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O. Hataji
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-027 - Randomized Phase 2 Study Comparing CBDCA+PTX+BEV and CDDP+PEM+BEV in Treatment-Naïve Advanced Non-Sq NSCLC (CLEAR Study) (ID 8490)
09:30 - 09:30 | Author(s): O. Hataji
- Abstract
Background:
The study objective was to compare efficacy and safety of CBDCA+PTX+BEV and CDDP+PEM+BEV in non-squamous (non-Sq) NSCLC patients.
Method:
Treatment-naïve patients aged 20-74 with advanced or recurrent EGFR/ALK-negative non-Sq NSCLC were randomly assigned at 1:2 ratio to either treatment A (4 cycles of CBDCA [AUC 6] + PTX [200mg/m[2]] + BEV [15mg/kg] q3wk, and maintenance therapy with BEV q3wk until progression) or treatment B (4 cycles of CDDP [75mg/m[2]] + PEM [500mg/m[2]] + BEV q3wk, and maintenance therapy with PEM + BEV until progression). The primary endpoint was PFS by central review. The secondary endpoints included OS and safety profile. Target enrollment number was 210.
Result:
A total of 55 sites across Japan enrolled 199 patients: 67/132 (A/B). The median age was 67/66 years, 70%/74% were male, 54%/52% were PS 0, 75%/73% were stage IV and 93%/98% had adenocarcinomas. As of April 14, 2017, patients had completed a median of 7/8 treatment cycles, while 94%/80% had discontinued treatment. The most common ≥G3 adverse events were neutropenia (75%/24%), and hyponatraemia (6%/10%). The most common BEV-related adverse events (≥G1) were hypertension (44%/58%), proteinuria (52%/43%) and epistaxis (26%/14%). Dose reduction was necessary due to an adverse event in 31%/22% patients. Treatment-related death (pulmonary infection) was reported in 1 patient receiving treatment B.
Conclusion:
CBDCA+PTX+BEV and CDDP+PEM+BEV had different safety profiles. Efficacy results including the primary endpoints will be presented in 2018.
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P2.14 - Radiotherapy (ID 715)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.14-020a - Retrospective Research on Radiofrequency Ablation (RFA) for Liver Metastasis Due to NSCLC: A Single Institutional Experience (ID 10493)
09:30 - 09:30 | Author(s): O. Hataji
- Abstract
Abstract not provided
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P3.07 - Immunology and Immunotherapy (ID 723)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.07-013b - The Comparison Analysis of PD-1 Status Between 22C3 and 28-8 IHC Assay in Clinical Practice: A Single Institutional Experience (ID 10499)
09:30 - 09:30 | Author(s): O. Hataji
- Abstract
Background:
Recently, progress in the treatment of NSCLC patients with PD-L1 expression has been heralded in the field of immune-oncology. Pembrolizumab and Nivolumab are anti-PD-1 (Programmed death) agents used in the treatment of NSCLC patients with PD-L1 expression, and the efficacy of these agents tremendously prolong the overall survival times (OS). Although, the data of concordance for staining each anti-body in clinical course is limited.
Method:
We reviewed all 81 patients who were diagnosed with, or suspected of having NSCLC and received a tissue biopsy between February 2017 and April 2017 in Matsusaka Municipal Hospital. A total of 81 NSCLC tumors were stained with four PD-L1 IHC assays (22C3 and 28-8) The aim of this study was to evaluate the clinical characteristics and to compare concordance between both groups, when divided into three groups as follows; no(negative), low(≧1-49%/1-5%),high(≧50%/≧5%), and to compare the concordance of PD-1 expression between old (stained after 6 months) and fresh (stained within 6months) samples.
Result:
The median age was 75 [range: 58-89], 59 were male, 22(27.1%) were never-smokers. 55(67.9%) and 21(25.9%) patients was diagnosed with adenocarcinoma and squamous cell carcinoma, respectively. Negative/low/high/unevaluable in PD-1 status were 38/21/16/6 and 39/19/18/5 in 22C3 and 22-8, respectively. In both group 22C3 and 22-8 PD-L1 staining group, no significant differences were seen in the characteristics of the results, whether positive or negative. The concordance rate between 22C3 and 28-8 staining was 75% in all stages, 87% in early stage, and 77 % in advance stage cases. The concordance rate of old samples against fresh ones was 75% versus 84%.
Conclusion:
The concordance between 22C3 and 28-8 was high value in clinical practice. This study also demonstrated the similar concordance of PD-1 expression between fresh and old samples, or between early stage and advanced stage.
