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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

Cited 146 time in Web of Science Cited 171 time in Scopus
Authors
Park, Joon Oh; Kim, Sang-We; Ahn, Jin Seok; Suh, Cheolwon; Lee, Jung Shin; Jang, Joung Soon; Cho, Eun Kyung; Yang, Sung Hyun; Choi, Jin-Hyuk; Heo, Dae Seog; Park, Suk Young; Shin, Sang Won; Ahn, Myung Ju; Lee, Jong Seok; Yun, Young Ho; Lee, Jae-Won; Park, Keunchil
Issue Date
2007-11-21
Publisher
American Society of Clinical Oncology
Citation
J Clin Oncol. 2007 Nov 20;25(33):5233-9.
Keywords
AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy Protocols/*administration &dosage/adverse effectsCarcinoma, Non-Small-Cell Lung/*drug therapy/mortality/psychologyCisplatin/administration & dosageDisease ProgressionFemaleHumansLung Neoplasms/*drug therapy/mortality/psychologyMaleMiddle AgedQuality of LifeTime Factors
Abstract
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.
ISSN
1527-7755 (Electronic)
Language
English
URI
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18024869

http://hdl.handle.net/10371/29739
DOI
https://doi.org/10.1200/JCO.2007.10.8134
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College of Medicine/School of Medicine (의과대학/대학원)Program in Cancer Biology (협동과정-종양생물학전공)Journal Papers (저널논문_협동과정-종양생물학전공)
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