Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy

Nasser Hanna, Frances A. Shepherd, Frank V. Fossella, Jose R. Pereira, Filippo Demarinis, Joachim Von Pawel, Ulrich Gatzemeier, Thomas Chang Yao Tsao, Miklos Pless, Thomas Muller, Hong Liang Lim, Christopher Desch, Klara Szondy, Radj Gervais, Shaharyar, Christian Manegold, Sofia Paul, Paolo Paoletti, Lawrence Einhorn, Paul A. Bunn

Research output: Contribution to journalArticle

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Abstract

Purpose: To compare the efficacy and toxicity of pemetrexed versus docetaxel in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy. Patients and Methods: Eligible patients had a performance status 0 to 2, previous treatment with one prior chemotherapy regimen for advanced NSCLC, and adequate organ function. Patients received pemetrexed 500 mg/m2 intravenously (IV) day 1 with vitamin B 12, folic acid, and dexamethasone or docetaxel 75 mg/m2 IV day 1 with dexamethasone every 21 days. The primary end point was overall survival. Results: Five hundred seventy-one patients were randomly assigned. Overall response rates were 9.1% and 8.8% (analysis of variance P = .105) for pemetrexed and docetaxel, respectively. Median progression-free survival was 2.9 months for each arm, and median survival time was 8.3 versus 7.9 months (P = not significant) for pemetrexed and docetaxel, respectively. The 1-year survival rate for each arm was 29.7%. Patients receiving docetaxel were more likely to have grade 3 or 4 neutropenia (40.2% v 5.3%; P < .001), febrile neutropenia (12.7% v 1.9%; P < .001), neutropenia with infections (3.3% v 0.0%; P = .004), hospitalizations for neutropenic fever (13.4% v 1.5%; P < .001), hospitalizations due to other drug related adverse events (10.5% v 6.4%; P = .092), use of granulocyte colony-stimulating factor support (19.2% v 2.6%, P < .001) and all grade alopecia (37.7% v 6.4%; P < .001) compared with patients receiving pemetrexed. Conclusion: Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel in the second-line treatment of patients with advanced NSCLC and should be considered a standard treatment option for second-line NSCLC when available.

Original languageEnglish
Pages (from-to)1589-1597
Number of pages9
JournalJournal of Clinical Oncology
Volume22
Issue number9
DOIs
StatePublished - 2004

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docetaxel
Pemetrexed
Non-Small Cell Lung Carcinoma
Drug Therapy
Neutropenia
Dexamethasone
Hospitalization
Febrile Neutropenia
Survival
Alopecia
Granulocyte Colony-Stimulating Factor
Therapeutics
Vitamin B 12
Drug-Related Side Effects and Adverse Reactions
Folic Acid
Disease-Free Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. / Hanna, Nasser; Shepherd, Frances A.; Fossella, Frank V.; Pereira, Jose R.; Demarinis, Filippo; Von Pawel, Joachim; Gatzemeier, Ulrich; Tsao, Thomas Chang Yao; Pless, Miklos; Muller, Thomas; Lim, Hong Liang; Desch, Christopher; Szondy, Klara; Gervais, Radj; Shaharyar; Manegold, Christian; Paul, Sofia; Paoletti, Paolo; Einhorn, Lawrence; Bunn, Paul A.

In: Journal of Clinical Oncology, Vol. 22, No. 9, 2004, p. 1589-1597.

Research output: Contribution to journalArticle

Hanna, N, Shepherd, FA, Fossella, FV, Pereira, JR, Demarinis, F, Von Pawel, J, Gatzemeier, U, Tsao, TCY, Pless, M, Muller, T, Lim, HL, Desch, C, Szondy, K, Gervais, R, Shaharyar, Manegold, C, Paul, S, Paoletti, P, Einhorn, L & Bunn, PA 2004, 'Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy', Journal of Clinical Oncology, vol. 22, no. 9, pp. 1589-1597. https://doi.org/10.1200/JCO.2004.08.163
Hanna, Nasser ; Shepherd, Frances A. ; Fossella, Frank V. ; Pereira, Jose R. ; Demarinis, Filippo ; Von Pawel, Joachim ; Gatzemeier, Ulrich ; Tsao, Thomas Chang Yao ; Pless, Miklos ; Muller, Thomas ; Lim, Hong Liang ; Desch, Christopher ; Szondy, Klara ; Gervais, Radj ; Shaharyar ; Manegold, Christian ; Paul, Sofia ; Paoletti, Paolo ; Einhorn, Lawrence ; Bunn, Paul A. / Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. In: Journal of Clinical Oncology. 2004 ; Vol. 22, No. 9. pp. 1589-1597.
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T1 - Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy

AU - Hanna, Nasser

AU - Shepherd, Frances A.

AU - Fossella, Frank V.

AU - Pereira, Jose R.

AU - Demarinis, Filippo

AU - Von Pawel, Joachim

AU - Gatzemeier, Ulrich

AU - Tsao, Thomas Chang Yao

AU - Pless, Miklos

AU - Muller, Thomas

AU - Lim, Hong Liang

AU - Desch, Christopher

AU - Szondy, Klara

AU - Gervais, Radj

AU - Shaharyar,

AU - Manegold, Christian

AU - Paul, Sofia

AU - Paoletti, Paolo

AU - Einhorn, Lawrence

AU - Bunn, Paul A.

PY - 2004

Y1 - 2004

N2 - Purpose: To compare the efficacy and toxicity of pemetrexed versus docetaxel in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy. Patients and Methods: Eligible patients had a performance status 0 to 2, previous treatment with one prior chemotherapy regimen for advanced NSCLC, and adequate organ function. Patients received pemetrexed 500 mg/m2 intravenously (IV) day 1 with vitamin B 12, folic acid, and dexamethasone or docetaxel 75 mg/m2 IV day 1 with dexamethasone every 21 days. The primary end point was overall survival. Results: Five hundred seventy-one patients were randomly assigned. Overall response rates were 9.1% and 8.8% (analysis of variance P = .105) for pemetrexed and docetaxel, respectively. Median progression-free survival was 2.9 months for each arm, and median survival time was 8.3 versus 7.9 months (P = not significant) for pemetrexed and docetaxel, respectively. The 1-year survival rate for each arm was 29.7%. Patients receiving docetaxel were more likely to have grade 3 or 4 neutropenia (40.2% v 5.3%; P < .001), febrile neutropenia (12.7% v 1.9%; P < .001), neutropenia with infections (3.3% v 0.0%; P = .004), hospitalizations for neutropenic fever (13.4% v 1.5%; P < .001), hospitalizations due to other drug related adverse events (10.5% v 6.4%; P = .092), use of granulocyte colony-stimulating factor support (19.2% v 2.6%, P < .001) and all grade alopecia (37.7% v 6.4%; P < .001) compared with patients receiving pemetrexed. Conclusion: Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel in the second-line treatment of patients with advanced NSCLC and should be considered a standard treatment option for second-line NSCLC when available.

AB - Purpose: To compare the efficacy and toxicity of pemetrexed versus docetaxel in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy. Patients and Methods: Eligible patients had a performance status 0 to 2, previous treatment with one prior chemotherapy regimen for advanced NSCLC, and adequate organ function. Patients received pemetrexed 500 mg/m2 intravenously (IV) day 1 with vitamin B 12, folic acid, and dexamethasone or docetaxel 75 mg/m2 IV day 1 with dexamethasone every 21 days. The primary end point was overall survival. Results: Five hundred seventy-one patients were randomly assigned. Overall response rates were 9.1% and 8.8% (analysis of variance P = .105) for pemetrexed and docetaxel, respectively. Median progression-free survival was 2.9 months for each arm, and median survival time was 8.3 versus 7.9 months (P = not significant) for pemetrexed and docetaxel, respectively. The 1-year survival rate for each arm was 29.7%. Patients receiving docetaxel were more likely to have grade 3 or 4 neutropenia (40.2% v 5.3%; P < .001), febrile neutropenia (12.7% v 1.9%; P < .001), neutropenia with infections (3.3% v 0.0%; P = .004), hospitalizations for neutropenic fever (13.4% v 1.5%; P < .001), hospitalizations due to other drug related adverse events (10.5% v 6.4%; P = .092), use of granulocyte colony-stimulating factor support (19.2% v 2.6%, P < .001) and all grade alopecia (37.7% v 6.4%; P < .001) compared with patients receiving pemetrexed. Conclusion: Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel in the second-line treatment of patients with advanced NSCLC and should be considered a standard treatment option for second-line NSCLC when available.

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