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Terufumi Kato
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MA10 - Considerations in Immunotherapy / Real World (ID 911)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 10:30 - 12:00, Room 105
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MA10.08 - Choice of Taxane and Outcomes in the KEYNOTE-407 Study of Pembrolizumab Plus Chemotherapy for Metastatic Squamous NSCLC (ID 14698)
11:25 - 11:30 | Author(s): Terufumi Kato
- Abstract
- Presentation
Background
In the randomized, double-blind, phase 3 KEYNOTE-407 study (NCT02775435), pembrolizumab plus chemotherapy with carboplatin and paclitaxel or nab-paclitaxel significantly prolonged OS (HR 0.64, 95% CI 0.49-0.85, P=0.0008) and PFS (HR 0.56, 95% CI 0.45-0.70, P<0.0001) compared with placebo plus chemotherapy in patients with previously untreated, metastatic squamous NSCLC. The benefit of pembrolizumab plus chemotherapy was observed irrespective of PD-L1 TPS. Pembrolizumab plus chemotherapy also had a manageable safety profile. We performed an exploratory analysis of outcomes by investigator’s choice of paclitaxel or nab-paclitaxel, which was a randomization stratification factor.
a9ded1e5ce5d75814730bb4caaf49419 Method
559 eligible patients were randomized 1:1 to pembrolizumab 200 mg or placebo Q3W for up to 35 cycles plus 4 cycles of carboplatin AUC 6 mg/mL/min Q3W and investigator’s choice of paclitaxel 200 mg/m2 Q3W or nab-paclitaxel 100 mg/m2 QW. Primary end points were OS and PFS; ORR and safety were secondary.
4c3880bb027f159e801041b1021e88e8 Result
Paclitaxel was the chosen taxane in 60% of patients. The addition of pembrolizumab to chemotherapy improved OS, PFS, and ORR regardless of choice of carboplatin and paclitaxel or carboplatin and nab-paclitaxel (Table). Incidence of grade 3-5 AEs in the pembrolizumab plus chemotherapy arm vs placebo plus chemotherapy arm was 63.9% vs 59.3% in paclitaxel recipients and 78.9% vs 81.4% in nab-paclitaxel recipients. AEs led to discontinuation of all treatment in 13.6% vs 8.4% of paclitaxel recipients and 12.8% vs 3.5% of nab-paclitaxel recipients and led to discontinuation of any treatment in 19.5% vs 13.2% and 29.4% vs 9.7%, respectively. Immune-mediated AEs occurred in 29.6% vs 9.6% of paclitaxel recipients and 27.5% vs 7.1% of nab-paclitaxel recipients.
8eea62084ca7e541d918e823422bd82e Conclusion
Adding pembrolizumab to chemotherapy with carboplatin and a taxane improved efficacy and was generally tolerable compared with chemotherapy alone as first-line therapy in patients with metastatic squamous NSCLC regardless of whether paclitaxel or nab-paclitaxel was the chosen taxane.
Carboplatin plus Paclitaxel Carboplatin plus Nab-Paclitaxel Pembrolizumab + Chemotherapy
N = 169
Placebo + Chemotherapy
N = 167
Pembrolizumab + Chemotherapy
N = 109
Placebo + Chemotherapy
N = 114
OS, median
(95% CI), mo
14.0 (12.6-16.6) 10.3 (8.2-14.8) NR (NE-NE) 12.6 (9.6-NE) HR (95% CI)a 0.67 (0.48-0.93) 0.59 (0.36-0.98) PFS, median
(95% CI), mo
6.4 (6.0-8.3) 4.4 (4.2-5.1) 6.5 (6.2-8.5) 5.9 (4.4-6.9) HR (95% CI)a 0.52 (0.40-0.68) 0.65 (0.45-0.94) ORR, % (95% CI) 57.4 (49.6-65.0) 37.7 (30.4-45.5) 58.7 (48.9-68.1) 39.5 (30.4-49.1) aBased on a Cox regression model with treatment as a covariate.
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-40 - Randomized Phase II Study of Docetaxel Plus Bevacizumab or Pemetrexed Plus Bevacizumab for Elderly pts with Untreated Advanced NSCLC: TORG1323 (ID 12868)
16:45 - 18:00 | Author(s): Terufumi Kato
- Abstract
Background
The addition of bevacizumab (B) to platinum doublets prolongs the survival for non-squamous NSCLC. The role of monotherapy with B is unclear for elderly non-squamous NSCLC pts.
a9ded1e5ce5d75814730bb4caaf49419 Method
Pts were pathologically diagnosed untreated elderly (≥75 years old) non-squamous NSCLC, who were stage IIIB, IV, or recurrent disease, and PS 0-1. EGFR mutation or ALK rearranged pts were allowed after receiving each tyrosine kinase inhibitor. Pts were randomized 1:1 to receiving either docetaxel (D) or pemetrexed (P) with B. The primary endpoint was progression-free survival (PFS) assessed by independent review committee. B was administered 15 mg/kg, D was 50 mg/m2, or P was 500 mg/m2 every 3 weeks until disease progression or unacceptable toxicity based on our previous studies. Selection design was adopted for this study. The planned sample size was 120 pts to yield 80% power to select an optimal regimen correctly and PB is chosen for the further evaluation if the point estimate of hazard ratio (HR) for PFS was ≤1.20.
4c3880bb027f159e801041b1021e88e8 Result
Enrollment was terminated in early at the end of March 2017 because of slow accrual. Total 103 pts (DB/PB= 51/52 pts) were enrolled and 99 pts (49/50 pts) were full analysis set. Patient characteristics were well balanced between two arms. Median age was 78 (range: 75-88) in DB and 79 (75-94) in PB. EGFR mutation+/ALK translocation+/wild type/unknown= 13/0/34/2 in DB and 13/2/33/2 in PB. Total 77 events occurred at data cut-off, which corresponded to 77.7% power. The median PFS of DB and PB were 6.1 months and 4.6 months (HR 1.03, 95%C.I. 0.66-1.61: p=0.901). The response rates were 43% and 40% (p=0.840), respectively. The incident of ≥Grade 3 leukopenia (69% vs. 27%, p<0.001), neutropenia (86% vs. 44%, p<0.001) and fatigue (10% vs. 0%, p=0.027) were higher in DB. However, the frequency of febrile neutropenia was not different (16% vs.12%, p=0.578). One patient in PB was died of rupture of abdominal aortic aneurysm.
8eea62084ca7e541d918e823422bd82e Conclusion
PB is less toxic and the efficacy is comparable between two arms for elderly (≥75 years old) advanced non-squamous NSCLC. PB is a candidate for the further evaluation. Clinical Trial information: UMIN000012786.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.01-88 - C-Reactive Protein (CRP) as a Predictive Marker for Survival in Patients with Advanced NSCLC Treated with First Line Pembrolizumab Monotherapy (ID 13612)
16:45 - 18:00 | Author(s): Terufumi Kato
- Abstract
Background
Pembrolizumab have shown longer activity in patients with advanced non-small cell lung cancer (NSCLC) especially when PD-L1 expression was high. But even with high PD-L1 expression, more than half of them failed to response. We focused on C-reactive protein (CRP), inflammatory protein measured routinely in clinical practice, to find out its role as predictive biomarker for pembrolizumab.
a9ded1e5ce5d75814730bb4caaf49419 Method
We analyzed advanced NSCLC patients with PD-L1 high expression (EGFR mutation (-), EML-4-ALK fusion (-)) who were treated with pembrolizumab as first-line therapy in our clinical practice. Patients received pembrolizumab (200mg/body, q3W) until progressive disease or unacceptable toxicity. During treatment period we measured serum biochemistry and blood cell count regularly.
We evaluated the association the factors such as serum marker including inflammatory protein, age, performance status, histology, smoking status, prior radiation therapy and presence or absence ofimmune-related adverse events after treatment with the effect such as antitumor response, progression‑free survival (PFS) and overall survival (OS).
4c3880bb027f159e801041b1021e88e8 Result
A total of 31 patients treated with pembrolizumab from March 2017 to February 2018 were analyzed for this research. Their characteristics were: median age 72 (range 37-84),male/female 24/7, adenocarcinoma/squamous cell carcinoma/pleomorphic carcinoma/neuroendocrine carcinoma/NOS 17/5/3/1/5, clinical stage IIIB/IV/recurrence 3/21/7, median CRP level at pretreatment 1.15mg/dL (0.07-15.27). Among the candidate biomarker, there were no association except for CRP. Serum CRP level at pretreatment was not predictive, but change of serum CRP level at 6 weeks after anti-PD-1 therapy initiation was most predictive in the analysis. Depressed CRP group showed longer PFS and OS than elevated group (PFS: p=0.08, HR 0.29, OS: p=0.08, HR 0.28, log-rank test).
8eea62084ca7e541d918e823422bd82e Conclusion
Our analysis suggests that serum CRP elevation at 6 weeks of treatment predict for longer survival when pembrolizumab was given as first-line treatment.This finding might be related to inflammation status of patients and efficacy of anti-PD-1 inhibitor.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P2.16 - Treatment of Early Stage/Localized Disease (Not CME Accredited Session) (ID 965)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.16-18 - Study of Interstitial Lung Disease and Acute Exacerbation in Patients Receiving Radiation Therapy for Lung Cancer in Japan. (ID 12699)
16:45 - 18:00 | Author(s): Terufumi Kato
- Abstract
Background
Radiation therapy (RT) for lung cancer in patients who have interstitial lung disease (ILD) is considered to be a risk for acute exacerbation (AE).
The indication for RT in such patients is determined in each facility.
The ratio of patients with ILD who have received RT for lung cancer, the incidence of AE in such patients, and the risk factors for AE are unclear.
To clarify these, a nationwide survey was carried out by the Lung and Mediastinal Tumor Committee of the Japan Radiation Oncology Study Group (JROSG).
a9ded1e5ce5d75814730bb4caaf49419 Method
(1) Questionnaire survey on the diagnosis of ILD, determination of the indication for RT and the state of implementation.
(2) Multi-institutional retrospective cohort study in fiscal year 2014. Statistical analysis of risk factors for AE. ILD confirmation using CT images by two central radiation diagnosticians.
These two studies were included.
4c3880bb027f159e801041b1021e88e8 Result
(1) Questionnaires were returned by 47 institutes. RT was not an option for patients with ILD in 8 of the institutes. Some of the institutes excluded RT from options because of experience of severe adverse events. RT was an option even for patients with ILD depending on conditions of the case in 39 of the institutes.
In 37 of the institutes, 3.7% of lung cancer patients (78/2128 patients) in fiscal year 2014 had ILD.
(2) Sixty-seven patients were enrolled. AE occurred in 5 cases including 4 photon RT cases. AE occurred in 4 (7.7%) of 52 cases in which photon RT was performed, and there was one RT-induced AE-related death (25.0%).
Regarding risk factors for AE, in the t-test, grade of radiation pneumonitis, FEV1, and lung V30 were significant. Age, lung mean dose, lung V20, and DLco were marginally significant.
However, they were not significant in multivariate analysis.
AE occurred in 1 of 15 cases in which particle RT was performed.
In a review of CT images, 59 cases were analyzable. ILD was confirmed in 58 cases (98.3%). Diagnosis of ILD by each institute was almost the same as that in the review by central radiation diagnosticians.
Post-irradiation exacerbation of ILD (PIE-ILD) on CT was revealed in 23 (43.4%) of 53 cases. We considered that PIE-ILD does not necessarily progress to AE.
8eea62084ca7e541d918e823422bd82e Conclusion
We surveyed actual conditions of RT for patients with ILD in Japan.
RT was an option even for patients with ILD in many institutes, though cases in which it was actually implemented were limited.
6f8b794f3246b0c1e1780bb4d4d5dc53
