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Kenya Kanazawa
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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: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.01-83 - Efficacy and Safety of EGFR-TKI Rechallenge Treatment in Elderly Patients with Advanced NSCLC Harboring Sensitive EGFR Mutations (Now Available) (ID 81)
08:00 - 18:00 | Author(s): Kenya Kanazawa
- Abstract
Background
Epidermal growth factor receptor–tyrosine kinase inhibitor (EGFR–TKI) is effective as first-line chemotherapy for patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive EGFR mutations. However, whether the efficacy of second-line EGFR–TKI treatment after first-line EGFR–TKI treatment was poorly studied in elderly patients aged ≥ 75 years harboring sensitive EGFR mutations. Therefore, we aimed to investigate the efficacy and safety of EGFR-TKI re-administration after first-line EGFR–TKI treatment in elderly patients with NSCLC harboring sensitive EGFR mutations.
Method
Between October 2002 and December 2015, 22 elderly patients with advanced NSCLC harboring sensitive EGFR mutations who were initiated on EGFR–TKI Rechallenge at four Japanese institutions were included in this study.
The eligibility criteria were histologically or cytologically confirmed NSCLC, unresectable stage III/IV disease, and a drug-sensitive EGFR mutation (exon 19 deletion or exon 21 L858R).
All patients were initially treated with gefitinib (250 mg/day) or erlotinib (150 mg/day) and after recurrence, re-administration of EGFR-TKIs (gefitinib, erlotinib, afatinib) was performed as a secondary chemotherapy
Result
Ultimately, 22 cases of this study were studied. The median age was 77.5 years (range 75-87 years).
Although it was a retrospective analysis, even with re-administration of EGFR-TKI rechallenge, the response rate was 23%, PFS 5.26 months, OS (after EGFR-TKI rechallenge) 14.4 months (the administration lines were 2, 3 and 4 lines ).
Conclusion
Until now it was said that EGFR-TKI rechallenge does not contribute to OS in LUX-LUNG 1 and so on.
On the other hand, there are also reports on the usefulness of EGFR-TKI rechallenge.
From the results of this study it can be said that it can be one of the options among the limited treatment options for elderly EGFR positive lung cancer.
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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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MA13.10 - A Phase II Study of Carboplatin and Nab-Paclitaxel for Advanced Non-Small Cell Lung Cancer with Interstitial Lung Disease (HOT1302) (Now Available) (ID 990)
14:00 - 15:30 | Author(s): Kenya Kanazawa
- Abstract
- Presentation
Background
Because of the high risk of exacerbation of pre-existing interstitial lung disease (ILD), patients with concomitant advanced non-small cell lung cancer (NSCLC) and ILD have been excluded from most clinical trials of chemotherapy, despite the high prevalence (around 10%) of all NSCLC cases. This study prospectively evaluated the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) in combination with carboplatin in advanced NSCLC patients with pre-existing ILD.
Method
Enrolled patients had treatment-naïve, advanced NSCLC with pre-existing ILD. Patients received 100 mg/m2nab-paclitaxel weekly and carboplatin at area under the concentration-time curve (AUC) 6 once every 3 weeks for 4-6 cycles. The primary endpoint was overall response rate (ORR); secondary endpoints included toxicity, progression-free survival (PFS) and overall survival (OS). The interactions between histology [Squamous (Sq) vs. Non-Squamous (Non-Sq)] and treatment outcomes were also investegated.
Result
Thirty-six patients were enrolled between April 2014 and September 2017. Sixteen patients (44.4%) had an adenocarcinoma, followed by 15 (41.7%) squamous cell carcinoma, and 5 (13.9%) non-small cell carcinoma. The median number of cycles administered were 4 (range: 1-6). The ORR, the primary endpoint, was 55.6% (95% confidence interval [CI]: 39.6-70.5%). The median PFS and OS were 5.3 months (95% CI: 3.9-8.2 months) and 15.4 months (95% CI: 9.4-18.7 months), respectively. There was no significant difference between two groups, however, numerically better treatment outcomes were observed in the Sq group: the ORR was 66.7% (95% CI: 41.7–84.8%) in the Sq group compared with 47.6 % (95% CI: 28.3–67.6%) in the Non-Sq group (P =0.254); median PFS was 8.2 months (95% CI: 4.0–10.2 months) in the Sq group vs. 4.1 months (95% CI: 3.3-5.4 months) in the Non-Sq group (HR, 0.60 [95% CI, 0.30–1.20]; p=0.15); median OS was 16.8 months (95% CI: 9.8 months–not reached) in the Sq group vs. 11.9 months (95% CI: 7.3-17.4 months) in the Non-Sq group (HR, 0.56 [95% CI, 0.24–1.28]; p=0.17). Two patients (5.6%) experienced grade ≥2 pneumonitis and one patient (2.8%) died.
Conclusion
This is the first prospective phase 2 study of weekly nab-paclitaxel in combination with carboplatin in advanced NSCLC patients with pre-existing ILD. This treatment showed favorable efficacy and was well tolerated.
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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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P1.01-08 - Randomized Phase II Trial of CBDCA+nab-PTX vs CDDP+GEM in Patients with Chemo-Naïve Squamous Cell Lung Cancer: NJLCG1302 (Now Available) (ID 971)
09:45 - 18:00 | Author(s): Kenya Kanazawa
- Abstract
Background
The subset analysis of CA031 trial showed a significant improvement of overall response rate (ORR) for carboplatin (CBDCA) plus weekly nab-PTX versus CBDCA plus PTX in patients (pts) with squamous cell histology (41% vs 24%). We conducted a phase II study comparing CBDCA plus weekly nab-PTX (CnP) to cisplatin plus gemcitabine (CG), one of the standard regimens in pts with squamous cell lung cancer (SCC).
Method
Chemo-naïve stage IIIB/IV or postoperative recurrent SCC pts were randomly assigned to receive either cisplatin (80 mg/m2) on day 1 plus gemcitabine (1000 mg/m2) on days 1, 8 every 3 weeks or CBDCA (area under the curve [AUC] 6 mg/ml/min) on day 1 plus nab-PTX (75 mg/m2) on days 1, 8, 15 every 3 weeks. The primary endpoint was ORR. Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and toxicity. Assuming that an ORR of 40% in eligible pts indicates potential usefulness and ORR of 20% is the lower limit of interest, the estimated accrual was 32 pts in each arm. Allowing for dropouts, the accrual goal was determined to be 35 pts in each arm (alpha, 0.05; beta, 0.20).Thisstudy was planned to enroll 70 pts in total.
Result
Between June 2013 and October 2018, 71 pts were enrolled and assigned to CG arm (n=35) and CnP arm (n=36). The median follow-up time was 10.8months. At data cutoff (March 31, 2019), ORR was 43% (95% confidence interval [CI]: 27.3-58.5) in CG arm and 47% (95%CI: 31.7-62.7) in CnP arm. DCR was 77% in CG arm and 80% in CnP arm. Median PFS was 4.6 months in CG arm and 4.1months in CnP arm. Median OS was 15.2months in CG arm and 10.2months in CnP arm. Of the grade 3 or higher adverse events, anemia was more common in CnP arm (CG, 17% and CnP, 53%). There was one treatment-related death in CG arm and no treatment-related death in CnP arm.
Conclusion
In this study, CBDCA plus weekly nab-PTX was likely to be equivalent to cisplatin plus gemcitabine despite carboplatin-based regimen. CBDCA plus weekly nab-PTX could be a promising regimen for SCC.
