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© 2004 Oxford University Press
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Randomized Trial of Intraportal and/or Systemic Adjuvant Chemotherapy in Patients With Colon Carcinoma
For The ACOI/GIVIO/GISCAD Investigators
Affiliations of authors: Unità Operativa di Oncologia Medica, Ospedali Riuniti, Bergamo, Italy (RL); Laboratory of Clinical Cancer Research, Mario Negri Institute (RF, VT), SENDO Foundation (SM), Unità Operativa di Oncologia Medica, Casa di Cura IGEA (GP), Milan, Italy; Unità Operativa di Oncologia, Casa di Cura Poliambulanza, Brescia, Italy (AZ); Istituto Clinica Chirurgica II, University of Padua, Padua, Italy (DN); I Chirurgia generale e trapianti d’organo, Careggi Hospital, Florence, Italy (LB, MS); IRCCS "Casa Sollievo della Sofferenza," S. Giovanni Rotondo, Italy (BT, NM); Medicina, Civile Hospital, Merate, Lecco, Italy (SB); Unità Operativa di Chirurgia, Pontedera Hospital, Pisa, Italy (GC).
Correspondence to: Roldano Fossati, MD, Istituto Mario Negri, Via Eritrea 62, Milan, Italy (e-mail: fossati{at}marionegri.it)
Background: 5-Fluorouracil–based adjuvant chemotherapy after surgical resection of colon cancer is standard treatment. However, the choice of best delivery route—that is, systemic (i.e., intravenous or oral) or regional (i.e., intraportal, intraperitoneal, or hepatic arterial infusion)—has been controversial. In a randomized clinical trial of patients with colon cancer, we compared the benefits of chemotherapy delivered by these routes individually or in combination. Methods: From April 2, 1992, through April 30, 1998, 1084 eligible patients with Dukes’ stage B or C colon carcinoma were randomly assigned: 369 patients to the IP regimen (continuous portal vein infusion of 5-fluorouracil at 500 mg/m2 of body surface daily and heparin at 5000 IU daily for 7 consecutive days, beginning on the day of surgery), 358 patients to the SY regimen (six 28-day courses of systemic leucovorin at 100 mg/m2 daily on days 1 through 5 followed by systemic bolus 5-fluorouracil at 370 mg/m2 daily on days 1 through 5, with treatment initiated 15–35 days after surgery), and 357 patients to the IP+SY regimen (the IP regimen followed by the SY regimen, with the same scheduling). Primary survival was analyzed with the log-rank statistic and a Cox multivariable regression model. All statistical tests were two sided. Results: At a median follow-up time of 99 months, 389 events (recurrences, second malignancies, or deaths) had occurred, and 361 patients died. Sites of first recurrences were similar among the three arms. At 5 years, overall and event-free survival rates were similar among those on the IP (74% and 68%, respectively), SY (78% and 71%), and IP+SY (73% and 67%) regimens. When compared with the group on the SY regimen, the risk for death associated with the IP regimen (hazard ratio [HR] = 1.05, 95% confidence interval [CI] = 0.82 to 1.36) was similar to that associated with the IP+SY regimen (HR = 1.12, 95% CI = 0.78 to 1.45) (P = .69), as were the risks for first event (HR = 1.07, 95% CI = 0.84 to 1.37 and HR = 1.10, 95% CI = 0.86 to 1.41, respectively) (P= .74). Conclusion: Overall and event-free survival rates were similar in all three arms. The combined regimen was no better than either single regimen alone.
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Editorial about this Article
- Mature Results of Adjuvant Colon Cancer Trials From the Fluorouracil-Only Era
- Jean L. Grem
J Natl Cancer Inst 2004 96: 727-729.[Extract] [Full Text] [PDF]
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