Phase II study of a fixed dose-rate infusion of gemcitabine associated with docetaxel in advanced non-small-cell lung carcinoma View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2004-08-21

AUTHORS

J. De Castro, A. Lorenzo, S. Morales, J. Belón, J. Dorta, J. Lizón, C. Madroñal, P. M. Gallurt, E. Casado, J. Feliu, M. González Barón, Oncopaz Cooperative Group

ABSTRACT

PurposeTo evaluate the efficacy and toxicity profile of the combination of docetaxel and prolonged gemcitabine infusion in front-line chemonaive patients with advanced non-small-cell lung cancer (NSCLC).Patients and methodsA total of 50 chemonaive patients diagnosed with advanced NSCLC according to the AJCC/TNM classification system were included in the present study. Treatment consisted of 1000 mg/m2 gemcitabine given as a 100-min continuous infusion (10 mg/m2 per min) on days 1 and 8 of each course and 75 mg/m2 docetaxel as a 60-min infusion on day 8, repeating each course every 21 days.ResultsThe ECOG performance status of the patients were as follows: 0 (10%), 1 (60%), and 2 (30%). All patients had two-dimensionally measurable disease. Their median age was 63 years (range 41–75 years). Of the 50 patients, 28 (56%) had squamous cell carcinoma, 14 adenocarcinoma (28%), and 8 (16%) large-cell carcinoma, and 40% and 60% of patients presented with stage IIIB and IV disease, respectively. Of those with stage IV disease, 33% had more than one metastatic site. A total of 220 courses were administered with a median of five courses per patient. Of 46 patients assessed for response, 12 (26%) had a partial remission (95% CI 13–39%). In 19 patients (41%) the disease remained stable, while disease progression was observed in 15 (33%). The median time to disease progression was 4 months, and median survival time was 7 months. At 1 year, 25% of patients remained alive, and the main grade 3/4 toxicity (according to the WHO scale) consisted of neutropenia (n=6, 12%), asthenia (n=4, 8%), peripheral edema (n=3, 6%), dyspnea (n=3, 6%), and diarrhea (n=2, 4%).ConclusionsProlonged gemcitabine infusion combined with docetaxel is well tolerated and its efficacy is similar to that of other chemotherapeutic schemes used for NSCLC treatment. However, the prolonged infusion of gemcitabine did not appear to result in any improvement in outcome or toxicity versus the standard dose rate. More... »

PAGES

197-202

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00280-004-0869-z

DOI

http://dx.doi.org/10.1007/s00280-004-0869-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1028377904

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/15322824


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22 schema:description PurposeTo evaluate the efficacy and toxicity profile of the combination of docetaxel and prolonged gemcitabine infusion in front-line chemonaive patients with advanced non-small-cell lung cancer (NSCLC).Patients and methodsA total of 50 chemonaive patients diagnosed with advanced NSCLC according to the AJCC/TNM classification system were included in the present study. Treatment consisted of 1000 mg/m2 gemcitabine given as a 100-min continuous infusion (10 mg/m2 per min) on days 1 and 8 of each course and 75 mg/m2 docetaxel as a 60-min infusion on day 8, repeating each course every 21 days.ResultsThe ECOG performance status of the patients were as follows: 0 (10%), 1 (60%), and 2 (30%). All patients had two-dimensionally measurable disease. Their median age was 63 years (range 41–75 years). Of the 50 patients, 28 (56%) had squamous cell carcinoma, 14 adenocarcinoma (28%), and 8 (16%) large-cell carcinoma, and 40% and 60% of patients presented with stage IIIB and IV disease, respectively. Of those with stage IV disease, 33% had more than one metastatic site. A total of 220 courses were administered with a median of five courses per patient. Of 46 patients assessed for response, 12 (26%) had a partial remission (95% CI 13–39%). In 19 patients (41%) the disease remained stable, while disease progression was observed in 15 (33%). The median time to disease progression was 4 months, and median survival time was 7 months. At 1 year, 25% of patients remained alive, and the main grade 3/4 toxicity (according to the WHO scale) consisted of neutropenia (n=6, 12%), asthenia (n=4, 8%), peripheral edema (n=3, 6%), dyspnea (n=3, 6%), and diarrhea (n=2, 4%).ConclusionsProlonged gemcitabine infusion combined with docetaxel is well tolerated and its efficacy is similar to that of other chemotherapeutic schemes used for NSCLC treatment. However, the prolonged infusion of gemcitabine did not appear to result in any improvement in outcome or toxicity versus the standard dose rate.
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65 improvement
66 infusion
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68 lung cancer
69 lung carcinoma
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71 measurable disease
72 median
73 median age
74 median survival time
75 median time
76 metastatic sites
77 methodsA total
78 months
79 neutropenia
80 outcomes
81 partial remission
82 patients
83 performance status
84 peripheral edema
85 phase II study
86 present study
87 profile
88 progression
89 prolonged infusion
90 rate
91 remission
92 response
93 scheme
94 sites
95 squamous cell carcinoma
96 stage IIIB
97 stage IV disease
98 standard dose rate
99 status
100 study
101 survival time
102 system
103 time
104 total
105 toxicity
106 toxicity profile
107 treatment
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