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T. Berghmans
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P2.07 - Poster Session/ Small Cell Lung Cancer (ID 222)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.07-005 - AVE plus Valproate for Refractory/Relapsing SCLC: A Phase II Study by the ELCWP (ID 142)
09:30 - 09:30 | Author(s): T. Berghmans
- Abstract
Background:
Salvage chemotherapy (CT) for relapsing or refractory small cell lung cancer (SCLC) to platinum-etoposide remains disappointing. In vitro experiments are suggesting that valproic acid, by inhibiting histone deacetylases (HDAC), could increase apoptosis of SCLC cell lines exposed to doxorubicin, vindesine and bis(2-chloroethyl)amine. The primary objective of this phase II study is to determine if epigenetic modulation with valproic acid in addition to a doxorubicin, vindesine, cyclophosphamide (AVE) regimen may allow adequate improved 6-months progression-free survival (PFS) in refractory/relapsing SCLC.
Methods:
Patients (pts) with previously pathologically proven SCLC, either primary or secondary refractory to prior chemotherapy regimen including platinum derivatives and etoposide, Karnofsky performance status ≥ 60, adequate haematological, hepatic, renal, lung and cardiac functions were eligible. After central registration, pts received AVE (doxorubicin 45 mg/m², vindesine 3 mg/m², cyclophosphamide 1 g/m² every 3 weeks) plus daily oral valproic acid to obtain serum concentration in the range of the recommended values for the treatment of epilepsy (50-100 μg/ml). Response was assessed after 3 courses and responders continued treatment until best response, unacceptable toxicity or cumulative dose of doxorubicin > 500 mg/m². The trial was designed to show that 6-months PFS was > 18%, powering the trial to detect an increase to at least 39%. With this assumption, at least 43 pts assessable for PFS had to be registered (a 10%, b 10%).
Results:
From 11/2008 to 12/2013, 64 pts were registered of whom 6 were ineligible. The main characteristics of the 58 eligible pts were: male/female 38/20 pts, PS 60-70/80-100 17/41 pts, median age 60 years, 19 pts received two or more previous lines of CT. Seven pts did not receive any CT leaving 51 pts assessable for the primary endpoint. Objective response rate was 19.6% (95% CI 8.7%-30.5%). Median PFS was 2.75 months (95% CI, 2.46 to 3.61) and 6-months PFS was 6%. Median survival time was 5.9 months (95% CI, 4.7 to 7.5) with 6 and 12-months survival rates of 50% and 6%. As expected, toxicity was mainly haematological with 88% and 26% grade 3-4 neutropenia and thrombopenia, respectively.
Conclusion:
Despite an interesting response rate, the addition of valproic acid to AVE did not translate into adequate PFS in relapsing/refractory SCLC to platinum/etoposide. This regimen cannot be recommended for further investigation.
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P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.04-053 - SPECTAlung: Screening Patients with Thoracic Tumors for Efficient Clinical Trial Access (ID 1386)
09:30 - 09:30 | Author(s): T. Berghmans
- Abstract
Background:
The identification of molecular alteration and its targeting has completely changed the treatment and prognosis of lung cancer. However, designing and implementing clinical trials in small subsets of patients with a particular molecular alteration is challenging because of lack of uniform screening program. Across Europe, screening for molecular alterations is center or country dependent and, generally limited to a small subset of genes. SPECTAlung is the first European standardized, quality-assured molecular screening program of the European Organization for the Research and Treatment of Cancer (EORTC) in collaboration with the European Thoracic Oncology Platform (ETOP) to facilitate clinical trial access for patients with thoracic tumors. It is expected to test 500 to 1000 patients each year with the overall goal of offering patients clinical trials with targeted agents.
Methods:
Patients sign the informed consent for their tumor tissue to be collected, centralized and processed according to defined international quality control standards at Gustave Roussy Biobank (Villejuif, France). Next Generation Sequencing (NGS) is performed at Sanger Institute (Cambridge, UK) where a panel of about 360 genes is analyzed for mutation, rearrangements and gene copy number. Eligible patients will be those having a pathological diagnosis of any thoracic tumor (lung cancer, malignant pleural mesothelioma and thymic malignancies) at any stage of disease, availability of tumor tissue, age at least 18 years, PS 0-2, life expectancy > 3 months, no active malignancy in the 5 years before study entry and absence of any exclusion criteria that may prevent inclusion into clinical trials. A molecular report will be released to the investigator highlighting identified molecular alterations and also the trials for which the patients might be eligible. The study has been submitted to ethical committees of 15 selected highly specialized and qualified thoracic centres in 12 countries in Europe. EORTC and ETOP will promote the implementation of clinical trials in molecularly selected groups of patients at the SPECTAlung centers. SPECTAlung offers innovative and attractive models of collaboration with commercial and research organizations, by improving patient access to novel therapeutic clinical trial and support the development of personalized medicine. Clinical trial registry number NCT02214134.
Results:
Not applicable
Conclusion:
Not applicable
