A phase II study of gefitinib as first line treatment for good performance advanced or metastatic non-small cell lung cancer in East Asian patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7167-7167 ◽  
Author(s):  
C. Yang ◽  
C. Yu ◽  
K. Chen ◽  
Z. Lin ◽  
S. Kuo ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Performance Status ◽  
East Asian ◽  
Response Rates ◽  
Ecog Performance Status ◽  
Metastatic Nsclc ◽  
Asian Patients ◽  
Nsclc Patients ◽  
East Asian Patients

7167 Background: Gefitinib is an effective treatment for chemotherapy-treated nonsmall cell lung cancer (NSCLC) in East Asian patients. There were only limited prospective studies on the use of gefitinib in chemonaive advanced or metastatic NSCLC patients. Methods: Eligibility included histological or cytological proven chemonaive stage IIIB/IV NSCLC, measurable disease, ECOG performance status of 0–2, good organ functions and candidate for platinum-based chemotherapy. Patients were treated with 250mg gefitinib per day. Tumor assessments were performed every two months by RECIST criteria. Responding patients were treated until progression. Patients with stable disease more than 2 months may continue treatment or shift to chemotherapy. The primary objective of this study was overall response rate of patients. Secondary objectives included 1-year progression-free survival, overall survival, and ancillary biomarker studies. Simon’s two-stage design was used to aim at a response rate more than 20%. Forty-four patients were planned in stage one and the study will be terminated if 5 or less patients responded to the treatment. A total of 106 patients are planned. Results: The planned interim analysis on the first 44 patients is reported here. There were 13 male and 31 female, median age was 63 (range 39–86), ECOG performance status of 0/1/2 were 0/40/4. 33 patients were nonsmokers. 39 patients had adenocarcinoma. The side effects of the treatment were mild and well accepted by patients. There were 24/9/10/1 patients with PR/SD/PD/NE. Overall response rate was 54.5% and disease control rate was 75%. The response rates for female / adenocarcinoma / nonsmoker were 58%/59%/61% respectively. The response rates for male / non-adenocarcinoma / smoker patients were 46%/20%/36%. The median time to progression for all patients was 6.3 months. Conclusions: Gefitinib is a very effective treatment for East Asian chemonaive advanced or metastatic NSCLC patients. Although the patients’ number was small, the response rates for patients with one unfavorable predictive factor were comparable to the response rates of patients receiving combination chemotherapy. The response rates and duration for 106 patients will be presented in the meeting. [Table: see text]

Pemetrexed (MTA) and carboplatin (CBDCA) in the treatment of advanced pleural mesothelioma (MPM)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7093-7093 ◽  
Author(s):  
B. Castagneto ◽  
M. Mencoboni ◽  
D. Degiovanni ◽  
A. Muzio ◽  
L. Giaretto ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Phase Ii Study ◽  
Performance Status ◽  
Entire Group ◽  
Hematologic Toxicity ◽  
First Line ◽  
Ecog Performance Status ◽  
Grade 3

7093 Background: Aim of this study was to evaluate the activity and toxicity of MTA and CBDCA combination as first line chemotherapy in advanced MPM. Methods: Chemonaive patients (pts) with histologically proven, an ECOG performance status (PS) 0–2, and measurable advanced MPM were considered. The schedule of administration was: pemetrexed 500 mg/m2 in combination with CBDA AUC 5, once every 21 days for 8 cycles. Results: From July 2003 to March 2005 76 pts (54 male and 22 female) have been treated with this combination chemotherapy. Median age was 62.7 years (range 40–70); median PS 0 (range 0–3); epithelial histologic findings were in 57 (75%), mixed in 13 (17.1%), sarcomatous in 3 (3.9%), and unspecified in 3 (3.9%) pts. A total of 537 cycles was administered (median 7, range 1 to 13). Grade 3 hematologic toxicity according to WHO criteria was seen in 43 (56.6%) pts (neutropenia in 30, thrombocytopenia in 8, and anemia in 5); grade 4 hematologic toxicity in 5 (6.6%) pts. The most common nonhematologic events were grade 3 nausea/vomiting in 10 (13.1%), and fever in 4 (5.3%) pts. 74 pts were evaluable for clinical response. There were 16 (21.%) partial responses (PR) and 3 (3.9%) complete responses (CR), for an overall response rate of 23.9%. 29 (38.2%) pts reported stable disease (SD). The overall survival was considered from date of diagnosis to date of death from any cause or to date of last follow-up. The median survival time for the entire group was estimated at 23 months. Conclusions: The results of this phase II study indicate that, at this dose and schedule, the combination of CBDCA and MTA is moderately active and that the profile of toxicity is acceptable in pts with advanced MPM. No significant financial relationships to disclose.

scholarly journals P70.01 Distribution of CCND1 Mutations in East Asian Patients With Non-Small Cell Lung Cancer

2021 ◽  
Vol 16 (3) ◽  
pp. S562-S563
Author(s):  
H. Feng ◽  
C. Xu ◽  
W. Wang ◽  
D. Wang ◽  
Y. Zhu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
East Asian ◽  
Small Cell ◽  
Small Cell Lung ◽  
Asian Patients ◽  
East Asian Patients

A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies

2021 ◽  
Author(s):  
Toshio Shimizu ◽  
Yasutoshi Kuboki ◽  
Chia-Chi Lin ◽  
Kan Yonemori ◽  
Tomoko Yanai ◽  
...  
Keyword(s):  
Phase 1 ◽  
East Asian ◽  
Phase 1 Study ◽  
Asian Patients ◽  
East Asian Patients

scholarly journals Phase 1 Study of MLN8237 (Alisertib) in Adult East Asian Patients (PTS) with Advanced Solid Tumors or Lymphomas

2013 ◽  
Vol 24 ◽  
pp. ix48
Author(s):  
W.S. Kim ◽  
K. Venkatakrishnan ◽  
T.M. Kim ◽  
C.-C. Lin ◽  
L.S. Thye ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Phase 1 ◽  
East Asian ◽  
Advanced Solid Tumors ◽  
Phase 1 Study ◽  
Asian Patients ◽  
East Asian Patients

scholarly journals 418 Phase 1b/2 KEYNOTE-365 cohort I: platinum-containing chemotherapy alone or in combination with pembrolizumab for treatment-emergent neuroendocrine prostate carcinoma

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A448-A448
Author(s):  
Johann De Bono ◽  
Neal Shore ◽  
Gero Kramer ◽  
Anthony Joshua ◽  
Xin Tong Li ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Carcinoma ◽  
Response Rate ◽  
Performance Status ◽  
Ecog Performance Status ◽  
End Points ◽  
Status Score ◽  
Modified Recist ◽  
Phase 1B ◽  
Performance Status Score

BackgroundTreatment-emergent neuroendocrine prostate carcinoma (t-NE) can occur de novo or after diagnosis of prostate adenocarcinoma. Treatment often includes platinum-containing chemotherapy because of t-NE’s histologic similarity to small cell lung cancer. The PD-1 inhibitor pembrolizumab has shown promising efficacy and acceptable safety when combined with olaparib, docetaxel, or enzalutamide for treatment of metastatic castration-resistant prostate cancer (mCRPC) in the multicohort phase 1b/2 KEYNOTE-365 study (NCT02861573). Cohort I will be used to compare platinum-containing chemotherapy alone with chemotherapy + pembrolizumab as treatment for t-NE.MethodsPatients who have t-NE (≥1% neuroendocrine cells in a recent biopsy specimen confirmed by central histology review); experienced progression within 6 months of starting a next-generation hormonal agent (NHA) for mCRPC or hormone-sensitive prostate cancer and experienced progression within 6 cycles of docetaxel treatment for mCRPC; and have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 are eligible. Prior therapy with ≤2 NHAs and 1 other chemotherapy for mCRPC is permitted. Patients will be randomly assigned 1:1 to receive pembrolizumab 200 mg IV on day 1 of each cycle every 3 weeks + carboplatin AUC of 5 IV on day 1 + etoposide 100 mg/m2 IV on days 1, 2, and 3 of each 21-day cycle for 4 cycles (arm 1) or the same chemotherapy regimen without pembrolizumab (arm 2); in each arm 40–100 patients will be enrolled. Pembrolizumab treatment will continue up to 2 years until disease progression, unacceptable toxicity, or withdrawal of consent. Patients will be stratified by ECOG performance status score (0 or 1). Computed tomography or magnetic resonance imaging will be performed every 9 weeks through week 54 and every 12 weeks thereafter. Primary end points are safety and tolerability, prostate-specific antigen (PSA) response rate, and objective response rate (ORR) per RECIST v1.1 by blinded independent central review (BICR). Secondary end points are time to PSA progression; ORR and radiographic progression-free survival (PFS) per PCWG3-modified RECIST v1.1 by BICR; duration of response and disease control rate per RECIST v1.1 by BICR and PCWG3-modified RECIST v1.1 by BICR; and overall survival. End points will be summarized for each arm without formal hypothesis testing.AcknowledgementsMedical writing and/or editorial assistance was provided by Matthew Grzywacz, PhD, of ApotheCom (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.Trial RegistrationClinicaltrials.gov, NCT02861573Ethics ApprovalThe study and the protocol were approved by the Institutional Review Board or ethics committee at each site.

scholarly journals Genomic Landscape and Immunological Profile of Glioblastoma in East Asian Patients

2021 ◽  
Author(s):  
Jean Zhao ◽  
Sheng Zhong ◽  
Bo Wu ◽  
Frank Dubois ◽  
Shanshan Jiang ◽  
...  
Keyword(s):  
East Asian ◽  
Marker Gene ◽  
European Ancestry ◽  
Asian Patients ◽  
Molecular Features ◽  
Immunological Profile ◽  
Genomic Landscape ◽  
Genetic Landscape ◽  
Genetic Features ◽  
East Asian Patients

Abstract While it is well known that Glioblastoma (GBM) shows profound inter- and intra-tumoral heterogeneity, disparities in molecular features across ancestry groups have been largely overlooked. We collected a large cohort of GBM samples from East Asian patients (EAS-GBM) and performed genomic and transcriptomic analyses of these samples (EAS-GBM, n=443). Further characterization and comparative analysis of the EAS-GBM with the predominantly European-ancestry TCGA GBM dataset (EUR-GBM, n=383) revealed differential genomic and genetic landscape and immunological profile of EAS-GBM from EUR-GBM. EAS-GBM showed an enrichment for NF1, H3F3A, TP53 and ATRX mutations compared to EUR-GBM. Transcriptomic clustering revealed distinct EAS-GBM specific subtypes, namely Proliferative (PL), Neuron-Synaptic (NS), Metabolic (MB) and Immunomodulatory (IM). Notably, the classic subtype of EUR-GBMs with EGFR as its main marker gene was absent in EAS-GBMs, Moreover, the IM subgroup in EAS-GBM with an expression profile that has been previously associated with response to immunotherapy in cancers. Together, our comprehensive characterization revealed the unique genomic and genetic features of EAS-GBMs, providing mechanistic rationale in patient stratification for molecular targeted therapy and drug development in the era of personalized medicine.

scholarly journals Efficacy of S-1 after pemetrexed in patients with non-small cell lung carcinoma: a retrospective multi-institutional analysis

2021 ◽  
Author(s):  
Shinnosuke Takemoto ◽  
Kazumasa Akagi ◽  
Sawana Ono ◽  
Hiromi Tomono ◽  
Noritaka Honda ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Small Cell Lung Carcinoma ◽  
Progression Free Survival ◽  
Small Cell Lung ◽  
Confidential Interval ◽  
Cell Lung Carcinoma ◽  
Free Survival ◽  
Time To Treatment Failure ◽  
Nsclc Patients

Abstract Background: This study was designed to evaluate the treatment effect of S-1 following PEM-containing treatment. Methods: This retrospective study included patients with advanced (c-stage III or IV, UICC 7th) or recurrent NSCLC who received S-1 monotherapy following the failure of previous PEM-containing chemotherapy at 6 hospitals in Japan. Primary endpoint: Overall response rate (ORR). Secondary endpoint: Disease control rate (DCR), time to treatment failure (TTF), progression-free survival (PFS), and overall survival (OS). Results: A total of 53 NSCLC patients met the criteria. Forty-six patients had adenocarcinoma (88.7%) and no patients had squamous cell carcinoma. Thirty-one patients (58.5%) received the standard S-1 regimen and 18 patients (34.0%) received the modified S-1 regimen. ORR was 1.9% (95% confidential interval (CI): 0.00-10.1%). Median TTF, PFS, and OS were 65 days, 84 days, and 385 days, respectively. Conclusion: Although there were several limitations in this study, the ORR of S-1 after PEM in patients with non-SQ NSCLC was low compared to the historical control. It might be one of the choices to avoid S-1 treatment in PEM-treated patients who need tumor shrinkage.

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