GIVIO-SITAC 01: A randomized trial of adjuvant 5-fluorouracil and folinic acid administered to patients with colon carcinoma - Long term results and evaluation of the indicators of health-related quality of life

Cancer

Volumn 82, Issue 11, 1998, Pages 2135-2144

  Zaniboni, Alberto ^a   Labianca, Roberto ^a   Marsoni, Silvia ^a   Torri, Valter ^a   Mosconi, Paola ^a   Grilli, Roberto ^a   Apolone, Giovanni ^a   Cifani, Stefania ^a   Tinazzi, Angelo ^a  

^a Via Gabriele Rosa 3 ^*

Author keywords

5 fluorouracil; Adjuvant treatment; Colon carcinoma; Folinic acid; Quality of life

Indexed keywords

FLUOROURACIL; FOLINIC ACID; LEVAMISOLE;

ADJUVANT THERAPY; ADULT; AGED; ARTICLE; CANCER MORTALITY; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; COLON CARCINOMA; DRUG MEGADOSE; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PATIENT COMPLIANCE; PRIORITY JOURNAL; QUALITY OF LIFE; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLONIC NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; QUALITY OF LIFE;

EID: 0032104281     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0142(19980601)82:11<2135::AID-CNCR7>3.0.CO;2-U     Document Type: Article

References (19)

1. Fleming ID, Cooper JS, Henson DE, Hutter RVP, Kennedy BJ, Murphy GP, et al, editors. American Joint Committee on Cancer staging manual. 5th edition. Philadelphia: Lippincott-Raven Publishers, 1997.
2. NIH Consensus Conference. Adjuvant therapy for patients with colon and rectal cancer. JAMA 1990;264:1444-50.
3. Francini G, Petrioli R, Lorenzini R, et al. Folinic acid and 5-fluorouracil as adjuvant chemotherapy in colon cancer. Gastroenterology 1994;106:899-906.
4. Wolmark N, Raced H, Fisher B, et al. The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer: results from National Surgical Adjuvant Breast and Bowel Project protocol C-03. J Clin Oncol 1993;11:1879-87.
5. O'Connell MJ, Mailliard JA, Kahn MJ, et al. Controlled trial of fluorouracil and low-dose leucovorin given for 6 months as postoperative adjuvant therapy for colon cancer. J Clin Oncol 1997;15:246-50.
6. IMPACT Investigators. Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. Lancet 1995;345:939-44.
7. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer 1981;47:207-10.
8. GIVIO Investigators. Impact of follow-up testing on survival and health-related quality of life in breast cancer patients: a multicenter randomized controlled trial. JAMA 1994;271: 1587-92.
9. Cronbach LJ, Warrington WG. Time-limit tests: estimating their reliability and degree of speeding. Psichometrika 1951; 314:1657-64.
10. Likert R. A technique for the measurement of attitudes. Arch Psychol 1932;140:5-55.
11. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
12. Tarone RI, Ware J. On distribution-free tests for equality of survival distributions. Biometrika 1977;64:156-60.
13. Cox DR. Regression models and life tables. J R Stat Soc B 1972;34:187-202.
14. Zaniboni A. Adjuvant chemotherapy in colorectal cancer with high-dose leucovorin and 5-fluorouracil: impact on disease-free survival and overall survival. J Clin Oncol 1997; 15:2432-41.
15. Wolmark N, Rockette H, Mamounas EP, et al. The relative efficacy of 5-FU-leucovorin (FU-LV), 5-FU-levamisole (FU-Lev), and 5-FU-leucovorin-levamisole in patients with Dukes B and C carcinoma of the colon: first report of NSABP C-04 [Abstract 460]. Proc Am Soc Clin Oncol 1996;15:205.
16. Haller DG, Catalano PJ, Macdonald JS, et al. Fluorouracil (FU), leucovorin (LV), and levamisole (LEV) adjuvant therapy for colon cancer: preliminary results of INT-0089 [Abstract 486]. Proc Am Soc Clin Oncol 1996;15:211.
17. O'Connell MJ, Laurie JA, Shepherd L, et al. A prospective evaluation of chemotherapy duration and regimens as surgical adjuvant treatment for high-risk colon cancer: a collaborative trial of the North Central Cancer Treatment Group and the National Cancer Institute of Canada Clinical Trials [Abstract 478]. Proc Am Soc Clin Oncol 1996;15: 209.
18. Gelber RD, Goldhirsch A, Cole BF, et al. A quality-adjusted time without symptoms or toxicity (Q-TWIST) analysis of adjuvant radiation therapy and chemotherapy for resectable rectal cancer. J Natl Cancer Inst 1996;88:1039-45.
19. Mamounas EP, Rockette H, Jones J, et al. Comparative efficacy of adjuvant chemotherapy in patients with Dukes B vs. C colon cancer: results from four NSABP adjuvant studies (C-01, C-02, C-03, C-04) [Abstract 461]. Proc Am Soc Clin Oncol 1996;15:205.