This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Schuette, W. Articles by Serke, M. Search for Related Content PubMed PubMed Citation Articles by Schuette, W. Articles by Serke, M. Social Bookmarking                            What's this?

Phase III Study of Second-Line Chemotherapy for Advanced Non–Small-Cell Lung Cancer With Weekly Compared With 3-Weekly Docetaxel

From the Martha-Maria City Hospital Halle-Doelau, Halle; Martin-Luther- University of Halle-Wittenberg; Johanniter-Krankenhaus, Oberhausen; Klinikum Chemnitz, Chemnitz; Lungenklinik Lostau, Lostau; Carl-Thiem-Klinikum Cottbus, Cottbus; Klinikum St Marien, Amberg; HELIOS Klinikum Wuppertal, Wuppertal; Friedrich-Schiller University of Jena, Jena; Lungenklinik Heckeshorn, Berlin, Germany

Address reprint requests to Wolfgang Schuette, MD, Martha-Maria City Hospital Halle-Doelau, Roentgenstraße 1, Halle 06120, Germany; e-mail: wolfgang.schuette{at}medizin.uni-halle.de

PURPOSE: A phase III study to determine whether a weekly docetaxel schedule improves the therapeutic index compared with the classic 3-weekly schedule.

PATIENTS AND METHODS: Patients with stage IIIB-IV non–small-cell lung cancer (NSCLC) were randomly assigned to docetaxel 75 mg/m² on day 1 every 3 weeks (3-weekly) and 35 mg/m² on days 1, 8, and 15 (weekly) for eight cycles. End points included survival (primary), toxicity, and response.

RESULTS: Of 215 patients enrolled, 208 (103 in the 3-weekly arm and 105 in the weekly arm) were assessable for response. At baseline, 24.5% of patients (51 out of 208) had received prior paclitaxel therapy and 43.3% of patients (90 out of 208) had been progression-free for more than 3 months after first-line therapy. After 12 months' follow-up, median survival was 6.3 months (95% CI, 4.68 to 7.84 months) with 3-weekly docetaxel and 9.2 months (95% CI, 5.83 to 12.59 months) with weekly docetaxel (P = .07) after a median of four (range, one to eight) and two (range, one to eight) treatment cycles, respectively. Overall, response rates were 12.6% v 10.5% with 3-weekly versus weekly docetaxel. Significantly fewer patients reported grade 3 to 4 toxicities with weekly docetaxel versus 3-weekly docetaxel (P .05). There were significantly lower rates of grade 3 to 4 anemia (P .05), leucopenia (P < .0001), and neutropenia (P .001) with weekly versus 3-weekly treatment. No grade 3 to 4 thrombocytopenia or mucositis was reported.

CONCLUSION: Weekly docetaxel 35 mg/m² demonstrated similar efficacy and better tolerability than standard 3-weekly docetaxel 75 mg/m² and can be recommended as a feasible alternative second-line treatment option for patients with advanced NSCLC.

Supported by a research grant from Aventis Pharmaceuticals, a member of the sanofi-aventis group.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				D. Tassinari, E. Scarpi, S. Sartori, E. Tamburini, C. Santelmo, P. Tombesi, and L. Lazzari-Agli Second-Line Treatments in Non-small Cell Lung Cancer: A Systematic Review of Literature and Metaanalysis of Randomized Clinical Trials Chest, June 1, 2009; 135(6): 1596 - 1609. [Abstract] [Full Text] [PDF]

				R. F. Riedel, A. Porrello, E. Pontzer, E. J. Chenette, D. S. Hsu, B. Balakumaran, A. Potti, J. Nevins, and P. G. Febbo A genomic approach to identify molecular pathways associated with chemotherapy resistance Mol. Cancer Ther., October 1, 2008; 7(10): 3141 - 3149. [Abstract] [Full Text] [PDF]

				M. H. Cullen, P. Zatloukal, S. Sorenson, S. Novello, J. R. Fischer, A. A. Joy, M. Zereu, P. Peterson, C. M. Visseren-Grul, and N. Iscoe A randomized phase III trial comparing standard and high-dose pemetrexed as second-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer Ann. Onc., May 1, 2008; 19(5): 939 - 945. [Abstract] [Full Text] [PDF]

				F. de Marinis and F. Grossi Clinical Evidence for Second- and Third-Line Treatment Options in Advanced Non-Small Cell Lung Cancer Oncologist, January 1, 2008; 13(suppl_1): 14 - 20. [Abstract] [Full Text] [PDF]

				T. E. Stinchcombe and M. A. Socinski Considerations for Second-Line Therapy of Non-Small Cell Lung Cancer Oncologist, January 1, 2008; 13(suppl_1): 28 - 36. [Abstract] [Full Text] [PDF]

				S. Lorenzen, M. Hentrich, C. Haberl, V. Heinemann, T. Schuster, T. Seroneit, N. Roethling, C. Peschel, and F. Lordick Split-dose docetaxel, cisplatin and leucovorin/fluorouracil as first-line therapy in advanced gastric cancer and adenocarcinoma of the gastroesophageal junction: results of a phase II trial Ann. Onc., October 1, 2007; 18(10): 1673 - 1679. [Abstract] [Full Text] [PDF]

				J. Hong, S. H. Park, S. J. Choi, S. H. Lee, K. C. Lee, J.-I. Lee, S. Y. Kyung, C. H. An, S. P. Lee, J. W. Park, et al. Nail Toxicity after Treatment with Docetaxel: A Prospective Analysis in Patients with Advanced Non-small Cell Lung Cancer Jpn. J. Clin. Oncol., June 21, 2007; (2007) hym042v1. [Abstract] [Full Text] [PDF]

				M. Di Maio, F. Perrone, P. Chiodini, C. Gallo, C. Camps, W. Schuette, E. Quoix, C.-M. Tsai, and C. Gridelli Individual Patient Data Meta-Analysis of Docetaxel Administered Once Every 3 Weeks Compared With Once Every Week Second-Line Treatment of Advanced Non-Small-Cell Lung Cancer J. Clin. Oncol., April 10, 2007; 25(11): 1377 - 1382. [Abstract] [Full Text] [PDF]

				S. Ramalingam and A. B. Sandler Salvage therapy for advanced non-small cell lung cancer: factors influencing treatment selection. Oncologist, June 1, 2006; 11(6): 655 - 665. [Abstract] [Full Text] [PDF]

				J. C. Ruckdeschel Second-Line Chemotherapy for Non-small Cell Lung Cancer. Chest, April 1, 2006; 129(4): 840 - 842. [Full Text] [PDF]