Sequential compared to combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (ACC): A Dutch Colorectal Cancer Group (DCCG) phase III study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4012-4012 ◽  
Author(s):  
C. J. Punt ◽  
M. Koopman ◽  
J. Douma ◽  
J. Wals ◽  
A. H. Honkoop ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Combination Therapy ◽  
Treatment Strategies ◽  
Sequential Therapy ◽  
Phase Iii ◽  
Cancer Group ◽  
Neutropenic Sepsis ◽  
Hand Foot Syndrome ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

4012 Background: Overall survival (OS) in phase III studies with 1st line combination therapy in ACC may be influenced by imbalances in salvage treatments. This is the first study that prospectively investigates the sequential vs the combined use of all available effective cytotoxic drugs. Methods: Previously untreated patients (pts), WHO PS 0–2 were randomized between 1st line capecitabine (Cap), 2nd line irinotecan (Iri), and 3rd line Cap + oxaliplatin (CapOx) (Arm A, sequential) vs 1st line CapIri and 2nd line CapOx (Arm B, combination). The dose of Cap was 1250 mg/m2 (mono) or 1,000 mg/m2 (combination) b.i.d. day 1–14, Iri 350 mg/m2 (mono) or 250 mg/m2 (combination), and Ox 130 mg/m2. All cycles were q 3 weeks with Iri/Ox given i.v. on day 1. Response was assessed q 3 cycles. Primary endpoint was OS. The study was designed to detect a 20% reduction in the hazard of death (HR=0.80) for an increase in median OS from 14 to 17.5 months (a=0.05, 2-tailed test). Results: 820 pts were randomized between Jan ‘03 and Dec ‘04 in 74 Dutch hospitals. Of 804 eligible pts, 796 received = 1 cycle. Median age was 63 (27–84) yrs, median WHO PS 0 (0–2), median follow-up 32 months. Pts (n) in arm A: 398 (1st line), 248 (2nd line), 141 (3rd line); arm B: 398 (1st line), 210 (2nd line). Median OS in arm A was 16.3 months (95%CI 14.3–18.2) and in arm B 17.7 months (95%CI 15.2–19.4), logrank p=0.2. Overall gr 3–4 toxicity over all lines did not differ significantly except for gr 3 hand-foot syndrome (HFS) (13% in A and 6% in B, p=0.0009). Death was probably related to treatment in 11 pts (neutropenic sepsis and/or diarrhea, 8 arm A, 3 arm B) and involved protocol violations in some. In 1st line significant differences in gr 3–4 toxicity in arm A vs arm B were diarrhea (10% vs 25%, p<0.0001), febrile neutropenia (1% vs 6%, p=0.0001) and HFS (12% vs 5%, p=0.0004). All-cause 60-day mortality was 3.0% (n=12) in arm A and 4.5% (n=18) in arm B. Updated results will be presented at the meeting, including data on QoL (EORTC QLQ C30). Conclusions: Combination therapy does not significantly improve OS compared with sequential therapy. Both treatment strategies are valid options for pts with ACC. No significant financial relationships to disclose.

Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases: The randomized phase III CAIRO5 study of the Dutch Colorectal Cancer Group.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. TPS3622-TPS3622 ◽  
Author(s):  
Joost Huiskens ◽  
Thomas M van Gulik ◽  
Krijn P van Lienden ◽  
Marc R.W. Engelbrecht ◽  
Gerrit A. Meijer ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Treatment Strategies ◽  
Phase Iii ◽  
Cancer Group ◽  
Colorectal Cancer Patients

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.

scholarly journals Psychometric validation of the Moroccan version of the EORTC QLQ-C30 in colorectal Cancer patients: cross-sectional study and systematic literature review

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yacir El Alami ◽  
Hajar Essangri ◽  
Mohammed Anass Majbar ◽  
Saber Boutayeb ◽  
Said Benamr ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Discriminant Validity ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Colorectal Cancer Patients

Abstract Background Health-related quality of life is mainly impacted by colorectal cancer which justified the major importance addressed to the development and validation of assessment questionnaires. We aimed to assess the validity and reliability of the Moroccan Arabic Dialectal version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) in patients with colorectal cancer. Methods We conducted a cross-sectional study using the Moroccan version of the EORTC QLQ-C30 on colorectal cancer patients from the National Oncology Institute of Rabat, in the period from February 2015 to June 2017. The QLQ-C30 was administered to 120 patients. Statistical analysis included reliability, convergent, and discriminant validity as well as known-groups comparisons. Results In total, 120 patients with colorectal cancer were included in the study with 38 (32%) patients diagnosed with colon cancers. Eighty-two patients (68%) had rectal cancer, among which 29 (24%) patients with a stoma. The mean age of diagnosis was 54 years (+/− 13.3). The reliability and validity of the Arabic dialectal Moroccan version of the EORTC QLQ-C30 were satisfactory. [Cronbach’s alpha (α =0.74)]. All items accomplished the criteria for convergent and discriminant validity except for question number 5, which did not complete the minimum required correlation with its own scale (physical functioning). Patients with rectal cancer presented with bad Global health status and quality of life (GHS/QOL), emotional functioning as well as higher fatigue symptoms compared to patients with colon cancer. The difference between patients with and without stoma was significant for diarrhea and financial difficulty. Conclusions The Moroccan Arabic Dialectal version of the QLQ-C30 is a valid and reliable measure of health-related quality of life (HRQOL) in patients with colorectal cancer.

scholarly journals Randomized phase III trial of S-1 versus capecitabine in the first-line treatment of metastatic colorectal cancer: SALTO study by the Dutch Colorectal Cancer Group

2017 ◽  
Vol 28 (6) ◽  
pp. 1288-1293 ◽  
Author(s):  
J.J.M. Kwakman ◽  
L.H.J. Simkens ◽  
J.M. van Rooijen ◽  
A.J. van de Wouw ◽  
A.J. ten Tije ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Phase Iii Trial ◽  
Cancer Group ◽  
First Line Treatment

scholarly journals Minimally important differences for interpreting the EORTC QLQ‐C30 in patients with advanced colorectal cancer treated with chemotherapy

2020 ◽  
Vol 22 (12) ◽  
pp. 2278-2287 ◽  
Author(s):  
J. Z. Musoro ◽  
S. C. Sodergren ◽  
C. Coens ◽  
A. Pochesci ◽  
M. Terada ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Multicenter phase II clinical trial of everolimus in Japanese patients with unresectable or metastatic renal cell carcinoma (mRCC) after failure of treatment with first-line tyrosine kinase inhibitor (TKI) therapy.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 455-455
Author(s):  
Seiichiro Ozono ◽  
Masafumi Oyama ◽  
Masahiro Nozawa ◽  
Kiyohide Fujimoto ◽  
Ken Kishida ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Kinase Inhibitor ◽  
Objective Response ◽  
Phase Iii ◽  
Second Line ◽  
First Line ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Line Setting

455 Background: Everolimus has shown the efficacy and the safety in the phase III trial (RECORD-1) in patients with mRCC after failure of Vascular Endothelial Growth Factor Receptor-TKI. However, 26% of patients received two TKIs (sunitinib and sorafenib) as previous therapy in RECORD-1. In addition, as pre-treatment before TKI, 65% of patients received cytokine therapy and 13% of patients received chemotherapy. Therefore, there is still no clear evidence of everolimus as second line setting after failure of 1st-line TKI therapy. Methods: This study is an open-label, multi-center, single-arm, phase II trial. Primary endpoint is progression-free survival (PFS), and secondary endpoints are overall survival, objective response rate, time-to-treatment-failure, safety and quality of life (EORTC QLQ-C30, FKSI-DRS, EQ-5D). Key eligibility criteria are RCC with clear cell component, patients who received one TKI as first line therapy, patients who did not receive cytokine and chemotherapy and ECOG performance status 0-1. Results: 57 patients were enrolled from 02/11 to 12/12. Median age was 63 years, common sites of metastasis were lung (32.7%) and bone (12.2%), 79.6% had previous nephrectomy, previous TKI therapy were sunitinib (69.4%), sorafenib (22.4%) and axitinib (8.2%). Median PFS was 4.4 months (95% confidence interval: 3.7-6.0). 8.2% had partial response and 57.1% had stable disease according to RECIST v.1.0. The incidence of adverse events (AEs) of all grades was 95.9%. Major AEs were stomatitis (49.0%), hypertriglyceridemia (26.5%) and hypercholesterolemia (24.5%). Serious AEs were stomatitis (10.2%), interstitial lung disease (6.1%) and rash (6.1%). There were no treatment related deaths. All QOL scores were not changed at 2 months, while dyspnea and global health scores of EORTC QLQ-C30 and FKSI-DRS score were worsened at 4 months. Conclusions: This study is a first report of everolimus as second line setting after failure of 1st-line TKI. Further study and long-term follow-up would be warranted. Clinical trial information: UMIN000004742.

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