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

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.

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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.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.15_suppl.3634 ◽

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

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NK cells infiltrate in primary tumor influences response to cetuximab (CTX) in first-line therapy of metastatic colorectal cancer (mCRC)

Journal of Clinical Oncology ◽

10.1200/jco.2008.26.15_suppl.22008 ◽

2008 ◽

Vol 26 (15_suppl) ◽

pp. 22008-22008 ◽

Cited By ~ 1

Author(s):

R. Maréchal ◽

N. Nagy ◽

A. Verrellen ◽

D. Larsimont ◽

A. Hendlisz ◽

...

Keyword(s):

Colorectal Cancer ◽

Metastatic Colorectal Cancer ◽

Nk Cells ◽

Primary Tumor ◽

First Line ◽

First Line Therapy ◽

Line Therapy

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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

Journal of Clinical Oncology ◽

10.1200/jco.21.01436 ◽

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.

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