The NIPRO Study: An Observational, Retrospective, Multicenter Study on the Safety of the Radiotherapy and Immunotherapy Combination for Advanced-Stage NSCLC.

Published on Feb 16, 2021in Clinical Lung Cancer3.55
· DOI :10.1016/J.CLLC.2021.02.005
Marco Perna5
Estimated H-index: 5
(UniFI: University of Florence),
Vieri Scotti19
Estimated H-index: 19
(UniFI: University of Florence)
+ 23 AuthorsAlessio Bruni15
Estimated H-index: 15
ABSTRACT Introduction : In this observational, retrospective, multi-center study, we aim to assess the safety of the combination of local metastasis-directed radiotherapy (RT) and immunotherapy in a cohort of advanced NSCLC (aNSCLC) patients. Material and Methods : We collected clinical data of aNSCLC patients who received concomitant RT and anti-PD1/PD-L1 inhibitors in seven Italian centers from September 2015 to June 2019. Concomitant RT was defined as delivered ≤4 weeks before or after the first/last administration of immunotherapy (IT), or within 2 consecutive cycles of ICI. All adverse events (AEs) apparently related to RT and/or IT were graded according to the CTCAE criteria version 4.0, and reported in terms of incidence and severity as immune-related or RT-related, or combined. Results : We analyzed the clinical charts of 187 patients. Median follow-up time was 23 months, and median OS 16.5 months (range 3-162). Thirteen patients developed pure RT-related side effects, and 43 (23.9%) developed immune-related side effects. No additive toxic effects were observed. A case of grade 5 pulmonary toxicity was recorded as a possible consequence of a combined effect. Conclusions : This analysis suggests that the combination of concomitant RT and anti-PD-1/PD-L1 agents is safe, and the two toxicity profiles are independent. MICRO-ABSTRACT This study aims to evaluate the tolerability of combination between radiotherapy and immunotherapy for patients with advanced lung cancer. We retrospectively analyzed data of 187 patients who received the combined treatment in seven Italian centers from September 2015 to June 2019. After a median follow up of 23 months, the majority of patients recovered from the adverse events. One patient experienced a grade 5 lung toxicity. Our analysis revealed a safety profile of the association of immunotherapy and radiotherapy.
#1David A. Palma (London Health Sciences Centre)H-Index: 55
#2Robert OlsonH-Index: 46
Last. Suresh Senan (VU: VU University Amsterdam)H-Index: 86
view all 24 authors...
PURPOSEThe oligometastatic paradigm hypothesizes that patients with a limited number of metastases may achieve long-term disease control, or even cure, if all sites of disease can be ablated. Howev...
76 CitationsSource
#1Rosario MazzolaH-Index: 19
#2Barbara Alicja Jereczek-Fossa (IEO: European Institute of Oncology)H-Index: 36
Last. Filippo Alongi (University of Brescia)H-Index: 33
view all 12 authors...
BACKGROUND: During these last years, new agents have dramatically improved the survival of the metastatic patients. Oligometastases represent a continuous field of interest in which the integration of metastases-directed therapy and drugs could further improve the oncologic outcomes. Herein a narrative review is performed regarding the main rationale in combining immunotherapy and target therapies with SBRT looking at the available clinical data in case of oligometastatic NSCLC, Melanoma and Kid...
10 CitationsSource
#1Bora Youn (Brown University)H-Index: 3
#2Nikolaos A. Trikalinos (WashU: Washington University in St. Louis)H-Index: 7
Last. Issa J Dahabreh (Brown University)H-Index: 41
view all 5 authors...
BACKGROUND: Limited data exist regarding the characteristics and survival outcomes of older adults with non-small cell lung cancer (NSCLC) who receive immune checkpoint inhibitors in routine oncology practice. METHODS: Using the Surveillance, Epidemiology, and End Results-Medicare linked database, we identified 1256 patients aged >/=65 years who were diagnosed with pathologically confirmed stage I to stage IV NSCLC between 2002 and 2015 and initiated nivolumab or pembrolizumab in 2016. We examin...
15 CitationsSource
#1Gishan Ratnayake (UQ: University of Queensland)H-Index: 4
#2Mihir Shanker (UQ: University of Queensland)H-Index: 4
Last. Benjamin Chua (UQ: University of Queensland)H-Index: 8
view all 10 authors...
Background: Studies suggest that combining radiotherapy (RT) with programmed cell death protein 1 (PD-1) blockade may elicit a synergistic antitumor response. We aimed to assess whether prior or concurrent RT was associated with improved disease control in patients with metastatic non-small cell lung cancer (NSCLC) treated with nivolumab. Methods: We conducted a retrospective study of patients receiving nivolumab as second or subsequent line therapy for metastatic NSCLC. Patients were categorize...
4 CitationsSource
#1Jhanelle E. GrayH-Index: 31
#2A. VillegasH-Index: 9
Last. Scott J. AntoniaH-Index: 80
view all 20 authors...
Abstract Background In the phase 3 PACIFIC study of patients with unresectable, Stage III NSCLC without progression after chemoradiotherapy (CRT), durvalumab demonstrated significant improvements versus placebo in the primary endpoints of progression-free survival (HR, 0.52; 95% CI, 0.42–65; P Methods Patients, stratified by age, sex and smoking history, were randomized (2:1) to receive durvalumab 10 mg/kg intravenously every 2 weeks or placebo, up to 12 months. OS was analyzed using a stratifie...
101 CitationsSource
#1Charu Singh (Yale University)H-Index: 2
#2Jack M. Qian (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 9
Last. Veronica Chiang (Yale University)H-Index: 38
view all 4 authors...
: OBJECTIVEConcurrent use of anti-PD-1 therapies with stereotactic radiosurgery (SRS) have been shown to be beneficial for survival and local lesional control in melanoma patients with brain metastases. It is not known, however, if immunotherapy (IT) confers the same outcome advantage in lung cancer patients with brain metastases treated with SRS.METHODSThe authors retrospectively reviewed 85 non-small cell lung cancer (NSCLC) patients with brain metastases who were treated with SRS between Janu...
24 CitationsSource
#1Sibo Tian (Emory University)H-Index: 16
#2Jeffrey M. Switchenko (Emory University)H-Index: 19
Last. Kristin Higgins (Emory University)H-Index: 29
view all 12 authors...
Abstract Background Radical treatment of metastases with stereotactic body radiotherapy (SBRT) is commonly implemented in patients receiving concurrent immune checkpoint inhibition (ICI), despite limited safety and toxicity data. The purpose of this study was to evaluate the safety and tolerability of lung SBRT with concurrent ICI. Methods Records from a single academic institution were reviewed to identify patients treated with lung SBRT and concurrent (within 30 days) ICI; a contemporaneous co...
9 CitationsSource
#1Alessio Bruni (University of Modena and Reggio Emilia)
#1Alessio BruniH-Index: 15
Last. Vieri ScottiH-Index: 19
view all 26 authors...
: Concurrent chemotherapy and radiotherapy (cCRT) is considered the standard treatment of locally advanced non-small cell lung cancer (LA-NSCLC). Unfortunately, management is still heterogeneous across different specialists. A multidisciplinary approach is needed in this setting due to recent, promising results obtained by consolidative immunotherapy. The aim of this survey is to assess current LA-NSCLC management in Italy. From January to April 2018, a 15-question survey focusing on diagnostic/...
3 CitationsSource
#1Farastuk BozorgmehrH-Index: 11
#2Adriane Hommertgen (DKFZ: German Cancer Research Center)H-Index: 4
Last. Stefan RiekenH-Index: 30
view all 12 authors...
Hypofractionated palliative radiotherapy for metastatic lung cancer patients is frequently used in order to ease pain, to increase bone stability, to treat local mass effects, or to prolong progression-free survival at critical sites. Recently introduced, immunotherapy for patients with non-squamous non-small cell lung carcinoma (NSCLC) has significantly improved outcome in this cohort. Preclinical and early clinical data suggest that the combination of photon radiation with programmed death-1 (...
8 CitationsSource
#1Mathieu Spaas (Ghent University Hospital)H-Index: 1
#2Yolande Lievens (Ghent University Hospital)H-Index: 23
For many years, conventional oncologic treatments such as surgery, chemotherapy and radiotherapy (RT) have dominated the field of non-small-cell lung cancer (NSCLC). The recent introduction of immunotherapy (IT) in clinical practice, especially strategies targeting negative regulators of the immune system, so-called immune checkpoint inhibitors, has led to a paradigm shift in lung cancer as in many other solid tumors. Although antibodies against programmed death protein-1 (PD-1) and programmed d...
18 CitationsSource
Cited By0