Observation of the treatment and outcomes of patients receiving chemotherapy for advanced NSCLC in Europe (ACTION study)

Abstract

Objective:

The ACTION (Assessment of Cost and ouTcomes of chemotherapy In an Observational setting) study investigated associations between chemotherapy, patient/disease characteristics and outcomes in advanced non-small cell lung cancer (NSCLC) patients in clinical practice.

Research design and methods:

Chemonaïve NSCLC patients from five European countries were observed for 18 months from initiation of first-line chemotherapy; care was at the physician’s discretion.

Main outcome measures:

Survival and associated prognostic factors were estimated using Kaplan–Meier methods and a Cox proportional hazards model, respectively. Cluster analyses of baseline patient characteristics were also performed. Toxicity data were not considered in these analyses.

Results:

A total of 975 eligible patients with NSCLC (Stage IIIb/IV) were enrolled and provided baseline and response data; cluster analysis was performed on 829 patients and survival data were available from 906 patients. In first-line treatment, a 39.8% response rate, a 39.5% 1-year survival rate and unadjusted median survival of 9.3 months were observed. Prognostic factors for survival included performance status (PS), number of metastatic organs, gender and age. Five patient clusters were identified, highlighting patient heterogeneity in terms of baseline condition and age. PS was maintained or improved throughout first-line and second-line chemotherapy in half the patients receiving these treatments.

Conclusions:

ACTION provides valuable information about patient population, disease characteristics, treatment choices, prescribing patterns and outcomes in routine clinical practice in advanced NSCLC in Europe. Our findings suggest that maintenance of PS after first and subsequent lines of chemotherapy, and survival rates may both be higher than previously anticipated. Our results also showed an association between age and survival, which suggests that age should not exclude patients from receiving chemotherapy if they meet all other eligibility criteria.

Key words::

• Chemotherapy
• Cluster analysis
• NSCLC
• Observational studies
• Prognostic factors
• Survival

Transparency

Declaration of funding

The study was sponsored by Eli Lilly (Study Code: B9E-EW-JHMU).

Declaration of financial/other relationships

H.G.B., B.V., F.P. and N.T. have disclosed that they received no direct funding for participation in this study and report no relevant conflicts of interest. J.A. has disclosed that he was employed by Eli Lilly at the time of this study. F.L. and M.I.L. have disclosed that they are employees of Eli Lilly.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgment

The authors acknowledge the following individuals as additional co-authors of this manuscript: Heather Anderson, Wythenshawe Hospital, Greater Manchester, UK; Henrik Riska, Helsinki University Central Hospital, Helsinki, Finland; Ciara Moneley, Mainstay Consulting, Winchester, Hampshire, UK; Carla Visseren-Grul, Eli Lilly, Houten, the Netherlands. They also acknowledge all ACTION investigators; thank Bente Frimodt-Moller and Veronique Ripoche for operational and data management support; and thank Rx Communications Ltd (UK) for editorial support with this article (funded by Eli Lilly).