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Shoichi Kuyama
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EP1.01 - Advanced NSCLC (ID 150)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 2
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.01-64 - Effect of Amrubicin in Patients with Previously Treated Non-Small-Cell Lung Cancer (Now Available) (ID 599)
08:00 - 18:00 | Author(s): Shoichi Kuyama
- Abstract
Background
Although the prognosis of non-small cell lung cancer (NSCLC) has been rapidly improved due to the appearance of various tyrosine kinase inhibitors and immune checkpoint inhibitors, cytotoxic chemotherapy are still important treatment for patients who can’t receive these drugs or are ineffective for these drugs. Amrubicin (AMR) couldn’t significantly improve the progression free survival compared with docetaxel in a randomized phase III trial of Japanese previously treated NSCLC patients, but median progression free survival (PFS) and overall survival (OS)were comparable in the amrubicin and docetaxel groups. The purpose of this study is to clarify the use of amrubicin in clinical practice.
Method
From January 2014 to March 2019, 479 progressive or recurrent NSCLC patients received chemotherapy or radiotherapy. Only 27 patients received AMR. We retrospectively evaluated these 27 patients.
Result
None of the NSCLC patients who received AMR had epidermal growth factor recepter gene mutations nor anaplastic lymphoma kinase gene translocations. Median number of prior chemotherapy regimens was four, and median PFS was 62 days and OS was 229 days. Overall response rate was 7.4% and disease control rate was 37.0%.
Conclusion
AMR was often used for patients considered to have a poor prognosis, and its effect was limited.
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EP1.01-99 - Effect of Immune Checkpoint Inhibitors Re-Administration in Non-Small-Cell Lung Cancer Patients (Now Available) (ID 236)
08:00 - 18:00 | Author(s): Shoichi Kuyama
- Abstract
Background
Immune checkpoint inhibitors, drugs targeting the programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) pathways, are approved for the treatment of patients with non-small-cell lung cancer (NSCLC) with impressive clinical activity and durable responses in some patients. But the re-administration of immune checkpoint inhibitors have not be clarified.
Method
From December 2015 to December 2018, 93 NSCLC patients received immune checkpoint inhibitor monotherapy. We retrospectively evaluated these 93 patients.
Result
6 patients received re-administration of immune checkpoint inhibitors. Median progression free survival of immune checkpoint inhibitors initial treatment and re-administration were 98 and 55 (p = 0.139). Overall response rate was 24.7% and 0% (p = 0.331) and disease control rate was 53.7% and 16.7% (p = 0.105). There was no significant difference between initial treatment and re-administration. The effect of re-administration of immune checkpoint inhibitor is not so high, but one patient received more than 6months.
Conclusion
The effect of re-administration of immune checkpoint inhibitors are not high, but few patients can receive long term of therapy.
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MA13 - Going Back to the Roots! (ID 139)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:Maurice Perol, Kaoru Kubota
- Coordinates: 9/09/2019, 14:00 - 15:30, Vancouver (2003)
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MA13.02 - Incidence of Venous Thromboembolism at the Time of Lung Cancer Diagnosis: A Multicenter, Prospective Observational Trial (Rising-VTE/NEJ037) (Now Available) (ID 1195)
14:00 - 15:30 | Author(s): Shoichi Kuyama
- Abstract
- Presentation
Background
Venous thromboembolism (VTE) is a most well-known kind of cancer associated thrombosis, and a common complication of malignancy. However, little is known about the incidence of VTE at the time of lung cancer diagnosis. This information is important for clinicians and patients to inform their decision-making about cancer treatment.
Method
The Rising-VTE/NEJ037 study was a multicenter, prospective, observational study with 40 participating Japanese institutions. It included 1,021 patients diagnosed with lung cancer unsuitable for radical resection or radiation between June 2016 and August 2018. The incidence of VTE and characteristics of patients diagnosed with VTE based on contrast-enhanced computed tomography or ultrasonography of the leg are described. Diagnosis of VTE was confirmed via central review by two radiologists.
Result
Baseline data was available for 1,013 patients. The median age was 71 years (range 30-94). Eighty-six percent of patients had non-small cell lung cancer and 13.5% had small cell lung cancer. Histological types included adenocarcinoma (N=645, 63.7%), squamous cell carcinoma (N=180, 17.8%), small-cell lung cancer (N=137, 13.5%) and others (N=42, 4.1%). There were 59 patients (5.8%) diagnosed with VTE, of whom 53.9% had deep vein thrombosis (DVT), 28.7% had pulmonary embolism (PE) and 24.6% had both DVT and PE. Most patients with VTE had adenocarcinomas (89.1%).
Conclusion
The incidence of VTE in this study seems to be higher than in the clinical setting, suggesting that screening may be desirable. Adenocarcinoma of the lung seems to be a risk factor for VTE that we should consider more carefully. The primary endpoint of this trial is the rate of symptomatic or asymptomatic recurrence or newly diagnosed VTE during 2 years after registration. Follow-up is ongoing, with a report of final findings planned for 2021. Clinical trial information: UMIN000020194. Funding: Daiichi Sankyo Company.
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P1.01 - Advanced NSCLC (ID 158)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.01-47 - Prospective Study for Usefulness of Plasma DNA on Prediction of Third Generation EGFR Tyrosine Kinase Inhibitors (S-PLAT Study) (Now Available) (ID 1112)
09:45 - 18:00 | Author(s): Shoichi Kuyama
- Abstract
Background
The AURA and FLAURA studies have shown that EGFR T790M mutation detected in cfDNA is correlated with efficacy of osimertinib as measured via overall response rate (ORR), and progression-free survival (PFS). However, the following clinical-related questions have been raised: Can other different assay systems confirm the results mentioned above? Does T790M level affect osimertinib treatment efficacy? Do mutations at loci other than EGFR influence treatment efficacy?
Method
This is a prospective observational study, joining 27 Japanese hospitals. Plasma samples from patients with non-small cell lung cancer (NSCLC) who acquired resistance to EGFR-TKI (gefitinib, erlotinib, afatinib) were collected between Feb 2017 and Jan 2019. We tested T790M by MBP-QP method which has been newly developed using cfDNA and investigated the concordance with the result by cobas EGFR mutation Test v.2 (tissue and/or plasma) which is commercially available. We also checked the allele frequency (AF) of T790M in cfDNA by ddPCR and the mutational status of cancer related actionable genes by cfDNA specific NGS (Guardant360). The major objectives were ORR, disease control rate (DCR) to osimertinib and PFS in patients with T790M positive by MBP-QP method.
Result
Among 145 NSCLC patients who acquired resistance to 1st or 2nd EGFR-TKI, T790M was detected in 57 patients by cobas (tissue and/or plasma), and these patients received osimertinib (80mg daily). T790M was detected by cobas in 16 patients from plasma, 44 patients from tissue, 3 patients from both samples. Among assessable patients, ORR, DCR and PFS in patients with T790M positive by cobas from plasma were 66.7%, 86.7%, 194 days, those of tissue were 53.5%, 97.7%, 186 days, respectively. In these 57 patients, MBP-QP also could detect T790M from 10 patients from plasma, and ORR, DCR and PFS in patients with T790M positive by MBP-QP from plasma were 75.0%, 87.5%, 184 days, respectively. These results suggest that T790M detection from cfDNA not only by cobas but also MBP-QP is correlated with RR of osimertinib. Now, using ddPCR and Guardant360, we have been investigating about the relationship between T790M AF and RR to osimertinib, and the influence of mutations at loci other on efficacy of osimertinib.
Conclusion
cfDNA analysis can be predictive for osimertinib efficacy, just as re-biopsy. Whether comprehensive approach including AF and coexistence of other actionable genes is more precisely informative for drug efficacy has been continuously analyzed.
