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Phase III Trial of Two Versus Four Additional Cycles in Patients Who Are Nonprogressive After Two Cycles of Platinum-Based Chemotherapy in Non–Small-Cell Lung Cancer

Joon Oh Park, Sang-We Kim, Jin Seok Ahn, Cheolwon Suh, Jung Shin Lee, Joung Soon Jang, Eun Kyung Cho, Sung Hyun Yang, Jin-Hyuk Choi, Dae Seog Heo, Suk Young Park, Sang Won Shin, Myung Ju Ahn, Jong Seok Lee, Young Ho Yun, Jae-Won Lee, Keunchil Park

From the Samsung Medical Center, Sungkyunkwan University School of Medicine; the Asan Medical Center, College of Medicine, University of Ulsan; the Korea Cancer Center Hospital; the Seoul National University Hospital; the Korea University Medical Center; the Hanyang University Hospital; the Chung-Ang University, College of Medicine; and the Korea University, Seoul; the Ajou University Hospital, Suwon; the Gyeongsang National University, Chinju; the Gachon University Gil Medical Center, Inchon; the Daejeon St Mary's Hospital, Daejeon; the Seoul National University Bundang Hospital, Sungnam; and the National Cancer Center, Goyang, Republic of Korea

Address reprint requests to Keunchil Park, MD, PhD, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-Dong, Gangnam-Gu, Seoul, Republic of Korea 135-710; e-mail: kpark{at}smc.samsung.co.kr

Purpose This trial was conducted to determine the optimal duration of chemotherapy in Korean patients with advanced non–small-cell lung cancer (NSCLC).

Patients and Methods Patients with stages IIIB to IV NSCLC who had not progressed after two cycles of chemotherapy were randomly assigned to receive either four (arm A) or two (arm B) more cycles of third-generation, platinum-doublet treatment.

Results Of the 452 enrolled patients, 314 were randomly assigned to the groups. One-year survival rates were 59.0% in arm A and 62.4% in arm B, and the difference of 3.4% (95% CI, –8.0 to 4.8) met the predefined criteria for noninferiority. The median time to progression (TTP), however, was 6.2 months (95% CI, 5.7 to 6.7 months) in arm A and 4.6 months (95% CI, 4.4 to 4.8 months) in arm B, the difference of which is statistically significant (P = .001). The frequencies of hematologic and nonhematologic toxicities were similar in the two arms.

Conclusion This study confirms the noninferiority of overall survival with four cycles compared with six cycles of chemotherapy for the first-line treatment of advanced NSCLC and supports the current American Society of Clinical Oncology guidelines. Notably, patients receiving six cycles of chemotherapy compared with four cycles showed a favorable TTP, suggesting that further investigation of the new strategies of maintenance therapy with less toxic agents after three to four cycles of induction chemotherapy might be warranted to improve survival, with consideration of both ethnicity and pharmacogenomic signatures.

Joon Oh Park and Sang-We Kim contributed equally to the work as first authors.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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• Duration of First-Line Chemotherapy in Advanced Non–Small-Cell Lung Cancer: Less Is More in the Era of Effective Subsequent Therapies
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  JCO 2007 25: 5155-5157 [Full Text]

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