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Patient-Reported Adverse Events during Neoadjuvant Therapy in a Phase 2 Borderline Resectable Pancreatic Cancer Clinical Trial (Alliance A021501)
Rebecca A. Snyder*1, Amylou C. Dueck2, Briant Fruth3, Qian Shi3, Joleen M. Hubbard4, Joseph Herman5, Eileen O'Reilly6, Matthew H. Katz1
1Surgical Oncology, UT MD Anderson Cancer Center, Houston, TX; 2Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ; 3Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; 4Medical Oncology, Mayo Clinic, Rochester, MN; 5Northwell Health Cancer Institute, New Hyde Park, NY; 6Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY

Objectives: Clinical guidelines recommend neoadjuvant chemotherapy and/or radiotherapy for patients with borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC). Quality of life (QOL) and self-reported adverse events (AEs) during neoadjuvant therapy have been incompletely characterized in this population. We sought to evaluate rates of symptomatic AEs among patients with BR-PDAC undergoing neoadjuvant therapy on clinical trial using the National Cancer Institute’s Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) and traditional adverse event reporting (CTCAE). PRO-CTCAE was recently developed to promote a patient-centered approach to AE measurement by allowing patients to self-report symptomatic AEs. Methods: A021501 was a prospective phase 2 trial (Feb 2017-Jan 2019) that randomized patients with BR-PDAC to preoperative therapy with: 8 doses of mFOLFIRINOX (Arm 1) or 7 doses of mFOLFIRINOX + hypofractionated radiotherapy (RT, Arm 2), followed by pancreatectomy and adjuvant FOLFOX6. Patients completed QOL (single-item linear analogue self-assessment items) and PRO-CTCAE assessments at baseline and PRO-CTCAE items on day 1 of each chemotherapy cycle and daily during RT. Fisher’s exact comparisons were performed between arms. Results: Of 126 enrolled patients, 96 (76%) completed a baseline plus at least one post-baseline PRO-CTCAE assessment (n=52, Arm 1; n=44, Arm 2). Mean baseline QOL score was 75.5 (SD 22.4) on a 0 (worst) to 100 (best) scale, and there were no differences between study arms (p=0.25). After adjustment for baseline PRO-CTCAE scores, there were no differences in individual self-reported severe (score=3) or very severe (score=4) AEs between groups in the neoadjuvant or adjuvant phase of treatment. Rates of symptomatic grade 3 or higher AEs ranged from 2-37% in patients using composite grades calculated from patient PRO-CTCAE scores. Rates of worsened and severe/frequent diarrhea, fatigue, nausea, and decreased appetite were reported by 30% of patients using the PRO-CTCAE assessment. Diarrhea and fatigue were the only symptomatic grade 3 or higher AE identified in 10% of patients based on traditional CTCAE grading. Conclusions: Rates of self-reported, symptomatic adverse effects of treatment did not differ between study arms among patients with BR-PDAC treated with neoadjuvant therapy on this clinical trial. Severe symptomatic AEs were as high as 30-40% by PRO-CTCAE compared to 10-20% by CTCAE reporting. These findings suggest that PRO-CTCAE may be a more sensitive assessment of severe or very severe symptomatic AEs and captures valuable patient-reported data. These results provide an important benchmark for future trials and should inform shared decision-making with patients considering a neoadjuvant therapy approach.
Support: U10CA180821,U10CA180882,UG1CA189823,U10CA180868(NRG); Trial Registration: Clinical trial information: NCT02839343.

Commonly occurring grade 3+ AEs using CTCAE and PRO-CTCAE
 Arm 1 mFOLFIRINOX n(%)Arm 2
Arm 1 mFOLFIRINOX n(%)Arm 2
During mFOLFIRINOX Cycles(n=65)(n=55)  
Diarrhea*10 (15.4%)12 (21.8%)17/50 (34.0%)17/42 (40.4%)
Hypokalemia10 (15.4%)7 (12.7%)----
Neutrophil count decreased9 (13.8%)5 (9.1%)----
Fatigue**6 (9.2%)7 (12.7%)16/52 (32.1%)13/42 (31.0%)
Anemia3 (4.6%)7 (12.7%)----
Nausea*5 (7.7%)5 (9.1%)16/51 (31.4%)14/40 (35.0%)
Platelet count decreased5 (7.7%)4 (7.3%)----
Dehydration6 (9.2%)1 (1.8%)----
White blood cell decreased6 (9.2%)1 (1.8%)----
Vomiting*4 (6.2%)2 (3.6%)4/52 (7.7%)4/41 (9.8%)
Alanine aminotransferase increased4 (6.2%)1 (1.8%)----
Febrile neutropenia2 (3.1%)3 (5.5%)----
Lymphocyte count decreased5 (7.7%)0 (0.0%)----
Anorexia/Decreased appetite**4 (6.2%)0 (0.0%)12/52 (23.1%)14/41 (34.1%)
During RT Cycles(n=0)(n=40)  
Anemia--2 (5.0%)----

*= Frequency item reported; **= Severity item reported

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