Docetaxel plus gemcitabine versus gemcitabine in elderly patients with advanced non-small cell lung cancer and use of a geriatric assessment : Lessons from a prematurely closed Hellenic Oncology Research Group randomized phase III study
Copyright © 2016 Elsevier Inc. All rights reserved..
OBJECTIVES: To compare first-line treatment with docetaxel plus gemcitabine (DG) versus gemcitabine (G) in elderly patients with advanced/metastatic non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS: Chemotherapy-naïve patients with inoperable stage IIIB/IV NSCLC, ≥70years, with an ECOG performance status (PS) of 0-2 were enrolled. Patients were stratified by PS and disease stage and randomized to either DG (docetaxel 30mg/m2 plus gemcitabine 900mg/m2 i.v.) or G (gemcitabine 1200mg/m2 i.v.) on days 1 and 8, every 3weeks. The study's primary end-point was overall survival (OS).
RESULTS: In this prematurely closed study, 106 patients with a median age of 75years (range, 70-92) were enrolled (DG: n=54; G: n=52); 77 (73%) had stage IV disease and 18 (17%) a PS of 2. There was no difference in terms of median OS (14.6 vs 12.2months; p=0.121), progression-free survival (PFS) (3.4 vs 2.6months; p=0.757) and overall response rate (26.0% vs 15.4%; p=0.233) between DG and G arm, respectively. Patients with an Instrumental Activities of Daily Living (IADL) score<7 had significantly lower median OS (7.6 vs 15.4months; p=0.002) and median PFS (1.7 vs 4.4months; p=0.009) than patients with higher IADL score. The regimens were well tolerated with no significant difference in severe toxicity.
CONCLUSION: DG and G demonstrated comparable efficacy in elderly patients with NSCLC and high IADL score was correlated with superior clinical outcome.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:8 |
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| Enthalten in: |
Journal of geriatric oncology - 8(2017), 1 vom: 28. Jan., Seite 23-30 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Karampeazis, Athanasios [VerfasserIn] |
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| Links: |
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| Themen: |
0W860991D6 |
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| Anmerkungen: |
Date Completed 06.12.2017 Date Revised 07.12.2022 published: Print-Electronic ClinicalTrials.gov: NCT00442026 Citation Status MEDLINE |
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| doi: |
10.1016/j.jgo.2016.05.002 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM261078038 |
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| 100 | 1 | |a Karampeazis, Athanasios |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Docetaxel plus gemcitabine versus gemcitabine in elderly patients with advanced non-small cell lung cancer and use of a geriatric assessment |b Lessons from a prematurely closed Hellenic Oncology Research Group randomized phase III study |
| 264 | 1 | |c 2017 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 06.12.2017 | ||
| 500 | |a Date Revised 07.12.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00442026 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2016 Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVES: To compare first-line treatment with docetaxel plus gemcitabine (DG) versus gemcitabine (G) in elderly patients with advanced/metastatic non-small-cell lung cancer (NSCLC) | ||
| 520 | |a PATIENTS AND METHODS: Chemotherapy-naïve patients with inoperable stage IIIB/IV NSCLC, ≥70years, with an ECOG performance status (PS) of 0-2 were enrolled. Patients were stratified by PS and disease stage and randomized to either DG (docetaxel 30mg/m2 plus gemcitabine 900mg/m2 i.v.) or G (gemcitabine 1200mg/m2 i.v.) on days 1 and 8, every 3weeks. The study's primary end-point was overall survival (OS) | ||
| 520 | |a RESULTS: In this prematurely closed study, 106 patients with a median age of 75years (range, 70-92) were enrolled (DG: n=54; G: n=52); 77 (73%) had stage IV disease and 18 (17%) a PS of 2. There was no difference in terms of median OS (14.6 vs 12.2months; p=0.121), progression-free survival (PFS) (3.4 vs 2.6months; p=0.757) and overall response rate (26.0% vs 15.4%; p=0.233) between DG and G arm, respectively. Patients with an Instrumental Activities of Daily Living (IADL) score<7 had significantly lower median OS (7.6 vs 15.4months; p=0.002) and median PFS (1.7 vs 4.4months; p=0.009) than patients with higher IADL score. The regimens were well tolerated with no significant difference in severe toxicity | ||
| 520 | |a CONCLUSION: DG and G demonstrated comparable efficacy in elderly patients with NSCLC and high IADL score was correlated with superior clinical outcome | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Docetaxel | |
| 650 | 4 | |a Elderly patients | |
| 650 | 4 | |a Gemcitabine | |
| 650 | 4 | |a NSCLC | |
| 650 | 7 | |a Antimetabolites, Antineoplastic |2 NLM | |
| 650 | 7 | |a Taxoids |2 NLM | |
| 650 | 7 | |a Deoxycytidine |2 NLM | |
| 650 | 7 | |a 0W860991D6 |2 NLM | |
| 650 | 7 | |a Docetaxel |2 NLM | |
| 650 | 7 | |a 15H5577CQD |2 NLM | |
| 650 | 7 | |a Gemcitabine |2 NLM | |
| 700 | 1 | |a Vamvakas, Lambros |e verfasserin |4 aut | |
| 700 | 1 | |a Kotsakis, Athanasios |e verfasserin |4 aut | |
| 700 | 1 | |a Christophyllakis, Charalambos |e verfasserin |4 aut | |
| 700 | 1 | |a Kentepozidis, Nikolaos |e verfasserin |4 aut | |
| 700 | 1 | |a Chandrinos, Vassilios |e verfasserin |4 aut | |
| 700 | 1 | |a Agelidou, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Polyzos, Aris |e verfasserin |4 aut | |
| 700 | 1 | |a Tsiafaki, Xanthi |e verfasserin |4 aut | |
| 700 | 1 | |a Hatzidaki, Dora |e verfasserin |4 aut | |
| 700 | 1 | |a Georgoulias, Vassilis |e verfasserin |4 aut | |
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| 773 | 1 | 8 | |g volume:8 |g year:2017 |g number:1 |g day:28 |g month:01 |g pages:23-30 |
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