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 language | English |
|---|---|
| Pages (from-to) | 3390-3399 |
| Number of pages | 10 |
| Journal | Journal of Clinical Oncology |
| Volume | 18 |
| Issue number | 19 |
| Publication status | Published - Oct 1 2000 |
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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 journal › Article
}
TY - JOUR
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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M3 - Article
C2 - 11013280
AN - SCOPUS:0034306321
VL - 18
SP - 3390
EP - 3399
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 19
ER -