After close to a decade at the helm, Richard Schilsky, MD, has retired from his role as chief medical officer of the American Society of Clinical Oncology (ASCO).
His legacy as the organization’s first CMO will be what he calls the “ASCO research enterprise” — launching ASCO’s first-ever clinical trial, increasing its ability to conduct observational studies, and tapping into the 40,000-person membership for original survey-based research.
“It was clear that while ASCO was a tremendous vehicle to disseminate and amplify research findings that were generated by various entities, ASCO itself didn’t actually do any research to contribute any knowledge to the field,” Schilsky told MedPage Today. “That seemed to me a missed opportunity.”
When he came on as CMO in 2013, he was given a “blank slate” by then-CEO Allen Lichter, MD.
“He basically said, ‘you’ve got lots of experience, come and help us make ASCO better,'” said Schilsky.
That experience included building an early-phase clinical trial program at the University of Chicago (U of C), 8 years as director of the university’s cancer center, and 15 years as chair of the Cancer and Leukemia Group B (CALGB), the National Cancer Institute (NCI) cooperative group.
During his stint from 1995 to 2010, many CALGB trials changed the cancer treatment landscape: demonstrating the utility of paclitaxel in adjuvant therapy for breast cancer; introducing dose-dense chemotherapy in that setting; setting a role for 5-azacitidine in myelodysplastic syndromes (MDS), which led to the first FDA approval in MDS; proving that lenalidomide (Revlimid) maintenance could prolong remissions in multiple myeloma patients following stem-cell transplant; and showing the effectiveness of midostaurin (Rydapt) in acute myeloid leukemia with FLT3 mutations, which was approved in this setting.
“There’s a long list of accomplishments — certainly not from me as an individual — but from the group that I was leading that changed the standard of care in many, many ways,” said Schilsky.
Asked about Schilsky’s contributions to ASCO and the field of oncology, Daniel Hayes, MD, of the University of Michigan in Ann Arbor and a past president of ASCO (2016-2017), had nothing but praise, referring to him as a mentor throughout his career. “I could be president of the Rich Schilsky fan club,” he joked.
“Rich Schilsky walked in with a clean white board, if you will, of what he thought the job of CMO should be for the American Society of Clinical Oncology, and he was just gangbusters,” Hayes told MedPage Today. “The things he did will leave fundamental legacies in ASCO.”
“There are a lot of us who say we’ve taken good care of patients and made individual patients improve based on applying principles and therapies we already know about. There are few of us who can say we did something in our lives that actually changed the standard of care so that patients were treated better,” said Hayes. “Rich Schilsky can say he changed, or was responsible for, or oversaw, multiple changes in standard of care, and patients with cancer are better off because of him, and I can’t say a nicer thing about anybody than that, frankly.”
ASCO Research Enterprise
After starting as CMO, Schilsky launched ASCO’s first prospective clinical trial in 2016 — the Targeted Agent and Profiling Utilization Registry (TAPUR) study, which tests approved targeted agents, off-label, in advanced cancer patients with various tumor types so long as they harbor a genomic alteration. Running at 125 locations around the U.S., and having enrolled over 2,000 patients to date, the trial continues to generate both positive and negative data.
“From our point of view, a negative finding in TAPUR is as important as the positive findings, because the negative finding basically informs oncologists about what treatments are not likely to be helpful to a patient,” said Schilsky. “A positive finding, of course, opens up new treatment possibilities.”
Positive results from the basket study have shown the combination of trastuzumab (Herceptin) and pertuzumab (Perjeta) to be effective in HER2-amplified colon cancer, the activity of olaparib (Lynparza) in prostate cancers with BRCA mutations, and the effectiveness of pembrolizumab (Keytruda) in breast and colon cancer patients with high tumor mutational burden.
Hayes pointed out that TAPUR “was done in a way that fills a niche that wasn’t being filled, that didn’t compete with what we were already doing with NCI-funded trials or cooperative groups, and it was an enormous success.”
As TAPUR grew in scope, it became clear ASCO would need scaffolding for the organization’s research endeavors, and in 2017 Schilsky helped launch the Center for Research & Analytics (CENTRA) to support, conduct, and organize all of ASCO’s research activities, and to help make clinical practice data available to the oncology community.
“Nobody was really putting it all together,” said Hayes. “And now that’s all together in one place, it’s searchable it’s available for research. It’s an enormous undertaking that has already started to pay off.”
During the pandemic, ASCO leaned on CENTRA’s resources to start a COVID-19 registry, which longitudinally tracks the symptoms, severity, and outcomes of COVID-19 in cancer patients (over 2,200 participants have enrolled so far).
“We anticipate that over time, it will generate a lot of valuable information about the impact of COVID-19 infection on cancer patients,” said Schilsky.
Under his watch, ASCO also set up a mechanism whereby members of the society could survey other members for research purposes. Historically, ASCO had taken the position that they would not allow that, said Schilsky.
“That never really made good sense to me,” he said. “It seemed like there was a lost opportunity to use the network, if you will, of ASCO members to help answer research questions in the field.”
ASCO established a process whereby members could opt in to participate (about 8,000 have so far). Requests are reviewed to determine whether the survey will likely answer an important question and if the methodology is appropriate. If so, ASCO conducts the survey on behalf of the researcher and then returns the data.
“ASCO’s ability to now actively participate in generating new knowledge, as opposed to just disseminating the research findings of others has grown dramatically,” Schilsky said. “I’m hopeful that as I move on from ASCO that the whole research enterprise will continue to grow and will continue to really benefit ASCO and, more importantly, our members and our patients for a long time to come.”
Hayes also credited Schilsky for facilitating collaborations between ASCO and the College of American Pathologists (CAP).
In 2005, following the emergence of trastuzumab as an effective therapy for HER2-positive breast cancer, the two societies had been independently developing tumor marker guidelines, but eventually partnered to develop joint guidance, said Hayes. This led to joint guidance on a number of other markers in breast, colorectal, and other cancers, as well as a joint road map for so-called liquid biopsies.
“ASCO and CAP and our patients have benefited incredibly from this collaboration,” said Hayes.
“While it probably would have happened without Rich, it happened spectacularly because of Rich,” he said. “I’d been involved with that from the get-go, and will be eternally grateful to Rich Schilsky for what he did to support that collaboration.”
Road to ASCO
Schilsky, who’s now 70, earned his MD at U of C in 1975, completed his residency in internal medicine at the University of Texas Southwestern, and trained as an oncologist at the NCI.
He spent the bulk of his academic career, from 1984 to 2012, at U of C — first in a laboratory and then as a clinical researcher — and specialized in gastrointestinal cancers.
After building the phase I trial program at the university, he became director of U of C’s cancer center, which became an NCI-designated comprehensive cancer center during his tenure. Schilsky said he was proud of his time as associate dean for clinical research there, a position he created and that oversees and coordinates clinical research across the entire medical school.
“It was a very necessary role at the time it was created,” he said. “We didn’t have organized infrastructure, we didn’t have organized training, we didn’t have organized regulatory oversight, and you know, we put all that in place and it has continued to develop to this day.”
Schilsky’s relationship with ASCO started over 40 years ago, and the society has played a major part in his career and professional development. He joined the organization as a member in 1980 after completing his fellowship in oncology, and became a fixture at the society’s ever-expanding annual meetings, participating in “every way, shape, and form,” he said.
“I have no recollection of having missed even one — it’s a lot of meetings,” he said, laughing.
He served as member or chair on 10 different ASCO committees, served on the board of directors in the early 2000s, and served as president in 2008-2009.
Line of Succession
Schilsky is succeeded as CMO by Julie Gralow, MD, of Fred Hutchinson Cancer Research Center in Seattle, whom he called experienced, thoughtful, and articulate.
Asked what advice or wisdom he might impart, he said his best recommendation for Gralow was to learn from her colleagues and listen to the members.
“The ASCO members will always tell us what they need, what their struggles are, how we can best help them, help their patients, and what ASCO programs and products and services are most useful to them,” said Schilsky.
“Enjoy the opportunity,” he added. “It’s a great organization — it is highly visible, highly impactful. People really do care what ASCO has to say about important issues in oncology, and I hope she will have a great time in this position.”
Pointing to Gralow’s interest and work in global health, Schilsky noted that ASCO is a global organization, with a third of its membership located outside the U.S. By 2030, it’s estimated that most of the world’s burden of cancer will be outside North America and Western Europe, he said.
“We have a responsibility, an obligation, and an opportunity to continue to work with oncologists around the world, to be sure that they have the knowledge and the tools that they need to optimally deliver care to the patients they care for,” said Schilsky. “I’m sure that’ll be high on Dr. Gralow’s list of things that she wants to tackle.”
Hayes called Gralow “a great choice” for the role of CMO, and expects her to have a different set of priorities. “I can’t wait to see what Julie does when she moves into her office and starts to decide what her mark on the society is going to be,” he said.
With his work at ASCO in the rearview, Schilsky will continue to be active, just not full time. “I’m at that point in my life where I’m looking to stay engaged, but to be able to pick and choose what I want to do,” he said.
He remains the principal investigator on TAPUR, will continue serving on the board of directors of Friends of Cancer Research and the Reagan-Udall Foundation for the FDA, and will stay on the protocol review committee of the Organisation for Research and Treatment of Cancer (EORTC). He also assured that he would keep attending ASCO’s annual meetings.
“As I said, I haven’t missed one yet. I don’t intend to start now,” he said.
Last Updated February 26, 2021
Source: MedicalNewsToday.com
