Levard H, Pouliquen X, Hay J M, Fingerhut A, Langlois-Zantain O, Huguier M, Lozach P, Testart J
Surgical Unit, Hôpital International de l'Université de Paris, France.
Eur J Surg. 1998 Nov;164(11):849-57. doi: 10.1080/110241598750005273.
To compare chemotherapy with no chemotherapy as palliative treatment for oesophageal squamous cell carcinoma.
Randomised study.
Multicentre trial in France.
Of 161 patients with histologically confirmed oesophageal squamous cell carcinoma located more than 5 cm from the mouth of the oesophagus, five were withdrawn because of protocol violation. The remaining 156 patients, 149 men and 7 women, mean (SD) age 58 (9) years range 36 to 77, were randomly allocated to either a control group without chemotherapy (n = 84) or a group treated by chemotherapy (n = 72). Patients were divided into four strata: I = complete resection of the tumour but with lymph node involvement (n = 62); II = incomplete resection of tumour leaving gross tumour behind (n = 58); III = no resection because of local or regional invasion (n = 22) ; and IV = no resection because of distant metastasis (n = 14). Exclusion criteria were histologically confirmed tracheobronchial involvement, oesophagotracheal fistula, Karnosky score < 50, cerebral metastases, or hepatic metastases occupying more than 30% of the liver, peritoneal carcinomatosis, associated or previously treated ear-nose-throat carcinoma, or complete resection of tumour without lymph node involvement.
5 fluorouracil (5FU) and cisplatin (CDDP) were given in 5-day courses, once every 28 days, for a maximum of eight cycles. 5 FU, 1 g/m2, was infused for 24 hours after a water overload, during five days. Cisplatin was given either in one dose of 100 mg/m2 at the beginning of the cycle or 20 mg/m2/day over three hours for five days. Duration of treatment ranged from 6-8 months.
Median and actuarial survival. The subsidiary endpoint was quality of survival judged by complications of treatment, swallowing disorders, and the duration of ability to feed normally.
There was no difference in survival, either overall (median = 12 months) or in any of the strata. There were however significantly more patients with neurological (p < 0.003), haematological (p < 0.0001), and renal (p < 0.0002) complications in the treated group compared with the control group. Four patients (6%) died of complications of chemotherapy. The course of swallowing disorders did not differ between the two groups. The duration of autonomous oral feeding was exactly the same in both groups (median = 10.5 months).
The results suggest that 5FU and CDDP do not help in patients with squamous cell carcinoma of the oesophagus whether or not the tumour has been resected.
比较化疗与不化疗作为食管鳞状细胞癌姑息治疗的效果。
随机研究。
法国的多中心试验。
161例经组织学确诊的食管鳞状细胞癌患者，肿瘤位于距食管入口5 cm以上，其中5例因违反方案退出。其余156例患者，149例男性和7例女性，平均（标准差）年龄58（9）岁，年龄范围36至77岁，被随机分配到不进行化疗的对照组（n = 84）或化疗治疗组（n = 72）。患者分为四层：I = 肿瘤完全切除但有淋巴结受累（n = 62）；II = 肿瘤切除不完全，残留大体肿瘤（n = 58）；III = 因局部或区域侵犯未切除（n = 22）；IV = 因远处转移未切除（n = 14）。排除标准为组织学确诊的气管支气管受累、食管气管瘘、卡诺夫斯基评分<50、脑转移、或肝转移占肝脏超过30%、腹膜癌转移、相关或先前治疗过的耳鼻咽喉癌、或肿瘤完全切除且无淋巴结受累。
5-氟尿嘧啶（5FU）和顺铂（CDDP）以5天疗程给药，每28天一次，最多8个周期。5FU，1 g/m²，在水负荷后持续输注24小时，共5天。顺铂在周期开始时单次给药100 mg/m²，或在5天内每天20 mg/m²持续3小时给药。治疗持续时间为6 - 8个月。
中位生存期和精算生存期。次要终点是根据治疗并发症、吞咽障碍和正常进食能力持续时间判断的生存质量。
总体生存期（中位生存期 = 12个月）或任何一层的生存期均无差异。然而，与对照组相比，治疗组神经（p < 0.003）、血液学（p < 0.0001）和肾脏（p < 0.0002）并发症患者明显更多。4例患者（6%）死于化疗并发症。两组吞咽障碍病程无差异。两组自主经口进食持续时间完全相同（中位生存期 = 10.5个月）。
结果表明，5FU和CDDP对食管鳞状细胞癌患者无论是肿瘤是否已切除均无帮助。
