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ESMO 2014 Scientific Meeting Report ESMO 2014 Congress Scientific Meeting Report – Lung Cancer Extract 26-30 September 2014 Madrid, Spain Summary The European Society for Medical Oncology (ESMO) Congress, held September 26 to 30 in Madrid, Spain, was a record-breaker on nearly all levels. It was resounding success and in a dedicated infographic you can find the congress statistics. A primary emphasis in the scientific programme was placed on precision medicine and how it will change the future treatment landscape in oncology. In addition, a number of scientific presentations were dedicated to cancer immunology and immunotherapy across multiple tumour types. This report is an overview of key scientific presentations made during the congress by leading international investigators. It attempts to represent the diversity and depth of the ESMO 2014 scientific programme, as well as advances in oncology. Infographic (right): ESMO 2014 record breaking Congress ESMO 2014 Congress Meeting Report Page 1 © Copyright 2014 European Society for Medical Oncology. All rights reserved worldwide. Contents Lung Cancer .................................................................................................................................... 3 Final results of the SAKK 16/00 trial: A randomised phase III trial comparing neoadjuvant chemoradiation to chemotherapy alone in stage IIIA/N2 NSCLC ................................................. 3 Adjuvant treatment with MAGE-A3 cancer immunotherapeutic in patients with resected NSCLC does not increase DFS: Results of the MAGRIT, a double-blind, randomised, placebo-controlled phase III study .............................................................................................................................. 4 TARGET: A phase II trial with vintafolide in second-line treatment of folate-receptor-positive NSCLC ......................................................................................................................................... 6 BRF113928: A phase II study with dabrafenib in patients with BRAF V600E-mutant advanced NSCLC ......................................................................................................................................... 7 A phase II study of neratinib with or without temsirolimus in patients with NSCLC carrying HER2 somatic mutations ........................................................................................................................ 8 IMPRESS: Continuation of gefitinib plus pemetrexed/cisplatin of no clinical benefit in NSCLC patients with acquired resistance to gefitinib .............................................................................. 10 New data on first- and second-line ALK inhibition in NSCLC patients ........................................ 12 Overall and intracranial efficacy results and time to symptom deterioration in the PROFILE 1014 study .............................................................................................................................. 12 Antitumour activity of alectinib in crizotinib pre-treated ALK-rearranged NSCLC .................... 14 Defining and refining the ALK treatment paradigm in NSCLC ................................................ 14 Results of LUX-Lung 8, the largest prospective trial to compare EGFR TKIs in patients with relapsed/refractory squamous cell carcinoma of the lung .......................................................... 15 Antitumour activity of pembrolizumab and correlation with PD-L1 expression in a pooled analysis of patients with advanced NSCLC ................................................................................ 17 How to guide the selection of chemotherapy regimen for non-squamous NSCLC ..................... 18 Docetaxel plus cisplatin vs. pemetrexed plus cisplatin in first line non-squamous NSCLC ..... 19 Pemetrexed plus cisplatin vs. gemcitabine plus cisplatin according to thymidylate synthase expression in non-squamous NSCLC ..................................................................................... 20 Prospective molecular evaluation of small cell lung cancer utilising the comprehensive mutation analysis programme at Memorial Sloan Kettering Cancer Center .............................................. 21 RELATED INFORMATION ............................................................................................................ 24 Save the date ............................................................................................................................. 24 Affiliations and Disclosure .......................................................................................................... 24 Acknowledgment ........................................................................................................................ 24 ESMO 2014 Congress Meeting Report Page 2 © Copyright 2014 European Society for Medical Oncology. All rights reserved worldwide. Lung Cancer Final results of the SAKK 16/00 trial: A randomised phase III trial comparing neoadjuvant chemoradiation to chemotherapy alone in stage IIIA/N2 NSCLC Prof. Miklos Pless of the Kantonsspital Winterthur, Winterthur, Switzerland reported results from the first completed phase III trial that evaluated the role of induction chemoradiotherapy and surgery, in comparison to neoadjuvant chemotherapy alone followed by surgery in patients with stage IIIA/N2 NSCLC. Radiotherapy was active; it increased response, complete resection and pCR rates. However, this failed to translate into an improvement of local control, EFS or OS. Notably, surgery after induction treatment was safe, including pneumonectomy. The OS rates of the neoadjuvant regimen in the study are very encouraging, especially for a multicenter setting. One standard option in the treatment of stage IIIA/N2 NSCLC is neoadjuvant chemotherapy followed by surgery. Swiss researchers investigated in a randomised trial whether the addition of neoadjuvant radiotherapy would improve the outcome. At ESMO 2014, they presented the final results of the study. Patients with pathologically proven, resectable stage IIIA/N2 NSCLC, PS 0-1, and adequate organ function were randomised 1:1 to chemoradiation with 3 cycles of neoadjuvant chemotherapy (cisplatin/docetaxel) followed by accelerated concomitant boost radiotherapy with 44 Gy in 22 fractions in 3 weeks, or neoadjuvant chemotherapy alone, with subsequent surgery for all patients. The primary endpoint was EFS (from randomisation to either relapse, progression, second tumour or death). In total 232 patients were randomised, the median follow-up was 53 months. Two thirds were men, median age was 60 years. Histology was squamous cell in 33%, and adenocarcinoma in 43%. Response rate to chemoradiotherapy was 61% vs. 44% with chemotherapy. Among all patients 85% underwent surgery, 30-day postoperative mortality was 1%. The rate of complete resection was 91% in chemoradiotherapy patients vs. 81% in chemotherapy patients and the pCR rate was 16% vs. 12%. The median EFS was 13.1 months for the chemoradiotherapy group vs. 11.8 months in the chemotherapy arm (p = 0.665). The median OS in chemoradiotherapy group was 37.1 months, and with chemoherapy 26.2 months (p = 0.938). The local failure rate was 23% in both arms. In the chemotherapy arm, 12 patients were given postoperative radiotherapy for R1 resection, 6 patients received postoperative radiotherapy in violation of the protocol. Patients with a pCR, mediastinal downstaging to ypN0/1 and complete resection had a better outcome. Toxicity of chemotherapy was substantial, especially febrile neutropaenia was common, whereas radiotherapy was well tolerated. Dr Rafal Dziadziuszko of the Medical University of Gdańsk, Gdańsk, Poland, who discussed the study results, said that the study hypothesis was that addition of sequential radiotherapy to induction chemotherapy followed by surgery improved event-free survival in potentially resectable stage IIIA/N2 NSCLC. He said that chemotherapy plus one local treatment remains the standard of care. Concurrent chemoradiation is most often used. Chemotherapy/surgery is still a valid option in selected patients (based on MDT, patient preference, comorbidities and surgical risk- assessment). ESMO 2014 Congress Meeting Report Page 3 © Copyright 2014 European Society for Medical Oncology. All rights reserved worldwide. This was an invesitigator-led study. It was supported by the Swiss State Secretariat for Education, Research and Innovation, Swiss Cancer League (Grant KLS-2745-02-2011), and Sanofi. Reference 1195O: Final results of the SAKK 16/00 trial: a randomized phase III trial comparing neoadjuvant chemoradiation to chemotherapy alone in stage IIIA/N2 non-small cell lung cancer (NSCLC) Adjuvant treatment with MAGE-A3 cancer immunotherapeutic in patients with resected NSCLC does not increase DFS: Results of the MAGRIT, a double-blind, randomised, placebo-controlled phase III study The MAGRIT global trial assessed the efficacy of the recMAGE-A3 + AS15 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive NSCLC. In this study, treatment with MAGE-A3 cancer immunotherapeutic did not increase DFS compared to placebo in either the overall population or in patients who did not receive adjuvant chemotherapy. The results were presented by Prof. Johann Vansteenkiste of the Respiratory Oncology Unit, University Hospitals Leuven - Campus Gasthuisberg, Leuven, Belgium. Adjuvant chemotherapy is the standard of care for stage II and IIIA NSCLC, and for high risk stage IB
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