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Yukiko Nakamura
Author of
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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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P1.01-33 - Randomized Phase 2 Study Comparing CBDCA+PTX+BEV and CDDP+PEM+BEV in Treatment-Naïve Advanced Non-Sq NSCLC (CLEAR study) (ID 12448)
16:45 - 18:00 | Author(s): Yukiko Nakamura
- Abstract
Background
Bevacizumab (BEV) combined with platinum-based chemotherapy is a standard treatment for advanced non-squamous non-small-cell lung cancer (non-Sq NSCLC). Cisplatin (CDDP) + pemetrexed (PEM) is suggested as the most promising chemotherapy regimen combined with BEV. However, no study has been conducted to evaluate the efficacy and safety of CDDP+PEM+BEV compared with carboplatin (CBDCA) + paclitaxel (PTX) + BEV for advanced non-Sq NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
Treatment-naïve patients with advanced or recurrent EGFR/ALK-negative non-Sq NSCLC from 55 sites across Japan were randomly assigned in a 2:1 ratio to either CDDP+PEM+BEV (4 cycles of CDDP [75 mg/m2] + PEM [500 mg/m2] + BEV [15 mg/kg] q3wk, followed by maintenance PEM + BEV q3wk until progression) or CBDCA+PTX+BEV (4 cycles of CBDCA [AUC 6] + PTX [200 mg/m2] + BEV q3wk, followed by maintenance BEV q3wk until progression). The primary endpoint was progression-free survival (PFS) by central review. The secondary endpoints were PFS by investigators, overall survival (OS), overall response rate (ORR) and safety profile. The target numbers of patients and events were determined to be 210 and 170, respectively, to observe a point estimate of HR for PFS (CDDP+PEM+BEV/CBDCA+PTX+BEV) <0.83 with a high probability (80%) when the true HR was 0.72.
4c3880bb027f159e801041b1021e88e8 Result
Between May 2014 and May 2016, 199 patients were randomly assigned to receive CDDP+PEM+BEV (N=132) or CBDCA+PTX+BEV (N=67). The median follow-up duration was 20.6 months. PFS events occurred in 171 patients. The HR for PFS by central review (CDDP+PEM+BEV/CBDCA+PTX+BEV) was 0.825 (95% CI 0.600-1.134, median PFS, 7.6 vs 7.0 months). The median PFS by investigators was longer with CDDP+PEM+BEV than with CBDCA+PTX+BEV (HR 0.634, 95% CI 0.464-0.867, median PFS, 7.4 vs 6.8 months). The median OS was 24.5 months for CDDP+PEM+BEV and 23.6 months for CBDCA+PTX+BEV (HR 0.955, 95% CI 0.620-1.470). The ORR was 57% for CDDP+PEM+BEV and 55% for CBDCA+PTX+BEV. The most common ≥G3 adverse events in both arms (CDDP+PEM+BEV/CBDCA+PTX+BEV) were neutropenia (24%/64%), hyponatraemia (11%/9%) and hypertension (30%/23%).
8eea62084ca7e541d918e823422bd82e Conclusion
CDDP+PEM is the most effective chemotherapy regimen combined with BEV for advanced non-Sq NSCLC.
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P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.01-37 - Phase II Study of Amrubicin Plus Erlotinib in Previously Treated, Advanced Non-Small Cell Lung Cancer Patients with Wild-Type EGFR: TORG 1320 (ID 12559)
12:00 - 13:30 | Author(s): Yukiko Nakamura
- Abstract
Background
The combination of amrubicin (AMR) and erlotinib (ERL) was reported to have synergistic effect on non-small cell lung cancer (NSCLC) cell line with wild-type EGFR in vitro. We accomplished a phase I study of AMR plus ERL in previously treated advanced NSCLC patients, and determined the maximum tolerated dose (MTD). Furthermore, we observed a high response rate of 33% (Am J Clin Oncol 2015).
a9ded1e5ce5d75814730bb4caaf49419 Method
We conducted a multi-center, single-arm phase II trial to evaluate the efficacy of AMR and ERL combination therapy in patients with previously treated, advanced NSCLC with wild-type EGFR. Patients were treated at 3weeks intervals with AMR (35mg/m2 on days 1-3) plus ERL (100mg/day on days 1-21). The patients without disease progression after 4 cycles continued ERL until disease progression or unacceptable toxicity. The primary endpoint is progression free survival (PFS). Secondary endpoints are response rate (RR), disease control rate (DCR), time to treatment failure (TTF), overall survival (OS), and toxicity. The concentration of trough ERL was measured after first cycle of treatment and in maintenance phase as an exploratory research to analyze relation between effectivity/safety and pharmacokinetics.
4c3880bb027f159e801041b1021e88e8 Result
From June 2013 to July 2016, 25 patients were enrolled. With a median follow-up of 14.3 months (95%CI: 10.9 – 17.6), median PFS was 3.6 months (95%CI: 2.1 - 5.1). The RR and the DCR were 24.0% and 64.0%, respectively. Median OS was 15.4 months (95%CI: 13.4 – 17.4). We observed grade 3 or 4 toxicities such as leukopenia (68%), neutropenia (72%), anemia (8%), febrile neutropenia (12%), anorexia (12%), oral mucositis (12%) and rash (8%). We had no treatment related death. In pharmacokinetic analysis, the mean (±SD) trough concentrations (C trough) of ERL in induction and maintenance phase were 1.070±0.463µg/mL and 0.879±0.427µg/mL, respectively. The C trough of ERL in induction phase was higher than that in maintenance phase (p=0.0371). There was no relation between C trough of ERL and any toxicity/response.
8eea62084ca7e541d918e823422bd82e Conclusion
Although the primary endpoint was not met in this trial, the PFS of AMR and ERL combination therapy was superior to that of AMR monotherapy which was previously reported. In this study, pharmacokinetic analysis showed that C trough of ERL were elevated in combination therapy. This combination therapy might be an optional treatment as cytotoxic chemotherapy for NSCLC patients after platinum-doublet failure. Clinical trial information: UMIN 000010582.
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