Phase II trial of oral vinorelbine for the treatment of metastatic breast cancer in patients ≥65 years of age: An NCCTG study

Annals of Oncology

Volumn 17, Issue 4, 2006, Pages 623-629

  Baweja, M ^a   Suman, V J ^b   Fitch, T R ^c   Mailliard, J A ^d   Bernath, A ^e   Rowland, K M ^f   Alberts, S R ^b   Kaur, J S ^b   Perez, Edith A ^a  

^a MAYO CLINIC   (United States)

^b MAYO CLINIC   (United States)

^c MAYO CLINIC   (United States)

^d MISSOURI VALLEY CANCER CONSORTIUM   (United States)

^e GEISINGER MEDICAL CENTER   (United States)

^f Carle Cancer Center CCOP   (United States)

Author keywords

Elderly; Metastatic breast cancer; Vinorelbine

Indexed keywords

ANTHRACYCLINE; CARBOPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; NAVELBINE; PACLITAXEL; TAXANE DERIVATIVE;

AGED; ARTICLE; ATAXIA; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; DIZZINESS; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEMALE; HUMAN; HYPERBILIRUBINEMIA; HYPOTENSION; INFECTION; LEUKOPENIA; LYMPHEDEMA; METASTASIS; MONOTHERAPY; MOTOR DYSFUNCTION; NEUROTOXICITY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SENSORY DYSFUNCTION; SURVIVAL RATE;

ADMINISTRATION, ORAL; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, PHYTOGENIC; BREAST NEOPLASMS; DISEASE PROGRESSION; FEMALE; HUMANS; NEOPLASM METASTASIS; NEUTROPENIA; SURVIVAL ANALYSIS; SURVIVAL RATE; VINBLASTINE;

EID: 33645304580     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdj130     Document Type: Article

References (40)

1. Potier P. The synthesis of Navelbine prototype of a new series of vinblastine derivatives. Semin Oncol 1989; 16: 2-4.
2. Liu G, Franssen E, Fitch MI et al. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997; 15: 110-115.
3. Rowinsky EK, Noe DA, Trump DL et al. Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors. J Clin Oncol 1994; 12: 1754-1763.
4. Bonneterre J, Chevalier B, Focan C et al. Phase I and pharmacokinetic study of weekly oral therapy with vinorelbine in patients with advanced breast cancer (ABC). Ann Oncol 2001; 12: 1683-1691.
5. Marty M, Fumoleau P, Adenis A et al. Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumors. Ann Oncol 2001; 12: 1643-1649.
6. Bugat R, Variol P, Roche H et al. The effects of food on the pharmacokinetic profile of oral vinorelbine. Cancer Chemother Pharmacol 2002; 50: 285-290.
7. Winer EP, Chu L, Spicer DV. Oral vinorelbine (Navelbine) in the treatment of advanced breast cancer. Semin Oncol 1995; 22: 72-79.
8. Vokes EE, Rosenberg R, Jahanzeb M et al. Oral vinorelbine (Navelbine) in the treatment of advanced non-small cell lung cancer: A preliminary report. Semin Oncol 1994; 21: 35-41.
9. Husband JE, Schwartz LH, Spencer J et al. Evaluation of the response to treatment of solid tumors - a consensus statement of the International Cancer Imaging Society. Br J Cancer 2004; 90: 2256-2260.
10. Simon R. Bayesian design and analysis of active control clinical trials. Biometrics 1999; 55: 484-487.
11. Kaplan E, Meier P. Nonparametric estimation from incomplete observation. J Am Stat Assoc 1958; 53: 456-481.
12. Carreca I, Balducci L, Extermann M. Cancer in the older person. Cancer Treat Rev 2005; Jun 17.
13. O'Neill VJ, Twelves CJ. Oral cancer treatment: Developments in chemotherapy and beyond. Br J Cancer 2002; 87: 933-937.
14. Partridge AH, Avorn J, Wang PS et al. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst 2002; 94: 652-661.
15. Ishikawa T, Utoh M, Sawada N et al. Tumor selective delivery of 5-fluorouracil by capecitabine, a new oral fluoropyrimidine carbamate, in human cancer xenografts. Biochem Pharmacol 1998; 55: 1091-1097.
16. Romero A, Rabinovich MG, Vallejo CT et al. Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 1994; 12: 336-341.
17. 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. Ann Oncol 2001; 12: 1375-1381.
18. Terenziani M, Demicheli R, Brambilla C et al. Vinorelbine: An active, non cross-resistant drug in advanced breast cancer. Results from a phase II study. Breast Cancer Res Treat 1996; 39: 285-291.
19. Vici P, Colucci G, Gebbia V et al. First-line treatment with epirubicin and vinorelbine in metastatic breast cancer. J Clin Oncol 2002; 20: 2689-2694.
20. Ellis GK, Gralow JR, Pierce HI et al. Infusional paclitaxel and weekly vinorelbine chemotherapy with concurrent filgrastim for metastatic breast cancer: High complete response rate in a phase I-II study of doxorubicin-treated patients. J Clin Oncol 1999; 17: 1407-1412.
21. Berruti A, Sperone P, Bottini A et al. Phase II study of vinorelbine with protracted fluorouracil infusion as a second- or third-line approach for advanced breast cancer patients previously treated with anthracyclines. J Clin Oncol 2000; 18: 3370-3377.
22. Ejlertsen B, Mouridsen HT, Langkjer ST et al. Phase III study of intravenous vinorelbine in combination with epirubicin versus epirubicin alone in patients with advanced breast cancer: A Scandinavian Breast Group Trial (SBG9403). J Clin Oncol 2004; 22: 2313-2320.
23. 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.
24. Rossi A, Gridelli C, Gebbia V et al. Single agent vinorelbine as first-line chemotherapy in elderly patients with advanced breast cancer. Anticancer Res 2003; 23: 1657-1664.
25. Jara-Sanchez C, Martin M, Garcia-Saenz JA et al. Vinorelbine as a 96-hour continuous infusion in heavily pretreated patients with metastatic breast cancer: A cooperative study by the GEICAM group. Clin Breast Cancer 2003; 3: 399-404.
26. Zelek L, Barthier S, Riofrio M et al. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer 2001; 92: 2267-2272.
27. Nistico C, Garufi C, Milella M et al. Weekly schedule of vinorelbine in pretreated breast cancer patients. Breast Cancer Res Treat 2000; 59: 223-229.
28. Udom DI, Vigushin DM, Linardou H et al. Two weekly vinorelbine: administration in patients who have received at least two prior chemotherapy regimes for advanced breast cancer. Eur J Cancer 2000; 36: 177-182.
29. Ibrahim NK, Rahman Z, Valero V et al. Phase II study of vinorelbine administered by 96-hour infusion in patients with advanced breast carcinoma. Cancer 1999; 86: 1251-1257.
30. Vogel C, O'Rourke M, Winer E et al. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Ann Oncol 1999; 10: 397-402.
31. Livingston RB, Ellis GK, Gralow JR et al. Dose-intensive vinorelbine with concurrent granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1997; 15: 1395-1400.
32. Gasco M, Gardin G, Repetto L et al. Vinorelbine as palliative therapy in advanced breast cancer. Anticancer Res 1997; 17: 1431-1433.
33. Weber BL, Vogel C, Jones S et al. Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 1995; 13: 2722-2730.
34. 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: 392-396.
35. 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: 990-993.
36. Garcia-Conde J, Lluch A, Martin M et al. Phase II trial of weekly i.v. vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 1994; 5: 854-857.
37. Toussaint C, Izzo J, Spielmann M et al. Phase I/II trial of continuous infusion vinorelbine for advanced breast cancer. J Clin Oncol 1994; 12: 2102-2112.
38. Barni S, Ardizzoia A, Bernardo G et al. Vinorelbine as single agent in pretreated patients with advanced breast cancer. Tumori 1994; 80: 280-282.
39. Degardin M, Bonneterre J, Hecquet B et al. Vinorelbine (navelbine) as a salvage treatment for advanced breast cancer. Ann Oncol 1994; 5: 423-426.
40. Fumoleau P, Blum JL, Reichardt P. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer 2003; 98: 1325-1326 [author reply: 1326-1327].