An East Asian subgroup analysis of PROCLAIM, a phase III trial of pemetrexed and cisplatin or etoposide and cisplatin plus thoracic radiation therapy followed by consolidation chemotherapy in locally advanced nonsquamous non-small cell lung cancer.
OBJECTIVE
PROCLAIM, a phase III trial of patients with nonsquamous non-small cell lung cancer comparing concurrent pemetrexed-cisplatin and thoracic radiation therapy followed by consolidation pemetrexed, did not meet its primary endpoint of superior overall survival versus etoposide-cisplatin and thoracic radiation therapy followed by a consolidation platinum doublet of choice. The results from an East Asian subgroup analysis are presented here.


METHODS
A subgroup analysis was performed for all patients randomized from China (n = 61), Taiwan (n = 25), and Korea (n = 11).


RESULTS
Baseline characteristics were balanced between treatment arms for East Asian patients. In the 97 randomized East Asian patients, median overall survival was 26.8 months for the pemetrexed-cisplatin arm and 36.3 months for the etoposide-cisplatin arm (hazard ratio: 1.23; 95% confidence interval: 0.70-2.14; P = 0.469). Median progression-free survival was 10.0 months for the pemetrexed-cisplatin arm and 7.6 months for the etoposide-cisplatin arm (hazard ratio: 0.97; 95% confidence interval: 0.61-1.54; P = 0.890). The objective response rate was 47.7% in the pemetrexed-cisplatin arm and 34.0% in the etoposide-cisplatin arm (P = 0.167). In the 90 treated East Asian patients, the overall incidence of drug-related grade 3-4 treatment-emergent adverse events was significantly lower in the pemetrexed-cisplatin arm versus the etoposide-cisplatin arm (61.4% vs 91.3%; P = 0.001).


CONCLUSIONS
For East Asian patients, pemetrexed-cisplatin combined with thoracic radiation therapy, followed by consolidation pemetrexed, did not improve overall survival but did have a good safety profile with a trend for improved progression-free survival and objective response rate compared to standard chemoradiotherapy for stage III unresectable nonsquamous non-small cell lung cancer.
Department of Radiotherapy, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
Luhua
L
Wang
Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.
Yi-Long
YL
Wu
Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Shun
S
Lu
Department of Radiotherapy, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
Lei
L
Deng
Samsung Medical Center, Gangnam-Gu, Seoul, The Republic of Korea.
Myung-Ju
MJ
Ahn
Division of Radiation Oncology, Department of Oncology, National Taiwan University Hospital, Taipei City, Taiwan.
Feng-Ming
FM
Hsu
Global Medical Affairs, Eli Lilly Canada Inc, Toronto, Canada.|Eli Lilly and Company, Indianapolis, Indiana, USA.
Neill
N
Iscoe
Statistical Sciences, Eli Lilly and Company, Indianapolis, Indiana, USA.
Anwar
A
Hossain
Emerging Markets, Eli Lilly and Company, Gurgaon, Haryana, India.
Tarun
T
Puri
Oncology, Lilly China Drug Development and Medical Affairs Center, Eli Lilly and Company, Shanghai, China.
Pinghai
P
Zhang
Emerging Markets, Eli Lilly and Company, Buenos Aires, Argentina.
Mauro
M
Orlando
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use; D060830:Consolidation Chemotherapy / Q000379:methods*; D005047:Etoposide / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068437:Pemetrexed / Q000008:administration & dosage / Q000627:therapeutic use*
D000068437:Pemetrexed; D005047:Etoposide; D002945:Cisplatin
Asians; carcinoma; chemoradiotherapy; combined modality therapy; non-small cell lung