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Background: In a Spanish Lung Cancer Group (SLCG) phase II trial, the combination of BRCA1 and receptor-associated protein 80 (RAP80) expression was significantly associated with outcome in Caucasian patients with nonsmall-cell lung cancer (NSCLC). The SLCG therefore undertook an industry-independent collaborative randomized phase III trial comparing nonselected cisplatin-based chemotherapy with therapy customized according to BRCA1/RAP80 expression. An analogous randomized phase II trial was carried out in China under the auspices of the SLCG to evaluate the effect of BRCA1/RAP80 expression in Asian patients.Patients and methods: Eligibility criteria included stage IIIB-IV NSCLC and sufficient tumor specimen for molecular analysis. Randomization to the control or experimental arm was 1 : 1 in the SLCG trial and 1 : 3 in the Chinese trial.

BackgroundThere have been few large-scale, real world studies in Spain to assess change in pain and quality of life (QOL) outcomes in cancer patients with moderate to severe pain. This study aimed to assess changes on both outcomes after 3 months of usual care and to investigate factors associated with change in QoL.Patients and methodsLarge, multi-centre, observational study in patients with lung, head and neck, colorectal or breast cancer experiencing a first episode of moderate to severe pain while attending one of the participating centres. QoL was assessed using the EuroQol-5D questionnaire and pain using the Brief Pain Inventory (BPI). Instruments were administered at baseline and after 3 months of follow up. Multivariate analyses were used to assess the impact of treatment factors, demographic and clinical variables, pain and other symptoms on QoL scores.Results1711 patients were included for analysis. After 3 months of usual care, a significant improvement was observed in pain and QoL in all four cancer groups (p<0.001). Effect sizes were medium to large on the BPI and EQ-5D Index and Visual Analogue Scale (VAS). Improvements were seen on the majority of EQ-5D dimensions in all patient groups, though breast cancer patients showed the largest gains. Poorer baseline performance status (ECOG) and the presence of anxiety/depression were associated with significantly poorer QOL outcomes. Improvements in BPI pain scores were associated with improved QoL.ConclusionIn the four cancer types studied, pain and QoL outcomes improved considerably after 3 months of usual care. Improvements in pain made a substantial contribution to QoL gains whilst the presence of anxiety and depression and poor baseline performance status significantly constrained improvement.

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7095 Background: Low molecular weight heparins (LMWH) could improve therapeutic outcomes in patients with advanced cancer. Heparin binding growth associated molecule is a member of growth factors involved in proliferation, angiogenesis and metastases in SCLC. LMWH associated with CT increase survival in cancer patients (Cochrane DB Systematic Reviews 2011). LMWH do not increase hemorrhagic events when used in neoplastic patients. Methods: Open randomized phase II multicentric trial to assess efficacy and safety of adding bemiparin to standard CT-RT in patients with SCLC with limited disease. CT: Cis/carboplatin + etoposide x 4-6 cycles. Concurrent early thoracic RT (45-50 Gy) and prophylactic cranial irradiation in case of response. Patients (p) were randomly allocated to addition of B at daily subcutaneous dose of 3.500 UI during 26 weeks. Primary end-point: progression free survival (PFS). Secondary end-points: response (RECIST), safety profile (CTC), venours thromboembolic (VTE) and hemorrhagic events incidence and overall survival (OS). Sample size 130 p. Preplanned interim analysis after inclusion 30 p. Results: From October-05 to January/10 39 p were included. Study was closed after interim analysis due to poor recruitment. 38 evaluable p. ITT analysis: 20 CR-RT + B vs 18 CT-RT. No significant disbalance in patient characteristics and prognostic factors. Median PFS 58.6 weeks (CT-RT+B) vs 38.8 w (CT-RT) (HR 2.576; Log-rank p=0,018). RR: 65% (CT-RT+B) vs 55% (CT-RT) (NS); Median OS 161.8 w (CT-RT+B) vs 49.3 w (CT-RT) (HR 2.96; Log-rank p=0,012). 2-year survival rate: 68.6% (CT-RT+B) vs 29.4% (CT-RT) (p=0,0042). Safety: G3-4 AE: 50% vs 67%; bleeding events: 10% vs 27% (NS); thrombocytopenia 15% vs 50% (p=0.024); VTE: 0 vs 22% (p=0.041). Conclusions: Addition of B (3.500 u/daily s.c. during 26 w) to CT-RT in SCLC with LD significantly increases PFS and OS. B does not increase hemorragic events and significantly reduces VTE. In spite of early closure of the trial due to poor accrual, these results warrants further research in this approach trying to improve current outcomes of SCLC. ClinicalTrials.gov Id: NCT00324558.

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