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J.L. González-Larriba
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ORAL 04 - Adjuvant Therapy for Early Stage Lung Cancer (ID 99)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Localized Disease - NSCLC
- Presentations: 1
- Moderators:E. Vallieres, Y. Ohe
- Coordinates: 9/07/2015, 10:45 - 12:15, 205+207
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ORAL04.05 - Results Ph III Trial Customized Adjuvant CT after Resection of NSCLC with Lymph Node Metastases SCAT: A Spanish Lung Cancer Group Trial (ID 2983)
11:28 - 11:39 | Author(s): J.L. González-Larriba
- Abstract
- Presentation
Background:
Postop platinum-based CT improves outcomes in completely resected NSCLC with nodal involvement (St II-IIIA) but compliance and outcomes remain limited. Analysis of expression of genes involved in DNA repair could be used to individualize optimal CT. BRCA1 is primarily involved in the repair of double strand DNA breaks and functions as a differential regulator of response to cisplatin (Cis) and antimicrotubule agents. BRCA1 defficiency can enhance Cis resistance. Loss of BRCA1 function is associated to sensitivity to DNA-damaging CT and may also be associated with resistance to spindle poisons
Methods:
Randomized phase III multicenter trial. After surgery patients (p) with St II and III NCSLC were random 1:3 to control arm (3 cycles Cis-Docetaxel) or to experimental arm with treatment assigned according BRCA1 expression levels (low levels: Cis-Gemcitabine; intermediate levels: Cis-Doc; high levels: Docetaxel alone). Stratifification factors: N1 vs N2; age < or > 65 y; non-Squamous vs Squamous (Sq) histology; lobectomy vs pneumonectomy). Planned PORT in N2. Primary end-point OS. Secondary end-points DFS, toxicity profile (CTCAE v 3.0) /compliance, recurrence pattern. Statistical hypothesis: increase 20% 5y survival rate control group (45%)
Results:
From June/2007 to May/2013, a total of 591 p were screened and 500 of them were randomized in the study, 108 in control arm, 392 in experimental arm. In experimental arm 110 p received Cis-Gem, 127 Cis-Doc and 110 Doc alone. There were no significant differences between arm for known prognostic factors: Median age 64 y; 79% males, 21% females; 43% Sq, 49% Adenoca, 8% others; 57% former smokers, 32% current smokers, 11% never smokers; pneumonectomy 26%; N1 58%, N2 48%. Median tumor size 4.4 cm (0.8-15.5 cm). Median mRNA BRCA1 levels 15.78 (0.73-132). Mean BRCA1 levels 6.95 in Adenoca vs 20.29 in Sq (p<0.001). P with Sq histology showed a longer DFS (HR 0.73; p=0.05) but without differences in OR (HR 1) Median follow-up 28 months (0-79 m), with a cut-off of March 15[th] 2015, median survival has not reached both arms and no significant differences have been seen for OS with hazard ratio (HR) 0.866 (p=0.45) or DFS with HR 1. In experimental group HR for OS was 0.842 (NS) comparing low with high-BRCA1 levels. In p with high-BRCA1 levels control treatment (Cis-Doc) was superior to experimental (Doc) with HR 1.24 (NS).In non-Sq histology experimental treatment was superior to control with HR 0.75. For p receiving all planned treatment HR is 0.63 with p = 0.043 compared with p not able to complete treatment.
Conclusion:
Overall survival data are still immature because median survival is not reached with a median f-u 28 m for this N+ population. At this time analysis BRCA1 based adjuvant CT does not improve overall OS. In p with high BRCA1 levels Doc alone is inferior to Cis-Doc. BRCA-1 levels are higher in Sq and in non-Sq histology a trend to better survival in experimental arm was found. Full dose of planned treatment confers a survival advantage, however, longer follow-up is still warranted.
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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): J.L. González-Larriba
- 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.
