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Isidoro Barneto
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OA01 - Improving Outcomes in Locoregional NSCLC I (ID 892)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 10:30 - 12:00, Room 107
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OA01.05 - Phase II Study of Neo-Adjuvant Chemo/Immunotherapy for Resectable Stages IIIA Non-Small Cell Lung Cancer- Nadim Study-SLCG (ID 12907)
11:15 - 11:25 | Author(s): Isidoro Barneto
- Abstract
- Presentation
Background
The combination of chemotherapy and immunotherapy (CT-IO) has a high response rate and longer survival in unselected patients (pts) with metastatic non-small cell lung cancer (NSCLC). There are no data about this combination in the neoadjuvant setting.
a9ded1e5ce5d75814730bb4caaf49419 Method
A Phase II, single-arm, open-label multicenter study of local-advanced resectable stage IIIA N2-NSCLC adult patients with CT plus IO (nivolumab (NV)) followed by adjuvant treatment for 1 year. Neoadjuvant treatment: Three cycles of NV 360mg IV Q3W + paclitaxel 200mg/m2 + carboplatin AUC 6 IV Q3W. After completing neoadjuvant therapy, tumor assessment is performed in patients prior to surgery. Surgery is performed in the 3rd or 4th week after day 21 of the third cycle of neoadjuvant treatment. Adjuvant treatment: NV 240mg IV Q2W for 4 months and NV 480mg IV Q4W for 8 months (total one year) after surgical resection. The study aims to recruit 46 pts. The primary endpoint is Progression-Free Survival (PFS) at 24 months. Efficacy is explored using objective pathologic response criteria. We present preliminary data on patients that completed 3 cycles and underwent surgical resection.
4c3880bb027f159e801041b1021e88e8 Result
At the time of submission, 46 pts had been included and 20 underwent surgery. CT-IO was well-tolerated and surgery was not delayed in any patient. None of the pts was withdrawn from the study preoperatively due to progression or toxicity.
Twenty surgeries had been performed and all tumors were deemed resectable. The overall clinical response rate was 5% complete (CR) and 65% PR. The pathological response evaluated after surgery: 13 cases (65.0%) achieved CR (CPR) (95% CI 40.8-84.6%), and 3 (15.0%) had a major pathologic response (MPR), defined as <10% viable tumor cells in the resection specimen. Considering both CPR and MPR, the overall response rate was 80.0% (95% CI 56.3-94.3%) and 60% of complete responses were unsuspected
8eea62084ca7e541d918e823422bd82e Conclusion
This is the first multicentric study testing CT-IO in the neoadjuvant setting with promising antitumor activity in locally advanced, potentially resectable NSCLC yields an unprecedented complete pathologic response rate. The data will be updated at the time of the congress. EudraCT Number: 2016-003732-20
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P2.04 - Immunooncology (Not CME Accredited Session) (ID 953)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.04-24 - Nivolumab in the "Real World": Are the Results of Clinical Trials Reproducible? (ID 12404)
16:45 - 18:00 | Author(s): Isidoro Barneto
- Abstract
Background
It have passed more than two years since the approval of nivolumab in the second or third lines of treatment of non-small cell lung cancer (NSCLC) in advanced or recurrent stages, so that we know the results in patients in our area.
a9ded1e5ce5d75814730bb4caaf49419 Method
The main objective of this study is to analyze the results in a "real" population of different hospitals in Spain since we will be able to compare our results with the once published previously.
We have reviewed 129 patients with NSCLC, advanced or recurrent stages, treated with nivolCutumab either in second and subsequent lines of treatment, after progression to a platinum-based scheme from its expanded use until April 2018, in five hospitals in Spain.
The information was collected retrospectively of clinical, analytical, pathological and treatment characteristics of the patients. Statistical analysis was performed using the SPSS software vs 21.0, considering the statistical significance if p <0.05
4c3880bb027f159e801041b1021e88e8 Result
With a median follow-up of 6 months (0-31), the overall survival (OS) was 9 months (5.86-12.14).
8eea62084ca7e541d918e823422bd82e Conclusion
Patients with ECOG 0-1 presented a median OS of 11 months compared to 3 months of median OS in patients with ECOG 2 (p: 0.001)
If the response to previous treatment was complete response, partial response or stabilization of the disease, they will have a median OS of 12 months compared to 6 months if the best response was progression (p: 0.002).
There is also a statistically significant difference in terms of overall survival in relation to the existence of toxicity for immunotherapy or not (median of 13 versus 6 months p: 0.004).
The overall survival of patients who had progressed beyond 6 months after the start of treatment with prior chemotherapy was significantly greater than patients who had progressed in the first 6 months after the start of chemotherapy (median of 4 months versus median of 13 months, p: 0.001)
Immunotherapy has come to stay taking part of the usual clinical practice of patients with lung cancer. The results obtained in our population are comparable to those previously published, with an important group of patients that responded to immunotherapy or stabilized even for a long time. However, we highlight that also there is a percentage of patients, who progress early. We see fundamental to find or recognize, not just the ideal biomarker that helps to predict response, but those clinical characteristics that can make us presage a poor result.
6f8b794f3246b0c1e1780bb4d4d5dc53
