Yi Lin, MD, PhD, consultant, Division of Hematology, Department of Internal Medicine, consultant, Division of Experimental Pathology and Laboratory Medicine, Department of Laboratory Medicine and Pathology, assistant professor of medicine and oncology, Mayo Clinic, discusses the importance of developing non-BCMA–targeting agents in multiple myeloma.

Multiple BCMA-directed CAR T-cell therapies, bispecific antibodies, and antibody-drug conjugates are demonstrating significant efficacy for patients with multiple myeloma. However, the field is developing non-BCMA–targeted options as well, Lin explains.

Early data with non-BCMA–targeting approaches are showing high rates of early responses in patients, says Lin. With the rapid growth of immunotherapy in multiple myeloma, data will likely emerge in the coming years showing that non-BCMA–directed therapies are good options for patients, concludes Lin. 

Yi Lin, MD, PhD, discusses the importance of developing non-BCMA–targeting agents in multiple myeloma. 



Dr. Lin on the Importance of Developing non-BCMA–Targeting Agents in Myeloma 

Yi Lin, MD, PhD

Ignace B. Vergote, MD, PhD, head of the Department of Obstetrics and Gynecology and Gynecologic Oncology, Catholic University of Leuven, Belgium, discusses the need to develop novel therapies in endometrial cancer.

Endometrial cancer is the most frequent gynecologic malignancy among women in the United States, says Vergote. Additionally, endometrial cancer has a high mortality and morbidity rate.

The current standard of care for patients with endometrial cancer is platinum-based chemotherapy in combination with a taxane, explains Vergote.

However, there are no established treatment options for patients who recur after first-line therapy, Vergote adds.

As such, developing novel therapies to treat patients who recur, maintaining remissions after first-line therapy, and extending the time patients are not on chemotherapy remain unmet clinical needs in endometrial cancer, concludes Vergote. 

Ignace B. Vergote, MD, PhD, discusses the need to develop novel therapies in endometrial cancer.



Dr. Vergote on the Need to Develop Novel Therapies in Endometrial Cancer

Ignace B. Vergote, MD, PhD

Thomas Cluzeau, MD, PhD, head of hematology department, Central University Hospital of Nice, in Nice, France, discusses the response rates of a phase 2 study with APR-246 and azacitidine in 

-mutated myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

Patients enrolled in the study were treated with APR-246 at 4500 mg intravenously from days 1 to 4 followed by azacitidine at 75mg/m2 from days 4 to 10 in 28-day cycles. A total of 52 patients were enrolled on the trial. Results pertaining to response to the treatment were promising, says Cluzeau; the overall response rate (ORR) was 58%, with 37% of patients achieving a complete response (CR).

Specifically, in 39 evaluable patients who received ≥3 cycles of treatment, the ORR was 77%, with 49% of patients achieving a CR, adds Cluzeau. When analyzing by subgroups, in 34 evaluable patients with MDS, the ORR was 75%, with 57% of patients experiencing a CR. For patients with AML with 20% to 30% of blasts, the ORR was 78%, with 33% of patients experiencing a CR.

Finally, in terms of survival, after a median follow-up of 9.7 months, the median overall survival (OS) was 12.1 months. In patients who received ≥3 cycles of treatment, the median OS was 13.7 months. Thus, the results from this study demonstrated great responseswith this treatment in this high-risk patient population, concludes Cluzeau.

Thomas Cluzeau, MD, PhD, discusses the response rates of a phase 2 study with APR-246 and azacitidine in TP53-mutated myelodysplastic syndromes and acute myeloid leukemia.

Dr. Cluzeau on the Efficacy of APR-246/Azacitidine in TP53-Mutated MDS and AML

Thomas Cluzeau, MD, PhD

Head and neck cancers represent a wide-ranging category of diseases, and the sixth most common cancer in the United States. More than two-thirds of patients who receive an initial diagnosis of head and neck cancer already have a malignancy that has progressed to an advanced stage requiring a multimodality approach to care that includes radiation and chemotherapy. Although the ability to treat head and neck cancer has certainly improved over the years, a significant percentage of patients experience recurrent disease after initial treatment. The challenge and promise in advancing treatment in head and neck cancer lies in a better characterization of at-risk patients and understanding of how cancers recur.

Multiple clinical risk factors have been used for their potential prognostic value of head and neck cancers; however, their use has not been clearly defined in identifying mechanisms of treatment resistance for the subset of patients who fail initial therapy. Moreover, the promise of genetic-based risk stratification in the era of parallel sequencing has yet to be realized.

At its core, cancer is a genetic disease. Every cell in the body is controlled by a series of instructions encoded in genes. Occasionally, mutations override the normal safety checks and lead to uncontrolled cell growth and proliferation, which in turn leads to cancer. By harnessing genetic differences, our team of investigators at Montefiore Health System and the National Cancer Institute–designated Albert Einstein Cancer Center in the Bronx, New York, developed a prognostic genetic risk score to identify which patients are at highest risk for disease recurrence.

The development of a genomic prognostic tool resulted from a collaboration with a team that comprised Chandan Guha, PhD, MBBS, director of the Albert Einstein College of Medicine Institute for Onco-Physics, and a professor and vice chair of the Department of Radiation Oncology; Michael B. Prystowsky, MD, PhD, a professor and chair of the Department of Pathology; and Thomas Ow, MD, an associate professor of otolarhinolaryngology and pathology. To assess which patients with locally advanced disease were at greatest risk, the investigators identified cases from The Cancer Genome Atlas, a landmark cancer genomics program that molecularly characterized more than 20,000 primary cancers, including cancers of the head and neck. Twenty-four cases with distant metastases—tumor cells which have broken away from the primary tumor and traveled to other areas of the body—and 48 matched nonmetastatic controls were selected. A total of 1100 genes were differentially expressed, with primary changes in epithelial-stromal remodeling, and cytokine-immune interactions on functional pathway analysis.

The team developed a genetic signature based on patients with reported distant metastatic treatment failure and used a Least Absolute Shrinkage and Selection Operator regression analysis to refine a clinically applicable 28-gene prognostic score.

The score was validated in an internal prospective multidepartmental study that comprised more than 120 patients treated at Montefiore. Results showed that patients with a high-risk score had significantly shorter distant metastasis-free survival (HR, 9.0; 95% CI, 2.6-31.7; 

). The risk score was superior to tumor and nodal stage for distant metastatic prognostication and remained significant after multivariate adjustment. The genetic score had improved predictive value for distant treatment failure in an elevated risk subgroup of cancers negative for human papillomavirus, an increasingly prevalent cause of head and neck cancer among nonsmokers (HR, 20.8; 95% CI, 2.6-166; 

Figure. Distant Metastasis-free Survival Using 28-Gene Risk Score

Gene expression from cancer samples are calculated as an average of admixed cellular genetics profiles of not only cancer cells, but also immune cells and supportive tissues. To get a better grasp of what is actually occurring within the tumor microenvironment, investigators applied single- cell RNA sequencing to approximate the distribution of various cell type proportions. Single-cell deconvolution study results revealed a significant increase in cancer- associated fibroblasts and T-cell subpopulation dysregulation within the tumor microenvironment among patients with distant metastatic treatment failure.

Current paradigms of cancer treatment are centered around targeting tumor cells. These treatments are often not enough to completely eradicate cancer, as the supportive cancer stroma may enable tumor recurrence and therapeutic resistance. In the past few years, available cancer therapies have expanded to improve endogenous immune cell responses through checkpoint blockades. We have seen a distinct benefit observed in some patients, including those with recurrent head and neck setting. However, efforts to replicate these successes for the definitive management of nonmetastatic advanced head and neck cancers have been unsuccessful.

One hypothesis is that T cells enable resistance to checkpoint inhibition in the microenvironment through cancer- associated fibroblast–TGF-β signaling. The microenvironment within head and neck cancers commonly consists of more than 80% fibroblasts. These fibroblasts are critical for various functions that regulate cancer progression through secreting soluble factors, metabolic effects, remodeling the extracellular matrix, and immune cross-talk. Furthermore, the stromal and immune cell composition of head and neck cancers have been demonstrated to be independent predictors of nodal metastasis and epithelial-mesenchymal transformation in results of single-cell, comparative, and cell culture studies. Thus, targeting this unique cell population within the tumor microenvironment of locally advanced head and neck cancer represents a promising, yet underexplored, method for overcoming treatment resistance.

The predictive risk-score research serves as the basis for the development of preclinical models to evaluate the feasibility of adjuvant tumor microenvironment modification with the goal of reducing the rate of distant metastatic disease.

Mo A, Hochfelder C, Berlot A, et al. Gene expression signature for distant metastasis in loco-regionally advanced head and neck squamous cell carcinoma. 

. 2020;108(suppl 3):S14-S15. doi:10.1016/j.ijrobp.2020.07.2094

Mo et al’s research, awarded first place in a paper session at the 2020 annual New York Head & Neck Society meeting, was presented during an oral scientific session at the 2020 American Society for Radiation Oncology Annual Meeting.

Although the ability to treat head and neck cancer has certainly improved over the years, a significant percentage of patients experience recurrent disease after initial treatment. 

28-Gene Score May Predict Distant Metastatic Recurrence in Advanced Head and Neck Cancers 

Allen Mo, MD, PhD

The coronavirus disease 2019 (COVID-19) crisis has changed all aspects of medical education but perhaps altered clinical education most dramatically.

 Clinical rotations at outside centers, previously a critical part of the application process in many specialties, have been eliminated almost entirely. This is concerning as these “away rotations” help provide students with a sense for a program’s culture, a chance to connect with future mentors, the ability to further assess their specialty choice, and an opportunity to have prolonged contact with a potential training program on an “audition” basis.

The 2020-2021 residency application process will be similarly altered.

 With most radiation oncology residency and hematology/oncology fellowship programs considering a shift to virtual interviews this cycle, programs will be challenged by the impersonal nature of the virtual platform.

 A potential way to bridge the gap between students and program is to use virtual resources such as clerkships, meet-and-greets, office hours, visiting professors, and interviews. Herein we describe our experience transitioning to a fully virtual environment while capturing the immersive experience typical of an in-person environment. We hope our experience in the specialty of radiation oncology will be helpful to other residents and fellows and programs, even those outside radiation oncology, as they make similar adaptations.

In lieu of away rotations, structured online experiences have been constructed to provide clinical exposure and curricula at outside institutions. Specifically in radiation oncology, the Radiation Oncology Virtual Education Rotation (ROVER) provides access to introductory disease site-specific videos and organizes multi-institutional teaching sessions featuring experts across the country, geared specifically toward senior medical students.

 Patient cases are written and moderated by radiation oncology residents and discussed with attendings, including details on appropriate workup and treatment options for each case. These sessions are recorded and widely available to students.

Many programs also have been offering 1- to 4-week virtual clerkships to increase student exposure and engagement in radiation oncology.

 These clerkships are available through the Visiting Student Application Service, just as in-person away rotations typically have been, and qualify for course credit. Virtual clerkships integrate medical students into radiation oncology clinics, didactics, tumor boards, chart rounds, and treatment planning, and can give them an opportunity for an end-of-rotation presentation to the department on a topic of their choice.

To best approximate the in-person environment and ensure a successful rotation, students should have access to the electronic health record (EHR) system to prepare for clinic ahead of time. On clinic day, patients should be asked for permission before bringing medical students into the room. Medical students may be set up on a device capable of running videoconferencing software with audio and video capabilities. Mounting the camera on a tripod is a simple thing that can ensure that interactions between the patient and the resident or attending are as natural as possible.

In the room, the student should be positioned so that the entire clinical interaction is viewable. Between patients, students can stay with the attending and resident, discuss cases, and learn radiation oncology decision-making. Virtual mentoring opportunities can also become available through 1-on-1 interactions with faculty.

All of this is available without the added personal and financial burdens of traveling, obtaining lodging, and being away from family. The benefits of virtual rotations described herein may also improve diversity and equity in the field among applicants for whom financial and personal barriers might otherwise prevent pursuit of an away rotation. For these reasons, it is possible that virtual rotations may continue post pandemic.

Virtual meet-and-greets provide an avenue for medical students interested in virtually connecting with radiation oncology residency programs and residents without committing to a full rotation. Such sessions have been offered by many residency programs and provide information about the program, the field of radiation oncology, and the interview process. Most of these sessions occur before Electronic Residency Application Service opens for submission and can help educate students on which program or programs would help them be most successful.

Meet-and-greets can be held via platforms such as Zoom, Skype, GoToMeeting, Facebook Live, or Instagram. Students can be recruited through social media, emails from schools, word of mouth, or posting on medical forums. Students are encouraged to register and receive a private invitation via email to prevent deliberate disruptions (“Zoom-bombing”). Programs are encouraged to identify a moderator to help facilitate smooth transitions. Sessions are typically limited to an hour and can include residents only, attendings only, or a combination. Resident-led sessions are important to provide insight into the program’s culture, and attending engagement is important to provide insight into potential mentorship, educational, and research opportunities. These can help medical students gain a deeper sense for the attending and resident dynamic, especially in a time when they will not be physically visiting departments to observe interactions.

Topics of discussion can include program overview and curriculum, elective and professional development opportunities, residency benefits, alumni job placements, resident life, and open question-and-answer sessions—anything that can give prospective students a sense of the program and faculty. Organizers can arrange breakout sessions to provide a more intimate setting for discussion.

In larger sessions, the chat function may be especially helpful to moderate discussions. Meet-and-greets can help provide an easy way for students to get a glimpse into what their life would be like as a resident, in a more casual virtual setting.

Despite Limitations, Virtual Education Is Likely to Remain Here to Stay

The rapid evolution of medical student education and outreach during the COVID-19 pandemic comes with inherent limitations. Virtual clerkships and meet-and-greets help provide students insight into a program’s day-to-day operations but are still limited by their remote nature. Even with audio and video capabilities, it is easy to miss the many subtleties of in-person interactions, making it more challenging for students to demonstrate their clinical knowledge and skills while expressing their personalities. Travel and lodging costs are eliminated, but so, too, are the opportunities to tour the facilities, eat at the cafeteria, or experience life in the area where the program is located. Likewise, programs will not have the opportunity to observe students examining patients or interacting with their peers and future colleagues.

Medical education and the residency application process have been completely uprooted by the COVID-19 pandemic. Although many students have participated in away rotations in the past, new safety regulations shifted many facets of medical education to the virtual space. Virtual rotations, meet-and-greets, and other educational experiences have emerged to fill these voids and help provide students insight into programs and avenues for mentorship. Despite the inherent limitations, they may become a staple of interdepartmental experience even beyond the COVID-19 pandemic.

Meriem Mokhtech, MD, PGY-3, Department of Therapeutic Radiology at the Yale School of Medicine in New Haven, CT; Wesley J. Talcott MD, MBA, PGY-4, Department of Therapeutic Radiology at the Yale School of Medicine in New Haven, CT; and Henry S. Park, MD, MPH, assistant professor, Department of Therapeutic Radiology at the Yale School of Medicine in New Haven, CT; and the Yale Therapeutic Radiology Virtual Rotation Committee authored this piece.

Nipun Verma, MD, PhD; Megan E. Kassick, MD; Joseph A. Miccio, MD; Jason M. Beckta, MD, PhD; Vikram Jairam, MD; Suzanne B. Evans, MD, MPH; Roy H. Decker, MD, PhD; and Kimberly L. Johung, MD, PhD; contributed equally to this report.

Rose S. Medical student education in the time of COVID-19. 

. 2020;323(21):2131-2132. doi:10.1001/jama.2020.5227

Hammoud MM, Standiford T, Carmody JB. Potential implications of COVID-19 for the 2020-2021 residency application cycle. 

Kouzy R, Abi Jaoude J, Yue J, et al. Applying to radiation oncology amid a pandemic. 

. 2020;5(4):777-779. doi:10.1016/j.adro.2020.06.017

Virtual Radiation Oncology for Medical Students. Accessed October 23, 2020. https://www.radoncvirtual.com

Pollom EL, Sandhu N, Frank J, et al. Continuing medical student education during the coronavirus disease 2019 (COVID-19) pandemic: development of a virtual radiation oncology clerkship. 

. 2020;5(4):732-736. doi:10.1016/j.adro.2020.05.006

The coronavirus disease 2019 crisis has changed all aspects of medical education but perhaps altered clinical education most dramatically.

Creating the In-Person Experience on a Virtual Platform

Henry S. Park, MD, MPH

Results From the Phase 1b/2 CARTITUDE-1 Study for Ciltacabtagene Autoleucel in R/R Multiple Myeloma

Rapid Readouts: Phase 1b/2 CARTITUDE-1 Study

Deepu Madduri, MD, Mount Sinai Hospital

Treatment Advances in Metastatic Breast Cancer

Long-Term Disease Control in Metastatic Breast Cancer

Cytotoxic Chemotherapy for Metastatic Breast Cancer

Assessing Response to Chemotherapy in Metastatic Breast Cancer

Breast cancer oncologists explore more recent advances using oral chemotherapies to treat metastatic breast cancer.

The Role and Rationale for Oral Options in the Treatment of Metastatic Breast Cancer

Adam M. Brufsky, MD, PhD, University of Pittsburgh/UPMC Hillman Cancer Center

At the beginning of his career as a medical oncologist in the 1990s, lung cancer specialist Rogerio C. Lilenbaum, MD, was squarely focused on diagnosing and treating his patients while translating emerging clinical research into practice. 

Now, as director and senior physician executive of the Banner MD Anderson Cancer Center, headquartered in Gilbert, Arizona, one of his priorities is fostering a patient-centered experience from an institutional perspective—and his definition of the term is far broader than “this automatic reflex of thinking about welcoming patients or being nice to patients,” which he calls “the minimum expected of everyone in health care.” Instead, he seeks to deliver consistent and timely quality care that encompasses clinical, operational, financial, and cultural considerations.

“It’s the totality of the experience,” Lilenbaum said in an interview with 

®. Cancer centers, for example, think of access as being “a business opportunity” rather than part of a patient-centered experience, he noted. “If you see patients quickly, they’ll come to you, as opposed to having to wait a week or 2 to go to a better center. That’s how many people, right or wrong, choose where they go [for treatment]. 

“And yet at the end of the day, it really is unconscionable to keep someone who was just given a diagnosis of cancer waiting weeks to see a physician,” Lilenbaum said. “And that’s a humanistic responsibility. It’s not about market share. It’s the way we all expect to be treated under these circumstances.”

Lilenbaum will bring his real-world blend of patient-centered oncology into focus from February 5 to 7, 2021, at the 

Winter Lung Cancer Conference®. He is serving as a conference cochair along with Mark A. Socinski, MD, executive medical director of AdventHealth Cancer Institute in Orlando, Florida; and Julie R. Brahmer, MD, MSc, director of the Thoracic Oncology Program and professor of oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland. The conference, hosted by Physicians’ Education Resource®, LLC (PER®), will be held as a virtual meeting.

The hallmark of the conference, Lilenbaum said, will be the opportunity not only to learn about the most impactful recent trial and study findings but to hear opinions and analysis from leading lung cancer experts. Topics include discussions of when to stop immunotherapy, the role of palliative care in patients with thoracic malignancies, and strategies for treating patients with immunotherapy while molecular testing results are pending.

A special keynote program on addressing critical clinical issues in lung cancer will be held during the opening session on February 5 at 7:55 pm. According to Lilenbaum, one of the most important discussions during that session will center around the optimal use of targeted therapy for patients with non–small cell lung cancer (NSCLC).

Lilenbaum’s concerns involve the uptake of biomarker testing. Although molecular testing is recommended for all patients with advanced nonsquamous NSCLC and certain populations with squamous cell disease, rates of adoption vary depending on the aberration in the United States and in other countries. Whereas testing for 

 translocations has reached as high as 87% and 69%, respectively, in some US areas, testing for 

alterations was only at 28% in one study.

“Are we testing everyone for all the actionable mutations? And are we treating those patients according to evidence-based algorithms and guidelines?” Lilenbaum asked. “This may seem a very obvious thing to do, but it’s far from common practice. Testing, in this day and age, still is somewhat erratic. It’s not pervasive or as generalized as it should be. And then even within each category—

 V600E—the information about how to best manage those patients is not always within the domain of the general oncologist.”

The introduction of immune checkpoint inhibitors (ICIs) into the treatment paradigm has further complicated therapeutic strategies, illustrating the need for a greater understanding of which patients would most benefit from ICIs, Lilenbaum continued.

Heather A. Wakelee, MD, a professor of medicine and faculty director of the Stanford Cancer Clinical Trials office at Stanford University Medical Center in California and president elect of the International Association for the Study of Lung Cancer, agreed with the need to improve patient selection approaches.“

It is critical to wait for full information about a newly diagnosed lung cancer before starting a patient on treatment,” said Wakelee, who will serve as a cochair of the 

International Lung Cancer Congress® in July 2021. “PD-L1 results come back very quickly, and the molecular results for 

 [alterations] and so on can take several weeks. Patients with molecular driver mutations like 

 are much better treated with targeted therapy and do poorly on immunotherapy. If immunotherapy is started too quickly, it can complicate use of targeted therapy because of increased toxicity risks. So it is much better to wait for full information so a patient can be started on the best therapy instead of rushing to start immunotherapy when only some information [on PD-L1] is back.” 

It would be a significant step forward to have additional biomarkers beyond PD-L1 expression levels for recommending patients with NSCLC for ICI therapy, Lilenbaum stated. “The question is, how do we identify patients who truly benefit from checkpoint inhibitors beyond just the PD-L1 marker?” he asked. “We’ve seen now, years into this research, that in some patients, the benefit is nothing short of extraordinary. And in other patients, it’s fairly modest. Yes, PD-L1 is a marker that can help ascertain that magnitude of benefit, but it’s far from perfect. I think we need additional predictive factors to justify the cost and the toxicity of these agents.”

At the same time, Lilenbaum said, the PD-L1 inhibitor durvalumab (Imfinzi) appears to be underused in the consolidation setting, a problem he called “baffling.” In February 2018, the FDA approved durvalumab for patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemoradiation therapy (cCRT).

The decision, which represented a new standard in this disease setting, was based on findings from the phase 3 PACIFIC trial (NCT02125461) in which 713 patients in this population who had received at least 2 cycles of cCRT were randomized 2:1 to receive durvalumab or placebo. At a prespecified interim analysis, median overall survival (OS) was not reached (NR) among participants treated with durvalumab (95% CI, 34.7 months-NR) compared with 28.7 months (95% CI, 22.9-NR) for those who received placebo, translating into a hazard ratio favoring durvalumab of 0.68 (95% CI, 0.53-0.87; 

 = .0025). Median progression-free survival was 16.8 months (95% CI, 13.0-18.10) with durvalumab versus 5.5 months (95% CI, 4.6-7.8) with placebo (HR, 0.52; 95% CI, 0.420.65; 

In updated findings reported after a median follow-up of 33.3 months, the median OS with durvalumab was still NR (95% CI, 38.4-NR) versus 29.1 months (95% CI, 22.1-35.1) with placebo (stratified HR, 0.69; 95% CI, 0.55-0.86). The OS rates with durvalumab compared with placebo, respectively, were 83.1% versus 74.6% at 12 months, 66.3% versus 55.3% at 24 months, and 57.0% versus 43.5% at 36 months.

“We have unequivocal data that 1 checkpoint inhibitor, durvalumab, improves outcomes” for patients with stage III unresectable disease, Lilenbaum said. “And yet, to the best of my knowledge, the utilization of that strategy is not as high as it should be.” 

The management of therapeutic choices for this patient population is complex, Lilenbaum acknowledged. “In order to get to the durvalumab piece, [the patient] has to have received concomitant chemotherapy and radiation and not everybody does.” Nevertheless, he said, “it surprises me at times that powerful data like these are still not applied more widely.” 

Findings from a recent survey reflect Lilenbaum’s concerns. The percentage of patients with unresectable stage III NSCLC who received guideline-recommended cCRT as initial therapy was an average of 48% and, of those, only 55% subsequently received immunotherapy, according to responses from 150 US medical oncologists published in October 2020 in 

Looking forward, Lilenbaum anticipates that molecularly targeted therapies as well as immunotherapies will be used earlier in the NSCLC treatment timeline. Recent clinical data for osimertinib (Tagrisso) in patients with completely resected 

-positive stage earlier-stage disease represent “a breakthrough that will change the way we do adjuvant treatment,” Lilenbaum said. 

In the phase 3 ADAURA trial (NCT02511106), 682 patients with stage II to IIIA disease were randomized 1:1 to receive osimertinib or placebo (

). At 24 months, 89% of participants treated with osimertinib (95% CI, 85%-92%) were alive and disease-free versus 52% of those who received a placebo (95% CI, 46%-58%), which translated to an overall hazard ratio for disease recurrence or death for osimertinib therapy of 0.20 (99.12% CI, 0.14-0.30; 

The FDA has granted a priority review for a supplemental new drug application for osimertinib as adjuvant treatment for patients with early-stage 

-mutant NSCLC after complete tumor resection. A decision is expected during the first quarter of 2021, according to AstraZeneca, the company developing the drug.

“I think we’re going to see similar data for other molecular alterations,” Lilenbaum said. “And more importantly, we will see data for immunotherapy in the early-stage settings. How you apply the knowledge that we’ve acquired in late-stage disease to early-stage disease is one of the most potentially impactful areas of research because in early stage, what you’re doing is beyond prolonging life, you’re increasing the cure rate. And that’s what we want to see.” 

Throughout his career in the lung cancer field, Lilenbaum has often focused on helping to define best practices and optimal treatment choices. He has participated in crafting National Comprehensive Cancer Network guidelines for NSCLC and malignant pleural mesothelioma as well as American College of Chest Physician recommendations for the use of chemotherapy in patients with stage IV NSCLC. 

“I believe in the power of guidelines,” Lilenbaum said, adding that such recommendations should be routinely used in clinical practice. Beyond that, guidelines are incorporated into clinical pathways that are integrated into electronic medical records. “Clinical pathways address, to some extent, heterogeneity in how people choose to treat certain diseases, and bring some measure of consistency in how a certain practice decides to treat a group of patients.” 

Lilenbaum’s path to his administrative role at Banner MD Anderson spans 2 continents. His early years were spent in his native Brazil. After earning his medical degree from the Federal University of the State of Rio de Janeiro School of Medicine and Surgery and starting his training in the late 1980s, he realized he wanted to become a medical oncologist. He came to the United States in the mid 1990s to pursue opportunities in cancer care.

“I enjoyed not only the practice of medicine in the United States, but also the academic component, specifically the opportunity to be involved in clinical research,” Lilenbaum said. “By the time I was finishing my fellowship, I really couldn’t see myself in any other place. And I was very fortunate to have outstanding mentors who opened a lot of doors and opportunities for me. So I had an early entry into the world of lung cancer investigation and research.”

The attraction to oncology at that point was the development of chemotherapy drugs that offered promise for the treatment of patients with NSCLC. “This was a disease that up until the early to mid ’90s had essentially 1 or 2 regimens that had shown some efficacy, and by the way, horrendous toxicity as well,” Lilenbaum noted. “The new drugs at the time seemed to provide greater benefit, and lower toxicities.”

At the outset of his career, Lilenbaum spent 80% or more of his time seeing patients. After approximately 15 years of an active clinical practice, however, he decided he wanted to find ways to influence how treatment is delivered in broader terms, and then take that experience into organizations that were creating a comprehensive, integrated cancer care delivery system.

“In many ways, it’s more challenging than clinical care or clinical research, but no less important,” said Lilenbaum, who now sees patients less than 10% of the time. Part of the challenge is learning the skills needed to be an administrator.“

Certainly, physicians in my generation were not trained for this,” Lilenbaum said. “We don’t necessarily graduate from a fellow-ship with organization skills or leadership skills. If anything, we’re trained to acquire a certain body of knowledge and make decisions independently on behalf of the individual in front of you who happens to be a patient at the time.” 

Lilenbaum’s opportunity to translate his knowledge in a more foundational way came when he was recruited to be chief medical officer for the Yale Cancer Center and Smilow Cancer Hospital at Yale New Haven Health in Connecticut, where he oversaw clinical programs and clinical operations, as well as quality, safety, and network development for the cancer program. Working with some of the country’s top practitioners in cancer care propelled him forward.

In February 2020, Lilenbaum began his new role as director and senior physician executive of a group of facilities at Banner MD Anderson Cancer Center,7 where instilling the patient-centered experience throughout the organization is one of his main goals. “People need comfort, support, guidance, because they are overwhelmed by what’s going on with them,” he said.

To illustrate his point, Lilenbaum related an anecdote from a colleague at another center who was able to obtain VIP treatment for her elderly father when he was diagnosed with cancer. Her father saw multiple doctors and received an infusion on the same day. The visit overall was exhausting but appeared to be a complete success; the marathon day wrapped up around 7 pm.

“But when they left the facility, the valet guy was no longer there,” Lilenbaum recalled. “And they could not find the keys to their car. They spent another 45 minutes trying to find the keys. That particular moment, in a way, tainted their entire experience of what until then had been an excellent day.”

The challenge at Banner MD Anderson is fully integrated treatment across about 10 facilities in Arizona and Colorado. In short, regardless of where patients are treated, they should receive the same level of treatment and have a similar experience. 

“Different allocation of resources is expected. For example, you’re not going to have a bone marrow program in every one of your facilities,” Lilenbaum said. “But basic services need to be widely available. To create that alignment, to create that sense that it’s all one experience, is a pretty challenging goal from an administrative and financial perspective.”

Like all cancer centers in America, Banner Health has been forced to meet the challenge of how to maintain care in the face of coronavirus disease 2019 (COVID-19). Banner’s Arizona facilities were put to the test, treating approximately 45% of all patients with COVID-19 in the state, Lilenbaum pointed out. By taking numerous preventive measures, they were able to keep the cancer center campus 100% free of the virus.

“That was a spectacular win for our patients and our staff,” Lilenbaum said. “Patients who came in and were found to have COVID-19 were transferred to other facilities, and we would take other patients from those facilities to make sure that we were all managing the bed utilization appropriately. But we did not want to have patients with COVID-19 on this campus [in Gilbert, Arizona] because this is where we have our most vulnerable, at-risk patients.”

“We also started to test our patients early on before certain types of cancer intervention,” he explained. “So we knew that if they were to be subjected to interventions that might diminish their resistance or increase their vulnerability to the virus, we would at least know that they were negative ahead of time. Then we started to test high-risk staff members, so that we knew that they could interact with those patients.”

Banner MD Anderson was also included in the first wave of telehealth use, he noted, allowing staff to become comfortable with the process from the outset and enabling them to treat patients with cancer without bringing them on campus unnecessarily. Lilenbaum predicted that insurance companies might tighten up on reimbursements for telehealth, but now that the technology has been put to use, there is no turning back.

“I don’t know that we will have as much freedom and flexibility as we had during the peak of the pandemic, but I think everybody realizes that this is a technology that is here to stay,” he said.

1. Pennell NA, Arcila ME, Gandara DR, West H. Biomarker testing for patients with advanced non–small cell lung cancer: real-world issues and tough choices. 

. 2019;39:531-542. doi:10.1200/EDBK_237863

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Expert Sees Need for Better Guideline Adherence in NSCLC

Larry Hanover

Andrei Gafita, MD, Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University Munich in Germany, discusses key takeaways from a retrospective analysis evaluating lutetium-177 PSMA-617 (

Lu-PSMA-617) in patients with metastatic castration-resistant prostate cancer (mCRPC). 

, Gafita presented findings from the study, revealing that 

Ga-PSMA-11 PET/CT derived parameters served as critical prognostic markers for progression-free survival and overall survival in men with mCRPC.

These indicate that PSMA expression within the tumor is predictive of survival and treatment response, says Gafita.

Additionally, these prognostic models may inform the clinical utility, outcomes, and clinical trial designs with 

Lu-PSMA-617 therapy in mCRPC, concludes Gafita.

Andrei Gafita, MD, discusses key takeaways from a retrospective analysis evaluating lutetium-177 PSMA-617 in patients with metastatic castration-resistant prostate cancer.  


Authors