Randomized phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with extensive-stage small-cell lung cancer: Cancer and Leukemia Group B trial 9732

Harvey B. Niell, James E. Herndon, Antonius A. Miller, Dorothy M. Watson, Alan B. Sandler, Karen Kelly, Randolph S. Marks, Micheal C. Perry, Rafat H. Ansari, Grefory Otterson, John Ellerton, Everett E. Vokes, Mark R. Green

Research output: Contribution to journalArticle

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Abstract

Purpose: To determine, in a randomized comparison, whether the addition of paclitaxel to etoposide and cisplatin improves the time to progression and overall survival in patients with extensive small-cell lung cancer (SCLC) compared with standard etoposide and cisplatin and to compare the regimens' toxicity. Patients and Methods: Eligible patients (N = 587) with untreated extensive SCLC were randomly assigned to receive either cisplatin 80 mg/m 2 on day 1 and etoposide 80 mg/m2 on days 1 through 3 administered every 3 weeks for six cycles (EP) or cisplatin 80 mg/m2 on day 1, paclitaxel 175 mg/m2 over 4 hours on day 1, and etoposide 80 mg/m2 on days 1 to 3 followed by recombinant human granulocyte colony-stimulating factor on days 4 to 18 administered every 3 weeks for six cycles (PET). Results: Reporting of demographics, response, and survival included 565 patients, of whom 282 were randomly assigned to receive EP and 283 were assigned to receive PET. Overall response rates were 68% for the EP arm and 75% for the PET arm. Median failure-free survival time was 5.9 months for the EP arm and 6 months for the PET arm (P = .179). Median overall survival time was 9.9 months for patients on EP and 10.6 months for patients on PET (P = .169). Toxic deaths occurred in 2.4% of the patients on EP and 6.5% of patients on PET. Conclusion: PET did not improve the time to progression or survival in patients with extensive SCLC compared with EP alone and was associated with unacceptable toxicity.

Original languageEnglish (US)
Pages (from-to)3752-3759
Number of pages8
JournalJournal of Clinical Oncology
Volume23
Issue number16
DOIs
StatePublished - 2005
Externally publishedYes

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Small Cell Lung Carcinoma
Granulocyte Colony-Stimulating Factor
Etoposide
Paclitaxel
Cisplatin
Leukemia
Neoplasms
Survival
Poisons
Demography

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Randomized phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with extensive-stage small-cell lung cancer : Cancer and Leukemia Group B trial 9732. / Niell, Harvey B.; Herndon, James E.; Miller, Antonius A.; Watson, Dorothy M.; Sandler, Alan B.; Kelly, Karen; Marks, Randolph S.; Perry, Micheal C.; Ansari, Rafat H.; Otterson, Grefory; Ellerton, John; Vokes, Everett E.; Green, Mark R.

In: Journal of Clinical Oncology, Vol. 23, No. 16, 2005, p. 3752-3759.

Research output: Contribution to journalArticle

Niell, Harvey B. ; Herndon, James E. ; Miller, Antonius A. ; Watson, Dorothy M. ; Sandler, Alan B. ; Kelly, Karen ; Marks, Randolph S. ; Perry, Micheal C. ; Ansari, Rafat H. ; Otterson, Grefory ; Ellerton, John ; Vokes, Everett E. ; Green, Mark R. / Randomized phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with extensive-stage small-cell lung cancer : Cancer and Leukemia Group B trial 9732. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 16. pp. 3752-3759.
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abstract = "Purpose: To determine, in a randomized comparison, whether the addition of paclitaxel to etoposide and cisplatin improves the time to progression and overall survival in patients with extensive small-cell lung cancer (SCLC) compared with standard etoposide and cisplatin and to compare the regimens' toxicity. Patients and Methods: Eligible patients (N = 587) with untreated extensive SCLC were randomly assigned to receive either cisplatin 80 mg/m 2 on day 1 and etoposide 80 mg/m2 on days 1 through 3 administered every 3 weeks for six cycles (EP) or cisplatin 80 mg/m2 on day 1, paclitaxel 175 mg/m2 over 4 hours on day 1, and etoposide 80 mg/m2 on days 1 to 3 followed by recombinant human granulocyte colony-stimulating factor on days 4 to 18 administered every 3 weeks for six cycles (PET). Results: Reporting of demographics, response, and survival included 565 patients, of whom 282 were randomly assigned to receive EP and 283 were assigned to receive PET. Overall response rates were 68{\%} for the EP arm and 75{\%} for the PET arm. Median failure-free survival time was 5.9 months for the EP arm and 6 months for the PET arm (P = .179). Median overall survival time was 9.9 months for patients on EP and 10.6 months for patients on PET (P = .169). Toxic deaths occurred in 2.4{\%} of the patients on EP and 6.5{\%} of patients on PET. Conclusion: PET did not improve the time to progression or survival in patients with extensive SCLC compared with EP alone and was associated with unacceptable toxicity.",
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T1 - Randomized phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with extensive-stage small-cell lung cancer

T2 - Cancer and Leukemia Group B trial 9732

AU - Niell, Harvey B.

AU - Herndon, James E.

AU - Miller, Antonius A.

AU - Watson, Dorothy M.

AU - Sandler, Alan B.

AU - Kelly, Karen

AU - Marks, Randolph S.

AU - Perry, Micheal C.

AU - Ansari, Rafat H.

AU - Otterson, Grefory

AU - Ellerton, John

AU - Vokes, Everett E.

AU - Green, Mark R.

PY - 2005

Y1 - 2005

N2 - Purpose: To determine, in a randomized comparison, whether the addition of paclitaxel to etoposide and cisplatin improves the time to progression and overall survival in patients with extensive small-cell lung cancer (SCLC) compared with standard etoposide and cisplatin and to compare the regimens' toxicity. Patients and Methods: Eligible patients (N = 587) with untreated extensive SCLC were randomly assigned to receive either cisplatin 80 mg/m 2 on day 1 and etoposide 80 mg/m2 on days 1 through 3 administered every 3 weeks for six cycles (EP) or cisplatin 80 mg/m2 on day 1, paclitaxel 175 mg/m2 over 4 hours on day 1, and etoposide 80 mg/m2 on days 1 to 3 followed by recombinant human granulocyte colony-stimulating factor on days 4 to 18 administered every 3 weeks for six cycles (PET). Results: Reporting of demographics, response, and survival included 565 patients, of whom 282 were randomly assigned to receive EP and 283 were assigned to receive PET. Overall response rates were 68% for the EP arm and 75% for the PET arm. Median failure-free survival time was 5.9 months for the EP arm and 6 months for the PET arm (P = .179). Median overall survival time was 9.9 months for patients on EP and 10.6 months for patients on PET (P = .169). Toxic deaths occurred in 2.4% of the patients on EP and 6.5% of patients on PET. Conclusion: PET did not improve the time to progression or survival in patients with extensive SCLC compared with EP alone and was associated with unacceptable toxicity.

AB - Purpose: To determine, in a randomized comparison, whether the addition of paclitaxel to etoposide and cisplatin improves the time to progression and overall survival in patients with extensive small-cell lung cancer (SCLC) compared with standard etoposide and cisplatin and to compare the regimens' toxicity. Patients and Methods: Eligible patients (N = 587) with untreated extensive SCLC were randomly assigned to receive either cisplatin 80 mg/m 2 on day 1 and etoposide 80 mg/m2 on days 1 through 3 administered every 3 weeks for six cycles (EP) or cisplatin 80 mg/m2 on day 1, paclitaxel 175 mg/m2 over 4 hours on day 1, and etoposide 80 mg/m2 on days 1 to 3 followed by recombinant human granulocyte colony-stimulating factor on days 4 to 18 administered every 3 weeks for six cycles (PET). Results: Reporting of demographics, response, and survival included 565 patients, of whom 282 were randomly assigned to receive EP and 283 were assigned to receive PET. Overall response rates were 68% for the EP arm and 75% for the PET arm. Median failure-free survival time was 5.9 months for the EP arm and 6 months for the PET arm (P = .179). Median overall survival time was 9.9 months for patients on EP and 10.6 months for patients on PET (P = .169). Toxic deaths occurred in 2.4% of the patients on EP and 6.5% of patients on PET. Conclusion: PET did not improve the time to progression or survival in patients with extensive SCLC compared with EP alone and was associated with unacceptable toxicity.

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DO - 10.1200/JCO.2005.09.071

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