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MA 10 - Immunotherapy I (ID 664)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Immunology and Immunotherapy
- Presentations: 1
MA 10.06 - Real-World Results in Non-Squamous Non-Small Cell Lung Cancer Patients: Italian Nivolumab Expanded Access Programme (ID 9580)
11:00 - 12:30 | Author(s): D. Signorelli
Nivolumab monotherapy has shown survival benefit in patients (pts) with different tumors, including melanoma, lung cancer, renal cell carcinoma, head and neck cancer and Hodgkin lymphoma. Controlled clinical trial setting differs from what experienced by pts and physicians in routine clinical practice. Here, we report efficacy and safety results of nivolumab in pts with non-squamous non-small cell lung cancer (Non-Sq-NSCLC) treated in the Expanded Access Programme in Italy.
Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV non-Squamous NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received at least one dose of nivolumab and were monitored for adverse events (AE) using Common Terminology Criteria for Adverse Events.
Overall, 1588 pts were enrolled in the EAP across 168 Italian centers. Baseline characteristics of pts were representative of Non-Sq-NSCLC population, in the advanced disease setting. As of March 2017, median overall survival (OS) was 11 months (10.0-12.0), with a median follow-up of 7.8 months (1-21.9) and a median of 7 doses (1-46). The best overall response rate (BORR) was 18%, including 10 pts (<1%) with complete response and 280 pts (17.6%) with partial response. Stable disease has been defined for 414 pts (26.0%) and totally 274 (17.2%) patients were treated beyond progression. Response rates and survival were comparable among pts regardless age (< and ≥ 75 years), presence of brain metastasis and number of prior therapies. Overall, among 1588 pts, 1254 discontinued treatment for any reason, with only 93 (7%) pts who discontinued treatment due to adverse events, in line with what observed in previous studies.
To date, this is the largest clinical experience with nivolumab in a real-world setting and these EAP data are in line with what reported in the registrative phase 3 clinical trial. According to these results, nivolumab seems to be an effective and safe therapy for pre-treated patients with non-squamous NCSLC, supporting its use in current clinical practice.
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P2.09 - Mesothelioma (ID 710)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Mesothelioma
- Presentations: 1
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
P2.09-001a - TNM or Tumor Volume for Predicting Prognosis in Malignant Pleural Mesothelioma: Still an Open Debate (ID 10192)
09:30 - 16:00 | Author(s): D. Signorelli
Malignant pleural mesothelioma (MPM) is a rare and aggressive tumor. Age, stage (TNM) and histotype are the only recognized prognostic factors but the site of disease makes staging difficult to be defined. Pleural tumor volume (TV) was suggested as an alternative in prognostic evaluation but the evidence is limited. The aim of our study was to assess the prognostic role of TV compared to that of the TNM.
Fifty-two MPM patients (pts), diagnosed in 2002-012, were retrospectively collected. A baseline CT scan was performed. Stage was defined according to TNM (7th edition) and TV was calculated using a dedicated computer system. We divided pts in 2 groups according to mean value of baseline TV(483 cm3 ; range 18-2329 cm3). Information on age, sex, histology, and surgery were collected. We evaluated disease site based on the pleural localization: mediastinal-diaphragmatic-parietal. Kaplan-Meier analysis and log-rank test were performed on OS to determine significant prognostic factors. Cox regression analysis adjusted for the prognostic factors was used for investigating their effect on OS.
Thirty-five pts were men; mean age was 62 years (range:25-74). Forty-four pts had epithelioid and 8 had mixed histology. Twenty-five pts had radical surgery. Six pts were diagnosed in early stage(I-II), 20 in III stage and 26 in IV stage. Median overall survival(OS) was 20.8 months (range:0.3–94.3). OS was significantly associated to: TV, stage (I-II, III, IV), T (T1,1B;T2;T3;T4,4B). Cox models adjusted by age, histology, sex, surgery, were used for investigating the effect of stage group and T separately on OS to avoid multicollinearity. The effect of mean TV on OS was evaluated with the Cox regression adding the number of involved sites to the above covariates. Cox regression analysis showed that: stage III (HR 3.75,95%CI 0.99-14.18;p<0.05) and IV (HR 5.43, 95%CI 1.43-20.68; p<0.01) were predictive of survival. With respect to extent of tumor, T3 and T4 were associated with worse prognosis (HR 4.99, 95%CI 1.84-13.49; p<0.002; HR 4.65, 95%CI 1.61-13.47; p<0.005 respectively). Smaller TV was associated with better survival (HR=2.37, 95%CI 1.05-5.37; p<0.04) irrespective of tumor site.
We reported a significant association between TV and prognosis. However, stage and T seem to be better prognostic factors compared to TV most likely because they provide information also on adjacent organs infiltration. Our results should be interpreted with caution, considering the retrospective nature of our series and the small sample. Further collaborative studies are needed.