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)

Paul J. Hesketh, Kari Chansky, Derick H Lau, James H. Doroshow, Carol M. Moinpour, Robert A. Chapman, J. Wendall Goodwin, Howard M. Gross, John J. Crowley, David R Gandara

Research output: Contribution to journalArticle

25 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)537-544
Number of pages8
JournalJournal of Thoracic Oncology
Volume1
Issue number6
DOIs
StatePublished - Jul 2006

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docetaxel
Non-Small Cell Lung Carcinoma
Confidence Intervals
Survival
vinorelbine
Pleural Effusion
Neutropenia

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 journalArticle

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. / 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). In: Journal of Thoracic Oncology. 2006 ; Vol. 1, No. 6. pp. 537-544.
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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.",
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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

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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

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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.

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