内容紹介
Summary
Background: Gastric cancer with extensive lymph node metastasis(ELM)is commonly considered unresectable and has a poor prognosis. We conducted a phaseⅡ study to evaluate the safety and efficacy of capecitabine and cisplatin(XP)as preoperative chemotherapy for gastric cancer with ELM. Methods: The patients received 2 21-day cycles of XP therapy(capecitabine at 2,000 mg/m2 twice daily for 2 weeks and cisplatin at 80 mg/m2 on day 1)followed by gastrectomy with D2 plus para-aortic nodal dissection. After R0 resection, S-1 chemotherapy was administered for 1 year. The primary end point was response rate(RR). The planned sample size was 30. Results: Between April 2015 and November 2016, 4 patients were enrolled, but the enrollment was terminated because of poor patient recruitment. The clinical RR was 50%, and R0 resection was achieved in 75% of the patients. The common Grade 3 adverse events during XP therapy were leukocytopenia(25%), anemia(25%), and hyperlipidemia(25%). The common Grade 3 surgical morbidity was abdominal abscess(33%)and pancreatic fistula(33%). The pathological RR was 25%. Conclusions: Preoperative XP therapy was feasible, but its efficacy was difficult to evaluate because of the small sample size.
要旨
はじめに: 高度リンパ節転移を伴う進行胃癌は根治切除したとしても予後不良である。高度リンパ節転移を伴う進行胃癌に対する術前カペシタビン+シスプラチン(CDDP)療法の有効性と安全性を評価する臨床試験を計画した。対象と方法: 大動脈周囲の16a2/16b1あるいはbulky N2リンパ節のいずれか,あるいは両方を有する胃癌患者を対象として,CDDP 80 mg/m2 1日目,カペシタビン2,000 mg/m2 14日間連続投与を3週間隔で2サイクル実施した。D2郭清以上の胃切除術とS-1内服1年間の術後補助療法を試験治療とした。主要評価項目は奏効割合とし,予定登録症例は30例であった。結果: 本試験は集積不良のため試験中止となった。4例が登録され,奏効割合,根治切除割合,組織学的奏効割合は50%,75%,25%であった。Grade 3以上の血液毒性・非血液毒性は25%で,治療関連死は認めなかった。周術期の有害事象はGrade 3腹腔内膿瘍,膵液瘻それぞれ1例を認めた。結語: 本試験は中止となったが,登録例は安全に治療できた。有効性の評価は少数例のため困難であった。
目次
Background: Gastric cancer with extensive lymph node metastasis(ELM)is commonly considered unresectable and has a poor prognosis. We conducted a phaseⅡ study to evaluate the safety and efficacy of capecitabine and cisplatin(XP)as preoperative chemotherapy for gastric cancer with ELM. Methods: The patients received 2 21-day cycles of XP therapy(capecitabine at 2,000 mg/m2 twice daily for 2 weeks and cisplatin at 80 mg/m2 on day 1)followed by gastrectomy with D2 plus para-aortic nodal dissection. After R0 resection, S-1 chemotherapy was administered for 1 year. The primary end point was response rate(RR). The planned sample size was 30. Results: Between April 2015 and November 2016, 4 patients were enrolled, but the enrollment was terminated because of poor patient recruitment. The clinical RR was 50%, and R0 resection was achieved in 75% of the patients. The common Grade 3 adverse events during XP therapy were leukocytopenia(25%), anemia(25%), and hyperlipidemia(25%). The common Grade 3 surgical morbidity was abdominal abscess(33%)and pancreatic fistula(33%). The pathological RR was 25%. Conclusions: Preoperative XP therapy was feasible, but its efficacy was difficult to evaluate because of the small sample size.
要旨
はじめに: 高度リンパ節転移を伴う進行胃癌は根治切除したとしても予後不良である。高度リンパ節転移を伴う進行胃癌に対する術前カペシタビン+シスプラチン(CDDP)療法の有効性と安全性を評価する臨床試験を計画した。対象と方法: 大動脈周囲の16a2/16b1あるいはbulky N2リンパ節のいずれか,あるいは両方を有する胃癌患者を対象として,CDDP 80 mg/m2 1日目,カペシタビン2,000 mg/m2 14日間連続投与を3週間隔で2サイクル実施した。D2郭清以上の胃切除術とS-1内服1年間の術後補助療法を試験治療とした。主要評価項目は奏効割合とし,予定登録症例は30例であった。結果: 本試験は集積不良のため試験中止となった。4例が登録され,奏効割合,根治切除割合,組織学的奏効割合は50%,75%,25%であった。Grade 3以上の血液毒性・非血液毒性は25%で,治療関連死は認めなかった。周術期の有害事象はGrade 3腹腔内膿瘍,膵液瘻それぞれ1例を認めた。結語: 本試験は中止となったが,登録例は安全に治療できた。有効性の評価は少数例のため困難であった。