Details

Autor(en) / Beteiligte

• Kawachi, Hayato
• Fujimoto, Daichi
• Morimoto, Takeshi
• Ito, Munehiro
• Teraoka, Shunsuke
• Sato, Yuki
• Nagata, Kazuma
• Nakagawa, Atsushi
• Otsuka, Kojiro
• Tomii, Keisuke

Titel

Clinical Characteristics and Prognosis of Patients With Advanced Non–Small-cell Lung Cancer Who Are Ineligible for Clinical Trials

Ist Teil von

• Clinical lung cancer, 2018-09, Vol.19 (5), p.e721-e734

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2018

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• Little is known about the characteristics and clinical outcomes of patients with advanced non–small-cell lung cancer who are ineligible for clinical trials. We analyzed the characteristics, outcomes, and survival of these patients and found that most were ineligible for the trials and had poor treatment outcomes. These results should be considered when applying clinical trial outcomes to real-world patients. Most patients with non–small-cell lung cancer (NSCLC) are ineligible for clinical trials. However, few studies have reported on the profiles and treatment outcomes for these patients. Therefore, we investigated the characteristics, outcomes, and survival of patients with advanced NSCLC who were ineligible for clinical trials. We analyzed the data from a retrospective cohort of 786 consecutive patients with a diagnosis of advanced NSCLC. We reviewed the criteria of phase 1 to 3 clinical trials and classified patients according to the common first-line eligibility criteria for lung cancer. Of the 786 patients, 469 (60%) were ineligible for clinical trials. The main reasons for ineligibility were brain metastasis (41%), poor performance status (25%), and respiratory disease (24%). For all patients, ineligibility was identified as an independent predictor of overall survival (hazard ratio, 0.78; 95.0% confidence interval, 0.65-0.93; P = .008), even in those with a good performance status who had received chemotherapy (hazard ratio, 0.80; 95.0% confidence interval, 0.65-0.99; P = .037). In the subgroup analysis of ineligible patients, survival varied depending on the reasons for ineligibility. In particular, a history of cancer was not associated with a poor outcome, although this was a common reason for ineligibility. Most patients were ineligible for clinical trials and had a shorter overall survival, although this varied depending on the reason for their ineligibility. These results should be considered when applying clinical trial outcomes to real-world patients. Further studies of ineligible patients are needed to improve the treatment decisions in clinical settings.