Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer.
Open accessAbstract
OBJECTIVES--To compare the length of survival and quality of life in patients given combination chemotherapy in addition to supportive care and in patients given only supportive care. DESIGN--Randomised study. SETTING--Gastrointestinal oncology departments. PATIENTS--40 previously untreated patients with histologically confirmed, measurable colorectal cancer that was locally recurrent or metastatic. INTERVENTIONS--Patients were allocated randomly to receive chemotherapy or only supportive care in a ratio of 2:1 according to performance status, metastatic disease of the liver, and weight loss in the six months before entering the study. Chemotherapy consisted of four week cycles of intravenous leucovorin (200 mg/m2/day) followed by 5-fluorouracil (550 mg/m2/day) and cisplatin (20 mg/m2/day), each drug being given on the first four days of the cycle. MAIN OUTCOME MEASURES--Length of survival and quality of life score with an optimised functional living index-cancer scale. RESULTS--Overall survival was significantly longer for patients given chemotherapy (11.0 months) than for those receiving supportive care alone (5.0 months; p = 0.006). Despite common association of chemotherapy with mild to moderate gastrointestinal symptoms, there was no significant difference between the two groups in global or subgroup quality of life scores. In patients with abnormal scores before treatment, quality of life seemed better in the chemotherapy arm. CONCLUSIONS--In this sample of patients with disseminated colorectal cancer the chemotherapy regimen was an effective form of palliative treatment.
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Randomized controlled trials involving PS 0 to PS 2 patients have shown that chemotherapy groups have a significantly longer survival time than BSC groups that did not receive anticancer drugs.
“Randomized controlled trials involving PS 0 to PS 2 patients have shown that chemotherapy groups have a significantly longer survival time than BSC groups that did not receive anticancer drugs [54–56].”
From Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2016 for the treatment of colorectal cancer (2018) · cites this paper as [54]
The Results report significantly longer survival in the chemotherapy arm than in the supportive-care arm (median 11 versus 5 months; p=0.006). However, Table I groups some participants as PS 2–3, so this trial cannot establish that all participants had PS 0–2. The Results also state that two participants assigned to supportive care later received an anticancer drug. (LLM, conf=0.88)
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- Authors
- Scheithauer, W., Rosen, H., Kornek, G. V., Sebesta, C., & Depisch, D.
- Affiliations
- University of Vienna (AT)
- ORCID
- Sebesta, C
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 1993-03-20
- Volume
- 306
- Issue
- 6880
- Pages
- 752-755
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- OpenAlex
- W1969825132
- Cited by
- 654
- References
- 17
- Citations by year
- 2026: 1 · 2025: 8 · 2024: 7 · 2023: 9 · 2022: 7 · 2021: 7 · 2020: 10 · 2019: 14 · 2018: 12 · 2017: 14 · 2016: 19 · 2015: 19 · 2014: 26 · 2013: 16 · 2012: 20
- FWCI
- 7.94
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
- Locations
- BMJ (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
- Health Sciences › Medicine › Surgery › Intraperitoneal and Appendiceal Malignancies
- Keywords
- metastatic colorectal cancer, combination chemotherapy, supportive care, palliative care, leucovorin, 5-fluorouracil, cisplatin, overall survival, quality of life, gastrointestinal symptoms, treatment-naive patients
- MeSH terms
- Adenocarcinoma, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Cisplatin, Leucovorin, Colonic Neoplasms, Female, Fluorouracil, Humans, Male, Middle Aged, Palliative Care, Prognosis, Quality of Life, Rectal Neoplasms, Social Support
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