Abstract
Purpose or Objective
Dose-escalated chemoradiation (CRT, preceded by a boost of 5x3Gy) did not result in increased complete response rates in locally advanced rectal cancer (LARC) patients as compared to standard CRT in the randomized RECTAL-BOOST trial (Clinicaltrials.gov NCT01951521). However, dose-escalated CRT initiated significantly more tumor regression (Mandard 1-2), suggesting potential to enable organ preservation in selected patients. This study compared patient reported outcomes (PROs) and disease-free survival (DFS) between patients who received dose-escalated CRT (boost group) or standard CRT (control group) in the first 2 years following randomization.
Materials and Methods
Patients with LARC (n=128), participating in the RECTAL-BOOST trial, filled out EORTC QLQ-C30 and CR29 questionnaires on general and colorectal cancer specific quality of life (QoL) and symptoms at baseline, and at 3, 6, 12, 18 and 24 months following start of treatment. Between-group differences in functional QoL domains were estimated using a linear mixed effect model and expressed using the effect size (ES). Symptom scores were categorized as no (0), mild (1-49), moderate (50-99) or severe (100) and compared using the Mann-Whitney U test. PROs were analyzed per protocol (n=51 in boost group and n=64 in control group). 2-year DFS was estimated using Kaplan-Meier method and compared using log-rank test in intention-to treat analysis (n=64 in both groups).
Results
The boost group experienced a significantly stronger decline in global health at 3 and 6 months (ES -0,4 and ES -0,4), physical functioning at 6 months (ES -1,1), role functioning at 3 and 6 months (ES -0,8 and ES -0,6) and social functioning at 6 months (ES -0,6) compared to the control group. The boost group reported significantly more often fatigue at 3 and 6 months (83% vs. 66% resp. 89% vs. 76%), pain at 3 and 6 months (67% vs. 36% resp. 80% vs. 44%) and diarrhea at 3 months (45% resp.29%) compared to the control group. From 12 months onwards, QoL and symptoms were similar between groups, apart from more blood and mucus in stool in the boost group. DFS at 2 years was 75% [95% confidence interval (CI): 65-86] in the boost group and 80% [95%CI:70-90] in the control group (p=0,9).
Conclusion
In patients with LARC, dose-escalated CRT resulted in a transient deterioration in global health and physical, role, and social functioning and more pain, fatigue and diarrhea up to 6 months following start of treatment compared to standard CRT. From 12 months onwards, the impact of dose-escalated CRT on QoL largely resolved. Dose-escalated CRT did not affect 2-year DFS.
Dose-escalated chemoradiation (CRT, preceded by a boost of 5x3Gy) did not result in increased complete response rates in locally advanced rectal cancer (LARC) patients as compared to standard CRT in the randomized RECTAL-BOOST trial (Clinicaltrials.gov NCT01951521). However, dose-escalated CRT initiated significantly more tumor regression (Mandard 1-2), suggesting potential to enable organ preservation in selected patients. This study compared patient reported outcomes (PROs) and disease-free survival (DFS) between patients who received dose-escalated CRT (boost group) or standard CRT (control group) in the first 2 years following randomization.
Materials and Methods
Patients with LARC (n=128), participating in the RECTAL-BOOST trial, filled out EORTC QLQ-C30 and CR29 questionnaires on general and colorectal cancer specific quality of life (QoL) and symptoms at baseline, and at 3, 6, 12, 18 and 24 months following start of treatment. Between-group differences in functional QoL domains were estimated using a linear mixed effect model and expressed using the effect size (ES). Symptom scores were categorized as no (0), mild (1-49), moderate (50-99) or severe (100) and compared using the Mann-Whitney U test. PROs were analyzed per protocol (n=51 in boost group and n=64 in control group). 2-year DFS was estimated using Kaplan-Meier method and compared using log-rank test in intention-to treat analysis (n=64 in both groups).
Results
The boost group experienced a significantly stronger decline in global health at 3 and 6 months (ES -0,4 and ES -0,4), physical functioning at 6 months (ES -1,1), role functioning at 3 and 6 months (ES -0,8 and ES -0,6) and social functioning at 6 months (ES -0,6) compared to the control group. The boost group reported significantly more often fatigue at 3 and 6 months (83% vs. 66% resp. 89% vs. 76%), pain at 3 and 6 months (67% vs. 36% resp. 80% vs. 44%) and diarrhea at 3 months (45% resp.29%) compared to the control group. From 12 months onwards, QoL and symptoms were similar between groups, apart from more blood and mucus in stool in the boost group. DFS at 2 years was 75% [95% confidence interval (CI): 65-86] in the boost group and 80% [95%CI:70-90] in the control group (p=0,9).
Conclusion
In patients with LARC, dose-escalated CRT resulted in a transient deterioration in global health and physical, role, and social functioning and more pain, fatigue and diarrhea up to 6 months following start of treatment compared to standard CRT. From 12 months onwards, the impact of dose-escalated CRT on QoL largely resolved. Dose-escalated CRT did not affect 2-year DFS.
| Original language | English |
|---|---|
| Pages (from-to) | S108-S109 |
| Journal | Radiotherapy and Oncology |
| Volume | 161 |
| Issue number | S1 |
| DOIs | |
| Publication status | Published - Aug 2021 |