Phase II study of pemetrexed-gemcitabine combination in patients with advanced-stage non-small cell lung cancer

Christian Monnerat, Thierry Le Chevalier, Karen Kelly, Coleman K. Obasaju, Julie Brahmer, Silvia Novello, Takashi Nakamura, Astra M. Liepa, Laurence Bozec, Paul A. Bunn, David S. Ettinger

Research output: Contribution to journalArticle

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Abstract

Purpose: Cisplatin is one of the most active agents for the treatment of non-small cell lung cancer (NSCLC). It is also known for significant toxicity, which makes it unsuitable for certain patients. Our purpose was to evaluate the efficacy and toxicity of a promising cisplatin-free combination, gemcitabine plus pemetrexed, in NSCLC. Experimental Design: Chemo-naive patients with inoperable NSCLC were eligible for this study. Gemcitabine (1250 mg/m 2) was given intravenously on days 1 and 8, followed by intravenous pemetrexed (500 mg/m2) on day 8. After inclusion of 13 patients, folic acid and vitamin B12 supplementation was added to lower pemetrexed-induced toxicity. Quality of life was assessed with the Lung Cancer Symptom Scale. Results: Sixty patients enrolled; 58 were evaluable for response. All patients had a World Health Organization performance status of 0 or 1. Eighty-seven percent had stage IV disease. Nine patients had a confirmed partial response [overall response rate, 15.5%; 95% confidence interval (CI), 7.3-27.4%]. Twenty-nine (50.0%) patients had stable disease. Median overall survival was 10.1 months (95% CI, 7.9-13.0 months), with a 1- and 2-year overall survival of 42.6% (95% CI, 30.0-55.3%) and 18.5% (95% CI, 7.9-29.1%). Median progression-free survival was 5.0 months. Median response duration was 3.3 months. There were no deaths attributed to treatment. Common Toxicity Criteria grade 3/4 toxicities were neutropenia (61.7%), febrile neutropenia (16.7%), fatigue (23.3%), and elevations of aspartate aminotransferase (15.0%) and alanine aminotransferase (20.0%). Conclusions: This combination had good tolerance and achieved promising overall survival with extended 1- and 2-year survival rates. This cisplatin-free regimen warrants further evaluation in randomized trials.

Original languageEnglish (US)
Pages (from-to)5439-5446
Number of pages8
JournalClinical Cancer Research
Volume10
Issue number16
DOIs
StatePublished - Aug 15 2004
Externally publishedYes

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gemcitabine
Pemetrexed
Non-Small Cell Lung Carcinoma
Confidence Intervals
Cisplatin
Survival
Febrile Neutropenia
Vitamin B 12
Aspartate Aminotransferases
Neutropenia
Alanine Transaminase
Folic Acid
Disease-Free Survival
Fatigue
Lung Neoplasms
Research Design
Survival Rate
Quality of Life

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II study of pemetrexed-gemcitabine combination in patients with advanced-stage non-small cell lung cancer. / Monnerat, Christian; Le Chevalier, Thierry; Kelly, Karen; Obasaju, Coleman K.; Brahmer, Julie; Novello, Silvia; Nakamura, Takashi; Liepa, Astra M.; Bozec, Laurence; Bunn, Paul A.; Ettinger, David S.

In: Clinical Cancer Research, Vol. 10, No. 16, 15.08.2004, p. 5439-5446.

Research output: Contribution to journalArticle

Monnerat, C, Le Chevalier, T, Kelly, K, Obasaju, CK, Brahmer, J, Novello, S, Nakamura, T, Liepa, AM, Bozec, L, Bunn, PA & Ettinger, DS 2004, 'Phase II study of pemetrexed-gemcitabine combination in patients with advanced-stage non-small cell lung cancer', Clinical Cancer Research, vol. 10, no. 16, pp. 5439-5446. https://doi.org/10.1158/1078-0432.CCR-04-0218
Monnerat, Christian ; Le Chevalier, Thierry ; Kelly, Karen ; Obasaju, Coleman K. ; Brahmer, Julie ; Novello, Silvia ; Nakamura, Takashi ; Liepa, Astra M. ; Bozec, Laurence ; Bunn, Paul A. ; Ettinger, David S. / Phase II study of pemetrexed-gemcitabine combination in patients with advanced-stage non-small cell lung cancer. In: Clinical Cancer Research. 2004 ; Vol. 10, No. 16. pp. 5439-5446.
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abstract = "Purpose: Cisplatin is one of the most active agents for the treatment of non-small cell lung cancer (NSCLC). It is also known for significant toxicity, which makes it unsuitable for certain patients. Our purpose was to evaluate the efficacy and toxicity of a promising cisplatin-free combination, gemcitabine plus pemetrexed, in NSCLC. Experimental Design: Chemo-naive patients with inoperable NSCLC were eligible for this study. Gemcitabine (1250 mg/m 2) was given intravenously on days 1 and 8, followed by intravenous pemetrexed (500 mg/m2) on day 8. After inclusion of 13 patients, folic acid and vitamin B12 supplementation was added to lower pemetrexed-induced toxicity. Quality of life was assessed with the Lung Cancer Symptom Scale. Results: Sixty patients enrolled; 58 were evaluable for response. All patients had a World Health Organization performance status of 0 or 1. Eighty-seven percent had stage IV disease. Nine patients had a confirmed partial response [overall response rate, 15.5{\%}; 95{\%} confidence interval (CI), 7.3-27.4{\%}]. Twenty-nine (50.0{\%}) patients had stable disease. Median overall survival was 10.1 months (95{\%} CI, 7.9-13.0 months), with a 1- and 2-year overall survival of 42.6{\%} (95{\%} CI, 30.0-55.3{\%}) and 18.5{\%} (95{\%} CI, 7.9-29.1{\%}). Median progression-free survival was 5.0 months. Median response duration was 3.3 months. There were no deaths attributed to treatment. Common Toxicity Criteria grade 3/4 toxicities were neutropenia (61.7{\%}), febrile neutropenia (16.7{\%}), fatigue (23.3{\%}), and elevations of aspartate aminotransferase (15.0{\%}) and alanine aminotransferase (20.0{\%}). Conclusions: This combination had good tolerance and achieved promising overall survival with extended 1- and 2-year survival rates. This cisplatin-free regimen warrants further evaluation in randomized trials.",
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AU - Monnerat, Christian

AU - Le Chevalier, Thierry

AU - Kelly, Karen

AU - Obasaju, Coleman K.

AU - Brahmer, Julie

AU - Novello, Silvia

AU - Nakamura, Takashi

AU - Liepa, Astra M.

AU - Bozec, Laurence

AU - Bunn, Paul A.

AU - Ettinger, David S.

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N2 - Purpose: Cisplatin is one of the most active agents for the treatment of non-small cell lung cancer (NSCLC). It is also known for significant toxicity, which makes it unsuitable for certain patients. Our purpose was to evaluate the efficacy and toxicity of a promising cisplatin-free combination, gemcitabine plus pemetrexed, in NSCLC. Experimental Design: Chemo-naive patients with inoperable NSCLC were eligible for this study. Gemcitabine (1250 mg/m 2) was given intravenously on days 1 and 8, followed by intravenous pemetrexed (500 mg/m2) on day 8. After inclusion of 13 patients, folic acid and vitamin B12 supplementation was added to lower pemetrexed-induced toxicity. Quality of life was assessed with the Lung Cancer Symptom Scale. Results: Sixty patients enrolled; 58 were evaluable for response. All patients had a World Health Organization performance status of 0 or 1. Eighty-seven percent had stage IV disease. Nine patients had a confirmed partial response [overall response rate, 15.5%; 95% confidence interval (CI), 7.3-27.4%]. Twenty-nine (50.0%) patients had stable disease. Median overall survival was 10.1 months (95% CI, 7.9-13.0 months), with a 1- and 2-year overall survival of 42.6% (95% CI, 30.0-55.3%) and 18.5% (95% CI, 7.9-29.1%). Median progression-free survival was 5.0 months. Median response duration was 3.3 months. There were no deaths attributed to treatment. Common Toxicity Criteria grade 3/4 toxicities were neutropenia (61.7%), febrile neutropenia (16.7%), fatigue (23.3%), and elevations of aspartate aminotransferase (15.0%) and alanine aminotransferase (20.0%). Conclusions: This combination had good tolerance and achieved promising overall survival with extended 1- and 2-year survival rates. This cisplatin-free regimen warrants further evaluation in randomized trials.

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