Single-arm, multi-centre phase II study of lobaplatin combined with docetaxel for recurrent and metastatic nasopharyngeal carcinoma patients.
OBJECTIVE
The primarily aim of this phase II study is to evaluate the response rate (RR) and disease control rate (DCR). The secondary aim of this study is to assess the progression-free survival and overall survival of recurrent or metastatic nasopharyngeal carcinoma (NPC) patients treated with lobaplatin in combination with docetaxel.


METHODS
Patients with recurrent and metastatic NPC received docetaxel (75 mg/m(2) on day 1) and lobaplatin (30 mg/m(2) on day 2) every 3 weeks for two to six courses.


RESULTS
From April 2011 to July 2013, 39 patients were enrolled. In total, 3 patients (7.7%) had complete response, 21 (53.8%) had partial response, 9 (23.1%) had stable disease and 4 (10.3%) had progressive disease. The overall RR was 61.5% (95% CI, 46.2-76.8%), and the DCR was 84.6% (95% CI, 73.3-95.9%). The median time to progression was 10 months (95% CI, 7.3-12.8 months) after the median follow-up duration of 10.3 months (1.5-28.9 months). The most common grade 3/4 toxicities included leucopaenia and neutropaenia (17.9%), anaemia (5.1%) and increased aminotransferase level (2.6%). Other toxicities were grade 1/2 and minimal.


CONCLUSIONS
Lobaplatin in combination with docetaxel demonstrated clinical activity and an acceptable toxicity profile in recurrent and metastatic NPC patients. Lobaplatin may be effective for recurrent and metastatic NPC patients who previously received cisplatin-based chemotherapy.
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Road, Wuhan 430030, Hubei, China.
Guo Xian
GX
Long
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Road, Wuhan 430030, Hubei, China.
Jing Wen
JW
Lin
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Road, Wuhan 430030, Hubei, China.
Dong Bo
DB
Liu
Department of Oncology, Hubei Cancer Hospital, 116 South Zuodaoquan Road, Hongshan District, Wuhan 430030, Hubei, China.
Xiao Yi
XY
Zhou
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Road, Wuhan 430030, Hubei, China.
Xiang Lin
XL
Yuan
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Road, Wuhan 430030, Hubei, China.
Guang Yuan
GY
Hu
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Road, Wuhan 430030, Hubei, China.
Qi
Q
Mei
Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Road, Wuhan 430030, Hubei, China. Electronic address: gqhu@tjh.tjmu.edu.cn.
Guo Qing
GQ
Hu
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D003503:Cyclobutanes / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D012008:Recurrence; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
D003503:Cyclobutanes; D009944:Organoplatinum Compounds; D043823:Taxoids; D000077143:Docetaxel; C066228:lobaplatin
Docetaxel; Lobaplatin; Metastasis; Nasopharyngeal carcinoma; Recurrence