The relationship between quality of life (QoL) and tumor response in patients (pts) with metastatic colorectal cancer (mCRC) receiving panitumumab (pmab) plus FOLFIRI as first-line therapy: An analysis of study 314.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 3634-3634
Author(s):  
M. Karthaus ◽  
J. Thaler ◽  
R. Hofheinz ◽  
L. Mineur ◽  
H. Letocha ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Tumor Response ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
The Relationship

scholarly journals Capecitabine Versus Active Monitoring in Stable or Responding Metastatic Colorectal Cancer After 16 Weeks of First-Line Therapy: Results of the Randomized FOCUS4-N Trial

2021 ◽  
pp. JCO.21.01436
Author(s):  
Richard A. Adams ◽  
David J. Fisher ◽  
Janet Graham ◽  
Jenny F. Seligmann ◽  
Matthew Seymour ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Maintenance Therapy ◽  
Metastatic Colorectal Cancer ◽  
Strong Evidence ◽  
First Line ◽  
Active Monitoring ◽  
First Line Therapy ◽  
Line Therapy

PURPOSE Despite extensive randomized evidence supporting the use of treatment breaks in metastatic colorectal cancer (mCRC), they are not universally offered to patients despite improvements in quality of life without detriment to overall survival (OS). FOCUS4-N was set up to explore the impact of oral maintenance therapy in patients who are responding to first-line therapy. METHODS FOCUS4 was a molecularly stratified trial program that registered patients with newly diagnosed mCRC. The FOCUS4-N trial was offered to patients in whom a targeted subtrial was unavailable or biomarker tests failed. Patients were randomly assigned using a 1:1 ratio between maintenance capecitabine and active monitoring (AM). The primary outcome was progression-free survival (PFS) with secondary outcomes including OS toxicity and tolerability. RESULTS Between March 2014 and March 2020, 254 patients were randomly assigned (127 to capecitabine and 127 to AM) across 88 UK sites. Baseline characteristics were balanced. There was strong evidence of efficacy for PFS (hazard ratio = 0.40; 95% CI, 0.21 to 0.75; P < .0001), but no significant improvement in OS (hazard ratio, 0.93; 95% CI, 0.69 to 1.27; P = .66) was observed. Compliance with treatment was good, and toxicity from capecitabine versus AM was as expected with grade ≥ 2 fatigue (25% v 12%), diarrhea (23% v 13%), and hand-foot syndrome (26% v 3%). Quality of life showed little difference between the groups. CONCLUSION Despite strong evidence of disease control with maintenance therapy, OS remains unaffected and FOCUS4-N provides additional evidence to support the use of treatment breaks as safe management alternatives for patients who are stable or responding to first-line treatment for mCRC. Capecitabine without bevacizumab may be used to extend PFS in the interval after 16 weeks of first-line therapy.

Response to the first-line FOLFOX plus bevacizumab (BEV) therapy to predict responses to the subsequent therapies and survival in the BEV beyond progression (BBP) strategy for metastatic colorectal cancer: A retrospective analysis of CCOG-0801 study.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 428-428
Author(s):  
Goro Nakayama ◽  
Keisuke Uehara ◽  
Naomi Hayashi ◽  
Chie Tanaka ◽  
Daisuke Kobayashi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Tumor Response ◽  
Statistical Significance ◽  
Tumor Shrinkage ◽  
Second Line ◽  
First Line ◽  
Data Set ◽  
First Line Therapy ◽  
Line Therapy

428 Background: The aim of this study was to evaluate the association of early tumor response to the first-line bevacizumab (BEV) combination therapy with efficacy of the subsequent therapies and survival during the BEV beyond progression (BBP) strategy for metastatic colorectal cancer (mCRC) patients. Methods: We analyzed a pooled data set from the previous phase II studies of mCRC, testing BBP strategy with the first-line mFOLFOX plus BEV (N=47) and the second-line FOLFIRI plus BEV (N=31). Patients were classified into either responders (R group, n=29) with tumor shrinkage (complete response [CR] + partial response [PR]), sub-responders (SR group, n=11) with stable disease (SD) and non-responders (NR group, n=5) with disease progression (PD) at the point of initial three months of the first-line therapy. The tumor response and PFS in the subsequent therapies and OS were evaluated. Results: In the first-line FOLFOX+BEV therapy, further tumor shrinkage was not achieved after the initial three months. PFS was 15.0 months for the R group, 8.9 months for the SR group and 2.9 months for the NR group, respectively, and there was statistical significance favoring the R group (p=0.001). In the second-line FOLFIRI+BEV, RR and DCR were 39 and 78% in the R group, 14 and 57% in the SR group, and 0 and 0% in the NR group, respectively. No additional response to the first-line therapy was observed in all groups, except for only one patient in the SR group. PFS was 8.8 months for the R group, 6.0 months for SR group and 1.4 months for NR group, respectively, and the R group was significant predictor for prolonged PFS in the second-line setting. OS were 30.8 months for the R group, 24.7 months for the SR group, and 11.1 months for the NR group, respectively. Early disease control (R+SR) was significant predictor for OS (hazard ratio [HR]: 8.48, p<0.01) in multivariate analysis. Conclusions: These findings indicate that the tumor response within initial three months of first-line BEV combination chemotherapy could predict efficacies of subsequent treatments and OS in the BBP strategy for mCRC patients. Clinical trial information: UMIN000006818.

Determinants of choice in offering drug holidays during first-line therapy for metastatic colorectal cancer

2020 ◽  
Vol 16 (32) ◽  
pp. 2645-2660
Author(s):  
Silvio Ken Garattini ◽  
Marta Bonotto ◽  
Luca Porcu ◽  
Elena Ongaro ◽  
Lorenzo Gerratana ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Primary Tumor ◽  
Treatment Interruption ◽  
First Line ◽  
Factors Associated ◽  
Primary Rectal Cancer ◽  
First Line Therapy ◽  
Line Therapy

Background: ‘Drug holidays’ (DH) for metastatic colorectal cancer (mCRC) were introduced to preserve quality of life. We studied factors associated to a DH offer in first line. Materials & methods: We retrospectively analyzed 754 consecutive patients treated with chemotherapy for mCRC in two Italian institutions between 2005 and 2017. Associations between baseline clinical-pathological factors and DH (56 or more days of treatment interruption) were investigated. Results: In 754 patients, previous metastasectomy, previous thermoablation and previous surgery of primary tumor were independently associated with DH. Excluding procedures or clinical trials: primary rectal cancer and resection of primary tumor were significantly associated to DH. Conclusions: DH was offered to patients with lower burden of disease, but further investigations are needed to safely guide a holiday strategy.

scholarly journals Efficacy of CapeOX plus Cetuximab Treatment as a First-Line Therapy for Patients with Extended RAS/BRAF/PIK3CA Wild-Type Advanced or Metastatic Colorectal Cancer

2018 ◽  
Vol 9 (22) ◽  
pp. 4092-4098
Author(s):  
Shigeyoshi Iwamoto ◽  
Hiromichi Maeda ◽  
Shoichi Hazama ◽  
Koji Oba ◽  
Naoko Okayama ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Wild Type ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy
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