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DIANA Giannarelli
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-53 - Bone Metastases and Efficacy of Immunotherapy in Patients with Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC) (ID 11980)
16:45 - 18:00 | Author(s): DIANA Giannarelli
- Abstract
Background
Approximately 40% of NSCLC patients develop bone metastases (BoM). Bone has active functions in regulating immune system. To date, no trial evaluated the role of BoM in modulating response to immunotherapy. Aim of the present study was to investigate whether presence of BoM impact on immunotherapy efficacy.
a9ded1e5ce5d75814730bb4caaf49419 Method
Two different cohorts of pretreated NSCLC patients (cohort A: Non-squamous; cohort B: Squamous) were evaluated for nivolumab efficacy in terms of objective response rate (ORR), progression free survival (PFS), and overall survival (OS) according to presence or absence of BoM. All patients received nivolumab at standard dose of 3 mg/kg every 2 weeks within the Italian Expanded Access Program.
4c3880bb027f159e801041b1021e88e8 Result
Cohort A accounted for 1588 patients with non-squamous NSCLC: 626 (39%) with (BoM+) and 962 (61%) without BoM (BoM-). Cohort B accounted for 370 patients with squamous histology: 102 BoM+ (32%) and 251 BoM- (68%). In Cohort A, BoM+ had a significantly lower ORR (12% versus 34%; p < 0.0001), shorter PFS (2.0 versus 4.0 months, p < 0.0001) and shorter OS (7.4 versus 15.3 months, p <0.0001). In cohort B, BoM+ had significantly lower ORR (15% versus 22%; p < 0.04), shorter PFS (2.7 versus 5.4 months, p <0.0001) and shorter OS (5.0 versus 10.9 months, p <0.0001). Presence of BoM negatively affected outcome irrespective of PS (OS cohort A: PS-0 BoM+ 12.0 versus 20.9 months in PS-0 BoM-, p<0.0001; OS cohort B: PS-0 BoM+ 5.8 versus 16.4 months in PS-0 BoM-, p<0.0001). Multivariate analysis confirmed that presence of BoM independently associated with higher risk of death with HR 1.64 and HR 1.78, for Cohort A and B, respectively.
8eea62084ca7e541d918e823422bd82e Conclusion
Our results, the first assessing BoM in patients treated with immunotherapy, suggested that BoM predict lower efficacy of immunotherapy. BoM should be included as stratification factor in clinical trials.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P1.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 947)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.15-01 - Radiotherapy (RT) and Nivolumab in Non-Small-Cell Lung Cancer (NSCLC): A Multicenter Real-Life Experience (ID 12194)
16:45 - 18:00 | Author(s): DIANA Giannarelli
- Abstract
Background
The combination of RT and programmed death 1 (PD-1) inhibitors seems augment antitumor immune responses. The aim of this study was to assess the outcome of patients (pts) with NSCLC previously undergone to RT before receiving nivolumab, a PD-1 inhibitor
a9ded1e5ce5d75814730bb4caaf49419 Method
We conducted an observational, retrospective analysis of 95 consecutive pts with advanced NSCLC who received any RT within 10 months prior nivolumab, as clinically indicated, at seven Italian institutions. Tumor response to treatment was defined according to RECIST criteria version 1.1. Median overall survival (OS) and the 95% confidence interval (CI) were estimated with the Kaplan -Meier method.
4c3880bb027f159e801041b1021e88e8 Result
95 pts (median age 66 years [range 41-82]; male:63.2%) with advanced NSCLC (adenocarcinoma [adc]:66.3%; squamous cells [sqc]:33.7%) were treated with nivolumab after RT. Median OS was 11.9 months (mo) [95% CI, 6.6-17.2 (adc: 13.0 mo [95% CI,6.7-19.3], sqc 10.5 mo [95%CI,3.9-17.1]). Median progression free survival (PFS) was 6.3mo [95% CI,4.6-8.0] (adc: 6.4 mo[ 95% CI,4.5-8.3]; sqc: 3.7 mo [95% CI,0.0-8.3]). A better performance status (PS) according to ECOG scale was associated with an improved OS (PS 0[38 pts]: 17.9 mo [95% CI,12.3-23.5; p<0.0001]; PS1[50pts]: 6.9 mo [95%CI,3.2-10.6]; PS2[7pts]: 4.4 mo [95% CI,3.9-4.9]). Median OS in 70 pts who received ≤ 1 previous systemic therapy was 13.0 mo [95% CI, 10.4-15.6] and in 25 pts who received ≥2 prior lines was 7.4 mo [95% CI, 1.8-12.9]. Median OS in 69 pts (72.6%) receiving extracranical RT was 12.0 mo [95%CI,6.6-17.4] and in 26 (27.4%) pts with cranial RT was 11.7 mo [95%CI,NE]; p=0.31. Median OS was shorter in 36 pts receiving bone-RT [7.3 mo; 95% CI, (0-15.3)] when compared with 59 pts receiving extra-bone RT [14.4 mo; 95% CI, (10.3-18.5); p=0.007]. Median OS in 68 pts aged < 70 years was 11.9 mo [95% CI,6.5-17.3] and in 27 elderly (≥ 70 years) was 12.0 mo [95% CI, 3.8-20.1]. 1 (1.0%) complete response, 25(26.3%) partial response, 28(29.5%) stable disease and 41 (43.2%) progressive disease have been observed.
8eea62084ca7e541d918e823422bd82e Conclusion
This study shows that combining irradiation with nivolumab for the treatment of advanced NSCLC leads to improve OS and promote tumor control both locally and distantly.This potentially synergistic effect was comparable among pts regardless previous lines of therapy, histology, type of RT and age.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P3.08 - Oligometastatic NSCLC (Not CME Accredited Session) (ID 974)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.08-04 - OMEGA, A Randomized Trial of Local Ablative Therapy Vs. Conventional Treatment in Oligometastatic NSCLC – Trial in Progress (ID 13971)
12:00 - 13:30 | Author(s): DIANA Giannarelli
- Abstract
Background
A recent randomized phase 2 study has shown that local ablative therapy in addition to systemic treatment was superior to maintenance therapy in prolonging disease-free survival in NSCLC patients harboring up to three metastatic sites.
Oligometastatic lung cancer (OM-NSCLC) seems thus to be associated with a better prognosis than usual Stage IV non-small cell lung cancer when radical local therapy of all metastatic sites is administered but the impact of such an approach on overall survival and quality of life remains unclear
a9ded1e5ce5d75814730bb4caaf49419 Method
A consortium of tertiary referral centres involved in Lung Cancer management at the national level was established with the aim of setting up a randomized trial addressing this issue
4c3880bb027f159e801041b1021e88e8 Result
A randomized trial of local ablative therapy in OM-NSCLC patients with potentially resectable or locally controlled primary tumors has been designed and 7 tertiary referral centers agreed to participate
Patients with synchronous or metachronous oligometastatic lung cancer (1-3 metastatic lesions) will be randomized to local ablative therapy + standard treatment Vs. standard treatment.
Balancing between study arms will be performed according to synchronous vs. metachronous presentation, Number of oligometastases, Nodal status and Oncogene-addiction or PDL-1 expression.
Primary outcome will be Overall Survival (OS) from randomization. The sample size is set to 195 patients.
Inclusion criteria include adequate performance status, primary tumor controlled or controllable staging with whole-body FDG PET scan and brain MRI, fit to receive at least 3 cycles of platinum-based doublet chemotherapy, or immunotherapy or targeted agents according to molecular profile.
Exclusion criteria include cerebral oligometastasis alone (will receive local therapy in any case),
metastasis in sites where normal radiotherapy constraints cannot be met, multiple subsolid nodules in the absence of extrapulmonary metastasis, prior malignant tumor with some exceptions, relevant co-morbidities that would significantly reduce life expectancy on their own,
Disease state and life status assessed on a 2-monthly basis by physical examination, whole-body CT scan plus repeat PET-scan if needed and Brain MRI if brain metastasis at enrolment. Toxicity and adverse events will be assessed according to NCI-Common Terminology Criteria. Quality of life will be assessed at randomization and after six months by the SF36/LCSS.
8eea62084ca7e541d918e823422bd82e Conclusion
There is a clear need for randomized controlled trials with overall survival as their main endpoint to confirm whether local ablative therapy indeed has a role in the management of oligometastatic lung cancer. The Omega trial will try to respond to such a need.
6f8b794f3246b0c1e1780bb4d4d5dc53
