聚谷氨酸紫杉醇（PPX-Xyotax）与食管癌和胃癌同步放疗：一项I期研究。
Paclitaxel poliglumex (PPX-Xyotax) and concurrent radiation for esophageal and gastric cancer: a phase I study.
作者信息
Dipetrillo Tom, Milas Luka, Evans Devon, Akerman Paul, Ng Thomas, Miner Tom, Cruff Dennis, Chauhan Bharti, Iannitti David, Harrington David, Safran Howard
机构信息
Brown University Oncology Group, Providence, RI, USA.
出版信息
Am J Clin Oncol. 2006 Aug;29(4):376-9. doi: 10.1097/01.coc.0000224494.07907.4e.
OBJECTIVES
To determine the maximal tolerated dose (MTD) and dose limiting toxicities of poly(l-glutamic acid)-paclitaxel (PPX) and concurrent radiation (PPX/RT) for patients with esophageal and gastric cancer.
METHODS
Patients with esophageal or gastric cancer receiving chemoradiation for loco-regional, adjuvant, or palliative intent were eligible. The initial dose of PPX was 40 mg/m2/wk, for 6 weeks with 50.4 Gy radiation. Dose levels were increased in increments of 10 mg/m2/wk of PPX.
RESULTS
Twenty-one patients were enrolled over 5 dose levels. Sixteen patients had esophageal cancer and 5 had gastric cancer. Twelve patients received PPX/RT as definitive loco-regional therapy, 4 patients had undergone resection and received adjuvant PPX/RT, and 5 patients had metastatic disease and received PPX/RT for palliation of dysphagia. Dose limiting toxicities of gastritis, esophagitis, neutropenia, and dehydration developed in 3 of 4 patients treated at the 80 mg/m2 dose level. Four of 12 patients (33%) with loco-regional disease had a complete clinical response.
CONCLUSIONS
The maximally tolerated dose of PPX with concurrent radiotherapy is 70 mg/m2/wk for patients with esophageal and gastric cancer.
目的
确定聚（L-谷氨酸）-紫杉醇（PPX）与同步放疗（PPX/RT）联合应用于食管癌和胃癌患者时的最大耐受剂量（MTD）及剂量限制性毒性。
方法
符合条件的患者为因局部区域、辅助或姑息治疗目的而接受放化疗的食管癌或胃癌患者。PPX的初始剂量为40mg/m²/周，共6周，同时进行50.4Gy的放疗。PPX的剂量水平以10mg/m²/周的增量增加。
结果
21例患者分5个剂量水平入组。其中16例为食管癌患者，5例为胃癌患者。12例患者接受PPX/RT作为确定性局部区域治疗，4例患者接受了手术切除并接受辅助性PPX/RT，5例患者有转移性疾病并接受PPX/RT以缓解吞咽困难。在80mg/m²剂量水平治疗的4例患者中有3例出现了胃炎、食管炎、中性粒细胞减少和脱水等剂量限制性毒性。12例局部区域疾病患者中有4例（33%）获得了完全临床缓解。
结论
对于食管癌和胃癌患者，PPX与同步放疗联合应用时的最大耐受剂量为70mg/m²/周。
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