title: 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.
abstract: OBJECTIVE
  This trial was conducted to determine the optimal duration of chemotherapy in Korean patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-Dong, Gangnam-Gu, Seoul, Republic of Korea.
authors.forename: Joon Oh
authors.initials: JO
authors.lastname: Park
authors.forename: Sang-We
authors.initials: SW
authors.lastname: Kim
authors.forename: Jin Seok
authors.initials: JS
authors.lastname: Ahn
authors.forename: Cheolwon
authors.initials: C
authors.lastname: Suh
authors.forename: Jung Shin
authors.initials: JS
authors.lastname: Lee
authors.forename: Joung Soon
authors.initials: JS
authors.lastname: Jang
authors.forename: Eun Kyung
authors.initials: EK
authors.lastname: Cho
authors.forename: Sung Hyun
authors.initials: SH
authors.lastname: Yang
authors.forename: Jin-Hyuk
authors.initials: JH
authors.lastname: Choi
authors.forename: Dae Seog
authors.initials: DS
authors.lastname: Heo
authors.forename: Suk Young
authors.initials: SY
authors.lastname: Park
authors.forename: Sang Won
authors.initials: SW
authors.lastname: Shin
authors.forename: Myung Ju
authors.initials: MJ
authors.lastname: Ahn
authors.forename: Jong Seok
authors.initials: JS
authors.lastname: Lee
authors.forename: Young Ho
authors.initials: YH
authors.lastname: Yun
authors.forename: Jae-Won
authors.initials: JW
authors.lastname: Lee
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology; D002945:Cisplatin / Q000008:administration & dosage; D018450:Disease Progression; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013997:Time Factors
chemical_list: D002945:Cisplatin