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96小时紫杉醇用于既往接受过治疗的晚期食管癌患者的II期试验。

Phase II trial of 96-hour paclitaxel in previously treated patients with advanced esophageal cancer.

作者信息

Anderson Sibyl E, O'Reilly Eileen M, Kelsen David P, Ilson David H

机构信息

Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, Department of Medicine, Weill-Cornell Medical College, New York, New York, USA.

出版信息

Cancer Invest. 2003;21(4):512-6. doi: 10.1081/cnv-120022360.

DOI:10.1081/cnv-120022360
PMID:14533440
Abstract

BACKGROUND

A 96-hour infusion schedule of paclitaxel demonstrates tolerability and antitumor activity in lung cancer and breast cancer refractory to short-duration infusion paclitaxel. Given the activity of paclitaxel in esophageal cancer, a phase II trial of 96-hour infusion paclitaxel in esophageal cancer was undertaken.

METHODS

Both adenocarcinoma and squamous cell histology were included. Paclitaxel was administered at 140 mg/m2 over 96 hours every 21 days. Patients who had metastatic disease to the liver and transaminases greater than two times normal value received 120 mg/m2. Response to treatment was evaluated after the first two cycles and subsequently every third cycle.

RESULTS

Ten men and four women were entered. All were eligible for response and had stage IV disease. Thirteen patients were previously treated. All 13 received prior short-duration paclitaxel-containing chemotherapy regimens. Eleven patients had adenocarcinoma and three squamous cell cancer. Patients completed a mean of two cycles (range one to eight) prior to disease progression. No major responses were observed. Toxicity was minimal and included grade 3/4 neutropenia in 14% of patients. One patient with adenocarcinoma demonstrated stable disease for 28 weeks.

CONCLUSION

No major activity was observed in a population of previously treated patients. Ninety-six-hour paclitaxel in metastatic esophageal cancer is generally well tolerated with minimal toxicity; however, it is ineffective in previously treated patients. Further evaluation of this schedule of paclitaxel in combination with concurrent radiotherapy, where its radiosensitizing potential may be useful, is ongoing in locally advanced esophageal cancer.

摘要

背景

紫杉醇96小时输注方案在对短时间输注紫杉醇难治的肺癌和乳腺癌中显示出耐受性和抗肿瘤活性。鉴于紫杉醇在食管癌中的活性,开展了一项食管癌中紫杉醇96小时输注的II期试验。

方法

纳入腺癌和鳞状细胞组织学类型的患者。紫杉醇以140mg/m²的剂量在96小时内每21天给药一次。有肝转移且转氨酶高于正常值两倍的患者接受120mg/m²的剂量。在前两个周期后及随后每第三个周期评估治疗反应。

结果

入组10名男性和4名女性。所有患者均符合反应评估条件且为IV期疾病。13名患者曾接受过治疗。所有13名患者均接受过含紫杉醇的短时间化疗方案。11名患者为腺癌,3名患者为鳞状细胞癌。患者在疾病进展前平均完成了两个周期(范围为1至8个周期)的治疗。未观察到主要反应。毒性轻微,14%的患者出现3/4级中性粒细胞减少。一名腺癌患者疾病稳定28周。

结论

在既往接受过治疗的患者群体中未观察到主要活性。转移性食管癌中紫杉醇96小时输注通常耐受性良好且毒性轻微;然而,其对既往接受过治疗的患者无效。紫杉醇此输注方案与同步放疗联合应用的进一步评估正在局部晚期食管癌中进行,其放射增敏潜力可能有用。

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