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Antonio Santo
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P1.16 - Treatment in the Real World - Support, Survivorship, Systems Research (ID 186)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Treatment in the Real World - Support, Survivorship, Systems Research
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.16-43 - Prevalence of Clinical and Sub-Clinical Malnutrition in Advanced Non-Small-Cell Lung Cancer Patients and Association with Outcome (ID 1757)
09:45 - 18:00 | Author(s): Antonio Santo
- Abstract
Background
While weight loss and lean body mass wasting are common hallmarks of non-small-cell lung cancer (NSCLC), their early detection and management are usually overlooked in clinical routine. The present study aimed to explore the prevalence of malnutrition and its correlation with outcome in advance (A)-NSCLC pts.
Method
A-NSCLC pts treated at AOUI of Verona (2016-2018) received nutritional counseling by a qualified dietitian. Prevalence of malnutrition was assessed by nutritional screening score (NRS). Bilateral psoas major muscles were measured at L3 vertebrae level with routine staging-computed tomography (CT). Changes in psoas muscles observed in subsequent scans were evaluated using Wilcoxon signed-rank test. Clinical, pathological and nutritional data were correlated to progression-free/overall survival (PFS/OS) and response rate (ORR) using a Cox and logistic regression model. Kaplan-Meier curves were compared with Log-Rank.
Result
Data from 38 pts (20 males [52.6%], 18 females [47.4%]) were gathered (median age 59 years [range 42-82], with a median follow-up of 21 months (range 1-197). At baseline, 18.4% were underweight, 18.4% normal weight, 34.2% overweight and 31.6% obese. The majority (65.8%) were at risk of malnutrition (NRS≥3). At multivariate analysis, stage (HR 4.99, 95% CI 1.05-27.74, p = 0.04), performance status (HR 4.99, 95% CI 1.55-16.03, p = 0.007) and NRS (HR 7.61, 95% CI 1.52-38.11, p = 0.01), were significant independent predictors for PFS. Pts with baseline NRS≤3 had significantly longer 1-year PFS (58.6% vs 16.7%, p = 0.04) and 2-year OS (90.6% vs 68.3%, p = 0.03) and a better ORR than those with NRS > 3 (66.7% vs 21.4%). Conversely, BMI did not affect PFS/OS. A significant loss in psoas muscle mass was detected in pts treated with both immunotherapy and other therapies (p = 0.01 and p=0.002, respectively). Of interest, in immunotherapy-treated pts (n = 16) loss in psoas muscle mass correlated with worse ORR, PFS and OS, although differences did not reach a statistical significance due to the limited sample.
Conclusion
Our analysis suggests that malnutrition has a detrimental impact on ORR, PFS and OS in A-NSCLC. Particularly, in pts treated with immunotherapy, muscle mass wasting seems to impact on efficacy outcome, suggesting a potential interaction between immunological and nutritional parameters. Therefore, the introduction in the clinical routine of a comprehensive nutritional profiling and monitoring, beyond body weight and BMI, is highly recommended in A-NSCLC. A comparison between NSCLC pts who underwent a personalized nutritional intervention during therapy and who did not is ongoing, together with a series of biomolecular analysis.
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P2.04 - Immuno-oncology (ID 167)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.04-49 - Nivolumab Plus Ipilimumab (NI) Versus Chemotherapy Plus Nivolumab (CN) in Squamous Cell Lung Cancer (SqCLC): The SQUINT Trial (ID 1557)
10:15 - 18:15 | Author(s): Antonio Santo
- Abstract
Background
Treatment landscape for patients with advanced NSCLC is rapidly evolving, with recent randomized phase III trials demonstrating superiority of chemo-immuno combinations versus chemotherapy alone. Role of chemo-free combinations, including NI, is under investigation with limited available data. Aim of the present trial is to investigate outcome of SqCLC patients when treated with NI or CN.
Method
SQUINT (NCT03823625) is an open-label, randomized, parallel, non-comparative phase II study designed to assess the efficacy of NI (Arm A) or CN (Arm B) in patients with advanced, metastatic SqCLC. Eligibility requires age ≥ 18 years, histologically confirmed stage IV or recurrent stage IIIB SqCLC, p63+/p40+ and TTF- tumour tissue, availability of PD-L1 status, no prior systemic therapy, ECOG performance status 0-1, adequate organ functions. Key exclusion criteria include concomitant radiotherapy or chemotherapy, prior treatment with immune checkpoint inhibitors, untreated brain metastases, other serious illness or medical condition potentially interfering with the study or with NI administration. Patients are randomly assigned 1:1 to receive N 360 mg Q3W plus I 1 mg/kg Q6W (Arm A) or plus platinum-based chemotherapy up to 6 cycles plus nivolumab 360 mg Q3W (Arm B), and stratified by PD-L1 expression (<1% versus ≥1%), presence of bone metastases (yes/no) and liver metastases (yes/no). In both arms, immunotherapy is given until disease progression, unacceptable toxicity, patient refusal and in any case for up to 24 months. Primary endpoint is 1-year overall survival (OS) rate in Arm A and B. Secondary endpoints include: response rate (RR), duration of response (DoR), median progression free survival (PFS) and median OS in Arm A and B, and according to predefined stratification factors. Sample size has been calculated assuming for each arm a minimum acceptable 1-year OS rate of 40% and an auspicated 1-year OS rate of 60%, a power of 90% and a one side significant level of 0.05. Based on such premises, the total number of patients required for the study is 112.
Result
At the time of this analysis a total of 11 Italian Centers are recruiting and 25 subjects have been enrolled.
Conclusion
We expect to conclude enrolment by January 2020.
