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Patients with Claudin-6–positive advanced solid tumors, including platinum-resistant ovarian cancer, tended to respond to therapy with TORL-1-23

TORL-1-23 Generates Responses in Heavily Pretreated CLDN6-Positive Solid Tumors

While adjuvant pembrolizumab and chemotherapy with or without radiation did not boost DFS in the overall high-risk endometrial cancer population, but showed a trend toward improved DFS in one patient subgroup. 

Postsurgical Pembrolizumab/Chemotherapy Misses DFS Goal in Endometrial Cancer

Retifanlimab plus carboplatin and paclitaxel boosted PFS for certain patients with recurrent or metastatic SCAC. 

Retifanlimab Plus Carboplatin and Paclitaxel Improve PFS in Recurrent/Metastatic Anal Cancer

The addition of radium-223 to enzalutamide led to significant rPFS and OS benefits compared to enzalutamide alone in metastatic castration-resistant prostate cancer.

Radium-223 Plus Enzalutamide Boosts Survival in mCRPC

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®. Gina joined the company in 2015 and has held various positions on 

Prior to joining MJH Life Sciences, she worked at Gannett as a full-time reporter with the Asbury Park Press. Email: gmauro@onclive.com

Megan is an assistant editor at MJH. She joined the company in 2022 after graduating from UMass Amherst with majors in communication and english. When not at work, Megan enjoys fishing, spending time with her twin sister, and listening to Taylor Swift on repeat. Email Megan at mhollasch@onclive.com

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Mark Lazenby, PhD, APRN, FAPOS, associate professor at Yale School of Nursing and incoming president of American Psychosocial Oncology Society (APOS), discusses psychosocial topics that concern APOS. 

Mark Lazenby on Psychosocial Topics Concerning APOS

Mark Lazenby, PhD, APRN, FAPOS, associate professor, Yale School of Nursing, discusses tools to measure distress in a patient with cancer.

Mark Lazenby on Measuring Distress in a Patient

As CAR T-cell therapy continues to revolutionize the treatment of patients with multiple myeloma, oncology nurses play a vital role in managing the adverse effects associated with this therapy, highlighting the importance of early detection, prompt intervention, patient education, and interdisciplinary collaboration, an expert said.

Donna Catamero, ANP-BC, OCN, CCRC, associate director of the Multiple Myeloma Research Program at The Mount Sinai Health System in New York, New York, discussed the use of CAR T-cell therapy to treat patients with multiple myeloma.

The treatment landscape for multiple myeloma has seen significant advancements with the introduction of CAR T-cell therapy. This innovative approach offers new hope for patients with relapsed or refractory multiple myeloma.

However, the complex nature of CAR T-cell therapy comes with its own set of challenges, especially regarding the management of adverse effects. Oncology nurses play a pivotal role in ensuring the safety and well-being of patients undergoing this treatment.

Understanding CAR T-Cell Therapy and Its Adverse Effects

CAR T-cell therapy involves reprogramming a patient’s T-cells to target and destroy cancer cells. For example, ciltacabtagene autoleucel (Carvykti; cilta-cel), a BCMA-directed CAR T-cell therapy, has shown impressive efficacy in clinical trials. Despite its promising results, the therapy is associated with significant adverse effects, primarily cytokine release syndrome (CRS) and neurotoxicity.

CRS is an acute inflammatory response caused by the rapid activation of CAR T-cells, leading to the release of cytokines. Symptoms range from mild flu-like symptoms to severe, life-threatening reactions such as high fever, hypotension, and respiratory distress. Neurotoxicity, on the other hand, can manifest as confusion, aphasia, seizures, and, in severe cases, cerebral edema.

The Role of Oncology Nurses in Managing CRS

Early detection and prompt management of CRS are crucial for patient safety. Standard premedications, such as acetaminophen and antihistamines, are administered to mitigate mild symptoms. For moderate to severe CRS, interventions include the administration of tocilizumab (Actemra), an IL-6 receptor antagonist, and corticosteroids. Oncology nurses must be adept at implementing these protocols and collaborating with the healthcare team to provide timely care.

Neurotoxicity presents another significant challenge in CAR T-cell therapy. Oncology nurses conduct regular neurological assessments to detect early signs of neurotoxicity. In cases of severe neurotoxicity, interventions may include corticosteroids, anti-seizure medications, and supportive care in an intensive care setting. Continuous monitoring and timely communication with the medical team are essential to manage these complex cases effectively.

Educating and Supporting Patients and Families

Patient education is a fundamental aspect of managing patients during and after CAR T-cell therapy. Oncology nurses are responsible for preparing patients and their families for the potential adverse effects of the treatment.

Nurses educate patients about the signs and symptoms of CRS and neurotoxicity, emphasizing the importance of reporting any changes immediately. This proactive approach enables early intervention and improves patient outcomes. Additionally, providing emotional support and counseling helps alleviate anxiety and fosters a positive treatment experience.

Education also becomes a critical component for other members of the healthcare team who may care for patients experiencing adverse effects from CAR T-cell therapy. This becomes a factor especially for patients who return to receiving care at community centers compared with larger institutions.

Staying updated on the latest developments in CAR T-cell therapy is crucial for oncology nurses. Participation in ongoing education and research enhances their ability to manage adverse effects effectively. Receiving this information to then disperse it to patients is important to prepare them for any potential scenarios with CAR T-cell therapy. 

Donna Catamero, ANP-BC, OCN, CCRC, discusses the importance of quickly identifying and managing adverse effects from CAR T-cell therapy in patients with multiple myeloma.

Managing Adverse Effects of CAR T-Cell Therapy in Multiple Myeloma

CURE Media Group honored Meaghan Mooney, B.S.N., RN, OCN, as the recipient of its 2024 Extraordinary Healer® award, celebrating nurses in the cancer community who passionately dedicate themselves to improving the lives of patients and their families.

Essays were submitted by colleagues, patients and family members identifying Mooney, 2 finalists and 73 other Extraordinary Healer® nominees, all detailing the noble acts of oncology nurses, from, “they leave no stone unturned when meeting and assessing patients,” to “it is not just about the cancer or the patient’s treatment; it is about the person and seeing their smiles through often sad times.”

The Extraordinary Healer® award event, sponsored by Johnson & Johnson, was hosted on April 24, during an in-person celebration held in conjunction with the 49th Annual Oncology Nursing Society Congress in Washington, D.C.

The night featured a keynote address from Kristen Dahlgren, an award-winning journalist turned breast cancer advocate. Throughout her career, she has traveled the world to document major news stories for outlets like NBC Nightly News and NBC’s Today Show. Earlier this year, she announced on the Today Show that she would be stepping down from her role at the network to start the Cancer Vaccine Coalition (formerly the Pink Eraser Project), which is teaming up with cancer vaccine researchers to get a safe and effect breast cancer vaccine on the market in the next five to 10 years.

Dahlgren also has a personal connection to cancer, as she was diagnosed with of stage 2 breast cancer in 2019. She recalled a family friend — who was also an oncology nurse — who took time off to come to the cancer center to spend time with Dahlgren while she underwent treatment.

“Really what I remember most is that through it all, she made me feel like a human, even a friend, at a time when nothing at all felt normal. That is a gift that I won’t forget,” she said.

Although she is currently a survivor, she emphasized the importance of the little efforts that meant so much to her throughout her cancer experience.

“Please know that all of those small, thoughtful things you do are noticed and appreciated,” she said. “In the throes of treatment, it is not always easy or top of mind for patients to say thank you, but from the bottom of our hearts, I’m going to do that for patients tonight and say thank you so much. In some of the most difficult moments of our lives, you bring hope and comfort. You give up yourselves to strangers. You sacrifice time with your families. And during the pandemic, you put yourselves at risk. All of that is appreciated. You care for every single patient who comes through the door. So we see you, we appreciate you, and while you’re about to meet all of these wonderful ladies who were nominated tonight, I think all of you are heroes.”

Mooney, chief of staff at Ascension Medical Group Texas in Austin, was nominated by Meredith R. Cooper, cofounder of the organization Wonders & Worries, which provides support services for children and teenagers of parents with cancer and other serious illnesses. Since serving as a chair in 2023 and cochair in 2024, she has helped to raise over $2.1 million to make sure that children receive the support they need during their parents’ illness.

In addition, she uses her years of experience as an oncology nurse to move from clinical roles to significant roles overseeing the wellbeing of patients of Ascension Medical Group.

“It is Meaghan’s unwavering dedication to supporting children and families during a parent’s illness, along with her willingness to take her direct patient care to practices within her professional position and her community service, that allows me to say Meaghan is truly an extraordinary healer deserving of this honor,” Cooper said during the ceremony.

The other finalists for the Extraordinary Healer award were Jessica McDade, B.S.N., RN, OCN, charge nurse at the Dana-Farber Cancer Institute in Boston, and Lauren Yakelis, B.S.N., RN, manager of the Bone Marrow Transplant Clinical Program at Benson Cancer Center at Ochsner Health in New Orleans.

Encircling Patients With Care and Kindness

McDade was nominated by Susan Ayers, M.S.N., RN, OCN, of the Dana-Farber Cancer Institute, who detailed the many ways that she has been dedicated to her role as an oncology nurse since 2009. She provides care to patients with cancer, leads her department, supports new staff, serves as a resource to her team, and teaches nursing students in the clinical setting at a nearby nursing school.

In Ayers’ nominating essay, she detailed a patient on their hematology oncology unit who had a complex history of opioid use disorder while newly diagnosed with metastatic bladder cancer.

“The patient was frustrated, feeling the medical world had judged and failed her,” Ayers said. “Jessica, a master of the art of nursing, bonds with patients who it can be hard to make connections with. Jessica encircles them with care and kindness. Patients talk to Jessica, and share hardships and challenges that were unknown to others.”

McDade also continued that care to the patient’s family to help them participate in her care.

“She helped Kim’s family cope with her poor prognosis,” Ayers noted. “Jessica taught them how to care for Kim and treat her like a person and not just a patient. Jessica helps patients find their voice and supports the patient during challenging conversations with family members.”

Illuminating the Pivotal Influence of Oncology Nurses

Yakelis was nominated by Kristin Linde, MHA, B.S.N., RN, BMTCN, of Benson Cancer Center, who mentioned her innate ability to lead by example and go beyond the call of duty. Some of these examples include washing the clothes of some of her hospitalized patients, organizing a Christmas reunion for a mother undergoing a stem cell transplant, and personally transporting a patient’s mother to her apartment so she can retrieve the patient’s necessary medication while they were unexpectedly admitted to the hospital 26 days after transplant.

She also played a role in launching a CAR T-cell program, marking the first of its kind in Louisiana.

“Lauren’s efforts successfully onboarded three CAR T medications into their program, significantly broadening the spectrum of treatment options for three distinct patient populations that previously faced limited prospects,” Linde said. “She stands as an exemplary role for nurses, simultaneously illuminating the pivotal influence that nurses can have within the realm of healthcare."

‘A Composition of Compassion, Expertise, and Resilience’

Kristie L. Kahl, vice president of oncology content at MJH Life Sciences, the parent company of CURE Media Group, reflected on the nominations that were received for this year’s Extraordinary Healer® award and the appreciation that shone through them all.

“Each of you in this room encompasses a composition of compassion, expertise, and resilience,” she said during the ceremony. “We are so proud to have the unique opportunity to recognize our oncology nurses. This was apparent to me how adored all of you are.…It is through these essays that a picture is painted of how you go above and beyond the call of duty, forging deep connections with patients, forging trust and understanding.”

Lynn Hall, Senior Director of Patient Experience in the Oncology Patient Engagement Customer Solutions Organization at Johnson & Johnson, noted how the role oncology nurses play in patient care is engrained in the company’s mission.

“We know it takes nurses to make healthcare work and support for our nurses improves healthcare for all,” Hall said during the event.

She also looked back at her own experience with cancer and how the nurses she encountered before she underwent surgery gave her the confidence she needed during a scary time.

“I have these incredible nurses around me who really lightened my fear and helped me feel confident that I would beat my cancer,” she added.

Also during the event, Robert M. Goldsmith, senior vice president of corporate development at MJH Life Sciences, recognized the commitment oncology nurses have in the caring of patients with cancer.

“To be committed to oncology nursing and ultimately to give care to patients with cancer and the cancer community worldwide is a mission that our company stands behind and something that we are very excited about,” he said. “We’re just so thrilled to be here with all of you to celebrate and give back to our wonderful oncology nurses. We can’t thank you enough for what you do each and every day of caring for cancer patients. So thank you. You are all truly heroes, and we appreciate all that you do.”

Over 500 attendees at this in-person event celebrated the incredible efforts made by oncology nurses when caring for patients with cancer.  

Meaghan Mooney, B.S.N., RN, OCN, Receives CURE’s 2024 Extraordinary Healer® Award

The FDA approved first-line amivantamab-vmjw (Rybrevant) plus lazertinib (Lazcluze) to treat adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring 

 exon 19 deletions or exon 21 L858R substitution mutations.

The regulatory decision was supported by data from the phase 3 MARIPOSA trial (NCT04487080) which showed that amivantamab plus lazertinib reduced the risk of progression or death by 30 percent compared with osimertinib (Tagrisso; HR, 0.70; 95% CI, 0.58-0.85; 

 < .001). Patients treated with the combination (n = 429) experienced a median progression-free survival (PFS) of 23.7 months compared with 16.6 months for those treated with osimertinib (n = 429).

The objective response rate (ORR) was 86% (95% CI, 83%-89%) in the amivantamab/lazertinib arm vs 85% (95% CI, 81%-88%) in the osimertinib arm. The median duration of response (DOR) was 25.8 months (95% CI, 20.1–not estimable [NE]) in the experimental arm vs 16.8 months (95% CI, 14.8-18.5) in the control arm.

"This approval is a crucial development for patients with 

-mutated NSCLC, who have faced significant unmet needs for far too long," Jill Feldman, lung cancer survivor and co-founder of the EGFR Resisters, a patient advocacy group, stated in a news release.

 "Having witnessed firsthand the remarkable evolution in lung cancer treatment, this profoundly important milestone brings a novel therapeutic approach to patients and their families. I'm thrilled that more patients can now experience the PFS benefits seen in the MARIPOSA study."

MARIPOSA was an international, randomized trial that enrolled patients at least 18 years of age with previously untreated locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations. Patients were permitted to have asymptomatic or stable brain metastases.

Patients were randomly assigned 2:2:1 to receive amivantamab plus lazertinib, osimertinib monotherapy, or lazertinib monotherapy. Amivantamab was given at 1050 mg (or 1400 mg in those with a body weight of at least 80 kg) once per week for the first 4 weeks, which included a split of the first infusion over 2 days (350 mg on cycle 1, day 1, and the remainder given on cycle 1, day 2). In cycle 2 and beyond, amivantamab was given once every 2 weeks. Osimertinib at 80 mg and lazertinib at 240 mg given once per day.

Blinded independent central review–assessed PFS per RECIST 1.1 criteria for the combination arm vs the osimertinib arm served as the trial's primary end point. Secondary end points included overall survival (OS), ORR, DOR, and safety.

The median OS was NE in both the amivantamab/lazertinib and osimertinib arms (HR, 0.80; 95% CI, 0.61-1.05). The 18- and 24-month OS rates in the experimental arm were 82% (95% CI, 78%-85%) and 74% (95% CI, 69%-78%), respectively. In the osimertinib arm, those respective rates were 79% (95% CI, 75%-83%) and 69% (95% CI, 64%-74%).

Regarding safety, the most common adverse effects reported in at least 20% of patients treated with amivantamab/lazertinib were rash, nail toxicity, infusion-related reactions with amivantamab, musculoskeletal pain, edema, stomatitis, venous thromboembolism, paresthesia, fatigue, diarrhea, constipation, COVID-19 infection, hemorrhage, dry skin, decreased appetite, pruritus, nausea, and ocular toxicity.

Venous thromboembolic events were observed with lazertinib plus amivantamab, and the FDA recommended the use of prophylactic anticoagulation for the first 4 months of therapy.

The recommended dose for lazertinib is 240 mg once per day in combination with amivantamab with or without food. The recommended amivantamab dose is based on baseline body weight.

Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. News release. Johnson & Johnson. August 20, 2024. Accessed August 20, 2024. https://www.investor.jnj.com/news/news-details/2024/RYBREVANT-amivantamab-vmjw-plus-LAZCLUZE-lazertinib-approved-in-the-U.S.-as-a-first-line-chemotherapy-free-treatment-for-patients-with-EGFR-mutated-advanced-lung-cancer/default.aspx

Cho BC, Lu S, Felip E, et al. Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. 

. Published online June 26, 2024. doi:10.1056/NEJMoa2403614

FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer. FDA. August 19, 2024. Accessed August 20, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer

First-line amivantamab plus lazertinib has been approved by the FDA for locally advanced or metastatic EGFR-mutated non–small cell lung cancer.

First-Line Amivantamab Plus Lazertinib Receives FDA Approval for EGFR-Positive Advanced NSCLC

Tumor-stroma proportion (TSP) may predict clinical outcome measures, including progression-free survival (PFS), platinum chemoresistance, and overall survival (OS), in high-grade serous ovarian cancer, according to findings from a retrospective analysis that were published in 

This prognostic study included tumors from 103 patients with ovarian carcinoma collected by The Cancer Genome Atlas (TCGA) that were diagnosed and treated at several institutions from 1993 to 2013; tumors from an independent cohort of resected diagnostic and tissue microarray clinical specimens from 192 patients with suspected or known high-grade serous ovarian carcinomas collected from 2004 to 2014 by the University of Tübingen in Germany were also assessed. No significant association between TSP levels and chemoresistance was observed in the TCGA cohort. In the Tübingen cohort, more patients with high TSP (34.1%; n = 14) were platinum resistant vs those with low TSP (14.6%; n = 22). Conversely, more patients with low TSP (85.4%; n = 129) were platinum sensitive vs those with high TSP (65.9%; n = 27).

TSP, defined as the extent of tumor involvement with stromatous tumor microenvironment components, has been associated with poor outcomes in several cancers.

 Furthermore, a prospective observational study published in 2019 demonstrated that 4 out of 5 newly diagnosed, platinum-resistant ovarian tumors harboring TSP exhibited a high TSP, in contrast to 5 out of 19 platinum-sensitive tumors (

“The discovery that high TSP was associated with platinum resistance offered TSP as a potentially effective and low-cost predictive biomarker of drug resistance that, if confirmed and validated, could advance the field of ovarian cancer treatment by helping to tailor treatment for patients in whom platinum therapy was predicted to be less effective than in others,” Emil Lou, MD, PhD, FACP, lead study author, and coauthors, wrote in the paper.

 “Thus, we next sought to confirm these results in a larger patient cohort.”

Lou is a medical oncologist, neuro-oncologist, and gastrointestinal oncologist, as well as an associate professor of medicine in the Division of Hematology, Oncology, and Transplantation at the University of Minnesota Medical School in Minneapolis.

This study was conducted from January 2021 to January 2024. The primary outcomes were the predictive ability of TSP for platinum chemoresistance, PFS, and OS.

TSP scoring was conducted by 1 clinician and 1 pathologist who identified the most densely populated cellular areas of each tumor specimen slide and labeled the relative amounts of tissue represented by cancer cells vs stromal tissue using 50% as a previously validated cutoff. Tumors with a stroma population of less than 50% were considered to have low TSP, and those with a stroma population of 50% or greater were considered to have high TSP. Stromal tissue that did not clearly correlate with the peritumoral stroma was excluded from the evaluation, and areas that were necrotic, empty, mucinous, or large and inflammatory were not included in TSP scoring.

Patients in the TCGA cohort had a mean age of 61.6 years (SD, 11.1), 70.9% had International Federation of Gynecology and Obstetrics (FIGO) stage III disease, and 73.8% had residual disease after surgical debulking. Furthermore, 11.7% and 30.1% of patients had chemoresistant disease and unknown chemoresistance status, respectively, which limited confirmation in this analysis. A total of 18 patients (17.5%) had high TSP, and the remaining 85 patients had low TSP. TSP levels were balanced across clinical and demographic characteristics.

Patients in the Tübingen cohort had a mean age of 63.7 years (SD, 11.1) at diagnosis, 69.8% had FIGO stage III disease, and 49.5% had node-positive disease. Moreover, 68.8% of patients had no evidence of distant metastasis, and 56.3% had residual disease after surgical debulking. Forty-one patients (21.4%) had high TSP, and 151 patients (78.6%) had low TSP. Fourteen patients (34.1%) with high TSP had FIGO stage IV disease at the time of initial diagnosis vs 22 patients (14.6%) with low TSP (

= .04). In both the TSP-high and -low groups, the most frequent T and N stages were T3C and N0, respectively; The authors noted that this may be explained by the higher rate of distant metastases in the high TSP group (34.1%) vs the low TSP group (14.6%; 

 = .01). TSP levels were balanced across age, tumor size, tumor number, and extent of affected lymph nodes.

All patients in the TCGA cohort underwent surgery followed by standard-of-care (SOC) adjuvant chemotherapy; no history of neoadjuvant chemotherapy was reported in this population. All patients in the Tübingen cohort underwent debulking surgical resection of their tumors followed by SOC systemic therapy.

In the TGCA cohort, high TSP following initial diagnosis and treatment was not associated with a worse PFS rate (HR, 1.661; 95% CI, 0.7661-3.603; 

= .20). Additionally, high TSP after the first several years from diagnosis was not associated with OS (HR, 1.906; 95% CI, 0.9622-3.776; 

= .06). The authors noted that since chemoresistance status was unknown or not listed for 31 patients in this cohort, further investigation using a larger and more complete dataset is needed to determine whether there is an association between high TSP and a worse PFS rate.

In the Tübingen cohort, when adjusted for primary metastasis, age at diagnosis, and the presence of residual disease, high TSP was associated with significantly lower PFS (HR, 1.586; 95% CI, 1.093-2.302; 

= .02) and OS (HR, 1.867; 95% CI, 1.249-2.789; 

Patients in the Tübingen cohort with low TSP were more likely to achieve PFS vs those with high TSP at all time points during follow-up (HR, 1.573; 95% CI, 1.090-2.270; 

= .02). The presence of residual disease following surgery was also associated with worse PFS rates (HR, 2.038; 95% CI, 1.436-2.892; 

< .001). However, the presence of distant metastases, which were more commonly observed in patients with high TSP, was not associated with PFS rates after adjusting for the contributions of other variables. Additionally, patients with low TSP had a higher OS rate at all time points excluding the initial months (HR, 0.726; 95% CI, 1.166-2.557; 

= .006). The presence of residual disease (HR, 2.604; 95% CI, 1.764-3.844; 

< .001), metastases (HR, 1.572; 95% CI, 1.040-2.375; 

= .03), and age (HR, 1.035; 95% CI, 1.018-1.052; 

< .001) were also associated with a lower OS rate.

Since several retrospective studies investigating reactive tumor stroma patterns use a tissue microarray (TMA)–based approach with available resection specimens, the investigators aimed to determine whether the TMA approach would generate the same results as whole-slide assessment, as differences in tumor preparation could lead to potential outcome differences. In this study, TMAs consisted of 6 0.8-mm diameter punches for each clinical specimen. Investigators assigned a single TSP category to each patient depending on the mode from their 6 TSP values. From this process, patients were classified as stroma-rich (high TSP) or stroma-poor (low TSP). A univariable analysis was conducted to compare PFS and OS rates for patients with high vs low TSP.

An analysis of TMAs from 185 patients from the Tübingen cohort, included 143 patients who were TSP low and 42 patients who were TSP high, translating to a 15.6% disparity in TSP levels between the whole-slide assessment and the TMA-based scoring. This univariable analysis showed an association between high TSP and significantly lower PFS (HR, 1.675; 95% CI, 1.012-2.772; 

= .04) and OS (HR, 2.491; 95% CI, 1.585-3.912; 

Progression-free survival and platinum chemoresistance may be predicted by tumor-stroma proportion in patients with high-grade serous ovarian cancer.

Mark Lazenby, PhD, APRN, FAPOS

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