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

Research output: Contribution to journalArticlepeer-review

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

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Fingerprint Dive into the research topics of 'Phase III comparative study of high-dose cisplatin versus a combination of paclitaxel and cisplatin in patients with advanced non-small-cell lung cancer'. Together they form a unique fingerprint.

Cite this