All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: An International Phase II Trial

British Journal of Cancer

Volumn 101, Issue 2, 2009, Pages 232-237

  Tubiana Mathieu, N ^a   Bougnoux, P ^b   Becquart, D ^c   Chan, A ^d   Conte, P F ^e   Majois, F ^f   Espie, M ^g   Morand, M ^h   Vaissiere, N ^h   Villanova, G ^h  

^a DUPUYTREN UNIVERSITY HOSPITAL   (France)

^b CHU BRETONNEAU   (France)

^c MIDDELHEIM HOSPITAL   (Belgium)

^d ROYAL PERTH HOSPITAL   (Australia)

^e UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^f Hospital de Jolimont   (Belgium)

^g SAINT LOUIS HOSPITAL   (France)

^h INSTITUT DE RECHERCHE PIERRE FABRE   (France)

Author keywords

First line chemotherapy; HER2 negative; Metastatic breast cancer; Oral therapy

Indexed keywords

ANTIEMETIC AGENT; CAPECITABINE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GRANULOCYTE COLONY STIMULATING FACTOR; NAVELBINE; SEROTONIN 3 ANTAGONIST; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; FLUOROURACIL; VINBLASTINE;

ADULT; AGED; ALOPECIA; ANOREXIA; ARTICLE; BLOOD TOXICITY; BREAST CANCER; CLINICAL TRIAL; DIARRHEA; DRUG DOSE ESCALATION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; EMBOLISM; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HUMAN; INFECTION; MAJOR CLINICAL STUDY; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SEPSIS; STOMATITIS; THROMBOSIS; TREATMENT RESPONSE; VOMITING; BREAST TUMOR; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; ENZYMOLOGY; METABOLISM; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PATHOLOGY;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; RECEPTOR, ERBB-2; VINBLASTINE;

EID: 67650632393     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6605156     Document Type: Article

References (28)

1. Albain K, Nag S, Calderillo-Ruiz G, Jordaan J, Llombart A, Pluzanska A, Rolski J, Melemed A, Reyes-Vidal J, Sekhon J, Simms L, O'Shaughnessy J (2008) Gemcitabine plus paclitaxel vs paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. J Clin Oncol 26: 3950-3957
2. Anton A, Lluch A, Casado A, Provencio M, Munoz M, Lao J, Bermejo B, Paules A, Gayo J, Martin M (2008) Phase I-II study of oral vinorelbine and capecitabine in metastatic breast cancer: results of the phase I trial. J Clin Oncol 26: 67s (abstract 1105)
3. Coates A, Stockler M, Wilcken N (2003) Controversies in Metastatic Breast Cancer: Optimal Duration of Chemotherapy. ASCO Educational Book. pp 119-121
4. Delcambre C, Veyret C, Levy C, Switsers O, Allouache D, Raban N, Grellard JM, Leconte A, Delozier T (2005) A phase I/II study of capecitabine combined with oral vinorelbine as first or second line therapy in locally advanced or metastatic breast cancer. Breast Cancer Res Treat 94: S67 (abstract 1061)
5. Ershler W (2006) Capecitabine monotherapy: safe and effective treatment for metastatic breast cancer. Oncologist 11: 325-335
6. Findlay M, Von Minckwitz G, Wardley A (2008) Effective oral chemotherapy for breast cancer: pillars of strength. Ann Oncol 19: 212-222
7. Finek J, Holubec Jr L, Svoboda T, Sefrhansova L, Pavlikova I, Votavova M, Sediva M, Filip S, Kosevnikova R, Kormunda S (2009) A phase II trial of oral vinorelbine and capecitabine in anthracycline pretreated patients with metastatic breast cancer. Anticancer Res 29: 667-670
8. Fleming TR (1982) One sample multiple testing procedure for phase II clinical trials. Biometrics 38: 143-151
9. Freyer G, Delozier T, Lichinister M, Gedouin D, Bougnoux P, His P, Imadalou K, Trillet-Lenoir V (2003) Phase II study of oral vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 21: 35-40
10. Gennari A, Sormani M, Bruzzi N, Wilcken O, Nanni M, Fornier M, Stockler R (2008) A meta-analysis of chemotherapy duration in metastatic breast cancer. J Clin Oncol 26: 57s (abstract 1067)
11. Ghosn M, Kattan J, Farhat F, Younes F, Gasmi J (2006) Phase II trial of capecitabine and vinorelbine as first-line chemotherapy for metastatic breast cancer patients. Anticancer Res 26: 2451-2456
12. Harris J, Lippmann ME, Morrow M, Osborne CK (2000) Diseases of the Breast, 2nd edn
13. Hess D, Thurlimann B, Pagani O, Aebi S, Rauch D, Ballabeni P, Rufener B, Castiglione-Gertsch M, Goldhirsch A (2004) Capecitabine and vinorelbine in elderly patients (≥65 years) with metastatic breast cancer: a phase I trial (SAKK 25/99). Ann Oncol 15: 1760-1765
14. Iodice G, D'Aiuto G, Comella P, Thomas R, Rubulotta R, Maiorino L, Bianco M, Petrillo A, Frasci G, Comella G (2006) Dose-escalated vinorelbine- capecitabine in elderly metastatic breast cancer patients. A SICOG phase II study. Ann Oncol 17(Supplement 9): ix73 (abstract 155)
15. Kataja V, Castiglione M (2008) Locally recurrent or metastatic breast cancer: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. Ann Oncol 19(Supplement 2): ii11-ii13
16. Kellokumpu-Lehtinen P, Sunela K, Lehtinen I, Joensuu H, Sjostrom-Mattson J, for the Finnish Breast Cancer Group (2006) A phase I study of an all oral combination of vinorelbine/capecitabine in patients with metastatic breast cancer previously treated with anthracyclines and/or taxanes. Clin Breast Cancer 7: 401-405
17. Liu G, Franssen E, Fitch M, Warner E (1997) Patient preferences for oral vs intravenous palliative chemotherapy. J Clin Oncol 15: 110-115
18. Miller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez E, Shenkier T, Cella D, Davidson N (2007) Paclitaxel plus bevacizumab vs paclitaxel alone for metastatic breast cancer. NEJM 357: 2666-2676
19. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer (2009) Version 1.2009
20. Nole F, Catania C, Sanna G, Imadalou K, Munzone E, Adamoli L, Longerey B, Blanchot G, Goldhirsch A (2006) Dose-finding and pharmacokinetic study of an all-oral combination regimen of oral vinorelbine and capecitabine for patients with metastatic breast cancer. Ann Oncol 17: 322-329
21. Nole F, Crivellari D, Mattioli R, Pinotti G, Foa P, Verri E, Fougeray R, Brandely M, Goldhirsch A (2009) Phase II study of an all-oral regimen combining oral vinorelbine with capecitabine as first-line chemotherapy of metastatic breast cancer. Cancer Chemother Pharmacol, DOI 10.1007/ s00280-008-0915-3
22. O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub J, Cervantes G, Fumoleau P, Jones S, Lui W, Mauriac L, Twelves C, Van Hazel G, Verma S, Leonard R (2002) Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 20: 2812-2823
23. O'Shaughnessy J (2005) Extending survival with chemotherapy in metastatic breast cancer. Oncologist 10(suppl 3): 20-29
24. Palumbo R, Bernardo A, Strada M, Teragni C, Poggi G, Frascaroli M, Amatu A, Palumbo I, Bernardo G (2008) Activity and safety of vinorelbine and capecitabine as first-line treatment in patients with metastatic breast cancer - a phase II trial. Eur J Cancer 67 (supplement): 177 (abstract 425)
25. Sawada N, Fujimoto-Ouchi K, Ishikawa T, Tanaka Y, Ishituka H (2002) Antitumour activity of combination therapy with capecitabine plus vinorelbine, and capecitabine plus gemcitabine in human tumor xenograft models. Proc Am Assoc Cancer Res (abstract 5388)
26. Therasse P, Arbuck S, Eisenhauer E, Wanders J, Kaplan R, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom A, Christian M, Gwyther S (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92: 205-216
27. Welt A, von Minckwitz G, Oberhoff C, Borquez D, Schleucher R, Loibl S, Harstrick A, Kaufmann M, Seeber S, Vanhoefer U (2006) Phase I/II study of capecitabine and vinorelbine in pretreated patients with metastatic breast cancer. Ann Oncol 16: 64-69
28. Wilcken N, Dear R (2008) Chemotherapy in metastatic breast cancer: a summary of all randomised trials reported 2000-2007. Eur J Cancer 44: 2218-2225