A. Garant1, L. Poggi2, M. Boutros3, K. Ma4, C. A. V. Vasilevsky4, N. Morin4, M. Lecavalier4, A. G. Martin5, and T. Vuong6; 1Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, 2Jewish General Hospital, Montreal, QC, Canada, 3Cleveland Clinic, Weston, FL, 4McGill University, Montreal, QC, Canada, 5CHU de Québec – Université Laval, Radiation Oncology, Québec, Canada, Quebec, QC, Canada, 6Department of Radiation Oncology, Jewish General Hospital, McGill University, Montreal, QC, Canada
Purpose/Objective(s):Planned non-operative management (NOM) for patients with rectal cancer is gaining much popularity. However, clinical trial availability, specialized equipment and provider expertise may influence access to NOM. In the PATHOS study, we seek to characterize both patient-related and provider-related factors which may impact the likelihood of proceeding with NOM. We present the findings from the first 40 patients who enrolled on this study. Materials/
Methods: Patients seen in the Radiation Oncology clinic of an academic center were invited to participate in this questionnaire-based study. Adult patients were included if they were diagnosed with biopsy-proven, surgically resectable rectal cancer, and able to respond to two questionnaires. The first questionnaire focuses on socio-demographic details, and initial understanding of their diagnosis and treatment options. Upon completion of this questionnaire, patients proceed with the radiation consultation and receive a brochure, which provides an overview of treatment options. A second questionnaire at the next visit focuses on baseline symptoms, and tradeoffs between treatment preferences and potential toxicities. The sample size of this study is n=178 patients, which provides a 90% power to detect a significant effect of patient age on treatment decision, assuming 10% attrition between questionnaires. We conducted a planned query upon accrual of 40 patients for descriptive review. Results: Among the 40 participants, 76% were male, and 86% were non-smokers. Most participants had completed high school. Subjects had received their diagnosis from a surgeon (46%) or gastroenterologist (30%); they felt that this provider gave sufficient information on staging procedures (73%), radiotherapy (50%), chemotherapy (47%), and surgery (54%). Prior to the Radiation Oncology visit, the worst perceived toxicity would consist of a permanent stoma (72%), or fecal incontinence (22%). In the second questionnaire, 39% of patients were experiencing major Lower Anterior Resection Syndrome (LARS) symptoms at baseline, with 25% having minor LARS, and 36% without LARS. If given the option of participating in a NOM trial, 55% would “definitely participate”, and 38% would “maybe participate”. Moreover, 55% of respondents expressed that a minimum of 60% long-term surgical avoidance would be required to consider the risks of a trial. In terms of overall survival (OS), 48% of patients were willing to accept a decline in OS of 6% or more in order to achieve organ preservation, with 52% willing to risk 5% or less OS loss. Finally, when choosing experimental therapy escalation, 86% of respondents would prefer radiation intensification instead of 14% electing systemic therapy intensification. Conclusion: The preliminary findings of the PATHOS study suggest that patients wish to be involved in their cancer-related treatment decisions. A clear definition of treatment outcomes, benefits and risks can facilitate patient participation in NOM programs.