Abstract
BACKGROUND: This phase II study (S0027) evaluated the efficacy and tolerability of planned sequential single-agent chemotherapy with vinorelbine followed by docetaxel in patients with advanced non-small cell lung cancer (NSCLC) age 70 and older and/or a performance status (PS) of 2. METHODS: Patients with stage IIIB (pleural effusion) or stage IV NSCLC, age 70 and older with a PS of 0-1 or 2, any age, received three cycles of vinorelbine 25 mg/m days 1 and 8 every 21 days followed by three cycles of docetaxel 35 mg/m days 1, 8, and 15 every 28 days. RESULTS: A total of 125 patients entered the study; 117 patients were assessable for response, survival, and toxicity. Seventy-five patients were in stratum1 (age 70 and older, PS 0-1) and 42 patients in stratum 2 (PS 2, any age). Objective response was 19% (95% confidence interval [CI]: 11%-30%) and 11% (95% CI: 3%-25%) in strata 1 and 2, respectively. Median survival was 9.1 months (95% CI: 7.1-12.7) and 5.5 months (95% CI: 3.1-6.5) in strata 1 and 2, respectively. Survival at 12 months was 41% and 13% in strata 1 and 2, respectively. Grade 3/4 neutropenia was seen in 32% and 31% of patients in strata 1 and 2, respectively. Three deaths probably related to treatment were noted: one in stratum 1 and two in stratum 2. CONCLUSION: Sequential vinorelbine and docetaxel is a well-tolerated and effective regimen in comparison with reports of other treatments tested in patients with advanced NSCLC age 70 and older and/or with a PS of 2.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 537-544 |
| Number of pages | 8 |
| Journal | Journal of Thoracic Oncology |
| Volume | 1 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jul 2006 |
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Keywords
- Chemotherapy
- Elderly
- Lung cancer
- Performance status 2
- Phase II clinical trial
ASJC Scopus subject areas
- Oncology
- Pulmonary and Respiratory Medicine
- Medicine(all)
Cite this
Sequential vinorelbine and docetaxel in advanced non-small cell lung cancer patients age 70 and older and/or with a performance status of 2 : A phase II trial of the Southwest Oncology Group (S0027). / Hesketh, Paul J.; Chansky, Kari; Lau, Derick H; Doroshow, James H.; Moinpour, Carol M.; Chapman, Robert A.; Goodwin, J. Wendall; Gross, Howard M.; Crowley, John J.; Gandara, David R.
In: Journal of Thoracic Oncology, Vol. 1, No. 6, 07.2006, p. 537-544.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Sequential vinorelbine and docetaxel in advanced non-small cell lung cancer patients age 70 and older and/or with a performance status of 2
T2 - A phase II trial of the Southwest Oncology Group (S0027)
AU - Hesketh, Paul J.
AU - Chansky, Kari
AU - Lau, Derick H
AU - Doroshow, James H.
AU - Moinpour, Carol M.
AU - Chapman, Robert A.
AU - Goodwin, J. Wendall
AU - Gross, Howard M.
AU - Crowley, John J.
AU - Gandara, David R
PY - 2006/7
Y1 - 2006/7
N2 - BACKGROUND: This phase II study (S0027) evaluated the efficacy and tolerability of planned sequential single-agent chemotherapy with vinorelbine followed by docetaxel in patients with advanced non-small cell lung cancer (NSCLC) age 70 and older and/or a performance status (PS) of 2. METHODS: Patients with stage IIIB (pleural effusion) or stage IV NSCLC, age 70 and older with a PS of 0-1 or 2, any age, received three cycles of vinorelbine 25 mg/m days 1 and 8 every 21 days followed by three cycles of docetaxel 35 mg/m days 1, 8, and 15 every 28 days. RESULTS: A total of 125 patients entered the study; 117 patients were assessable for response, survival, and toxicity. Seventy-five patients were in stratum1 (age 70 and older, PS 0-1) and 42 patients in stratum 2 (PS 2, any age). Objective response was 19% (95% confidence interval [CI]: 11%-30%) and 11% (95% CI: 3%-25%) in strata 1 and 2, respectively. Median survival was 9.1 months (95% CI: 7.1-12.7) and 5.5 months (95% CI: 3.1-6.5) in strata 1 and 2, respectively. Survival at 12 months was 41% and 13% in strata 1 and 2, respectively. Grade 3/4 neutropenia was seen in 32% and 31% of patients in strata 1 and 2, respectively. Three deaths probably related to treatment were noted: one in stratum 1 and two in stratum 2. CONCLUSION: Sequential vinorelbine and docetaxel is a well-tolerated and effective regimen in comparison with reports of other treatments tested in patients with advanced NSCLC age 70 and older and/or with a PS of 2.
AB - BACKGROUND: This phase II study (S0027) evaluated the efficacy and tolerability of planned sequential single-agent chemotherapy with vinorelbine followed by docetaxel in patients with advanced non-small cell lung cancer (NSCLC) age 70 and older and/or a performance status (PS) of 2. METHODS: Patients with stage IIIB (pleural effusion) or stage IV NSCLC, age 70 and older with a PS of 0-1 or 2, any age, received three cycles of vinorelbine 25 mg/m days 1 and 8 every 21 days followed by three cycles of docetaxel 35 mg/m days 1, 8, and 15 every 28 days. RESULTS: A total of 125 patients entered the study; 117 patients were assessable for response, survival, and toxicity. Seventy-five patients were in stratum1 (age 70 and older, PS 0-1) and 42 patients in stratum 2 (PS 2, any age). Objective response was 19% (95% confidence interval [CI]: 11%-30%) and 11% (95% CI: 3%-25%) in strata 1 and 2, respectively. Median survival was 9.1 months (95% CI: 7.1-12.7) and 5.5 months (95% CI: 3.1-6.5) in strata 1 and 2, respectively. Survival at 12 months was 41% and 13% in strata 1 and 2, respectively. Grade 3/4 neutropenia was seen in 32% and 31% of patients in strata 1 and 2, respectively. Three deaths probably related to treatment were noted: one in stratum 1 and two in stratum 2. CONCLUSION: Sequential vinorelbine and docetaxel is a well-tolerated and effective regimen in comparison with reports of other treatments tested in patients with advanced NSCLC age 70 and older and/or with a PS of 2.
KW - Chemotherapy
KW - Elderly
KW - Lung cancer
KW - Performance status 2
KW - Phase II clinical trial
UR - http://www.scopus.com/inward/record.url?scp=34247871475&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34247871475&partnerID=8YFLogxK
U2 - 10.1097/01243894-200607000-00007
DO - 10.1097/01243894-200607000-00007
M3 - Article
C2 - 17409914
AN - SCOPUS:34247871475
VL - 1
SP - 537
EP - 544
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
SN - 1556-0864
IS - 6
ER -