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

, Nilesh Kalariya, PhD, AGPCNP-BC, AOCNP; and Laura J. Zitella, MS, RN, ACNP-BC, AOCN, discuss data from the 64th American Society of Hematology Annual Meeting and Exposition that have the greatest potential to change oncology nursing practice.

Kalariya, a nurse practitioner with the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center, recently spoke with 

highlighted research from the University of Pennsylvania which showed clinical utility of a frailty phenotype tool and contextualized the role of CAR T-cell therapy for patients with multiple myeloma. He also discussed whether data from a subgroup analysis of patients with multiple myeloma who received the anti-BCMA CAR T-cell therapy in the KarMMa-2 trial (NCT03601078) supports moving it forward in the treatment lineup.

Zitella, a nurse practitioner in the Department of Hematology, Blood & Marrow Transplant, and Cellular Therapies Program at the UCSF Helen Diller Family Comprehensive Cancer Center and an associate clinical professor with the School of Nursing University of California, San Francisco, also spoke with 

, highlighting exciting advances with BTK inhibitors and how nurses can promote safe eating habits after data from ASH demonstrated that the neutropenic diet does not benefit patients. on which data from the 2022 ASH meeting might have the greatest impact on nurses working in hematologic oncology.

Interested in learning more from ASH? Check out our coverage of the 

We want to hear from you! Which ASH data do you think will be practice-changing? Email 

“This study that came out at ASH in a transplant population, which is the most immunocompromised population really highlights the [neutropenic diet] and brings it front and center. Hopefully, this will be enough to convince people to abandon the neutropenic diet.” 

“What we see here is that CAR T-cell therapy, followed by maintenance therapy might be a key in frontline settings to have a longer duration of response.” 

“For relapsed or refractory chronic lymphocytic leukemia, zanubrutinib [Brukinsa] had a better overall response rate and progression-free survival than ibrutinib [Imbruvica].” 

Stephanie Jackson Unpacks Recent Advances in Leukemia Treatments

FDA Grants Pirtobrutinib Accelerated Approval for Relapsed/Refractory MCL

Noncovalent BTK Inhibitors May Fill Unmet Needs in CLL and Other Top ASH Takeaways

Optimizing Frailty Tools Are A Vital Component of Improving Care Across Hematologic Malignancies

Phase 3 Data Support Leaving the “Neutrodiet” Behind After Stem Cell Transplant

Induction and Maintenance With Ibrutinib Proves Effective for Mantle Cell Lymphoma

Zanubrutinib Outperforms Ibrutinib in Head-to-Head Trial for Relapsed/Refractory CLL/SLL

Aaron Gerds on JAK Inhibitor Therapy for Anemic Patients With Myelofibrosis

Gardner A, Mattiuzzi G, Faderl S, et al. Randomized comparison of cooked and noncooked diets in patients undergoing remission induction therapy for acute myeloid leukemia. 

. 2008;26(35):5684-5688. doi:10.1200/JCO.2008.16.4681

Usmani S, Patel K, Hari P, et al. KarMMa-2 cohort 2a: efficacy and safety of idecabtagene vicleucel in clinical high-risk multiple myeloma patients with early relapse after frontline autologous stem cell transplantation. 

. 2022;140(suppl 1):875-877. doi:10.1182/blood-2022-162469

Dhodapkar M, Alsina M, Berdeja J, et al. KarMMa-2 cohort 2c: efficacy and safety of idecabtagene vicleucel in patients with clinical high-risk multiple myeloma due to inadequate response to frontline autologous stem cell transplantation. 

. 2022;140 (suppl 1):7441–7443. doi:10.1182/blood-2022-162615

Stella F, Marasco V, Levati GV, et al. Non-restrictive diet does not increase infections in patients with neutropenia after stem cell transplantation: final analysis of the Neutrodiet multicenter, randomized trial. Presented at ASH 2022. December 10-13, 2022. Abstract 169.

Brown JR, Eichhorst B, Hillmen P, et al. Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia. 

. Published online December 13, 2022. doi:10.1056/NEJMoa2211582

Mato AR, Woyach, JA, Brown, JR, et al. Efficacy of pirtobrutinib in covalent BTK-Inhibitor pre-treated relapsed / refractory CLL/SLL: additional patients and extended follow-up from the phase 1/2 BRUIN study. 

Dreyling M, Doorduijn, JK,Gine E, et al. Efficacy and safety of ibrutinib combined with standard first-line treatment or as substitute for autologous stem cell transplantation in younger patients with mantle cell lymphoma: results from the randomized triangle trial by the european MCL network. 

Podcasts

Nilesh Kalariya, PhD, AGPCNP-BC, AOCNP; and Laura J. Zitella, MS, RN, ACNP-BC, AOCN, discuss practice-changing presentations from the 64th American Society of Hematology Annual Meeting and Exposition.

ASH Data Offer Treatment Direction for Oncology Nursing Professionals  

Neoadjuvant pembrolizumab (Keytruda) elicited high clinical activity in patients with mismatch repair deficiency (dMMR)/microsatellite instability high (MSI-H) solid tumors and was well tolerated, according to data from a phase 2 study (NCT04082572) published in the 

. Patients who underwent nonoperative management demonstrated promising benefit from the treatment in addition to those who had surgical resection.

The primary end point of the study was pathological complete response (pCR) among those who received 3 doses of pembrolizumab prior to resection. Fifteen patients were evaluable for this end point and had a pCR rate of 67% (95% CI, 38%-88%). At the time of data cutoff, March 31, 2022, 17 patients (49%) underwent surgical resection—including 1 patient after cycle 1, and 1 patient after cycle 2—and achieved a pathological CR rate of 65%. Although the pCR rate of 65% was lower than the study goal of 80%, patients with colorectal cancer (n = 11/14) experienced a pCR rate of 79%.

Among all patients evaluable for radiographic response (n = 33) the overall response rate (ORR) was 82% with a complete response (CR) rate of 30%. Eighteen patients did not undergo surgical resection and either had nonoperative management after 1 year of pembrolizumab (n = 10) or received pembrolizumab for less than a year (n = 8). At median follow-up of approximately 9.5 months (range, 0-26), only 2 patients in the efficacy-evaluable nonoperative arm (n = 17) experienced progression events.

In the cohort of patients who received pembrolizumab for less than a year, 5 patients opted for nonoperative management, 3 patients achieved CRs, 2 experienced stable disease, 1 patient withdrew consent, and 2 patients died from causes unrelated to treatment. Additionally, both patients on the trial with pancreatic cancer (n = 2), experienced adaptive progression and did not achieve a pCR.

“One of the most intriguing findings from this prospective trial is the suggestion that neoadjuvant PD-1–based therapy may represent a definitive approach for dMMR solid tumors enabling organ preservation,” wrote lead study author Kaysia Ludford, MD, of The University of Texas MD Anderson Cancer Center, in Houston, TX, and colleagues, in the paper.

The investigator-initiated, open-label trial was conducted at The University of Texas MD Anderson Cancer Center in Houston and enrolled a total of 35 patients from October 31, 2019, to March 25, 2021. Most patients (77%) had colorectal adenocarcinomas, which included colon adenocarcinoma (54%), rectal adenocarcinoma (23%), pancreatic adenocarcinoma (6%), duodenal adenocarcinoma (6%), and other (11%).

Patients had unresectable cancer at a rate of 26%, with 74% of patients presenting with clinical stage 3 disease and 23% with stage 2 disease. Additionally, 74% of patients were not previously treated and 11% of patients had prior radiation, 9% surgery, and 6% chemotherapy.

The coprimary end points were safety and pCR. Key secondary end points included ORR and organ-sparing at 1 year for patients who declined surgery.

Pembrolizumab 200 mg was administered intravenously once every 3 weeks for 8 treatments followed by surgical resection. A nonsurgical management option included was for patients to receive pembrolizumab for 16 treatments followed by observation.

Eligible patients were at least 18 years of age with measurable disease by RECIST 1.1 with locally advanced, defined as a 20% chance or greater of recurrence with solely surgical resection, dMMR/MSI-H solid cancers. The median age was 62 years (range, 25-90) and more than half of patients were women (57%). Limitations of the study design included the small patient population, enrollment at only 1 institution, and the choice given to the patient and/or treating physician to decide whether to proceed with surgical resection.

Thirty patients (86%) in the trial had luminal gastrointestinal cancers. Additional findings from the study showed that among the 19 who were evaluable for endoscopic response, 63% experienced a CR and 37% had incomplete responses with a median time to response of 17 weeks (range, 6-31). Five patients who had a CR underwent surgical resection, all of whom achieved a pCR. Additionally, 3 of the patients who had incomplete responses underwent surgical resections with 2 experiencing a pCR and 1 residual disease.

Moreover, 19 patients had serial sample and detectable circulating tumor DNA (ctDNA) at baseline and 13 of 15 patients with ctDNA decrease had no progression. The study authors noted that an early decrease in ctDNA was predictive of no future progression events (

No new safety signals were reported for pembrolizumab. Grade 1 or 2 adverse events (AEs) occurred in 37% of patients in the safety population (n = 35) and 6% experienced grade 3 AEs. No grade 4 AEs were reported. Out of the 17 patients who underwent surgery, 3 postoperative complications were experienced consisting of grade 3b surgical site abscess, grade 1 abdominal wall hematoma, and grade 2 diarrhea occurring.

Pembrolizumab was previously granted accelerated approval by the FDA on May 23, 2017, for the treatment of adult and pediatric patients with unresectable or metastatic, MSI-H/dMMR solid tumors whose disease had progressed after prior treatment.2 Additionally, the PD-1–targeted antibody gained a standard approval from the agency for the first-line treatment of patients with unresectable or metastatic MSI-H/dMMR colorectal cancer on June 29, 2020.

MSI-H and dMMR tumors are most commonly found in colorectal, endometrial, and gastric cancers and are typically seen in the early-stage of disease. Although therapy for localized dMMR cancer is based on treatments for proficient MMR/microsatellite stable tumors which includes surgery, chemotherapy, and/or radiation, data have indicated that chemotherapy may not provide the same level of benefit for dMMR disease.

MSI-H tumors, regardless of PD-L1immunohistochemistry expression levels, have had greater responses to checkpoint blockades with PD-1 or PD-L1 inhibitors than microsatellite stable tumors.

 Additionally, dMMR tumors have a high prevalence in colorectal adenocarcinomas; an analysis of 16,065 evaluable biopsy specimens demonstrated an overall dMMR prevalence of 13.4% compared with only 2.7% within the rectal cancer subset.

“When the immune profiles between progressors and nonprogressors were compared, progressors demonstrated a trend toward higher presence of granulocytic cell cluster and exhausted T cells…the presence of CD151 granulocytic cell types and their close proximity to CD81 T cells associate with progression in dMMR cancers,” study authors noted. 

Future directions for this research include further investigating checkpoint inhibitors, which have established efficacy in this patient population, in the neoadjuvant space as well as enrolling larger studies on dMMR solid tumors to define duration of therapy. The best assessment to evaluate luminal tumors also requires more investigation according to the study authors.

Ludford K, Ho WJ, Thomas JV, et al. Neoadjuvant pembrolizumab in localized microsatellite instability high/deficient mismatch repair solid tumors. 

. Published online January 9, 2023. doi:10.1200/JCO.22.01351

Ciombor KK, Eng C. Immunotherapy in localized microsatellite instability-high/mismatch repair deficient solid tumors: are we ready for a new standard of care? 

. Published online January 9, 2023. doi:10.1200/JCO.22.02564

FDA approves pembrolizumab for first-line treatment of MSI-H/dMMR colorectal cancer. FDA. Updated June 30, 2020. Accessed January 25, 2023. bit.ly/3XXORkO

Marginean EC, Melosky B. Is there a role for programmed death ligand-1 testing and immunotherapy in colorectal cancer with microsatellite instability? Part II-the challenge of programmed death ligand-1 testing and its role in microsatellite instability-high colorectal cancer. 

. 2018;142(1):26-34. doi:10.5858/arpa.2017-0041-RA

Articles

Neoadjuvant pembrolizumab elicited high clinical activity in patients with mismatch repair deficiency/microsatellite instability high solid tumors and was well tolerated.

Neoadjuvant Pembrolizumab Elicits High Response Among dMMR/MSI-H Solid Tumors

Radiation therapy remains a pillar of oncology treatment, yet palliative radiotherapy is often misunderstood, according to Reanne Booker, MN, NP.

However, nurses can play an important role in educating patients about this treatment and determining if it is appropriate for patients.

“Oncology nurses play a huge role in helping to address misperceptions and educating patients about the goals of palliative care,” said Booker, who is a nurse practitioner with the palliative and end of life care services program at the Foothills Medical Centre at Alberta Health Services in Calgary, Alberta, as well as a PhD candidate at the University of Victoria in British Columbia, in an interview with 

“Nurses already are fantastic at providing or adopting a palliative approach to care,” she added. “[When it comes to palliative radiation], it’s all about listening to the patient, and making sure that the treatments we’re offering are aligning with patient’s goals and wishes.”

Booker recently performed a literature review on palliative radiation. The findings from her research, which were published in the 

, provide foundational information for nurses on indications for palliative radiation therapy, possible adverse effects and toxicities associated with treatment, and potential accessibility barriers patients may face.

 Booker highlighted the key takeaways form this research and the broader implications for oncology nursing practice.

®: Are all patients eligible for palliative radiotherapy?

 We know that approximately half of all patients will receive radiation therapy at some point in their disease and treatment trajectories. Approximately half of all prescribed radiotherapy is with palliative intent. But there are some patients who are better suited to receive palliative intent radiation therapy compared with others.

It’s really important that we consider a patient’s goals and wishes and to make sure that our treatment aligns with [that]. When it comes to radiation therapy, it can take between 1 to 4 weeks for patients to realize the full benefit of the treatment. So, if their prognosis is thought to be quite short—in the neighborhood of days or weeks—then that might not be the best option for them, because they wouldn’t potentially be able to realize the benefit of the treatment. Patients [also] need to be able to tolerate laying still on a hardtop table for at least 15 minutes. Depending on their physical condition, they may not be able to tolerate that. Some patients don’t like to have masks or things placed over their face, and, depending on the treatment sites, they may have to have that. [This] can cause anxiety and claustrophobia for some patients. Additionally, patients have to travel to and from the cancer center. If they live quite a distance, you have to really weigh those risks and benefits in terms of what’s the best option for the patient.

Can you differentiate between radiation therapy for curative intent vs palliative radiation therapy?

The biggest difference is the intent or the goals of the treatment. Palliative-intent radiation is meant to alleviate symptoms rather than cure the disease.

We really need to talk about the risks and benefit: what are the possible adverse effects that might happen? If the intent is to alleviate symptoms, but not necessarily cure the disease, then we need to make sure that those adverse effects of treatment don’t outweigh the benefits, especially in the palliative context. We have studies to show that patients are very often willing to deal with diminished quality of [life] if the treatment is meant to be curative. It’s a bit different [when] we know that the treatment won’t be curing the underlying cancer. Many patients would really argue that their quality of life is key, [so we] want to really think about that balance.

In your article, you present 2 very different case studies about patients and their decision to pursue or not pursue radiation therapy. What were the key concerns that these patients expressed and what advice might you have for nurses who find themselves in real-world situations similar to these?

These cases were based on real-[world] experiences I’ve had with details changed to preserve anonymity and confidentiality.

One patient is a 38-year-old nurse with history of metastatic breast cancer, who has undergone multiple lines of therapy. The other patient is a 78-year-old gentleman with many symptoms and a new diagnosis of multiple myeloma. In both cases, radiation was being offered as a palliative measure. So again, the goal was to alleviate symptoms to help improve quality of life.

It is imperative in the context of any palliative-intent treatment to ensure that the treatment harms don’t outweigh the benefits. So, for Abigail, the nurse, we knew her prognosis was estimated to be [approximately a few] short weeks. She’d already told us that she didn’t want to have any more disease directed treatment for breast cancer. Her goals were really to spend more time with her family and have good quality of life [and] she didn’t want to be spending her remaining time in the hospital or traveling to and from the cancer center. So, there are other options that we can pursue in terms of symptom management that were a better fit for her.

In contrast, for Justin, the gentleman, although the radiation therapy was also palliative, and not meant to cure the multiple myeloma, there was an expectation that the treatment would result in significant alleviation of his symptoms, as well as to help preserve function and prevent any further neurologic deterioration.

Both these cases highlight the importance of educating the patient first, and [define the] intent of the palliative treatment or any treatment. And then really making sure that we explore the goals and wishes of the patient to make sure that treatment aligns.

Nurses are well-suited to have these discussions with patients. We get to spend quite a bit of time with our patients, and we get to explore their situation comprehensively. For nurses who find these conversations challenging, [discuss the patient’s] goals and wishes and use that as a bit of a scaffolding or guide.

[Consider:] What does the patient hope to get out of treatment? Is their goal to live longer? Is it to live better? What are they willing to trade for the prospect of more time, what would be something that they would consider unacceptable in terms of a tradeoff? That might be adverse effects and might be time at the cancer center at the expense of time with their families, or loss of function.

What are some common barriers to receiving palliative radiation?

Access and equity can be a problematic challenge for many patients. I’m in Canada, but in both the United States and Canada, we know that patients who reside in very rural and remote areas have reduced access to some of these treatments and services, or, if they are able to access them, they are required to travel long distances and be away from family, and it is often a significant expense to be able to make those trips and travel.

I also think [there are] additional barriers in our language. For some patients, and even for some doctors and nurses and clinicians, hearing that word palliative can be very frightening. There are a lot of misperceptions that persist about palliative care where people still equate palliative care with end-of-life or hospice care. Sometimes, when we look at referring patients to palliative services, there can be reluctance because the clinicians don’t want to take away hope or they don’t want to cause undue distress to the patients. On the patient side, they can harbor those misperceptions about palliative care. They may not want to pursue any palliative treatments of any kind, because they might think that it means they’re dying.

Our language and explanations can be really helpful and as nurses, this is a place where we can provide that education to patients and their loved ones—to help them understand that palliative doesn’t mean the end or hospice, it just means we want to help make that experience as good as it possibly can be.

Globally, lack of access is a major problem, [with] 80% of the world’s patients with cancer [geographically residing] in low- and middle-income countries [and] having approximately 5% of global radiotherapy resources. So, access is a huge issue worldwide.

I often feel [that] when a patient decides to forego or move away from disease-directed or disease-modifying treatments there’s a sense that we’re giving up or there’s nothing more that can be done. In the palliative care world, we like to tell patients, there’s always more we can do. It may be that the goal has shifted a little bit and may not be cure anymore, but there’s still other goals we can work towards, and we can help patients achieve [them]. I feel there’s always so much we can do in terms of alleviating symptoms and helping to optimize quality of life.

Is there anything else that I didn't ask you that you wanted to highlight?

It would be ideal if cancer centers routinely integrated palliative care into standard patient care. That might just mean that we have triggers for when to refer patients. But embedding palliative care services right alongside even curative intent treatment can be really helpful.

Booker R. Palliative radiation therapy: the role of radiation therapy in palliative and end-of-life care. 

Reanne Booker, MN, NP, shares how nurses can increase patient understanding on the role of palliative care in oncology. 

 Discussions Around Palliative Radiation Are Key To Improving Both Patient and Provider Understanding 

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

RNs and social workers in oncology are key players in promoting cervical cancer awareness and advocating for patients.

As discussed in this series, January is cervical prevention month. As patient advocates, RNs and social workers can help push the agenda of eradicating this disease entirely in a few generations.

The ribbon associated with this disease is the color teal. The significance of this color is that it can be indelibly linked to this disease in the way that red is linked to HIV/AIDS and pink to breast cancer. These movements give individuals a way to physical picture the disease awareness.

Being able to visualize awareness efforts is important, as the percentage of cases worldwide are high. There were 604,000 new cases of cervical cancer in 2020 and 342,000 deaths all reported to the World Health organization (WHO).

 India has one-quarter of all new cases, and accounts for one-third of incidences of death.

Nurses are in a position to promote patient education by encouraging them to listen to informative podcasts, videos, and webinars. A visit to a gynecologist’s office is a prime example of an educational opportunity. Podcasts, videos, and webinars can all be offered when a woman waits for an appointment. The RN or ARNP can present the material as part of a patient education outreach effort. In the hospital setting, the nurse and social worker can review preventive measures such as not smoking or going to smoking cessation classes for current smokers, and the importance of scheduling annual Papanicolaou test or receiving HPV vaccines‚ if applicable to the age group.

The Centers for Disease Control and Prevention (CDC) has a series of podcasts for patient audiences that can be listened to while waiting in the office.

 The podcasts are short, approximately, 1 minute and 15 seconds and the transcripts are also available.

 There are also webinars and videos for RNs and social workers on the CDC website concerning cervical cancer.

 For example, there is a video on preventing this disease in the 21st century that I found quite useful. There is another video on community-based efforts to prevent this disease.

Moreover, drug companies, such as Merck, the manufacturer of pembrolizumab (Keytruda), an immunotherapy used against cervical cancer also has a comprehensive website for health care professionals and patients discussing this drug and its’ use against this cancer as well as others.

 I find many of these resources to be helpful and easy to understand.

Finally, I would like to highlight a famous patient advocate that oncology RNs and social workers should be aware of. Miss USA Ellie Smith is the leader of the Louisville chapter of the National Cervical Cancer Coalition (NCCC), which merged with the American Sexual Health Association (ASHA) in 2011. ASHA is a nonprofit association that focuses on sexual health issues and teaching.

Smith’s late grandmother’s cause of death was cervical cancer in 2015.As a result, she has dedicated her platform to cervical cancer awareness.

Because of her grandmother’s journey, she decided to incorporate the topic of cervical cancer awareness into her public role. According to Smith’s family, Ellie’s grandmother did not follow up with routine check-ups, including Papanicolaou test, because she was very busy as a caretaker for own mother, who had Parkinson Disease and leukemia.

From prevention, Papanicolaou test and screening guidelines, navigating treatments options, and encouraging awareness, oncology RNs and social workers play a key role in advocating for patients with cervical cancer. I applaud nurses and social workers for their work and encourage you to continue advocating for patients.

Cervical cancer. World Health Organization. February 22, 2022. Accessed January 27, 2023. bit.ly/3jd3IJa

Vital signs-cervical cancer is preventable! Centers for Disease Control and Prevention. Accessed January 25, 2023. https://bit.ly/3kRSgDd

Webinars and other videos. Centers for Disease Control and Prevention. Accessed January 25, 2023. 

HCP & patient resources. Merck. Accessed January 26, 2023. 

Schaefer S. Elle Smith has been crowned Miss
USA 2021, and part of her platform is cervical cancer awareness, as
a memorial to her grandmother. November 30, 2021. Accessed January 27, 2023. https://bit.ly/3Y0Hb15 



January is cervical cancer awareness month. This fourth article in a series underscores the role of the nurse or social workers in patient advocacy. 

Oncology RNs and Social Workers Play Key Role in Cervical Cancer Awareness and Advocacy 

Frontline treatment with tislelizumab produced superior health-related quality of life (QOL) outcomes compared with sorafenib (Nexavar) among patients with unresectable hepatocellular carcinoma (HCC), according to results presented at the 2023 Gastrointestinal Cancers Symposium.

In the phase 3 RATIONALE-301 trial (NCT03412773), tislelizumab demonstrated improved EORLC GHS/QoL (European Organisation for Research and Treatment of Cancer Global Health Score/Quality of Life) scores, physical functioning, fatigue, and HCC symptom index versus sorafenib. However, it did not significantly reduce pain compared with sorafenib. QOL was maintained from cycle 4 to 6 in the tislelizumab arm whereas patients who received sorafenib deteriorated more significantly over the treatment period.

“Liver cancer represents a global health burden and while there have been advances of recent in the management of the disease, still new treatments are required,” Richard S. Finn, MD, a professor at UCLA’s Geffen School of Medicine, stated in his presentation.

The global RATIONALE-301 trial randomly assigned 674 patients to receive tislelizumab, an IgG4 anti–PD-1 monoclonal antibody, or sorafenib, a tyrosine kinase inhibitor (TKI). The efficacy results of the study previously demonstrated noninferiority of tislelizumab versus sorafenib for overall survival and objective response rate (ORR), as well as showing improvements in tolerability.

The participants in this study had treatment-naive HCC, Child-Pugh class A, ECOG performance status of 0 or 1, and no tumor thrombus involving main the trunk of portal vein, inferior vena cava, or clinical evidence of portal hypertension with bleeding varices at screening.

Health-related QOL was a key secondary end point in the study, and investigators employed 3 patient-reported outcome (PRO) surveys: the EORTC QLQ-C30 questionnaire for physical functioning and fatigue, the HCC-specific QLQ-HCC18 index, fatigue, and pain scores, and the EQ-5D-5L for descriptive purposes. Over 95% completed surveys at baseline, and the adjusted completion rates for both arms at cycle 4 and 6 were greater than 92%.

When looking at the QLQ-C30 survey’s GHS/QoL scores, patients maintained QOL with tislelizumab and QOL declined with sorafenib. The least square mean difference in scores between the arms was 4.3 favoring tislelizumab (95% CI, 1.4 to 7.3; nominal 

 ≤ .01). Tislelizumab’s mean score change from baseline to cycle 4 was -0.7 (95% CI, -3.0 to 1.6) vs -5.1 (95% CI, -7.6 to -2.6; 

= .0037) for sorafenib. At cycle 6, the mean difference increased to 5.0 favoring tislelizumab (95% CI, 1.8 to 8.2; nominal 

 ≤ .01) and the mean score change from baseline to cycle 6 was -0.9 with tislelizumab (95% CI, -3.4 to 1.6) and -5.9 with sorafenib (95% CI, -8.6 to -3.2; 

 = .0022). The hazard ratio (HR) was 0.68 favoring tislelizumab (95% CI, 0.49 to 0.94).

The QLQ-C30 estimated mean physical functioning score showed a difference of 6.4 favoring tislelizumab (95% CI, 4.2 to 8.6; nominal 

 ≤ .01) after 4 cycles of treatment. After 6 cycles, the difference was 6.2 (95% CI, 3.7 to 8.6; nominal 

 ≤ .01) favoring tislelizumab. The HR for reduced physical functioning was 0.46 (95% CI, 0.33-0.64)

When evaluating reported fatigue based on the QLQ-C30 results, the mean difference in reported fatigue score was -7.6 (95% CI, -10.6 to -4.7; nominal 

 ≤ .01) at 4 cycles and -7.6 (95% CI, -10.8 to -4.3; nominal 

 ≤ .01) at 6 cycles. The HR favoring tislelizumab was 0.48 (95% CI, 0.37 to 0.63).

For the EORTC QLQ-HCC18 index score, the HR favoring tislelizumab was 0.53 (95% CI, 0.34 to 0.81; nominal 

 ≤ .01). At cycle 4, the mean difference was -2.3 (95% CI, -3.8 to -0.8; nominal 

 ≤ .01) and at cycle 6 the mean difference was -2.7 (95% CI, -4.7 to -0.7; nominal 

When looking at patient-reported fatigue based on the QLQ-HCC18 questionnaire, the mean treatment difference in fatigue at 4 cycles was -6.2 (95% CI, -9.0 to -3.4; nominal 

 ≤ .01) and at 6 cycles was -6.0 (95% CI, -9.4 to -2.5; nominal 

 ≤ .01), both favoring tislelizumab. The HR for fatigue favoring tislelizumab was 0.60 (95% CI, 0.46 to 0.80).

The QLQ-HCC18 results for patient-reported pain impacting their QOL showed the mean difference in reported pain score was -0.6 (95% CI, -3.3 to 2.1) at 4 cycles and -0.4 (95% CI, -3.6 to 2.9) at 6 cycles. The HR favoring tislelizumab was 0.78 (95% CI, 0.56 to 1.09), not showing a significant difference in reported pain between the 2 study arms.

In the EQ-5D-5L VAS (visual analogue scale) for general health status, patients who received sorafenib appeared to decline further from baseline between cycles 4 and 6. There was a mean change from baseline of -4.3 (standard deviation [SD], 12.92) at cycle 4 and a mean change of -5.4 (SD, 13.09) at cycle 6 with sorafenib, whereas those who received tislelizumab had a mean change of -0.4 (SD, 14.52) at cycle 4 and -0.2 (SD, 17.03) at cycle 6.

These results, along with the improvements in survival, response, and safety shown in the original presentation of the study findings, suggest that overall health-related QOL will be improved with the single-agent immunotherapy vs the TKI.

“In conclusion, RATIONALE-301 met its primary end point of demonstrating noninferiority to sorafenib in the frontline setting. It also met key clinical end points of including increasing ORR, as well as a favorable safety profile consistent with the class of the PD-1 inhibitor,” said Finn. “As we see here in this noninferiority study, QOL readouts favored tislelizumab versus sorafenib. And together these data support the potential of tislelizumab as a frontline option for patients who may not be a candidate for PD-1 doublet therapy.”

Finn RS, Qin S, Kudo M, et al. Tislelizumab versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: Impact on health-related quality of life in RATIONALE-301 population. 

. 2023;41(suppl 4):495. doi:10.1200/JCO.2023.41.3_suppl.495

Kudo M, Qin S, Meyer T, et al. Final analysis of RATIONALE-301: Randomized, phase III study of tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. 

. 2022;33(suppl_7):S808-S869. doi:10.1016/annonc/annonc1089.

Patients with hepatocellular carcinoma experienced better health-related quality of life outcomes with tislelizumab vs sorafenib.

HRQOL Analysis Favors Tislelizumab Over Sorafenib in Hepatocellular Carcinoma 

Encorafenib plus cetuximab, along with chemotherapy, was linked to antitumor activity and a manageable safety profile in patients with BRAF V600E-mutant metastatic colorectal cancer. 

Encorafenib Triplet Elicits Antitumor Activity in BRAF V600E+ mCRC

The FDA has granted an accelerated approval to elacestrant (Orserdu) for the treatment of patients with estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer following at least 1 prior lines of endocrine therapy.

FDA Approves Oral SERD Elacestrant for ESR1-Mutant ER+, HER2– Metastatic Breast Cancer

Pirtobrutinib has been approved for patients with mantle cell lymphoma. The prescribing label comes with warnings for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, second primary malignancies, and embryo-fetal toxicity.


Neoadjuvant chemoradiation followed by pancreaticoduodenectomy resulted in 0.14 more quality-of-life years than upfront surgery followed by adjuvant chemotherapy in patients with resectable pancreatic cancer. 

Neoadjuvant Treatment Crosses Cost-Effective Threshold Vs Upfront Surgery in Pancreatic Cancer

Videos

Closing their discussion, the panel shares advice for new nurse practitioners caring for patients who have endometrial cancer.

Advice for New Nurse Practitioners Working With Patients With Endometrial Cancer

Heather Jackson, PhD, FNP-BC, NEA-BC, FAANP, provides a case-based perspective on the benefit of auricular acupuncture as a tool for managing cancer pain.

Auricular Acupuncture Offers Complimentary Approach to Manage Cancer Pain

The panel shares the most critical unmet needs for patients with endometrial cancer.

Greatest Unmet Needs for Patients with Endometrial Cancer

Pembrolizumab has been approved by the FDA as an adjuvant treatment for patients with stage IB, II, or IIIA following resection and platinum-based chemotherapy.

Adjuvant Pembrolizumab Gets FDA Approval in NSCLC

Findings from the phase 3 SUNLIGHT study showed that adding bevacizumab to trifluridine/tipiracil boosted overall survival in metastatic colorectal cancer.

Trifluridine/Tipiracil Plus Bevacizumab Improves OS in Refractory Metastatic Colorectal Cancer

Investigators identified underrepresentation and imbalances in demographic and geographic representation in clinical trials leading to FDA approvals. 

Pivotal Multiple Myeloma, Leukemia Trials May Not Represent the Populations They Serve

Patients with breast cancer who carry BRCA1, BRCA2, CHEK2, or PALB2 germline pathogenic variants may be at a greater risk for contralateral breast cancer and may benefit from enhanced surveillance and risk-reduction strategies. 

Patients With Breast Cancer and BRCA1, BRCA2, CHEK2, or PALB2 Germline Pathogenic Variants May Benefit From Enhanced Surveillance

The median overall survival with frontline liposomal irinotecan/NALIRIFOX was 11.1 months vs 9.2 months with nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.

Frontline Liposomal Irinotecan/NALIRIFOX Confers OS Benefit in Metastatic Pancreatic Ductal Adenocarcinoma

The median overall survival with nivolumab plus chemotherapy was 12.8 months, vs 10.7 months with chemotherapy alone, in patients with treatment-naïve advanced esophageal squamous cell carcinoma.

CheckMate 648 Update Showcases Long-Term Survival Benefit With Frontline Nivolumab in ESCC 

An analysis of 141 children who had prenatal exposure to maternal cancer showed promising cognitive and behavioral functions at age 9 years. 

Children Exposed to Maternal Cancer Show Normal Cognitive and Behavioral Outcomes

Both the gastric and breast cancer HER2 scoring algorithms may be useful in determining which patients with metastatic colorectal cancer may derive benefit with tucatinib/ trastuzumab.

Top Medical News

ASH Data Offer Treatment Direction for Oncology Nursing Professionals

Neoadjuvant Pembrolizumab Elicits High Response Among dMMR/MSI-H Solid Tumors

Discussions Around Palliative Radiation Are Key To Improving Both Patient and Provider Understanding

Oncology RNs and Social Workers Play Key Role in Cervical Cancer Awareness and Advocacy

HRQOL Analysis Favors Tislelizumab Over Sorafenib in Hepatocellular Carcinoma

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