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국소 진행된 직장암의 수술전 방사선 조사시 5 Fluorouracil 경정맥주사와 경구용 Doxifluridine 복용의 전향적 비교 연구

Prospective Randomized Trial Comparing Intravenous 5 Fluorouracil and Oral Doxifluridine as Preoperative Concurrent Chemoradiation for Locally Advanced Rectal Cancer

대한대장항문학회지 2000년 16권 6호 p.469 ~ 473
김남규 ( Kim Nam-Kyu ) - 연세대학교 의과대학 외과학교실

박재균 ( Park Jea-Kun ) - 연세대학교 의과대학 외과학교실
윤성현 ( Yun Seong-Hyeun ) - 연세대학교 의과대학 외과학교실
노재경 ( Noh Jae-Kyung ) - 연세대학교 의과대학 종양내과학교실
민진식 ( Min Jin-Sik ) - 연세대학교 의과대학 외과학교실
성진실 ( Seong Jin-Sil ) - 연세대학교 의과대학 방사선종양학교실

Abstract


Purpose: Preoperative radiation treatment with concomittant intravenous infusion of 5-fluorouracil has been known to be effective in shrinking and downstaging the tumor. Treatment with Doxifluridine (synthetic 5-deoxynucleoside derivative) medication prolongs drug exposure to tumor tissue, so it can be considered synergistic to concurrent radiotherapy. Intravenous 5-FU and oral Doxifluridine were compared with respect to tumor response, toxicity, and quality of life of patients.

Methods: Twenty eight patients with rectal cancer, staged as over T3N1 or T4 by transrectal ultrasonography between July 1997 and December 1998 were included. Intravenous 5-FU (450 mg/m2/day) and leucovorin (20 mg/m2) was given for five consecutive days during first and fifth weeks of irradiation therapy (50.4 Gy) (N=14). Oral Doxifluridine (700 mg/m2/day) and leucovorin (20 mg/m2) was given daily during radiation treatment (N=14). Quality of life was scored according to twenty two activity items (good: >77, fair: >58, poor: <57). Surgical resection was performed four weeks after completion of concurrent chemoradiation treatment. Tumor response was classified as CR (Complete Response), PR (Partial Response: 50% diminution of tumor volume or downstaging), or NR (No Response).

Results: Tumor response was CR: 3/14 (21.4%), PR: 7/14 (50%) and NR: 4/14 (28.6%) in IV arm versus CR: 2/14 (14.2%), PR: 6/14 (42.9%) and NR: 6/14 (42.9%) in oral arm (p=0.16, 0.23, 0.24, respectively). Quality of life was poor (36.4% vs 33.3%), fair and good (63.6% vs 66.7%, respectively) between IV arm and oral arm. Systemic recurrence during follow up periods was 1/14 (7.1%) in IV arm and 2/14 (14.3%) in oral arm, respectively (p=0.307). One local recurrence was observed in oral arm. Hematologic toxicity was 3/14 (21.4%) in IV arm versus 4/14 (28.5%) in oral arm, respectively. Gastrointestinal toxicity was 2/14 (14.3%) versus 5/14 (35.7%) and stomatitis was observed in IV arm (1/14, 7.1%)

Conclusion: Oral doxifluridine based chemotherapy shows a comparable tumor response and oncologic results, but there was no benefits as far as quality of life and toxicity were concerned.

키워드

직장암;수술 전 방사선 및 항암약물 병합치료
5 Fluorouracil;Rectal cancer;Preoperative chemoradiation;Intravenous 5 fluorouracil;Oral doxifluridine
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