Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.99
H. Koyi, G. Hillerdal, S. Friesland, K. Kölbeck, Olov Andersson, Per Bergman, L. Orre, P. Liv, E. Brandén
99 Background: For patients with NSCLC clinical stages I and II disease with no medical contraindications, surgery is treatment of choice showing 5-year survival rates of about 60–80% for stage I and 40–50% for stage II, respectively. However, for patients who are medically or technically unfit for surgery and for patients refusing surgery, SBRT is an alternative with local control rates > 90% at 3 years. Methods: Medical journals in all patients with stage I or II NSCLC who were underwent surgery and treated with SBRT at the Department of oncology or thoracic surgery, Karolinska University Hospital, Sweden from 2003 to 2010 were retrospectively reviewed. Results: In all, 267 (74.8%) underwent surgery and 90 (25.2%) were treated with SBRT. Mean, median and range of age among the surgery group was 69.2, 70.0 and 41-85 years, while in the SBRT group, these figures were 77.6, 79.0 and 52-90 years. The difference in age between the groups was significant (p < 0.001).There were significantly more comorbidites in the SBRT group. Among the surgery group, 90.2% were smokers or former smokers. The figures for SBRT group was 91.1%. The difference in smoking habits between the groups was not significant (p < 0.713). There was a significant difference in performance status (PS) between the groups (p < 0.001) with with PS 0-1 in 99.3% in the surgery group compared with 66.7% in the SBRT group. There was a significant difference in lung function with median FEV1 2.11 liter in surgery group compared to 1.3 in the SBRT group. The figures for median FEV1% was 85.0% respectively 57.0%. The median overall survival was 7.7 years for the surgery group and 3.72 years for the SBRT group (p < 0.001). Five years survival was 65.5% in the surgery group and 31.6% in the SBRT group (p < 0.001). Conclusions: The much worse median overall survival in the SBRT group can be explained by the selection of patients, but still, a median survival for nearly 4 years in an elderly group with so many comorbidities and a poor PS indicates that SBRT has been of value.
{"title":"Stereotactic body radiotherapy (SBRT) or surgery in early stage (I & II) non small cell lung cancer (NSCLC).","authors":"H. Koyi, G. Hillerdal, S. Friesland, K. Kölbeck, Olov Andersson, Per Bergman, L. Orre, P. Liv, E. Brandén","doi":"10.1200/jgo.2019.5.suppl.99","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.99","url":null,"abstract":"99 Background: For patients with NSCLC clinical stages I and II disease with no medical contraindications, surgery is treatment of choice showing 5-year survival rates of about 60–80% for stage I and 40–50% for stage II, respectively. However, for patients who are medically or technically unfit for surgery and for patients refusing surgery, SBRT is an alternative with local control rates > 90% at 3 years. Methods: Medical journals in all patients with stage I or II NSCLC who were underwent surgery and treated with SBRT at the Department of oncology or thoracic surgery, Karolinska University Hospital, Sweden from 2003 to 2010 were retrospectively reviewed. Results: In all, 267 (74.8%) underwent surgery and 90 (25.2%) were treated with SBRT. Mean, median and range of age among the surgery group was 69.2, 70.0 and 41-85 years, while in the SBRT group, these figures were 77.6, 79.0 and 52-90 years. The difference in age between the groups was significant (p < 0.001).There were significantly more comorbidites in the SBRT group. Among the surgery group, 90.2% were smokers or former smokers. The figures for SBRT group was 91.1%. The difference in smoking habits between the groups was not significant (p < 0.713). There was a significant difference in performance status (PS) between the groups (p < 0.001) with with PS 0-1 in 99.3% in the surgery group compared with 66.7% in the SBRT group. There was a significant difference in lung function with median FEV1 2.11 liter in surgery group compared to 1.3 in the SBRT group. The figures for median FEV1% was 85.0% respectively 57.0%. The median overall survival was 7.7 years for the surgery group and 3.72 years for the SBRT group (p < 0.001). Five years survival was 65.5% in the surgery group and 31.6% in the SBRT group (p < 0.001). Conclusions: The much worse median overall survival in the SBRT group can be explained by the selection of patients, but still, a median survival for nearly 4 years in an elderly group with so many comorbidities and a poor PS indicates that SBRT has been of value.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48875675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.75
Kanchanaporn Takonkitsakul, Voranuch Thanakit, N. Poovorawan, Suleepon Uttamapinan, V. Sriuranpong, N. Parinyanitikul
75 Background: Approximately one third of hormonal receptor (HR) positive, HER2 negative early breast cancer reported disease relapse after adjuvant treatments. Both clinicopathologic features and multigene assays consider to be predicting factor of relapse. Cyclin B1, one of proliferative markers used in OncotypeDx has been explored previously for predicting recurrence in this subgroup of breast cancers. Our study aims to determine the prognostic significance of cyclin B1 in combination with clinicopathologic factors in recurrent HR positive, HER2 negative breast cancer. Methods: Two-hundred and forty-five HR positive, HER2 negative early breast cancers who were diagnosed during 2010 to 2015 in King Chulalongkorn Memorial Hospital were retrospectively reviewed. All clinicopathologic factors and level of cyclin B1 expression were evaluated. Correlation of cyclin B1 expression with clinicopathologic features was also compared in recurrence and non-recurrence group. Results: In 245 patients, 65 patients were recurrence group while 180 patients were non-recurrence group. Mean age at breast cancer diagnosis were 53 years. Recurrence group had high pathological staging, tumor grade, LVI, Ki-67 and lymph node involvement compared to non-recurrence group ( p < 0.05). Mean cyclin B1 expression was 9.61% (19.62 % in recurrence group and 5.88 % in non-recurrence group; p< 0.001). We have used cut-off of cyclin B1 expression at ≥ 10 % (7th decile) to classify high and low of expression. Cyclin B1 high expression were demonstrated in 53.4% of recurrence group compared to 22.4% of non-recurrence group. In multivariate analysis, tumor grade (OR 8.42, 95%CI 1.04-67.98; p = 0.046), receiving neoadjuvant chemotherapy (NAC) (OR 4.27, 95%CI 1.41-12.87; p = 0.010) and % cyclin B1 expression (OR 1.04, 95%CI 1.00-1.07; p = 0.013) were associated with recurrent disease. Five-year relapse free survival for cyclin B1 low and high expression were 84.9% and 60.1%, respectively. Conclusions: Tumor grade, receiving NAC and % cyclin B1 expression were associated with risk of recurrence in HR positive and HER2 negative early breast cancer.
{"title":"Prognostic significance of cyclin B1 expression plus clinicopathologic features in hormonal positive, HER2 negative early breast cancer in King Chulalongkorn Memorial Hospital During 2010-2015.","authors":"Kanchanaporn Takonkitsakul, Voranuch Thanakit, N. Poovorawan, Suleepon Uttamapinan, V. Sriuranpong, N. Parinyanitikul","doi":"10.1200/jgo.2019.5.suppl.75","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.75","url":null,"abstract":"75 Background: Approximately one third of hormonal receptor (HR) positive, HER2 negative early breast cancer reported disease relapse after adjuvant treatments. Both clinicopathologic features and multigene assays consider to be predicting factor of relapse. Cyclin B1, one of proliferative markers used in OncotypeDx has been explored previously for predicting recurrence in this subgroup of breast cancers. Our study aims to determine the prognostic significance of cyclin B1 in combination with clinicopathologic factors in recurrent HR positive, HER2 negative breast cancer. Methods: Two-hundred and forty-five HR positive, HER2 negative early breast cancers who were diagnosed during 2010 to 2015 in King Chulalongkorn Memorial Hospital were retrospectively reviewed. All clinicopathologic factors and level of cyclin B1 expression were evaluated. Correlation of cyclin B1 expression with clinicopathologic features was also compared in recurrence and non-recurrence group. Results: In 245 patients, 65 patients were recurrence group while 180 patients were non-recurrence group. Mean age at breast cancer diagnosis were 53 years. Recurrence group had high pathological staging, tumor grade, LVI, Ki-67 and lymph node involvement compared to non-recurrence group ( p < 0.05). Mean cyclin B1 expression was 9.61% (19.62 % in recurrence group and 5.88 % in non-recurrence group; p< 0.001). We have used cut-off of cyclin B1 expression at ≥ 10 % (7th decile) to classify high and low of expression. Cyclin B1 high expression were demonstrated in 53.4% of recurrence group compared to 22.4% of non-recurrence group. In multivariate analysis, tumor grade (OR 8.42, 95%CI 1.04-67.98; p = 0.046), receiving neoadjuvant chemotherapy (NAC) (OR 4.27, 95%CI 1.41-12.87; p = 0.010) and % cyclin B1 expression (OR 1.04, 95%CI 1.00-1.07; p = 0.013) were associated with recurrent disease. Five-year relapse free survival for cyclin B1 low and high expression were 84.9% and 60.1%, respectively. Conclusions: Tumor grade, receiving NAC and % cyclin B1 expression were associated with risk of recurrence in HR positive and HER2 negative early breast cancer.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44648112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.10
S. Sirilerttrakul, Nopakan Wannakansophon, Patamaporn Tangteerakoon, Suluck Vongterapak, M. Jirajarus, Sineenuch Ckumdee, E. Sirachainan, P. Chansriwong
10 Background: Colorectal cancer is an important health problems in Thailand. Chemotherapy treatment that was once delivered only in hospital environments is now administered at patient's home that helping patients to live normal lives during receiving chemotherapy. The chemotherapy regimens are based on a 48 hours 5-fluorouracil infusion combined that need patients to be hospitalized, consequence to decrease QOL and increase cost of treatment. Methods: An observational cohort which enrolled 156 patients at the Ramathibodi hospital from Dec 2015 to Nov 2016. Ambulatory chemotherapy (AC) administered by the central venous access device (CVAD). The regimen as FOLFOX or FOLFIRI, 5-FU were in the elastomeric infusion pump and administered at the patients’ home. The questionnaire of FACT-G and FACT-C scale, cost of treatment were collected at time of enrolment, 2 months and end of treatment. DFS and OS were analyzed in patients who treated with first regimen of metastasis chemotherapy. Nurse coordinator followed up them by phone. Aims: Compares the DFS, OS, QOL score, and cost difference in AC patients compared with inpatient treatment. Results: 156 patients are enrolled that 111 patients treated with AC and 45 patients treated with inpatient. Questionnaire response rate was 86%. Intention to treat analysis revealed significantly improved in social wellbeing and FACT-G (p < 0.001) in AC group. No difference in DFS between AC and inpatient group (12.6 vs 11.9 months, HR 0.82, p = 0.33). Overall survival trended to longer survival in AC arm (2.43 vs 1.83 years, HR 0.78, P = 0.28). The AC reduced cost about 338 US dollars per cycle of chemotherapy. Conclusions: Ambulatory chemotherapy helps colorectal cancer patients to live normal lives by administer treatment at patients' home and results to significantly improve in quality of life . No difference in DFS and OS benefit, but trends in gaining more benefits in ambulatory treatment. Moreover, ambulatory chemotherapy reduced cost of chemotherapy treatment.
{"title":"Evaluating survival and quality of life with ambulatory chemotherapy in metastatic colorectal cancer.","authors":"S. Sirilerttrakul, Nopakan Wannakansophon, Patamaporn Tangteerakoon, Suluck Vongterapak, M. Jirajarus, Sineenuch Ckumdee, E. Sirachainan, P. Chansriwong","doi":"10.1200/jgo.2019.5.suppl.10","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.10","url":null,"abstract":"10 Background: Colorectal cancer is an important health problems in Thailand. Chemotherapy treatment that was once delivered only in hospital environments is now administered at patient's home that helping patients to live normal lives during receiving chemotherapy. The chemotherapy regimens are based on a 48 hours 5-fluorouracil infusion combined that need patients to be hospitalized, consequence to decrease QOL and increase cost of treatment. Methods: An observational cohort which enrolled 156 patients at the Ramathibodi hospital from Dec 2015 to Nov 2016. Ambulatory chemotherapy (AC) administered by the central venous access device (CVAD). The regimen as FOLFOX or FOLFIRI, 5-FU were in the elastomeric infusion pump and administered at the patients’ home. The questionnaire of FACT-G and FACT-C scale, cost of treatment were collected at time of enrolment, 2 months and end of treatment. DFS and OS were analyzed in patients who treated with first regimen of metastasis chemotherapy. Nurse coordinator followed up them by phone. Aims: Compares the DFS, OS, QOL score, and cost difference in AC patients compared with inpatient treatment. Results: 156 patients are enrolled that 111 patients treated with AC and 45 patients treated with inpatient. Questionnaire response rate was 86%. Intention to treat analysis revealed significantly improved in social wellbeing and FACT-G (p < 0.001) in AC group. No difference in DFS between AC and inpatient group (12.6 vs 11.9 months, HR 0.82, p = 0.33). Overall survival trended to longer survival in AC arm (2.43 vs 1.83 years, HR 0.78, P = 0.28). The AC reduced cost about 338 US dollars per cycle of chemotherapy. Conclusions: Ambulatory chemotherapy helps colorectal cancer patients to live normal lives by administer treatment at patients' home and results to significantly improve in quality of life . No difference in DFS and OS benefit, but trends in gaining more benefits in ambulatory treatment. Moreover, ambulatory chemotherapy reduced cost of chemotherapy treatment.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46766794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.59
Xiufeng Wu, Lina Tang, Yi Zeng, Xia Chen
59 Background: The aim of this prospective study was to evaluate the feasibility of contrast-enhanced ultrasonography (CEUS) for the identification of sentinel lymph node (SLN) in breast cancer patients with cN0 following neoadjuvant chemotherapy (NAC). Methods: Patients with cN0 following NAC (n=66) received a periareolar injection of SonoVue followed by ultrasound (US) to identify contrast-enhanced SLN before surgery. All patients underwent axillary lymph node dissection for verification of axillary node status after the SLN biopsy. The identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value was recorded. Results: In almost all cases, the SLNs were easily identified with an identification rate of 98.5 % (65/66). Compared with pathological diagnosis, sensitivity, specificity, accuracy, and false negative rate of CEUS for SLN diagnosis were 66.7%, 95.8%, 78.8%, and 14.3% respectively. Conclusions: Identification of SLN by CEUS is a technically feasible method with an identification rate as high as 98.5%. [Table: see text][Table: see text]
{"title":"Identification of sentinel lymph nodes using contrast-enhanced ultrasound in breast cancer patients who underwent neoadjuvant chemotherapy.","authors":"Xiufeng Wu, Lina Tang, Yi Zeng, Xia Chen","doi":"10.1200/jgo.2019.5.suppl.59","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.59","url":null,"abstract":"59 Background: The aim of this prospective study was to evaluate the feasibility of contrast-enhanced ultrasonography (CEUS) for the identification of sentinel lymph node (SLN) in breast cancer patients with cN0 following neoadjuvant chemotherapy (NAC). Methods: Patients with cN0 following NAC (n=66) received a periareolar injection of SonoVue followed by ultrasound (US) to identify contrast-enhanced SLN before surgery. All patients underwent axillary lymph node dissection for verification of axillary node status after the SLN biopsy. The identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value was recorded. Results: In almost all cases, the SLNs were easily identified with an identification rate of 98.5 % (65/66). Compared with pathological diagnosis, sensitivity, specificity, accuracy, and false negative rate of CEUS for SLN diagnosis were 66.7%, 95.8%, 78.8%, and 14.3% respectively. Conclusions: Identification of SLN by CEUS is a technically feasible method with an identification rate as high as 98.5%. [Table: see text][Table: see text]","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46862682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.4
D. Poprawski
4 Background: Tyranny of distance in Australia has motivated oncologists to try innovations in oncology care to improve cost efficiency, access, and compliance. This is often done with little budget availability as health funds are metrocentric. The aim is to bring novel approaches to utilisation of oncology care and show its applicability to most countries even with financial constraints. Methods: Mt Gambier Hospital is a regional hospital in South Eastern South Australia (SE SA). The data collected from clinics was commenced in January 2016, to gain knowledge of epidemiology of cancer in the region, and numbers of patients seen. Despite gold standard cancer care being performed in consultations which are face-to-face, we rolled out telemedicine consultations. We also, implemented a Survivorship Care Model, and entered into a Teletrials Project which sets up a regional trials centre with support from a tertiary hospital, Flinders Medical Centre. Results: Telemedicine has been made in Mt Gambier Hospital’s cancer service a part of every day practice to save patients from unnecessary travel. From January 2016, until May 2019, there were 812 consultations with nurse practitioner, 2542 consultations with consultant in clinic, and 246 telemedicine consultations. Survivorship clinic has been implemented according to South Australian Framework for Survivorship with no extra funding. Since 2017, 49 patients were seen with curative therapy. A re-alignment of appointment scheduling will see 6 patients in the next 2 months, thus increasing clinic potential. Teletrials Project was born from collaboration with Flinders Medical Centre, and gained funding by Beat Cancer South Australia. We are now entering into final stages of Governance agreement for our 1st trial, 18 months from commencing the project. Since then, we also got 2 more collaboration grants from Beat Cancer SA. Conclusions: With limited resources, regional cancer centres are able to maximise their patient outcomes by applying novel strategies. These novel ways of doing things, may be able to be implemented on either existing budgets or through collaboration with metropolitan cancer centres to attract financial grants to improve patient outcomes.
{"title":"Budget poor, but outcomes rich: How to set up tele-assisted systems in a regional and rural cancer center.","authors":"D. Poprawski","doi":"10.1200/jgo.2019.5.suppl.4","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.4","url":null,"abstract":"4 Background: Tyranny of distance in Australia has motivated oncologists to try innovations in oncology care to improve cost efficiency, access, and compliance. This is often done with little budget availability as health funds are metrocentric. The aim is to bring novel approaches to utilisation of oncology care and show its applicability to most countries even with financial constraints. Methods: Mt Gambier Hospital is a regional hospital in South Eastern South Australia (SE SA). The data collected from clinics was commenced in January 2016, to gain knowledge of epidemiology of cancer in the region, and numbers of patients seen. Despite gold standard cancer care being performed in consultations which are face-to-face, we rolled out telemedicine consultations. We also, implemented a Survivorship Care Model, and entered into a Teletrials Project which sets up a regional trials centre with support from a tertiary hospital, Flinders Medical Centre. Results: Telemedicine has been made in Mt Gambier Hospital’s cancer service a part of every day practice to save patients from unnecessary travel. From January 2016, until May 2019, there were 812 consultations with nurse practitioner, 2542 consultations with consultant in clinic, and 246 telemedicine consultations. Survivorship clinic has been implemented according to South Australian Framework for Survivorship with no extra funding. Since 2017, 49 patients were seen with curative therapy. A re-alignment of appointment scheduling will see 6 patients in the next 2 months, thus increasing clinic potential. Teletrials Project was born from collaboration with Flinders Medical Centre, and gained funding by Beat Cancer South Australia. We are now entering into final stages of Governance agreement for our 1st trial, 18 months from commencing the project. Since then, we also got 2 more collaboration grants from Beat Cancer SA. Conclusions: With limited resources, regional cancer centres are able to maximise their patient outcomes by applying novel strategies. These novel ways of doing things, may be able to be implemented on either existing budgets or through collaboration with metropolitan cancer centres to attract financial grants to improve patient outcomes.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65926797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.55
H. A. Pham, L. S. Tran, U. V. Tran, Thanh-Truong Tran, H. Nguyen, H. Giang, A. Dang, D. Le, S. Nguyen, N. Nguyen, V. Nguyen, B. Vo, N. H. Nguyen, C. Nguyen, Cam Phuong Pham, Anh Tuan Dang-Mai, Thien Kim Dinh-Nguyen, V. Phan, T. Do, K. T. Dinh
55 Background: The identification and quantification of actionable mutations are of critical importance for effective genotype-directed therapies, prognosis and drug response monitoring in patients with non-small-cell lung cancer (NSCLC). Although tumor tissue biopsy remains the gold standard for diagnosis of NSCLC, the analysis of plasma circulating tumor DNA (ctDNA), known as liquid biopsy, has recently emerged as an alternative and noninvasive approach for exploring tumor genetic constitution. In this study, we developed a mutation detection approach for liquid biopsy using ultra-deep massively parallel sequencing (MPS) with unique molecular identifier (UID) tagging and evaluated its performance for the identification and quantification of tumor-derived mutations from plasma of patients with advanced NSCLC. Methods: Tissue biopsy and plasma samples were collected from a total of 58 patients diagnosed with NSCLC in Vietnam. Genetic alterations in four driver genes including EGFR, KRAS, NRAS and BRAF were identified by using ultra-deep MPS combined with UID tagging. Subsequently, the concordance rate of mutation testing between matched plasma and tissue samples was assessed. Additionally, a commercially available ddPCR (Bio-rad) assay was used to conduct a cross-platform comparison with ultra-deep MPS for the detection and quantification of the three most common actionable EGFR mutations (del19, L858R and T790M). Results: Compared to the mutations detected in paired tissue samples, the plasma based ultra-deep MPS achieved high concordance rate of 87.5%. Cross-platform comparison with droplet digital PCR demonstrated comparable detection performance (91.4% concordance, Cohen's kappa coefficient of 0.85 with 95% CI = 0.72 – 0.97) and great reliability in quantification of mutation allele frequency (Intraclass correlation coefficient of 0.96 with 95% CI = 0.90 – 0.98). Conclusions: Our results highlight the potential application of liquid biopsy using ultra-deep MPS as a routine assay in clinical practice for both detection and quantification of actionable mutation landscape in NSCLC patients.
{"title":"An optimized ultra-deep massively parallel sequencing with unique molecular identifier tagging for detection and quantification of circulating tumor DNA from lung cancer patients.","authors":"H. A. Pham, L. S. Tran, U. V. Tran, Thanh-Truong Tran, H. Nguyen, H. Giang, A. Dang, D. Le, S. Nguyen, N. Nguyen, V. Nguyen, B. Vo, N. H. Nguyen, C. Nguyen, Cam Phuong Pham, Anh Tuan Dang-Mai, Thien Kim Dinh-Nguyen, V. Phan, T. Do, K. T. Dinh","doi":"10.1200/jgo.2019.5.suppl.55","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.55","url":null,"abstract":"55 Background: The identification and quantification of actionable mutations are of critical importance for effective genotype-directed therapies, prognosis and drug response monitoring in patients with non-small-cell lung cancer (NSCLC). Although tumor tissue biopsy remains the gold standard for diagnosis of NSCLC, the analysis of plasma circulating tumor DNA (ctDNA), known as liquid biopsy, has recently emerged as an alternative and noninvasive approach for exploring tumor genetic constitution. In this study, we developed a mutation detection approach for liquid biopsy using ultra-deep massively parallel sequencing (MPS) with unique molecular identifier (UID) tagging and evaluated its performance for the identification and quantification of tumor-derived mutations from plasma of patients with advanced NSCLC. Methods: Tissue biopsy and plasma samples were collected from a total of 58 patients diagnosed with NSCLC in Vietnam. Genetic alterations in four driver genes including EGFR, KRAS, NRAS and BRAF were identified by using ultra-deep MPS combined with UID tagging. Subsequently, the concordance rate of mutation testing between matched plasma and tissue samples was assessed. Additionally, a commercially available ddPCR (Bio-rad) assay was used to conduct a cross-platform comparison with ultra-deep MPS for the detection and quantification of the three most common actionable EGFR mutations (del19, L858R and T790M). Results: Compared to the mutations detected in paired tissue samples, the plasma based ultra-deep MPS achieved high concordance rate of 87.5%. Cross-platform comparison with droplet digital PCR demonstrated comparable detection performance (91.4% concordance, Cohen's kappa coefficient of 0.85 with 95% CI = 0.72 – 0.97) and great reliability in quantification of mutation allele frequency (Intraclass correlation coefficient of 0.96 with 95% CI = 0.90 – 0.98). Conclusions: Our results highlight the potential application of liquid biopsy using ultra-deep MPS as a routine assay in clinical practice for both detection and quantification of actionable mutation landscape in NSCLC patients.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45057796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.2
D. Graham, Gemma Wickert, L. Goodwin, J. Clarke, C. Timmins, D. Chang, A. Walker, A. Rees, S. Stringer, Adam Theis, L. Carter, N. Cook, M. Krebs, F. Thistlethwaite, J. Bradford, J. Royle, A. Hughes
2 Background: Data capture in early phase cancer clinical trials (EPCCT) is usually via paper records with manual transcription to the sponsor’s case report form. Capturing real time trial data directly to computer (eSource) may reduce errors and increase completeness and timeliness of data entry. A simulated system pilot took place between Oct 2018 and Jan 2019 at an EPCCT facility to appraise Foundry Health’s eSource system “ClinSpark”. Aims were to assess consistency and effectiveness of creating electronic templates for source data capture and live data collection compliance. Methods: A multidisciplinary focus group (MFG) (2 research nurses, 1 doctor, 3 data managers) was created to collaborate with Foundry Health staff. Specialised features of the eSource system were adapted to handle the complex needs of EPCCT. The pilot incorporated a 5 day boot camp for familiarisation to the digital platform; a conference room test using simulated patient data; construction of a trial template including contingency planning; and a clinic floor test with live simulated patient data collection using digital tablets. The MFG agreed on a 52 item user acceptance test listing ideal features for a data collection tool, with items classified as high, medium or low priority. Results: During the 3 month pilot, templates for 2 EPCCT were planned and created by the MFG. Using eSource, 43 items (83%) of the acceptance test were passed compared with 27 items (52%) for the current (paper) system. For the 30 high-priority items, eSource passed 30 (100%) compared with 22 for the paper system (73%). The paper system was not superior to eSource for any items assessed. Time saving and potential error reduction were noted as additional benefits. Conclusions: This process demonstrates that a multidisciplinary approach can be used to successfully integrate a customised eSource system working with previously untrained staff. Improved performance across pre-specified domains and potential additional benefits were noted. As FDA encourages use of digital solutions in clinical trials, using eSource provides a potential solution for compliant and efficient data capture from protocol assessments at investigator sites and rapid data transfer to sponsors.
{"title":"A multidisciplinary-tailored digital solution to data capture in early phase clinical trials.","authors":"D. Graham, Gemma Wickert, L. Goodwin, J. Clarke, C. Timmins, D. Chang, A. Walker, A. Rees, S. Stringer, Adam Theis, L. Carter, N. Cook, M. Krebs, F. Thistlethwaite, J. Bradford, J. Royle, A. Hughes","doi":"10.1200/jgo.2019.5.suppl.2","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.2","url":null,"abstract":"2 Background: Data capture in early phase cancer clinical trials (EPCCT) is usually via paper records with manual transcription to the sponsor’s case report form. Capturing real time trial data directly to computer (eSource) may reduce errors and increase completeness and timeliness of data entry. A simulated system pilot took place between Oct 2018 and Jan 2019 at an EPCCT facility to appraise Foundry Health’s eSource system “ClinSpark”. Aims were to assess consistency and effectiveness of creating electronic templates for source data capture and live data collection compliance. Methods: A multidisciplinary focus group (MFG) (2 research nurses, 1 doctor, 3 data managers) was created to collaborate with Foundry Health staff. Specialised features of the eSource system were adapted to handle the complex needs of EPCCT. The pilot incorporated a 5 day boot camp for familiarisation to the digital platform; a conference room test using simulated patient data; construction of a trial template including contingency planning; and a clinic floor test with live simulated patient data collection using digital tablets. The MFG agreed on a 52 item user acceptance test listing ideal features for a data collection tool, with items classified as high, medium or low priority. Results: During the 3 month pilot, templates for 2 EPCCT were planned and created by the MFG. Using eSource, 43 items (83%) of the acceptance test were passed compared with 27 items (52%) for the current (paper) system. For the 30 high-priority items, eSource passed 30 (100%) compared with 22 for the paper system (73%). The paper system was not superior to eSource for any items assessed. Time saving and potential error reduction were noted as additional benefits. Conclusions: This process demonstrates that a multidisciplinary approach can be used to successfully integrate a customised eSource system working with previously untrained staff. Improved performance across pre-specified domains and potential additional benefits were noted. As FDA encourages use of digital solutions in clinical trials, using eSource provides a potential solution for compliant and efficient data capture from protocol assessments at investigator sites and rapid data transfer to sponsors.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44916520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.7
S. Sabesan
7 Background: Australasian Teletrial Model (ATM) was developed in Australia to enhance rural and regional access to clinical trials using Telehealth. Under this model, trial clusters are established by connecting smaller satellite centers with larger primary sites using telehealth; governed by standard operating procedures and streamlined approval and contractual processes recently developed by the department of health of state of Queensland. Principal Investigator oversight and roles and responsibilities of sites are documented on supervision plans. We describe the implementation of an Eli Lilly’s adjuvant breast cancer trial MonarchE using ATM in Queensland. Methods: Two larger trial sites as primary sites were linked to four smaller centres to form Northern and Goldcoast clusters. This is a descriptive study of implementation research including perspectives of clinical trial staff. Results: Between February 2018-Feb 2019, four new sites and eight new satellite staff acquired clinical trial capabilities locally. Site initiation and regular trial meetings within clusters were conducted via telehealth. 11 patients were enrolled at satellite sites. No protocol violations occurred at any of the sites including documentation and investigator product handling. Staff (six trial nurses, and 10 medical oncologists) welcomed the model for facilitating inter-site collaboration and enhancing trial access to patients. Eli Lilly incurred additional cost for conducting one-off site visits to satellites and managing medication transport to satellites. Staff spent additional time for cluster coordination and development of new processes. Conclusions: Regional sites and their staff can acquire capabilities to offer clinical trials locally using the teletrial model. Consequently, rural patients can gain access to clinical trials closer to home without needing to travel long distances. Staff welcome this model for its many benefits to patients and the system. Initial increase in set-up cost is likely to be offset by better recruitment rates. With maturity, set-up costs and time to coordinate cluster processes are likely to lessen.
{"title":"Enhancing rural and regional access to clinical trial using the Australasian Teletrial Model (ATM): Experience from MonarchE adjuvant breast cancer trial in Queensland, Australia.","authors":"S. Sabesan","doi":"10.1200/jgo.2019.5.suppl.7","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.7","url":null,"abstract":"7 Background: Australasian Teletrial Model (ATM) was developed in Australia to enhance rural and regional access to clinical trials using Telehealth. Under this model, trial clusters are established by connecting smaller satellite centers with larger primary sites using telehealth; governed by standard operating procedures and streamlined approval and contractual processes recently developed by the department of health of state of Queensland. Principal Investigator oversight and roles and responsibilities of sites are documented on supervision plans. We describe the implementation of an Eli Lilly’s adjuvant breast cancer trial MonarchE using ATM in Queensland. Methods: Two larger trial sites as primary sites were linked to four smaller centres to form Northern and Goldcoast clusters. This is a descriptive study of implementation research including perspectives of clinical trial staff. Results: Between February 2018-Feb 2019, four new sites and eight new satellite staff acquired clinical trial capabilities locally. Site initiation and regular trial meetings within clusters were conducted via telehealth. 11 patients were enrolled at satellite sites. No protocol violations occurred at any of the sites including documentation and investigator product handling. Staff (six trial nurses, and 10 medical oncologists) welcomed the model for facilitating inter-site collaboration and enhancing trial access to patients. Eli Lilly incurred additional cost for conducting one-off site visits to satellites and managing medication transport to satellites. Staff spent additional time for cluster coordination and development of new processes. Conclusions: Regional sites and their staff can acquire capabilities to offer clinical trials locally using the teletrial model. Consequently, rural patients can gain access to clinical trials closer to home without needing to travel long distances. Staff welcome this model for its many benefits to patients and the system. Initial increase in set-up cost is likely to be offset by better recruitment rates. With maturity, set-up costs and time to coordinate cluster processes are likely to lessen.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44959278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.97
S. Agrawal, Nawed Alam, N. Rastogi, K. Das
97 Background: CT is the standard of care in advanced GBC [LA-GBC and metastatic GBC (M-GBC)]. The survival rates with CT are better in LA-GBC than M-GBC. Should responders to CT with good performance status (PS) be offered consolidation chemo-radiation (cCTRT) to delay progression and improve survival? There is scarcity of literature on this approach in the literature. We present our experience with this approach in LA-GBC which presents in endemic proportions in this region. Methods: We reviewed the records of consecutive GBC patients over 3 year period (2014-2016) after ethics approval. Out of 550 patients, 145 were LA-GBC who were treated with radical intent. Patients with good PS and responders to CT (partial and stable disease) but unresectable, were treated with cCTRT. Radiotherapy was given to GB bed, peri-portal, common hepatic, coeliac, superior mesentric and para aortic lymph-nodes (upto L2 vertebra) upto a dose of 45-54 Gy in 25 to 28 fractions along with concurrent capecitabine @ 1250 mg/m2. Response to treatment was categorised according to RECIST criteria based on CECT abdomen. Treatment toxicity, OS and factors affecting OS were computed by Cox-Regression analysis. Results: Burden of disease was [T3 (55%), T4 (45%), N1 (30%), N2 (70%)]. 65% patients underwent CT alone and 35% received CT followed by cCTRT. 10 patients underwent Radical Surgery ( 6 after CT and 3 after cCTRT). The incidence of grade 2 toxicity were: gastritis (10%) and diarrhoea (5%). 65% patients achieved partial response (PR), 12% static disease (SD), 10% progressive disease (PD) and 13% were non-evaluable (NE) [ did not complete 6 cycles CT or lost to follow-up]. At a median follow-up of 8 months (IQR 5-15 months), the median OS was 9 months for all, 7 months with CT and 14 months with cCTRT arm (p=0.04).The median OS was 57 months for CR, 12 months for PR and SD, 7 months for PD and 5 months for NE (p=0.008). OS was 10 months for KPS >80 and 5 months for KPS <80 (p=0.008). Type of treatment and response to treatment were retained as independent prognostic factors affecting OS. Conclusions: CT followed by cCTRT doubles survival in responders with good PS. This innovative approach should be tested in a randomised study.
{"title":"Consolidation chemoradiation improves survival in responders to first-line chemotherapy (CT) in locally advanced GBC (LA-GBC).","authors":"S. Agrawal, Nawed Alam, N. Rastogi, K. Das","doi":"10.1200/jgo.2019.5.suppl.97","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.97","url":null,"abstract":"97 Background: CT is the standard of care in advanced GBC [LA-GBC and metastatic GBC (M-GBC)]. The survival rates with CT are better in LA-GBC than M-GBC. Should responders to CT with good performance status (PS) be offered consolidation chemo-radiation (cCTRT) to delay progression and improve survival? There is scarcity of literature on this approach in the literature. We present our experience with this approach in LA-GBC which presents in endemic proportions in this region. Methods: We reviewed the records of consecutive GBC patients over 3 year period (2014-2016) after ethics approval. Out of 550 patients, 145 were LA-GBC who were treated with radical intent. Patients with good PS and responders to CT (partial and stable disease) but unresectable, were treated with cCTRT. Radiotherapy was given to GB bed, peri-portal, common hepatic, coeliac, superior mesentric and para aortic lymph-nodes (upto L2 vertebra) upto a dose of 45-54 Gy in 25 to 28 fractions along with concurrent capecitabine @ 1250 mg/m2. Response to treatment was categorised according to RECIST criteria based on CECT abdomen. Treatment toxicity, OS and factors affecting OS were computed by Cox-Regression analysis. Results: Burden of disease was [T3 (55%), T4 (45%), N1 (30%), N2 (70%)]. 65% patients underwent CT alone and 35% received CT followed by cCTRT. 10 patients underwent Radical Surgery ( 6 after CT and 3 after cCTRT). The incidence of grade 2 toxicity were: gastritis (10%) and diarrhoea (5%). 65% patients achieved partial response (PR), 12% static disease (SD), 10% progressive disease (PD) and 13% were non-evaluable (NE) [ did not complete 6 cycles CT or lost to follow-up]. At a median follow-up of 8 months (IQR 5-15 months), the median OS was 9 months for all, 7 months with CT and 14 months with cCTRT arm (p=0.04).The median OS was 57 months for CR, 12 months for PR and SD, 7 months for PD and 5 months for NE (p=0.008). OS was 10 months for KPS >80 and 5 months for KPS <80 (p=0.008). Type of treatment and response to treatment were retained as independent prognostic factors affecting OS. Conclusions: CT followed by cCTRT doubles survival in responders with good PS. This innovative approach should be tested in a randomised study.","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43362954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-10-07DOI: 10.1200/jgo.2019.5.suppl.77
K. Perry, R. Staruch, S. Pichardo, Yuexi Huang, M. McGuffin, A. Partanen, Shun Wong, G. Czarnota, K. Hynynen, Kelvin K. W. Chan, W. Chu
77 Background: MR-HIFU Hyperthermia (HT) is a non-invasive treatment modality with real-time thermometry that ensures accurate and precise heating of a target with minimal effect on adjacent tissue. This energy deposition within a tumour can produce local bioeffects resulting in thermal chemo- and radiosensitization. MR-HIFU has been shown to be safe and feasible in a companion phase I study for recurrent rectal cancer. The purpose of this study is to determine the feasibility of MR-HIFU in treating primary rectal tumours. Methods: With ethics approval, the anatomic characteristics and surrounding structures of rectal tumours diagnosed at Sunnybrook from 2014-2019 were retrospectively analyzed. Three orthogonal views of MR images were used to determine the potential ultrasound (US) beam path and organs at risk (OAR). In part 2 of the study, the gross tumour volume was delineated for 30 rectal tumours (10 low, mid &high). Image datasets were imported into the Sonalleve MR-HIFU workstation for virtual treatment simulation and planning to determine tumour targetability, coverage, optimal patient set-up, and transducer positioning. Results: Of the 105 tumours analyzed, 36, 52, and 17 were low, mid, and high, respectively. The average width of the acoustic window (sciatic notch) for the US beam path was 5.8 ± 1.4cm, average tumour length was 5.24 ± 2.0cm, and average beam path (skin to tumour edge) was 7.3 ± 1.9cm. Eighty one percent of tumours were ≤ 0.3cm from an OAR. Of the 24 virtually simulated tumours to date, 6/8 lower, 6/8 mid, and 1/8 upper rectal tumours were targetable by MR-HIFU. Conclusions: This is the first virtual analysis to evaluate MR-HIFU HT targetability in primary rectal cancer. Results from this study will support MR-HIFU HT as an option to enhance the treatment of primary rectal cancer. Acknowledgments: This study has been funded by the Canadian Cancer Society. Patient & tumour characteristics. [Table: see text]
{"title":"Magnetic resonance-guided high intensity focused ultrasound (MR-HIFU) hyperthermia for primary rectal cancer: A virtual feasibility analysis.","authors":"K. Perry, R. Staruch, S. Pichardo, Yuexi Huang, M. McGuffin, A. Partanen, Shun Wong, G. Czarnota, K. Hynynen, Kelvin K. W. Chan, W. Chu","doi":"10.1200/jgo.2019.5.suppl.77","DOIUrl":"https://doi.org/10.1200/jgo.2019.5.suppl.77","url":null,"abstract":"77 Background: MR-HIFU Hyperthermia (HT) is a non-invasive treatment modality with real-time thermometry that ensures accurate and precise heating of a target with minimal effect on adjacent tissue. This energy deposition within a tumour can produce local bioeffects resulting in thermal chemo- and radiosensitization. MR-HIFU has been shown to be safe and feasible in a companion phase I study for recurrent rectal cancer. The purpose of this study is to determine the feasibility of MR-HIFU in treating primary rectal tumours. Methods: With ethics approval, the anatomic characteristics and surrounding structures of rectal tumours diagnosed at Sunnybrook from 2014-2019 were retrospectively analyzed. Three orthogonal views of MR images were used to determine the potential ultrasound (US) beam path and organs at risk (OAR). In part 2 of the study, the gross tumour volume was delineated for 30 rectal tumours (10 low, mid &high). Image datasets were imported into the Sonalleve MR-HIFU workstation for virtual treatment simulation and planning to determine tumour targetability, coverage, optimal patient set-up, and transducer positioning. Results: Of the 105 tumours analyzed, 36, 52, and 17 were low, mid, and high, respectively. The average width of the acoustic window (sciatic notch) for the US beam path was 5.8 ± 1.4cm, average tumour length was 5.24 ± 2.0cm, and average beam path (skin to tumour edge) was 7.3 ± 1.9cm. Eighty one percent of tumours were ≤ 0.3cm from an OAR. Of the 24 virtually simulated tumours to date, 6/8 lower, 6/8 mid, and 1/8 upper rectal tumours were targetable by MR-HIFU. Conclusions: This is the first virtual analysis to evaluate MR-HIFU HT targetability in primary rectal cancer. Results from this study will support MR-HIFU HT as an option to enhance the treatment of primary rectal cancer. Acknowledgments: This study has been funded by the Canadian Cancer Society. Patient & tumour characteristics. [Table: see text]","PeriodicalId":15862,"journal":{"name":"Journal of global oncology","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46632301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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