A review of oxaliplatin and its clinical use in colorectal cancer
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Colorectal cancer is one of the leading causes of death from malignant diseases in the Western world. Worldwide, approximately 50% of patients who present with colorectal cancer will develop metastatic disease and eventually die from this malignancy. Recently, significant advances have been made in the medical treatment of advanced colorectal cancer with the introduction of novel cytotoxic drugs, such as irinotecan and oxaliplatin. Based on the results of recent Phase III trials, combination regimens of infusional 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX) have emerged as a new standard of care in the palliative and adjuvant treatment of colorectal cancer. The addition of biological agents targeting angiogenesis or oncogenes such as epidermal growth factor receptor (EGFR) to FOLFOX will conceivably further enhance the activity of treatment regimens. Making use of all available active therapeutic options in the course of disease has significantly improved median overall survival of metastatic colorectal cancer into a chronic disease, with implications for treatment strategies and pharmacoeconomic considerations.Keywords:
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Oxaliplatin with 5-fluorouracil plus leucovorin (FOLFOX) has become the standard treatment in patients with colorectal cancer.Among known toxicities induced by oxaliplatin, hematological, gastrointestinal and neurological toxicities are common.However, acute pulmonary toxicity associated with oxaliplatin is unusual.One case of interstitial lung disease associated with the FOLFOX protocol is reported here.(
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fluorouracil＋folinate＋oxaliplatin（FOLFOX）療法が奏効し，経口摂取が可能となった腹膜播種を伴う切除不能進行胃癌の２例を経験した．症例１は66歳の男性で，食思不振，腹痛の精査で４型胃癌を指摘され，当院紹介となった．食道浸潤および腹膜播種をきたしていた．姑息手術による経口摂取改善は困難と考えられたが，全身状態は保たれており，FOLFOX療法を開始した．RECIST基準で部分奏効となり，腹水の消失および経口摂取の改善が得られた．症例２は73歳の女性で，経口摂取不良の精査で４型胃癌を指摘され，当院紹介となった．審査腹腔鏡にて多発腹膜播種を認め，FOLFOX療法を開始した．部分奏効となり，腹水の消失および経口摂取の改善が得られた．QOLの改善および予後改善という観点から，腹膜播種を伴う経口摂取不能の切除不能進行胃癌に対して，FOLFOX療法は有効な選択肢の一つと考える．
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Aim: Investigate the safety, pharmacokinetics (PK) and efficacy of BTH1677/cetuximab, with and without irinotecan, in patients with metastatic colorectal cancer (mCRC). Patients & methods: Patients with recurrent or progressive mCRC were assigned to BTH1677/cetuximab/irinotecan (group 1; n = 10) or BTH1677/cetuximab (group 2; n = 22). Adverse events, PK parameters and tumor response were assessed. Results & conclusion: Adverse events were consistent with those expected of the backbone therapy of cetuximab/irinotecan (group 1) or cetuximab alone (group 2). The BTH1677 PK profiles were similar in the two groups. The overall response rates were 30.0% (group 1) and 22.7% (group 2); in KRAS wild-type subset analysis, rates were 42.9% and 45.5%, respectively. BTH1677 therapy was tolerable and warrants further evaluation for treatment of mCRC.
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目的：FOLFOX 是第三期大腸直腸癌術後標準輔助性化學治療。但是許多病人無法完成完整療程。本研究欲探討完成完整FOLFOX 療程的比率及其無法完成的原因。方法：由台北榮總大腸直腸外科資料庫收集2009 年一月至2015 年十二月第三期大腸直腸癌術後接受FOLFOX 治療之病人之基本資料、接受Oxaliplatin 之劑量及無法完成之原因做分析。結果：研究期間內內共866 個第三期大腸直腸癌病人接受手術。其中110 人沒有接受後續輔助性化學藥物治療，199 人接受其他療法，5 人於其他他醫院治療。最後收集572人分析。290 人 (50.6%) 完成完整療程，其Oxaliplatin 累計計劑量之中位數為984 mg/m^2(644~1210 mg/m^2)。無法完成完整療程的病人中，78 人 (27.7%) 是因為主治醫師預防性停藥，72 人 (25.5%) 因週邊神經病變，30 人 (10.6%) 因疾病進展更換療法，18 人 (6.4%)因對Oxaliplatin 過敏，19 人 (6.7%) 因為白血球過低過肝腎功能惡化，17 人 (6.0%) 因嚴重噁心嘔吐，12 人 (4.3%) 因為整體身體狀況變差，36 人 (12.8%) 自行要求停藥。因週邊神經病變而中斷治療的患者，其Oxaliplatin 的累積劑量中位數為746 mg/m^2，而因對Oxaliplatin 過敏中斷治療的患者，其累積劑量中位數為680.4 mg/m^2。結論：半數病人能完成完整療程，週邊神經病變及及醫師預防性停藥是無法完成完整療程之主因。研發預防或減緩週邊神經經病變副作用之化學治療方法應能增加完整療程達成率。
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［背景］Oxaliplatinは，日本で合成された第3 世代の白金錯体系の抗悪性腫瘍剤であり，欧米ではOxaliplatin と持続投与5-FU/LV 併用（FOLFOX 療法）が進行再発大腸癌に対する標準的な化学療法としての地位を確立し広く施行されている。本邦では，2005 年4 月にOxaliplatinが承認され，当院でも切除不能進行・再発大腸癌に対するfirst-lineの化学療法としてFOLFOX 療法を積極的に施行している。［方法］2005 年6 月より2007 年8 月までに切除不能進行・再発大腸癌に対し，first-line としてFOLFOX4 およびmFOLFOX6 を施行した23 例を対象とし，その効果・安全性を検討した。FOLFOX4 は13 例に，mFOLFOX6は10 例に施行された。［結果］奏効率は50.0％であり，全生存期間は17.4 か月であった。投与回数の中央値は8.0，Oxaliplatinのrelative dose intensityは74.5％である。有害事象は，血液毒性ではGrade 3 以上の白血球減少を4 例，好中球減少を12 例に認め，非血液毒性ではGrade 3 の消化器毒性を1 例，Grade 3 の末梢神経障害を1例に認めたのみであった。［結語］FOLFOX 療法は，日本人においても進行再発大腸癌に対するfirst-lineの化学療法として比較的高い奏効性と安全性をもつ治療法であることが確認された。
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Oxaliplatin with 5-fluorouracil plus leucovorin (FOLFOX) has become the standard treatment in patients with colorectal cancer. Among known toxicities induced by oxaliplatin, hematological, gastrointestinal and neurological toxicities are common. However, acute pulmonary toxicity associated with oxaliplatin is unusual. One case of interstitial lung disease associated with the FOLFOX protocol is reported here. (Korean J Gastroenterol 2010;55: 340-343)
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