Randomized controlled trial of lobaplatin plus etoposide vs. cisplatin plus etoposide as first‑line therapy in patients with extensive‑stage small cell lung cancer

Cheng,Ying; Fan,Yun; Liu,Xiaoqing; Liu,Yunpeng; Liu,Jiwei; Wang,Dong; Yu,Yan; Qin,Shukui; Liu,Wei; Huang,Cheng; Zhang,Helong; Liang,Jun; Shi,Jianhua; Sheng,Lijun; Yu,Hao

doi:10.3892/ol.2019.10125

Randomized controlled trial of lobaplatin plus etoposide vs. cisplatin plus etoposide as first‑line therapy in patients with extensive‑stage small cell lung cancer

Authors:
- Ying Cheng
- Yun Fan
- Xiaoqing Liu
- Yunpeng Liu
- Jiwei Liu
- Dong Wang
- Yan Yu
- Shukui Qin
- Wei Liu
- Cheng Huang
- Helong Zhang
- Jun Liang
- Jianhua Shi
- Lijun Sheng
- Hao Yu
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Affiliations: Department of Oncology, Jilin Cancer Hospital, Changchun, Jilin 130021, P.R. China, Department of Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022, P.R. China, Department of Chest Tumor, 307th Hospital of The Academy of Military Medical Sciences, Beijing 100071, P.R. China, Department of Oncology, The First Hospital of China Medical University, Shenyang, Liaoning 110001, P.R. China, Department of Oncology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, P.R. China, Department of Oncology, The Daping Hospital of Third Military Medical University, Chongqing 400042, P.R. China, Department of Oncology, The Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang 150081, P.R. China, Department of Oncology, People's Liberation Army Cancer Center of Nanjing 81 Hospital, Nanjing, Jiangsu 210002, P.R. China, Department of Oncology, Hebei Cancer Hospital, Shijiazhuang, Hebei 050011, P.R. China, Department of Oncology, Fujian Province Cancer Hospital, Fuzhou, Fujian 350014, P.R. China, Department of Oncology, The Tangdu Hospital of Fourth Military Medical University, Xi'an, Shanxi 710038, P.R. China, Department of Oncology, Peking University International Hospital, Peking University, Beijing 102206, P.R. China, Department of Oncology, Linyi Cancer Hospital, Linyi, Shandong 251500, P.R. China, Department of Oncology, Affiliated Hospital of Shandong Academy of Medical Sciences, Jinan, Shandong 250031, P.R. China, Department of Biostatistics, Nanjing Medical University, Nanjing, Jiangsu 211166, P.R. China
Published online on: March 8, 2019 https://doi.org/10.3892/ol.2019.10125
Pages: 4701-4709

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Abstract

The majority of previous studies of lobaplatin in small cell lung cancer (SCLC) are small phase I‑II studies. The present study aimed to verify the non‑inferiority (in terms of efficacy) of lobaplatin plus etoposide (EL) vs. cisplatin plus etoposide (EP) in patients with previously untreated extensive‑stage SCLC (ES‑SCLC). This phase III non‑inferiority randomized clinical trial enrolled patients at 17 sites between September 2010 and May 2013. Patients were randomized to EL (30 mg/m2 lobaplatin on day 1 and 100 mg/m2 etoposide on days 1‑3, for 21‑day cycles) or EP (80 mg/m2 cisplatin on day 1 and 100 mg/m2 etoposide on days 1‑3, for 21‑day cycles). The primary endpoint was progression‑free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate, disease control rate (DCR), toxicity and quality of life (QoL). A total of 234 patients were randomized to the EL (n=122) and EP (n=112) treatment groups. The median PFS, median OS and DCR were 5.1 vs. 5.3 months (P=0.786), 10.6 vs. 9.7 months (P=0.701) and 85.5 vs. 86.7% (P=0.848) in the EL vs. EP groups, respectively. Patients in the EL group had significantly lower frequencies of nephrotoxicity (2.5 vs. 11.7%; P=0.008), nausea (22.3 vs. 40.5%; P=0.003) and vomiting (14.1 vs. 35.1%; P<0.001) than those in the EP group. Overall, EL was not inferior to EP in terms of PFS and OS. The tolerance and QoL of the EL regimen were better than those of the EP regimen. EL is thus an alternative choice for the first‑line treatment of ES‑SCLC.

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