Elizabeth Dudnik1, Mor Moskovitz2, Sameh Daher3, Sivan Shamai4, Ekaterina Hanovich5, Ahuva Grubstein6, Tzippy Shochat7, Mira Wollner2, Jair Bar3, Ofer Merimsky4, Alona Zer8, Daniel A Goldstein9, Ariel Hammerman10, Arnold Cyjon5, Yelena Shechtman2, Mahmood Abu-Amna2, Dov Flex8, Laila C Roisman8, Nir Peled8. 1. Thoracic Cancer Unit, Davidoff Cancer Center, Rabin Medical Center, Beilinson Campus, Petah Tikva 49100, Israel. Electronic address: elizabeth.dudnik1603@gmail.com. 2. Thoracic Cancer Unit, Rambam Health Care Campus, Haifa 3109601, Israel. 3. Thoracic Cancer Unit, Sheba Cancer Center and Institute of Oncology, Tel HaShomer, Ramat Gan 5262000, Israel. 4. Thoracic Cancer Unit,Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. 5. Institute of Oncology, Asaf ha-Rofe Medical Center, Zerifin 70300, Israel. 6. Department of Diagnostic Radiology, Rabin Medical Center, Beilinson Campus, Petah Tikva 49100, Israel. 7. Statistical Consulting Unit, Rabin Medical Center, Beilinson Campus, Petah Tikva 49100, Israel. 8. Thoracic Cancer Unit, Davidoff Cancer Center, Rabin Medical Center, Beilinson Campus, Petah Tikva 49100, Israel. 9. Genito-urinary Cancer Unit, Davidoff Cancer Center, Rabin Medical Center, Beilinson Campus, Petah Tikva 49100, Israel. 10. Department of Pharmaceutical Technology Assessment, Chief Physician's Office, Clalit Health Services Headquarters, Tel Aviv 62098, Israel.
Abstract
OBJECTIVES: Nivolumab has recently received regulatory approval as a 2nd-line treatment of non-small cell lung cancer (NSCLC). The data regarding its effectiveness and safety in real life setting is lacking. MATERIALS AND METHODS: 260 consecutive patients with advanced NSCLC treated with nivolumab at five Israeli cancer centers between January 2015 and March 2016 were evaluated for overall survival (OS) and toxicity. OS was analyzed by the Cox proportional-hazards regression model. Overall response rate (ORR) and progression-free survival (PFS) were assessed in 49 patients using RECIST, v.1.1. RESULTS: Median age was 67y (41-99); males 68%; smokers 76%; ECOG PS ≥2 46%; non-squamous/squamous/other/NR 70%/23%/6%/1%; brain metastases 21%; liver metastases 21%; treatment line: 1st/2nd/3rd+-line/NR 6%/64%/26%/4%. With median survival follow-up of 18.5 months (range, 12.0-26.9), 155 (60%) patients died; median OS comprised 5.9 months (95% CI 4.7-7.4). In univariate and multivariate analysis, the only variable which significantly correlated with OS was ECOG PS. Median OS of patients with ECOG PS 0/1 and ECOG PS ≥2 comprised 9.5 months (95% CI, 6.7-NR) and 3.5 months (95% CI, 2.6-4.5), respectively. For 49 patients evaluable for response (median follow-up of 8.4 months (range, 2-16.8), ORR was 35%, median PFS was 2.8 months (95% CI, 1.8-7.7), incidence of pseudo-progression was 9%. The nivolumab safety profile was in accordance with the literature data, except for febrile neutropenia and pericarditis (observed in 1 case each). CONCLUSION: In real life setting, the effectiveness of nivolumab is reasonable yet less prominent than it has been demonstrated in clinical trials. ECOG PS ≥2 is associated with poor prognosis.
OBJECTIVES:Nivolumab has recently received regulatory approval as a 2nd-line treatment of non-small cell lung cancer (NSCLC). The data regarding its effectiveness and safety in real life setting is lacking. MATERIALS AND METHODS: 260 consecutive patients with advanced NSCLC treated with nivolumab at five Israeli cancer centers between January 2015 and March 2016 were evaluated for overall survival (OS) and toxicity. OS was analyzed by the Cox proportional-hazards regression model. Overall response rate (ORR) and progression-free survival (PFS) were assessed in 49 patients using RECIST, v.1.1. RESULTS: Median age was 67y (41-99); males 68%; smokers 76%; ECOG PS ≥2 46%; non-squamous/squamous/other/NR 70%/23%/6%/1%; brain metastases 21%; liver metastases 21%; treatment line: 1st/2nd/3rd+-line/NR 6%/64%/26%/4%. With median survival follow-up of 18.5 months (range, 12.0-26.9), 155 (60%) patients died; median OS comprised 5.9 months (95% CI 4.7-7.4). In univariate and multivariate analysis, the only variable which significantly correlated with OS was ECOG PS. Median OS of patients with ECOG PS 0/1 and ECOG PS ≥2 comprised 9.5 months (95% CI, 6.7-NR) and 3.5 months (95% CI, 2.6-4.5), respectively. For 49 patients evaluable for response (median follow-up of 8.4 months (range, 2-16.8), ORR was 35%, median PFS was 2.8 months (95% CI, 1.8-7.7), incidence of pseudo-progression was 9%. The nivolumab safety profile was in accordance with the literature data, except for febrile neutropenia and pericarditis (observed in 1 case each). CONCLUSION: In real life setting, the effectiveness of nivolumab is reasonable yet less prominent than it has been demonstrated in clinical trials. ECOG PS ≥2 is associated with poor prognosis.
Authors: R A Juergens; C Mariano; J Jolivet; N Finn; J Rothenstein; M N Reaume; A Faghih; C Labbé; S Owen; F A Shepherd; J Villeneuve; F Romeyer; F Pettersson; C Butts Journal: Curr Oncol Date: 2018-12-01 Impact factor: 3.677
Authors: Iwona Kwiecień; Elżbieta Rutkowska; Małgorzata Polubiec-Kownacka; Agata Raniszewska; Piotr Rzepecki; Joanna Domagała-Kulawik Journal: Transl Lung Cancer Res Date: 2021-04