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E. Nadal
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P1.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 224)
- Event: WCLC 2015
- Type: Poster
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.08-008 - Efficacy of Palliative Chemotherapy in Malignant Pleural Mesothelioma from Spanish BEMME Database. The Spanish Lung Cancer Group (SLCG) (ID 2356)
09:30 - 09:30 | Author(s): E. Nadal
- Abstract
Background:
Palliative chemotherapy with cisplatin and antifolate (pemetrexed or raltitrexed) conferred a median overall survival of 12 months with a response rate of 24% to 43% in malignant pleural mesothelioma (MPM) patients. BEMME (Base Epidemiológica Mesotelioma Maligno en España) is an observational and retrospective study sponsored by the Spanish Lung Cancer Group that aimed to characterize the patient’s and tumor’s features as well as the treatment modalities outcomes of patients diagnosed with mesothelioma in Spain.
Methods:
Clinical records of patients with malignant pleural mesothelioma were retrospectively reviewed to collect epidemiological and survival data into an electronic and anonymous database. Thirty-five Spanish hospitals participated in the project and 538 MPM patients were included in the BEMME database. Here we present a descriptive analysis of MPM patients (stage III and IV) treated with palliative chemotherapy.
Results:
From January 2008 to December 2013, 297 of 538 patients (p) (55%) with MPM were treated with palliative chemotherapy. Most patients were males (79%), aged between 60-70y (40%), and 60% had a performance status 1 at diagnosis. No exposure to asbestos was reported in 54% of patients. Epithelioid was the most frequent histological subtype (66%), followed by sarcomatoide (12%), biphasic (9%) and not specified (14%). In stage IV, the most frequent metastatic site was lung (35%). Among patients who received chemotherapy, 55% were treated with palliative intent and reached a disease control rate (CR+PR+SD) of 62%. Platinum plus pemetrexed was the most common schedule used as a palliative treatment, without differences in ORR according to platinum-based agent used (Cisplatin: 36% vs. Carboplatin: 32%). A total of 61 of the 297p (21%) received maintenance treatment with an ORR of 10% and stable disease in 50% of p. The median overall survival (OS) for all patients was 12.6 months (95% CI 10.8 – 14.3). There were statistically significant differences in OS according histological subtype. The median OS for epithelioid was significantly longer (15 months, 95% CI 13.8-18) as compared with non-epithelioid (7 months 95% CI 4.3-9, p<0.001). There were no statistically significant differences in OS according to gender, asbestos exposure or type of platinum chemotherapy (Cisplatin 15.2 months 95% CI: 13.7-18.75; vs. Carboplatin 18 months 95% 12-25.3, p=0.32).
Conclusion:
In Spain, OS of MPM patients treated with platinum palliative chemotherapy exceeded the median OS reported in phase III trials.
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-091 - Multicenter, Randomized, Double-Blind Study of Erlotinib plus Ramucirumab or Placebo in Patients with EGFR Mutation-Positive Metastatic NSCLC (ID 1560)
09:30 - 09:30 | Author(s): E. Nadal
- Abstract
Background:
Ramucirumab, a human IgG1 monoclonal antibody, binds to Vascular Endothelial Growth Factor (VEGF) Receptor 2, preventing binding of VEGF-A, C and D. Ramucirumab in combination with docetaxel has demonstrated improvement in overall survival, progression free survival (PFS), objective response rate and disease control rate in 2nd line treatment of NSCLC patients in the phase III REVEL study, which included non-squamous and squamous cell carcinoma patients. Although erlotinib is recognized as one of the standard of care options in the frontline treatment of patients whose tumors harbor an Epidermal Growth Factor Receptor (EGFR) mutation, it is hypothesized that the duration of disease control would be greater when an antiangiogenic agent such as ramucirumab is added to erlotinib. This global phase Ib/III trial will assess safety, tolerability and efficacy (phase III) of the combination of ramucirumab with erlotinib in previously untreated stage IV NSCLC patients harboring activating EGFR mutations. The trial is planned to be conducted in ~120 sites in the Americas, Europe, and Asia and is currently open for enrollment. (RELAY, NCT02411448)
Methods:
In part A (phase Ib) approximately 12 patients (6 Japan + 6 US/EU) will receive ramucirumab (10mg/kg on day 1) every two weeks + erlotinib (150 mg/day). DLT assessment will be performed after patients complete four weeks of treatment. In part B (phase III), approximately 450 patients will be randomized in a 1:1 ratio to receive ramucirumab or placebo every two weeks with erlotinib until disease progression, unacceptable toxicity, or other withdrawal criteria are met. The primary endpoint is PFS. There are 3 planned interim analyses that will evaluate safety, futility and efficacy, respectively. Other secondary endpoints include overall survival, objective response rate, disease control rate, duration of response, safety and quality of life.
Results:
Not applicable
Conclusion:
Not applicable
