Doc Talk: PROSPECT trial: Dr. Schrag (2023)

In this Doc Talk hosted by Colontown and brought to you by Dr. Manju George, Scientific Director at Paltown, Dr. Deborah Schrag, Chair of Medicine at Memorial Sloan Kettering Cancer Center, presents the findings of the PROSPECT trial, a pivotal study investigating whether select patients with rectal cancer can safely skip pelvic radiation and still achieve the same outcomes using FOLFOX chemotherapy alone. With over a decade of research and more than 1,100 patients enrolled, the trial provides critical insight into organ preservation, toxicity, quality of life, and evolving treatment standards in rectal cancer. What you'll learn: - The origin of the PROSPECT trial and why changing standard treatment was considered risky but necessary - Which patients were eligible (T2N+, T3N0, and T3N+ rectal cancers without very distal or bulky tumors) - How the trial was designed to compare FOLFOX-first treatment to standard pelvic chemoradiation Key results showing non-inferiority of chemotherapy alone in disease-free and overall survival - The low rates of local recurrence and identical survival outcomes in both arms at 5 years - How the intervention group had fewer temporary ostomies and more opportunities for sphincter preservation - Detailed analysis of side effects, toxicity timing, and long-term symptom resolution - The impact of treatment type on bowel function, neuropathy, fatigue, and validated sexual function scores - Why patient-reported outcomes (PRO-CTCAE) offer better insight than physician-only toxicity scoring - Limitations of the trial and next steps, including studies on more distal tumors and non-operative management Timestamps: 00:00 – Introduction and background on advances in rectal cancer surgery and screening 02:11 – Rationale for testing chemotherapy alone in mid-rectal cancers 04:23 – Study design, inclusion criteria, and randomization to FOLFOX vs chemoradiation 07:55 – Disease-free and overall survival results showing non-inferiority of FOLFOX 10:38 – Local recurrence rates, surgery outcomes, and complete pathologic response data 13:50 – Toxicity comparisons between arms, including neuropathy, diarrhea, fatigue, and Zofran-related constipation 17:00 – Patient-reported symptom data over time, with 90% participation 19:12 – Quality of life findings on EQ-5D, bowel function, and statistically significant sexual function scores 24:12 – Discussion on who was excluded from the trial and generalizability of results 28:00 – Clarification on distance from anal verge, use of low anterior resection, and ostomy data 30:45 – Future studies on very distal tumors and non-operative strategies 34:31 – Why stage 1 patients were excluded and additional trial limitations 35:04 – Discussion on spreading awareness, influencing care standards, and how patient advocates play a role Additional resources: - colontown.org - learn.colontown.org #Paltown #Colontown #LearnColontown #PROSPECTTrial #RectalCancer #FOLFOX #OrganPreservation #ChemoVsRadiation #NonInferiorityTrial #PatientReportedOutcomes #ColorectalCancer #CancerSurvivorship #CancerTreatmentOptions #SexualFunctionAfterCancer #ColorectalSurgery #ClinicalTrials