Patient-Reported Adverse Effects in 15-Fraction Pancreatic Cancer Radiation Therapy

Abstract

Fifteen-fraction radiotherapy (RT) regimens have emerged as a standard option in the treatment of patients with pancreas cancer. Patient-reported outcomes (PROs) during and after pancreas cancer RT have not been well characterized. There is an even greater paucity of data among patients treated with 15-fraction regimens. We aimed to characterize gastrointestinal (GI) PROs in a cohort of patients treated with 15-fraction pancreas RT. This was an IRB-approved retrospective cohort study including patients with primary pancreas tumors treated with pre-operative or definitive 15-fraction RT from 2013 to 2022. PROs, including anorexia, nausea, diarrhea, stool incontinence, and abdominal pain, were prospectively collected and characterized per PRO-common terminology criteria for adverse events (PRO-CTCAE). Acute PROs were defined as occurring during RT through 110 days post-RT but prior to oncological surgery. Grade 3 or 4 PROs were respectively scored as "quite a bit" or "very much" in symptom interference questions, "frequently" or "almost constantly" in symptom frequency questions, and "severe" or "very severe" in symptom severity questions. A total of 330 patients were analyzed. Patient characteristics included a median age of 67 years (IQR: 60 - 72), ECOG 0-1 (96%), and male sex (56%). Most patients had pancreatic ductal adenocarcinoma (96%). Resectability status included resectable (12%), borderline resectable (46%), and locally advanced (42%). 37% had lymph node involvement. 97% of patients received neoadjuvant chemotherapy and 98% received concurrent chemotherapy, most commonly with 5-fluorouracil or capecitabine (88%) or gemcitabine (11%). 99% were treated with intensity modulated RT. Median RT dose was 4500 cGy (IQR 4500 - 4500) to gross disease with margin and 3750 cGy (IQR 3750 - 3750) to elective nodal regions. 59% proceeded with oncologic resection. Grade 3 or higher acute PROs are demonstrated in the table. Often considered more sensitive than physician assessments, PROs provide vital metrics that allow for a better understanding of the patient experience during cancer treatment. We report a comprehensive assessment of prospectively collected PROs per standardized PRO-CTCAE with the goals of raising awareness of the patient experience during 15-fraction pancreas cancer RT and helping guide future clinical trial designs focused on patient quality of life endpoints.