Academic Oncologist Research Articles

Abstract P6-09-04: Oncologist-reported Barriers and Facilitators to enrolling patients in optimization trials that test less intense cancer treatment

Abstract Background: As outcomes improve in early-stage breast cancer, clinical trials are undergoing a paradigm shift from intensification trials (more therapy) to improve survival to optimization trials, which assess the potential for using less toxic therapy while preserving survival outcomes. However, little is known about physician perspectives in community and academic settings about possible barriers and facilitators that could impact accrual to optimization clinical trials and about the generalizability of future findings. Methods: We conducted a qualitative study with semi-structured interviews of medical oncologists from different academic and community practices to assess their perspectives on optimization trials. Interviews were audio-recorded and transcribed. Three independent coders utilized a content analysis approach to analyze transcripts using NVivo. Major themes and exemplary quotes were extracted. Results: Forty-six physicians were approached from 3/31/21-11/5/21; 39 oncologists from different oncology practices across 17 states completed interviews, 7 either declined or did not respond to email requests. Physician characteristics were balanced: men vs. women (49% vs 51%) and community oncologist vs. academic oncologist (49% vs 51%); and time practicing as medical oncologist (31% 0-9 years; 33% 10-19 years; 36% 20+ years). All 39 physicians reported that they would enroll patients in optimization clinical trials. Oncologists reported the need for treatment optimization, with one oncologist noting “historically, we’ve given way too much treatment to patients.” Oncologists highlighted specific reasons to consider optimization trials. They included quality of life improvement by reducing toxicity; reduction in financial toxicity; fertility preservation; ability to avoid chemotherapy; minimization of overtreatment in patients with comorbid conditions; personalized treatment; opportunities to test novel therapies; and leveraging the availability of targeted therapies. At the same time, there was hesitancy amongst some oncologists with this approach, “All my life I’ve worked to try to improve things and so I am not totally philosophically comfortable with the notion that I’m going to be happy with a result that says, we haven’t improved it but we can get by with less.” In addition, oncologists also identified accrual barriers, like tumor-specific biology, individual (host) factors (e.g. disease characteristics, patient demographics, patient psychological state, patient preferences), prognostic markers of risk, access to therapies, provider experience, and system constraints. They voiced recommendations regarding preliminary data, trial design, and tools to support communication about and enrollment in optimization trials. Conclusions: While optimization clinical trials are generally accepted to be beneficial by oncologists, barriers impact their acceptance. Scientifically robust design and education to overcome barriers are needed to support future enrollment on trials tailoring therapy based on risk and potential benefit to allow true personalization of treatment. Citation Format: Gabrielle B. Rocque, Andrews Courtney, Rachel M. Frazier, Lawhon Valerie, Stacey A. Ingram, Mary Lou Smith, Lynne I. Wagner, Lisa Zubkoff, Nadine Tung, Lauren P. Wallner, Antonio C. Wolff. Oncologist-reported Barriers and Facilitators to enrolling patients in optimization trials that test less intense cancer treatment [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-09-04.

Navigating the Expanded Access Pathway to Investigational Drugs as an Academic Oncologist

This qualitative study explores academic oncologists’ needs and satisfaction with expanded patient access to investigational drugs.

OCEAN (wOmen’s Career choicEs About oNcology) Study: Motivations to pursue or not pursue academic oncology.

11040 Background: Although women outnumber men in US medical school enrollment, women constitute < 50% of faculty in academic oncology. This study aimed to determine factors affecting women oncologists’ decisions to pursue academic versus non-academic oncology in Hematology/Oncology (HO), Pediatric Oncology (PO), Radiation Oncology (RO), and Surgical Oncology (SO), and to characterize the challenges women oncologists face. Methods: A survey was designed to collect cross-sectional data on factors affecting career choices among US women oncologists. The survey was distributed via email and social media. Data were collected anonymously and analyzed using t-tests for continuous variables and Chi-squared tests for categorical variables. Results: Six hundred sixty-seven women oncologists responded: 245 (45.3%) specialized in HO, 173 (25.9%) RO, 88 (13.2%) PO, 56 (8.4%) SO, and 48 (7.2%) other. Four-hundred twenty-two (63.2%) women identified as an academic oncologist (AO); 245 (36.8%) women identified as a non-academic oncologist (non-AO). Approximately ¼ of women oncologists reported their partner (156, 23.5%) or family (176, 26.4%) extremely or moderately impacted their decision whether to pursue academic practice. There was no difference in the timing of childbearing between AO and non-AO. AO perceived the biggest sacrifice of pursuing academics to be time with loved ones (181, 42.9%). Non-AO perceived the biggest sacrifice for AO to be pressure for academic promotion (102, 41.6%), which was the third most common response (44, 18.0%) among AO. Thirty-three (7.9%) AO and 5 (2.0%) non-AO reported feeling that they rarely or never have a sense of belonging in their work environment (p < 0.01). AO and non-AO had significantly different perceptions on how their gender impacted their ability to obtain a chosen job (p < 0.01), with 100 (23.8%) AO and 52 (21.2%) non-AO reporting a negative or somewhat negative impact, and 116 (27.6%) AO and 101 (41.2%) non-AO reporting a positive or somewhat positive impact. More than half of women surveyed (230 AO, 54.6%; 123 non-AO, 50.6%; p = 0.61) felt that they were somewhat or much less likely to be promoted compared to male colleagues. The majority of women reported they would choose the same career path again (71% of AO, 69% of non-AO); however, 92 (21.9%) of AO responded that they were likely or very likely to pursue a career outside academics in the next 5 years. Conclusions: While partners/family have a substantial impact on 1 in 4 women oncologists, this does not differ between AO and non-AO. Significantly more non-AO find their gender to have positively impacted their ability to obtain their chosen job. In contrast, a meaningful number of AO report a poor sense of belonging and perceived discrimination in obtaining jobs and being promoted; 1 in 5 are considering leaving academia. Academic oncology remains at high risk for continued gender inequality if the culture is not addressed.

Introduction of #PancChat: A novel Twitter platform to inform and engage the pancreatic cancer community.

242 Background: Twitter provides a platform for health care stakeholders to disseminate information about diseases to patients, caregivers, and doctors. Chats are especially effective because participants can interact directly with experts. Pancreatic cancer (PC) conversations on Twitter previously were sporadic and inconsistent. The authors report the creation of #PancChat, a first-of-its-kind Tweet Chat developed to provide relevant, credible, and timely information to the PC community. A collaboration between leading PC organizations, a pharmaceutical company, and an academic oncologist, PancChat is an example of successful outreach using an accessible communications tool. Methods: Launched in April 2016, the hour-long monthly chat is a live event publicized and promoted through multiple social media channels and major news outlets. It is moderated and focused around a pre-selected topic. The hashtag #PancChat is used to filter specific chatter into a single conversation. Participants include patients, caregivers, physicians, researchers, top ASCO social media influencers, AACR members, and advocacy organizations. Moderators and participants are drawn from 23 academic institutions. The PancChat team corresponds with participants and replies to tweets that are not addressed during the chat. Results: Since its inception, PancChat has had a total of 28 million impressions (the total number of times each tweet is seen) from 16 chats, averaging 1.75 million per chat. Popular topics include clinical trials (1.4 million), familial/hereditary PC (2.9 million), and early detection (2.2 million). The average engagement rate is 72% which measures how much people interact with a tweet by clicking or sharing links. From April 2016-August 2017 there were 8,502 tweets using #PancChat. Conclusions: Impression and engagement numbers show that this novel PancChat platform fulfills a need for the PC community. The narrow focus of each chat provides an opportunity to learn about the disease, research, and clinical trials. Participants return knowing that they will interact with PC experts. The popularity of PancChat among patients and doctors confirms the power of social media to reach a specific community.

Integrated post-surgical colon cancer care planning at the Rutgers Cancer Institute of New Jersey and Robert Wood Johnson University Hospital.

75 Background: Colorectal cancer is the second leading cause of cancer death in the United States each year. The use of adjuvant chemotherapy after surgical resection of colon cancer has been associated with a survival benefit. Timely initiation of adjuvant chemotherapy has been shown to have an effect on overall and disease-free survival. There is no integrated post-surgical colon cancer care planning for patients who have surgery at our institution. Poor understanding on the part of patients and ancillary providers regarding appropriate follow up may cause delay in time to adjuvant chemotherapy initiation. Methods: Baseline data was obtained for the ASCO Quality Training Program. Chart review was conducted on patients with stage III colorectal cancer that were treated at the Cancer Institute of New Jersey and Robert Wood Johnson University Hospital to identify average time to adjuvant chemotherapy initiation and factors which were thought to have a strong influence on chemotherapy initiation. Time to initiation of adjuvant chemotherapy, pathology report resulting, central access obtainment, and outpatient medical oncology appointment was abstracted from patient charts. Other factors including the presence of intraoperative or postoperative complications, type of surgeon, academic versus private medical oncologist, and the presence of an inpatient medical oncology consult were also identified and reviewed. Results: 128 patient charts were reviewed. Mean number of days from surgery to adjuvant chemotherapy (n = 79) was 49.6, to pathology report resulting (n = 70) was 4.92, to central access obtainment (n = 49) was 40, and to outpatient medical oncology appointment (n = 38) was 30. The presence of intraoperative (p < 0.059) and postoperative complications (p < 0.0155) was found to have a statistically significant effect on time to initiation of adjuvant chemotherapy. Conclusions: While there are some uncontrollable factors like operative complications that delay time to initiation of chemotherapy, engaging the patient may help decrease the time to adjuvant chemotherapy by increasing patient awareness of the importance of seeking aggressive postoperative care.

Obligations of an academic and clinical oncologist: historical reflections.

Obligations are derived from one's core values-those fundamental, enduring, deeply held beliefs that guide one's everyday actions. Gandhi stated it more eloquently than I ever could: "Your beliefs become your thoughts, your thoughts become your words, your words become your actions, your actions become your habits, your habits become your values, your values become your destiny." So what are the obligations of the academic oncologist and clinician? I believe there are a few indubitable and fundamental obligations: professionalism, patient care, stewardship, maintenance of knowledge, productivity, and mentorship). I might add that I do not see these obligations as unique to the academician but rather applicable to all physicians.

Charles M. Balch: specializing surgeons is going to be a trend.

Dr. Charles M. Balch, M.D., FACS, Professor of Surgery, University of Texas Southwestern Medical Center, was previously Deputy Director for Clinical Trials and Outcomes Research at Johns Hopkins Institute and Executive Vice President and Chief Executive Officer of American Society of Clinical Oncology (ASCO). He has led a distinguished career as a clinical and academic oncologist for the past 35 years, as a leading authority in both melanoma and breast cancer. He has also made significant contributions to laboratory research in tumor immunology and human T lymphocyte differentiation.

Treatment of the Future, Today?

DOI: 10.1200/JCO.2012.45.5923 A patient in her early 60s was referred to me for a discussion of adjuvant chemotherapy after she underwent a lobectomy for clinical stage I adenocarcinoma of the lung. Unfortunately, pathologic evaluation revealed hilar lymph node involvement, which upstaged her to pathologic stage II disease. This should have been a fairly routine discussion. Several well-done, phase III randomized clinical trials have demonstrated an improvement in overall survival with the use of adjuvant cisplatin-based chemotherapy versus observation alone after resection of stages II and III non–small-cell lung cancer (NSCLC), and such treatment has been the standard of care since 2004. She was upset by the fact that the cancer was a higher stage than initially thought and was terribly afraid of the potential adverse effects of chemotherapy. She truly saw the higher stage of cancer as a death sentence. I assured her that the complete surgical resection she had already undergone offered her a 50% chance of cure and that adjuvant chemotherapy could improve the cure rate by another 5% to 10%. The chemotherapy would amount to throwing the kitchen sink at the cancer to do all we could to prevent it from recurring. Her husband voraciously wrote down my every word and asked a multitude of pointed questions. Despite my best efforts to explain her situation and my recommendation for adjuvant treatment, they left my office still despondent and unsure of how to proceed, so I suggested a return office visit in a couple of weeks, when she had more fully recovered from surgery and more thoroughly digested the information I had shared with them. The next week, her husband called to tell me that they had sought a second opinion and that this new oncologist had asked for the molecular profile of the tumor (epidermal growth factor receptor (EGFR) mutation, KRAS mutation, and EML4-ALK rearrangement). He was quite upset that I had not discussed molecular analysis during my initial visit with them, and it was clear from his tone that he felt I had not given his wife all of the available options. I could already feel his confidence in my professional abilities eroding. At first, I did not know what to say. I am an academic thoracic oncologist. I keep up on the lung cancer literature. I know that presently, all of the data that justify molecular profiling and the use of targeted therapy, such as gefitinib, erlotinib, and crizotinib, are from studies in patients with metastatic NSCLC. In fact, all of these agents were approved by the US Food and Drug Administration only in the setting of metastatic disease. I assured him that molecular testing was not relevant in his wife’s situation, that there was no proven benefit for targeted therapy in the postoperative setting, and that adjuvant cisplatin-based chemotherapy was still the best option for improving her long-term survival. Despite my explanations of the current state of our knowledge and standard of care, he cancelled the subsequent visit with me and the planned chemotherapy. The tumor tissue had indeed been sent for reflex molecular analysis and was positive for an EGFR sensitizing mutation. It can be rationally argued that reflex molecular analysis based on histology in patients who have undergone potentially curative therapy is not an appropriate use of medical resources, because there are no data justifying the use of adjuvant EGFR inhibitors in patients with completely resected NSCLC. Or are there? The oncologist with whom they had sought a second opinion had offered adjuvant erlotinib, given the patient’s reluctance to receive adjuvant chemotherapy. I felt panicked and uneasy. I knew that, thus far, data were available from only one randomized trial evaluating the adjuvant use of an EGFR inhibitor in patients with resected NSCLC and that this trial had demonstrated no survival benefit, even in the subset of patients with EGFRmutant tumors. Had I somehow missed a practicechanging clinical trial that had demonstrated a survival benefit for adjuvant EGFR inhibitors in patients with resected, EGFR-mutant NSCLC? A quick literature search revealed a recent article entitled, “Impact on Disease-Free Survival of Adjuvant Erlotinib or Gefitinib in Patients With Resected Lung Adenocarcinomas That Harbor EGFR Mutations.” This was a retrospective study in which 56 patients with resected, early-stage, EGFR-mutant NSCLC who had been treated with adjuvant EGFR inhibitors either in a phase II clinical trial or “at the discretion of their physicians” were compared with 111 similar patients who had not received adjuvant JOURNAL OF CLINICAL ONCOLOGY A R T O F O N C O L O G Y VOLUME 30 NUMBER 32 NOVEMBER 1

Prenatal Diagnosis, Preimplantation Genetic Diagnosis, and Cancer: Was Hamlet Wrong?

Prenatal Diagnosis, Preimplantation Genetic Diagnosis, and Cancer: Was Hamlet Wrong?

Report on Status of Regulatory Science at FDA

Frank Torti, MA, MD, MPH, was appointed as the US Food and Drug Administration (FDA)’s first Chief Scientist and Principal Deputy Commissioner on 15 May 2008. Formerly, Dr Torti was an academic oncologist and epidemiologist, most recently as Professor of Medicine and Chair of the Department of Cancer Biology at Wake Forest Medical School. His earlier career was spent at Harvard and Stanford. Dr Torti’s report, with the same title as this Editorial, was issued at the end of February 2009. It clearly builds upon two reports that emanated prior to his appointment. Presuming that this report is intended to be taken seriously, some close review and comment upon it may be justified. Dr Torti builds his mission on five principles, none of which would be questioned by anybody wishing progressive change at FDA: 1. FDA must develop an overarching scientific strategy with an accompanying implementation plan, deliverables, timetables and budget; 2. FDA scientific strategy must be pre-emptive; 3. FDA must maintain and enhance its infrastructure, core expertise and human capital; 4. FDA must tell its story; 5. FDA cannot do it alone. It would be wrong to hold these five principles to the standards of other types of organizations.While the first four might be found in a typical research university or pharmaceutical company, the last (‘‘FDA cannot do it alone’’) distinguishes the special mission of a regulatory organization, and indeed represents a desirable situation (pace those who are deluded in thinking that the Agency conspires with its stakeholders). By analogy, judges often have the warring barristers before them do much of the legal research on points of law, without ceding any judicial ground. Evidently in consultation across the various centres within FDA, a variety of priority projects are then identified in the report and are sorted against these five principles. Here, the report is somewhat ‘retro’ and repetitive of what we have all known for a few years already: for example, overarching scientific priorities include rapid detection of pharmacovigilance signals, development of biomarkers, more efficient clinical designs and analyses, etc. Microbial contamination (a highvisibility issue for both foods and drugs in the US at the moment) appears more than once. An original idea is that an ‘omics’ czar is proposed, to deal with genomic, proteomic andmetabolomic issues across centres and reviewing divisions. This could well be seminal for the development of personalizedmedicine and is consonant with an FDA Science Board emphasis on differential drug response between racial groups. Combination product coordination also receives attention. However, its guru will only be an FDA fellow (essentially a 2-year post-graduate internship within the Agency). Outside interactions (‘‘FDA cannot do it alone’’) are thought to benefit especially the areas of drug-induced liver injury, nano-engineered products, and the development of centres of excellence in collaboration with academia. However, the report states: ‘‘Small biotechnology firms represent a flexible resource. They are operationally and scientifically nimble, and often have capability to devote a large proportion of human capital to a single project. Biotech firms that have an interest in partnering to resolve mission-critical FDA questions will be identified and engaged through contracts and other funding mechanisms.’’ Another opinion might be that the FDA seems oblivious of how small companies work. First, the present financial situation makes it unlikely that there will be any substantive venture capital for biotech for the next 5 years. Moreover, those few companies that survive might be expected to have their own mission-critical questions that will take priority over the FDA’s. It is also telling that this report refers to FDA staff as being ‘‘well-trained physicians and scientists’’, and even that FDA Fellows are ‘‘highly qualified and selected scientists’’; meanwhile, the biotech companies who are going to provide all this help evidently contain ‘‘human capital’’. EDITORIAL Pharm Med 2009; 23 (1): 1-2 1178-2595/09/0001-0001/$49.95/0

Clinical trials in cancer therapy: Efforts to improve patient enrollment by community oncologists

A prerequisite for the completion of a clinical trial is the accrual of adequate numbers of patients. It is estimated that over 90-95% of all cancer patients are now treated in their local communities by practicing oncologists and are not seen by primary investigators at teaching hospitals. One risk of this trend is decreased patient enrollment into clinical trials. The private practitioner often lacks the academic oncologist's incentives to participate in clinical research. The Hoosier Oncology Group (HOG) is composed of community medical and radiation oncologists (85%) and Indiana University faculty members (15%). In an effort to improve patient enrollment onto clinical cancer research trials, HOG has attempted to identify 1) the major obstacles to patient enrollment by community oncologists and 2) potential aids to overcome such obstacles. One hundred fourteen members were surveyed and 75 responded (66%). The major obstacles were, in descending order: time demands on both the oncologist and his staff; explaining clinical trials to patients; completing flow sheets; perceived increased cost to the patient; remembering protocols; adhering to a rigid protocol. Aids identified as potentially most helpful were, in descending order: pocket-sized synopses of protocols; computer generated, individualized prompts; the availability of a clinical trials specialist to explain the clinical trial to patients and assist in obtaining informed consent; the availability of a video tape which could be used to explain clinical trials to patients. These aids are being implemented with the attempt to systemically study their impact on patient accrual.