scholarly journals Quality-of-life findings from a randomised phase-III study of XELOX vs FOLFOX-6 in metastatic colorectal cancer

2009 ◽  
Vol 102 (1) ◽  
pp. 59-67 ◽  
Author(s):  
T Conroy ◽  
M Hebbar ◽  
J Bennouna ◽  
M Ducreux ◽  
M Ychou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Phase Iii Study

Phase III Comparison of Two Irinotecan Dosing Regimens in Second-Line Therapy of Metastatic Colorectal Cancer

2003 ◽  
Vol 21 (5) ◽  
pp. 807-814 ◽  
Author(s):  
Charles S. Fuchs ◽  
Melvin R. Moore ◽  
Graydon Harker ◽  
Luis Villa ◽  
David Rinaldi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Significant Difference ◽  
Global Quality Of Life ◽  
Grade 3

Purpose: Randomized trials in fluorouracil (FU)-refractory colorectal cancer demonstrate significant survival advantages for patients receiving irinotecan. We prospectively compared the efficacy and tolerability of two irinotecan regimens (once a week for 4 weeks followed by a 2-week rest period [weekly] v once every 3 weeks) in such patients. Patients and Methods: This multicenter, open-label, phase III study randomly assigned patients in a 1:2 ratio to irinotecan given either weekly (125 mg/m2) or once every 3 weeks (350 mg/m2, or 300 mg/m2 in patients who were ≥ 70 years of age, who had Eastern Cooperative Oncology Group performance status equal to 2, or who had prior pelvic irradiation). Results: With median follow-up of 15.8 months, there was no significant difference in 1-year survival (46% v 41%, respectively; P = .42), median survival (9.9 v 9.9 months, respectively; P = .43), or median time to progression (4.0 v 3.0 months, respectively; P = .54) between the two regimens. Grade 3/4 diarrhea occurred in 36% of patients treated weekly and in 19% of those treated once every 3 weeks (P = .002). Grade 3/4 neutropenia occurred in 29% of patients treated weekly and 34% of those treated once every 3 weeks (P = .35). Treatment-related mortality occurred in five patients (5.3%) receiving irinotecan weekly and three patients (1.6%) given therapy once every 3 weeks (P = .12). Global quality of life was not statistically different between treatment groups. Conclusion: Irinotecan schedules of weekly and of once every 3 weeks demonstrated similar efficacy and quality of life in patients with FU-refractory, metastatic colorectal cancer. The regimen of once every 3 weeks was associated with a significantly lower incidence of severe diarrhea.

Patient-reported quality of life data from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: Interim results of the TALLISUR study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3526-3526
Author(s):  
Meinolf Karthaus ◽  
Albrecht Kretzschmar ◽  
Stefan Fuxius ◽  
Jorge Riera Knorrenschild ◽  
Florian Kaiser ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Primary Endpoint ◽  
Late Stage ◽  
Phase Iii ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

3526 Background: Compared to placebo, trifluridine/tipiracil (FTD/TPI) significantly improved overall and progression-free survival in patients (pts) with pre-treated metastatic colorectal cancer (mCRC) in the phase III RECOURSE trial. Although time to deterioration of ECOG performance status (PS) from 0/1 to ≥ 2 was significantly longer in pts treated with FTD/TPI, health-related quality of life (HRQoL) was not formally assessed by direct means. Therefore, a two-arm trial with best supportive care (BSC) as appropriate comparative treatment was designed to specifically address the effect of FTD/TPI on HRQoL. Methods: In this prospective, multi-center, German, open-label, phase IV study, pts with pre-treated mCRC could choose between BSC or oral FTD/TPI (35 mg/m2 bid on days 1-5 and 8-12 of each 28-day cycle). EORTC QLQ-C30 and EQ-5D-5L questionnaires were employed to assess HRQoL. Primary endpoint was the rate of responders with stabilized ( > -10 and < 10 scores) or improved (≥ 10 scores) response (RR). Response was calculated as the mean score of the EORTC QLQ-C30 global health status/ QoL scale from the 2nd cycle until the end of treatment/ observation compared to the baseline score. Results: Of 194 eligible pts, 185 pts chose treatment with FTD/TPI (median 3 cycles), while 9 pts decided to receive BSC only. Questionnaires from 109 pts receiving FTD/TPI and from 6 pts with BSC were evaluable for RR. The primary endpoint (RR) was 59.6% (95% CI 49.8 – 68.9) in FTD/TPI-treated pts and 50.0% (95% CI 11.8 – 88.2) in pts receiving BSC. Analysis of the extended follow-up period, demonstrated that RR was 67.0% (95% CI 57.3 – 75.7) in FTD/TPI-treated pts. In the FTD/TPI-group, median time to deterioration of HRQoL was 121 days ( n = 61; 95% CI 87 – 151) according to EORTC QLQ-C30 and 119 days ( n = 63; 95% CI 85 – 138) according to EQ-5D-5L. Conclusions: If pts can choose between treatment and BSC in late-stage CRC, the vast majority opts for treatment. According to the present results, FTD/TPI-treatment induced prolonged stabilization of HRQoL, a highly desired attribute of therapies for pts with late-stage cancer. Clinical trial information: No 2017-000292-83.

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