Skip to main content
Top
Published in: Cancer Chemotherapy and Pharmacology 1/2011

01-01-2011 | Original Article

Biweekly vinorelbine and gemcitabine as second-line and beyond treatment in ovarian cancer

Authors: N. Xenidis, K. Neanidis, K. Amarantidis, P. Dimopoulos, E. Chamalidou, D. Pitsiava, A. Tentes, E. Chatzaki, P. Karakitsos, S. Kakolyris

Published in: Cancer Chemotherapy and Pharmacology | Issue 1/2011

Login to get access

Abstract

Purpose

To evaluate the activity and tolerance of vinorelbine (VRL) in combination with gemcitabine (GEM) in pre-treated patients with refractory ovarian cancer.

Patients and methods

Seventeen patients with ovarian cancer who had disease progression after a carboplatin and taxane front-line regimen were treated with VRL 30 mg/m2 IV over 10 min followed by GEM 1,200 mg/m2 IV over 30 min on days 1 and 15 of each 28 days cycle. Chemotherapy was given in a initial prospective plan of six cycles, unless disease progression or unacceptable toxicity was seen, giving more cycles as consolidation therapy in the case of CR, PR or SD. The median age of patients was 67 years old, and the performance status (WHO) was 1 for 13 and 2 for 4 patients. The treatment was second-line for 11 (65%) and >third-line for 6 (35%) patients.

Results

One complete and one partial response were observed (ORR:11%). Stable disease was seen in 4 (24%) patients and progressive disease in 11 (65%). The median time to tumor progression was 4 months (range 2–11), and the median survival has not yet been reached. Myelotoxicity was rare. Grade 1 neutropenia was observed just in one patient and grade 2/3 anemia in four patients (24%). Thrombocytopenia was absent. Non-hematologic toxicity was also predictable and easily manageable.

Conclusion

The vinorelbine plus gemcitabine combination at the present doses and schedule is a safe but ineffective regimen, and therefore, is not recommended as second-line and beyond treatment in patients with refractory ovarian cancer.
Literature
1.
go back to reference Markman M (1998) “Recurrence within 6 months of platinum therapy”: an adequate definition of “platinum-refractory” ovarian cancer? Gynecol Oncol 69:91–92CrossRefPubMed Markman M (1998) “Recurrence within 6 months of platinum therapy”: an adequate definition of “platinum-refractory” ovarian cancer? Gynecol Oncol 69:91–92CrossRefPubMed
2.
go back to reference Fung-Kee-Fung M, Oliver T, Elit L et al (2007) Optimal chemotherapy treatment for women with recurrent ovarian cancer. Curr Oncol 14:195–208CrossRefPubMed Fung-Kee-Fung M, Oliver T, Elit L et al (2007) Optimal chemotherapy treatment for women with recurrent ovarian cancer. Curr Oncol 14:195–208CrossRefPubMed
3.
go back to reference Lorusso D, Di Stefano A, Fanfani F et al (2006) Role of gemcitabine in ovarian cancer treatment. Ann Oncol 17:188–194 (abstr)CrossRef Lorusso D, Di Stefano A, Fanfani F et al (2006) Role of gemcitabine in ovarian cancer treatment. Ann Oncol 17:188–194 (abstr)CrossRef
4.
go back to reference Rothenberg ML, Liu PY, Wilczynski S et al (2004) Phase II trial of vinorelbine for relapsed ovarian cancer: a southwest oncology group study. Gynecol Oncol 95:506–512CrossRefPubMed Rothenberg ML, Liu PY, Wilczynski S et al (2004) Phase II trial of vinorelbine for relapsed ovarian cancer: a southwest oncology group study. Gynecol Oncol 95:506–512CrossRefPubMed
5.
go back to reference Besenval M, Delgado M, Demarez JP et al (1989) Safety and tolerance of Navelbine in phase I-II clinical studies. Semin Oncol 16:37–40PubMed Besenval M, Delgado M, Demarez JP et al (1989) Safety and tolerance of Navelbine in phase I-II clinical studies. Semin Oncol 16:37–40PubMed
6.
go back to reference Carmichael J (1998) The role of gemcitabine in the treatment of other tumours. Br J Cancer 78(Suppl 3):21–25PubMed Carmichael J (1998) The role of gemcitabine in the treatment of other tumours. Br J Cancer 78(Suppl 3):21–25PubMed
7.
go back to reference Huang P, Chubb S, Hertel LW et al (1991) Action of 2′, 2′-difluorodeoxycytidine on DNA synthesis. Cancer Res 51:6110–6117PubMed Huang P, Chubb S, Hertel LW et al (1991) Action of 2′, 2′-difluorodeoxycytidine on DNA synthesis. Cancer Res 51:6110–6117PubMed
8.
go back to reference Juergens R, Brahmer J, Ettinger D (2007) Gemcitabine and vinorelbine in recurrent advanced non-small cell lung cancer: sequence does matter. Cancer Chemother Pharmacol 59:621–629CrossRefPubMed Juergens R, Brahmer J, Ettinger D (2007) Gemcitabine and vinorelbine in recurrent advanced non-small cell lung cancer: sequence does matter. Cancer Chemother Pharmacol 59:621–629CrossRefPubMed
9.
go back to reference Stathopoulos GP, Rigatos SK, Pergantas N et al (2002) Phase II trial of biweekly administration of vinorelbine and gemcitabine in pretreated advanced breast cancer. J Clin Oncol 20:37–41CrossRefPubMed Stathopoulos GP, Rigatos SK, Pergantas N et al (2002) Phase II trial of biweekly administration of vinorelbine and gemcitabine in pretreated advanced breast cancer. J Clin Oncol 20:37–41CrossRefPubMed
10.
go back to reference Cattel L, Airoldi M, Passera R et al (2004) Gemcitabine plus vinorelbine chemotherapy regimens: a pharmacokinetic study of alternate administration sequences. Pharm World Sci 26:238–241CrossRefPubMed Cattel L, Airoldi M, Passera R et al (2004) Gemcitabine plus vinorelbine chemotherapy regimens: a pharmacokinetic study of alternate administration sequences. Pharm World Sci 26:238–241CrossRefPubMed
11.
go back to reference Therasse P, Arbuck SG, Eisenhauer EA et al (2000) New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, national cancer institute of the United States, national cancer institute of Canada. J Natl Cancer Inst 92:205–216CrossRefPubMed Therasse P, Arbuck SG, Eisenhauer EA et al (2000) New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, national cancer institute of the United States, national cancer institute of Canada. J Natl Cancer Inst 92:205–216CrossRefPubMed
12.
go back to reference Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1–10CrossRefPubMed Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1–10CrossRefPubMed
13.
go back to reference Kaplan E, Meier P (1958) Nonparametric estimation from incomplete observations, 53rd edn, pp 457–481 Kaplan E, Meier P (1958) Nonparametric estimation from incomplete observations, 53rd edn, pp 457–481
14.
go back to reference Cox DR (1970) The analysis of binary data. London, Methuen Cox DR (1970) The analysis of binary data. London, Methuen
15.
go back to reference Parmar MK, Ledermann JA, Colombo N et al (2003) Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet 361:2099–2106CrossRefPubMed Parmar MK, Ledermann JA, Colombo N et al (2003) Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet 361:2099–2106CrossRefPubMed
16.
go back to reference Pfisterer J, Plante M, Vergote I et al (2006) Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol 24:4699–4707CrossRefPubMed Pfisterer J, Plante M, Vergote I et al (2006) Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol 24:4699–4707CrossRefPubMed
17.
go back to reference Sehouli J, Stengel D, Oskay-Oezcelik G et al (2008) Nonplatinum topotecan combinations versus topotecan alone for recurrent ovarian cancer: results of a phase III study of the North-Eastern German society of gynecological oncology ovarian cancer study group. J Clin Oncol 26:3176–3182CrossRefPubMed Sehouli J, Stengel D, Oskay-Oezcelik G et al (2008) Nonplatinum topotecan combinations versus topotecan alone for recurrent ovarian cancer: results of a phase III study of the North-Eastern German society of gynecological oncology ovarian cancer study group. J Clin Oncol 26:3176–3182CrossRefPubMed
18.
go back to reference Mutch DG, Orlando M, Goss T et al (2007) Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol 25:2811–2818CrossRefPubMed Mutch DG, Orlando M, Goss T et al (2007) Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol 25:2811–2818CrossRefPubMed
19.
go back to reference Gridelli C, Cigolari S, Gallo C et al (2001) Activity and toxicity of gemcitabine and gemcitabine + vinorelbine in advanced non-small-cell lung cancer elderly patients: phase II data from the multicenter Italian lung cancer in the elderly study (MILES) randomized trial. Lung Cancer 31:277–284CrossRefPubMed Gridelli C, Cigolari S, Gallo C et al (2001) Activity and toxicity of gemcitabine and gemcitabine + vinorelbine in advanced non-small-cell lung cancer elderly patients: phase II data from the multicenter Italian lung cancer in the elderly study (MILES) randomized trial. Lung Cancer 31:277–284CrossRefPubMed
20.
go back to reference Zhou NN, Teng XY, Jiang WQ et al (2007) Efficacy and toxicity of gemcitabine combined vinorelbine on metastatic breast cancer: a report of 34 cases. Ai Zheng 26:1373–1376PubMed Zhou NN, Teng XY, Jiang WQ et al (2007) Efficacy and toxicity of gemcitabine combined vinorelbine on metastatic breast cancer: a report of 34 cases. Ai Zheng 26:1373–1376PubMed
21.
go back to reference Martin M, Ruiz A, Munoz M et al (2007) Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish breast cancer research group (GEICAM) trial. Lancet Oncol 8:219–225CrossRefPubMed Martin M, Ruiz A, Munoz M et al (2007) Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish breast cancer research group (GEICAM) trial. Lancet Oncol 8:219–225CrossRefPubMed
22.
go back to reference Herbst RS, Lynch C, Vasconcelles M et al (2001) Gemcitabine and vinorelbine in patients with advanced lung cancer: preclinical studies and report of a phase I trial. Cancer Chemother Pharmacol 48:151–159CrossRefPubMed Herbst RS, Lynch C, Vasconcelles M et al (2001) Gemcitabine and vinorelbine in patients with advanced lung cancer: preclinical studies and report of a phase I trial. Cancer Chemother Pharmacol 48:151–159CrossRefPubMed
23.
go back to reference Budman DR, Calabro A, Kreis W (1998) In vitro evaluation of synergism or antagonism with combinations of new cytotoxic agents. Anticancer Drugs 9:697–702CrossRefPubMed Budman DR, Calabro A, Kreis W (1998) In vitro evaluation of synergism or antagonism with combinations of new cytotoxic agents. Anticancer Drugs 9:697–702CrossRefPubMed
24.
go back to reference Green MR (1996) Gemcitabine safety overview. Semin Oncol 23:32–35PubMed Green MR (1996) Gemcitabine safety overview. Semin Oncol 23:32–35PubMed
Metadata
Title
Biweekly vinorelbine and gemcitabine as second-line and beyond treatment in ovarian cancer
Authors
N. Xenidis
K. Neanidis
K. Amarantidis
P. Dimopoulos
E. Chamalidou
D. Pitsiava
A. Tentes
E. Chatzaki
P. Karakitsos
S. Kakolyris
Publication date
01-01-2011
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 1/2011
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-010-1284-2

Other articles of this Issue 1/2011

Cancer Chemotherapy and Pharmacology 1/2011 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine