Phase III comparative study of high-dose cisplatin versus a combination of paclitaxel and cisplatin in patients with advanced non-small-cell lung cancer

Ulrich Gatzemeier, Joachim Von Pawel, Maya Gottfried, G. P M Ten Velde, Karin Mattson, Filipo DeMarinis, Peter Harper, Franco Salvati, Gilles Robinet, Antonio Lucenti, Jan Bogaerts, Gilles Gallant

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Abstract

Purpose: New effective chemotherapy is needed to improve the outcome of patients with advanced non-small-cell lung cancer (NSCLC). Paclitaxel administered as a single agent or in combination with cisplatin has been shown to be a potentially new useful agent for the treatment of NSCLC. Patients and Methods: Between January 1995 and April 1996, 414 patients with stage IIIB or IV NSCLC were randomized to received either a control arm of high-dose cisplatin (100 mg/m2) or a combination of paclitaxel (175 mg/m2, 3-hour infusion) and cisplatin (80 mg/m2) every 21 days. Results: Compared with the cisplatin-only arm, there was a 9% improvement (95% confidence interval, 0% to 19%) in overall response rate for the paclitaxel/cisplatin arm (17% v 26%, respectively; P = .028). Median time to progression was 2.7 and 4.1 months in the control and paclitaxel/cisplatin arm, respectively (P = .026). The study, however, failed to show a significant improvement in median survival for the paclitaxel/cisplatin arm (8.6 months in the control arm v 8.1 months in the paclitaxel/cisplatin arm, P = .862). There was more hematotoxicity, peripheral neuropathy, and arthralgia/myalgia on the paclitaxel/cisplatin arm, whereas the high-dose cisplatin arm produced more ototoxicity, nausea, vomiting and nephrotoxicity. Quality of life (QOL) was similar overall between the two arms. Conclusion: This large randomized phase III trial failed to show a significant improvement in survival for the paclitaxel/cisplatin combination compared with high-doze cisplatin in patients with advanced NSLC. However, the paclitaxel/cisplatin combination did produce a better clinical response, resulting in an increased time to progression while providing a similar QOL. (C) 2000 by American Society of Clinical Oncology.

Original languageEnglish
Pages (from-to)3390-3399
Number of pages10
JournalJournal of Clinical Oncology
Volume18
Issue number19
Publication statusPublished - Oct 1 2000

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Non-Small Cell Lung Carcinoma
Cisplatin
Paclitaxel
Quality of Life
Survival
Myalgia
Arthralgia
Peripheral Nervous System Diseases
TP protocol
Nausea
Vomiting
Confidence Intervals
Drug Therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase III comparative study of high-dose cisplatin versus a combination of paclitaxel and cisplatin in patients with advanced non-small-cell lung cancer. / Gatzemeier, Ulrich; Von Pawel, Joachim; Gottfried, Maya; Ten Velde, G. P M; Mattson, Karin; DeMarinis, Filipo; Harper, Peter; Salvati, Franco; Robinet, Gilles; Lucenti, Antonio; Bogaerts, Jan; Gallant, Gilles.

In: Journal of Clinical Oncology, Vol. 18, No. 19, 01.10.2000, p. 3390-3399.

Research output: Contribution to journalArticle

Gatzemeier, U, Von Pawel, J, Gottfried, M, Ten Velde, GPM, Mattson, K, DeMarinis, F, Harper, P, Salvati, F, Robinet, G, Lucenti, A, Bogaerts, J & Gallant, G 2000, 'Phase III comparative study of high-dose cisplatin versus a combination of paclitaxel and cisplatin in patients with advanced non-small-cell lung cancer', Journal of Clinical Oncology, vol. 18, no. 19, pp. 3390-3399.
Gatzemeier, Ulrich ; Von Pawel, Joachim ; Gottfried, Maya ; Ten Velde, G. P M ; Mattson, Karin ; DeMarinis, Filipo ; Harper, Peter ; Salvati, Franco ; Robinet, Gilles ; Lucenti, Antonio ; Bogaerts, Jan ; Gallant, Gilles. / Phase III comparative study of high-dose cisplatin versus a combination of paclitaxel and cisplatin in patients with advanced non-small-cell lung cancer. In: Journal of Clinical Oncology. 2000 ; Vol. 18, No. 19. pp. 3390-3399.
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abstract = "Purpose: New effective chemotherapy is needed to improve the outcome of patients with advanced non-small-cell lung cancer (NSCLC). Paclitaxel administered as a single agent or in combination with cisplatin has been shown to be a potentially new useful agent for the treatment of NSCLC. Patients and Methods: Between January 1995 and April 1996, 414 patients with stage IIIB or IV NSCLC were randomized to received either a control arm of high-dose cisplatin (100 mg/m2) or a combination of paclitaxel (175 mg/m2, 3-hour infusion) and cisplatin (80 mg/m2) every 21 days. Results: Compared with the cisplatin-only arm, there was a 9{\%} improvement (95{\%} confidence interval, 0{\%} to 19{\%}) in overall response rate for the paclitaxel/cisplatin arm (17{\%} v 26{\%}, respectively; P = .028). Median time to progression was 2.7 and 4.1 months in the control and paclitaxel/cisplatin arm, respectively (P = .026). The study, however, failed to show a significant improvement in median survival for the paclitaxel/cisplatin arm (8.6 months in the control arm v 8.1 months in the paclitaxel/cisplatin arm, P = .862). There was more hematotoxicity, peripheral neuropathy, and arthralgia/myalgia on the paclitaxel/cisplatin arm, whereas the high-dose cisplatin arm produced more ototoxicity, nausea, vomiting and nephrotoxicity. Quality of life (QOL) was similar overall between the two arms. Conclusion: This large randomized phase III trial failed to show a significant improvement in survival for the paclitaxel/cisplatin combination compared with high-doze cisplatin in patients with advanced NSLC. However, the paclitaxel/cisplatin combination did produce a better clinical response, resulting in an increased time to progression while providing a similar QOL. (C) 2000 by American Society of Clinical Oncology.",
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T1 - Phase III comparative study of high-dose cisplatin versus a combination of paclitaxel and cisplatin in patients with advanced non-small-cell lung cancer

AU - Gatzemeier, Ulrich

AU - Von Pawel, Joachim

AU - Gottfried, Maya

AU - Ten Velde, G. P M

AU - Mattson, Karin

AU - DeMarinis, Filipo

AU - Harper, Peter

AU - Salvati, Franco

AU - Robinet, Gilles

AU - Lucenti, Antonio

AU - Bogaerts, Jan

AU - Gallant, Gilles

PY - 2000/10/1

Y1 - 2000/10/1

N2 - Purpose: New effective chemotherapy is needed to improve the outcome of patients with advanced non-small-cell lung cancer (NSCLC). Paclitaxel administered as a single agent or in combination with cisplatin has been shown to be a potentially new useful agent for the treatment of NSCLC. Patients and Methods: Between January 1995 and April 1996, 414 patients with stage IIIB or IV NSCLC were randomized to received either a control arm of high-dose cisplatin (100 mg/m2) or a combination of paclitaxel (175 mg/m2, 3-hour infusion) and cisplatin (80 mg/m2) every 21 days. Results: Compared with the cisplatin-only arm, there was a 9% improvement (95% confidence interval, 0% to 19%) in overall response rate for the paclitaxel/cisplatin arm (17% v 26%, respectively; P = .028). Median time to progression was 2.7 and 4.1 months in the control and paclitaxel/cisplatin arm, respectively (P = .026). The study, however, failed to show a significant improvement in median survival for the paclitaxel/cisplatin arm (8.6 months in the control arm v 8.1 months in the paclitaxel/cisplatin arm, P = .862). There was more hematotoxicity, peripheral neuropathy, and arthralgia/myalgia on the paclitaxel/cisplatin arm, whereas the high-dose cisplatin arm produced more ototoxicity, nausea, vomiting and nephrotoxicity. Quality of life (QOL) was similar overall between the two arms. Conclusion: This large randomized phase III trial failed to show a significant improvement in survival for the paclitaxel/cisplatin combination compared with high-doze cisplatin in patients with advanced NSLC. However, the paclitaxel/cisplatin combination did produce a better clinical response, resulting in an increased time to progression while providing a similar QOL. (C) 2000 by American Society of Clinical Oncology.

AB - Purpose: New effective chemotherapy is needed to improve the outcome of patients with advanced non-small-cell lung cancer (NSCLC). Paclitaxel administered as a single agent or in combination with cisplatin has been shown to be a potentially new useful agent for the treatment of NSCLC. Patients and Methods: Between January 1995 and April 1996, 414 patients with stage IIIB or IV NSCLC were randomized to received either a control arm of high-dose cisplatin (100 mg/m2) or a combination of paclitaxel (175 mg/m2, 3-hour infusion) and cisplatin (80 mg/m2) every 21 days. Results: Compared with the cisplatin-only arm, there was a 9% improvement (95% confidence interval, 0% to 19%) in overall response rate for the paclitaxel/cisplatin arm (17% v 26%, respectively; P = .028). Median time to progression was 2.7 and 4.1 months in the control and paclitaxel/cisplatin arm, respectively (P = .026). The study, however, failed to show a significant improvement in median survival for the paclitaxel/cisplatin arm (8.6 months in the control arm v 8.1 months in the paclitaxel/cisplatin arm, P = .862). There was more hematotoxicity, peripheral neuropathy, and arthralgia/myalgia on the paclitaxel/cisplatin arm, whereas the high-dose cisplatin arm produced more ototoxicity, nausea, vomiting and nephrotoxicity. Quality of life (QOL) was similar overall between the two arms. Conclusion: This large randomized phase III trial failed to show a significant improvement in survival for the paclitaxel/cisplatin combination compared with high-doze cisplatin in patients with advanced NSLC. However, the paclitaxel/cisplatin combination did produce a better clinical response, resulting in an increased time to progression while providing a similar QOL. (C) 2000 by American Society of Clinical Oncology.

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