内容紹介
Effect of Weekly Paclitaxel Followed by 5-fluorouracil, Epirubicin, and Cyclophosphamide as Neoadjuvant Treatment for Patients with Triple-Negative and Luminal-Type Breast Cancer―A Multicenter Study
Summary
This study examined the pathological complete response(pCR)rate and safety of induction chemotherapy with 12 cycles of weekly paclitaxel(80 mg/m2)followed by 4 cycles of 5-fluorouracil(500 mg/m2), epirubicin(100 mg/m2), and cyclophosphamide(500 mg/m2). The study medication was administered to female patients(n=31)with a mean age of 51 years, diagnosed with stageⅡA(n=18), ⅡB(n=11)and ⅢA(n=2)disease and with an estrogen receptor positive rate of 65%(20/31). No patient was HER2-IHC[human epidermal growth factor receptor 2(HER2)immunohistochemistry(IHC)](3+)or HER2-FISH(fluorescence in situ hybridization)positive. Twenty-eight patients completed the treatment regimen. Treatment was halted in 2/31 patients due to progression of disease in one patient and a Grade 3 non-hematological adverse effect of skin eruption and itching in the other patient. A third patient died of causes unrelated to the study medication. Central review ascertained a pCR in 6 patients. In patients with triple-negative disease we observed a pCR rate of 67%(6/9). In patients with the Luminal(A+B)subtype, 0%(0/19)had a pCR. Grade 3/4 toxicity included leucopenia(58%), neutropenia(58%), febrile neutropenia(26%), fatigue(10%), and ALT elevation(7%). In terms of pCR, patients presenting with triple-negative disease and manageable safety profiles appear to respond well to this treatment regimen, while only a modest response was observed in patients with Luminal subtype disease.
要旨
早期乳癌に対する術前化学療法において,病理学的完全奏効(pCR)は良好な予後と相関する。本研究では,12サイクルの毎週投与パクリタキセル(80 mg/m2)と4サイクルの5-FU(500 mg/m2)・エピルビシン(100 mg/m2)・シクロフォスファミド(500 mg/m2)療法の術前順次化学療法を行い,pCR率と安全性を検討した。対象は早期乳癌31例,平均年齢51歳。病期はstageⅡA(n=18),ⅡB(n=11),ⅢA(n=2)。エストロゲンレセプター陽性率は65%(20/31例)。HER2陽性例なし。治療は28例で完遂できた。中止例の理由は病状進行1例,Grade 3の皮疹・掻痒感1例,他病死が1例であった。病理スライドの中央判定にて6例がpCR。サブタイプ別のpCR率はトリプルネガティブタイプ67%(6/9例),ルミナールタイプ(A+B)で0%(0/19例)であった。Grade 3/4の有害事象は白血球減少(58%),好中球減少(58%),発熱性好中球減少症(26%),倦怠感(10%),ALT上昇(7%)が認められた。本レジメンの副作用は管理可能であり,トリプルネガティブ乳癌に対し高い効果を有している。しかし,ルミナールタイプにはpCRをめざすという観点での高い効果を期待することは難しいと思われる。
目次
Summary
This study examined the pathological complete response(pCR)rate and safety of induction chemotherapy with 12 cycles of weekly paclitaxel(80 mg/m2)followed by 4 cycles of 5-fluorouracil(500 mg/m2), epirubicin(100 mg/m2), and cyclophosphamide(500 mg/m2). The study medication was administered to female patients(n=31)with a mean age of 51 years, diagnosed with stageⅡA(n=18), ⅡB(n=11)and ⅢA(n=2)disease and with an estrogen receptor positive rate of 65%(20/31). No patient was HER2-IHC[human epidermal growth factor receptor 2(HER2)immunohistochemistry(IHC)](3+)or HER2-FISH(fluorescence in situ hybridization)positive. Twenty-eight patients completed the treatment regimen. Treatment was halted in 2/31 patients due to progression of disease in one patient and a Grade 3 non-hematological adverse effect of skin eruption and itching in the other patient. A third patient died of causes unrelated to the study medication. Central review ascertained a pCR in 6 patients. In patients with triple-negative disease we observed a pCR rate of 67%(6/9). In patients with the Luminal(A+B)subtype, 0%(0/19)had a pCR. Grade 3/4 toxicity included leucopenia(58%), neutropenia(58%), febrile neutropenia(26%), fatigue(10%), and ALT elevation(7%). In terms of pCR, patients presenting with triple-negative disease and manageable safety profiles appear to respond well to this treatment regimen, while only a modest response was observed in patients with Luminal subtype disease.
要旨
早期乳癌に対する術前化学療法において,病理学的完全奏効(pCR)は良好な予後と相関する。本研究では,12サイクルの毎週投与パクリタキセル(80 mg/m2)と4サイクルの5-FU(500 mg/m2)・エピルビシン(100 mg/m2)・シクロフォスファミド(500 mg/m2)療法の術前順次化学療法を行い,pCR率と安全性を検討した。対象は早期乳癌31例,平均年齢51歳。病期はstageⅡA(n=18),ⅡB(n=11),ⅢA(n=2)。エストロゲンレセプター陽性率は65%(20/31例)。HER2陽性例なし。治療は28例で完遂できた。中止例の理由は病状進行1例,Grade 3の皮疹・掻痒感1例,他病死が1例であった。病理スライドの中央判定にて6例がpCR。サブタイプ別のpCR率はトリプルネガティブタイプ67%(6/9例),ルミナールタイプ(A+B)で0%(0/19例)であった。Grade 3/4の有害事象は白血球減少(58%),好中球減少(58%),発熱性好中球減少症(26%),倦怠感(10%),ALT上昇(7%)が認められた。本レジメンの副作用は管理可能であり,トリプルネガティブ乳癌に対し高い効果を有している。しかし,ルミナールタイプにはpCRをめざすという観点での高い効果を期待することは難しいと思われる。