Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer

Chandra Belani, J. S. Lee, M. A. Socinski, F. Robert, D. Waterhouse, K. Rowland, R. Ansari, R. Lilenbaum, R. B. Natale

Research output: Contribution to journalArticle

108 Citations (Scopus)

Abstract

Background: The present study was designed to evaluate the efficacy and safety of the regimen of carboplatin plus paclitaxel (investigational arm) versus the reference regimen of cisplatin plus etoposide for the treatment of advanced or metastatic non-small-cell lung cancer. Patients and methods: A total of 369 patients were enrolled, 179 on arm A (cisplatin 75 mg/m2 and etoposide 100 mg/m2) and 190 on arm B (carboplatin AUC=6 mg/ml min and paclitaxel 225 mg/m2), with cycles repeated every 3 weeks. The arms were well balanced with respect to age, performance status, weight loss, stage of disease and disease measurability. However, significantly more women were randomized to arm A than to arm B (P=0.039). Results: The objective response rate (ORR) was 15% on arm A compared with 23% on arm B (P=0.061). Median survival time, time to progression and 1-year survival rates for arms A and B were 274 days and 233 days (P=0.086), 111 days and 121 days (T=P=0.877), and 37% and 32%, respectively. The most prevalent toxicities were neutropenia and leukopenia and they occurred at a higher rate in arm A than in arm B. Conclusion: There was no statistically significant survival advantage for carboplatin-paclitaxel compared with cisplatin-etoposide. However, there was an overall benefit in quality of life with the carboplatin-paclitaxel regimen.

Original languageEnglish (US)
Pages (from-to)1069-1075
Number of pages7
JournalAnnals of Oncology
Volume16
Issue number7
DOIs
StatePublished - Jul 1 2005

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Carboplatin
Etoposide
Paclitaxel
Non-Small Cell Lung Carcinoma
Cisplatin
Survival
Leukopenia
Neutropenia
Area Under Curve
Weight Loss
Survival Rate
Quality of Life
Safety
Therapeutics

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

Cite this

Belani, Chandra ; Lee, J. S. ; Socinski, M. A. ; Robert, F. ; Waterhouse, D. ; Rowland, K. ; Ansari, R. ; Lilenbaum, R. ; Natale, R. B. / Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer. In: Annals of Oncology. 2005 ; Vol. 16, No. 7. pp. 1069-1075.
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Belani, C, Lee, JS, Socinski, MA, Robert, F, Waterhouse, D, Rowland, K, Ansari, R, Lilenbaum, R & Natale, RB 2005, 'Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer', Annals of Oncology, vol. 16, no. 7, pp. 1069-1075. https://doi.org/10.1093/annonc/mdi216

Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer. / Belani, Chandra; Lee, J. S.; Socinski, M. A.; Robert, F.; Waterhouse, D.; Rowland, K.; Ansari, R.; Lilenbaum, R.; Natale, R. B.

In: Annals of Oncology, Vol. 16, No. 7, 01.07.2005, p. 1069-1075.

Research output: Contribution to journalArticle

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T1 - Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer

AU - Belani, Chandra

AU - Lee, J. S.

AU - Socinski, M. A.

AU - Robert, F.

AU - Waterhouse, D.

AU - Rowland, K.

AU - Ansari, R.

AU - Lilenbaum, R.

AU - Natale, R. B.

PY - 2005/7/1

Y1 - 2005/7/1

N2 - Background: The present study was designed to evaluate the efficacy and safety of the regimen of carboplatin plus paclitaxel (investigational arm) versus the reference regimen of cisplatin plus etoposide for the treatment of advanced or metastatic non-small-cell lung cancer. Patients and methods: A total of 369 patients were enrolled, 179 on arm A (cisplatin 75 mg/m2 and etoposide 100 mg/m2) and 190 on arm B (carboplatin AUC=6 mg/ml min and paclitaxel 225 mg/m2), with cycles repeated every 3 weeks. The arms were well balanced with respect to age, performance status, weight loss, stage of disease and disease measurability. However, significantly more women were randomized to arm A than to arm B (P=0.039). Results: The objective response rate (ORR) was 15% on arm A compared with 23% on arm B (P=0.061). Median survival time, time to progression and 1-year survival rates for arms A and B were 274 days and 233 days (P=0.086), 111 days and 121 days (T=P=0.877), and 37% and 32%, respectively. The most prevalent toxicities were neutropenia and leukopenia and they occurred at a higher rate in arm A than in arm B. Conclusion: There was no statistically significant survival advantage for carboplatin-paclitaxel compared with cisplatin-etoposide. However, there was an overall benefit in quality of life with the carboplatin-paclitaxel regimen.

AB - Background: The present study was designed to evaluate the efficacy and safety of the regimen of carboplatin plus paclitaxel (investigational arm) versus the reference regimen of cisplatin plus etoposide for the treatment of advanced or metastatic non-small-cell lung cancer. Patients and methods: A total of 369 patients were enrolled, 179 on arm A (cisplatin 75 mg/m2 and etoposide 100 mg/m2) and 190 on arm B (carboplatin AUC=6 mg/ml min and paclitaxel 225 mg/m2), with cycles repeated every 3 weeks. The arms were well balanced with respect to age, performance status, weight loss, stage of disease and disease measurability. However, significantly more women were randomized to arm A than to arm B (P=0.039). Results: The objective response rate (ORR) was 15% on arm A compared with 23% on arm B (P=0.061). Median survival time, time to progression and 1-year survival rates for arms A and B were 274 days and 233 days (P=0.086), 111 days and 121 days (T=P=0.877), and 37% and 32%, respectively. The most prevalent toxicities were neutropenia and leukopenia and they occurred at a higher rate in arm A than in arm B. Conclusion: There was no statistically significant survival advantage for carboplatin-paclitaxel compared with cisplatin-etoposide. However, there was an overall benefit in quality of life with the carboplatin-paclitaxel regimen.

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