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M. Steele
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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-037 - Clinical Safety of Combinational Therapy of Immune Checkpoint Inhibitors and Viscum Album L. in Patients with Advanced or Metastasized Cancer (ID 5056)
14:30 - 14:30 | Author(s): M. Steele
- Abstract
Background:
Newly approved anti-PD-1/PDL-1 and anti-CTLA-4 immune checkpoint monoclonal antibodies (ICM) significantly improve overall survival in advanced or metastasized melanoma and lung cancer. Viscum album L. (VA) may improve survival and supports health related quality of life in cancer patients. The primary objective of the present study was to determine the safety profile of combinatory ICM/VA therapy in advanced or metastasized cancer.
Methods:
Safety of ICM/VA therapy was examined in an observational open phase IV study in a certified Oncology Centre. ICM or combinational ICM/VA therapies were applied in patients with progressive or metastasized cancer (non-small cell lung cancer or melanoma) in an integrative oncology setting. Toxicity rates of both therapy groups were compared. Evaluation of disease response was performed.
Results:
A total of 16 cancer patients were treated with nivolumab (75%), ipilimumab (19%) or pembrolizumab (6%). The median age of the study population was 64 years; 44% were male. 11 patients were diagnosed with lung cancer (69%), 4 patients with malignant melanoma (25%) and one patient with a pleural mesothelioma (6%). 9 patients received VA (ICM/VA: 56%) and the remaining 7 received no VA treatment during ICM treatment (ICM: 44%). The adverse event rate for patients treated with combinational ICM/VA was not statistically different from the rate in patients treated with ICM therapy alone (67% vs. 71%, p = 0.060). 73% of adverse events in the ICM/VA group were suspected ICM reactions according to SmPCs. 19% of the total patient cohort showed partial disease response to ICM therapy in line with reported rates in literature. No statistical significant differences were seen between both groups with respect to partial disease response (ICM/VA: 22% vs. ICM: 14%, p > 0.999) and stable disease rates (ICM/VA: 33% vs. ICM: 86%; p = 0.060).
Conclusion:
This is the first study evaluating the clinical safety profile of immune checkpoint inhibitors in combination with VA in patients with advanced or metastasized cancer. These results indicate that concomitant VA application may not alter adverse event rates in patients treated with nivolumab, ipilimumab or pembrolizumab. Positive ICM-induced disease response has been maintained during additive VA therapy. Adverse event rates and partial disease response rates of the present study were within the range of reported rates. Further prospective studies in larger study cohorts should focus on the assessment of clinical efficacy, pharmacology and quality of life in patients with combinational ICM/VA therapy.
