Oral versus intravenous administration of vinorelbine as a single agent for the first-line treatment of metastatic nonsmall cell lung carcinoma (NSCLC): A randomized phase II trial

Vera Hirsh, Pierre Desjardins, Burton M. Needles, James R. Rigas, Mohammad Jahanzeb, Laurent Nguyen, Denise Zembryki, Lance H. Leopold

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

OBJECTIVES: Many patients with metastatic nonsmall cell lung carcinoma (NSCLC) cannot tolerate intravenous chemotherapy. Orally active agents would be more convenient and thus could improve their quality of life. METHODS: A total of 189 patients were randomized 2:1, 181 patients received treatment, 120 PO and 61 IV vinorelbine, 158 patients had stage IV and 31 stage IIIB disease. Among patients who received PO vinorelbine, the median age was 72 years, 62% were males; the Karnofski Performance Status (KPS) was 80-100 in 71%. These compare with a median age of 70 years, 56% male, and KPS of 80-100 in 65% of patients who received IV vinorelbine. Oral vinorelbine 60 mg/m was to be dose-escalated to 70 mg/m after the initial 3-weekly doses if there was no unacceptable toxicity. Intravenous vinorelbine was to be given 30 mg/m weekly. RESULTS: Five patients (4%) on PO and 8 (13%) on IV vinorelbine had a confirmed partial response, 56 (44%) and 29 (46%) had stable disease, respectively. Median time-to-disease-progression was 16.6 weeks (PO) versus 23.9 weeks (IV), and the median survival was 26 weeks (PO) versus 40.9 weeks IV vinorelbine. Median survival on PO vinorelbine for patients with KPS 60-70 was 8.3 weeks versus 43 weeks (IV). On PO vinorelbine 59 patients (57%) were dose escalated, 9 (7.5%) were dose reduced, and 10 (8.3%) did not receive PO vinorelbine at week 4. Pharmacokinetic studies confirmed PO vinorelbine exposure was significantly less than IV exposure. CONCLUSION: The inability to escalate the dose of PO vinorelbine above 60 mg/m weekly resulted in inferiority to IV vinorelbine at 30 mg/m weekly, especially in patients with poor performance status.

Original languageEnglish
Pages (from-to)245-251
Number of pages7
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume30
Issue number3
DOIs
StatePublished - Jun 1 2007
Externally publishedYes

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Intravenous Administration
Carcinoma
Lung
Therapeutics
vinorelbine
Survival
Disease Progression
Pharmacokinetics
Quality of Life
Drug Therapy

Keywords

  • Intravenous vinorelbine
  • Nonsmall cell lung carcinoma
  • Oral vinorelbine
  • Randomized phase II study

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Oral versus intravenous administration of vinorelbine as a single agent for the first-line treatment of metastatic nonsmall cell lung carcinoma (NSCLC) : A randomized phase II trial. / Hirsh, Vera; Desjardins, Pierre; Needles, Burton M.; Rigas, James R.; Jahanzeb, Mohammad; Nguyen, Laurent; Zembryki, Denise; Leopold, Lance H.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 30, No. 3, 01.06.2007, p. 245-251.

Research output: Contribution to journalArticle

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abstract = "OBJECTIVES: Many patients with metastatic nonsmall cell lung carcinoma (NSCLC) cannot tolerate intravenous chemotherapy. Orally active agents would be more convenient and thus could improve their quality of life. METHODS: A total of 189 patients were randomized 2:1, 181 patients received treatment, 120 PO and 61 IV vinorelbine, 158 patients had stage IV and 31 stage IIIB disease. Among patients who received PO vinorelbine, the median age was 72 years, 62{\%} were males; the Karnofski Performance Status (KPS) was 80-100 in 71{\%}. These compare with a median age of 70 years, 56{\%} male, and KPS of 80-100 in 65{\%} of patients who received IV vinorelbine. Oral vinorelbine 60 mg/m was to be dose-escalated to 70 mg/m after the initial 3-weekly doses if there was no unacceptable toxicity. Intravenous vinorelbine was to be given 30 mg/m weekly. RESULTS: Five patients (4{\%}) on PO and 8 (13{\%}) on IV vinorelbine had a confirmed partial response, 56 (44{\%}) and 29 (46{\%}) had stable disease, respectively. Median time-to-disease-progression was 16.6 weeks (PO) versus 23.9 weeks (IV), and the median survival was 26 weeks (PO) versus 40.9 weeks IV vinorelbine. Median survival on PO vinorelbine for patients with KPS 60-70 was 8.3 weeks versus 43 weeks (IV). On PO vinorelbine 59 patients (57{\%}) were dose escalated, 9 (7.5{\%}) were dose reduced, and 10 (8.3{\%}) did not receive PO vinorelbine at week 4. Pharmacokinetic studies confirmed PO vinorelbine exposure was significantly less than IV exposure. CONCLUSION: The inability to escalate the dose of PO vinorelbine above 60 mg/m weekly resulted in inferiority to IV vinorelbine at 30 mg/m weekly, especially in patients with poor performance status.",
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AU - Hirsh, Vera

AU - Desjardins, Pierre

AU - Needles, Burton M.

AU - Rigas, James R.

AU - Jahanzeb, Mohammad

AU - Nguyen, Laurent

AU - Zembryki, Denise

AU - Leopold, Lance H.

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N2 - OBJECTIVES: Many patients with metastatic nonsmall cell lung carcinoma (NSCLC) cannot tolerate intravenous chemotherapy. Orally active agents would be more convenient and thus could improve their quality of life. METHODS: A total of 189 patients were randomized 2:1, 181 patients received treatment, 120 PO and 61 IV vinorelbine, 158 patients had stage IV and 31 stage IIIB disease. Among patients who received PO vinorelbine, the median age was 72 years, 62% were males; the Karnofski Performance Status (KPS) was 80-100 in 71%. These compare with a median age of 70 years, 56% male, and KPS of 80-100 in 65% of patients who received IV vinorelbine. Oral vinorelbine 60 mg/m was to be dose-escalated to 70 mg/m after the initial 3-weekly doses if there was no unacceptable toxicity. Intravenous vinorelbine was to be given 30 mg/m weekly. RESULTS: Five patients (4%) on PO and 8 (13%) on IV vinorelbine had a confirmed partial response, 56 (44%) and 29 (46%) had stable disease, respectively. Median time-to-disease-progression was 16.6 weeks (PO) versus 23.9 weeks (IV), and the median survival was 26 weeks (PO) versus 40.9 weeks IV vinorelbine. Median survival on PO vinorelbine for patients with KPS 60-70 was 8.3 weeks versus 43 weeks (IV). On PO vinorelbine 59 patients (57%) were dose escalated, 9 (7.5%) were dose reduced, and 10 (8.3%) did not receive PO vinorelbine at week 4. Pharmacokinetic studies confirmed PO vinorelbine exposure was significantly less than IV exposure. CONCLUSION: The inability to escalate the dose of PO vinorelbine above 60 mg/m weekly resulted in inferiority to IV vinorelbine at 30 mg/m weekly, especially in patients with poor performance status.

AB - OBJECTIVES: Many patients with metastatic nonsmall cell lung carcinoma (NSCLC) cannot tolerate intravenous chemotherapy. Orally active agents would be more convenient and thus could improve their quality of life. METHODS: A total of 189 patients were randomized 2:1, 181 patients received treatment, 120 PO and 61 IV vinorelbine, 158 patients had stage IV and 31 stage IIIB disease. Among patients who received PO vinorelbine, the median age was 72 years, 62% were males; the Karnofski Performance Status (KPS) was 80-100 in 71%. These compare with a median age of 70 years, 56% male, and KPS of 80-100 in 65% of patients who received IV vinorelbine. Oral vinorelbine 60 mg/m was to be dose-escalated to 70 mg/m after the initial 3-weekly doses if there was no unacceptable toxicity. Intravenous vinorelbine was to be given 30 mg/m weekly. RESULTS: Five patients (4%) on PO and 8 (13%) on IV vinorelbine had a confirmed partial response, 56 (44%) and 29 (46%) had stable disease, respectively. Median time-to-disease-progression was 16.6 weeks (PO) versus 23.9 weeks (IV), and the median survival was 26 weeks (PO) versus 40.9 weeks IV vinorelbine. Median survival on PO vinorelbine for patients with KPS 60-70 was 8.3 weeks versus 43 weeks (IV). On PO vinorelbine 59 patients (57%) were dose escalated, 9 (7.5%) were dose reduced, and 10 (8.3%) did not receive PO vinorelbine at week 4. Pharmacokinetic studies confirmed PO vinorelbine exposure was significantly less than IV exposure. CONCLUSION: The inability to escalate the dose of PO vinorelbine above 60 mg/m weekly resulted in inferiority to IV vinorelbine at 30 mg/m weekly, especially in patients with poor performance status.

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