内容紹介
Safety of Pemetrexed According to the Duration of Vitamin B12 and Folic Acid Supplementation Prior to the First Dose of Pemetrexed
Summary
Objective: Administration of vitamin B12 and folic acid for 7 days prior to the administration of the first dose of pemetrexed is recommended. However, vitamin supplementation rarely is initiated less than 7 days prior to the first dose of pemetrexed. Therefore, we analyzed the safety of pemetrexed with vitamin supplementation for less than 7 days prior to the first dose of pemetrexed. Methods: Patients were classified into 2 groups according to the duration of vitamin supplementation prior to the first dose of pemetrexed: group A received vitamin supplementation for 7 days or more, and group B received vitamin supplementation for less than 7 days. We analyzed adverse effects, such as myelosuppression, rash, and diarrhea, after 1 cycle of pemetrexed therapy. Results: A total of 70 patients were administered pemetrexed; 40 patients were men and 30 were women with a median age of 64.5 years(range, 43-86 years). A total of 57 patients were classified into group A and 13 into group B; 33 patients were administered pemetrexed as a first-line treatment. Neutropenia of Grade 3 or more was observed in 4/49(8.2%)patients in group A and 2/13(15.4%)patients in group B(p=0.60). There were no significant differences in the rates of occurrence of neutropenia, rash, and diarrhea. Conclusion: This retrospective study indicated that patients could be safely treated with pemetrexed if vitamin supplementation is initiated for less than 7 days prior to the first administration of pemetrexed. However, further studies are needed because of a lack of statistical power and adjustment for confounding factors.
要旨
背景・目的: ペメトレキセド(pemetrexed: PEM)治療時,重篤な副作用軽減のためにビタミンB12製剤と葉酸の前投薬を7日以上前から行うことが推奨される。しかし,実臨床ではやむ得ない事情により前投薬が7日未満となる場合も散見される。そのため,前投薬投与7日未満での安全性を検討した。方法: 前投薬投与期間から,A群7日間以上,B群7日間未満とした。1サイクル治療後の副作用(骨髄抑制,皮疹,下痢)の発現状況を検討した。結果: ペメトレキセド治療患者は70名であり,男女比は40/30名,年齢の中央値は64.5(43～86)歳であった。first-lineで使用した患者は33名,A群/B群は57/13名であった。Grade 3以上の好中球減少はA群4/49名(8.2%),B群2/13名(15.4%)であった(p=0.60)。Grade 3以上の血小板減少,皮疹,下痢についても同様の検討をしたが有意差は認められなかった。結論: 本研究では,前投薬投与7日間未満でも安全にPEM治療を施行できる可能性が示唆された。しかし,交絡因子の調整や検出力不足もあり,さらなる検討が必要である。
目次
Summary
Objective: Administration of vitamin B12 and folic acid for 7 days prior to the administration of the first dose of pemetrexed is recommended. However, vitamin supplementation rarely is initiated less than 7 days prior to the first dose of pemetrexed. Therefore, we analyzed the safety of pemetrexed with vitamin supplementation for less than 7 days prior to the first dose of pemetrexed. Methods: Patients were classified into 2 groups according to the duration of vitamin supplementation prior to the first dose of pemetrexed: group A received vitamin supplementation for 7 days or more, and group B received vitamin supplementation for less than 7 days. We analyzed adverse effects, such as myelosuppression, rash, and diarrhea, after 1 cycle of pemetrexed therapy. Results: A total of 70 patients were administered pemetrexed; 40 patients were men and 30 were women with a median age of 64.5 years(range, 43-86 years). A total of 57 patients were classified into group A and 13 into group B; 33 patients were administered pemetrexed as a first-line treatment. Neutropenia of Grade 3 or more was observed in 4/49(8.2%)patients in group A and 2/13(15.4%)patients in group B(p=0.60). There were no significant differences in the rates of occurrence of neutropenia, rash, and diarrhea. Conclusion: This retrospective study indicated that patients could be safely treated with pemetrexed if vitamin supplementation is initiated for less than 7 days prior to the first administration of pemetrexed. However, further studies are needed because of a lack of statistical power and adjustment for confounding factors.
要旨
背景・目的: ペメトレキセド(pemetrexed: PEM)治療時,重篤な副作用軽減のためにビタミンB12製剤と葉酸の前投薬を7日以上前から行うことが推奨される。しかし,実臨床ではやむ得ない事情により前投薬が7日未満となる場合も散見される。そのため,前投薬投与7日未満での安全性を検討した。方法: 前投薬投与期間から,A群7日間以上,B群7日間未満とした。1サイクル治療後の副作用(骨髄抑制,皮疹,下痢)の発現状況を検討した。結果: ペメトレキセド治療患者は70名であり,男女比は40/30名,年齢の中央値は64.5(43～86)歳であった。first-lineで使用した患者は33名,A群/B群は57/13名であった。Grade 3以上の好中球減少はA群4/49名(8.2%),B群2/13名(15.4%)であった(p=0.60)。Grade 3以上の血小板減少,皮疹,下痢についても同様の検討をしたが有意差は認められなかった。結論: 本研究では,前投薬投与7日間未満でも安全にPEM治療を施行できる可能性が示唆された。しかし,交絡因子の調整や検出力不足もあり,さらなる検討が必要である。