Summary
Because both vindesine and gemcitabine are active drugs in advanced non-small-cell lung cancer (NSCLC), with different modes of action and only partly overlapping toxicity, a phase II study was performed. Gemcitabine 1000 mg m–2 was given on days 1, 8 and 15 every 4 weeks, while vindesine 3 mg m–2 was administered weekly for 7 weeks, then every 2 weeks. A total of 42 patients with nonresectable NSCLC were included. The median age of patients was 56 years; 57% were men, 52% had adenocarcinoma, 31% squamous cell carcinoma and 17% had large-cell carcinoma. The performance status ranged from 0 to 2 with 83% in performance status 1. The majority (55%) had stage IV disease, while 40% had stage III B and 5% stage III A disease. WHO grade 3–4 leucopenia occurred in five patients (12%) and 9% had grade 4 neutropenia. Thrombocytopenia grade 3–4 was observed in six patients (15%). There were no septic death or bleeding episodes. One patient had a transient WHO grade 4 increase in bilirubin, and four patients had a decrease in glomerular filtration rate below the normal limit; one of these patients developed a non-reversible renal insufficiency. Ten patients (24%) complained of dyspnoea of uncertain mechanism, possibly involving bronchoconstriction. There were one complete and seven partial responses among 40 assessable patients (20%, 95% confidence limits 9–36%). Median response duration was 31 weeks (range 11–83 weeks) and median survival time 31 weeks (range 2–171 weeks). The current combination of gemcitabine and vindesine does not appear to be promising for further examination because of the toxicity and somewhat disappointing activity.
Similar content being viewed by others
Article PDF
Change history
16 November 2011
This paper was modified 12 months after initial publication to switch to Creative Commons licence terms, as noted at publication
References
Aaronson, N. K., Ahmedzai, S., Bergman, B., et al (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85: 365–376.
Abratt, R. P., Bezwoda, W. R., Goedhals, L. & Hacking, D. J. (1997). Weekly gemcitabine with monthly cisplatin: effective chemotherapy for advanced non-small-cell lung cancer. J Clin Oncol 15: 744–749.
Anderson, H., Thatcher, N., Walling, J., et al (1994). Gemcitabine and palliation of symptoms in non-small cell lung cancer (NSCLC). Proc, 13 367
Bakker, W., van Oosterom, A. T. & Aaronson, N. K. (1986). Vindesine, cisplatin, and bleomycin combination chemotherapy in non-small cell lung cancer: survival and quality of life. Eur J Cancer Clin Oncol 22: 963–970.
Batel-Copel, L. M., Kornblith, A. B., Batel, PCCC & Holland, J. C. (1997). Do oncologists have an increasing interest in the quality of life of their patients? A literature review of the last 15 years. Eur J Cancer 33: 29–32.
Bayssas, M., Gouveia, J., de Vassal, F., Misset, J-L, Schwarzenberg, L., Ribaus, P., Musset, M., Jasmin, C., Hayat, M. & Mathe, G. (1980). Vindesine: a new vinca alkaloid. Recent Res Cancer Res 74: 91–97.
Bergman, B., Sullivan, M. & Sorenson, S. (1991). Quality of life during chemotherapy for small cell lung cancer. I. An evaluation with generic health measures. Acta Oncol 30: 947–957.
Bergman, B., Sullivan, M. & Sörenson, S. (1992). Quality of life during chemotherapy for small cell lung cancer II. A longitudinal study of the EORTC Core Quality of Life Questionnaire and Comparison with the Sickness Impact Profile. Acta Oncol 31: 19–28.
Bergman, B., Aaronson, N. K., Ahmedzai, S., et al (1994). The EORTC QLQ-L13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQQ-C30) for use in lung cancer clinical trials. Eur J Cancer 30A: 635–642.
Billingham, L. J., Cullen, M. H., Woods, J., et al (1997). Mitomycin, ifosfamide and cisplatin (MIC) in non-small cell lung cancer: results of a randomised trial evaluating palliation & quality of life. Lung Cancer 18(suppl.1): 9–10.
Cojean, I. & Le Chevalier, T. (1995). Chemotherapy of stage IIIB and IV non-small-cell lung cancer. Ann Oncol 6(suppl.3): S41–S44.
Comis, R. L. & Friedland, D. M. (1995). New chemotherapy agents in the treatment of advanced non-small cell lung cancer: an update including data from the Seventh World Conference on Lung Cancer. Lung Cancer 12(suppl.2): S63–S99.
Crino, L., Scagliotti, G., Marangolo, M., et al (1997). Cisplatin-Gemcitabine Combination in Advanced Non-Small-Cell Lung Cancer: A Phase II study. J Clin Oncol 15: 297–303.
Edelman, M. J. & Gandara, D. R. (1996). Promising new agents in the treatment of non-small cell lung cancer. Cancer Chemother Pharmacol 37: 385–393.
Ganz, P. A., Figlin, R. A., Haskell, C. M., et al (1989). Supportive care versus supportive care and combination chemotherapy in metastatic non-small cell lung. Does chemotherapy make a difference? Cancer 63: 1271–1278.
Groth, S. & Aasted, M. (1981). 51Cr-EDTA clearance determined by one plasma sample. Clin Physiol 1: 417–425.
Guchelaar, H-J, Richel, D. J. & van Knapen, A. (1996). Clinical, toxicological and pharmacological aspects of Gemcitabine. Cancer Treat Rev 22: 15–31.
Hansen, H. H. & Sørensen, J. B. (1997). Efficacy of single-agent gemcitabine in advanced non-small cell lung cancer: a review. Sem Oncol 24(suppl.2): S38–S41.
Helsing, M., Bergman, B., Thaning, L. & Hero, U. (1998). Quality of life and survival in patients with advanced non-small cell lung cancer receiving supportive care plus chemotherapy with carboplatin and etoposide or supportive care only. A multicentre randomized phase III trial. Eur J Cancer, (in press)
Kaasa, S. & Mastekaasa, A. (1988). Psychosocial well-being of patients with inoperable non-small cell lung cancer. Acta Oncol 27: 829–835.
Kaasa, S., Mastekaasa, A. & Thorud, E. (1988). Toxicity, physical function and everyday activity reported by patients with inoperable non-small lung cancer in a randomised trial (chemotherapy versus radiotherapy). Acta Oncol 27: 343–349.
Kosty, M. P., Fleishman, S. B., Herndon, J. E. et al (1994). Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small cell lung cancer: a randomized placebo-controlled, double-blind phase III study of Cancer and Leukemia Group B. J Clin Oncol 12: 1113–1120.
Krajnik, G., Mohn-staudner, A., Marhold, F., et al (1997). Vinorelbine/gemcitabine in advanced non-small cell lung cancer (NSCLC): a phase I trial. Proc Am Soc 16: 206
Maasilta, P. K., Rautonen, J. K., Mattson, M. T. & Mattson, K. V. (1990). Quality of life assessment during chemotherapy for non-small cell lung cancer. Eur J Cancer 26: 706–708.
Minet, P., Bartsch, P., Chevalier, P. et al (1987). Quality of life in patients with non-small cell lung cancer treated with chemotherapy. Radiother Oncol 8: 217–230.
Pujol, J. L. & Monnier, A. Berilleet al (1994). Phase II study of nitrosourea fotemustine as single-drug chemotherapy in poor-prognosis non-small cell lung cancer. Br J Cancer 69: 1136–1140.
Sarna, L. P. (1990). Impact of chemotherapy on the quality of life and functional status of older adults with non-small cell lung cancer. Dis Abst Int 51: 1748
Schipper, H., Clinch, J., McMurray, A. & Levitt, M. (1984). Measuring the quality of life in cancer patients: The Functional Living Index-Cancer. J Clin Oncol 2: 472–483.
Shepherd, F., Cormier, Y., Burkes, R., et al (1994). Phase I study of gemcitabine and cisplatin for advanced non-small cell lung cancer. Lung Cancer 11(suppl.): 116
Sørensen, J. B. (1994). The role of chemotherapy in non-small cell lung cancer. Radiol Oncol 28: 386–394.
Sørensen, J. B. & Hansen, H. H. (1993). Is there a role for vindesine in the treatment of non-small cell lung cancer?. Invest New Drugs 11: 103–133.
Souquet, P. J., Chauvin, F., Boissel, J. P., Cellerino, R., Cormeier, Y., Ganz, P. A., Kaasa, S., Pater, J. L., Quoix, E., Rapp, E., Tumarello, D., Williams, J., Woods, B. L. & Bernard, J. P. (1993). Polychemotherapy in advanced non-small cell lung cancer: a meta-analysis. Lancet 342: 19–21.
Steward, W. P., Dunlop, D. J., Cameron, C., et al (1994). Cisplatin + gemcitabine in non-small cell lung cancer. A phase I dose escalation study. Lung Cancer 11(suppl.): 114
WHO (1979). Handbook for Reporting Results of Cancer Treatment, Offset publication 42. World Wealth Organization: Geneva
Author information
Authors and Affiliations
Rights and permissions
From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/
About this article
Cite this article
Sørensen, J., Bergman, B., Nielsen, A. et al. Phase II study of gemcitabine and vindesine in patients with previously untreated non-resectable non-small-cell lung cancer. Br J Cancer 79, 875–881 (1999). https://doi.org/10.1038/sj.bjc.6690140
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1038/sj.bjc.6690140