Phase Ⅰ study of weekly PTX+DDP, and postoperative radiotherapy for early cervical cancer in Chinese women
10.3760/cma.j.issn.1004-4221.2016.08.009
- VernacularTitle:早期宫颈癌术后每周紫杉醇＋顺铂同步3 DCRT的Ⅰ期临床研究
- Author:
Lihong ZHU
;
Suqing TIAN
;
Ang QU
;
Hao WANG
;
Junjie WANG
;
Hongyan GUO
- Publication Type:Journal Article
- Keywords:
Cervical neoplasms/chemoradiotherapy;
Radiotherapy,three-dimensional conformal;
Chemotherapy,PTX+DDP;
Phase Ⅰ study
- From:
Chinese Journal of Radiation Oncology
2016;25(8):834-838
- CountryChina
- Language:Chinese
-
Abstract:
Objective To determine the maximum tolerated dose ( MTD) and dose?limiting toxicity ( DLT) of weekly PTX and DDP concurrent postoperative radiotherapy in Chinese women with high?and intermediate?risk early cervical cancer. Methods Women with high risks postoperative cervical carcinoma, ECOG≤2 were eligible. Pelvis RT (6/10 MV X?ray,3DCRT 40 Gy/20f,para?metrial boost 10?20 Gy/5?10f) was followed by 2?4f brachytherapy applications ( 192 Ir,5 Gy/f) . Concurrent weekly chemotherapy was started at DDP 20 mg/m2 and PTX 10 mg/m2 weekly,and escalated in three?patient cohorts according to 3+3 methods. Results 25 patients were enrolled and treated over seven doses levels until dose?limiting toxicity (DLT) was reached. Median age was 48 years (range,34?66).All of patients finished RT in 7 weeks. Grade 3,4 non?hematologic toxicities were diarrhea and observed in two patients (4 cycles,DLT) at level 7.Grade 3,4 hematologic,principally leukopenia and neutropenia,and occurs late cycles. One grade 4 leukopenia and neutropenia was observed at dose level 6 but not seen in three additional patients. No one was delayed treatment time by concurrent chemotherapy.22 patients finished 6 cycles. Median follow?up is 59. 5 months. Three patients have died of cancer metastasis and recurrence. One patient has died of respiratory failure. Conclusions Combination PTX and DDP administered concurrently with pelvic EBRT can be safely administered at the MTD of DDP 35 mg/m2 and PTX 30 mg/m2 weekly for six cycles in Chinese women with postoperative cervical cancer.
