Tumor genomic profiling (TGP) in metastatic colorectal cancer (CRC): Bridging the community and the tertiary cancer center through genomic consultation (GC).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 538-538
Author(s):  
John M. Kaczmar ◽  
Karen S. Gustafson ◽  
Yu Ning Wong ◽  
Carl J. Minniti ◽  
Vijay Krishna Sandilya ◽  
...  

538 Background: TGP of cancers is increasingly accessible to oncologists (MDs) and patients (pts). Despite efforts to provide clinical interpretation and decision support within TGP reports, results are complex and their interpretation remains fraught with uncertainty. In an ongoing pilot, we provide community MDs access to a 50-gene next generation sequencing (NGS)-based TGP assay and expert guidance through remote access to genomic tumor board (GTB) resources via telephone-based GC. Our goal is to explore how access to GTB expertise impacts community patterns of care. In parallel, we examine MDs and pts perceptions of TGP with a focus on awareness and expectations. Methods: MDs from 4 community practices participated. Participating MDs and their pts with metastatic unresectable CRC receiving 2nd line or beyond chemotherapy provide informed consent and complete baseline and follow-up surveys. Adequate tumor samples are tested with the Fox Chase 50-gene NGS-based TGP assay. All results are presented at a bi-monthly GTB or are reviewed with the GTB chair. MDs have a ~10 min GC by telephone with the PI to summarize findings and convey GTB recommendations. Results: 9 MDs have enrolled 22 pts and TGP has been completed on 15 samples (4 additional in process and 3 insufficient for TGP). Pts report diverse ancestry (24% Hispanic or non-White) and SES (33% income < $25K). To date, all completed TGPs have reported > 1 mutation. Of 11 pts who have received TGP results, 1 has sought consultation at a tertiary center for a clinical trial. Pts with higher education were more aware of TGP (p = 0.05). Most (80%) pts felt TGP would improve their MD’s ability to treat their cancer. Male sex and higher education were associated with stronger belief that TGP will improve life expectancy. Conclusions: A partnership with community MDs to provide TGP and GTB expertise through GC is feasible. Pts exhibit high expectations of TGP, despite limited data to support improved outcomes from TGP-guided treatment. Further research into optimizing partnership between community MDs and tertiary centers is valuable to guide treatment and clinical trial participation based on TGP results.

2021 ◽  
pp. 859-875
Author(s):  
Amanda O. L. Seet ◽  
Aaron C. Tan ◽  
Tira J. Tan ◽  
Matthew C. H. Ng ◽  
David W. M. Tai ◽  
...  

PURPOSE Precision oncology has transformed the management of advanced cancers through implementation of advanced molecular profiling technologies to identify increasingly defined subsets of patients and match them to appropriate therapy. We report outcomes of a prospective molecular profiling study in a high-volume Asian tertiary cancer center. PATIENTS AND METHODS Patients with advanced cancer were enrolled onto a prospective protocol for genomic profiling, the Individualized Molecular Profiling for Allocation to Clinical Trials Singapore study, at the National Cancer Center Singapore. Primary objective was to identify molecular biomarkers in patient's tumors for allocation to clinical trials. The study commenced in February 2012 and is ongoing, with the results of all patients who underwent multiplex next-generation sequencing (NGS) testing until December 2018 presented here. The results were discussed at a molecular tumor board where recommendations for allocation to biomarker-directed trials or targeted therapies were made. RESULTS One thousand fifteen patients were enrolled with a median age of 58 years (range 20-83 years). Most common tumor types were lung adenocarcinoma (26%), colorectal cancer (15%), and breast cancer (12%). A total of 1,064 NGS assays were performed, on fresh tumor tissue for 369 (35%) and archival tumor tissue for 687 (65%) assays. TP53 (39%) alterations were most common, followed by EGFR (21%), KRAS (14%), and PIK3CA (10%). Of 405 NGS assays with potentially actionable alterations, 111 (27%) were allocated to a clinical trial after molecular tumor board and 20 (4.9%) were enrolled on a molecularly matched clinical trial. Gene fusions were detected in 23 of 311 (7%) patients tested, including rare fusions in new tumor types and known fusions in rare tumors. CONCLUSION Individualized Molecular Profiling for Allocation to Clinical Trials Singapore demonstrates the feasibility of a prospective broad molecular profiling program in an Asian tertiary cancer center, with the ability to develop and adapt to a dynamic landscape of precision oncology.


2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 157-157
Author(s):  
Dare Olatoye ◽  
Michael Anthony Carducci ◽  
Norma Kanarek

157 Background: Adequate and representative enrollment in therapeutic clinical trials is important to an NCI cancer center. Clinical trial participation is a string of 6 sequential patient and physician decisions beginning with an available therapeutic trial to enrollment in the trial. Opportunities for participation may be lost at any one of these steps. The objective of this study was to calculate transitional probabilities that measure patient, especially minority patient, accrual to clinical trials at the Sidney Kimmel Comprehensive Cancer Center and to describe the barriers for those dropping out at each step. Methods: Records for “first visit” medical oncology patients seen by three SKCCC physicians from January to April 2010 were abstracted. Prostate cancer case reports from the hospital cancer registry and a medical record review provided age, race, Hispanic ethnicity, place of residence, tumor characteristics, and prior treatment history. At each transition step, we calculated the proportion of patients who remained enrollable. Results: Overall, prostate cancer clinical trial participation was 17% (16/94). Minority accrual was similar to Caucasian accrual at 19% and 17% , respectively. Retention at each step of trial participation was highest for “discussed” (98%), “enrolled” (94%), “eligibility” for available trials (79%), and “consented” (71%). Two bottlenecks were qualitatively identified: “trial availability” (65%) and “patient interest” (51%). Forty-two percent of those for whom there was no trial available were older than 70 years and 33% were patients with rising PSA after local therapy and hormone-naïve. The “patient interest” step was shaped primarily by disinterest due to distance to SKCCC (83%). Conclusions: For prostate cancer patients, recruitment to medical oncology clinical trials is robust. Minority patients however are only 17% of all patients seen and half drop out when no trial is available and half of those remaining judged distance to be a problem (hence, no interest). This study approach has clarified which factors are likely to be barriers to participation and is likely useful to making adjustments that can reduce identified barriers by adding to trial portfolio as an example.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1587-1587
Author(s):  
Michael J. Hall ◽  
Yana Chertock ◽  
Elizabeth Handorf ◽  
John M. Kaczmar ◽  
Julie Innocent ◽  
...  

1587 Background: MGTP use in routine cancer (CA) care is likely to increase w/lower costs for NGS-based testing and growing numbers of actionable targets coupled with targeted therapeutics. Early MGPT uptake has been slow among community oncologists (COs) due to their lower confidence to order, interpret, and act upon results of MGTP. This study evaluated the provision of telephone genomic consultation (GC) via an academic clinician link to an institutional genomic tumor board to support MGTP testing of CA patients (PTs) by COs. Methods: 4 practices of COs participated: 9 COs recruited 25 PTs w/metastatic CA. All PTs/COs completed baseline and follow-up (FU) assessments. Tumor blocks were evaluated at Fox Chase Cancer Center (FCCC) and tested w/a 50-gene MGTP. 12% blocks were inadequate. MGTP results were presented when appropriate at FCCC’s Genomic Tumor Board. All MGTP yielded > 1 variant (Var) [range 1-6]: 13/22 (59%) pts tested had a clinically relevant V; 6 other Vars were potentially actionable w/ approved therapy, while 3 Vars have novel therapies in Phase I/II studies. MGTP were called out to COs (by MJH) < 2 wks of resulting. A tailored summary was provided to COs. Results: At baseline, COs (n = 9) had limited experience w/MGTP (78%, < 5 ordered). Barriers for COs were: poor understanding of MGTPs (67%), cost (89%), uncertain benefit (44%), and poor access to targeted therapies (67%). At FU, 4/8 (50%) COs found GC “very useful”, and 63% reported MGPT paired w/GC would “probably/definitely” increase their use of MGTPs. Most (88%) felt MGPTs should be offered to PTs w/incurable CA. Among PTs at baseline (n = 25), awareness of MGTP was moderate (50%), but 79% reported it would help doctors take better care of their PTs. Valuation of MGTP was mixed—30% would pay $0 out of pocket, yet 30% also said they would travel “any distance” for an MGT-targeted experimental therapy. At FU (n = 14), 86% PTs felt MGPT was valuable, yet only 46% would “definitely” retest, and only 31% would pay > $100 to retest, even for 500+ genes. Conclusions: GC can be effective to support COs to use MGTPs. PTs w/CA have high expectations of MGTPs to improve their care, and yet attribute modest value to retest or to have a larger MGTP.


2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 89-89
Author(s):  
Laurence J. Heifetz ◽  
Ahrin B. Koppel ◽  
Elaine Melissa Kaime ◽  
Daphne Palmer ◽  
Thomas John Semrad ◽  
...  

89 Background: In 2006, Tahoe Forest Hospital District—a 25-bed hospital in Truckee, CA, a mountain resort community one hour from regional and two hours from academic cancer services—designed and implemented an oncology program utilizing effective telecommunications with a committed academic partner, the UC Davis Comprehensive Cancer Center in Sacramento. Methods: The UC Davis Cancer Care Network was established with four remote cancer programs, enabling participation in daily virtual tumor boards, clinical trial enrollment, and quality assurance assistance. (Richard J. Bold, et. al., Virtual tumor boards: community-university collaboration to improve quality of care. Community Oncol 10(11):310-315, November 2013.; Laurence J. Heifetz, MD, et. al., A Model for Rural Oncology. J Oncol Pract, 7:168-171, May 2011.). An increasing number of patients were observed to in-migrate to Truckee from even more remote rural areas in the mountains. In 2013, the now Gene Upshaw Memorial Tahoe Forest Cancer Center developed four remote telemedicine clinics to allow even more physically distant patients the capacity to be followed locally. Results: Since we opened the remote telemedicine clinics, our Sullivan-Luallin patient satisfaction scores have averaged 4.82/5.00 for “overall satisfaction with the practice” and 4.90/5.00 for “recommending your provider to others”; our in-migration rate of patients from outside our primary catchment area increased from 43% to 52%: and clinical trial accrual rate averaged 10%. Conclusions: Reducing cancer health disparities is an ASCO mission. (cover, ASCO Connection, July 2014; Laurence J. Heifetz, MD. Country Docs with City Technology Can Address Rural Cancer Care Disparities. Oncol, 29(9):641-644, September 2015.). We believe this synaptic knowledge network effectively addresses that mission for rural communities. This model can be scaled in many configurations to address the inherent degradation of quality care as a function of physical distance to an academic center that rural doctors and patients deal with on a daily basis. The key is to insist on a cultural shift – Do something smart at lunch every day. Attend a virtual tumor board.


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 298-298
Author(s):  
Matthew Carnell ◽  
Martin D. Fleming ◽  
David Craig Portnoy ◽  
Matthew T. Ballo ◽  
Kristopher Fisher ◽  
...  

298 Background: Clinical pathways are valuable in reducing treatment variation, improving outcomes, and reducing costs in an oncology setting. With input of clinical stakeholders at West Cancer Center, we created and implemented a melanoma clinical pathway to improve care and facilitate standardization between melanoma sub-specialists and general oncologists. Retrospective pathway adherence was assessed to inform quality improvement goals. Methods: Using national guidelines and expert literature review, we developed a pathway defining a center-wide algorithmic approach to treat melanoma. Prior adherence to the pathway was retrospectively assessed by evaluating treatment during 1 year across 8 metrics. All patients who received systemic melanoma therapy during the study period at a large cancer center ( > 5000 new patients annually) were included in the assessment. Of the included patients, metric adherence was only measured when applicable. Adherence rates were described for predefined melanoma subspecialists versus predefined general oncologists without a declared subspecialty in melanoma. Significance was assessed with fisher exact test. Results: The following metrics were defined by the expert team as essential components of melanoma pathway; receipt of wide local excision; receipt of sentinel lymph node biopsy; presentation at multidisciplinary conference; molecular profiling before treatment of metastatic disease; treatment with preferred regimens in 1st line, 2nd line, and 3rd line; and clinical trial participation. Ninety patients were evaluated. Conclusions: Most differences in pathway adherence were found to be not significant. Clinical trial accrual was higher among melanoma subspecialists compared to general oncologists. Clinical pathways allow patients treated by general oncologists to benefit from the expertise of subspecialists and improve quality of care.[Table: see text]


2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 168-168
Author(s):  
Ofilio Ramon Vigil ◽  
Dana Ann Little ◽  
Kristin J. Mensonides ◽  
Richard J. Bold

168 Background: The UC Davis Health Cancer Care Network (CCN) in Sacramento improves quality through partnerships with community cancer centers and the UC Davis Comprehensive Cancer Center (UCDCCC). The UCDCCC, as an NCI Lead Academic Participating Site (LAPS) grant recipient, lists Adventist Health Rideout Cancer Center (RCC) in Marysville (42 miles north of Sacramento) as a component. The Adventist Health Feather River Cancer Center (FRCC) and the town of Paradise were devastated by the 2018 Camp Fire, forcing FRCC’s relocation to the city of Chico (49 miles north of Marysville). FRCC was forced to disband its local IRB and unable to continue clinical trials research operations during the aftermath of this natural disaster. The CCN established an affiliation with the FRCC in April 2019. Future plans include establishing an IRB agreement and adding FRCC as a LAPS component. The CCN identified strategies to facilitate the participation of FRCC patients in clinical trials. Methods: The CCN identified 13 NCTN clinical trials with 34 enrolled patients that were in need of appropriate research oversight. Four of these trials were previously never activated at the UCDCCC or its affiliates. CCN staff engaged leaders at the various institutions involved: Quality Assurance (QA) Managers at each NCTN research base, the CIRB, the local IRB, the CTSU, and other leaders within UC Davis and Adventist Health. Results: Stakeholders acknowledged the unusual and urgent nature of our requests and questions, while contributing to the development of a plan allowing patients to continue clinical trial participation. QA managers approved a plan transferring patients to the RCC, allowing research staff to collect and submit data while patients continue receiving care closer to home. Together we developed a notification letter to inform patients of this plan. Conclusions: The relocation of facilities and patients brought rare challenges while conducting clinical research in rural communities. We learned that the cooperation and flexibility of all parties involved was crucial in supporting the continued care for FRCC's clinical trial patients and research contributions.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1538-1538
Author(s):  
Alex Chehrazi-Raffle ◽  
Nicholas Salgia ◽  
Joann Hsu ◽  
Zeynep Busra Zengin ◽  
Sabrina Salgia ◽  
...  

1538 Background: Although many tertiary cancer centers offer access to myriad research protocols, the majority of patients nevertheless receive treatment at community practices. We sought to examine the barriers that hamper clinical collaboration between tertiary and community practice environments in Southern California. Methods: A 31-item survey was distributed to community and tertiary oncologists using REDCap, a browser-based electronic data capture system. Survey questions assessed the following attributes: demographics and features of clinical practice, referral patterns, availability and knowledge pertaining to clinical trials, strategies for knowledge acquisition, and integration of community and tertiary practices. Results: The survey was distributed to 98 oncologists, 85 (87%) of whom completed it in full. The most common institutional affiliations were City of Hope Comprehensive Cancer Center (58%), University of California, Los Angeles (10%), and Cedars Sinai Medical Center (8%). In total, 52 (61%) respondents were community practitioners and 33 (38%) were tertiary oncologists. A majority (56%) of community oncologists defined themselves as general oncologists whereas almost all (97%) tertiary oncologists reported a subspecialty. Clinical trial availability was the most common reason for pt referrals to tertiary centers (73%). The most frequent barrier to tertiary referral was financial considerations (59%). Clinical trials were offered by 97% of tertiary practitioners as compared to 67% of community oncologists (p = 0.001). Of note, while a majority of tertiary center providers (52%) described the primary value of community practices to be a source of referrals for clinical trials, most community oncologists (82%) reported only a minimal-to-moderate understanding of clinical trials available at regional tertiary centers. Conclusions: Community oncologists refer patients to tertiary centers primarily with the intent of clinical trial enrollment; however, significant gaps exist in their knowledge of trial availability. Our results identify the need for enhanced communication and collaboration between community and tertiary providers to expand patients’ access to clinical trials.


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