Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer

A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study

Mary M. Huerter, Jane L Meza, M. Sitki Copur, Addison Tolentino, Alissa S Marr, Marsha Ketcham, Holly DeSpiegelaere, Susan Kruse, Mary E. Kos, Karin Swenson, Sarah E. Radniecki, Anne Kessinger, Apar Kishor P Ganti

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective: Platinum-based doublet chemotherapy is the standard for most patients with advanced non-small cell lung cancer (NSCLC). Toxicity concerns limit chemotherapy for patients over 70. years. Vinorelbine and paclitaxel are effective as single agents in advanced NSCLC. This phase II study evaluates safety and efficacy of a combination of these two agents in patients > 70. years with advanced NSCLC. Materials and Methods: Patients with treatment naïve metastatic NSCLC received two cycles comprising 6 weekly doses of vinorelbine and paclitaxel, with restaging scans at week 8. Patients with radiographic progression came off study. The estimated sample size was 29. Toxicity analyses were conducted after 10 patients and again after 19 patients were enrolled. Outcomes were safety and efficacy, progression free (PFS) and overall survival (OS) and quality of life (QOL). Results: The study closed at second interim analysis as 6/19 patients had ≥. grade 4 non-hematologic toxicity (respiratory failure, sepsis, ischemic encephalopathy, pneumonia, hypoxemia, cardiopulmonary arrest, neutropenic fever, death). Of the 16 evaluable patients, 7 completed the study. Disease control rate (partial response + stable disease) was 47% (n = 9); 37% (n = 7) progressed. No complete responses were seen. Median PFS was 3.5. months (95% CI: 1.4, 5.5) and OS 7.8. months (95% CI: 1.9, 13.6). QOL did not change compared to baseline, at week 9, but increased at week 17. Conclusions: Although the combination met its response end points, increased toxicity makes this combination unsuitable for older patients. While QOL improved over the study, the small sample hinders interpretation.

Original languageEnglish (US)
JournalJournal of Geriatric Oncology
DOIs
StateAccepted/In press - Dec 3 2015

Fingerprint

Paclitaxel
Non-Small Cell Lung Carcinoma
Clinical Trials
Neoplasms
Quality of Life
Safety
vinorelbine
Drug Therapy
Survival
Proxy
Heart Arrest
Platinum
Brain Ischemia
Respiratory Insufficiency
Sample Size
Sepsis
Pneumonia
Fever

Keywords

  • Advanced non-small cell lung cancer
  • Geriatric oncology
  • Paclitaxel
  • Quality of life
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Geriatrics and Gerontology

Cite this

Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer : A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study. / Huerter, Mary M.; Meza, Jane L; Copur, M. Sitki; Tolentino, Addison; Marr, Alissa S; Ketcham, Marsha; DeSpiegelaere, Holly; Kruse, Susan; Kos, Mary E.; Swenson, Karin; Radniecki, Sarah E.; Kessinger, Anne; Ganti, Apar Kishor P.

In: Journal of Geriatric Oncology, 03.12.2015.

Research output: Contribution to journalArticle

Huerter, Mary M. ; Meza, Jane L ; Copur, M. Sitki ; Tolentino, Addison ; Marr, Alissa S ; Ketcham, Marsha ; DeSpiegelaere, Holly ; Kruse, Susan ; Kos, Mary E. ; Swenson, Karin ; Radniecki, Sarah E. ; Kessinger, Anne ; Ganti, Apar Kishor P. / Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer : A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study. In: Journal of Geriatric Oncology. 2015.
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abstract = "Objective: Platinum-based doublet chemotherapy is the standard for most patients with advanced non-small cell lung cancer (NSCLC). Toxicity concerns limit chemotherapy for patients over 70. years. Vinorelbine and paclitaxel are effective as single agents in advanced NSCLC. This phase II study evaluates safety and efficacy of a combination of these two agents in patients > 70. years with advanced NSCLC. Materials and Methods: Patients with treatment na{\"i}ve metastatic NSCLC received two cycles comprising 6 weekly doses of vinorelbine and paclitaxel, with restaging scans at week 8. Patients with radiographic progression came off study. The estimated sample size was 29. Toxicity analyses were conducted after 10 patients and again after 19 patients were enrolled. Outcomes were safety and efficacy, progression free (PFS) and overall survival (OS) and quality of life (QOL). Results: The study closed at second interim analysis as 6/19 patients had ≥. grade 4 non-hematologic toxicity (respiratory failure, sepsis, ischemic encephalopathy, pneumonia, hypoxemia, cardiopulmonary arrest, neutropenic fever, death). Of the 16 evaluable patients, 7 completed the study. Disease control rate (partial response + stable disease) was 47{\%} (n = 9); 37{\%} (n = 7) progressed. No complete responses were seen. Median PFS was 3.5. months (95{\%} CI: 1.4, 5.5) and OS 7.8. months (95{\%} CI: 1.9, 13.6). QOL did not change compared to baseline, at week 9, but increased at week 17. Conclusions: Although the combination met its response end points, increased toxicity makes this combination unsuitable for older patients. While QOL improved over the study, the small sample hinders interpretation.",
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T1 - Weekly vinorelbine and paclitaxel in older patients with advanced non-small cell lung cancer

T2 - A phase II Fred and Pamela Buffet Cancer Center Clinical Trials Network study

AU - Huerter, Mary M.

AU - Meza, Jane L

AU - Copur, M. Sitki

AU - Tolentino, Addison

AU - Marr, Alissa S

AU - Ketcham, Marsha

AU - DeSpiegelaere, Holly

AU - Kruse, Susan

AU - Kos, Mary E.

AU - Swenson, Karin

AU - Radniecki, Sarah E.

AU - Kessinger, Anne

AU - Ganti, Apar Kishor P

PY - 2015/12/3

Y1 - 2015/12/3

N2 - Objective: Platinum-based doublet chemotherapy is the standard for most patients with advanced non-small cell lung cancer (NSCLC). Toxicity concerns limit chemotherapy for patients over 70. years. Vinorelbine and paclitaxel are effective as single agents in advanced NSCLC. This phase II study evaluates safety and efficacy of a combination of these two agents in patients > 70. years with advanced NSCLC. Materials and Methods: Patients with treatment naïve metastatic NSCLC received two cycles comprising 6 weekly doses of vinorelbine and paclitaxel, with restaging scans at week 8. Patients with radiographic progression came off study. The estimated sample size was 29. Toxicity analyses were conducted after 10 patients and again after 19 patients were enrolled. Outcomes were safety and efficacy, progression free (PFS) and overall survival (OS) and quality of life (QOL). Results: The study closed at second interim analysis as 6/19 patients had ≥. grade 4 non-hematologic toxicity (respiratory failure, sepsis, ischemic encephalopathy, pneumonia, hypoxemia, cardiopulmonary arrest, neutropenic fever, death). Of the 16 evaluable patients, 7 completed the study. Disease control rate (partial response + stable disease) was 47% (n = 9); 37% (n = 7) progressed. No complete responses were seen. Median PFS was 3.5. months (95% CI: 1.4, 5.5) and OS 7.8. months (95% CI: 1.9, 13.6). QOL did not change compared to baseline, at week 9, but increased at week 17. Conclusions: Although the combination met its response end points, increased toxicity makes this combination unsuitable for older patients. While QOL improved over the study, the small sample hinders interpretation.

AB - Objective: Platinum-based doublet chemotherapy is the standard for most patients with advanced non-small cell lung cancer (NSCLC). Toxicity concerns limit chemotherapy for patients over 70. years. Vinorelbine and paclitaxel are effective as single agents in advanced NSCLC. This phase II study evaluates safety and efficacy of a combination of these two agents in patients > 70. years with advanced NSCLC. Materials and Methods: Patients with treatment naïve metastatic NSCLC received two cycles comprising 6 weekly doses of vinorelbine and paclitaxel, with restaging scans at week 8. Patients with radiographic progression came off study. The estimated sample size was 29. Toxicity analyses were conducted after 10 patients and again after 19 patients were enrolled. Outcomes were safety and efficacy, progression free (PFS) and overall survival (OS) and quality of life (QOL). Results: The study closed at second interim analysis as 6/19 patients had ≥. grade 4 non-hematologic toxicity (respiratory failure, sepsis, ischemic encephalopathy, pneumonia, hypoxemia, cardiopulmonary arrest, neutropenic fever, death). Of the 16 evaluable patients, 7 completed the study. Disease control rate (partial response + stable disease) was 47% (n = 9); 37% (n = 7) progressed. No complete responses were seen. Median PFS was 3.5. months (95% CI: 1.4, 5.5) and OS 7.8. months (95% CI: 1.9, 13.6). QOL did not change compared to baseline, at week 9, but increased at week 17. Conclusions: Although the combination met its response end points, increased toxicity makes this combination unsuitable for older patients. While QOL improved over the study, the small sample hinders interpretation.

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KW - Geriatric oncology

KW - Paclitaxel

KW - Quality of life

KW - Vinorelbine

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