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Updated: Jun 6, 2026
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Competing-Risk Nomogram for Predicting Cancer-Specific Survival in Multiple Primary Colorectal Cancer Patients after Surgery
Published on: September 27, 2024
Intermittent versus continuous chemotherapy in advanced colorectal cancer: a randomised 'GISCAD' trial
R Labianca1, A Sobrero2, L Isa3
1Oncologia Medica, Ospedali Riuniti, Bergamo.
Summary
Intermittent chemotherapy with levo-leucovorin, 5-fluorouracil, and irinotecan showed comparable efficacy to continuous treatment in advanced colorectal cancer. This approach offers a drug holiday without compromising overall survival or progression-free survival.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Advanced colorectal cancer treatment often involves continuous chemotherapy until progression.
- Continuous chemotherapy can lead to cumulative toxicity and reduced patient tolerance.
- Alternative treatment schedules are needed to manage therapeutic burden.
Purpose of the Study:
- To compare the efficacy and safety of intermittent versus continuous chemotherapy regimens in advanced colorectal cancer.
- To evaluate if an intermittent schedule of levo-leucovorin + 5-fluorouracil (5-FU) + irinotecan (CPT-11) is non-inferior to continuous administration.
- To assess overall survival (OS), progression-free survival (PFS), and toxicity in previously untreated metastatic colorectal cancer patients.
Main Methods:
- A randomized trial involving 337 patients from 27 institutions.
- Arm A: Intermittent chemotherapy (2 months on, 2 months off) with levo-leucovorin, 5-FU, and CPT-11 every 2 weeks.
- Arm B: Continuous administration of the same regimen until disease progression. Main endpoint: OS; Secondary endpoints: PFS and toxicity.
Main Results:
- Median follow-up of 41 months.
- Comparable OS (18 months vs. 17 months) and PFS (6 months vs. 6 months) between intermittent and continuous arms.
- Similar rates of Grade 3-4 toxicity (myelosuppression, fever, diarrhea) and similar use of second-line oxaliplatin-based treatment (66%).
- Median chemotherapy-free period in the intermittent arm was 3.5 months.
Conclusions:
- Reducing the chemotherapy burden through an intermittent schedule does not diminish treatment efficacy in advanced colorectal cancer.
- Intermittent chemotherapy offers a viable strategy for managing toxicity while maintaining therapeutic benefits.
- Further research incorporating biological agents with this intermittent strategy is warranted.
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