Abstract
The activity and mild toxicity profile of single-agent gemcitabine therapy in untreated (chemonaive) patients with non-small-cell lung cancer (NSCLC) is well documented. This phase II trial was conducted to determine the objective tumour response rate and toxicity profile of single-agent gemcitabine in pretreated patients with NSCLC. Patients with histological evidence of advanced NCSLC stage IIIB or IV; at least one prior chemotherapy regimen including a platinum or taxane analogue; an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2; clinically measurable disease; adequate bone marrow reserve; and adequate renal function; received 1000 mg m–2 gemcitabine administered over 30 min on days 1, 8 and 15 of a 28-day cycle defined as 3 weekly treatments followed by 1 week of rest. Twenty-nine patients were evaluated for efficacy and 32 for toxicity. One patient achieved a complete response and five patients had a partial response resulting in a total response rate of 20.6% (95% confidence interval (CI) 6–34). Median response duration was 7 months (range 4–11 months). Twelve (41%) patients reached stable disease after two cycles of therapy and 11 (38%) patients had disease progression. Median progression-free survival time was 3 months and median overall survival time was 5.5 months. Toxicity was generally mild (grades 0–2). Severe (grade 3 or 4) haematological toxicities included grade 3 anaemia in one patient and grade 3 thrombocytopenia in two patients. Severe non-haematological toxicities included one patient each with grade 3 liver transaminase elevations, nausea/vomiting and diarrhoea. This study confirms the activity and safety of single-agent gemcitabine in pretreated patients with advanced NSCLC who are refractory or sensitive to first-line therapy.
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
Abratt, RP, Bezwoda, WR & Falkson, G et al (1994) Efficacy and safety profile of gemcitabine in non-small cell lung cancer: a phase II study. J Clin Oncol 12: 1535–1540.
Abratt, RP, Bezwoda, WR & Goedhale, L et al (1997) Weekly gemcitabine with monthly cisplatin: effective chemotherapy for advanced non-small cell lung cancer. J Clin Oncol 15: 744–749.
Anderson, H, Lund, B & Bach, F et al (1994) Single agent activity of weekly gemcitabine in advanced non-small cell lung cancer: a phase II study. J Clin Oncol 12: 1821–1826.
Crinó, L, Mosconi, A & Scagliotti, G et al ( 1997a) Salvage therapy in pretreated, advanced non-small-cell lung cancer. Proc Am Soc Clin Oncol 17: 1603 (Abstract)
Crino, L, Scagliotti, G & Marangolo, M et al ( 1997b) Cisplatin-gemcitabine combination in advanced non-small cell lung cancer. Proc Am Soc Clin Oncol 15: 297–303.
Einhorn, L (1997) Phase II trial of gemcitabine plus cisplatin in non-small cell lung cancer. Hoosier Oncology Group Study. Semin Oncol 24: S8 24–S8 26.
Fossella, F, Lee, JS & Hong, WK (1997) Management strategies for recurrent non-small cell lung cancer. Semin Oncol 24: 455–462.
Gatzemier, U, Shepherd, FA & Le-Chevalier, T et al (1996) Activity of gemcitabine in patients with non-small cell lung cancer: a multicenter extended phase II study. Eur J Cancer 32: 243–248.
Guerra, J, Lianes, P & Paz-Ares, L et al (1997). Efficacy and toxicity profile of gemcitabine in previously treated patients with non-small cell lung cancer. Lung Cancer (suppl) World Conference on Lung Cancer, Dublin (abstract no. 99).
Hertel, LW, Boder, GB & Kroin, JS et al (1990) Evaluation of the antitumor activity of gemcitabine (2′,2′-difluoro-2′-deoxycytidine). Cancer Res 50: 4417–4422.
Ihde, DC (1992) Chemotherapy of lung cancer. N Engl J Med 327: 1434–1441.
Lund, B, Kristjansen, PEG & Hansen, HH (1993) Clinical and preclinical activity of 2′,2′- difluoro-2′-difluorodeoxycytidine (gemcitabine). Cancer Treat Rev 19: 45–55.
Non-small Cell Lung Cancer Collaborative Group (1995) Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomized clinical trials. Br Med J 311: 899–909.
Piazza, E, Isa, L & Pavia, GF et al (1997). Gemcitabine in the treatment of pretreated metastatic non-small cell lung cancer: a preliminary report. Lung Cancer (suppl) World Conference on Lung Cancer, Dublin (Abstract no 138).
Rapp, E, Parer, IL & Willan, A et al (1988) Chemotherapy can prolong survival in patents with advanced non-small cell lung cancer: report of a Canadian multicenter randomized trial. J Clin Oncol 6: 633–641.
Rosvold, E, Langer, CJ & Schelder, R et al (1998) Salvage therapy with gemcitabine in advanced non-small cell lung cancer progressing after prior carboplatin-paclitaxel. Proc Am Soc Clin Oncol 12: 1797
Rothenberg, ML, Moore, MJ & Cripps, MC et al (1996) A phase II trial of gemcitabine in patients with 5-FU refractory pancreas cancer. Ann Oncol 7: 347–352.
Shepherd, F, Cormier, Y & Burkes, R et al (1997) Phase II trial study of gemcitabine and weekly cisplatin for advanced non-small cell lung cancer. Semin Oncol 24, (suppl 8) S27–S30.
Word Health Organization (1979). WHO Handbook for Reporting Results of Cancer Treatment p. 48. WHO: Geneva
Author information
Authors and Affiliations
Additional information
Hospital Durand, Buenos Aires, Argentina
Hospital Municipal de Oncologia Marie Curie, Buenos Aires, Argentina
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
Kooten, M., Traine, G., Cinat, G. et al. Single-agent gemcitabine in pretreated patients with non-small-cell lung cancer: results of an Argentinean multicentre phase II trial. Br J Cancer 81, 846–849 (1999). https://doi.org/10.1038/sj.bjc.6690774
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1038/sj.bjc.6690774
Keywords
This article is cited by
-
Single agent gemcitabine in the second-line treatment of advanced non-small cell lung cancer after treatment with taxane + platinum regimens
Medical Oncology (2008)
-
Phase II study of weekly chemotherapy with paclitaxel and gemcitabine as second-line treatment for advanced non-small cell lung cancer after treatment with platinum-based chemotherapy
Cancer Chemotherapy and Pharmacology (2007)
-
Non-small-cell lung cancer progression after first-line chemotherapy
Current Treatment Options in Oncology (2002)