Does Radiation Boost Dose Affect Organ Preservation Rates? A Secondary Analysis of the Organ Preservation in Patients With Rectal Adenocarcinoma Trial
Abstract
Purpose: The Organ Preservation in Patients with Rectal Adenocarcinoma trial was a randomized clinical trial investigating the optimal sequencing of total neoadjuvant therapy for patients with rectal cancer desiring organ preservation (OP). An optional higher-dose radiation boost was allowed on this trial. We aimed to determine whether a higher radiation boost dose was associated with the probability of clinical complete response and OP.
Methods and materials: Patients with clinical stage II/III rectal adenocarcinoma were randomized to induction chemotherapy followed by chemoradiation or chemoradiation followed by consolidation chemotherapy. Radiation therapy was delivered to the primary tumor and involved nodes to 4500 cGy with concurrent chemotherapy. The standard boost dose to the primary tumor was 500 to 540 cGy, but the treating physician was allowed to give an optional higher-dose boost of 900 to 1100 cGy. Post-total neoadjuvant therapy restaging assessment with flexible sigmoidoscopy and magnetic resonance imaging stratified patients into 3 tiers of clinical response. Patients with a clinical complete or near-complete response were offered OP, whereas those with an incomplete clinical response were recommended for total mesorectal excision. In a post hoc analysis, OP rates by radiation boost dose (standard-dose [SD] vs high-dose [HD] boost) were estimated using the Kaplan-Meier method and tested for statistical significance using the log-rank test. Tumor clinical…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 324 participants or records.
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