Safety and Efficacy of Nivolumab in Patients With Advanced Non–small-cell Lung Cancer Treated Beyond Progression

Biagio Ricciuti, Carlo Genova, Maria Bassanelli, Andrea De Giglio, Marta Brambilla, Giulio Metro, Sara Baglivo, Maria Giovanna Dal Bello, Anna Ceribelli, Francesco Grossi, Rita Chiari

Research output: Contribution to journalArticlepeer-review


Introduction: Treatment with immune checkpoint inhibitors beyond progression is associated with improved survival in patients with melanoma and clear-cell renal carcinoma. Whether this association exists for patients with non–small-cell lung cancer (NSCLC)is currently still unclear. Patients and Methods: We performed a multi-institutional retrospective study based on landmark and multivariable analyses to evaluate the safety and efficacy of treatment with nivolumab beyond Response Evaluation Criteria In Solid Tumors (RECIST)v1.1 progression in patients with advanced NSCLC. Criteria for receiving nivolumab beyond progression were investigator-assessed clinical benefit, stable performance status, tolerance of treatment, and no need of immediate intervention to prevent serious complication of progression. Results: Of 176 patients progressed to nivolumab according to RECIST v1.1, 60 (34.1%)were treated beyond progression (TBP)and 116 (65.9%)were not-TBP (NTBP). The median overall survival was significantly longer in the TBP group compared with the NTBP group (17.8 vs. 3.7 months; hazard ratio [HR], 0.32; 95% confidence interval [CI], 0.21-0.46; P <.0001). In a landmark analysis of evaluable patients beginning 6 weeks from first progression, the median overall survival for patients TBP was 10.7 months and for those NTBP, 3.4 months (HR, 0.48; 95% CI, 0.30-0.77; P =.002). Discontinuation of nivolumab at first progression was associated with shorter survival in multivariable analysis (HR, 2.98; 95% CI, 1.95-4.54; P <.001). No safety concerns emerged in patients who were in the TBP group. Conclusion: A subset of patients with NSCLC and progressive disease may continue to benefit from nivolumab beyond progression. Discontinuation of immunotherapy based only on RECIST v1.1 may be premature.

Original languageEnglish
Pages (from-to)178-185.e2
JournalClinical Lung Cancer
Issue number3
Publication statusPublished - May 1 2019


  • Nivolumab
  • Pseudoprogression
  • Treatment beyond progression

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research


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