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ESMO Open. 2018 Nov 1;3(6):e000327. doi: 10.1136/esmoopen-2018-000327. eCollection 2018.

Chemotherapy versus erlotinib as second-line treatment in patients with advanced non-small cell lung cancer and wild-type epidermal growth factor receptor: an individual patient data (IPD) analysis.

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Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
Osaka City University, Graduate School of Medicine, Osaka, Japan.
Ospedale San Raffaele Scientific Institute, Vimodrone, Italy.
Oncology Department, IRCCS-Mario Negri Institute for Pharmacological Research, Milano, Italy.
Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.
Istituto di Candiolo, Fondazione del Piemonte per l'Oncologia-IRCCS, Candiolo, Italy.
National Hospital Organization, Kinki-Chuo Chest Medical Center, Osaka, Japan.
Azienda Ospedaliero-Universitaria S. Luigi Gonzaga, Orbassano, Italy.
O.U. Medical Oncology, A.O. Fatebenefratelli e Oftalmico, Milan, Italy.
Division of Oncology, Azienda Ospedaliera Treviglio, Treviglio, Italy.


The efficacy of second-line treatment in patients with epidermal growth factor receptor (EGFR) wild-type tumours is still debatable. We assessed the efficacy of a standard second-line chemotherapy compared with erlotinib in an individual patient data approach for meta-analysis. The primary endpoint was overall survival (OS), and secondary endpoint was progression-free survival (PFS). Both were compared by log-rank test. The 'restricted mean survival time' (RMST) was estimated in each study and the difference in mean survival time up to the last available time point was calculated. The Cox proportional hazards model was used on survival analyses to provide HRs, to adjust for confounding variables and to test possible interaction with selected factors. Three randomised trials comparing chemotherapy versus erlotinib were analysed, including 587 randomised patients. Overall, 74% of patients included in the original trials were considered. 464 deaths and 570 progressions or deaths were observed. Compared with erlotinib, chemotherapy was associated to a decreased risk of progression (29%; HR: 0.71, 95% CI: 0.60 to 0.84, p< 0.0001;) but with no statistical significant reduction in OS (HR: 0.89, 95% CI: 0.74 to 1.06; p<0.20). No heterogeneity was found in both analyses. Patients treated with chemotherapy gained an absolute 1.5 and 1.6 months, respectively, in PFS and lifetime (RMST 95% CI: PFS 0.49 to 2.44; OS 95% CI: -1.04 to 4.25). These results showed that patients without a constitutively activated EGFR had better PFS with chemotherapy rather than with erlotinib while no statistical difference was observed in OS.


erlotinib; independent patients’ data (IPD); non-small cell lung cancer (NSCLC); wild-type epidermal growth factor receptor (wt-EGFR)

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