title: Surrogate endpoints for overall survival in advanced non-small-cell lung cancer patients with mutations of the epidermal growth factor receptor gene.
abstract: Subsequent therapies confound the ability to discern the effect of first-line chemotherapy on overall survival (OS). We investigated whether progression-free survival (PFS), post-progression survival (PPS) and tumor response were valid surrogate endpoints for OS following first-line chemotherapy in individual patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epidermal growth factor receptor gene mutations. We retrospectively analyzed 35 patients with advanced NSCLC treated with first-line gefitinib. The associations of PFS, PPS and tumor response with OS were analyzed. PPS was found to be strongly correlated with OS, unlike PFS and tumor shrinkage. The factors significantly associated with PPS were performance status (PS) after first-line treatment, best response to second-line treatment and number of regimens used after disease progression. PPS may be a surrogate for OS in this patient population and further therapy after disease progression following first-line chemotherapy may significantly affect OS. However, a larger study is required to validate these results.
authors: Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma 377-8511, Japan.
authors: Reiko
authors: R
authors: Yoshino
authors: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma 371-8511, Japan.
authors: Hisao
authors: H
authors: Imai
authors: Clinical Trial Coordination Office, Shizuoka Cancer Center, Nagaizumi, Shizuoka 411-8777, Japan.
authors: Keita
authors: K
authors: Mori
authors: Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma 377-8511, Japan.
authors: Kousuke
authors: K
authors: Takei
authors: Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma 377-8511, Japan.
authors: Mai
authors: M
authors: Tomizawa
authors: Department of Oncology Clinical Development, Gunma University Graduate School of Medicine, Maebashi, Gunma 371-8511, Japan.
authors: Kyoichi
authors: K
authors: Kaira
authors: Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma 377-8511, Japan.
authors: Akihiro
authors: A
authors: Yoshii
authors: Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma 377-8511, Japan.
authors: Yoshio
authors: Y
authors: Tomizawa
authors: Department of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma 377-8511, Japan.
authors: Ryusei
authors: R
authors: Saito
authors: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma 371-8511, Japan.
authors: Masanobu
authors: M
authors: Yamada
keywords: epidermal growth factor receptor mutation; non-small-cell lung cancer; overall survival; post-progression survival; progression-free survival; tumor response