Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
Italy, 6 Oncologia Medica – Gruppo Di Patologia Toracica, Istituto Scientifico
Romagnolo Per Lo Studio E La Cura Dei Tumori - IRCCS, Meldola/Italy, 7 U.O.S.D.
Dh Pneumoncologico, A.O. Dei Colli- Monaldi, Napoli/Italy, 8 Struttura Semplice
Dipartimentale Oncologia, Villa Scassi, Genova/Italy, 9 Sezione Pneumo-
Oncologica - Medicina Interna, IRCCS “casa Sollievo Della Sofferenza”, San Giovanni
Rotondo/Italy, 10 U.O. Oncologia, Presidio Ospedaliero V. Fazzi, Lecce/Italy,
11 Oncologia Medica, IRCCS Oncologico Giovanni Paolo Ii, Bari/Italy, 12 Dipartimento
Cardiotoracico – Pneumologia 2, A.O. Universitaria Pisana – Ospedale Cisanello,
Pisa/Italy, 13 U.O.S.D. Oncologia Medica, Policlinico Universitario Tor Vergata, Roma/
Italy, 14 Direzione Scientifica - Infrastruttura Ricerca E Statistica, Arcispedale Santa
Maria Nuova - IRCCS, Reggio Emilia/Italy
Background: In advanced NSCLC, erlotinib treatment was shown to improve
survival independently of EGFR status and induce high rates of prolonged
stable disease (SD). It has previously been reported that, after second-/thirdline
erlotinib, PFS and OS are long-lasting and similar between patients with SD
≥8 months and those attaining partial/complete response (PR/CR). The present
study investigated the clinical value of SD in a real-world setting of advanced
NSCLC. Methods: This Italian multicenter observational study enrolled patients
with stage IIIB-IV NSCLC on second-line erlotinib and wild-type/unknown
EGFR mutational status, with SD, CR or PR per RECIST v1.1 lasting for ≥4 weeks.
Patients were observed from the beginning of erlotinib for approximately 8
months or until death. Primary end-points were the rate and duration of SD
(i.e. time interval from erlotinib start to the last evidence of SD by RECIST)
or CR+PR. Secondary end-points were OS and PFS (i.e. time interval from the
erlotininb start to the first evidence of progression), estimated by the Kaplan-
Meier method and calculated by response duration or disease stabilization.
Adverse events occurring during the observation period were also recorded.
Results: At the cut-off date of 30/04/16, 144/172 (83.7%) enrolled patients
were evaluable for response (mean age 69.1 years, 61.8% males). At the start of
erlotinib treatment, 85.4% were non-smokers, 89.6% had an ECOG-PS of 0-1,
and 84.7% had stage IV NSCLC (83.3% adenocarcinoma and 11.8% squamous
cell carcinoma). Following second-line erlotinib, 82.6% (119/144) of patients
achieved SD and 17.4% (25/144) PR. Notably, SD was maintained for ≥8 months
in 27% (39/144) of cases. At the end of the observation period, 12 (8.3%) patients
had deceased, none with SD ≥8 months. Median OS had not been reached by
the entire population. According to SD duration, median OS was 4.3 months if