Cisplatin, etoposide, and paclitaxel with granulocyte colony-stimulating factor in untreated patients with extensive-stage small cell lung cancer

A phase II trial of the southwest oncology group

Karen Kelly, L. Lovato, Jr Bunn P.A., R. B. Livingston, J. Zangmeister, S. A. Taylor, D. Roychowdhury, David R Gandara, D. R. Gandara, B. Granados

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Purpose: This study was designed to determine the efficacy and toxicity of cisplatin, etoposide, and paclitaxel (PET) in patients with extensive-stage small cell lung cancer (ES-SCLC). Experimental Design: Chemo-naive adult patients with a performance status (PS) of 0-2 and adequate organ function were eligible. Patients received cisplatin 80 mg/m2 i.v., etoposide 80 mg/m-2 i.v., and paclitaxel 175 mg/m2 i.v. over a 3-h period on day 1 followed by etoposide 160 mg/m2 p.o. on days 2 and 3 every 21 days for six cycles. G-CSF 5 μg/kg was injected s.c. on days 4-14. Results: Eighty-eight patients were assessable. The median age was 60 years; 50% were male, 78% had PS of 0-1, 28% had PS of 2, 53% had multiple sites, and 13% had brain involvement. The overall response rate was 57% with 10 (12%) of 84 patients achieving a complete response. Median progression-free survival was 6 months [95% confidence interval (CI), 5-7 months] with a median survival of 11 months (95% CI, 8-13 months) and a 1-year survival rate of 43% (95% CI, 33-54%). Six patients (7%) died from toxicity. Grade 5 toxicity occurred in 3 (14%) of 22 patients (with a PS of 2) versus 3 (5%) of 61 patients (with a PS of 0-1; P, not significant). Grade 4 neutropenia developed in 40% of patients. Grade 3 nonhematological toxicities were primarily nausea (20%), vomiting (16%), and fatigue (14%). Conclusion: The survival result achieved was superior to prior SWOG experiences; however, the toxic death rate was unacceptably high in PS-2 patients. These results provide the largest database for the ongoing randomized Intergroup trial comparing PET to cisplatin+etoposide in PS-0-1 patients with ES-SCLC.

Original languageEnglish (US)
Pages (from-to)2325-2329
Number of pages5
JournalClinical Cancer Research
Volume7
Issue number8
StatePublished - 2001

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Small Cell Lung Carcinoma
Granulocyte Colony-Stimulating Factor
Etoposide
Confidence Intervals
Cisplatin
TP protocol
Survival
Poisons
Paclitaxel
Neutropenia
Nausea
Disease-Free Survival
Vomiting
Fatigue
Research Design
Survival Rate
Databases

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Cisplatin, etoposide, and paclitaxel with granulocyte colony-stimulating factor in untreated patients with extensive-stage small cell lung cancer : A phase II trial of the southwest oncology group. / Kelly, Karen; Lovato, L.; Bunn P.A., Jr; Livingston, R. B.; Zangmeister, J.; Taylor, S. A.; Roychowdhury, D.; Gandara, David R; Gandara, D. R.; Granados, B.

In: Clinical Cancer Research, Vol. 7, No. 8, 2001, p. 2325-2329.

Research output: Contribution to journalArticle

Kelly, Karen ; Lovato, L. ; Bunn P.A., Jr ; Livingston, R. B. ; Zangmeister, J. ; Taylor, S. A. ; Roychowdhury, D. ; Gandara, David R ; Gandara, D. R. ; Granados, B. / Cisplatin, etoposide, and paclitaxel with granulocyte colony-stimulating factor in untreated patients with extensive-stage small cell lung cancer : A phase II trial of the southwest oncology group. In: Clinical Cancer Research. 2001 ; Vol. 7, No. 8. pp. 2325-2329.
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abstract = "Purpose: This study was designed to determine the efficacy and toxicity of cisplatin, etoposide, and paclitaxel (PET) in patients with extensive-stage small cell lung cancer (ES-SCLC). Experimental Design: Chemo-naive adult patients with a performance status (PS) of 0-2 and adequate organ function were eligible. Patients received cisplatin 80 mg/m2 i.v., etoposide 80 mg/m-2 i.v., and paclitaxel 175 mg/m2 i.v. over a 3-h period on day 1 followed by etoposide 160 mg/m2 p.o. on days 2 and 3 every 21 days for six cycles. G-CSF 5 μg/kg was injected s.c. on days 4-14. Results: Eighty-eight patients were assessable. The median age was 60 years; 50{\%} were male, 78{\%} had PS of 0-1, 28{\%} had PS of 2, 53{\%} had multiple sites, and 13{\%} had brain involvement. The overall response rate was 57{\%} with 10 (12{\%}) of 84 patients achieving a complete response. Median progression-free survival was 6 months [95{\%} confidence interval (CI), 5-7 months] with a median survival of 11 months (95{\%} CI, 8-13 months) and a 1-year survival rate of 43{\%} (95{\%} CI, 33-54{\%}). Six patients (7{\%}) died from toxicity. Grade 5 toxicity occurred in 3 (14{\%}) of 22 patients (with a PS of 2) versus 3 (5{\%}) of 61 patients (with a PS of 0-1; P, not significant). Grade 4 neutropenia developed in 40{\%} of patients. Grade 3 nonhematological toxicities were primarily nausea (20{\%}), vomiting (16{\%}), and fatigue (14{\%}). Conclusion: The survival result achieved was superior to prior SWOG experiences; however, the toxic death rate was unacceptably high in PS-2 patients. These results provide the largest database for the ongoing randomized Intergroup trial comparing PET to cisplatin+etoposide in PS-0-1 patients with ES-SCLC.",
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T1 - Cisplatin, etoposide, and paclitaxel with granulocyte colony-stimulating factor in untreated patients with extensive-stage small cell lung cancer

T2 - A phase II trial of the southwest oncology group

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AU - Lovato, L.

AU - Bunn P.A., Jr

AU - Livingston, R. B.

AU - Zangmeister, J.

AU - Taylor, S. A.

AU - Roychowdhury, D.

AU - Gandara, David R

AU - Gandara, D. R.

AU - Granados, B.

PY - 2001

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N2 - Purpose: This study was designed to determine the efficacy and toxicity of cisplatin, etoposide, and paclitaxel (PET) in patients with extensive-stage small cell lung cancer (ES-SCLC). Experimental Design: Chemo-naive adult patients with a performance status (PS) of 0-2 and adequate organ function were eligible. Patients received cisplatin 80 mg/m2 i.v., etoposide 80 mg/m-2 i.v., and paclitaxel 175 mg/m2 i.v. over a 3-h period on day 1 followed by etoposide 160 mg/m2 p.o. on days 2 and 3 every 21 days for six cycles. G-CSF 5 μg/kg was injected s.c. on days 4-14. Results: Eighty-eight patients were assessable. The median age was 60 years; 50% were male, 78% had PS of 0-1, 28% had PS of 2, 53% had multiple sites, and 13% had brain involvement. The overall response rate was 57% with 10 (12%) of 84 patients achieving a complete response. Median progression-free survival was 6 months [95% confidence interval (CI), 5-7 months] with a median survival of 11 months (95% CI, 8-13 months) and a 1-year survival rate of 43% (95% CI, 33-54%). Six patients (7%) died from toxicity. Grade 5 toxicity occurred in 3 (14%) of 22 patients (with a PS of 2) versus 3 (5%) of 61 patients (with a PS of 0-1; P, not significant). Grade 4 neutropenia developed in 40% of patients. Grade 3 nonhematological toxicities were primarily nausea (20%), vomiting (16%), and fatigue (14%). Conclusion: The survival result achieved was superior to prior SWOG experiences; however, the toxic death rate was unacceptably high in PS-2 patients. These results provide the largest database for the ongoing randomized Intergroup trial comparing PET to cisplatin+etoposide in PS-0-1 patients with ES-SCLC.

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