding optimal care with opioid therapy.

3. What Oncology Nurses Should Understand About Medical Aid in Dying

Lisa Vigil Schattinger, MSN, RN, discusses her experience with medical aid in dying, and what oncology nurses need to understand when supporting patients at the end of their lives.

2. Prescribing 20 mg of Mozart for Chemotherapy-Induced Nausea

Might the day come when the oncology nurse delivers acetaminophen alongside 20 mg of Mozart? Hear from Jason Kiernan, PhD, RN, ACNP, a Michigan State University investigator, who is preparing to expand on an encouraging pilot study that used a music-listening intervention to influence chemotherapy-induced nausea.

How Social Media Helps AYA Patients With Cancer Find Support

The rise of social media platforms has helped foster a community for adolescent and young adult patients with cancer. Hear as our partners with CancerCare outline how social media can positively fill a unique social need for this patient population.

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 June 2022.

Oncology Nursing News Top Stories: June 2022

Creating a Safe Space Is The First Step in Initiating Sexual Health Conversations With Patients With Cancer 

Although not every patient with cancer will experience a sexual health crisis during treatment, each will experience some form of sexual health change, according to Sage Bolte, PhD, LCSW, CST.

 Therefore, it is important that oncology nurses establish that a patient can turn to them if and when they want to discuss issues related to their sexual health. 

“Every single one of them will have sexual changes,” said Bolte, chief philanthropy officer and president of the Inova Health Foundation. “They will have questions, whether it’s during treatment, after treatment, or 3 years after treatment. [Nurses] will be the ones that they reach out to so that they don’t feel scared and isolated and confused when those issues come up.” 

She added that with some patient populations, it is still not “necessarily generationally appropriate [to have these conversations], and it may be uncomfortable for them. So, it is [often] our providers [who need] to be the ones to bring forward the conversation.” 

In a presentation during the 47th Annual Oncology Nursing Society Congress, Bolte, along with Elaine Wittenberg, PhD, FACH, an associate professor at California State University, Los Angeles, and Joy Goldsmith, PhD, a professor of communication studies, at the University of Memphis in Tennessee, 

 strategies that oncology nurses can use in addressing sensitive topics with patients. 

To better engage with patients, oncology nurses may need to ask themselves: “What is my comfort level discussing sexual health?” and “What are my particular strengths in helping patients and their partners reclaim their own bodies?” Nurses may also need to reflect further on how comfortable they are with their own body and sexuality, their own positive image, and whether they are at a place of peace to overcome personal barriers and initiate these conversations. “It is OK if you’re uncomfortable with those words,” Bolte noted. “We’re taught to be a little uncomfortable with those words. [But] we have to look at what triggers that discomfort so we can show up for our patients without showing that discomfort.” 

Furthermore, nurses can help promote more meaningful dialogue by keeping the conversation positive and centered on the patient. For example, Bolte said it is a better approach to tell a patient, “Cancer and its treatments have such significant impacts on all aspects of our lives, including our sexual health. This is normal. I would love to provide you with some information,” rather than telling them, “You can discuss sexual failure with me” or “I am trained not to laugh.” Overall, Bolte recommended looking for “very simple, nonthreatening ways to open a conversation with the information that [the patient] is providing.”

Bolte S, Goldsmith JV, Wittenberg E. Tools of the trade: communicating sensitive topics. Presented at: 47th Annual Oncology Nursing Society Congress; April 27-May 1, 2022; Anaheim, CA.

Patients With Cancer Share Mixed Experiences With Immunotherapy 

Patients with cancer are divided on their expectations with checkpoint inhibitors, 

according to findings from a patient survey

 that were presented during the 47th Annual Oncology Nursing Society Congress.

Results revealed that 27% of patients believe that their immunotherapy treatment will “help [them] live longer,” whereas 19% believe the therapy will “cure the cancer,” and 15% believe it will “improve [their] life quality.” 

More than a quarter of patients expressed conviction that this treatment strategy would be “effective” against their disease, and another 25% felt it would be “very effective.” Fifteen percent were unsure whether it would be effective, 14% thought it would be somewhat effective, and 11% had no expectations. Other patients responded that they believed the treatment would allow them “to have less [adverse] effects [AEs] than chemotherapy,” “to stop the tumor from growing,” and “to delay the need for stronger chemotherapy.” 

In terms of symptoms, tiredness was found to be the most common AE. For those who experience an AE, calling the oncologist was the most common response (21%). However, 15% of patients responded by calling their oncology nurse, 10% discussed the AE with family, and 9% chose to manage the AE alone. Eight percent of patients reported that they ignored their symptoms. 

“We believe that the findings of this study will help improve the management of immunotherapy [AEs] and inform immunotherapy patient education and [AE] reporting,” Maryellen Potts, PhD, University of Kansas School of Nursing, explained in a poster presentation of the findings.

Potts M, Fleer R, Dionisi L, et al. Immunotherapy patient 20 Oncology Nursing News® June 2022 CLINICAL INSIGHTS experience: a cross-sectional survey of patient knowledge, expectations, and information seeking strategies. Presented at: 47th Annual Oncology Nursing Society Congress; April 27-May 1, 2022; Anaheim, CA.

Cannabis Use May Help Decrease Opioid Need in Patients With Cancer

Medical cannabis in conjunction with opioids may be an effective treatment strategy to reduce pain burden in patients with cancer, 

 at the 47th Annual Oncology Nursing Society Congress.

Furthermore, health care providers should continue to educate patients and caregivers about the potential benefits and risks associated with medical cannabis and keep them informed with current available evidence and emerging data to recommend efficacious dosing and formulations. 

In doing so, nurses can proactively care for patients experiencing pain burden by identifying which patients might benefit from this treatment based on current conditions, symptomology, and efficacy of previous therapeutics. Amber Nenner, BSN, RN; Felita Salim, BSN, RN, OCN; and Ryan Sandler, MS, RN, all of Columbia University School of Nursing in New York, New York, presented on the findings in a poster during this year’s congress. 

The authors noted that there is a wide range of symptoms that can affect patients with advanced cancer, including chronic pain, anorexia, chemotherapy-induced nausea and vomiting (CINV), anxiety, and diminished quality of life (QOL). Notably, dronabinol, a pharmaceutical form of Δ-9-tetrahydrocannabinol (THC), and nabilone, a synthetically made cannabinoid, are FDA approved to treat patients with certain conditions, including CINV.

Will Medical Cannabis Replace Opioid Use?

The cumulative evidence does not suggest that medical cannabis will replace standard opioid therapy, the authors concluded. However, it was found to be an effective adjunct among those who were opioid refractory and helped to reduce the overall need for opioid consumption by reducing pain intensity. 

In addition, THC-CBD formulations improved the conditions of patients with CINV, and THC/cannabidiol (CBD) tablets increased the weight and appetites of patients with anorexia and cachexia. The wide range of cannabinoid receptors in the body ultimately responded to the drugs and resulted in improved QOL by improving sleep, depression, and anxiety. 

Common AEs associated with cannabis included central nervous system [effects], dizziness, somnolence, disorientation, gastrointestinal disturbances, hallucinations, and altered functional status.

Nenner A, Salim F, Sandler R, et al. Cannabis and symptom management in cancer, efficacy, and implications for clinical use. Presented at: 47th Annual Oncology Nursing Society Congress; April 27-May 1, 2022; Anaheim, CA.

Catheter Represents Preferred Administration Equipment vs Injection Needle for Subcutaneous Immunotherapy Infusions 

The use of catheters instead of injection needles to administer intravenous (IV) immunotherapy is linked with increased comfort and satisfaction for patients and infusion nurses, according to 

 presented at the 47th Annual Oncology Nursing Society Congress.

“The BD Saf-T-Intima butterfly catheter is specifically geared toward subcutaneous administration of medications,” Georgina Rodgers, BSN, RN, OCN, NE-BC, of Cleveland Clinic Taussig Cancer Center, said in a poster presentation during the congress. “The nice thing about this particular piece of equipment is that once it is inserted into the patient, you remove the needle stylet—making it needle-less once you remove it from the patient, and what is left in the patient is a flexible catheter for administration.” 

Multiple large volume IV infusion immunotherapies have recently been converted to large volume subcutaneous formula infusions of 15 mL and whose administration time lasts up to 8 minutes. The therapy is administered with hyaluronidase to enhance absorption; however, erythema, edema, pruritus or itching, and rash at the injection sites continue to represent potential complications, which can occur up to 24 hours following injection. The large volume and duration time, as well as the difficulty of maintaining needle stability for 8 minutes and the lack of safety, cause nurses to voice concerns. 

Compared with traditional infusion via an injection needle, the use of a catheter was associated with a lack of occlusion, an overall reduction in injection site complications, and reports of nurse satisfaction and comfort with the procedure. Specifically, nurses can attach a syringe to the end of the catheter, creating more space between the patient and nurse and, in turn, increasing nurses’ comfort. In addition, because the catheter allows for slower infusion times, the injection site stability was increased and absorption enhanced.

Colvin C, Rodgers G. A novel approach to subcutaneous immunotherapy administration. Presented at: 47th Annual Oncology Nursing Society Congress; April 27-May 1, 2022; Anaheim, CA.

Nurses Help Bridge Patients Undergoing Chemotherapy to Scalp Cooling Therapy

A nurse-driven program successfully connected patients undergoing chemotherapy with scalp cooling treatment, according to 

 during the 47th Annual Oncology Nursing Society Congress.

Furthermore, patients who completed the program expressed high satisfaction levels with scalp cooling and retained 50% more hair than anticipated with this type of treatment.

More than 75% of patients with cancer fear experiencing alopecia because of chemotherapy. Since the FDA approved the expanded use of a cooling cap in 2017, patients and oncology care teams have become interested in its ability to reduce the volume of hair loss induced by treatment. 

Following favorable efficacy and safety data with scalp cooling, a team of oncology nurses piloted a scalp cooling program at a community-based cancer center connected to the Froedtert & the Medical College of Wisconsin in Milwaukee. 

Overall, 15 patients elected to undergo scalp cooling therapy and more than 80 treatments were administered since June 2021. Although 2 patients stopped treatment because they felt overwhelmed, patients who completed all cycles expressed high levels of satisfaction, according to the study authors.

In addition, the nursing staff reported satisfaction with the amount of training and resources provided during implementation and “are proud” that scalp cooling is offered at their institution. Many patients expressed gratitude for being connected to the therapy through testimonials. “It really sucks to go through cancer treatment; I am so glad I had scalp cooling…I am so appreciative I was given the chance to save my hair and keep a part of my identity,” a patient shared in a testimonial. 

“Nurses are at the forefront of promoting and educating patients throughout the care continuum for supportive care interventions, such as scalp cooling,” Linda Amacher, BSN, RN, OCN, of Froedtert & the Medical College of Wisconsin, added in a presentation of the findings. “[In this case,] there was quick adoption by nurses, and processes were integrated into clinic and infusion workflows without significant challenges.”

Amacher L, Herriges D, Portz D, et al. Hairs the deal: implementing scalp cooling for chemotherapy-induced alopecia at a community-based cancer center. Presented at: 47th Annual Oncology Nursing Society Congress; April 27-May 1, 2022; Anaheim, CA.

This year’s congress showcased strategies for communicating sensitive topics, patient experiences with immunotherapy treatments, updates in the utility of
medical cannabis, and more. 

ONS Annual Congress Focuses on Increasing Nurse Comfort and Patient Understanding in Cancer Care

Adding a Bispecific Antibody to Natural Killer Cells May Be Effective in Heavily Pretreated Lymphoma 

The addition of the innate cell engager AFM13 to preactivated and expanded natural killer (NK) cells may represent an effective treatment for pretreated patients with advanced lymphoma, according to 

(NCT04074746) that were presented during the American Association for Cancer Research Annual Meeting 2022.

Results showed that patients experienced a median overall response rate of 89.5% (n = 17/19). Overall, 10 patients experienced complete responses and 7 experienced partial responses.

 Lead author Yago Nieto, MD, PhD, a professor in the Department of Stem Cell Transplantation, Division of Internal Medicine, at The University of Texas MD Anderson Cancer Center in Houston, discussed the findings during a news conference during the meeting. He said the study team was pleasantly surprised by the quality of tumor responses in patients with resistant lymphomas. 

“This is the first clinical trial using off-theshelf cord blood–derived cytokine-induced memory-like ex vivo expanded NK cells precomplexed with the innate cell engager AFM13 construct to treat patients with CD30-positive relapsed/refractory Hodgkin lymphoma,” he said. “We saw very encouraging activity in this population of very heavily pretreated patients.”

Nieto Y, Banerjee P, Kaur I, et al. Innate cell engager (ICE) AFM13 combined with preactivated and expanded cord blood (CB)-derived NK cells for patients with refractory/relapsed CD30+ lymphoma. Presented at: 2022 AACR Annual Meeting; April 8-13, 2022; New Orleans, LA. Abstract CTPL01.

Frontline TTX-030 Plus Budigalimab/ mFOLFOX6 Is Safe, Tolerable in Advanced Gastric/GEJ Cancer 

Frontline treatment with TTX-030 plus budigalimab and modified FOLFOX6 (leucovorin calcium, fluorouracil, and oxaliplatin) was 

 in patients with locally advanced or metastatic HER2- negative gastroesophageal junction (GEJ) adenocarcinoma, according to phase 1 findings recently presented at the American Association for Cancer Research Annual Meeting 2022.

In addition, the anti-CD39 antibody yielded encouraging clinical activity across all participating populations, including patients with low PD-L1 combined positive scores. Investigators also observed that the combined therapeutic was linked to an increase of PD-L1 and CD8 T cells. Based on these data, investigators determined that TTX-030 can be safely combined with modified FOLFOX and anti–PD-1 agents and administered to patients, as long as there are no excessive or synergistic toxicities. 

“TTX-030 in combination with budigalimab and modified FOLFOX6 for the treatment of patients with HER2-negative metastatic gastric cancer was well tolerated without excessive toxicities,” Zev A. Wainberg, MD, professor of medicine at University of California, Los Angeles (UCLA), and codirector of the UCLA GI Oncology Program, said in a presentation of the findings.

1. Wainberg ZA, Kang YK, Lee KW, et al. Efficacy and safety of TTX-030, an anti-CD39 antibody, in combination with chemoimmunotherapy for thefirst-line treatment of locally advanced or metastatic gastric/GEJ cancer. Presented at: 2022 AACR Annual Meeting; April 8-13, 2022; New Orleans, LA. Abstract CT015.

2-Year Follow-up Showcases Sotorasib Benefit in KRAS G12C+ NSCLC

Patients with KRAS G12C–mutant non–small cell lung cancer (NSCLC) 

experienced an overall survival (OS) rate of 32.5%

 (95% CI, 25.0%-40.2%) following treatment with sotorasib (Lumakras), according to 2-year follow-up data from the phase 1/2 CodeBreaK 100 trial (NCT03600883) that were presented during the American Association for Cancer Research Annual Meeting 2022. 

Additional results showed that the overall response rate achieved with sotorasib was 40.7% (95% CI, 33.3%-48.4%) and the disease control rate was 83.7% (95% CI, 77.3%-88.9%). Moreover, the median duration of response was 12.3 months (95% CI, 7.1-15.0), and 50.6% (95% CI, 37.4%-62.4%) of responders were in response for at least 12 months. The median progression-free survival was 6.3 months (95% CI, 5.3-8.2) and the median OS was 12.5 months (95% CI, 10.0-17.8). At 1 year, the OS rate was 50.8% (95% CI, 42.8%-58.2%). 

“In this longest follow-up of patients on any KRAS G12C inhibitor, sotorasib demonstrated very meaningful and durable efficacy, as well as a safety profile [that was] consistent with what had been [previously] reported,” Grace K. Dy, MD, chief of thoracic oncology and professor of oncology at Roswell Park Comprehensive Cancer Center in Buffalo, New York, said in a news conference during the meeting.

Dy GK, Govindan R, Velcheti V, et al. Long-term outcomes with sotorasib in pretreated KRASp.G12C-mutated NSCLC: 2-year analysis of CodeBreaK100. Presented at: 2022 AACR Annual Meeting; April 8-13, 2022, New Orleans, LA. Abstract CT008.

Investigators Inch Closer to Unlocking CAR T-Cell Therapy Potential in Solid Tumors

 with the chimeric antigen receptor (CAR) T-cell therapy BNT211. Furthermore, the treatment yielded tolerable safety results, according to data from a phase 1 trial (NCT04503278) that were presented at the American Association for Cancer Research Annual Meeting 2022. 

The trial of BNT211, consisting of a Claudin-6–targeting CAR T-cell product plus the CAR T-cell cell-amplifying RNA vaccine (CARVac), had an overall response rate (ORR) of 43% and an acceptable safety profile in 14 patients with relapsed/refractory testicular cancer, ovarian cancer, or other solid tumors. 

“We found robust engraftment of CAR T cells in all patients, which translated into a very encouraging clinical benefit with an ORR of 43% and a disease control rate of 86%. CARVac really supports the T-cell engraftment and mediates expansion,” John Haanen, MD, PhD, of the Center for Cellular Therapy at the Netherlands Cancer Institute and professor of translational immunotherapy of cancer at Leiden University, said during his presentation.

Haanen JB, Mackensen A, Koenecke C, et al. CT002 - BNT211: A Phase I trial to evaluate safety and efficacy of CLDN6 CAR-T cells and CARVac-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors. Presented at: American Association for Cancer Research Annual Meeting; April 8-13, 2022; New Orleans, LA. Abstract CT002.

This year’s conference highlighted advances in natural killer cells, CD39 and KRAS G12C inhibitors, and CAR T-cell therapies. 

A Quick Look at the 2022 AACR Annual Meeting

Suppose you have a female patient who is 52 years old with a metastatic colorectal carcinoma (mCRC) diagnosis plus peritoneal carcinomatosis. This female patient has received 7 doses of FOLFIRI, followed by cytoreductive surgery with bilateral salpingo-oophorectomy, proximal colon, and omentectomy. After developing liver and lung metastases, this patient received 4 doses of FOLFIRI plus bevacizumab (Avastin).

One week following the final dose of FOLFIRI plus bevacizumab, she underwent a 13-cm small bowel resection for closed loop obstruction and lysis for adhesions.

This patient resumed chemotherapy for mCRC with 5 cycles of FOLFOX. However, on day 5 of cycle 5, she started to experience diffuse abdominal pain and arrived at the oncology urgent care. The night before, she drank a cup of tea and immediately vomited it; she found herself unable to tolerate any food or water over the prior 12 hours. Now she is still passing flatus but has not had any bowel movements since having a normal one yesterday morning.

What does ideal care for this patient look like?

In their presentation at the 47th Annual ONS Congress, “Complex Cases and Acute Management of Emergent Complications in Cancer Care,” Laura Zitella, MS, RN, ACNP-BC, AOCN, of the University of California San Francisco, discussed how best to care for a patient presenting this potential emergency.

Upon physical exam, it was revealed that this patient had mild tenderness to epigastrium, no abdominal distention nor any comorbidities, and an ECOG performance status of 1. A check of vital signs found that her temperature was 36.9o C, heart rate was 66 bpm, respirations are 18/min, and blood pressure is 124/72 mm Hg.

In addition, her white blood count was 8.8 x 109/L, hemoglobin was low at 11 g/dL, platelets count was 285,000/mm3, blood urea nitrogen (BUN) was 10 mg/dL, and creatine was 0.84 mg/dL. In addition, her potassium levels were 4.1 mEq/L, glucose was 107 mg/dL, calcium was low at 8.1 mg/dL, sodium was 137 mEq/L, chloride was 103 mEq/L, CO2 was 23 mgEq/L, albumin was 3.4 g/dL, magnesium was 2.mEq/L, and lactate was 1.1 mmol/L.

As a provider, it may seem there are many different potential diagnoses, Zitella noted. For example, the patient may be experiencing delayed chemotherapy-induced nausea and vomiting, pancreatitis, peritoneal metastases, appendicitis, bowel obstruction, gastroesophageal reflux disease, or a gastric ulcer. In this case a CT scan of the abdomen would be considered appropriate, she said.

“I find that workup of abdominal symptoms can be some of the most challenging,” she explained. “So, for this patient, we went straight to CT and got a CT of the abdomen. Often that’s what you have to do [because with] these patients there are so many different abnormalities, and it is really hard to assess [their condition] without having the proper imaging.”

The treatment algorithm for a case of malignant bowel obstruction is as follows: the provider must consider whether there is a concern for perforation, ischemia, or necrosis. If there is, then emergent surgery should be considered. If perforation, ischemia, or necrosis do not represent valid concerns, then surgery should be considered if there is evidence of closed-loop obstruction, volvulus, intussusception, or small bowel tumor.

If there is no evidence of these conditions, then a 24- to 72-hour trial of medical management should be applied. If this does not yield improvement, surgery may be considered, or, for some patients, a stent or venting gastrostomy tube may be appropriate.

The study authors noted that malignant bowel obstruction management decisions need to be highly individualized as this emergency is associated with a high rate of recurrence and morbidity.

Immediate management of malignant bowel obstruction involves the “drip and suck” approach: this comprises intravenous (IV) hydration with a normal saline solution or a lactated Ringer’s solution, a correction of fluid deficit, acid-base disorders, and electrolyte abnormalities, as well as nasogastric tube decompression if the patient is nauseated or vomiting.

Other important nursing considerations include an NPO order (nothing by mouth), monitoring urine output to assess hydration status, and serial abdominal exams. IV hydration helps prevents dehydration and correct electrolyte abnormalities, while opioids can help control pain.

Treatment with antiemetics can be useful for controlling nausea; steroids help decrease bowel edema, inflammation, and distention, while still providing antiemetic effects—dexamethasone at 4 mg/kg to 12 mg/day is recommended. Antisecretory medications can also be helpful in decreasing intestinal secretions, some treatment options include 1.5 mg of a scopolamine transdermal patch every 3 days, a histamine-2 blocker, glycopyrrolate at 0.1 mg to 0.2 mg IV 3 to 4 times daily, and octreotide at 100 mcg to 300 mcg subcutaneously 2 to 3 times per day or 10 mcg/h to 40 mcg/h continuous infusion. 

Finally, a nasogastric tube decompresses the stomach. This, in turn, can help resolve the obstruction. It can also be useful in preventing gastric content form aspirating. When placing the tube, output should be monitored and replaced with IV fluids. Additionally, when the output has become greater than 1 liter, the patient should be trialed for tube removal through clamping the tube. If there are residuals greater than 100 mL in 4 hours, the obstruction may have resolved.

A CT scan revealed that the patient was experiencing a partial small bowel obstruction with no evidence of peritoneal carcinomatosis or abdominal metastases.

“In this case, we managed her medically,” said Zitella. “This is in contrast to how she was managed earlier in the course of therapy when she did not have metastatic disease.”

Zitella added that the patient had a closed loop obstruction that was due to an adhesion.

“She was managed conservatively with bowel rest and IV fluids. NG (tube) to decompression was considered but she wasn't actively having nausea, vomiting, so we diverted as she preferred not to have it.

By her second day in the hospital, she began to feel less distended. She also had 2 bowel movements and was passing gas. She began a clear liquid diet, which she tolerated so well that she was advanced to a regular diet on the day of discharge.

Zitella noted that patients with a history of small bowel resection and adhesions may be at an increased risk for small bowel obstruction (SBO). This condition is often resolved spontaneous with medical management and there is currently no compelling evidence suggesting that surgery improved quality of life or survival in this patient population.

Patients with advanced cancer at an increased risk of recurrent SBO; surgically correctable caused may include closed-loop obstruction, volvulus, intussusception, and small bowel tumor.

Adhesions cannot be directly seen on any imaging studies, therefore adhesive SBO is diagnosed through exclusion: it is determined through a combination of known history of prior abdominal surgery with no alternative explanation for the obstruction.


Surgery should be considered carefully since it can be a transition to the terminal phase of the disease, it also carries the risk of additional adhesions.

“Surgery is really reserved for those cases where [there is] a keratitis or ischemia or a closed loop obstruction,” Zitella concluded, adding that, “the role of surgery [for] our patients has to be considered really carefully, because most patients who have a malignant bowel obstruction have a very poor survival and this would be a transition that this is sort of a crossroads in their in their face of care.”

Furthermore, small bowel obstruction is a diagnosis of exclusion, she reiterated to listeners. “It cannot be seen directly on any imaging adhesive,” she said. “It [involves] knowing that [patient’s] history and having no alternative explanation for the small bowel obstructions, and [understanding that], if there is advanced cancer, there's a very high risk of recurrence.”

1. Zitella L, Petrofsky M. Complex cases and acute management of emergent complications in cancer care. Presented at: 47th Annual Oncology Nursing Society Congress; April 27-May 1, 2022; Anaheim, CA.

2. Franke AJ, Iqbal A, Starr JS, Nair RM, George TJ Jr. Management of malignant bowel obstruction associated with GI cancers. 

. 2017;13(7):426-434. doi:10.1200/JOP.2017.022210.

Laura Zitella, MS, RN, ACNP-BC, AOCN, reviews a case study where a 52-year-old female patient with metastatic colorectal carcinoma begins experiencing diffuse abdominal pain. 

Complex Cancer Cases: Caring for a Patient With Malignant Bowel Obstruction 

		The overall goal is to update the healthcare professional’s knowledge of cancer detection and prevention and to understand current and new research regarding state-of-the-art care for those with or at risk for cancer.

		Intended for advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients.

		Upon completion, participants should be able to:

			Describe new preventive options and treatments for cancer patients

			Identify options for individualizing the treatment for cancer patients

			Review new evidence to facilitate survivorship and supportive care for cancer patients

		Dannemiller is approved by the California Board of Registered Nursing, Provider Number 4229, for 1.0 contact hours. 

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		Radiation Therapy for DCIS Does Not Increase Risk of Cardiovascular Disease

	Women with ductal carcinoma in situ (DCIS) treated with radiation therapy had no increased risk of cardiovascular disease (CVD) compared with women in the general population or women with DCIS treated with surgery, according to results of a study in The Netherlands. The study was presented at the 2013 Breast Cancer Symposium, held September 7-9, 2013 in San Francisco, California. Abstract 58

	“Doctors have been worried about late effects of breast radiation therapy, particularly cardiovascular disease,” said Naomi B. Boekel, MSc, the study’s lead author and a PhD student at The Netherlands Cancer Institute in Amsterdam. “Our findings suggest that routine radiation therapy for women with DCIS does not appear to increase the risk of developing cardiovascular disease later in life.”

	The researchers collected data on 10,468 women in The Netherlands diagnosed with DCIS before age 75 years between 1989 and 2004. About 71% of the women were treated with surgery alone (43% had a mastectomy and the rest underwent lumpectomy) and 28% were treated with surgery and radiotherapy. The median follow-up was 10 years; 19% of the women were followed for 15 years or more. The study compared the risk of CVD in women treated with radiotherapy with that of the general population of Dutch women and to different treatment groups of women with DCIS.

	Compared with the general population, women with DCIS had a similar risk of dying from any cause and a 30% lower risk of dying of CVD. No difference was found in the risk of CVD in women treated with radiotherapy versus surgery alone (8% of patients treated with surgery plus radiation were diagnosed with CVD vs 9% treated with surgery alone). Likewise, no significant differences in the risk of CVD were observed in patients who received left-side radiotherapy (7%) versus right-side (8%).

	The findings are important in light of current concerns about overtreating patients with DCIS, said Boekel. Radiation therapy following lumpectomy for DCIS approximately halves the rate of cancer recurrence in the same breast. However, previous studies in breast and other cancers have shown that radiation to the heart region can increase the long-term risk of CVD, and in recent years, radiation therapy protocols have been adjusted to decrease exposure of the heart to radiation.

	The slightly lower risk of dying from CVD in women with DCIS might be the result of those women being more health conscious than the general population, so that they underwent breast cancer screening or adopted a healthier lifestyle after DCIS diagnosis, Boekel said. In addition, factors such as education, socioeconomic status, and conflicting risk factors between CVD and DCIS (eg, age at menopause) may also play a role. “Studies with longer follow-up after breast radiation therapy are needed before definitive conclusions about cardiovascular disease risk can be drawn,” she said.

		T-DM1 in Previously Treated HER2+ Metastatic Breast Cancer

	An analysis of the T-PAS expanded access study of trastuzumab emtansine (T-DM1) in previously treated HER2+ metastatic breast cancer (MBC) confirmed existing information on the safety of the combination, and observed significant clinical activity in a patient population that averaged seven prior therapies. The analysis was presented at the 2013 Breast Cancer Symposium, held September 7-9 in San Francisco, California. Abstract 166

	The study enrolled 215 HER2+ (IHC 3+ or FISH/CISH+) patients with locally advanced or MBC and left ventricular ejection fraction (LVEF) ≥50%. All of the patients, who received 3.6 mg/kg of T-DM1 every 3 weeks, had already been treated with an anthracycline and a taxane as well as capecitabine or 5-FU and ≥2 HER2-directed agents (including trastuzumab and lapatinib).

	At baseline, the median LVEF was 60%, and 50% of patients had investigator-reported cardiovascular disease. The median follow-up was 5.9 months; median T-DM1 duration was 5.0 months, with 15.8% receiving >18 cycles. Objective response rate, as assessed by investigators on day 1 of every cycle, was 25.6%.

	The rate of ≥grade 3 adverse events was 43.7%, and rate of serious adverse events of any grade was 18.1%. The most common ≥ grade 3 adverse events were thrombocytopenia (7.9%), fatigue (4.7%), and increased aspartate aminotransferase and anemia (3.7%). Cardiac dysfunction (primarily asymptomatic decreases in LVEF) of any grade occurred in eight patients and of ≥ grade 3 in four patients. There were no ≥ grade 3 bleeding events.

		Breast Cancer Patients Prefer Subcutaneous Trastuzumab

	Women with HER2-positive early breast cancer favor subcutaneous over intravenous (IV) administration of trastuzumab (Herceptin), according to the results of the PrefHer study (

	Xavier Pivot, MD, with CHU Jean Minjoz in Besançon, France, and coworkers elsewhere randomized subjects to receive four cycles of 600-mg fixed-dose subcutaneous adjuvant trastuzumab administered via a single-use injection device or handheld syringe, followed by four cycles of IV trastuzumab, or the reverse sequence. Treatment regimens containing IV trastuzumab are the standard of care for patients with HER2-positive breast cancer.

	In the 596-patient, phase III HANNAH trial, subcutaneous trastuzumab demonstrated a pharmacokinetic profile and efficacy that was noninferior to IV administration, with a similar safety profile.

	The PrefHer study included women with HER2- positive primary invasive breast adenocarcinoma and evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy.

CE lesson worth 1.0 contact hour that is intended for advanced practice nurses, registered nurses, and other healthcare professionals who care for cancer patients.

Clinical Insights: October 2013

		Psychosocial Benefits Derived From Patient Website Chronicling

	A program to help patients with breast cancer to create personal websites, so that they can write about their experiences and communicate more effectively with their social network, yielded statistically significant improvement in depressive symptoms, positive mood, and life appreciation among its participants, establishing a basis for a larger study of the intervention. (

	To test their hypothesis that women trained in maintaining a personal website would reap psychological benefits from such engagement, researchers—led by Annette Stanton, PhD, professor in the Department of Psychology at UCLA and a member of the Division of Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center in Los Angeles, California&mdash;designed Project Connect Online (PCO), which comprises a 3-hour, hands-on, small-group workshop guiding patients in the construction of a personal website, follow-up phone communication to facilitate use of the tool, and a take-home manual.

Oncology Nursing News