- Email: [email protected]
P1.06-016 Pulmonary Tuberculosis among Newly Diagnosed-Therapy Naive Advanced NSCLC in Persahabatan Hospital Jakarta Indonesia
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related with SWT. However, in patients with better FSE treatment satisfaction was higher. Therefore, patients’ education about and management of adverse events may have added value in maintaining patients’ well-being during chemotherapy, ultimately resulting in higher treatment satisfaction. This study is funded by ZonMw, the Netherlands. Keywords: advanced NSCLC, treatment satisfaction, chemotherapy, pemetrexed
P1.06-015 Designing Transducer Arrays for the Delivery of TTFields Whilst Maximizing Patient Comfort and Field Intensity in the Thorax Topic: Advanced General
Journal of Thoracic Oncology
Vol. 12 No. 1S
realistic computational phantoms were used to evaluate the field distribution generated by these arrays, and optimize their design. Results: Novel array designs for delivering TTFields to the lungs were developed. These arrays are not designed as large patches, but comprise sets of interconnected small patches that adhere to the natural contours of the patient’s bodies. Simulations showed that these arrays deliver uniform field distributions to the lungs. A particularly noteworthy design is a pair of arrays in which one array was shaped as a circular ring placed around the neck and shoulders, and the second array was shaped as a belt placed on the lower torso. This design yielded a highly uniform and intense field directed longitudinally throughout the torso. Conclusion: The arrays presented in this study deliver high field intensities to the thorax whilst maintaining patient comfort. These designs could help to improve the outcome of TTFields therapy.
Zeev Bomzon,1 Hadas Hershkovich,1 Uri Weinberg,2 Eilon Kirson,1 Sholi Strauss1 1Novocure Ltd., Haifa/ Israel, 2Novocure GmbH, Lucerne/Switzerland
Keywords: Novel Therapy, TTFields, Tumor Treating Fields
Background: Tumor Treating Fields (TTFields) are an anti-mitotic therapy that utilizes low intensity electric fields in the intermediate frequency range to disrupt cell division. A study to test the efficacy of TTFields in combination with chemotherapy for the treatment of mesothelioma is underway, and a pivotal study testing the efficacy of TTFields in treating NSCLC is planned. TTFields are delivered via two pairs of transducer arrays placed on the patient’s skin. The transducer arrays comprise a set of ceramic disks that make electric contact with the skin through a thin layer of conductive medical gel. The disks in the arrays currently in use are arranged in an almost rectangular pattern. One pair of arrays is placed on the posterior and anterior sides of the patient’s thorax. The other pair is placed on the lateral and contralateral aspects of the patient. This configuration has several limitations: The array placed on the chest may not adhere well to body curvature, leading to sub-optimal electric contact that reduces field intensity in the tumor. In females and obese individuals, fields generated by arrays placed on the anterior and posterior have to traverse thick layers of adipose in the breast. The high resistivity of these layers damps the intensity of TTFields in the lungs. Here we present novel array designs intended to overcome these limitations.
P1.06-016 Pulmonary Tuberculosis among Newly Diagnosed-Therapy Naive Advanced NSCLC in Persahabatan Hospital Jakarta Indonesia
Methods: Multiple concepts for arrays designed to adhere comfortably to the body, whilst avoiding regions of high adipose were proposed. Finite element simulations using
Topic: Advanced General Jamal Zaini,1 Sita Laksmi Andarini,2 Ririen R. Ramadhani,2 Elisna Syahruddin,2 Achmad Hudoyo2 1Pulmonology and Respiratory Medicine/ Persahabatan Hospital, Faculty of Medicine Universitas Indonesia, Jakarta Timur/Indonesia, 2 Pulmonology and Respiratory Medicine/ Persahabatan Hospital, Faculty of Medicine Universitas Indonesia, Jakarta/Indonesia Background: The prevalence of lung cancer increased in the recent years in Indonesia, meanwhile pulmonary tuberculosis (TB) is still a major public health problem in this community. Malignancy such as lung cancer increase the risk of tuberculosis infection and reactivation, therefore evaluation of tuberculosis among lung cancer patients is needed. Methods: Newly diagnosed, therapy-naive advanced NSCLC subjects were enrolled from a referral respiratory hospital Persahabatan Hospital Jakarta Indonesia between 2014 and 2015. Active pulmonary tuberculosis were diagnosed by Xpert MTB/ RIF from induced sputum and LPA M. TB culture. Latent Tuberculosis
January 2017
Infection (LTBI) was determined by Quantiferon-TB Gold-In-Tube (QFT-GIT). Demographic and clinical characteristics were evaluated. Results: Of 50 lung cancer subjects enrolled, 30 (60%) men with mean of age 55 years old (31- 74 years old). Eighty five percents were adenocarcinoma (42 subjects) and 15% squamous cell lung cancer. Most of them were at end stage (87% stage IV and 13%stage IIIB) with WHO performance status (PS) 1 to 3 (20 % PS 1, 70% PS 2 and 10% PS 3). Comorbidities among this group were COPD (3 subjects), diabetes mellitus (2 subjects), hypertension (4 subjects), congestive heart failure (1 subjects). Active tuberculosis were diagnosed in 2 % (1 subject). Based on Quantiferon results, 14 % were positive (7 subjects) and classified as latent tuberculosis infection (LTBI); 60% (30 subjects) classified as nonLTBI (negative Quantiferon result) but 12 (24%) indeterminate cases. The characteristics of LTBI patients were 67% men, two third were adenocarcinomas, 80% stage IV of lung cancer, 80% having WHO PS 2 and 3, 50% were underweight (body mass index (BMI) < 17.5. Conclusion: Active pulmonary tuberculosis and latent tuberculosis infection is common among newly diagnosed therapy naive advanced NSCLC in this population. Most of them are men, adenocarcinoma, PS 2-3, and half of them were underweight. Keywords: advanced NSCLC, active tuberculosis, LTBI
P1.06-017 Observational Study on Prolonged Disease Stabilization in Advanced NSCLC EGFR WT/Unknown Patients Treated with Erlotinib in Second Line Topic: Advanced General Francesco Grossi,1 Agnese Montanino,2 Maria Rita Migliorino,3 Antonio Santo,4 Michele De Tursi,5 Angelo Delmonte,6 Fabiana Vitiello,7 Manlio Mencoboni,8 Vito D’Alessandro,9 Giampiero Romano,10 Erika Rijavec,1 Andrea Misino,11 Antonio Chella,12 Mario Roselli,13 Silvio Cavuto14 1Lung Cancer Unit, IRCCS Aou San Martino - Ist, Genova/Italy, 2U.O.C. Oncologia Medica Toraco-Polmonare, Istituto Nazionale Tumori, Naples/Italy, 3Uosd Pneumologia Oncologica, San Camillo - Forlanini Hospital, Roma/Italy, 4Givop (Gruppo Interdisciplinare Veronese Oncologia Polmonare), Azienda Ospedaliera Universitaria Integrata Di Verona, Verona/ Italy, 5Dip. Di Scienze Mediche, Orali E Biotecnologiche Sezione Di Oncologia Medica, Università G. D’Annunzio, Chieti/Italy, 6Oncologia Medica e Gruppo Di Patologia
Abstracts
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Toracica, Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - IRCCS, Meldola/Italy, 7U.O.S.D. Dh Pneumoncologico, A.O. Dei Colli- Monaldi, Napoli/Italy, 8 Struttura Semplice Dipartimentale Oncologia, Villa Scassi, Genova/Italy, 9Sezione Pneumo-Oncologica Medicina Interna, IRCCS “casa Sollievo Della Sofferenza”, San Giovanni Rotondo/Italy, 10U.O. Oncologia, Presidio Ospedaliero V. Fazzi, Lecce/Italy, 11Oncologia Medica, IRCCS Oncologico Giovanni Paolo Ii, Bari/Italy, 12 Dipartimento Cardiotoracico e Pneumologia 2, A.O. Universitaria Pisana e Ospedale Cisanello, Pisa/Italy, 13 U.O.S.D. Oncologia Medica, Policlinico Universitario Tor Vergata, Roma/Italy, 14Direzione Scientifica Infrastruttura Ricerca E Statistica, Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia/Italy Background: In advanced NSCLC, erlotinib treatment was shown to improve survival independently of EGFR status and induce high rates of prolonged stable disease (SD). It has previously been reported that, after second-/ third-line erlotinib, PFS and OS are long-lasting and similar between patients with SD 8 months and those attaining partial/complete response (PR/CR). The present study investigated the clinical value of SD in a realworld setting of advanced NSCLC. Methods: This Italian multicenter observational study enrolled patients with stage IIIB-IV NSCLC on secondline erlotinib and wild-type/unknown EGFR mutational status, with SD, CR or PR per RECIST v1.1 lasting for 4 weeks. Patients were observed from the beginning of erlotinib for approximately 8 months or until death. Primary end-points were the rate and duration of SD (i.e. time interval from erlotinib start to the last evidence of SD by RECIST) or CR+PR. Secondary endpoints were OS and PFS (i.e. time interval from the erlotininb start to the first evidence of progression), estimated by the Kaplan-Meier method and calculated by response duration or disease stabilization. Adverse events occurring during the observation period were also recorded. Results: At the cut-off date of 30/04/16, 144/172 (83.7%) enrolled patients were evaluable for response (mean age 69.1 years, 61.8% males). At the start of erlotinib treatment, 85.4% were non-smokers, 89.6% had an ECOG-PS of 0-1, and 84.7% had stage IV NSCLC (83.3% adenocarcinoma and 11.8% squamous cell carcinoma). Following second-line erlotinib, 82.6% (119/ 144) of patients achieved SD and 17.4% (25/144) PR. Notably, SD was maintained for 8 months in 27% (39/ 144) of cases. At the end of the observation period, 12 (8.3%) patients had deceased, none with SD 8 months. Median OS had not been reached by the entire population. According to SD duration, median OS was 4.3 months if <2 months, 6.8 if between 2 and 5 months,
related with SWT. However, in patients with better FSE treatment satisfaction was higher. Therefore, patients’ education about and management of adverse events may have added value in maintaining patients’ well-being during chemotherapy, ultimately resulting in higher treatment satisfaction. This study is funded by ZonMw, the Netherlands. Keywords: advanced NSCLC, treatment satisfaction, chemotherapy, pemetrexed
P1.06-015 Designing Transducer Arrays for the Delivery of TTFields Whilst Maximizing Patient Comfort and Field Intensity in the Thorax Topic: Advanced General
Journal of Thoracic Oncology
Vol. 12 No. 1S
realistic computational phantoms were used to evaluate the field distribution generated by these arrays, and optimize their design. Results: Novel array designs for delivering TTFields to the lungs were developed. These arrays are not designed as large patches, but comprise sets of interconnected small patches that adhere to the natural contours of the patient’s bodies. Simulations showed that these arrays deliver uniform field distributions to the lungs. A particularly noteworthy design is a pair of arrays in which one array was shaped as a circular ring placed around the neck and shoulders, and the second array was shaped as a belt placed on the lower torso. This design yielded a highly uniform and intense field directed longitudinally throughout the torso. Conclusion: The arrays presented in this study deliver high field intensities to the thorax whilst maintaining patient comfort. These designs could help to improve the outcome of TTFields therapy.
Zeev Bomzon,1 Hadas Hershkovich,1 Uri Weinberg,2 Eilon Kirson,1 Sholi Strauss1 1Novocure Ltd., Haifa/ Israel, 2Novocure GmbH, Lucerne/Switzerland
Keywords: Novel Therapy, TTFields, Tumor Treating Fields
Background: Tumor Treating Fields (TTFields) are an anti-mitotic therapy that utilizes low intensity electric fields in the intermediate frequency range to disrupt cell division. A study to test the efficacy of TTFields in combination with chemotherapy for the treatment of mesothelioma is underway, and a pivotal study testing the efficacy of TTFields in treating NSCLC is planned. TTFields are delivered via two pairs of transducer arrays placed on the patient’s skin. The transducer arrays comprise a set of ceramic disks that make electric contact with the skin through a thin layer of conductive medical gel. The disks in the arrays currently in use are arranged in an almost rectangular pattern. One pair of arrays is placed on the posterior and anterior sides of the patient’s thorax. The other pair is placed on the lateral and contralateral aspects of the patient. This configuration has several limitations: The array placed on the chest may not adhere well to body curvature, leading to sub-optimal electric contact that reduces field intensity in the tumor. In females and obese individuals, fields generated by arrays placed on the anterior and posterior have to traverse thick layers of adipose in the breast. The high resistivity of these layers damps the intensity of TTFields in the lungs. Here we present novel array designs intended to overcome these limitations.
P1.06-016 Pulmonary Tuberculosis among Newly Diagnosed-Therapy Naive Advanced NSCLC in Persahabatan Hospital Jakarta Indonesia
Methods: Multiple concepts for arrays designed to adhere comfortably to the body, whilst avoiding regions of high adipose were proposed. Finite element simulations using
Topic: Advanced General Jamal Zaini,1 Sita Laksmi Andarini,2 Ririen R. Ramadhani,2 Elisna Syahruddin,2 Achmad Hudoyo2 1Pulmonology and Respiratory Medicine/ Persahabatan Hospital, Faculty of Medicine Universitas Indonesia, Jakarta Timur/Indonesia, 2 Pulmonology and Respiratory Medicine/ Persahabatan Hospital, Faculty of Medicine Universitas Indonesia, Jakarta/Indonesia Background: The prevalence of lung cancer increased in the recent years in Indonesia, meanwhile pulmonary tuberculosis (TB) is still a major public health problem in this community. Malignancy such as lung cancer increase the risk of tuberculosis infection and reactivation, therefore evaluation of tuberculosis among lung cancer patients is needed. Methods: Newly diagnosed, therapy-naive advanced NSCLC subjects were enrolled from a referral respiratory hospital Persahabatan Hospital Jakarta Indonesia between 2014 and 2015. Active pulmonary tuberculosis were diagnosed by Xpert MTB/ RIF from induced sputum and LPA M. TB culture. Latent Tuberculosis
January 2017
Infection (LTBI) was determined by Quantiferon-TB Gold-In-Tube (QFT-GIT). Demographic and clinical characteristics were evaluated. Results: Of 50 lung cancer subjects enrolled, 30 (60%) men with mean of age 55 years old (31- 74 years old). Eighty five percents were adenocarcinoma (42 subjects) and 15% squamous cell lung cancer. Most of them were at end stage (87% stage IV and 13%stage IIIB) with WHO performance status (PS) 1 to 3 (20 % PS 1, 70% PS 2 and 10% PS 3). Comorbidities among this group were COPD (3 subjects), diabetes mellitus (2 subjects), hypertension (4 subjects), congestive heart failure (1 subjects). Active tuberculosis were diagnosed in 2 % (1 subject). Based on Quantiferon results, 14 % were positive (7 subjects) and classified as latent tuberculosis infection (LTBI); 60% (30 subjects) classified as nonLTBI (negative Quantiferon result) but 12 (24%) indeterminate cases. The characteristics of LTBI patients were 67% men, two third were adenocarcinomas, 80% stage IV of lung cancer, 80% having WHO PS 2 and 3, 50% were underweight (body mass index (BMI) < 17.5. Conclusion: Active pulmonary tuberculosis and latent tuberculosis infection is common among newly diagnosed therapy naive advanced NSCLC in this population. Most of them are men, adenocarcinoma, PS 2-3, and half of them were underweight. Keywords: advanced NSCLC, active tuberculosis, LTBI
P1.06-017 Observational Study on Prolonged Disease Stabilization in Advanced NSCLC EGFR WT/Unknown Patients Treated with Erlotinib in Second Line Topic: Advanced General Francesco Grossi,1 Agnese Montanino,2 Maria Rita Migliorino,3 Antonio Santo,4 Michele De Tursi,5 Angelo Delmonte,6 Fabiana Vitiello,7 Manlio Mencoboni,8 Vito D’Alessandro,9 Giampiero Romano,10 Erika Rijavec,1 Andrea Misino,11 Antonio Chella,12 Mario Roselli,13 Silvio Cavuto14 1Lung Cancer Unit, IRCCS Aou San Martino - Ist, Genova/Italy, 2U.O.C. Oncologia Medica Toraco-Polmonare, Istituto Nazionale Tumori, Naples/Italy, 3Uosd Pneumologia Oncologica, San Camillo - Forlanini Hospital, Roma/Italy, 4Givop (Gruppo Interdisciplinare Veronese Oncologia Polmonare), Azienda Ospedaliera Universitaria Integrata Di Verona, Verona/ Italy, 5Dip. Di Scienze Mediche, Orali E Biotecnologiche Sezione Di Oncologia Medica, Università G. D’Annunzio, Chieti/Italy, 6Oncologia Medica e Gruppo Di Patologia
Abstracts
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Toracica, Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - IRCCS, Meldola/Italy, 7U.O.S.D. Dh Pneumoncologico, A.O. Dei Colli- Monaldi, Napoli/Italy, 8 Struttura Semplice Dipartimentale Oncologia, Villa Scassi, Genova/Italy, 9Sezione Pneumo-Oncologica Medicina Interna, IRCCS “casa Sollievo Della Sofferenza”, San Giovanni Rotondo/Italy, 10U.O. Oncologia, Presidio Ospedaliero V. Fazzi, Lecce/Italy, 11Oncologia Medica, IRCCS Oncologico Giovanni Paolo Ii, Bari/Italy, 12 Dipartimento Cardiotoracico e Pneumologia 2, A.O. Universitaria Pisana e Ospedale Cisanello, Pisa/Italy, 13 U.O.S.D. Oncologia Medica, Policlinico Universitario Tor Vergata, Roma/Italy, 14Direzione Scientifica Infrastruttura Ricerca E Statistica, Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia/Italy Background: In advanced NSCLC, erlotinib treatment was shown to improve survival independently of EGFR status and induce high rates of prolonged stable disease (SD). It has previously been reported that, after second-/ third-line erlotinib, PFS and OS are long-lasting and similar between patients with SD 8 months and those attaining partial/complete response (PR/CR). The present study investigated the clinical value of SD in a realworld setting of advanced NSCLC. Methods: This Italian multicenter observational study enrolled patients with stage IIIB-IV NSCLC on secondline erlotinib and wild-type/unknown EGFR mutational status, with SD, CR or PR per RECIST v1.1 lasting for 4 weeks. Patients were observed from the beginning of erlotinib for approximately 8 months or until death. Primary end-points were the rate and duration of SD (i.e. time interval from erlotinib start to the last evidence of SD by RECIST) or CR+PR. Secondary endpoints were OS and PFS (i.e. time interval from the erlotininb start to the first evidence of progression), estimated by the Kaplan-Meier method and calculated by response duration or disease stabilization. Adverse events occurring during the observation period were also recorded. Results: At the cut-off date of 30/04/16, 144/172 (83.7%) enrolled patients were evaluable for response (mean age 69.1 years, 61.8% males). At the start of erlotinib treatment, 85.4% were non-smokers, 89.6% had an ECOG-PS of 0-1, and 84.7% had stage IV NSCLC (83.3% adenocarcinoma and 11.8% squamous cell carcinoma). Following second-line erlotinib, 82.6% (119/ 144) of patients achieved SD and 17.4% (25/144) PR. Notably, SD was maintained for 8 months in 27% (39/ 144) of cases. At the end of the observation period, 12 (8.3%) patients had deceased, none with SD 8 months. Median OS had not been reached by the entire population. According to SD duration, median OS was 4.3 months if <2 months, 6.8 if between 2 and 5 months,