Abstract
Quality of life data from randomized trials are lacking in older patients with metastatic colorectal cancer (mCRC). In the randomized NORDIC9-study, reduced-dose S1+oxaliplatin (SOx) showed superior efficacy compared to full-dose S1 monotherapy. We hypothesized that treatment with SOx does not result in inferior quality of life. Patients with mCRC aged ≥70 years and that were not a candidate for standard combination chemotherapy were included and randomly assigned to receive either S1 or SOx. The EORTC QLQ-C30 questionnaire was completed at baseline, after 9, and 18 weeks. The primary endpoint was global Quality of Life (QoL) at 9 weeks. For statistical analysis, a non-inferiority design was chosen applying linear mixed effects models for repeated measurements. The results were interpreted according to statistical significance and anchor-based, clinically relevant between-group minimally important differences (MID). A total of 160 patients aged (median (Interquartile range (IQR))) 78 years (76-81) were included. The QLQ-C30 questionnaire was completed by 150, 100, and 60 patients at baseline, at 9, and 18 weeks, respectively. The difference at 9 weeks in global QoL was 6.85 (95%CI-1.94; 15.65) and 7.37 (0.70; 14.05) in the physical functioning domain in favor of SOx exceeding the threshold for MID. At 18 weeks, the between-group MID in physical functioning was preserved. Dose-reduced combination chemotherapy may be recommended in vulnerable older patients with mCRC, rather than full-dose monotherapy.
Highlights
Colorectal cancer (CRC) predominantly affects older adults [1]; 56% of incidence and68% of mortality occur in patients aged ≥65 years [2]
The overarching objective of the present study was to investigate whether prolonged progression-free survival (PFS) with reduced-dose combination chemotherapy comes at the expense of poorer Quality of Life (QoL) and physical functioning
Our findings demonstrate that reduced-dose combination chemotherapy may be the treatment of choice in older vulnerable patients with metastatic colorectal cancer (mCRC) when preservation of QoL, physical functioning, and symptom relief are important goals of the treatment
Summary
Colorectal cancer (CRC) predominantly affects older adults [1]; 56% of incidence and. 68% of mortality occur in patients aged ≥65 years [2]. In the older population [3], comorbidities, impaired organ function, and geriatric-syndromes (e.g., fall-tendency, osteoporosis, urinary incontinence) are frequently present resulting in decreased physiological reserves, called vulnerability [4,5]. Vulnerability affects treatment outcomes due to compromising standard treatment approach [6], in the case of chemotherapy, monotherapy and/or dose-reduction are commonly applied. The optimal approach regarding palliative systemic treatment in older vulnerable patients with metastatic colorectal cancer (mCRC) remains unclear. The randomized NORDIC9-study explored this by including patients with mCRC aged ≥70 years and that were not a candidate for standard treatment, by comparing reduced-dose combination chemotherapy with S1+oxaliplatin (SOx) or full-dose monotherapy (S1) (Teysuno, Taiho Pharmaceutical Co. Ltd., Tokyo, Japan). Patients treated with SOx experienced less toxicity, and fewer hospitalizations, compared to S1 [7]
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