Time to progression as a surrogate marker for overall survival in patients with advanced non-small cell lung cancer

Katsuyuki Hotta, Yoshiro Fujiwara, Keitaro Matsuo, Katsuyuki Kiura, Nagio Takigawa, Masahiro Tabata, Mitsune Tanimoto

Research output: Contribution to journalArticlepeer-review

56 Citations (Scopus)


With the increasing number of active compounds available for advanced non-small cell lung cancer, it is useful to evaluate whether surrogate end points can replace survival in randomized trials for the rapid and efficient assessment of efficacy. We examined the association between differences in overall survival and time to progression (TTP) using a literature survey. Methods: We used median TTP (MTTP) and median survival time (MST) from 54 phase III trials of first-line chemotherapy involving 23,457 advanced non-small cell lung cancer patients in a multiple linear regression analysis. The MST ratio in each trial was defined as the ratio of MST in the investigational arm to that in the reference arm. The MTTP ratio was defined similarly. Results: The degree of the association between the MST and MTTP ratios was only moderate both in the overall cohort (R2 = 0.33) and various trial settings (R2 = 0.16-0.51), although the MTTP ratio was an independent factor influencing the MST ratio in the multiple regression model (p < 0.01). This means that the MTTP ratio could account for less than half of the variance in the MST ratio. Conclusions: The TTP potentially acts as a surrogate marker, but may not be still a definitive alternative in the first-line setting.

Original languageEnglish
Pages (from-to)311-317
Number of pages7
JournalJournal of Thoracic Oncology
Issue number3
Publication statusPublished - Mar 2009


  • Non-small cell lung cancer
  • Overall survival
  • Surrogate marker
  • Time to progression

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine


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