内容紹介
Study of S-1 and Oxaliplatin(SOX)plus Bevacizumab as First-Line Therapy in Patients with Unresectable Colorectal Cancer
Summary
We examined the safety and efficacy of S-1 and oxaliplatin plus bevacizumab(SOX+BV)as first-line therapy for advanced/recurrent unresectable colorectal cancer. The subjects were 14 patients with colorectal cancer who received ≧3 courses of SOX+BV therapy in our department. The dosing regimen for 1 course was as follows: BV(7.5 mg/kg)and oxaliplatin(130 mg/m2)were administered via intravenous drip infusion on the first day of the course, and S-1 was orally administered twice a day for 2 weeks, repeated every 3 weeks. All patients completed the study treatment, and the median number of courses completed was 9 courses(range: 3-17 courses). In terms of anti-tumor efficacy, complete remission(CR)was observed in 1 patient(7.1%); partial remission(PR), in 9 patients(64.3%); stable disease(SD), in 3 patients(21.4%); and progressive disease(PD), in 1 patient(7.1%), with a response rate of 71.4% and a disease control rate of 92.9%. The median relapse-free survival based on baseline PD was 12 months, and the median relapse-free survival based on PD according to the Response Evaluation Criteria in Solid Tumors(RECIST)was 10 months. The most common adverse events observed included peripheral sensory neuropathy(100%), fatigue(68.3%), anorexia(57.1%), and leukopenia/neutropenia(35.7%); however, almost all adverse events were Grade≦2 and could be managed. The SOX+BV therapy demonstrated an anti-tumor efficacy similar to that observed with oxaliplatin, fluorouracil, and folinic acid(FOLFOX)+BV therapy without the use of a central venous port. Therefore, the SOX+BV therapy may be among the effective option as first-line therapy for advanced/recurrent colorectal cancer.
要旨
臨床的に治癒切除不能と診断された進行再発大腸癌に対し,一次治療として施行したS-1+oxaliplatin+bevacizumab(SOX+BV)療法の安全性および有効性について検討した。対象は当科で同療法を3コース以上施行した大腸癌14例である。投与方法はBV 7.5 mg/kgおよびoxaliplatin 130 mg/m2を第1日目に点滴静注,S-1は40～60 mgを1日2回2週間内服投与し,以上を3週間ごとに繰り返した。全例が投与を終了しており,投与回数は中央値9(範囲: 3～17)コースであった。抗腫瘍効果はCR 1例(7.1%),PR 9例(64.3%),SD 3例(21.4%),PD 1例(7.1%)であり,奏効率71.4%,病勢制御率92.9%であった。baseline PDに基づく無再発生存期間は中央値12か月,RECIST PDに基づく無再発生存期間は中央値10か月であった。有害事象は,頻度が高いものとして末梢性感覚ニューロパチー100%,倦怠感68.3%,食欲不振57.1%,白血球・好中球減少35.7%などが認められたが,ほとんどはGrade 2以下でコントロール可能であった。SOX+BV療法は,中心静脈ポートの造設なしでFOLFOX+BV療法とほぼ同等の抗腫瘍効果が得られ,進行再発大腸癌に対する一次治療として有効な選択肢の一つであると考えられた。
目次
Summary
We examined the safety and efficacy of S-1 and oxaliplatin plus bevacizumab(SOX+BV)as first-line therapy for advanced/recurrent unresectable colorectal cancer. The subjects were 14 patients with colorectal cancer who received ≧3 courses of SOX+BV therapy in our department. The dosing regimen for 1 course was as follows: BV(7.5 mg/kg)and oxaliplatin(130 mg/m2)were administered via intravenous drip infusion on the first day of the course, and S-1 was orally administered twice a day for 2 weeks, repeated every 3 weeks. All patients completed the study treatment, and the median number of courses completed was 9 courses(range: 3-17 courses). In terms of anti-tumor efficacy, complete remission(CR)was observed in 1 patient(7.1%); partial remission(PR), in 9 patients(64.3%); stable disease(SD), in 3 patients(21.4%); and progressive disease(PD), in 1 patient(7.1%), with a response rate of 71.4% and a disease control rate of 92.9%. The median relapse-free survival based on baseline PD was 12 months, and the median relapse-free survival based on PD according to the Response Evaluation Criteria in Solid Tumors(RECIST)was 10 months. The most common adverse events observed included peripheral sensory neuropathy(100%), fatigue(68.3%), anorexia(57.1%), and leukopenia/neutropenia(35.7%); however, almost all adverse events were Grade≦2 and could be managed. The SOX+BV therapy demonstrated an anti-tumor efficacy similar to that observed with oxaliplatin, fluorouracil, and folinic acid(FOLFOX)+BV therapy without the use of a central venous port. Therefore, the SOX+BV therapy may be among the effective option as first-line therapy for advanced/recurrent colorectal cancer.
要旨
臨床的に治癒切除不能と診断された進行再発大腸癌に対し,一次治療として施行したS-1+oxaliplatin+bevacizumab(SOX+BV)療法の安全性および有効性について検討した。対象は当科で同療法を3コース以上施行した大腸癌14例である。投与方法はBV 7.5 mg/kgおよびoxaliplatin 130 mg/m2を第1日目に点滴静注,S-1は40～60 mgを1日2回2週間内服投与し,以上を3週間ごとに繰り返した。全例が投与を終了しており,投与回数は中央値9(範囲: 3～17)コースであった。抗腫瘍効果はCR 1例(7.1%),PR 9例(64.3%),SD 3例(21.4%),PD 1例(7.1%)であり,奏効率71.4%,病勢制御率92.9%であった。baseline PDに基づく無再発生存期間は中央値12か月,RECIST PDに基づく無再発生存期間は中央値10か月であった。有害事象は,頻度が高いものとして末梢性感覚ニューロパチー100%,倦怠感68.3%,食欲不振57.1%,白血球・好中球減少35.7%などが認められたが,ほとんどはGrade 2以下でコントロール可能であった。SOX+BV療法は,中心静脈ポートの造設なしでFOLFOX+BV療法とほぼ同等の抗腫瘍効果が得られ,進行再発大腸癌に対する一次治療として有効な選択肢の一つであると考えられた。