Skip to main content
The BMJ logoLink to The BMJ
. 1993 Mar 20;306(6880):752–755. doi: 10.1136/bmj.306.6880.752

Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer.

W Scheithauer 1, H Rosen 1, G V Kornek 1, C Sebesta 1, D Depisch 1
PMCID: PMC1677246  PMID: 7683942

Abstract

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.

Full text

PDF
752

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Arbuck S. G. Overview of clinical trials using 5-fluorouracil and leucovorin for the treatment of colorectal cancer. Cancer. 1989 Mar 15;63(6 Suppl):1036–1044. doi: 10.1002/1097-0142(19890315)63:6+<1036::aid-cncr2820631309>3.0.co;2-k. [DOI] [PubMed] [Google Scholar]
  2. Davis H. L. Chemotherapy of large bowel cancer. Cancer. 1982 Dec 1;50(11 Suppl):2638–2646. [PubMed] [Google Scholar]
  3. Erlichman C., Fine S., Wong A., Elhakim T. A randomized trial of fluorouracil and folinic acid in patients with metastatic colorectal carcinoma. J Clin Oncol. 1988 Mar;6(3):469–475. doi: 10.1200/JCO.1988.6.3.469. [DOI] [PubMed] [Google Scholar]
  4. Etienne M. C., Bernard S., Fischel J. L., Formento P., Gioanni J., Santini J., Demard F., Schneider M., Milano G. Dose reduction without loss of efficacy for 5-fluorouracil and cisplatin combined with folinic acid. In vitro study on human head and neck carcinoma cell lines. Br J Cancer. 1991 Mar;63(3):372–377. doi: 10.1038/bjc.1991.88. [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. Ganz P. A., Figlin R. A., Haskell C. M., La Soto N., Siau J. Supportive care versus supportive care and combination chemotherapy in metastatic non-small cell lung cancer. Does chemotherapy make a difference? Cancer. 1989 Apr 1;63(7):1271–1278. doi: 10.1002/1097-0142(19890401)63:7<1271::aid-cncr2820630707>3.0.co;2-6. [DOI] [PubMed] [Google Scholar]
  6. Lavin P., Mittelman A., Douglass H., Jr, Engstrom P., Klaassen D. Survival and response to chemotherapy for advanced colorectal adenocarcinoma: an Eastern Cooperative Oncology Group report. Cancer. 1980 Oct 1;46(7):1536–1543. doi: 10.1002/1097-0142(19801001)46:7<1536::aid-cncr2820460707>3.0.co;2-k. [DOI] [PubMed] [Google Scholar]
  7. Miller A. B., Hoogstraten B., Staquet M., Winkler A. Reporting results of cancer treatment. Cancer. 1981 Jan 1;47(1):207–214. doi: 10.1002/1097-0142(19810101)47:1<207::aid-cncr2820470134>3.0.co;2-6. [DOI] [PubMed] [Google Scholar]
  8. Peto R., Pike M. C., Armitage P., Breslow N. E., Cox D. R., Howard S. V., Mantel N., McPherson K., Peto J., Smith P. G. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples. Br J Cancer. 1977 Jan;35(1):1–39. doi: 10.1038/bjc.1977.1. [DOI] [PMC free article] [PubMed] [Google Scholar]
  9. Poon M. A., O'Connell M. J., Moertel C. G., Wieand H. S., Cullinan S. A., Everson L. K., Krook J. E., Mailliard J. A., Laurie J. A., Tschetter L. K. Biochemical modulation of fluorouracil: evidence of significant improvement of survival and quality of life in patients with advanced colorectal carcinoma. J Clin Oncol. 1989 Oct;7(10):1407–1418. doi: 10.1200/JCO.1989.7.10.1407. [DOI] [PubMed] [Google Scholar]
  10. Presant C. A., Wiseman C., Blayney D., Kennedy P., Gala K., King M. Proposed criteria for serial evaluation of quality of life in cancer patients. J Natl Cancer Inst. 1990 Feb 21;82(4):322–323. doi: 10.1093/jnci/82.4.322. [DOI] [PubMed] [Google Scholar]
  11. Scheithauer W., Rosen H., Schiessel R., Schüller J., Karall M., Ernst F., Sebesta C., Kornek G., Hentschel E., Marczell A. Treatment of patients with advanced colorectal cancer with cisplatin, 5-fluorouracil, and leucovorin. Cancer. 1991 Mar 1;67(5):1294–1298. doi: 10.1002/1097-0142(19910301)67:5<1294::aid-cncr2820670504>3.0.co;2-m. [DOI] [PubMed] [Google Scholar]
  12. Scheithauer W., Temsch E. M. A study of various strategies to enhance the cytotoxic activity of 5-fluorouracil/leucovorin in human colorectal cancer cell lines. Anticancer Res. 1989 Nov-Dec;9(6):1793–1798. [PubMed] [Google Scholar]
  13. Schipper H., Clinch J., McMurray A., Levitt M. Measuring the quality of life of cancer patients: the Functional Living Index-Cancer: development and validation. J Clin Oncol. 1984 May;2(5):472–483. doi: 10.1200/JCO.1984.2.5.472. [DOI] [PubMed] [Google Scholar]
  14. Vokes E. E., Schilsky R. L., Weichselbaum R. R., Kozloff M. F., Panje W. R. Induction chemotherapy with cisplatin, fluorouracil, and high-dose leucovorin for locally advanced head and neck cancer: a clinical and pharmacologic analysis. J Clin Oncol. 1990 Feb;8(2):241–247. doi: 10.1200/JCO.1990.8.2.241. [DOI] [PubMed] [Google Scholar]

Articles from BMJ : British Medical Journal are provided here courtesy of BMJ Publishing Group

RESOURCES