Skip to main content
Erschienen in: Drugs 10/2007

01.07.2007 | Leading Article

Oral Vinorelbine in the Treatment of Non-Small Cell Lung Cancer

Rationale and Implications for Patient Management

verfasst von: Dr Richard J. Gralla, Ulrich Gatzemeier, Vittorio Gebbia, Rudolf Huber, Mary O’Brien, Christian Puozzo

Erschienen in: Drugs | Ausgabe 10/2007

Einloggen, um Zugang zu erhalten

Abstract

Vinorelbine is an established treatment for advanced non-small cell lung cancer (NSCLC), both as a single agent and in combination chemotherapy. Recently, an oral form of this agent has been developed. Before accepting an established agent in a different administration form, rigorous testing is required to answer such questions as reliable bioavailability, continued safety and preservation of efficacy. In addition, an oral agent must provide patient convenience and acceptance, while being an economically sound approach.
Oral vinorelbine was found to have acceptable and reliable pharmacokinetic profiles at clinically relevant dosage levels. Oral vinorelbine was found to have approximately 40% bioavailability; thus, a dose of 80 mg/m2 orally is the equivalent of 30 mg/m2 intravenously, and 60 mg/m2 orally is the equivalent of 25 mg/m2 intravenously. Studies also concluded a lack of food effect on the administration of oral vinorelbine. In addition, no drug-drug interactions were found with a variety of commonly used antineoplastic agents.
Vinorelbine, either orally or intravenously, has been investigated in randomised phase II trials as a single agent and in combination with cisplatin or carboplatin in patients with NSCLC. In general, response and survival results with oral vinorelbine appeared similar to the intravenous agent. Adverse-effect profiles were also similar for the two formulations. Clearly, the issue of venous irritation does not exist with oral vinorelbine; however, nausea and vomiting were more frequent when vinorelbine was administered orally compared with intravenously when no planned antiemetic therapy is given.
Literatur
1.
Zurück zum Zitat Liu G, Franssen E, Fitch MI, et al. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997 Jan; 15(1): 110–5PubMed Liu G, Franssen E, Fitch MI, et al. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997 Jan; 15(1): 110–5PubMed
2.
Zurück zum Zitat Borner MM, Schoffski P, de Wit R, et al. Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer 2002 Feb; 38(3): 349–58PubMedCrossRef Borner MM, Schoffski P, de Wit R, et al. Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomised crossover trial in advanced colorectal cancer. Eur J Cancer 2002 Feb; 38(3): 349–58PubMedCrossRef
3.
Zurück zum Zitat Coates A, Dillenbeck CF, McNeil DR, et al. On the receiving end II: linear analogue self-assessment (LASA) in evaluation of aspects of the quality of life of cancer patients receiving therapy. Eur J Cancer Clin Oncol 1983 Nov; 19(11): 1633–7PubMedCrossRef Coates A, Dillenbeck CF, McNeil DR, et al. On the receiving end II: linear analogue self-assessment (LASA) in evaluation of aspects of the quality of life of cancer patients receiving therapy. Eur J Cancer Clin Oncol 1983 Nov; 19(11): 1633–7PubMedCrossRef
4.
Zurück zum Zitat Griffin AM, Butow PN, Coates AS, et al. On the receiving end V: patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol 1996 Feb; 7(2): 189–95PubMedCrossRef Griffin AM, Butow PN, Coates AS, et al. On the receiving end V: patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol 1996 Feb; 7(2): 189–95PubMedCrossRef
5.
Zurück zum Zitat Grim J, Chladek J, Martinkova J. Pharmacokinetics and pharmacodynamics of methotrexate in non-neoplastic diseases. Clin Pharmacokinet 2003; 42(2): 139–51PubMedCrossRef Grim J, Chladek J, Martinkova J. Pharmacokinetics and pharmacodynamics of methotrexate in non-neoplastic diseases. Clin Pharmacokinet 2003; 42(2): 139–51PubMedCrossRef
6.
Zurück zum Zitat Toffoli G, Corona G, Basso B, et al. Pharmacokinetic optimisation of treatment with oral etoposide. Clin Pharmacokinet 2004; 43(7): 441–66PubMedCrossRef Toffoli G, Corona G, Basso B, et al. Pharmacokinetic optimisation of treatment with oral etoposide. Clin Pharmacokinet 2004; 43(7): 441–66PubMedCrossRef
7.
Zurück zum Zitat Hoff PM, Royce M, Medgyesy D, et al. Oral fluoropoyrimidines. Semin Oncol 1999 Dec; 26(6): 640–6PubMed Hoff PM, Royce M, Medgyesy D, et al. Oral fluoropoyrimidines. Semin Oncol 1999 Dec; 26(6): 640–6PubMed
8.
Zurück zum Zitat Ormrod D, Spencer CM. Topotecan: a review of its efficacy in small cell lung cancer. Drugs 1999 Sep; 58(3): 533–51PubMedCrossRef Ormrod D, Spencer CM. Topotecan: a review of its efficacy in small cell lung cancer. Drugs 1999 Sep; 58(3): 533–51PubMedCrossRef
9.
Zurück zum Zitat Hoff PM. Practical considerations in the use of oral fluoropyrimidines. Semin Oncol 2003 Jun; 30 (3 Suppl. 6): 88–92PubMedCrossRef Hoff PM. Practical considerations in the use of oral fluoropyrimidines. Semin Oncol 2003 Jun; 30 (3 Suppl. 6): 88–92PubMedCrossRef
10.
Zurück zum Zitat Gridelli C, Manegold C, Mali P, et al. Oral vinorelbine given as monotherapy to advanced, elderly NSCLC patients: a multicentre phase II trial. Eur J Cancer 2004 Nov; 40(16): 2424–31PubMedCrossRef Gridelli C, Manegold C, Mali P, et al. Oral vinorelbine given as monotherapy to advanced, elderly NSCLC patients: a multicentre phase II trial. Eur J Cancer 2004 Nov; 40(16): 2424–31PubMedCrossRef
11.
Zurück zum Zitat O’Brien ME, Szczesna A, Karnicka H, et al. Vinorelbine alternating oral and intravenous plus carboplatin in advanced non-small-cell lung cancer: results of a multicentre phase II study. Ann Oncol 2004 Jun; 15(6): 921–7PubMedCrossRef O’Brien ME, Szczesna A, Karnicka H, et al. Vinorelbine alternating oral and intravenous plus carboplatin in advanced non-small-cell lung cancer: results of a multicentre phase II study. Ann Oncol 2004 Jun; 15(6): 921–7PubMedCrossRef
12.
Zurück zum Zitat Variol P, Nguyen L, Tranchand B, et al. A simultaneous oral/ intravenous population pharmacokinetic model for vinorelbine. Eur J Clin Pharmacol 2002 Oct; 58(7): 467–76PubMedCrossRef Variol P, Nguyen L, Tranchand B, et al. A simultaneous oral/ intravenous population pharmacokinetic model for vinorelbine. Eur J Clin Pharmacol 2002 Oct; 58(7): 467–76PubMedCrossRef
13.
Zurück zum Zitat Marty M, Fumoleau P, Adenis A, et al. Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumors. Ann Oncol 2001 Nov; 12(11): 1643–9PubMedCrossRef Marty M, Fumoleau P, Adenis A, et al. Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumors. Ann Oncol 2001 Nov; 12(11): 1643–9PubMedCrossRef
14.
Zurück zum Zitat Bugat R, Variol P, Roche H, et al. The effects of food on the pharmacokinetic profile of oral vinorelbine. Cancer Chemother Pharmacol 2002 Oct; 50(4): 285–90PubMedCrossRef Bugat R, Variol P, Roche H, et al. The effects of food on the pharmacokinetic profile of oral vinorelbine. Cancer Chemother Pharmacol 2002 Oct; 50(4): 285–90PubMedCrossRef
15.
Zurück zum Zitat Puozzo C, Gridelli C. Non-small-cell lung cancer in elderly patients: influence of age on vinorelbine oral pharmacokinetics. Clin Lung Cancer 2004 Jan; 5(4): 237–42PubMedCrossRef Puozzo C, Gridelli C. Non-small-cell lung cancer in elderly patients: influence of age on vinorelbine oral pharmacokinetics. Clin Lung Cancer 2004 Jan; 5(4): 237–42PubMedCrossRef
16.
Zurück zum Zitat Goa KL, Faulds D. Vinorelbine: a review of its pharmacological properties and clinical use in cancer chemotherapy [published erratum appears in Drugs Aging 1995 Aug; 7 (2): 116]. Drugs Aging 1994 Sep; 5(3): 200–34PubMedCrossRef Goa KL, Faulds D. Vinorelbine: a review of its pharmacological properties and clinical use in cancer chemotherapy [published erratum appears in Drugs Aging 1995 Aug; 7 (2): 116]. Drugs Aging 1994 Sep; 5(3): 200–34PubMedCrossRef
17.
Zurück zum Zitat Aapro MS, Harper P, Johnson S, et al. Developments in cytotoxic chemotherapy: advances in treatment utilising vinorelbine. Crit Rev Oncol Hematol 2001 Dec; 40(3): 251–63PubMedCrossRef Aapro MS, Harper P, Johnson S, et al. Developments in cytotoxic chemotherapy: advances in treatment utilising vinorelbine. Crit Rev Oncol Hematol 2001 Dec; 40(3): 251–63PubMedCrossRef
18.
Zurück zum Zitat Anderson H, Hopwood P, Stephens RJ, et al. Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer: a randomized trial with quality of life as the primary outcome. UK NSCLC Gemcitabine Group. Non-Small Cell Lung Cancer. Br J Cancer 2000; 83(4): 447–53 Anderson H, Hopwood P, Stephens RJ, et al. Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer: a randomized trial with quality of life as the primary outcome. UK NSCLC Gemcitabine Group. Non-Small Cell Lung Cancer. Br J Cancer 2000; 83(4): 447–53
19.
Zurück zum Zitat Gridelli C. The ELVIS trial: a phase III study of single-agent vinorelbine as first-line treatment in elderly patients with advanced non-small cell lung cancer. Elderly Lung Cancer Vinorelbine Italian Study. Oncologist 2001; 6 Suppl. 1: 4–7 Gridelli C. The ELVIS trial: a phase III study of single-agent vinorelbine as first-line treatment in elderly patients with advanced non-small cell lung cancer. Elderly Lung Cancer Vinorelbine Italian Study. Oncologist 2001; 6 Suppl. 1: 4–7
20.
Zurück zum Zitat Ranson M, Davidson N, Nicolson M, et al. Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 2000; 92(13): 1074–80PubMedCrossRef Ranson M, Davidson N, Nicolson M, et al. Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 2000; 92(13): 1074–80PubMedCrossRef
21.
Zurück zum Zitat Roszkowski K, Pluzanska A, Krzakowski M, et al. A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapynaive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC). Lung Cancer 2000 Mar; 27(3): 145–57PubMedCrossRef Roszkowski K, Pluzanska A, Krzakowski M, et al. A multicenter, randomized, phase III study of docetaxel plus best supportive care versus best supportive care in chemotherapynaive patients with metastatic or non-resectable localized non-small cell lung cancer (NSCLC). Lung Cancer 2000 Mar; 27(3): 145–57PubMedCrossRef
22.
Zurück zum Zitat Thatcher N, Chang A, Parikh P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005; 366 (9496): 1527–37 Thatcher N, Chang A, Parikh P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005; 366 (9496): 1527–37
23.
Zurück zum Zitat Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005 Jul 14; 353(2): 123–32PubMedCrossRef Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005 Jul 14; 353(2): 123–32PubMedCrossRef
24.
Zurück zum Zitat Jassem J, Ramlau R, Karnicka-Mlodkowska H, et al. A multicenter randomized phase II study of oral vs. intravenous vinorelbine in advanced non-small-cell lung cancer patients [published erratum appears in Ann Oncol 2002 Mar; 13 (3): 493]. Ann Oncol 2001 Oct; 12(10): 1375–81PubMedCrossRef Jassem J, Ramlau R, Karnicka-Mlodkowska H, et al. A multicenter randomized phase II study of oral vs. intravenous vinorelbine in advanced non-small-cell lung cancer patients [published erratum appears in Ann Oncol 2002 Mar; 13 (3): 493]. Ann Oncol 2001 Oct; 12(10): 1375–81PubMedCrossRef
25.
Zurück zum Zitat Jordan K, Kasper C, Schmoll HJ. Chemotherapy-induced nausea and vomiting: current and new standards in the antiemetic prophylaxis and treatment. Eur J Cancer 2005 Jan; 41(2): 199–205PubMedCrossRef Jordan K, Kasper C, Schmoll HJ. Chemotherapy-induced nausea and vomiting: current and new standards in the antiemetic prophylaxis and treatment. Eur J Cancer 2005 Jan; 41(2): 199–205PubMedCrossRef
26.
Zurück zum Zitat Socinski MA. Cytotoxic chemotherapy in advanced non-small cell lung cancer: a review of standard treatment paradigms. Clin Cancer Res 2004 Jun; 10 (12 Pt 2): 4210–14sCrossRef Socinski MA. Cytotoxic chemotherapy in advanced non-small cell lung cancer: a review of standard treatment paradigms. Clin Cancer Res 2004 Jun; 10 (12 Pt 2): 4210–14sCrossRef
27.
Zurück zum Zitat Barlesi F, Pujol JL. Combination of chemotherapy without platinum compounds in the treatment of advanced non-small cell lung cancer: a systematic review of phase III trials. Lung Cancer 2005 Sep; 49(3): 289–98PubMedCrossRef Barlesi F, Pujol JL. Combination of chemotherapy without platinum compounds in the treatment of advanced non-small cell lung cancer: a systematic review of phase III trials. Lung Cancer 2005 Sep; 49(3): 289–98PubMedCrossRef
28.
Zurück zum Zitat Gebbia V. Prospective randomized study of cisplatin plus weekly vinorelbine versus CDDP plus day 1+8 vinorelbine in advanced non small cell lung cancer. Proceedings of the 15th International Congress on Anti-Cancer Treatment (ICACT); 2004 Feb 9–12; Paris Gebbia V. Prospective randomized study of cisplatin plus weekly vinorelbine versus CDDP plus day 1+8 vinorelbine in advanced non small cell lung cancer. Proceedings of the 15th International Congress on Anti-Cancer Treatment (ICACT); 2004 Feb 9–12; Paris
29.
Zurück zum Zitat Jassem J, Kosmidis P, Ramlau R, et al. Oral vinorelbine in combination with cisplatin: a novel active regimen in advanced non-small-cell lung cancer. Ann Oncol 2003 Nov; 14(11): 1634–9PubMedCrossRef Jassem J, Kosmidis P, Ramlau R, et al. Oral vinorelbine in combination with cisplatin: a novel active regimen in advanced non-small-cell lung cancer. Ann Oncol 2003 Nov; 14(11): 1634–9PubMedCrossRef
30.
Zurück zum Zitat De Lena MD, Ramlau R, Hansen O. Phase II trial of oral vinorelbine in combination with cisplatin followed by consolidation therapy with oral vinorelbine in advanced NSCLC. Lung Cancer 2005 Apr; 48(1): 129–35PubMedCrossRef De Lena MD, Ramlau R, Hansen O. Phase II trial of oral vinorelbine in combination with cisplatin followed by consolidation therapy with oral vinorelbine in advanced NSCLC. Lung Cancer 2005 Apr; 48(1): 129–35PubMedCrossRef
31.
Zurück zum Zitat Pronzato P, Ghio E, Losardo PL, et al. Carboplatin and vinorelbine in advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 1996; 37(6): 610–2PubMedCrossRef Pronzato P, Ghio E, Losardo PL, et al. Carboplatin and vinorelbine in advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 1996; 37(6): 610–2PubMedCrossRef
32.
Zurück zum Zitat Santomaggio C, Tucci E, Rinaldini M, et al. Carboplatin and vinorelbine in the treatment of advanced non-small-cell lung cancer: a multicenter phase II study. Am J Clin Oncol 1998 Feb; 21(1): 67–71PubMedCrossRef Santomaggio C, Tucci E, Rinaldini M, et al. Carboplatin and vinorelbine in the treatment of advanced non-small-cell lung cancer: a multicenter phase II study. Am J Clin Oncol 1998 Feb; 21(1): 67–71PubMedCrossRef
33.
Zurück zum Zitat Cremonesi M, Mandala M, Cazzaniga M, et al. Vinorelbine and carboplatin in inoperable non-small cell lung cancer: a monoinstitutional phase II study. Oncology 2003; 64(2): 97–101PubMedCrossRef Cremonesi M, Mandala M, Cazzaniga M, et al. Vinorelbine and carboplatin in inoperable non-small cell lung cancer: a monoinstitutional phase II study. Oncology 2003; 64(2): 97–101PubMedCrossRef
34.
Zurück zum Zitat Pignon JP, Stewart LA. Randomized trials of radiotherapy alone versus combined chemotherapy and radiotherapy in stages IIIa and IIIb non small cell lung cancer: a meta-analysis. Cancer 1996 Jun; 77(11): 2413–4PubMedCrossRef Pignon JP, Stewart LA. Randomized trials of radiotherapy alone versus combined chemotherapy and radiotherapy in stages IIIa and IIIb non small cell lung cancer: a meta-analysis. Cancer 1996 Jun; 77(11): 2413–4PubMedCrossRef
35.
Zurück zum Zitat Fournel P, Robinet G, Thomas P, et al. Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d’Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study. J Clin Oncol 2005 Sep; 23(25): 5910–7PubMedCrossRef Fournel P, Robinet G, Thomas P, et al. Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d’Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study. J Clin Oncol 2005 Sep; 23(25): 5910–7PubMedCrossRef
36.
Zurück zum Zitat Schaake-Koning C, van den Bogaert W, Dalesio O, et al. Effects of concomitant cisplatin and radiotherapy on inoperable non-small-cell lung cancer. N Engl J Med 1992 Feb; 326(8): 524–30PubMedCrossRef Schaake-Koning C, van den Bogaert W, Dalesio O, et al. Effects of concomitant cisplatin and radiotherapy on inoperable non-small-cell lung cancer. N Engl J Med 1992 Feb; 326(8): 524–30PubMedCrossRef
37.
Zurück zum Zitat Vokes EE, Herndon JE II, Crawford J, et al. Randomized phase II study of cisplatin with gemcitabine or paclitaxel or vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy for stage IIIB non-small-cell lung cancer: cancer and leukemia group B study 9431. J Clin Oncol 2002 Oct; 20(20): 4191–8PubMedCrossRef Vokes EE, Herndon JE II, Crawford J, et al. Randomized phase II study of cisplatin with gemcitabine or paclitaxel or vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy for stage IIIB non-small-cell lung cancer: cancer and leukemia group B study 9431. J Clin Oncol 2002 Oct; 20(20): 4191–8PubMedCrossRef
38.
Zurück zum Zitat Krzakowski M, Provencio M, Utracka-Hutka B, et al. A new option for the treatment of stage III non-small lung cancer (NSCLC) [abstract no. P-520]. Poster presented at World Conference on Lung Cancer; 2005 Jul 3–6; Barcelona Krzakowski M, Provencio M, Utracka-Hutka B, et al. A new option for the treatment of stage III non-small lung cancer (NSCLC) [abstract no. P-520]. Poster presented at World Conference on Lung Cancer; 2005 Jul 3–6; Barcelona
39.
Zurück zum Zitat Beckmann G, Fietkau R, Huber RM, et al. Oral vinorelbine and cisplatin with concomitant radiotherapy in stage III non-small cell lung cancer (NSCLC): a feasibility study. Onkologie 2006 Apr; 29(4): 137–42PubMedCrossRef Beckmann G, Fietkau R, Huber RM, et al. Oral vinorelbine and cisplatin with concomitant radiotherapy in stage III non-small cell lung cancer (NSCLC): a feasibility study. Onkologie 2006 Apr; 29(4): 137–42PubMedCrossRef
Metadaten
Titel
Oral Vinorelbine in the Treatment of Non-Small Cell Lung Cancer
Rationale and Implications for Patient Management
verfasst von
Dr Richard J. Gralla
Ulrich Gatzemeier
Vittorio Gebbia
Rudolf Huber
Mary O’Brien
Christian Puozzo
Publikationsdatum
01.07.2007
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 10/2007
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.2165/00003495-200767100-00003

Weitere Artikel der Ausgabe 10/2007

Drugs 10/2007 Zur Ausgabe

Adis Drug Evaluation

Daptomycin