KEY TAKEAWAYS
- Phase 3 CORRECT and CONCUR trials evaluated REG for relapsed mCRC.
- The primary aim was to improve survival and delay time to the quality of life deterioration.
- EuroQol 5-Dimension questionnaire 3-level version (EQ-5D-3L) used to capture 5 dimensions of HRQoL.
- REG showed higher completion rates and percentages of NP in each dimension than PBO, with differences becoming larger with each cycle starting from cycle 3.
- 95% of ITT patients completed the EQ-5D questionnaire at baseline.
- Completion rates and NP percentages decline with each treatment cycle for both arms but more rapidly for PBO than REG.
In two significant randomized, double-blind, placebo-controlled multi-center phase III trials, CORRECT and CONCUR, for treating relapsed mCRC, Regorafenib (REG) improved survival and survival delay time to the quality of life deterioration compared to placebo (PBO).
Researchers present results from the two trials based on the five subscales of HRQoL. In the CORRECT and CONCUR trials, the EuroQol 5-Dimension questionnaire, version 3, was used to measure the five most important aspects of HRQoL (EQ-5D-3L). Mobilization, self-care, typical activities, pain/discomfort, and mood/anxiety are the 5 factors. No problems, some problems, and severe problems characterize each dimension. Researchers determined the percentage of patients in both trials who reported “no problems” (NP) across all five dimensions across all cycles and treatment arms.
There have already been reports detailing the trials in great detail. Space constraints necessitate a narrow focus on ACCURATE information. A total of 760 patients in the CORRECT trial were included in the (intent-to-treat) ITT analysis. Ninety-five percent of the ITT patients filled out the questionnaire at Baseline (BL), with the highest percentage of NP reported in self-care (87%) and the lowest percentage reported in pain/discomfort (35%). The percentage of patients who finish the EQ-5D and the number who report NP decrease with each treatment cycle. PBO, however, appeared to be going down much faster than REG.
At BL, the proportion of those on PBO who could finish the questionnaire and report NP in each dimension was slightly higher than that of those on REG; this trend persisted until only cycle 2 and then reversed utterly, beginning with cycle 3. Beginning with the third cycle, the disparities between the arms grew steadily larger. The results for CONCUR were comparable.
There was a significant difference between REG and PBO in the percentage of patients who could maintain mobility, self-care, usual activity, lack of pain and anxiety, and ability to complete the EQ-5D questionnaire. People whose EQ-5D scores had disappeared probably did poorly and gave up treatment because of disease progression, death, toxic side effects, or some other unfavorable factor. Toxicity is probably not the cause of PBO. Evidence like this suggests REG improves survival rates and survival quality. Additional confirmation studies are required.
Source:https://meetings.asco.org/abstracts-presentations/198534
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT01103323
Yun Su, Helene Ostojic, Savina Jaeger/“No problem” health-related quality of life (HRQoL) in patients treated with regorafenib (Reg) for relapsed metastatic colorectal cancer (mCRC)/J Clin Oncol 39, 2021 (suppl 15; abstr e15593)DOI10.1200/JCO.2021.39.15_suppl.e15593
