Second-line therapy for NSCLC in clinical practice: baseline results of the European SELECTTION observational study

Abstract

Objective:

Although the efficacy of a number of drugs for the second-line treatment of non-small cell lung cancer (NSCLC) has been demonstrated in Phase III trials, very limited evidence exists on optimal duration of second-line treatment or the reasons why this treatment is stopped in standard clinical practice. SELECTTION (Survey in European Lung Cancer Evaluating Choice of Treatment and Tolerability In Observed NSCLC) was designed to assess the time from initiation of second-line treatment for NSCLC to treatment discontinuation for any reason, the reasons for discontinuation, and the impact of discontinuation on outcomes.

Methods:

From October 2006 to January 2008, 1012 patients with advanced/metastatic NSCLC who completed or discontinued first-line treatment were enrolled in a multi-national, prospective observational cohort study (SELECTTION). Treatment cohorts were constructed based on the patients’ distribution across second-line treatments that were assigned by physician decision (pemetrexed, docetaxel, erlotinib, other treatments). This report presents a descriptive analysis of the baseline data collected, including patient/disease characteristics, treatment history and planned second-line treatments. Factors that may have affected treatment choice, selected by physicians from a range of options, were also identified.

Results:

Overall, 468 patients (46.2%) were enrolled in the pemetrexed cohort, 232 (22.9%) in docetaxel cohort, 206 (20.4%) in erlotinib cohort and 106 (10.5%) received other treatments. The profile of patients enrolled in the erlotinib cohort differed from those of patients enrolled in the pemetrexed or docetaxel cohorts in that erlotinib was more frequently planned for women, never-smokers and patients with adenocarcinomas. The primary reasons physicians gave for selection of the second-line treatment were tolerance and efficacy for pemetrexed, and preferred regimen for the particular patient and efficacy for the other treatments.

Conclusions:

In this observational study, pemetrexed, then docetaxel and erlotinib were the most frequently prescribed second-line treatments, which is in line with international guidelines. Erlotinib was most commonly prescribed to that subset of patients expected to gain the greatest benefit (those with adenocarcinoma, never-smokers and females). Pemetrexed was more frequently prescribed than docetaxel, with physicians most commonly choosing to prescribe the former agent because of its tolerability profile.

Key words:

• Chemotherapy
• Non-small cell lung cancer
• Observational study
• Second-line treatment

Transparency

Declaration of funding

The study was sponsored by Eli Lilly (Study Code: H3E-EW-B002).

Declaration of financial/other relationships

V.S., K.K. and C.V.-G. have disclosed that they are employed by Lilly. J.A. and C.L. have disclosed that they were employed by Lilly at the time of the study. D.M.-S. has disclosed that he has received consulting fees from Lilly, Roche and sanofi-aventis. A.V., E.F.S., B.P. and S.S. have disclosed that they have received consulting fees from Lilly for their involvement in the study. E.T. has disclosed that she has received consulting fees from Lilly and Roche.

Acknowledgements

Writing support was provided by Maryse Berlion, funded by Lilly. The authors acknowledge Caroline Spencer, Rx Communications Ltd, Mold, UK, for medical writing assistance funded by Lilly and Giovanni Zanotti, Lilly, for additional editorial assistance with the preparation of this article. Additional editorial and project management assistance was provided by Rx Communications Ltd, Mold, UK, funded by Lilly.