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Jie Wang
Moderator of
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MS 20 - Value-based Management for Special Populations (ID 542)
- Event: WCLC 2017
- Type: Mini Symposium
- Track: Nursing/Palliative Care/Ethics
- Presentations: 4
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MS 20.01 - When is a Treatment Considered Futile? (ID 7737)
11:00 - 12:30 | Presenting Author(s): Vera Hirsh
- Abstract
- Presentation
Abstract:
Introduction: Futile care is defined as care that fails to provide a clinical benefit. This term can be controversial, especially when it’s value of the caregivers, patient or his family are different. Discussion: Poor communication between physicians, patients and their family members can lead to the misalignment of perceptions, ie. about life expectancy with or without treatments, about toxicities to be expected from a specific treatment, what quality of life (QOL) can be expected on certain treatments and what it means to receive as an alternative treatment a palliative care only.[1] [2] [3] [4] Sometimes the patient might refuse to know his prognosis and palliative care discussion.[5] [6]Doctor’s perception is frequently influenced by patient’s poor performance status (PS) of 3 or 4, very short estimated survival (sometimes in weeks only), difficulties with the management of the treatment toxicities which can cause a decline of QOL, different interventions and hospitalizations. The perceived patient’s compliance with the treatments is an important factor, too. The interventions, ie. management of toxicities of the therapies, more frequent patients’ visits, hospitalizations and the treatments without benefit further stress the futility with an increased cost for the society and institutions providing the health care. [7] The goals of patient care have to be discussed between oncologist, patient and his family. [8] [9]The final decision has to be shared and agreed on. The decisions have to include non-curative interventions, ie. other drugs, transfusions or even participation in Phase I trials,[10] which are conducted for safety of the drugs without an evidence of efficacy, but they are still not futile. It is very important to review if all the reasonable options of the interventions and the treatments were attempted, regardless of the timing of the situation at the time of the diagnosis or at the time of disease progression. The emotional needs of patients’ caregivers, ie. family members, have to be considered and addressed, too. Conclusion: The discussion of disagreements with the patient, his family and health care providers regarding the treatment goals and interventions when considering the disease prognosis will lead to reasonable conclusions and avoid the futilities. As it was quoted, “In Oncology: clear and unequivocal situations of right and wrong are rare.” The concerns and wishes of the patients, patients’ families and oncologists have to be well balanced to avoid a futile treatment. [1] Jecker NS, Pearlman RA (1992) Medical futility. Who decides? Arch Intern Med 152: 1140-1144. [2] Jecker NS, Schneiderman LJ (1993) Medical futility: the duty not to treat. Camb Q Healthc Ethics 2: 151-159 [3] Schneiderman LJ, Jecker NS, Jonsen AR (1990) Medical futility: its meaning and ethical implications. Ann Intern Med 112: 949-954. [4] Veatch RM (2013) So-called futile care: The experience of the United States. Medical Futility. A Cross-National Study. Imperial College Press. London. [5] Jox RJ, Schaider A, Marckmann G, Borasio GD (2012) Medical futility at the end of life: the perspectives of intensive care and palliative care clinicians. J Med Ethics 38: 540-545. [6] Lantos JD, Singer PA Walker RM, Gramelspacher GP, Shapiro GR, et al. (1989) The illusion of futility in clnical practice. AM J Med 87: 81-84 [7] LO B (1995) Futile interventions. Resolving ethical dilemmas: A guide for clinicians. Baltimore: Williams & Wilkins, 73-81. [8] Youngner SJ (1990) Who defines futility? JAMA 260: 2094-2095. [9] Youngner SJ (1990) Futility in context. JAMA 264: 1295-1296. [10] Chen EX, Tannock IF (2004) Risks and benefits of phase 1 clinical trials evaluating new anticancer agents: a case for more innovation.
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MS 20.02 - Value-Based Judgment in Advanced NSCLC: The European Perspective (ID 7738)
11:00 - 12:30 | Presenting Author(s): Robert Pirker
- Abstract
- Presentation
Abstract:
Therapy of lung cancer depends on many factors including tumor-related factors, patient parameters and treatment-related factors. Tumor-related factors are histological subtype, molecular characteristics and stage as well as growth of tumors. Patient-related factors include age, life expectancy, gender, performance status, organ functions, co-morbidity, functional status, geriatric syndromes and patient preference. Drug-related parameters include convenience of administration, side effects of drugs, and polypharmacy. Costs, cost effectiveness and value-based judgements are also of major importance. Value-based judgements of anticancer therapies are based on the magnitude of the clinical benefit balanced against their costs (1). These judgements are gaining increasing importance because of the increasing costs of modern anticancer treatments including novel anticancer drugs. The benefit of treatments focus on living longer and living better. The evidence of the magnitude of the treatment benefit is derived from clinical trials such as phase 3 trials or from meta-analyses of randomized trials. Important outcome parameters focus on the impact of the treatments on overall survival, progression-free survival, response rates and symptom relief. Parameters for living longer are improved overall survival and/or improved surrogate of overall survival such as disease-free survival in the adjuvant setting or progression-free survival. With regard to living better, important parameters are improved quality of life, improved surrogate of quality of life, and reduced toxicity. The incremental cost-effectiveness ratio (ICER) is often used to evaluate the value of a new anticancer drug (2, 3). ICER refers to the costs per life year gained or costs per quality-adjusted life year gained. A drug is considered cost-effective if its ICER is below a certain threshold which depends on the country and may range from about 20.000 to 50.000 Euros or even higher. Several scientific and professional societies including ESMO have developed scales to determine the clinical benefit of systemic treatments in patients with cancer. The ESMO - Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a standardized, generic, validated tool to assess the magnitude of clinical benefit that can be expected form anticancer therapies (4, 5). This tool is dynamic and has been planned to be revised in regular intervals (4). Separate tools have been developed for the adjuvant and the palliative settings. For assessment of survival data, hazard ratios and median survival times are considered. Based on simulation data, the lower limit of the 95% confidence interval of the hazard ratios have been recommended for use (4). Form 1 of the ESMO-MCBS is used for adjuvant or neoadjuvant therapies and for localized or metastatic disease treated with curative intent (4). The grades are A, B and C, with grades A and B representing high levels of clinical benefit (4). Grade A refers to >5% improvement in survival or improvement in disease-free survival alone with a HR<0.65 in studies without mature survival data. Grade B refers to ≥3% but ≤5% improvement in survival or improvement in disease-free survival alone with hazard ratios <0.65-0.8 without mature survival data. In addition, non-inferior survival or disease-free survival with reduced treatment toxicity or improved quality of life, or non-inferior survival with reduced treatment costs are also graded as B. Grade C refers to <3% improvement of survival or improvement in disease-free survival alone with hazard ratios >0.8 in studies without mature survival data. Form 2 of the ESMO-MCBS is used for therapies without curative intent (4). The grades range from 1 to 5, with grades 4 and 5 representing high levels of proven clinical benefit (4). Form 2 is more complex and includes forms 2a, 2b and 2c. Form 2a is for therapies that are not likely to be curative and have overall survival as primary endpoint. Form 2b is for therapies that are not likely to be curative and have progression-free survival as primary endpoint. Form 2c is for therapies that are not likely to be curative and have primary endpoints other than overall survival or progression-free survival. The preliminary magnitude of clinical benefit is based on the efficacy of the treatment and is then adjusted according to quality of life and grade 3-4 toxicities. The preliminary score is upgraded by 1 if the treatment resulted in improved quality of life and/or less grade 3-4 toxicities. The ESMO-MCBS is planned for comparative analyses of different treatments (4, 5). The value of treatments of lung cancer measured according to the ESMO-MCBS in a single institution has recently been published (6). In summary, the evaluation of the clinical benefit of anticancer therapies in patients with lung cancer is a complex and rapidly moving area. It is based on the evidence from clinical trials, cost effectiveness analyses and, more recently, also valued-based judgements. The latter tools are dynamic and balance magnitudes of the benefits against the costs of specific treatments. Despite all these measures, clinically experienced doctors working in close co-operation with informed patients and their relatives are crucial for optimal treatment decisions in patients with lung cancer. References 1. Porter ME. NEJM 2010, 363, 2477 2. Dilla T et al. Patient Preference and Adherence 2016, 10, 1 3. Bae YHJ & Mullins CD. J Manag Care Pharm 2014, 20, 1086 4. Cherny NI et al, Ann Oncol 2015, 26, 1547 5. Cherny NI et al. ESMO Open 2016, 1, e000100 6. Kiesewetter B et al. ESMO Open 2016, 1, e000066
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MS 20.03 - What Do Patients Want at the End of Life? - East vs West (ID 7739)
11:00 - 12:30 | Presenting Author(s): Hiroaki Okamoto | Author(s): H. Kunikane
- Abstract
- Presentation
Abstract:
Although advance care planning (ACP) may prevent non-beneficial care that is discordant with patient wishes at the end-of-life (EOL), nearly 40% of bereaved families in the US said their loved ones had not discussed their EOL care preferences with them (Narang et al, JAMA Oncol 2015). Fewer Japanese studies on EOL discussions (EOLd) with patients have been reported than studies in Western countries. Similarly, few studies investigating what patients want at the EOL have been reported in Japan. Most Japanese studies related to EOL have focused on medical staff, bereaved families, or healthy persons in the general population, rather than on patients themselves. In addition, the most common method of data collection for these studies in Japan has been through administration of questionnaire surveys by mail (J-HOPE3 study 2016, in Japanese). While the perspectives of care providers and family may indirectly reflect the preferences of patients, previous studies have not assessed cancer patients directly and therefore knowledge regarding EOL preferences for this population remains limited and unclear. Possible reasons for not directly investigating the EOL preferences of cancer patients may be related to Japanese cultural taboos regarding discussion of death with cancer patients and the positive cultural value of living without awareness of death, even in the terminal stage of disease. These factors lead to reluctance in discussing EOL care among patients, family members, and medical staff. In contrast, 70% of cancer patients in Sweden had discussions about death with family members within 3 months of their death (Jonasson et al, Eur J Cancer 2011). In a previous study of 529 Japanese cancer patients, only half of the patients preferred to receive information regarding their life expectancy and 30% preferred not to receive such information. Furthermore, 90% of the patients preferred to have their physicians consider the feelings of their family as well (Fujimori et al, Psychooncology 2007). One Japanese research study on the hopes of terminally-ill patients found that symptom control was the most frequently expressed hope at the time of admission to a palliative care unit (PCU). However, patient hopes regarding symptom control and recovery decreased as death approached. In contrast, both existential hope and hope of good human relations increased by the time of death (Naka et al, Shi no rinsho 1998, in Japanese). EOLd should repeatedly occur among patients, families, and medical staff, before patients become incompetent, because patient preferences may change in unexpected ways, as was found in a study of advanced lung cancer patients (Pardon et al, Support Care Cancer 2012). Another Japanese study of advanced cancer patients found that patients strongly preferred that their physicians listen to their distress and concerns (96%), assure them that their painful symptoms would be controlled (97%), and explain the status of their illness and the physical symptoms that would likely occur in the future (95%) (Umezawa et al, Cancer 2015). Patient preferences or hopes near the EOL appear to be similar between Western and Japanese cultures. However, fewer Japanese studies on EOLd have been reported because of cultural taboo for talking about death. In our hospital, when patients with advanced lung cancer had an initial consultation with palliative care physicians to prepare for future PCU admission (N=46), the reasons expressed by patients or their families for considering PCU admission were “want to reduce pain (70%)”, “want to reduce distress (59%)”, “want to live without intensive life-sustaining care (52%)”, and “recommendation by attending physicians or caregivers (39%)”. However, only 9% of patients clearly understood their life expectancy when considering PCU admission. Interestingly, many terminally-ill Japanese cancer patients may wish to take a bath before death. For example, 40% of patients with advanced cancer were bathed while receiving home nursing services within 4 days of death (Tanabe et al, Hospice and Home Care 2015, in Japanese). The role of rehabilitation in PCUs remains unclear and one study found that only 20% of terminally ill cancer patients received rehabilitation in Japan. However, the rate of satisfaction for the rehabilitation reported by bereaved families was extremely high (80%) (J-HOPE3 study 2016, in Japanese). There is limited published information about how physicians obtain the skills necessary for managing their own discomfort with talking about death. Communicating in an honest manner, without taking away hope, is an essential skill for the physician treating terminally-ill cancer patients. Japanese physicians, however, are less likely to have educational opportunities to learn how to discuss bad news with patients. Japanese physicians, in particular, often feel discomfort with discussing prognosis, hospice, site of death, and do-not-resuscitate (DNR) status with patients. Improvement in the communication skills of physicians is key to facilitating more appropriate ACP with cancer patients. For communication with terminally-ill cancer patients, the classic strategy of “hope for the best and prepare for the worst” or “use more open questions rather than closed questions with patients” can be recommended as part of an ACP discussion. Using a palliative prognostic index may be helpful in predicting prognosis for terminally-ill cancer patients more accurately (Maltoni et al, Oncologist 2012). However, because accurate prognostic understanding has been found to be associated with lower quality of life (QOL) and worse anxiety, these patients should be offered psychosocial support (El-Jawahri, Cancer 2014). Discordance between the care desired and the care received by patients is another important EOL issue. The use of structured communication tools, rather than an ad-hoc approach, is recommended to facilitate more appropriate EOLd, and to avoid care not desired by patients (Oczkowski et al, PLoS One 2016). Finally, a phase III study evaluating the role of early palliative care (EPC) suggested that EPC provided significantly better QOL and better survival than usual care in patients with advanced non-small cell lung cancer (Temel et al, N Engl J Med 2010). Similarly, our feasibility study demonstrated that EPC provided better QOL in patients with advanced lung cancer (Yokoyama et al. WCLC 2015). We recommend EPC referrals for lung cancer patients to support earlier EOLd and earlier understanding of the hopes and goals of patients with advanced lung cancer.
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MS 20.04 - Treatment of Fragile Patients with Advanced NSCLC: Futile or Fertile? (ID 7740)
11:00 - 12:30 | Presenting Author(s): H.K. Ahn
- Abstract
- Presentation
Abstract not provided
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Author of
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JCSE 01 - Joint IASLC/CSCO/CAALC Session: Immunotherapy for Management of Lung Cancer: Ongoing Research from East and West (ID 630)
- Event: WCLC 2017
- Type: Joint Session IASLC/CSCO/CAALC
- Track: Immunology and Immunotherapy
- Presentations: 2
- Moderators:C. Bai, Fred R. Hirsch, Tony SK Mok, Yi-Long Wu
- Coordinates: 10/15/2017, 07:30 - 11:30, F203 (Annex Hall)
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JCSE 01.24 - Detection of EGFR, ALK and Other Driver Oncogenes from Plasma cfDNA by Single Molecule Amplification and Re-sequencing Technology (cSMART) (ID 10920)
07:30 - 11:30 | Author(s): Jie Wang
- Abstract
Background:
All patients with advanced stage NSCLC should have their EGFR and ALK mutation status known prior to initiation of first line therapy. Multiple plasma-based technologies such as ARMS and ddPCR are available for rapid detection of EGFR mutation, while only the more laborious Next Generation Sequencing (NGS) may cover EGFR, ALK and other uncommon mutations in a single blood test. cSMART is a novel NGS-based technology with rapid turnaround time that can detect EGFR, ALK and KRAS mutations plus others less common lung cancer specific driver oncogenes (BRAF, ROS-1, HER-2, PIK3CA, RET, MET14skipping).
Method:
Objectives of this study is to investigate the clinical application of cSMART on patients with advanced NSCLC. In cSMART assay, each cfDNA single allelic molecule is uniquely barcoded and universally amplified to make duplications. The amplified products are circularized and re-amplified with target-specific back-to-back primers. These DNA are then ligated with sequencing adapters and pair-end sequenced (>40,000x) with illumine sequencers. The original cfDNA molecules are reconstituted by multi-step bioinformatics pipeline for censor and correction. The final products are quantified for calculation of allele frequencies
Result:
Out of the 1664 samples tested, total of 1469 were of advanced stage NSCLC. We detected EGFR mutations in 758 (51.6%), ALK translocation in 34 (2.3%) and KRAS mutation in 78 (5.8%) patients. Among the patients with activating EGFR mutations, 301(39.7%) have exon 19 deletion and 279 (36.8%) have exon 21 point-mutation. Total of 6 (0.8%) patients with EGFR mutation have concurrent presence of ALK translocation. Incidence and mean allele frequency of the less common target mutation is summarized in Table. Median sample turnaround time is 7 days.Incidence (%) Median Mutation Allele frequency (%) BRAF 29 (1.97%) 0.08% ROS1 2 (0.14%) 0.77% HER-2 19 (1.29%) 0.20% PIK3CA 70 (4.77%) 0.17% RET 14 (0.95%) 0.57% MET14skipping 63 (4.29%) 0.08%
Conclusion:
cSMART is a novel plasma cfDNA-based technology that can detect the actionable target oncogenes for patients with advanced NSCLC. This is a sensitive method with capacity of detecting the uncommon targets at relatively low allele frequency.
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JCSE 01.25 - Detection of EGFR T790M Mutations by Four Testing Platforms in ctDNA from Chinese Patients with Advanced NSCLC (ID 10921)
07:30 - 11:30 | Author(s): Jie Wang
- Abstract
Background:
Osimertinib is used to treat patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Detection of the T790M mutation in tissue samples may not be possible in some patients due to unfeasible or unsuccessful rebiopsies; detection in circulating cell-free tumor DNA (ctDNA) may represent a promising alternative. Here we evaluated four platforms to detect T790M using ctDNA in plasma from Chinese patients as part of the ADELOS study.
Method:
ADELOS is being conducted in China in 256 patients with advanced NSCLC, sensitizing mutations and progression on previous tyrosine kinase inhibitor. T790M was detected in plasma ctDNA by cobas® real-time polymerase chain reaction (PCR), super amplification refractory mutation system (Super-ARMS) PCR, QuantStudio3D digital PCR, and next-generation sequencing (NGS). T790M positive patients by any of the four platforms received osimertinib 80 mg/day orally. The relationship between T790M detection by each platform and objective response rate (ORR) was investigated. Concordance, sensitivity and specificity, and positive/negative predictive value between platforms were assessed. T790M mutation level in ctDNA was dynamically monitored every 6 weeks using digital PCR and NGS during osimertinib treatment, and its correlation with clinical outcome was evaluated. NGS also provided information about the heterogeneity of other genetic alterations in patients before osimertinib treatment.
Result:
Section will be completed in late-breaking abstract submission
Conclusion:
Section will be completed in late-breaking abstract submission
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MA 11 - Emerging Diagnostic/Biomarkers in NSCLC (ID 668)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:M.I. Abdul Wahid, Martin Reck
- Coordinates: 10/17/2017, 11:00 - 12:30, Room 313 + 314
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MA 11.03 - Gefitinib as First-Line Treatment of Plasma CtDNA EGFR Mutation-Positive NSCLC Detected by DdPCR: BENEFIT Study (CTONG1405) (ID 9278)
11:00 - 12:30 | Presenting Author(s): Jie Wang
- Abstract
- Presentation
Background:
EGFR mutations in plasma circulating free tumor-derived DNA (ctDNA) as a predictor of EGFR TKI efficacy in patients with NSCLC requires validation in prospective studies. The large, prospective Phase II, single-arm, multicenter BENEFIT study (CTONG1405; NCT02282267) validated the efficacy of first-line gefitinib in EGFR mutation-positive NSCLC detected in plasma ctDNA using droplet digital PCR (ddPCR).
Method:
Patients with stage IV lung adenocarcinoma and plasma ctDNA EGFR-sensitizing mutations (exon 19 del or exon 21 L858R; by ddPCR) received first-line gefitinib (250 mg once-daily) until progressive disease (PD). Blood samples were collected every 8 weeks for dynamic EGFR analysis until PD. Primary endpoint was ORR. Secondary endpoints included PFS, DCR (Week 8), and analysis of baseline ctDNA samples by next-generation sequencing (NGS).
Result:
From December 2014-January 2016, 426 patients from 15 Chinese centers were screened: 391 had matched tissue and blood samples; 188 had ctDNA EGFR mutation-positive NSCLC and received gefitinib; and 183 had ≥1 post-baseline tumor assessment and plasma samples every 8 weeks until PD. At data cutoff (January 31, 2017), 152 patients had progressed. ORR was 72.1% (95% CI 65.0%,78.5%); DCR (Week 8) was 92.3% (95% CI 87.5%,95.8%); and median PFS was 9.5 months (95% CI 9.07,11.04). PFS was significantly shorter in the subgroup with baseline ctDNA de novo T790M mutations (5.0%, n=9) versus the EGFR-sensitizing mutations subgroup (5.6 vs 9.6 months, HR=2.60; 95% CI 1.32,5.12, p=0.004). In patients with Week 8 on-treatment plasma samples (n=167), the subgroup who showed EGFR mutation clearance in ctDNA by ddPCR (88%, 147/167) had longer PFS compared with those who did not (11.0 vs 2.1 months, HR=7.28; 95% CI 4.35,12.18, p<0.0001). The median time to emergence of acquired T790M mutation in plasma was 7.6 months. The T790M-positive rate increased from Week 24 (15.7%) to Week 48 (32.6%), with a corresponding increase in PD rate (24.7% at Week 24, 56.9% at Week 48). Among 180 patients with baseline NGS data, 21 (11.7%) harbored aberrations in additional oncogenic drivers (MET, ERBB2, KRAS, BRAF, RET, or ROS1) and tumor suppressors (TP53, RB1, and PTEN). This subgroup had worse PFS versus those with EGFR-sensitizing mutations alone (3.9 vs 13.0 months, HR=2.83; 95% CI 1.65,4.87, p=0.00016).
Conclusion:
The BENEFIT study prospectively demonstrated that ctDNA-based EGFR mutation detection can be used to select patients for treatment with first-line gefitinib. Dynamic alterations in EGFR mutations could be used to predict efficacy and disease progression, ahead of radiological results.
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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.01-032 - Detection of EGFR, ALK and Other Driver Oncogenes from Plasma cfDNA by Single Molecule Amplification and Re-sequencing Technology (cSMART) (ID 8603)
09:30 - 16:00 | Author(s): Jie Wang
- Abstract
Background:
All patients with advanced stage NSCLC should have their EGFR and ALK mutation status known prior to initiation of first line therapy. Multiple plasma-based technologies such as ARMS and ddPCR are available for rapid detection of EGFR mutation, while only the more laborious Next Generation Sequencing (NGS) may cover EGFR, ALK and other uncommon mutations in a single blood test. cSMART is a novel NGS-based technology with rapid turnaround time that can detect EGFR, ALK and KRAS mutations plus others less common lung cancer specific driver oncogenes (BRAF, ROS-1, HER-2, PIK3CA, RET, MET14skipping).
Method:
Objectives of this study is to investigate the clinical application of cSMART on patients with advanced NSCLC. In cSMART assay, each cfDNA single allelic molecule is uniquely barcoded and universally amplified to make duplications. The amplified products are circularized and re-amplified with target-specific back-to-back primers. These DNA are then ligated with sequencing adapters and pair-end sequenced (>40,000x) with illumine sequencers. The original cfDNA molecules are reconstituted by multi-step bioinformatics pipeline for censor and correction. The final products are quantified for calculation of allele frequencies
Result:
Out of the 1664 samples tested, total of 1469 were of advanced stage NSCLC. We detected EGFR mutations in 758 (51.6%), ALK translocation in 34 (2.3%) and KRAS mutation in 78 (5.8%) patients. Among the patients with activating EGFR mutations, 301(39.7%) have exon 19 deletion and 279 (36.8%) have exon 21 point-mutation. Total of 6 (0.8%) patients with EGFR mutation have concurrent presence of ALK translocation. Incidence and mean allele frequency of the less common target mutation is summarized in Table. Median sample turnaround time is 7 days.Incidence (%) Median Mutation Allele frequency (%) BRAF 29 (1.97%) 0.08% ROS1 2 (0.14%) 0.77% HER-2 19 (1.29%) 0.20% PIK3CA 70 (4.77%) 0.17% RET 14 (0.95%) 0.57% MET14skipping 63 (4.29%) 0.08%
Conclusion:
cSMART is a novel plasma cfDNA-based technology that can detect the actionable target oncogenes for patients with advanced NSCLC. This is a sensitive method with capacity of detecting the uncommon targets at relatively low allele frequency.
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P1.04 - Clinical Design, Statistics and Clinical Trials (ID 690)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.04-010 - CheckMate 870: An Open-label Safety Study of Nivolumab in Previously Treated Patients With Non-Small Cell Lung Cancer in Asia (ID 8231)
09:30 - 16:00 | Author(s): Jie Wang
- Abstract
Background:
Programmed death-1 (PD-1) is an immune checkpoint receptor that attenuates T-cell activation by binding to its ligands, PD-L1 and PD-L2, which are expressed on tumor cells. Nivolumab, an anti–PD-1 antibody, showed durable antitumor activity and a favorable safety profile compared with docetaxel in previously treated patients with advanced non-small cell lung cancer (NSCLC) in 2 global phase 3 studies (CheckMate 017 and CheckMate 057). Data from these trials led to the approval of weight-based nivolumab 3 mg/kg administered as a 60-minute infusion every 2 weeks (Q2W) in previously treated patients with NSCLC. Data from exposure-response simulations indicated that flat-dose nivolumab 240 mg Q2W has comparable pharmacokinetic, safety, and efficacy profiles to the weight-based dose, and data from CheckMate 153 demonstrated that nivolumab 3 mg/kg can be safely infused over 30 minutes. CheckMate 078 is an ongoing phase 3 registrational trial evaluating second-line nivolumab 3 mg/kg as 60-minute infusions Q2W versus docetaxel in patients with advanced NSCLC in a predominantly Chinese population. CheckMate 078 excludes patients with hepatitis B virus (HBV) infection, which represent a clinically relevant subgroup of patients in Asia; approximately 15% of patients with lung cancer in China are seropositive for HBV surface antigens. CheckMate 870 is an open-label, single-arm phase 3b study evaluating the safety and tolerability of flat-dose nivolumab 240 mg infused over 30 minutes Q2W in Asian patients with advanced or metastatic NSCLC, with or without HBV infection.
Method:
Approximately 400 patients in Asia with advanced or metastatic NSCLC and disease progression during or after 1 prior systemic platinum-based therapy will be enrolled; those with EGFR mutations (maximum of 40 patients) or ALK translocations should have received 2 prior systemic treatments including a tyrosine kinase inhibitor and chemotherapy. Nivolumab will be administered 240 mg over 30 minutes Q2W until disease progression or unacceptable toxicity, for a maximum of 24 months. Nivolumab may be reinitiated for subsequent disease progression and administered for up to 1 additional year. The primary objective is to evaluate the safety and tolerability of nivolumab in non–HBV-infected patients with NSCLC. The secondary objective is to assess safety and tolerability in all patients and in HBV-infected patients. Exploratory objectives include efficacy, patient-reported outcomes, health care resource utilization and direct medical costs, biomarker characterization in all patients, and viral load change and HBV reactivation rate in HBV-infected patients.
Result:
Section not applicable
Conclusion:
Section not applicable
