Chemotherapy in non-small cell lung cancer patients after prior immunotherapy: The multicenter retrospective CLARITY study

CLARITY study, Melissa Bersanelli, Sebastiano Buti, Diana Giannarelli, Alessandro Leonetti, Alessio Cortellini, Giuseppe Lo Russo, Diego Signorelli, Luca Toschi, Michele Milella, Sara Pilotto, Emilio Bria, Claudia Proto, Arianna Marinello, Giovanni Randon, Sabrina Rossi, Emanuele Vita, Giulia Sartori, Ettore D'Argento, Eva QakoElisa Giaiacopi, Laura Ghilardi, Anna Cecilia Bettini, Elena Rapacchi, Francesca Mazzoni, Daniele Lavacchi, Vieri Scotti, Lucia Pia Ciccone, Michele De Tursi, Pietro Di Marino, Daniele Santini, Marco Russano, Paola Bordi, Massimo Di Maio, Marco Audisio, Marco Filetti, Raffaele Giusti, Rossana Berardi, Ilaria Fiordoliva, Giulio Cerea, Elio Gregory Pizzutilo, Alessandra Bearz, Elisa De Carlo, Fabiana Cecere, Davide Renna, Roberta Camisa, Giuseppe Caruso, Corrado Ficorella, Giuseppe Luigi Banna, Diego Cortinovis, Marina Chiara Garassino

Research output: Contribution to journalArticlepeer-review


Objectives: In the most of cases, for non-small cell lung cancer (NSCLC) patients who progressed to previous immune checkpoint inhibitors (CKI) administered as first- or as second-line therapy, chemotherapy (CT) remains the only viable options in the absence of “druggable” mutations. We aimed to explore the efficacy of salvage chemotherapy after immunotherapy (SCAI) in advanced NSCLC patients. Materials and Methods: We designed a retrospective, multicenter study, involving 20 Italian centers, with the primary objective of describing the clinical outcome of advanced NSCLC patients treated with SCAI at the participating institutions from November 2013 to July 2019. The primary endpoint of the study was represented by overall survival (OS), defined as the time from CT initiation to death. Secondary outcome endpoints of the SCAI (progression free survival, PFS, objective response rate, ORR and toxicity) and explorative biomarkers (lactate dehydrogenase, LDH, and neutrophil-to-lymphocyte ratio, NLR during immunotherapy) were also analyzed. Results: In our study population of 342 NSCLC patients, SCAI obtained a median OS of 6.8 months (95 % confidence interval, CI 5.5–8.1), median PFS of 4.1 months (95 % CI 3.4−4.8) and ORR of 22.8 %. A “Post-CKI score” was constructed by combining significant predictors of OS at the multivariate analyses (sex, ECOG PS, disease control with prior immunotherapy), Harrell'C was 0.65, (95 % CI:0.59−0.71). Conclusions: Despite the late-line settings, our findings support the hypothesis that previous immunotherapy might increase the sensitivity of the tumor to the subsequent chemotherapy. The “Post-CKI score” was clinically effective in successfully discriminating three distinct prognostic subgroups of patients after the failure of CKI, representing a possibly useful tool for the tailored decision-making process of advanced treatment-line settings in NSCLC.
Original languageEnglish
Pages (from-to)123-131
Number of pages9
JournalLung Cancer
Publication statusPublished - Dec 2020


  • Chemotherapy after immunotherapy
  • Immune checkpoint inhibitors
  • Salvage chemotherapy


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