Abstract
The aim of the study was to evaluate efficacy and tolerance of epirubicin and gemcitabine as first-line chemotherapy in patients with advanced non-small-cell lung cancer. A phase I study was performed with the combination of escalating doses of epirubicin intravenously on day 1 and a fixed dose of gemcitabine on days 1 and 8 of a 21-day cycle. Eighteen patients were included in the phase I part of the study before the maximum tolerated dose was found. Dose-limiting toxicity was febrile neutropenia. The phase II part of the study was continued with epirubicin 100 mg m–2on day 1 and gemcitabine 1125 mg m–2on days 1 and 8 of a 21-day cycle. Forty-three chemotherapy-naive patients were included. The median age of the patients was 60 years (range 26–75). Most patients (74%) were in stage IV. Granulocytopenia CTC grade 4 occurred in 32.5% and thrombocytopenia grade 4 in 11.6% of cycles. Febrile neutropenia occurred in six patients. Non-haematological toxicity was mainly mucositis CTC grade 2 and 3 in 35% of patients. The tumour response rate was 49% (95% confidence interval (CI) 35–63%). The median survival time for the patients was 42 weeks (95% CI 13–69). © 2000 Cancer Research Campaign
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 NK, Culla Kaasa S and Sprangers MAG (1994) The EORTC modular approach to quality of life assessment in oncology. Int J Mental Health 23: 75–96
Abratt RP, Bezwoda WR, Falkson G, Goedhals L, Hacking D and Rugg TA (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 RW, Goedhals T and Hacking DJ (1997) Weekly gemcitabine with monthly cisplatin: effective chemotherapy for advanced non-small-cell lung cancer. J Clin Oncol 15: 744–749
American Society of Clinical Oncology (1997) Clinical practice guidelines for the treatment of unresectable non-small-cell lung cancer. J Clin Oncol 15: 2996–3018
Anton A, Diaz-Fernandez N, Gonzalez Larriba JL, Vadell C, Masutti B, Montalar J, Barneto I, Artal A and Rosell R (1998) Phase II trial assessing the combination of gemcitabine and cisplatin in advanced non-small-cell lung cancer. Lung Cancer 22: 139–149
Bakker M, Groen HJM, Smit EF, Smeets JBE, Riggi M and Postmus PE (1995) Phase I study of high-dose epirubicin and vinorelbine in previously untreated non-small-cell lung cancer stage IIIb–IV. Br J Canc 72: 1547–1550
Billingham LJ, Cullen MH, Woods J, Chetiyawardane AD, Joshi RC, Cook J and Woodroffe CM (1998) Mitomycine, ifosfamide and cisplatin in non-small-cell lung cancer: results of a randomized trial evaluating palliation and quality of life. Lung Cancer 18: 9 (abstract 26)
Brocato N, Bruno MF, Araujo CE, Cervellino JC, Pirisi C, Temperley G, Sparrow C, Savulsky C and Balbiani LR (1995) Treatment of non-small-cell lung cancer with ifosfamide and epirubicin and platinum versus ifosfamide and epirubicin. Oncology 52: 24–31
Bunn PA (1989) The expanding role of cisplatin in the treatment of non-small-cell lung cancer. Semin Oncol 16: 27–33
Cardenal F, Paz Lopez-Cabrerizo M, Anton A, Alberola V, Massuti B, Carrato A, Barneto I, Lomas M, Garcia M, Lianes P, Montalar J, Vadell C, Gonzelez-Larriba JL, Nguyen B, Artal A and Rosell R (1999) Randomized phase III study of gemcitabine–cisplatin versus etoposide–cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 17: 12–17
Crino L, Scagliotti G, Marangolo M, Figoli F, Clerici M, DE Marinis F, Salvati F, Cruciani G, Dogliotti L, Pucci F, Paccagnella A, Adamo V, Altavilla G, Incoronato P, Trippetti M, Mosconi AM, Santucci A, Sorbolini S, Oliva C and Tonato M (1997) Cisplatin–gemcitabine combination in advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 15: 297–303
Crino L, Conte P, DE Marinis F, Rinaldi M, Gridelli C, Ceribelli A, Matano E, Marangola M, Bartolucci R, Oliva C and Tonto M for the Italian Lung Cancer Project (1998) A randomized trial of gemcitabine–cisplatin versus mitomycine, ifosfamide and cisplatin in advanced non-small-cell lung cancer. A multicenter phase III study. Proc Am Soc Clin Oncol 17: 455a (abstract 1750)
Cullen MH (1993) The MIC-regimen in non-small-cell lung cancer. Lung Cancer 14: 81–89
Feld R, Wierzbicki R, Walde PLD, Shepherd FA, Evans WK, Gupta S, Shannon P and Lassus M (1992) Phase I–II study of high-dose epirubicin in advanced non-small-cell lung cancer. J Clin Oncol 10: 297–303
Gatzemeier U, Shepherd FA, LE Chevalier T, Weynants P, Cottier B, Groen HJM, Rosso R, Mattson K, Cortes-Funes H, Tonato M, Burkes RL, Gottfried M and Voi M (1996) Activity of gemcitabine in patients with non-small-cell lung cancer: a multicentre, extended phase II study. Eur J Cancer 32: 243–248
Georgoulias V, Kouroussis C, Androlakis N, Kakol Yris S, Dimopoulos MA, Papadakis E, Bouros D, Apostolopoulou F, Papadimitriou C, Agelidou A, Hatzakis K, Kalkabis K, Kotsakis A, Vardakis N and Vlachonicolis J (1999) Front-line treatment of advanced non-small-cell lung cancer with docetaxel and gemcitabine: a multicenter phase II trial. J Clin Oncol 17: 914–920
Grant SC, Gralle RJ, Kris MG, Orazen J and Kitsis EA (1992) Single-agent chemotherapy trials in small-cell lung cancer, 1970 to 1990: the case for studies in previously treated patients. J Clin Oncol 10: 484–498
Launchbury AP and Habboubi N (1993) Epirubicin and doxorubicin: a comparison of their characteristics, therapeutic activity and toxicity. Cancer Treat Rev 19: 197–228
Lilenbaum RC, Langenberg P and Dickersin K (1998) Single agent versus combination chemotherapy in patients with advanced non-small-cell lung cancer. Cancer 82: 116–126
Marino P, Pampallona S, Preatoni A, Cantoni A and Invernizzi F (1994) Chemotherapy versus supportive care in advanced non-small-cell lung cancer: results of a meta-analysis of the literature. Chest 106: 861–865
NSCLC Collaborative Group (1995) Chemotherapy in non-small-cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. Br Med J 311: 899–909
Plosker GL and Faulds D (1993) Epirubicin. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cancer chemotherapy. Drugs 45: 788–856
Sandler AB, Ansari R, McClean J, Fisher W, Dorr A and Einhorn LH (1995) A Hoosier Oncology Group phase II study of gemcitabine plus cisplatin in non-small-cell lung cancer. Proc Am Soc Clin Oncol 14: 357 (abstract 1089)
Sandler A, Crino L and Steward WP (1996) Extended survival in stage III and IV non-small-cell lung cancer patients treated with gemcitabine plus monthly cisplatin. Ann Oncol 7: 91
Sandler A, Nemunaitis J, Dehnam C, Cormier Y, Von Pawel J, Niyikiza C, Nguyen B and Einhorn L Hoosier Oncology Group (1998) Phase III study of cisplatin with or without gemcitabine in patients with advanced non-small-cell lung cancer. Proc Am Soc Clin Oncol 17: 454a, (abstract 1747)
Smit EF, Berendsen HH, Piers DA, Smeets J, Riva A and Postmus PE (1992) A phase II study of high dose epirubicin in unresectable non-small-cell lung cancer. Br J Cancer 65: 405–408
Souquet PJ, Chauvin F, Boissel JP, Cellerino R, Cormier Y, Ganz PA, Kaasa S, Pater JL, Quoix E, Rapp E, Tumarello D, Williams J and Bernard JP (1993) Polychemotherapy in advanced non-small-cell lung cancer: a meta-analysis. Lancet 342: 19–21
Wilkes JD (1998) Prevention and treatment of oral mucositis following cancer chemotherapy. Semin Oncol 25: 538–551
Wils J, Ultama I, Sala L, Smeets J and Riva A (1990) Phase II study of high dose epirubicin in non-small-cell lung cancer. Eur J Cancer 26: 1140–1141
Who World Health Organization (1979). WHO Handbook for Reporting Results of Cancer Treatment, Geneva, Switzerland
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
van Putten, J., Eppinga, P., Erjavec, Z. et al. Activity of high-dose epirubicin combined with gemcitabine in advanced non-small-cell lung cancer: a multicenter phase I and II study. Br J Cancer 82, 806–811 (2000). https://doi.org/10.1054/bjoc.1999.1003
Received:
Revised:
Accepted:
Published:
Issue date:
DOI: https://doi.org/10.1054/bjoc.1999.1003
Keywords
This article is cited by
-
Detection of risk factors related to administration suspension and severe neutropenia in gemcitabine and nab-paclitaxel treatment
Supportive Care in Cancer (2021)
-
A phase I/II multicentric trial of gemcitabine and epirubicin in patients with advanced pancreatic carcinoma
British Journal of Cancer (2006)
-
First-line gemcitabine with cisplatin or epirubicin in advanced non-small-cell lung cancer: a phase III trial
British Journal of Cancer (2003)
-
Weekly gemcitabine plus Epirubicin as effective chemotherapy for advanced pancreatic cancer: a multicenter phase II study
British Journal of Cancer (2002)
