Efficacy of pemetrexed-cisplatin (PC) in East Asian patients (pts): Subgroup analysis of a phase III study comparing PC versus gemcitabine-cisplatin (GC) in first-line treatment of advanced non-small cell lung cancer (NSCLC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8045-8045
Author(s):  
M. Orlando ◽  
J. S. Lee ◽  
C. Yang ◽  
L. Simms ◽  
K. Park
Keyword(s):  
Subgroup Analysis ◽  
Smoking Status ◽  
East Asian ◽  
Phase Iii ◽  
Smoking History ◽  
Asian Ethnicity ◽  
Disease Characteristics ◽  
Phase Iii Study ◽  
Egfr Tkis ◽  
Nonsquamous Nsclc

8045 Background: East Asian ethnicity is a recognized favorable prognostic factor in the treatment of NSCLC in trials with either chemotherapy or EGFR tyrosine-kinase inhibitors (TKIs). In a global phase III study (Scagliotti JCO 2008), superior efficacy of PC was shown for pts with nonsquamous NSCLC, while Asian ethnicity was prognostic in the overall population. The purpose of this analysis is to describe the patient and disease characteristics of the East Asian pts enrolled in this study and assess efficacy according to histology and smoking history. Methods: This retrospective analysis of a large phase III study included only patients enrolled from Korea and Taiwan. For survival and progression-free survival (PFS), Cox-adjusted analyses were used to estimate the hazard ratio and 95% CI, while medians were estimated using Kaplan-Meier method. Results: Results for PFS and response rate showed trends similar to overall survival in East Asian pts, favoring PC therapy in nonsquamous pts. The use of post-discontinuation targeted therapies such as EGFR-TKIs was similar between treatment arms in the overall population and in nonsquamous pts. In East Asian pts, EGFR-TKI use was slightly higher in the GC arm, in both the overall population and in nonsquamous pts. In a further subgroup analysis defined by smoking status, East Asian nonsquamous pts treated with PC had longer survival (not statistically significant). Conclusions: Pt and disease characteristics between the East Asian subgroup and the overall population were similar, with notable differences in the percentage of pts with no smoking history and the greater use of EGFR-TKIs as post-discontinuation therapy. This analysis shows the improved efficacy outcomes for East Asian nonsquamous pts treated with PC is consistent with the previously observed treatment effect of PC on nonsquamous NSCLC. [Table: see text] [Table: see text]

Phase III study (MONET1) of motesanib plus carboplatin/paclitaxel (C/P) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC): Asian subgroup analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7549-7549
Author(s):  
Yukito Ichinose ◽  
Kaoru Kubota ◽  
Giorgio Scagliotti ◽  
David R. Spigel ◽  
Joo-Hang Kim ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Objective Response ◽  
Stage Iv ◽  
Phase Iii ◽  
Stage Iv Disease ◽  
Phase Iii Study ◽  
Prior Systemic Therapy ◽  
Mortality Table ◽  
Nonsquamous Nsclc

7549 Background: MONET1 evaluated overall survival (OS) in patients (pts) with nonsquamous NSCLC receiving motesanib (an oral VEGFR 1, 2 and 3, PDGFR and Kit inhibitor) plus C/P compared with pts receiving placebo plus C/P. Analysis of the total population (N=1090) showed that motesanib + C/P did not significantly improve OS vs C/P alone (primary endpoint). Here we present results of a subgroup analysis of Asian pts. Methods: Asian pts (Japan, S. Korea, Philippines, Hong Kong, Taiwan, Singapore) with stage IIIB/IV or recurrent nonsquamous NSCLC and no prior systemic therapy for advanced NSCLC were analysed. Pts were randomized to up to six 3-wk cycles of C (AUC 6 mg/mL·min) and P (200 mg/m2) with either motesanib 125 mg QD (Arm A) or placebo QD (Arm B) orally continuously. Results: 227 Asian pts (incl. 106 Japanese pts) with nonsquamous NSCLC were randomized (Arm A/B, n=110/117); 198 had adenocarcinoma (n=97/101). Median age was 60 y (range 30–78); 80% had stage IV disease. At the time of analysis, 139 pts had died (118 pts with adenocarcinoma). Pts received a median of 164 days of motesanib vs 125 days of placebo (vs 106 and 126 days in non-Asian pts). Median follow-up was 63 wks. Efficacy results are shown in the table. Motesanib/placebo-related AEs were seen in 94/74% of pts respectively; Gr ≥3 related AEs in 48/22%. Most common emergent AEs were (Arm A/B) alopecia (78/76%), diarrhea (63/33%), and nausea (55/43%); gallbladder disorders (Gr 1–2) were seen in 9/2% of pts. Gr ≥3 AEs more frequent in Arm A vs B included neutropenia (36/22%) and hypertension (13/3%). Emergent Gr 5 events were seen in (Arm A/B) 5/4% vs 16/11% in non-Asian pts. Conclusions: In contrast to non-Asian pts, in the subgroup of Asian pts with advanced nonsquamous NSCLC, motesanib plus C/P treatment was associated with increased OS, PFS, and objective response rates (ORR) compared with C/P alone, with no excess of treatment-related mortality. [Table: see text]

Activity of Eribulin in Patients With Advanced Liposarcoma Demonstrated in a Subgroup Analysis From a Randomized Phase III Study of Eribulin Versus Dacarbazine

2017 ◽  
Vol 35 (30) ◽  
pp. 3433-3439 ◽  
Author(s):  
George D. Demetri ◽  
Patrick Schöffski ◽  
Giovanni Grignani ◽  
Jean-Yves Blay ◽  
Robert G. Maki ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Eribulin Mesylate ◽  
Systemic Treatments ◽  
Phase Iii Study

Purpose A phase III study comparing eribulin with dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma showed a significant improvement in overall survival (OS) for the eribulin arm, with a manageable toxicity profile. We now report the histology-specific subgroup analysis of the efficacy and safety of eribulin compared with dacarbazine in patients with LPS, an independently randomized stratified subgroup of this phase III trial. Methods Patients ≥ 18 years with advanced or metastatic dedifferentiated, myxoid/round cell, or pleomorphic LPS incurable by surgery or radiotherapy were included. Patients with Eastern Cooperative Oncology Group performance status ≤ 2 and two or more prior systemic treatment regimens, including one with anthracycline, were randomly assigned 1:1 to receive eribulin mesylate (1.4 mg/m2 intravenously on days 1 and 8) or dacarbazine (850, 1,000, or 1,200 mg/m2 intravenously on day 1) every 21 days. OS, progression-free survival (PFS), and safety were analyzed. Results In the LPS subgroup, OS was significantly improved: 15.6 versus 8.4 months (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P < .001) with eribulin versus dacarbazine, respectively. Longer OS with eribulin was observed in all LPS histologic subtypes and in all geographic regions evaluated. PFS was also improved with eribulin versus dacarbazine (2.9 v 1.7 months, respectively; hazard ratio, 0.52; 95% CI, 0.35 to 0.78; P = .0015). Adverse events were similar between arms. Conclusion In patients with previously treated LPS, eribulin was associated with significantly superior OS and PFS compared with dacarbazine. Eribulin represents an important treatment option for patients with LPS, a sarcoma subtype for which limited effective systemic treatments are available. Further studies are justified to explore the role of eribulin in earlier lines of therapy as well as in combination with other agents.

Subgroup Analysis of Japanese Patients in a Phase III Study of Atezolizumab in Extensive-stage Small-cell Lung Cancer (IMpower133)

2019 ◽  
Vol 20 (6) ◽  
pp. 469-476.e1 ◽  
Author(s):  
Makoto Nishio ◽  
Shunichi Sugawara ◽  
Shinji Atagi ◽  
Hiroaki Akamatsu ◽  
Hiroshi Sakai ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Subgroup Analysis ◽  
Japanese Patients ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Phase Iii Study ◽  
Extensive Stage

Randomized Phase III Study of Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin for Completely Resected Stage II to IIIA Nonsquamous Non–Small-Cell Lung Cancer

2020 ◽  
Vol 38 (19) ◽  
pp. 2187-2196 ◽  
Author(s):  
Hirotsugu Kenmotsu ◽  
Nobuyuki Yamamoto ◽  
Takeharu Yamanaka ◽  
Katsuo Yoshiya ◽  
Toshiaki Takahashi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell ◽  
Stage Ii ◽  
Phase Iii ◽  
Recurrence Free Survival ◽  
Small Cell Lung ◽  
Free Survival ◽  
Pathologic Stage ◽  
Phase Iii Study ◽  
Nonsquamous Nsclc

PURPOSE To evaluate the efficacy of pemetrexed plus cisplatin versus vinorelbine plus cisplatin as postoperative adjuvant chemotherapy in patients with pathologic stage II-IIIA nonsquamous non–small-cell lung cancer (NSCLC). PATIENTS AND METHODS We performed a randomized, open-label, phase III study at 50 institutions within 7 clinical study groups in Japan. Patients with completely resected pathologic stage II-IIIA (TNM 7th edition) nonsquamous NSCLC were randomly assigned to receive either pemetrexed (500 mg/m2, day 1) plus cisplatin (75 mg/m2, day 1) or vinorelbine (25 mg/m2, days 1 and 8) plus cisplatin (80 mg/m2, day 1) with stratification by sex, age, pathologic stage, EGFR mutation, and institution. These treatments were planned to be given every 3 weeks for 4 cycles. The primary end point was recurrence-free survival in the modified intent-to-treat population, excluding ineligible patients. RESULT Between March 2012 and August 2016, 804 patients were enrolled (402 assigned to vinorelbine plus cisplatin and 402 assigned to pemetrexed plus cisplatin). Of 784 eligible patients, 410 (52%) had stage IIIA disease and 192 (24%) had EGFR-sensitive mutations. At a median follow-up of 45.2 months, median recurrence-free survival was 37.3 months for vinorelbine plus cisplatin and 38.9 months for pemetrexed plus cisplatin, with a hazard ratio of 0.98 (95% CI, 0.81 to 1.20; 1-sided P = .474). Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6% v 0.3%, respectively), neutropenia (81.1% v 22.7%, respectively), and anemia (9.3% v 2.8%, respectively). One treatment-related death occurred in each arm. CONCLUSION Although this study failed to show the superiority of pemetrexed plus cisplatin for patients with resected nonsquamous NSCLC, this regimen showed a better tolerability as adjuvant chemotherapy.

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