Literature DB >> 12216095

A Phase II trial of topotecan and gemcitabine in patients with previously treated, advanced nonsmall cell lung carcinoma.

David A Rinaldi1, Nancy A Lormand, Joseph E Brierre, James L Cole, Brian C Barnes, Glen Mills, Siva Yadlapati, M Felicia Fontenot, Eric J Buller, John M Rainey.   

Abstract

BACKGROUND: Multiple trials have been performed to evaluate second-line clinical chemotherapy in patients with advanced nonsmall cell lung carcinoma (NSCLC). However, no single agent or combination has demonstrated superior activity.
METHODS: Patients with advanced NSCLC who had already received one chemotherapeutic regimen were treated with topotecan (0.75 mg/m(2) over 30 minutes, Days 1-5) and gemcitabine (400 mg/m(2) over 30 minutes, Days 1 and 5) every 21 days.
RESULTS: Of 35 patients who were treated, 4 (11%) achieved a partial responses and 8 (23%) hadstable disease for at least four courses of treatment. The response rate for patients with refractory disease (progressing during frontline chemotherapy) was 18% (3 of 17) with 18% having stable disease for at least four courses of treatment. The median survival of the entire group was 7 months (range, 1.5-44 months) and 20% (7 of 35) of patients were alive 1 year from the initiation of topotecan and gemcitabine treatment. Patients with refractory disease had a median survival of 4(1/2) months, with 6-month and 1-year survival rates of 47% and 18%, respectively. During Course 1, five patients (14%) developed Grade IV neutropenia and three patients (9%) developed Grade IV thrombocytopenia. Nonhematologic toxicity was relatively mild, with one patient developing Grade III side effects (fatigue) and eight patients (23%) developing Grade II nonhematologic side effects.
CONCLUSIONS: The combination of topotecan and gemcitabine demonstrated antitumor activity with a modest side effect profile in patients with advanced, previously treated NSCLC. Copyright 2002 American Cancer Society.

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Year:  2002        PMID: 12216095     DOI: 10.1002/cncr.10806

Source DB:  PubMed          Journal:  Cancer        ISSN: 0008-543X            Impact factor:   6.860


  4 in total

1.  A phase I study of topotecan and gemcitabine in advanced solid tumors.

Authors:  Derek S Serna; Tanios Bekaii-Saab; Eric H Kraut
Journal:  Invest New Drugs       Date:  2010-06-25       Impact factor: 3.850

2.  A phase I study of weekly topotecan in combination with pemetrexed in patients with advanced malignancies.

Authors:  Howard A Burris; Jeffrey R Infante; Roxanne C Jewell; David R Spigel; F Anthony Greco; Dana S Thompson; Suzanne F Jones
Journal:  Oncologist       Date:  2010-08-26

3.  Phase I trial of weekly topotecan and gemcitabine in patients with solid tumors.

Authors:  William N William; Joseph L Lee; Dong M Shin; Waun K Hong; Suyu Liu; J Jack Lee; Scott M Lippman; Fadlo R Khuri; Edward S Kim
Journal:  Am J Clin Oncol       Date:  2009-02       Impact factor: 2.339

4.  Interaction between gemcitabine and topotecan in human non-small-cell lung cancer cells: effects on cell survival, cell cycle and pharmacogenetic profile.

Authors:  E Giovannetti; V Mey; R Danesi; F Basolo; S Barachini; M Deri; M Del Tacca
Journal:  Br J Cancer       Date:  2005-02-28       Impact factor: 7.640

  4 in total

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