[A randomized controlled trial of postoperative adjuvant chemotherapy for colorectal cancer-optimal duration of the treatment].

Abstract

METHODS:

Subjects were 239 patients with colorectal cancer who underwent curative resection surgery from December 1994 to March 1997(Stage I-III b). The patients were given 5'-DFUR for postoperative 10 months as scheduled. They had been allocated into either a 1-year group or a 3-year group by dynamic randomization. 5'-DFUR was administered by an intermittent regimen such as 1,200 mg/body/day for five days followed by two days rest. All patients were followed for five years at least.

RESULTS:

239 patients were enrolled in the study. Favorable prognoses in both groups were observed. Although no statistically significant differences in overall survival curves of full analysis set based on the drug administration durations, were detected(log-rank test, p=0.734), a better prognosis was found in the 3-year group(5-year OS: 92.0%; 1- year group, 91.4%; 3-year group). Adverse drug reactions resulted in low rates such as 14.8% in the 1-year group and 19.5% in the 3-year group. Grade 3 was found in either group.

CONCLUSIONS:

Due to a result in the present study that 5-year survival rates in both groups were far higher than anticipated, we could not finally clarify the optimal administration duration of 5'-DFUR. However, the results of the present study indicate that 5'-DFUR results in a good prognosis for colorectal cancer patients and is safe over a long / administration period.

• Authors: Keiji Hirata, Shosaku Nakahara, Tomohisa Shimokobe, Tetsuo Imamura, Yoshitaka Sakamoto, Tadashi Hirano, Ryuji Abe, Nobuyoshi Kuroki, Koki Konomi, Hidenori Kato, Hiroshi Fujiwara, Norio Fukuyama, Masayuki Hotokezaka, Yasuhiro Miyazaki, Reiji Terasaka, Masayuki Shiraishi, Ryo Miyazaki, Akinori Iwashita, Shigeyuki Nakano, Hideaki Ito
• Journal: Gan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 36 Issue 1 Pg. 77-82 (Jan 2009) ISSN: 0385-0684 [Print] Japan
• PMID: 19151567 (Publication Type: English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents
• Floxuridine
• doxifluridine

Topics

• Adult
• Aged
• Antineoplastic Agents (adverse effects, therapeutic use)
• Chemotherapy, Adjuvant
• Colorectal Neoplasms (drug therapy, pathology, surgery)
• Floxuridine (adverse effects, therapeutic use)
• Follow-Up Studies
• Humans
• Middle Aged
• Prospective Studies
• Survival Rate
• Time Factors