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D. Signorelli
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-006 - Treatment beyond Progression in Patients with Advanced Squamous NSCLC Participating in the Expanded Access Programme (EAP) (ID 5450)
14:30 - 14:30 | Author(s): D. Signorelli
- Abstract
Background:
Response patterns of immunotherapies differ from those seen with other therapies approved for the treatment of tumors. Due to this reason, immunotherapy protocols generally allow patients (pts) to continue treatment beyond investigator-assessed radiographic progressive disease (PD) as long as there is ongoing clinical benefit, but to date no data has been reported regarding treatment beyond PD in routine clinical practice. Here we report the analysis about the subgroup of pts treated beyond initial PD in the italian cohort of nivolumab EAP for pts with squamous non small cell lung cancer (Sq-NSCLC).
Methods:
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 Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events (AE) using Common Terminology Criteria for Adverse Events. Patients were allowed to continue treatment beyond initial PD as long as they met the following criteria: investigator-assessed clinical benefit, absence of rapid PD, tolerance of program drug, stable performance status and no delay of an imminent intervention to prevent serious complications of PD.
Results:
With a median follow-up of 5.2 months (range 0-12.9), 363 pts were evaluable for response. Prior to first progression, the objective response rate (ORR) was 14%, with 1 complete response (CR) and 50 (14%) partial responses (PR), and the disease control rate (DCR) was 41%. Sixty-six pts were treated beyond RECIST defined progression, with 23 pts obtaining a non-conventional benefit, meaning a subsequent tumor reduction or stabilization in tumor lesions. In particular, 17 pts obtained a SD and 6 pts obtained a PR. As to July 2016, median overall survival in these pts had not been reached (95% CI: 3.2-4.6) and 6 months and 12 months OS were 75% and 53%, respectively. The safety profile was consistent to what already observed in the general population.
Conclusion:
As already observed in clinical trials, these preliminary EAP data seem to confirm that a proportion of pts who continued treatment beyond PD demonstrated sustained reduction or stabilization of tumor burden, with an acceptable safety profile. Further investigations are warranted in order to better define and identify pts who can benefit from treatment beyond progression.
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P3.03 - Poster Session with Presenters Present (ID 473)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.03-042 - Study Comparing Volume and TNM in Predicting Clinical Outcome in Malignant Pleural Mesothelioma (ID 6018)
14:30 - 14:30 | Author(s): D. Signorelli
- Abstract
Background:
Malignant pleural mesothelioma (MPM) is a rare cancer with relatively poor outcome. Only stage (TNM) and histotype can be considered prognostic factors, but TNM still results inaccurate and difficult to be classified. Several studies investigated the use of tumor volume (TV) for response assessment, but its role as predictor of survival is unclear. A cut-off of 600 cm[3 ]seemed to divide patients (pts) with different prognosis. Our objective is to assess the association between baseline TV, stage/TNM and overall survival (OS).
Methods:
We retrospectively selected 49 MPM pts treated from August 2002 to January 2012. All pts had a digitally available baseline chest computed tomography (CT), performed before any treatment and up to 3 months after histological diagnosis. CT staging was carried out by two thoracic radiologists according to TNM staging system (7[th] Edition). Pleural disease volume mesaurements were obtained by a computer system. Major prognostic variables (age, sex, histology, TV, stage/TNM, treatment) were collected. Pts were divided in 2 groups according to baseline TV (large volume >600cm[3]; small volume <=600cm[3]). Association of volume groups, stage, T, N, M separately and OS was tested using Cox models adjusted by age, sex, histology and surgery.
Results:
Thirty-three pts were men, 16 women; median age was 62 years (range 25-78). Forty pts had epithelioid MPM, 7 mixed histology, 2 unknown histology. Four pts were diagnosed in early stage (I-II) and 45 in advanced stage (III-IV). The mean baseline TV was 494.15 cm[3 ](range 17.91- 2,329.03). Pts with small volume had a slight but not statistically significant tendency to survive longer than pts with large volume (3-year OS=32% vs 21%, respectively). The HR was 1.5 (95% CI=0.6-3.7) for large volume pts, 4.3 (p=0.08;95%CI=0.8-22.1) and 7.5 (p=0.02;95%CI=1.4-39.9) for stage III and IV, 7.0 (p=0.001;95%CI=2.3-21) and 5.4 (p=0.005;95%CI=1.7-17.4) for T3 and T4, respectively. Regarding N and M, not statistically significant results were observed.
Conclusion:
Coherently with the available literature, we report an association between baseline TV and prognosis; however it seems weak and barely near to statistical significancy. On the contrary, stage, in particular T3, showed a stronger association with prognosis. Considering the small sample and the wide 95% CI, our results should be interpreted with caution; nevertheless they open a critical question on the TV prognostic role and suggest a greater relevance of adjacent organs infiltration in predicting prognosis. Further collaborative studies are needed.
