Kodaira Takeshi, Fuwa Nobukazu, Kamata Minoru, Furutani Kazuhisa, Tachibana Hiroyuki, Yamazaki Takuya
Department of Therapeutic Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Anticancer Res. 2006 Jan-Feb;26(1B):471-8.
To assess the efficacy and feasibility of alternating chemoradiotherapy for esophageal cancer.
Patients, with previously untreated esophageal cancer, Eastern Cooperative Oncology Group performance status of 0 to 2, age 20 to 75 years and sufficient organ function, were eligible for this study. Three cycles of systemic chemotherapy with the continuous infusion of 3500 mg/m2 of 5-fluorouracil (5-FU: days 1-5) and a 6-h infusion of nedaplatin (NDP; day 6: 120-140 mg/m2), were accompanied by thoracic irradiation of 63 Gy in 35 fractions over 7 weeks. Radiation therapy was stopped during systemic chemotherapy (alternating setting). In the phase I part, the dose of nedaplatin was increased to define dose-limiting toxicities. For the phase II part, patients with distant metastasis were excluded.
From 1998 through 2002, 40 patients were recruited for this protocol study. The median patient age was 54 years (range, 49-65 years) for the phase I and 58 years (range, 44-73 years) for the phase II trials. There were 35 men and 5 women in this study. For the phase I part (n = 15), the maximal tolerated dose of NDP was 140 mg/m2; thus, the recommended dose was 130 mg/m2. Twenty-five patients were treated with the recommended doses in the phase II part of the study. Ten patients had T4 disease and 14 patients had stage IV disease in the phase II part of the study. The overall survival rates at 1 and 2 years were 58.9% and 45.9%, respectively. The most frequent toxicities were leukopenia (grade 3 or greater: 80%), followed by thrombocytopenia (56%), granulocytopenia (56%) and anemia (28%). Radiation esophagitis of grade 3 or greater developed in 6 patients (24%). Two patients died of radiation pneumonitis. The actual dose intensities of NDP and 5-FU were 68.8% and 73.3%, respectively.
This intensive treatment for esophageal cancer was feasible and effective; however, moderate-to-severe toxicity occurred. This protocol warrants further clinical evaluation in a multi-institutional prospective study.
评估交替放化疗治疗食管癌的疗效和可行性。
入选本研究的患者需满足以下条件：既往未接受过治疗的食管癌患者，东部肿瘤协作组（Eastern Cooperative Oncology Group）体能状态评分为0至2分，年龄在20至75岁之间且器官功能良好。接受三个周期的全身化疗，持续输注3500mg/m²的5-氟尿嘧啶（5-FU，第1至5天），并在第6天6小时内输注奈达铂（NDP，120 - 140mg/m²），同时在7周内分35次给予胸部63Gy的照射。在全身化疗期间（交替模式）停止放疗。在I期部分，增加奈达铂剂量以确定剂量限制性毒性。在II期部分，排除有远处转移的患者。
从1998年至2002年，40例患者入选本方案研究。I期试验患者的中位年龄为54岁（范围49 - 65岁），II期试验为58岁（范围44 - 73岁）。本研究中有35名男性和5名女性。在I期部分（n = 15），奈达铂的最大耐受剂量为140mg/m²；因此，推荐剂量为130mg/m²。在研究的II期部分，25例患者接受了推荐剂量的治疗。在II期部分，10例患者患有T4期疾病，14例患者患有IV期疾病。1年和2年的总生存率分别为58.9%和45.9%。最常见的毒性反应为白细胞减少（3级及以上：80%），其次为血小板减少（56%）、粒细胞减少（56%）和贫血（28%）。6例患者（24%）发生3级及以上放射性食管炎。2例患者死于放射性肺炎。奈达铂和5-FU的实际剂量强度分别为68.8%和73.3%。
这种食管癌强化治疗是可行且有效的；然而，出现了中度至重度毒性反应。该方案值得在多机构前瞻性研究中进行进一步的临床评估。
