Phase II trial of paclitaxel, carboplatin, and topotecan with G-CSF support in previously untreated patients with extensive stage small cell lung cancer: Southwest Oncology Group 9914

Paul J. Hesketh, Jason McCoy, Frank R. Dunphy, James D. Bearden, Geoffrey R. Weiss, Jeffrey K. Giguere, James N. Atkins, Shaker R. Dakhil, Karen Kelly, John J. Crowley, David R Gandara

Research output: Contribution to journalArticle

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Abstract

PURPOSE: This phase II study (S9914) evaluated the efficacy and toxicity of the three-drug combination of paclitaxel, carboplatin, and topotecan with granulocyte colony-stimulating factor support in previously untreated patients with extensive stage small cell lung cancer. PATIENTS AND METHODS: Patients with newly diagnosed extensive stage small cell lung cancer received topotecan 1.0 mg/m intravenously on days 1 through 4; paclitaxel 175 mg/m intravenously on day 4, and carboplatin AUC = 5 intravenously on day 4, treatments were repeated every 21 days for a maximum of six cycles. All patients also received granulocyte colony-stimulating factor 5 μg/kg/day beginning on day 5 of each cycle. RESULTS: A total of 88 patients were enrolled on the study; 79 patients were assessable for survival and toxicity and 74 patients for response. Objective response was observed in 50 patients (68%; 95% confidence interval [CI]: 56%-78%) with nine patients (12%) achieving a complete response. Median progression-free survival was 7 months (95% CI: 6-8 months) and median overall survival was 12 months (95% CI: 11-14 months). The 1- and 2-year survival rates were 48% (95% CI: 37%-59%) and 20% (95% CI: 11%-29%), respectively. The most common toxicities were hematologic. Grade 3 and 4 neutropenia was noted in 17 (22%) and 27 (34%) patients, respectively. Febrile neutropenia developed in only four patients. Two patients (3%) died of treatment-related causes. CONCLUSION: The combination of paclitaxel, carboplatin, and topotecan combined with granulocyte colony-stimulating factor support is an active and reasonably well-tolerated regimen for the treatment of extensive stage small cell lung cancer.

Original languageEnglish (US)
Pages (from-to)991-995
Number of pages5
JournalJournal of Thoracic Oncology
Volume1
Issue number9
DOIs
StatePublished - Nov 2006

Fingerprint

Topotecan
Carboplatin
Small Cell Lung Carcinoma
Granulocyte Colony-Stimulating Factor
Paclitaxel
Confidence Intervals
Febrile Neutropenia
Survival
Drug Combinations
Neutropenia
Disease-Free Survival
Area Under Curve
Therapeutics
Survival Rate

Keywords

  • Chemotherapy
  • Phase II trial
  • Small cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

Phase II trial of paclitaxel, carboplatin, and topotecan with G-CSF support in previously untreated patients with extensive stage small cell lung cancer : Southwest Oncology Group 9914. / Hesketh, Paul J.; McCoy, Jason; Dunphy, Frank R.; Bearden, James D.; Weiss, Geoffrey R.; Giguere, Jeffrey K.; Atkins, James N.; Dakhil, Shaker R.; Kelly, Karen; Crowley, John J.; Gandara, David R.

In: Journal of Thoracic Oncology, Vol. 1, No. 9, 11.2006, p. 991-995.

Research output: Contribution to journalArticle

Hesketh, Paul J. ; McCoy, Jason ; Dunphy, Frank R. ; Bearden, James D. ; Weiss, Geoffrey R. ; Giguere, Jeffrey K. ; Atkins, James N. ; Dakhil, Shaker R. ; Kelly, Karen ; Crowley, John J. ; Gandara, David R. / Phase II trial of paclitaxel, carboplatin, and topotecan with G-CSF support in previously untreated patients with extensive stage small cell lung cancer : Southwest Oncology Group 9914. In: Journal of Thoracic Oncology. 2006 ; Vol. 1, No. 9. pp. 991-995.
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abstract = "PURPOSE: This phase II study (S9914) evaluated the efficacy and toxicity of the three-drug combination of paclitaxel, carboplatin, and topotecan with granulocyte colony-stimulating factor support in previously untreated patients with extensive stage small cell lung cancer. PATIENTS AND METHODS: Patients with newly diagnosed extensive stage small cell lung cancer received topotecan 1.0 mg/m intravenously on days 1 through 4; paclitaxel 175 mg/m intravenously on day 4, and carboplatin AUC = 5 intravenously on day 4, treatments were repeated every 21 days for a maximum of six cycles. All patients also received granulocyte colony-stimulating factor 5 μg/kg/day beginning on day 5 of each cycle. RESULTS: A total of 88 patients were enrolled on the study; 79 patients were assessable for survival and toxicity and 74 patients for response. Objective response was observed in 50 patients (68{\%}; 95{\%} confidence interval [CI]: 56{\%}-78{\%}) with nine patients (12{\%}) achieving a complete response. Median progression-free survival was 7 months (95{\%} CI: 6-8 months) and median overall survival was 12 months (95{\%} CI: 11-14 months). The 1- and 2-year survival rates were 48{\%} (95{\%} CI: 37{\%}-59{\%}) and 20{\%} (95{\%} CI: 11{\%}-29{\%}), respectively. The most common toxicities were hematologic. Grade 3 and 4 neutropenia was noted in 17 (22{\%}) and 27 (34{\%}) patients, respectively. Febrile neutropenia developed in only four patients. Two patients (3{\%}) died of treatment-related causes. CONCLUSION: The combination of paclitaxel, carboplatin, and topotecan combined with granulocyte colony-stimulating factor support is an active and reasonably well-tolerated regimen for the treatment of extensive stage small cell lung cancer.",
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T1 - Phase II trial of paclitaxel, carboplatin, and topotecan with G-CSF support in previously untreated patients with extensive stage small cell lung cancer

T2 - Southwest Oncology Group 9914

AU - Hesketh, Paul J.

AU - McCoy, Jason

AU - Dunphy, Frank R.

AU - Bearden, James D.

AU - Weiss, Geoffrey R.

AU - Giguere, Jeffrey K.

AU - Atkins, James N.

AU - Dakhil, Shaker R.

AU - Kelly, Karen

AU - Crowley, John J.

AU - Gandara, David R

PY - 2006/11

Y1 - 2006/11

N2 - PURPOSE: This phase II study (S9914) evaluated the efficacy and toxicity of the three-drug combination of paclitaxel, carboplatin, and topotecan with granulocyte colony-stimulating factor support in previously untreated patients with extensive stage small cell lung cancer. PATIENTS AND METHODS: Patients with newly diagnosed extensive stage small cell lung cancer received topotecan 1.0 mg/m intravenously on days 1 through 4; paclitaxel 175 mg/m intravenously on day 4, and carboplatin AUC = 5 intravenously on day 4, treatments were repeated every 21 days for a maximum of six cycles. All patients also received granulocyte colony-stimulating factor 5 μg/kg/day beginning on day 5 of each cycle. RESULTS: A total of 88 patients were enrolled on the study; 79 patients were assessable for survival and toxicity and 74 patients for response. Objective response was observed in 50 patients (68%; 95% confidence interval [CI]: 56%-78%) with nine patients (12%) achieving a complete response. Median progression-free survival was 7 months (95% CI: 6-8 months) and median overall survival was 12 months (95% CI: 11-14 months). The 1- and 2-year survival rates were 48% (95% CI: 37%-59%) and 20% (95% CI: 11%-29%), respectively. The most common toxicities were hematologic. Grade 3 and 4 neutropenia was noted in 17 (22%) and 27 (34%) patients, respectively. Febrile neutropenia developed in only four patients. Two patients (3%) died of treatment-related causes. CONCLUSION: The combination of paclitaxel, carboplatin, and topotecan combined with granulocyte colony-stimulating factor support is an active and reasonably well-tolerated regimen for the treatment of extensive stage small cell lung cancer.

AB - PURPOSE: This phase II study (S9914) evaluated the efficacy and toxicity of the three-drug combination of paclitaxel, carboplatin, and topotecan with granulocyte colony-stimulating factor support in previously untreated patients with extensive stage small cell lung cancer. PATIENTS AND METHODS: Patients with newly diagnosed extensive stage small cell lung cancer received topotecan 1.0 mg/m intravenously on days 1 through 4; paclitaxel 175 mg/m intravenously on day 4, and carboplatin AUC = 5 intravenously on day 4, treatments were repeated every 21 days for a maximum of six cycles. All patients also received granulocyte colony-stimulating factor 5 μg/kg/day beginning on day 5 of each cycle. RESULTS: A total of 88 patients were enrolled on the study; 79 patients were assessable for survival and toxicity and 74 patients for response. Objective response was observed in 50 patients (68%; 95% confidence interval [CI]: 56%-78%) with nine patients (12%) achieving a complete response. Median progression-free survival was 7 months (95% CI: 6-8 months) and median overall survival was 12 months (95% CI: 11-14 months). The 1- and 2-year survival rates were 48% (95% CI: 37%-59%) and 20% (95% CI: 11%-29%), respectively. The most common toxicities were hematologic. Grade 3 and 4 neutropenia was noted in 17 (22%) and 27 (34%) patients, respectively. Febrile neutropenia developed in only four patients. Two patients (3%) died of treatment-related causes. CONCLUSION: The combination of paclitaxel, carboplatin, and topotecan combined with granulocyte colony-stimulating factor support is an active and reasonably well-tolerated regimen for the treatment of extensive stage small cell lung cancer.

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