Lee Jeeyun, Im Young-Hyuck, Cho Eun Yoon, Hong Yong Sang, Lee Hyo Rak, Kim Hyo Song, Kim Mi-Jin, Kim Kwhanmien, Kang Won Ki, Park Keunchil, Shim Young Mog
Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-dong, Kangnam-gu, Seoul 135-710, Korea.
Cancer Chemother Pharmacol. 2008 Jun;62(1):77-84. doi: 10.1007/s00280-007-0577-6. Epub 2007 Aug 31.
The combination of 5-fluorouracil (5-FU) and cisplatin (FP) remains the mostly used regimen for metastatic esophageal squamous carcinoma. This phase II study assessed the efficacy and safety of capecitabine/cisplatin (XP) as a first-line chemotherapy in a homogenous cohort of patients with metastatic or recurrent esophageal squamous cell carcinoma.
Patients received 60 mg/m(2) of cisplatin intravenously (IV) on day 1 and capecitabine 1,250 mg/m(2)/dose orally twice a day on days 1-14. Treatment cycles were repeated every 3 weeks until the documented disease progression, unacceptable toxicity, or patient's refusal. Immunohistochemical studies against thymidylate synthase (TS) and thymidine phosphorylase (TP) were performed to seek predictive markers for treatment response.
Between December 2003 and March 2006, 45 patients entered the study. All patients had histologically proven squamous cell carcinoma of the esophagus. The overall response rate (ORR) was 57.8% (95% CI, 43.3-72.2) with 0 CR and 26 PRs. The median duration of response in responders was 4.6 months (1.0-15.6 months). With a median follow-up duration of 25.7 months (10.8-42.6 months), the median time to progression was 4.7 months (95% CI, 2.5-7.0) and the median survival time was 11.2 months (95% CI, 8.5-13.9). Common grade 3 or 4 non-hematological adverse events were anorexia (18/191, 9.4%), fatigue (9/191, 4.7%), constipation (6/191, 3.1%), hand-foot syndrome (6/191, 3.1%) and diarrhea (4/191, 2.1%). The most common grade 3 or 4 hematological adverse events were neutropenia (33/191, 17.3%), followed by leucopenia (11/191, 5.8%), anemia (2/191, 1.0%) and thrombocytopenia (1/191, 0.5%). There was no treatment-related death. Neither TS nor TP showed predictive value for treatment response.
The XP regimen demonstrated a promising antitumor activity in metastatic esophageal squamous cell carcinoma, which may potentially replace the FP regimen.
5-氟尿嘧啶（5-FU）和顺铂（FP）联合方案仍是转移性食管鳞癌最常用的治疗方案。本II期研究评估了卡培他滨/顺铂（XP）作为转移性或复发性食管鳞癌患者一线化疗方案的疗效和安全性。
患者在第1天静脉注射60mg/m²顺铂，在第1 - 14天口服卡培他滨1250mg/m²/次，每日2次。每3周重复治疗周期，直至记录到疾病进展、出现不可接受的毒性或患者拒绝治疗。进行针对胸苷酸合成酶（TS）和胸苷磷酸化酶（TP）的免疫组织化学研究，以寻找治疗反应的预测标志物。
2003年12月至2006年3月，45例患者进入研究。所有患者均经组织学证实为食管鳞癌。总缓解率（ORR）为57.8%（95%CI，43.3 - 72.2），0例完全缓解（CR），26例部分缓解（PR）。缓解者的中位缓解持续时间为4.6个月（1.0 - 15.6个月）。中位随访时间为25.7个月（10.8 - 42.6个月），中位疾病进展时间为4.7个月（95%CI，2.5 - 7.0），中位生存时间为11.2个月（95%CI，8.5 - 13.9）。常见的3/4级非血液学不良事件为厌食（18/191，9.4%）、疲劳（9/191，4.7%）、便秘（6/191，3.1%）、手足综合征（6/191，3.1%）和腹泻（4/191，2.1%）。最常见的3/4级血液学不良事件为中性粒细胞减少（33/191，17.3%），其次是白细胞减少（11/191，5.8%）、贫血（2/191，1.0%）和血小板减少（1/191，0.5%）。无治疗相关死亡。TS和TP均未显示出对治疗反应的预测价值。
XP方案在转移性食管鳞癌中显示出有前景的抗肿瘤活性，可能会取代FP方案。
