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N. Morikawa
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P1.07 - Poster Session/ Small Cell Lung Cancer (ID 221)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.07-006 - Final Results of Randomized Phase II Study of Carboplatin plus Irinotecan vs. Carboplatin plus Amrubicin for ED-SCLC (ID 931)
09:30 - 17:00 | Author(s): N. Morikawa
- Abstract
Background:
Carboplatin-based regimens, such as carboplatin plus etoposide (CE), are among the standard regimens for the management of extended disease small-cell lung cancer (ED-SCLC). However, the efficacy of carboplatin-based regimens is unsatisfactory. Carboplatin plus irinotecan (CI) and carboplatin plus amrubicin (CA) are promising new carboplatin-based regimens identified in our previous studies. Accordingly, we conducted this randomized phase II study to identify the appropriate regimen for comparison with CE in future phase III trials.
Methods:
Chemotherapy-naïve patients with ED-SCLC were randomly assigned to receive 4–6 cycles of carboplatin (area under the curve [AUC] 5.0, day 1) plus irinotecan (70 mg/m[2], days 1 and 8) every 3 weeks (CI arm) or carboplatin (AUC 4.0, day 1) plus amrubicin (35 mg/m[2], days 1–3) every 3 weeks (CA arm). The primary endpoint was the overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity.
Results:
Between December 2009 and March 2013, 71 patients were enrolled. One patient in each arm did not receive any protocol treatment owing to rapid disease progression. The characteristics of the treated patients were as follows: median age, 70 years (range 51–84 years) and proportion of males, 84%. Delivered mean dose intensities (mean actual dose/mean planned dose) were similar for both arms: carboplatin 98% and irinotecan 94% for CI arm, and carboplatin 97% and amrubicin 94% for CA arm. The ORRs were 79% and 89%, median PFS was 5.1 and 6.2 months (CA; hazard ratio [HR] = 0.59, 95% CI: 0.35–0.98, P = 0.042), and median OS was 12.2 and 15.9 months in the CI and CA arms, respectively (CA; HR, 0.77; 95% CI: 0.49–1.29; P =.318). Grade 3 or higher neutropenia (CI, 53% and CA, 89%), anemia (CI, 26% and CA, 20%), thrombocytopenia (CI, 18% and CA, 14%), and febrile neutropenia (CI, 12% and CA, 29%) were observed. No treatment-related deaths were observed. Overall, 25 patients (74%) in the CI arm and 28 patients (80%) in the CA arm received post-discontinuation therapies.
Conclusion:
CA was numerically effective than CI in chemotherapy-naïve patients with ED-SCLC, with acceptable toxicity. Therefore, CA could be selected for future phase III trials.
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-072 - A Phase II Study of Carboplatin/Pemetrexed/Bevacizumab Followed by Bevacizumab/Erlotinib Maintenance for NonSq-NSCLC with Wild-Type EGFR (ID 1677)
09:30 - 17:00 | Author(s): N. Morikawa
- Abstract
Background:
Maintenance therapy (MT) after platinum doublet chemotherapy has been shown to improve progression-free survival (PFS) and overall survival (OS) in advanced non-small-cell lung cancer (NSCLC), whereas optimal strategies for MT, such as continuation or switch maintenance, have yet to be determined. ATLAS trial adopted a combination maintenance strategy design in which both EGFR-positive and -negative NSCLC patients received platinum doublet chemotherapy at the choice of investigators plus bevacizumab (Bev) followed by Bev with either erlotinib (Erl) or a placebo as a maintenance therapy. The trial demonstrated that Erl plus Bev was favorable for PFS, but not for either OS or toxicity, when compared with placebo plus Bev. The aim of this phase II study was to clarify the effects and safety of a fixed induction regimen: carboplatin (Cb)/pemetrexed (PEM)/Bev followed by Bev plus Erl as a maintenance therapy in non-squamous (nonSq)-NSCLC patients with wild-type (WT) EGFR.
Methods:
All eligible patients (pts) had treatment-naive nonSq-NSCLC (stage IIIB, IV, or postoperative recurrent) with WT EGFR. Cb (AUC 5), PEM (500 mg/m[2]) and Bev (15mg/kg) were administered on Day 1 every three weeks for four-to-six cycles and maintenance therapy with Bev (15mg/kg) once every three weeks plus continuous Erl (150mg/body) was administered until occurrence of either disease progression or unacceptable toxicity. The primary endpoint was PFS at 6 months (mo). The secondary endpoints included OS, tumor response, toxicity, and quality of life (QOL).
Results:
From September 2011 to June 2014, 51 pts were enrolled. Fifty pts were evaluated for the efficacy and safety of the treatment. The median follow-up duration was 14.3 months (range: 1.1-30.7). The median age was 64 years (range: 36-74); male/female=27/23 (54/46%); ECOG PS 0/1=28/22 (56/44%); Stage IIIB/IV/recurrent=5/41/4 (10/82/8%); adenocarcinoma/NSCLC=48/2 (96/4%). The median cycles of the induction/maintenance therapy were 4 (range: 1-6)/4 (range: 1-20). Twenty-nine pts (58%) received the MT. Overall response rate was 48.0% (95% CI: 34.8-61.5%), and disease control rate was 86% (95% CI: 73.8-93.0%). Six-month PFS rate was 59.5% (95% CI: 45.0-72.6%). Median OS and PFS were 18.4 mo (95% CI: 11.9-24.9 mo) and 6.5 mo (95% CI: 5.8-7.2 mo), respectively. CTCAE Grade (Gr) 3/4 hematological toxicities were neutropenia (48%/3.4%), anemia (18%/3.4%) and thrombocytopenia (22%/0%). The most frequent Gr 3/4 non-hematological toxicities were anorexia (14%/3.4%), hypertension (10%/3.4%), malaise (6%/3.4%), nausea (6%/0%) and rash (0%/10%). There were two interstitial lung diseases (Gr1), one gastrointestinal perforation (Gr4), and one treatment-related death due to ventricular fibrillation. QOL results are still under analysis.
Conclusion:
Cb/PEM/Bev followed by maintenance Bev/Erl was effective and well tolerated in NS-NSCLC pts with WT EGFR.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-071 - RAS Inhibitor Prevent Proteinuria of NSCLC Patients Who Received Bevasizumab Chemotherapy: NJLCG 1303 (ID 1204)
09:30 - 17:00 | Author(s): N. Morikawa
- Abstract
Background:
Proteinuria caused by bevacizumab (BV) often becomes an obstacle to continuation of the treatment. Renin-angiotensin system inhibitor (RASI), angiotensin receptor blocker and angiotensin converting enzyme inhibitor, has demonstrated anti-proteinuria effect in diabetic nephropathy and nondiabetic kidney disease. This retrospective observational study was conducted to evaluate the anti-proteinuria effect of RASI for NSCLC patients (pts) who received BV chemotherapy.
Methods:
We reviewed the medical records of NSCLC pts between 2008 and 2014 at 11 hospitals. Eligible pts had a treatment of BV chemotherapy, no proteinuria, and no diabetes mellitus. Clinical characteristics, use of the antihypertensive drugs, change of the blood pressure, and proteinuria generation were investigated during first 6 courses of BV chemotherapy.
Results:
A total of 211 pts were enrolled. Pts characteristics were: male/female 121/90; median age 63 (range 35-88); ECOG performance status 0-1/2-3 199/12; stage Ⅳ/recurrent 189/22; dose of BV(/kg) 7.5mg/15mg 21/190; BV cycle 1-2/3-4/5-6 18/55/138; antihypertensive drugs RASI/non-RASI/none 59/44/108. Proteinuria was observed in 49 pts (23%) as grade 1/2/3 33/14/2. The rate of proteinuria generation was significantly lower in the RASI group than non-RASI group (17% vs. 41%, P=0.025). Multivariate analysis revealed that RASI significantly reduced proteinuria (HR=0.43, 95% CI=0.17-0.91, P=0.043).
Conclusion:
RASI demonstrated anti-proteinuria effect for NSCLC pts who received BV therapy.
