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M.A. Sala



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    MO25 - NSCLC - Combined Modality Therapy II (ID 112)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 1
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      MO25.01 - Interim analysis of the Spanish Lung Cancer Group (SLCG) randomized phase II trial of thoracic radiotherapy (RT) concurrent with cisplatin (P) plus oral vinorelbine (OV) or etoposide (E) for unresectable locally advanced (LA) stage III non-small cell lung cancer (NSCLC). (GECP10/02). (ID 2658)

      10:30 - 10:35  |  Author(s): M.A. Sala

      • Abstract
      • Presentation
      • Slides

      Background
      Chemoradiation is the standard of care for the treatment of unresectable LA-NSCLC. Cisplatin plus either etoposide or vinorelbine are two of the chemotherapy (CT) regimens widely used for the disease concurrently with radiotherapy. Oral vinorelbine is a formulation which has achieved comparable results to the IV vinorelbine. The purpose of the study is to evaluate the efficacy and safety of cisplatin when combined with etoposide or oral vinorelbine with radical radiation for the management of stage III NSCLC.

      Methods
      Patients (pts) between 18 and 75 years, with histologically proven untreated and unresectable LA stage IIIA/IIIB NSCLC, adequate bone marrow, hepatic and renal function, ECOG PS 0-1, were randomized to: Arm OV-P: OV 60 mg/m[2] D1, D8 cycle 1 and 80 mg/m[2] cycle 2 (if no grade 3-4 toxicity) plus P 80 mg/m[2] D1 every 3 weeks for 2 cycles as induction; patients without progression received OV 40 mg/m[2] D1, D8, and P 80 mg/m[2] D1 every 3 weeks for 2 more cycles (4 cycles in total). Arm E-P: E 50 mg/m[2] intravenously D1 to D5 plus P 50 mg/m[2] D1, D8 every 4 weeks for 2 cycles. Both regimens administered with concurrent RT 66 Gy in 6.5 weeks. The primary endpoint was progression free survival using RECIST 1.1, and secondary endpoints were overall response rate, overall survival, and safety profile. To guarantee an overall type-1 α error (one side) no greater than 0.05 and a type II (β) error 0.1 for the primary endpoint of PFS, a sample size of 134 pts allocated in a 1:1 ratio is planned.

      Results
      Since August 2011 77 pts have been recruited. 46 pts have been included in the interim analysis, 23 pts have been randomly allocated to each treatment arm. Patient’s characteristics were: Male 91.3%; median age 64 (range 44-75); PS1 56.5%; smokers 46.8%; adenocarcinoma 40.4% / squamous 55.3%; stage IIIA 46.8% / IIIB 53.2%. Median of months between initial diagnosis and study start was 1 (range 0.3-15.7). Safety: 118 cycles (cy) were analysed, 79 in arm OV-P and 39 in arm E-P. Hematological toxicities arms OV-P/E-P (% cy): grade (g) 3/4 neutropenia 8.9%/13.1%; g3 thrombocytopenia 0%/5.3%; g3 anemia 0%/2.6%; febrile neutropenia 3 cases on OV-P arm (all during induction CT on cy 1) and 1 case on E-P arm (during concurrent chemoradiation). Non-hematological toxicities arms OV-P/E-P (% cy): g3 esophagitis/mucositis 1.3%/15.5%; g3 infection without neutropenia 1.3%/5.1%. No treatment-related deaths were reported. There was no remarkable difference in other toxicities between both arms. 39 pts completed the treatment as per protocol, 19 in arm OV-P and 20 in arm E-P. Overall response rates were 73.7% and 50% for the OV-P and the E-P arm, respectively.

      Conclusion
      This interim analysis shows that OV-P and E-P when administered concurrently with RT have a manageable safety profile with efficacy. Safety data is consistent with other studies reported for both chemoradiation regimens. Based on these positive results for safety, accrual is ongoing. Clinical trial information EudraCT 2010-022927-31.

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    O15 - NSCLC - Chemotherapy II (ID 109)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      O15.02 - The Spanish Lung Cancer Group (SLCG) BRCA1-RAP80 Expression Customization (BREC) randomized phase III trial of customized chemotherapy in advanced non-small-cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor (EGFR) (NCT00617656/GECP-BREC) (ID 1157)

      10:40 - 10:50  |  Author(s): M.A. Sala

      • Abstract
      • Presentation
      • Slides

      Background
      RAP80, a component of the BRCA1 complex, influenced outcome both in p with low BRCA1 expression treated with cisplatin (cis)/gemcitabine (gem) and in p with intermediate/high BRCA1 levels treated with cis/docetaxel (doc) or with doc alone in the SLCG phase II customized chemotherapy trial (NCT00883480). Based on these findings, the SLCG and the French Lung Cancer Group performed a prospective, randomized phase III trial in metastatic NSCLC patients to compare non-customized cis/doc with customized therapy customized according to BRCA1 and RAP80 mRNA expression levels.

      Methods
      From 2008 to 2013, patients with wild-type EGFR were randomized 1:1 to the control or experimental arm. Planned accrual was 391 patients. Treatment in the control arm was cis/doc, while patients in the experimental arm received treatment according to their BRCA1 and RAP80 levels: 1) those with low RAP80, regardless of BRCA1 levels, received cis/gem; 2) those with intermediate/high RAP80 and low/intermediate BRCA1 received cis/doc; and 3) those with intermediate/high RAP80 and high BRCA1 received doc alone. The primary endpoint was progression-free survival (PFS).

      Results
      At 15 October 2012, 279 patients had been included and the planned interim analysis was performed. PFS was 5.49 months (m) in the control and 4.38 m in the experimental arm (P=0.07). Overall survival (OS) was 12.66 m in the control and 8.52 m in the experimental arm (P=0.006). Response rate (RR) was 37.3% in the control and 27% in the experimental arm (P=0.07). In the multivariate analysis including PS, treatment arm, BRCA1, RAP80, histology, smoking status and metastatic site, only extrathoracic metastases were associated with an increased risk of progression (HR, 1.78; P=0.02). In a post hoc analysis restricted to patients with ECOG PS 0, PFS was 3.91 m in the control and 7.47 m in the experimental arm (P=0.01) for those with low RAP80 levels (experimental group 1). PFS for patients in experimental groups 1, 2 and 3 was 7.47, 7.01 and 3.22 m, respectively (P=0.02). OS for patients in experimental groups 1, 2 and 3 was 28.88, 15.86 and 11.81 m, respectively (P=0.04).

      Conclusion
      Based on the negative results for PFS at the interim analysis, accrual was closed on this study. The negative results may be due to the poor predictive capacity of RAP80 and/or to the inclusion of doc alone as a treatment in the experimental arm. In addition, doc/cis may not have been the ideal combination for the control arm. Customized chemotherapy could be further encouraged in oncogene-driven pan-negative patients with PS 0.

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