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S. Cedres Perez
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OA22 - Novel Trials and Biomarkers in Malignant Pleural Mesothelioma (ID 403)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:H. Pass, N. Van Zandwijk
- Coordinates: 12/07/2016, 14:20 - 15:50, Strauss 3
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OA22.01 - STELLAR - Interim Results of a Phase 2 Trial of TTFields with Chemotherapy for First Line Treatment of Malignant Mesothelioma (ID 6034)
14:20 - 14:30 | Author(s): S. Cedres Perez
- Abstract
- Presentation
Background:
Tumor Treating Fields (TTFields) are an anti-mitotic, regional treatment modality, based on low intensity alternating electric fields delivered non-invasively using a portable, home use, medical device. In-vitro, human mesothelioma cells were found to be highly susceptible to TTFields. TTFields have been shown to extend survival of patients with glioblastoma when added to standard of care chemotherapy.
Methods:
The trial will accrue a total of 80 patients with unresectable, previously untreated mesothelioma. Patients are treated with TTFields in combination with pemetrexed and cisplatin or carboplatin. Continuous TTFields at 150 kHz for a minimum of 18 hours/day are applied to the thorax together with standard dosing of chemotherapy. Inclusion criteria include ECOG 0-1, pathological evidence mesothelioma and at least one measurable lesion according to modified RECIST criteria. Patients are followed q3 weeks (CT scan q6 weeks) until disease progression. The primary endpoint is overall survival (OS) and secondary endpoints are response rate, progression free survival (PFS) and treatment-emergent toxicity. This prospective, single arm study assumes that historical control has an exponential survival distribution and a median survival of 12.1 Months (Vogelzang et al.). The sample size provides 80% power with a two sided alpha of 0.05 to detect a Hazard Ratio of 0.67 for OS, compared to the historical data.
Results:
To date, 42 patients have been enrolled in the trial with an average follow up time of 11.5 months. Median age is 67±9 (range 43-78), 79% are male and 48% smokers. 14% (6 patients) have metastatic disease and 33% (14 patients) have an ECOG score of 1. Median survival has not been reached at this time. The 12-month survival rate is 79.7% (95% CI 57.2-91.2) and median PFS is 7.3 months (95% CI 5.6-NA). No device-related serious adverse events (AEs) have been reported to date. Expected TTFields-related dermatitis was reported in 55% (23 patients). Only 2 patients had grade 3 dermatitis. The following severe (grade 3-4) systemic AEs were reported: hematological (26%), hepatobiliary (2%), respiratory (2%).
Conclusion:
These interim results of the ongoing STELLAR study demonstrated no safety concerns for the combination of TTFields to the thorax together with standard chemotherapy for previously untreated mesothelioma patients. The 12-month survival rate was significantly higher, and PFS longer, than that of historical controls reported by Vogelzang et al. Final analysis of the study will be performed after enrollment and follow up of all 80 patients in the study are completed.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-063 - Lactate Dehydrogenase (LDH) as a Surrogate Biomarker to Checkpoint-Inhibitors for Patient with Advanced Non–Small-Cell Lung Cancer (NSCLC) (ID 5073)
14:30 - 14:30 | Author(s): S. Cedres Perez
- Abstract
Background:
Effectiveness of immunotherapy has been observed in around 20% of cases, nowadays there is no accurate biomarker to select those patients (pts) who will benefit the most.
Methods:
We evaluated retrospectively pretreatment (baseline) and post-treatment (every 2 months) serum-LDH in 94 pts with NSCLC treated with anti-PD1/PDL1. Repeated measures ANOVA, Kaplan-Meier and the proportional COX model were used to examine the association of LDH with overall survival (OS). The cutoff level of LDH was 400 based on the median of the sample. (normal range 105-333 UI/L).
Results:
From July 2013 to February 2016, 94 pts were treated with immunotherapy based in anti-PD1 (77,6%) and anti-PDL1 (22,4 %), in trials at VHIO. Median age was 62 (39-86). Histological subtypes were: adecocarcinoma 53.2%, squamous 42.5%, others 4.2 %. The OS was significantly different in pts treated with immunotherapy according to baseline LDH, if LDH ≥ 400 median OS was 8.2 months, while in pts with LDH <400 median survival was not reached (Figure 1) Figure 1 There were statistically significant differences in the evolution of LDH, with better responses if there was a downward trend in LDH levels. In long responding pts (45 of 94 pts), defined as ≥ 3 evaluations (6 months), a LDH level at the time of 6 months treatment below than the baseline LDH predicts better responses (22/45 pts): 68.2% partial response (RP); 18.2% stable disease (SD); 13.6% disease progression (PD). In contrast, when LDH at third evaluation was higher than baseline LDH (23/45 pts): 39.1% PR; 56.5% SD; 4.3% PD, (p=0.022). There were differences between the level of LDH pre and post-progression. 66.67% of patients who progressed had a higher level of LDH at the time of progression than at the previous assessment (p=0.03).
Conclusion:
LDH may be a potential predictive biomarker of survival benefit conferred by immunotherapy in patients with NSCLC.
