Colorectal cancer, medical illustration 3D illustration: © Anatomy Insider – Stock.adobe.com
Results from ORCHESTRA’s prespecified exploratory analysis show that even the addition of maximal tumor debulking to standard systemic therapy is associated with lower risk of cancer in patients with metastatic colorectal cancer (mCRC) compared to systemic therapy alone. trial (NCT01792934) that had no significant impact on overall quality of life (QoL).1
Of 300 patients randomized to standard (n = 152) vs. intervention group (n = 148), serious adverse events (AEs) were observed in 21% of patients vs. 43 of patients. %, and there were differences in the proportion of patients. The number of people experiencing serious AEs between study groups was statistically significant (P ≤.001).2
Health-related quality of life (HRQol) analyzes found no statistically or clinically relevant differences between study groups over time for all preselected HRQoL and fatigue scales. For the standard and intervention groups, the overall mean difference in scores was -3.1 (95% CI, -6.21-0.04). global health status, -2.9 (95% CI, -7.81-1.97); Physical functioning, -3.5 (95% CI, -7.45-0.40); emotional functioning, +1.0 (95% CI, -3.50-5.52). General fatigue, +0.9 (95% CI, -0.21-1.96); physical fatigue, +0.8 (95% CI, -0.37-1.89).
“This may mean that the negative impact on quality of life from complications is temporary and is eventually balanced out by a reduction in tumor-related symptoms after treatment. It is also possible to adapt the perception of HRQoL during the course of treatment,” lead author Lotte Backels, MD, of the Radboud Institute for Health Sciences in the Netherlands, explained in a press release.1
In the ongoing ORCHESTRA trial, researchers are evaluating standard palliative chemotherapy alone versus palliative chemotherapy plus either surgery, ablative therapy, and/or radiation therapy to reduce tumor burden. There is. A total of 300 patients were randomized to receive standard treatment or additional intervention.
Patients were eligible for enrollment if they achieved clinical benefit after three or four cycles of first-line palliative systemic therapy with a fluoropyrimidine and oxaliplatin with or without bevacizumab (Avastin). These patients were then randomized to receive maximal tumor debulking followed by systemic therapy or systemic therapy alone. The patient should have multisystem mCRC, and a weight loss of 80% was considered achievable.2
To enroll in this study, patients were required to complete the EORTC QoL Questionnaire-Core 30 and the Multidimensional Fatigue Inventory questionnaire at prespecified time points during treatment. This study focused on the results of a preplanned exploratory secondary endpoint of her HRQoL from the ORCHESTRA trial. This was measured using the EORTC QOL Questionnaire-Core 30 and the Multidimensional Fatigue Inventory questionnaire at prespecified time points during treatment.
Additional findings from 300 patients showed that across study groups, HRQoL after 1 year of treatment was not significantly different from HRQoL at randomization. In the intervention group, patients experienced serious AEs twice as often as those in the standard group.
Furthermore, in patients with multisystem mCRC, the combination of maximal tumor debulking and palliative systemic therapy was significantly associated with more severe AEs caused by local therapy. However, there was no difference between HRQoL and palliative systemic therapy alone, indicating that there was no association between the occurrence of serious AEs and their impact on HRQoL.
“Given the significant amount of complications associated with topical treatment, we expected to see a greater impact on overall and durable quality of life in the experimental group.” fact [adverse] It is very interesting that the effect did not translate into a significant decrease in patients’ perceived quality of life and warrants further investigation. These results, including the risk of complications, should be considered in the office to determine together with the patient what the appropriate treatment options are for each individual,” Buckels added in the press release. Ta.1