Chemotherapy initiation with single-course methotrexate alone or combined with dactinomycin versus multi-course methotrexate for low-risk gestational trophoblastic neoplasia: a multi-centric randomized clinical trial.
10.1007/s11684-021-0855-4
- Author:
Lili CHEN
1
;
Ling XI
2
;
Jie JIANG
3
;
Rutie YIN
4
;
Pengpeng QU
5
;
Xiuqin LI
6
;
Xiaoyun WAN
1
;
Yaxia CHEN
1
;
Dongxiao HU
1
;
Yuyan MAO
1
;
Zimin PAN
1
;
Xiaodong CHENG
1
;
Xinyu WANG
1
;
Qingli LI
4
;
Danhui WENG
2
;
Xi ZHANG
3
;
Hong ZHANG
5
;
Quanhong PING
5
;
Xiaomei LIU
6
;
Xing XIE
1
;
Beihua KONG
7
;
Ding MA
8
;
Weiguo LU
9
Author Information
1. Department of Gynecological Oncology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, 310006 s, China.
2. Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
3. Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, 250012, China.
4. Department of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, 610041, China.
5. Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, 300052, China.
6. Shengjing Hospital of China Medical University, Shenyang, 110021, China.
7. Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, 250012, China. kongbeihua@sdu.edu.cn.
8. Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. dingma424@126.com.
9. Department of Gynecological Oncology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, 310006 s, China. lbwg@zju.edu.cn.
- Publication Type:Randomized Controlled Trial
- Keywords:
dactinomycin (ACTD);
gestational trophoblastic neoplasia (GTN);
methotrexate (MTX)
- MeSH:
Antineoplastic Combined Chemotherapy Protocols/adverse effects*;
Dactinomycin/adverse effects*;
Female;
Gestational Trophoblastic Disease/drug therapy*;
Humans;
Methotrexate/therapeutic use*;
Pregnancy;
Retrospective Studies
- From:
Frontiers of Medicine
2022;16(2):276-284
- CountryChina
- Language:English
-
Abstract:
We aimed to evaluate the effectiveness and safety of single-course initial regimens in patients with low-risk gestational trophoblastic neoplasia (GTN). In this trial (NCT01823315), 276 patients were analyzed. Patients were allocated to three initiated regimens: single-course methotrexate (MTX), single-course MTX + dactinomycin (ACTD), and multi-course MTX (control arm). The primary endpoint was the complete remission (CR) rate by initial drug(s). The primary CR rate was 64.4% with multi-course MTX in the control arm. For the single-course MTX arm, the CR rate was 35.8% by one course; it increased to 59.3% after subsequent multi-course MTX, with non-inferiority to the control (difference -5.1%,95% confidence interval (CI) -19.4% to 9.2%, P = 0.014). After further treatment with multi-course ACTD, the CR rate (93.3%) was similar to that of the control (95.2%, P = 0.577). For the single-course MTX + ACTD arm, the CR rate was 46.7% by one course, which increased to 89.1% after subsequent multi-course, with non-inferiority (difference 24.7%, 95% CI 12.8%-36.6%, P < 0.001) to the control. It was similar to the CR rate by MTX and further ACTD in the control arm (89.1% vs. 95.2%, P =0.135). Four patients experienced recurrence, with no death, during the 2-year follow-up. We demonstrated that chemotherapy initiation with single-course MTX may be an alternative regimen for patients with low-risk GTN.
