ACTIVITY OF TAXOL IN PATIENTS WITH SQUAMOUS-CELL CARCINOMA AND ADENOCARCINOMA OF THE ESOPHAGUS
ACTIVITY OF TAXOL IN PATIENTS WITH SQUAMOUS-CELL CARCINOMA AND ADENOCARCINOMA OF THE ESOPHAGUS
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DOI：
10.1093/jnci/86.14.1086
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发表时间：
1994-07-20
期刊：
影响因子：
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通讯作者：
KELSEN, DP
中科院分区：
文献类型：
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作者：
AJANI, JA;ILSON, DH;KELSEN, DP
背景资料：食管癌和胃食管连接部癌是罕见的，约占美国所有恶性肿瘤的1%。这些部位的晚期鳞状细胞癌或腺癌仍然无法治愈。患者的中位生存期为4至8个月，其预后在过去几十年中没有改变。毫无疑问，迫切需要开发新的有效药物用于食管癌或胃食管连接部癌患者。目的：我们的目的是评价在既往未经治疗的不可切除的局部区域或转移性食管癌患者中的缓解率、缓解持续时间和毒性作用，这些患者参加了紫杉醇（Taxol）的II期研究。方法：52例转移性或局部区域不可切除的食管癌患者入选本研究。所有患者术前均给予地塞米松、西咪替丁和盐酸苯海拉明预防过敏反应。紫杉醇的起始剂量为250 mg/m2，每21天重复一次。患者在紫杉醇治疗结束后24小时接受5 μ g/kg粒细胞集落刺激因子（G-CSF）皮下注射，以减少粒细胞减少症的持续时间和严重程度。结果：在最初入组的52例患者中，对50例（44例男性和6例女性）进行了毒性反应和反应评价。腺癌32例，鳞状细胞癌18例。中位年龄为58岁（范围：36-77岁）。中位Zubrod体能状态为1（范围，0-1）。课程的中位数为4个，开办的课程总数为227个。紫杉醇的中位剂量为250 mg/m2（范围：150-280 mg/m2）。在227个疗程中，52个疗程（23%）减少了紫杉醇剂量，15个疗程（7%）增加了紫杉醇剂量。16例（32%）患者达到完全或部分缓解，11例（22%）达到轻微缓解。在32例腺癌患者中，11例（34%; 95%置信区间[CI] = 18%-50%）完全或部分缓解，6例轻微缓解。18例鳞状细胞癌患者中有5例（28%; 95% CI = 7%-49%）部分缓解，5例（28%）轻微缓解。部分缓解的中位持续时间为17周（范围：7至≥ 58周）。在中位随访9个月时，32例患者仍然存活，精算中位生存期为13.2个月（范围：2至大于或等于117.5个月）。紫杉醇后G-CSF的耐受性非常好。结论：这些数据表明紫杉醇是一种有效的治疗食管腺癌和鳞状细胞癌的药物。
Background: Carcinomas of the esophagus and gastroesophageal junction are uncommon and account for approximately 1% of all malignancies in the United States. Advanced squamous cell carcinoma or adenocarcinoma of these sites remains incurable. The median survival of patients is between 4 and 8 months, and their prognosis has not changed in the past several decades. Undoubtedly, there is an urgent need to develop new effective drugs for patients with carcinoma of the esophagus or the gastroesophageal junction. Purpose: Our purpose was to evaluate the response rate, duration of response, and toxic effects in previously untreated patients with unresectable local-regional or metastatic carcinoma of the esophagus who were enrolled in a phase II study of paclitaxel (Taxol). Methods: Fifty-two patients with either metastatic or local-regional unresectable carcinoma of the esophagus were eligible for this study. All patients were premedicated with dexamethasone, cimetidine, and diphenhydramine hydrochloride to prevent allergic reaction. The starting dose of paclitaxel was 250 mg/m(2) repeated every 21 days. Patients received 5 mu g/kg granulocyte-colony stimulating factor (G-CSF) subcutaneously daily 24 hours after the completion of paclitaxel to reduce the duration and severity of granulocytopenia. Results: Of the 52 patients who were initially enrolled, 50 (44 men and six women) were evaluated for toxic effects and response. Thirty-two had adenocarcinoma, and 18 had squamous cell carcinoma. The median age was 58 years (range, 36-77 years). The median Zubrod performance status was 1 (range, 0-1). The median number of courses was four, and the total number of courses administered was 227. The median dose of paclitaxel was 250 mg/m(2) (range, 150-280 mg/m(2)). Paclitaxel dosage was reduced in 52 (23%) of 227 courses and increased in 15 (7%) of 227 courses. Sixteen (32%) patients achieved either a complete or partial response, and 11 (22%) achieved a minor response. Among 32 patients with adenocarcinoma, 11 (34%; 95% confidence interval [CI] = 18%-50%) had either a complete or partial response and six had a minor response. Five (28%; 95% CI = 7%-49%) of 18 patients with squamous cell carcinoma had a partial response, and five (28%) had a minor response. The median duration of partial response was 17 weeks (range, 7 to greater than or equal to 58 weeks). At a median follow-up of 9 months, 32 patients remain alive, with an actuarial median survival duration of 13.2 months (range, 2 to greater than or equal to 117.5 months). Paclitaxel followed by G-CSF was very well tolerated. Conclusions: These data indicate that paclitaxel is an active agent against adenocarcinoma and squamous cell carcinoma of the esophagus.