Dunton Charles J, King Stephanie A, Neufeld Julia, Tolosa Jorge, Perez Gonzalo, Avila Andres, Underhill Kelly
Division of Gynecologic Oncology, Jefferson Medical College, Philadelphia, Pennsylvania 19107, USA.
Gynecol Oncol. 2002 Apr;85(1):185-7. doi: 10.1006/gyno.2002.6609.
The goal of this study was to determine the maximal tolerated dose (MTD) of topotecan given with external-beam radiotherapy in advanced cervical cancer.
A prospective Phase I trial of topotecan given with standard external-beam radiotherapy was performed in patients with advanced squamous cell carcinoma of the cervix. Patients were treated with a starting dose of 0.5 mg/m(2) and escalated by 0.25 mg/m(2). Nine patients were treated. Hematologic and nonhematologic toxicity were measured.
Patients were treated with 1.0 mg/m(2) daily for 5 days on Days 1-5 and 22-26 concomitantly with radiotherapy without significant toxicity. Grade III anemia in one case and Grade II leukopenia in two cases were seen in the three patients at this dose level. Dose-limiting toxicity was not reached.
Topotecan can be safely administered at a dose of 1.0 mg/m(2) during external-beam radiotherapy for advanced cervical cancer.
本研究的目的是确定在晚期宫颈癌患者中，拓扑替康与外照射放疗联合使用时的最大耐受剂量（MTD）。
对晚期宫颈鳞状细胞癌患者进行了一项拓扑替康与标准外照射放疗联合使用的前瞻性I期试验。患者起始剂量为0.5mg/m²，以0.25mg/m²递增。共治疗9例患者。对血液学和非血液学毒性进行了测量。
患者在第1 - 5天和第22 - 26天每天接受1.0mg/m²的治疗，持续5天，同时接受放疗，未出现明显毒性。在此剂量水平的3例患者中，1例出现III级贫血，2例出现II级白细胞减少。未达到剂量限制性毒性。
在晚期宫颈癌的外照射放疗期间，拓扑替康可以1.0mg/m²的剂量安全给药。
