The relevance of stable disease (SD) as a surrogate end-point in advanced non-small cell lung cancer (NSCLC) patients treated with erlotinib (E) as the second/third line

Autor: Francesco Grossi, G. Dal Bello, Carlo Genova, Giulia Barletta, Claudio Sini, Giovanni L. Pappagallo, E. Rijavec, Paolo Pronzato, Paola Venturino
Rok vydání: 2012
Předmět:
Zdroj: Publons
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2012.30.15_suppl.7577
Popis: 7577 Background: SD has often been viewed as a result with an uncertain clinical value.With the advent of E in advanced NSCLC, increasing numbers of patients (pts) achieve SD as a best response. A common observation in clinical practice is that a high proportion of patients receiving E have durable SD.The aim of this analysis was to compare the progression-free survival (PFS) and overall survival (OS) in pts with advanced NSCLC who achieved confirmed SD or complete/partial response (CR+PR) after second/third line treatment with E. Methods: Data from 684 Italian pts from the TRUST trial (Tiseo M et al. Lung Cancer 2008) were analyzed. E was administered orally at 150 mg per day and was continued until disease progression, development of unacceptable toxicity or patient’s refusal. We define confirmed SD (cSD) if the patients’ PFS was ≥5 months (response to E was evaluated per protocol every two months) and reconfirmed SD (rSD) if the patients’ PFS was ≥8 months. Results: Pts’ characteristics included the following: median age, 67 years (31-89); females/males= 219/465 pts (32%/68%); never/former smokers= 191/493 pts (28%/72%); squamous/adeno/BAC/large cell/NOS= 163/361/26/21/113 pts (24%/53%/4%/3%/16%); ECOG PS 0-1/2-3= 557/127 pts (81%/19%). In 83 pts (12%), E was administered as the first-line therapy in pts who were unable to receive chemotherapy; 305 pts (45%) had received 1 prior line of chemotherapy, and 296 pts (43%) had received 2 prior lines of chemotherapy. A total of 428 pts were evaluable for a response: 44 pts (10%) exhibited CR+PR, 226 pts (53%) attained SD, which consisted of 139 pts (32%) with cSD and 83 pts (19%) with rSD. The median PFS estimates (with 95% CI) were 13.1 months (9.8-16.4) for CR+PR pts, 9.9 months (8.2-11.4) for cSD pts and 14 months (12-16) for rSD. The median OS estimates (with 95% CI) were 24.0 months (17-31) for CR+PR pts, 17.9 months (14.4-21.5) for cSD pts and 24.9 months (18.1-31.7) for rSD. Conclusions: Our findings are the first to demonstrate the relevance of achieving stable disease with E treatment. Pts obtaining cSD or rSD had durable PFS and OS comparable, particularly for rSD, with PFS and OS of those having CR+PR.
Databáze: OpenAIRE
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