Multicenter phase II study of combination chemotherapy with capecitabine and intravenous vinorelbine in patients with pretreated metastatic breast cancer

Asia-Pacific Journal of Clinical Oncology

Volumn 3, Issue 1, 2007, Pages 37-43

  Davis, Alison J ^a,g   Brew, Sue ^b   Gebski, Val J ^c   Lewis, Craig R ^d   Moylan, Eugene ^e   Parnis, Francis X ^f   Ackland, Stephen P ^b  

^a AUSTRALIAN NATIONAL UNIVERSITY   (Australia)

^b NEWCASTLE MATER HOSPITAL   (Australia)

^c UNIVERSITY OF SYDNEY   (Australia)

^d PRINCE OF WALES HOSPITAL   (Australia)

^e LIVERPOOL HOSPITAL   (Australia)

^f Ashford Cancer Center   (Australia)

^g CANBERRA HOSPITAL   (Australia)

Author keywords

Breast cancer; Capecitabine; Metastatic; Vinorelbine

Indexed keywords

ANTHRACYCLINE DERIVATIVE; ANTIEMETIC AGENT; CAPECITABINE; NAVELBINE; TAXANE DERIVATIVE;

ADULT; ANEMIA; ARTICLE; BLOOD TOXICITY; BONE MARROW SUPPRESSION; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DISEASE ACTIVITY; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HUMAN; LEUKOPENIA; LIVER TOXICITY; METASTASIS; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; NEUTROPHIL COUNT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; THROMBOCYTE COUNT; THROMBOCYTOPENIA;

EID: 33846949369     PISSN: 17437555     EISSN: 17437563     Source Type: Journal    
DOI: 10.1111/j.1743-7563.2006.00083.x     Document Type: Article

References (34)

1. Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin 2000; 50: 7-33.
2. Harris JR, Lippman ME, Veronesi U, Willett W. Breast cancer (1). N Engl J Med 1992; 327: 319-28.
3. Early Breast Cancer Trialists' Collaborative Group. Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy: 133 randomised trials involving 31000 recurrences and 24000 deaths among 750 00 women. Lancet 1992; 339: 1-15.
4. Budman DR, Meropol NJ, Reigner B et al. Preliminary studies of a novel oral fluoropyrimidine carbamate: Capecitabine. J Clin Oncol 1998; 16: 1795-802.
5. Blum JL, Jones SE, Buzdar AU et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1999; 17: 485-93.
6. Fumoleau P, Largillier R, Clippe C et al. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer 2004; 40: 536-42.
7. Canobbio L, Boccardo F, Pastorino G et al. Phase-II study of Navelbine in advanced breast cancer. Semin Oncol 1989; 16 (Suppl. 4): 33-6.
8. Fumoleau P, Delgado FM, Delozier T et al. Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 1993; 11: 1245-52.
9. Garcia-Conde J, Lluch A, Martin M et al. Phase II trial of weekly IV vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 1994; 5: 854-7.
10. Bruno S, Puerto VL, Mickiewicz E et al. Phase II trial of weekly i.v. vinorelbine as a single agent in first-line advanced breast cancer chemotherapy. The Latin-American experience. Am J Clin Oncol 1995; 18: 392-6.
11. Romero A, Rabinovich MG, Vallejo CT et al. Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 1994; 12: 336-41.
12. Twelves CJ, Dobbs NA, Curnow A et al. A phase II, multicentre, UK study of vinorelbine in advanced breast cancer. Br J Cancer 1994; 70: 990-3.
13. Degardin M, Bonneterre J, Hecquet B et al. Vinorelbine (navelbine) as a salvage treatment for advanced breast cancer. Ann Oncol 1994; 5: 423-6.
14. Gasparini G, Caffo O, Barni S et al. Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients: A phase II study. J Clin Oncol 1994; 12: 2094-101.
15. Dieras V, Extra JM, Bellissant E et al. Efficacy and tolerance of vinorelbine and fluorouracil combination as first-line chemotherapy of advanced breast cancer: Results of a phase II study using a sequential group method. J Clin Oncol 1996; 14: 3097-104.
16. Hochster HS, Vogel CL, Burman SL, White R. Activity and safety of vinorelbine combined with doxorubicin or fluorouracil as first-line therapy in advanced breast cancer: A stratified phase II study. Oncologist 2001; 6: 269-77.
17. Nole F, de Braud F, Aapro M et al. Phase I-II study of vinorelbine in combination with 5-fluorouracil and folinic acid as first-line chemotherapy in metastatic breast cancer: A regimen with a low subjective toxic burden. Ann Oncol 1997; 8: 865-70.
18. Lombardi D, Magri MD, Crivellari D et al. Combination chemotherapy with navelbine and continuous infusion of 5-fluorouracil in metastatic, chemotherapy refractory breast cancer. Ann Oncol 2000; 11: 1041-3.
19. Zambetti M, Demicheli R, De Candis D et al. Five-day infusion fluorouracil plus vinorelbine i.v. in metastatic pretreated breast cancer patients. Breast Cancer Res Treat 1997; 44: 255-60.
20. Froudarakis ME, Catimel G, Guastalla JP, Rebattu P, Clavel M. Phase II trial of navelbine and fluorouracil as second-line chemotherapy in metastatic breast carcinoma. Oncology 1998; 55: 87-8.
21. Ahn JH, Kim SB, Kim TW et al. Capecitabine and vinorelbine in patients with metastatic breast cancer previously treated with anthracycline and taxane. J Korean Med Sci 2004; 19: 547-53.
22. Hess D, Thurlimann B, Pagani O etal. Capecitabine and vinorelbine in elderly patients (≥65 years) with metastatic breast cancer: A phase I trial (SAKK 25/99). Ann Oncol 2004; 15: 1760-5.
23. Welt A, von Minckwitz G, Oberhoff C et al. Phase I/II study of capecitabine and vinorelbine in pretreated patients with metastatic breast cancer. Ann Oncol 2005; 16: 64-9.
24. Nole F, Catania C, Munzone E et al. Capecitabine/vinorelbine: An effective and well-tolerated regimen for women with pretreated advanced-stage breast cancer. Clin Breast Cancer 2006; 6: 8-24.
25. Therasse P, Arbuck SG, Eisenhauer EA et al. 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 2000; 92: 205-16.
26. National Cancer Institute. National Cancer Institute Common Toxicity Criteria. National Institutes of Health, Bethesda 2003. Available from: http://ctep.info.nih.gov/CTC3/ctc/htm.
27. O'Shaughnessy J, Miles D, Vukelja S et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results. J Clin Oncol 2002; 20: 2812-23.
28. Freyer G, Delozier T, Lichinister M et al. Phase II study of oral vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 2003; 21: 35-40.
29. Bartsch R, Wenzel C, Pluschnig U et al. Oral vinorelbine alone or in combination with trastuzumab in advanced breast cancer: Results from a pilot trial. Cancer Chemother Pharmacol 2006; 57: 554-8.
30. Baweja M, Suman VJ, Fitch TR et al. Phase II trial of oral vinorelbine for the treatment of metastatic breast cancer in patients ≥65years of age: An NCCTG study. Ann Oncol 2006; 17: 623-9.
31. Nole F, Catania C, Sanna G et al. Dose-finding and pharmacokinetic study of an all-oral combination regimen of oral vinorelbine and capecitabine for patients with metastatic breast cancer. Ann Oncol 2006; 17: 322-9.
32. Lorusso V, Spada M, Giampaglia M et al. Oral vinorelbine plus capecitabine (oral vincap) combination in patients with advanced breast cancer. A phase II study of the GOIM (Gruppo Oncologico dell'Italia Meridionale). Ann Oncol 2006; 17 (Suppl. 7): Vii15-17.
33. Lorusso V, Crucitta E, Silvestris N et al. A phase I study of capecitabine in combination with vinorelbine in advanced breast cancer. Clin Breast Cancer 2003; 4: 138-41.
34. O'Shaughnessy J, Nag S, Calderillo-Ruiz G et al. Gemcitabine plus paclitaxel versus paclitaxel as first-line treatment for anthracycline pretreated metastatic breast cancer: Interim results of a global phase III study. J Clin Oncol (Meeting Abstracts) 2003; 22 (Abstract 25).