Phase I and pharmacologic study of weekly bolus topotecan for advanced non-small-cell lung cancer.

Abstract:

PURPOSE:We conducted a phase I trial of the topoisomerase I inhibitor topotecan for the purpose of determining the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of topotecan when administered weekly to patients with advanced non-small-cell lung cancer. PATIENTS AND METHODS:Twelve patients with stage IIIB or IV disease were treated with topotecan by 30-minute intravenous infusion on days 1, 8, and 15 every 4 weeks. The dose was escalated in 2-mg/m2 increments from the starting dose of 4 mg/m2 until the MTD was reached. After the MTD had been reached in previously treated patients, chemotherapy-naive patients were enrolled for treatment at that dose, and the dose was escalated to estimate the MTD in the treatment-naive group. RESULTS:The MTD of topotecan was determined to be 6 mg/m2 in the previously treated group and 8 mg/m2 in the chemotherapy-naive group. All 3 previously treated patients experienced DLT at the 6-mg/m2 dose level. Although only 1 of the 3 previously treated patients experienced DLT (grade 4 neutropenia for > or = 3 days) at the 8-mg/m2 dose level, skipping the topotecan dose on day 15 because of neutropenia was reported in 2 patients. Anorexia and general fatigue were the common nonhematologic toxicities. CONCLUSION:The recommended dose of topotecan for phase II studies in previously untreated patients is 6 mg/m2 on days 1, 8, and 15, every 28 days, and 4 mg/m2 appears to be a suitable dose for use in previously treated patients with this schedule.

journal_name

Clin Lung Cancer

journal_title

Clinical lung cancer

authors

Masuda N,Matsui K,Negoro S,Takeda K,Kudoh S,Nakagawa K,Mukaiyama A,Arase H,Yoshida P,Ijima T,Takada M,Fukuoka M

doi

10.3816/CLC.2010.n.035

subject

Has Abstract

pub_date

2010-07-01 00:00:00

pages

271-9

issue

4

eissn

1525-7304

issn

1938-0690

pii

S1525-7304(11)70029-8

journal_volume

11

pub_type

杂志文章
  • PROCLAIM: A phase III study of pemetrexed, cisplatin, and radiation therapy followed by consolidation pemetrexed versus etoposide, cisplatin, and radiation therapy followed by consolidation cytotoxic chemotherapy of choice in locally advanced stage III no

    abstract::This clinical trial summary provides the background and rationale for a randomized trial examining the benefits of pemetrexed/ cisplatin chemotherapy combined with radiation followed by consolidation pemetrexed in patients with unresectable stage IIIA/B non-small-cell lung cancer. The rationale for the selection of th...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,随机对照试验

    doi:10.3816/CLC.2009.n.027

    authors: Vokes EE,Senan S,Treat JA,Iscoe NA

    更新日期:2009-05-01 00:00:00

  • The emerging role of biomarkers in advanced non-small-cell lung cancer.

    abstract::Novel therapies, particularly those that target vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR), have improved the treatment of advanced non-small-cell lung cancer (NSCLC). The search continues for biomarkers that can predict which patients are most likely to benefit from these th...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,评审

    doi:10.3816/CLC.2010.n.019

    authors: Socinski MA

    更新日期:2010-05-01 00:00:00

  • Multitargeted inhibitors in lung cancer: new clinical data.

    abstract::Novel therapies have been added to the treatment arsenal of physicians treating lung cancer in recent years. Most promising are agents that target the major pathways involved in cancer evolution, mostly proliferation and angiogenesis. Some of these treatments have been shown to synergize with traditional chemotherapy ...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,评审

    doi:10.3816/CLC.2008.s.014

    authors: Bar J,Herbst RS,Onn A

    更新日期:2008-01-01 00:00:00

  • Pathological examination and the reporting of lung cancer specimens.

    abstract::The Lung Cancer Disease Site Group (DSG) of the Cancer Care Ontario Practice Guidelines Initiative first met in January of 1994. Included in the membership were three pathologists who, with the other members of the DSG, felt that a useful contribution to the work of the group would be a recommendation on standardized ...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.3816/clc.2000.n.008

    authors: Chamberlain DW,Wenckebach GF,Alexander F,Fraser RS,Kolin A,Newman T

    更新日期:2000-05-01 00:00:00

  • Importance of quality of life in patients with non-small-cell lung cancer.

    abstract::The therapeutic options for patients with advanced non-small-cell lung cancer (NSCLC) are palliative. Therefore, the quality of life in oncology is considered as an endpoint in clinical trials, and several scales have been accepted for its measurement in parallel with other clinical determinations. However, its use in...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,评审

    doi:10.3816/CLC.2009.n.010

    authors: Camps C,del Pozo N,Blasco A,Blasco P,Sirera R

    更新日期:2009-03-01 00:00:00

  • Pharmacokinetic evaluation of gefitinib when administered with chemotherapy.

    abstract::Gefitinib is a small-molecule agent specifically targeted to inhibit the epidermal growth factor receptor-tyrosine kinase (EGFR-TK). Tumor responses have been achieved with gefitinib treatment in large, randomized monotherapy trials. In preclinical studies, gefitinib has shown additive and even supra-additive antitumo...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,评审

    doi:10.3816/clc.2003.s.011

    authors: Hammond LA

    更新日期:2003-09-01 00:00:00

  • Carboplatin and paclitaxel plus ASA404 as first-line chemotherapy for extensive-stage small-cell lung cancer: a multicenter single arm phase II trial (SAKK 15/08).

    abstract:INTRODUCTION:Small-cell lung cancer (SCLC) is a highly vascularized tumor. ASA404 is a tumor vascular disrupting agent. This is the first trial to report the effects of combining chemotherapy with ASA404 in SCLC. METHODS:Patients with untreated metastatic SCLC were treated with carboplatin (area under curve, 6) plus p...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.cllc.2012.04.001

    authors: Früh M,Cathomas R,Siano M,Tscherry G,Zippelius A,Mamot C,Erdmann A,Krasniqi F,Rauch D,Simcock M,Küttel E,Fustier P,Pless M,Swiss Group for Clinical Cancer Research.

    更新日期:2013-01-01 00:00:00

  • Classifications of n2 non-small-cell lung cancer based on the number and rate of metastatic mediastinal lymph nodes.

    abstract:BACKGROUND:Subdivisions of N2 non-small-cell lung cancer (NSCLC) cases based on metastatic status of mediastinal and non-mediastinal lymph nodes have been proposed. This study aimed to evaluate N2 disease classification by mediastinal lymph nodes alone. PATIENTS AND METHODS:We reviewed 187 patients with NSCLC pN1-N2 w...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2013.04.012

    authors: Ito M,Yamashita Y,Tsutani Y,Misumi K,Harada H,Miyata Y,Okada M

    更新日期:2013-11-01 00:00:00

  • Third-line chemotherapy in small-cell lung cancer: an international analysis.

    abstract:INTRODUCTION:Small-cell lung cancer is an aggressive disease for which the mainstay of treatment is chemotherapy. Despite good initial responses most patients will relapse. Some will receive second-line therapy with clinical benefit, but for third-line chemotherapy there is little evidence to guide treatment decisions ...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.cllc.2013.11.003

    authors: Simos D,Sajjady G,Sergi M,Liew MS,Califano R,Ho C,Leighl N,White S,Summers Y,Petrcich W,Wheatley-Price P

    更新日期:2014-03-01 00:00:00

  • Efficacy and Safety of Lorlatinib in Korean Non-Small-Cell Lung Cancer Patients With ALK or ROS1 Rearrangement Whose Disease Failed to Respond to a Previous Tyrosine Kinase Inhibitor.

    abstract:INTRODUCTION:Non-small-cell lung cancer (NSCLC) patients harboring ALK or ROS1 rearrangements invariably acquire resistance to the first- and second-generation tyrosine kinase inhibitors (TKIs), most notably ALK G1202R and ROS1 G2032R. Lorlatinib, a novel third-generation TKI, produced remarkable results from the first...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2018.12.020

    authors: Lee J,Sun JM,Lee SH,Ahn JS,Park K,Choi Y,Ahn MJ

    更新日期:2019-05-01 00:00:00

  • Comparing Outcomes of Patients With Early-Stage Non-Small-Cell Lung Cancer Treated With Stereotactic Body Radiotherapy Based on Frailty Status.

    abstract:INTRODUCTION:Frailty of surgical patients has been associated with worse outcomes. There is limited literature discussing frailty in patients with lung cancer treated with stereotactic body radiotherapy (SBRT). This study assesses the relationship between frailty and overall survival (OS), tumor control, and toxicity i...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2018.05.008

    authors: Raghavan G,Shaverdian N,Chan S,Chu FI,Lee P

    更新日期:2018-09-01 00:00:00

  • ROS1 immunohistochemistry among major genotypes of non-small-cell lung cancer.

    abstract:BACKGROUND:ROS1 gene fusions cause several cancers by constitutively activating the ROS1 tyrosine kinase receptor. ROS1-targeted inhibitor therapy improves survival in the approximately 1% to 2% of patients with lung adenocarcinoma with ROS1 gene fusions. Although fluorescence in situ hybridization (FISH) is the standa...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2014.10.003

    authors: Boyle TA,Masago K,Ellison KE,Yatabe Y,Hirsch FR

    更新日期:2015-03-01 00:00:00

  • Adjuvant therapy in non-small cell lung cancer: future treatment prospects and paradigms.

    abstract::There is a high risk of relapse after curative-intent resection for even early-stage non-small cell lung cancer (NSCLC), and thus adjuvant chemotherapy has been explored with the goal of eliminating occult metastases and consequently reducing the risk of recurrence. Although adjuvant chemotherapy confers a survival ad...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,评审

    doi:10.1016/j.cllc.2011.06.002

    authors: Carbone DP,Felip E

    更新日期:2011-09-01 00:00:00

  • Mature results of a phase II trial of gemcitabine/paclitaxel given every 2 weeks in patients with advanced non-small-cell lung cancer.

    abstract:PURPOSE:This phase II study evaluated the efficacy and toxicity of gemcitabine/paclitaxel given every 2 weeks in patients with advanced-stage non-small-cell lung cancer. Treatment with 1 previous chemotherapy regimen was allowed. Patients received gemcitabine 3000 mg/m(2) intravenously over 30 minutes and paclitaxel 15...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.3816/CLC.2007.n.010

    authors: Wozniak AJ,Belzer K,Heilbrun LK,Kucuk O,Gadgeel S,Kalemkerian GP,Venkatramanamoorthy R,Kraut MJ

    更新日期:2007-03-01 00:00:00

  • Gemcitabine and carboplatin in advanced non small-cell lung cancer: a review.

    abstract::Both gemcitabine and carboplatin have demonstrated activity in advanced non small-cell lung cancer. The combination of gemcitabine and cisplatin has demonstrated equivalent or superior efficacy to other commonly used agents and two-drug combinations, and a recent Eastern Cooperative Oncology Group trial suggested that...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.3816/clc.2000.s.008

    authors: Masters GA

    更新日期:2000-12-01 00:00:00

  • Prevalence and clinical significance of incidental and clinically suspected venous thromboembolism in lung cancer patients.

    abstract:BACKGROUND:It is unclear what proportion of VTE events in lung cancer patients are incidentally discovered and whether incidental events affect mortality. PATIENTS AND METHODS:We conducted a retrospective cohort study of lung cancer patients seen at the University of Rochester between January 1, 2006 and December 31, ...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2013.06.003

    authors: Connolly GC,Menapace L,Safadjou S,Francis CW,Khorana AA

    更新日期:2013-11-01 00:00:00

  • Sequential chemotherapy: rationale and clinical trial design in advanced non-small-cell carcinoma.

    abstract::Recent developments in the chemotherapy of advanced and metastatic non small-cell lung cancer have led to significant, albeit modest, improvements in survival and quality of life. The plethora of new agents with activity in this disease has led to questions as to how these drugs can best be added to existing regimens....

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.3816/clc.1999.n.009

    authors: Edelman MJ,Gandara DR

    更新日期:1999-11-01 00:00:00

  • Prognostic role of ERCC1 in advanced non-small-cell lung cancer: a systematic review and meta-analysis.

    abstract:UNLABELLED:Small observational studies have demonstrated an association between high ERCC1 expression level and poor prognosis in advanced NSCLC treated with platinum-based chemotherapy. This meta-analysis presents pooled estimates of association from 11 studies. High ERCC1 patients had lower response rates and higher ...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,评审

    doi:10.1016/j.cllc.2011.04.005

    authors: Roth JA,Carlson JJ

    更新日期:2011-11-01 00:00:00

  • Comparison of Radiotherapy and Chemoradiotherapy for Locoregional Recurrence of Non-small-cell Lung Cancer Developing After Surgery.

    abstract:BACKGROUND:The optimal treatment strategy for locoregional recurrences developing after surgical resection in patients with non-small-cell lung cancer (NSCLC) is yet to be clearly established. PATIENTS AND METHODS:To investigate the efficacy and safety of radiotherapy (RT) and chemoradiotherapy (CRT), we reviewed the ...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2017.05.005

    authors: Nakamichi S,Horinouchi H,Asao T,Goto Y,Kanda S,Fujiwara Y,Nokihara H,Yamamoto N,Ito Y,Watanabe SI,Ohe Y

    更新日期:2017-11-01 00:00:00

  • Treatment Response and Prophylactic Cranial Irradiation Are Prognostic Factors in a Real-life Limited-disease Small-cell Lung Cancer Patient Cohort Comprehensively Staged With Cranial Magnetic Resonance Imaging.

    abstract:INTRODUCTION:Prophylactic cranial irradiation (PCI) has proven to decrease the incidence of brain metastases (BMs), with a modest improvement in survival. PATIENTS AND METHODS:The impact of PCI was evaluated in 184 patients treated with chemoradiotherapy. PCI was applied to patients with disease with partial and compl...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2016.11.005

    authors: Eze C,Roengvoraphoj O,Niyazi M,Hildebrandt G,Fietkau R,Belka C,Manapov F

    更新日期:2017-07-01 00:00:00

  • Correlations Between the Immune-related Adverse Events Spectrum and Efficacy of Anti-PD1 Immunotherapy in NSCLC Patients.

    abstract:BACKGROUND:Immune-related adverse events (irAEs) developed during immunotherapy with anti-PD-1 agents, could be a predictive surrogate marker of clinical benefit in patients with advanced non-small-cell lung cancer (NSCLC). METHODS:Patients with NSCLC, treated with anti-PD-1 agents, were retrospectively evaluated. Uni...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.cllc.2019.02.006

    authors: Cortellini A,Chiari R,Ricciuti B,Metro G,Perrone F,Tiseo M,Bersanelli M,Bordi P,Santini D,Giusti R,Grassadonia A,Di Marino P,Tinari N,De Tursi M,Zoratto F,Veltri E,Malorgio F,Garufi C,Russano M,Anesi C,Zeppola T,

    更新日期:2019-07-01 00:00:00

  • Epidermal Growth Factor Receptor Mutational Testing and Erlotinib Treatment Among Veterans Diagnosed With Lung Cancer in the United States Department of Veterans Affairs.

    abstract:INTRODUCTION:We examined mutational testing of the epidermal growth factor gene (EGFR) and erlotinib treatment among veterans diagnosed with non-small-cell lung cancer in the United States Department of Veterans Affairs (VA). Our objectives were to identify the prevalence of clinically actionable EGFR mutations, to det...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2016.11.018

    authors: Lynch JA,Berse B,Chun D,Rivera D,Filipski KK,Kulich S,Viernes B,DuVall SL,Kelley MJ

    更新日期:2017-07-01 00:00:00

  • Comorbidity Assessment Using Charlson Comorbidity Index and Simplified Comorbidity Score and Its Association With Clinical Outcomes During First-Line Chemotherapy for Lung Cancer.

    abstract:BACKGROUND:Limited data is available on comorbidity assessment in patients with lung cancer. The present prospective study assessed the prevalence and association of the Charlson comorbidity index (CCI) and simplified comorbidity score (SCS) with clinical outcomes in patients with newly diagnosed lung cancer undergoing...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2015.10.002

    authors: Singh N,Singh PS,Aggarwal AN,Behera D

    更新日期:2016-05-01 00:00:00

  • Single-agent gefitinib in patients with untreated advanced non-small-cell lung cancer and poor performance status: a Minnie Pearl Cancer Research Network Phase II Trial.

    abstract:BACKGROUND:Patients with advanced non-small-cell lung cancer (NSCLC) and poor performance status (PS) are often excluded from trials. Gefitinib is a safe oral agent that may benefit these patients. PATIENTS AND METHODS:Seventy-two patients with poor PS and advanced NSCLC were enrolled onto this study of gefitinib 250 ...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,多中心研究

    doi:10.3816/CLC.2005.n.028

    authors: Spigel DR,Hainsworth JD,Burkett ER,Burris HA,Yardley DA,Thomas M,Jones SF,Dickson NR,Scullin DC,Bradof JE,Rubinsak JR,Brierre JE,Greco FA

    更新日期:2005-09-01 00:00:00

  • Clinical implications and added costs of incidental findings in an early detection study of lung cancer by using low-dose spiral computed tomography.

    abstract:INTRODUCTION:To prospectively evaluate the frequency and spectrum of incidental findings (IF) in a 5-year lung cancer screening program with low-dose spiral computed tomography (CT) and to estimate the additional costs of their imaging workup incurred from subsequent radiologic follow-up evaluation. MATERIALS AND METH...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2012.05.005

    authors: Priola AM,Priola SM,Giaj-Levra M,Basso E,Veltri A,Fava C,Cardinale L

    更新日期:2013-03-01 00:00:00

  • A phase II study of topotecan in patients with relapsed small-cell lung cancer.

    abstract::An early phase II study of topotecan produced favorable results in a small number of untreated and previously treated patients with small-cell lung cancer (SCLC). This multicenter study was conducted in patients with relapsed SCLC at 19 medical institutions in Japan. Topotecan 1.0 mg/m2/day was administered for 5 cons...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.3816/clc.2003.n.002

    authors: Takeda K,Negoro S,Sawa T,Nakagawa K,Kawahara M,Isobe T,Kudoh S,Masuda N,Niitani H,Fukuoka M

    更新日期:2003-01-01 00:00:00

  • Survival of Asian Females With Advanced Lung Cancer in the Era of Tyrosine Kinase Inhibitor Therapy.

    abstract:INTRODUCTION:We examined the effect of access to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy on survival for Asian female (AF) EGFR mutation-enriched patients with advanced lung adenocarcinoma. MATERIALS AND METHODS:We used the Surveillance Epidemiology and End Results database to s...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2016.08.008

    authors: Becker DJ,Wisnivesky JP,Grossbard ML,Chachoua A,Camidge DR,Levy BP

    更新日期:2017-01-01 00:00:00

  • Real-World Clinical Impact of Immune Checkpoint Inhibitors in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer After Platinum Chemotherapy.

    abstract:BACKGROUND:The real-world effect of anti-programmed death ligand 1 (PD-L1) therapies is unclear. We compared US patients who received second-line therapy for non-small-cell lung cancer (NSCLC) before and shortly after US Food and Drug Administration (FDA) approval of PD-L1 inhibitors. PATIENTS AND METHODS:Patients in ...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2019.04.004

    authors: Schwartzberg L,Korytowsky B,Penrod JR,Zhang Y,Le TK,Batenchuk C,Krug L

    更新日期:2019-07-01 00:00:00

  • Assessing response to treatment in non--small-cell lung cancer: role of tumor volume evaluated by computed tomography.

    abstract:INTRODUCTION:We set out to investigate whether volumetric tumor measurements allow for a prediction of treatment response, as measured by patient survival, in patients with advanced non-small-cell lung cancer (NSCLC). MATERIALS AND METHODS:Patients with nonresectable NSCLC (stage III or IV, n = 100) who were repeatedl...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章

    doi:10.1016/j.cllc.2013.11.001

    authors: Knollmann FD,Kumthekar R,Fetzer D,Socinski MA

    更新日期:2014-03-01 00:00:00

  • First-line chemotherapy for advanced-stage non-small-cell lung cancer: focus on docetaxel.

    abstract::Systemic chemotherapy results in modest improvements in survival and quality of life for patients with advanced-stage non-small-cell lung cancer (NSCLC). Administration of a platinum compound in combination with a taxane (paclitaxel or docetaxel), gemcitabine, vinorelbine, or irinotecan is considered optimal first-lin...

    journal_title:Clinical lung cancer

    pub_type: 杂志文章,评审

    doi:10.3816/clc.2005.s.014

    authors: Ramalingam S

    更新日期:2005-12-01 00:00:00