Sequential vinorelbine–capecitabine followed by docetaxel in advanced breast cancer: long-term results of a pilot phase II trial
Tóm tắt
To evaluate the response rate of the combination of capecitabine (C) and vinorelbine (V) followed by Docetaxel (D) in the 1st line treatment of advanced and metastatic breast cancer patients. Patients with measurable disease and no prior chemotherapy in advanced disease were eligible. Pts received V 25 mg/m2 on day 1 and 8 in combination with C 825 mg/m2 twice a day from day 1 to 14 every 3 weeks for four cycles followed by 12 consecutive weeks of D 25 mg/m2/w. Between March 2002 and November 2003, 40 patients were enrolled. Median age was 57 years. Of patients, 77.5% of pts had visceral involvement and 32.5% had more than two metastatic sites. In the adjuvant setting, 62.5% received anthracycline and 10% Taxanes. In the intent-to-treat population, an overall objective response was observed in 25 patients (62.5, 95% CI, 45.8–77.27) and stable disease in 5 (12.5%). Median time till progression (TTP) was 12.3 months (range 1.5–48; 95% CI, 10.05–14.54). The median survival was 35.7 months (range 2–47). Reported grade 3–4 toxicities under Navcap were neutropenia (4 pts), anemia (1 pt), thrombopenia (1 pt) and febrile neutropenia (3 pts). Reported grade 3–4 toxicities under weekly Docetaxel were neutropenia (1 pt), thrombopenia (2 pts), leucopenia (1 pt) and anemia (1 pt). The sequential use of Navcap followed by weekly Docetaxel demonstrated an interesting efficacy with a prolonged TTP and OS and warrants further evaluation.
Tài liệu tham khảo
Mariani G (2005) New developments in the treatment of metastatic breast cancer: from chemotherapy to biological therapy. Ann Oncol 16(suppl 2):ii191–ii194
Bernard-Marty C, Cardoso F, Piccart MJ (2004) Facts and controversies in systemic treatment of metastatic breast cancer. Oncologist 9:617–632
Fumoleau P, Delgado FM, Delozier T et al (1993) Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 11:1245–1252
Berruti A, Sperone P, Bottini A et al (2000) Phase II study of protracted fluorouracil infusion as second or third-line approach for advanced breast cancer patients previously treated with anthracycline. J Clin Oncol 18:3370–3377
Aboul Enein M, Moussa M, Sabri A et al (2004) Vinorelbine-5 fluorouracil combination as first line chemotherapy in anthracycline pretreated patients with metastatic breast cancer. Ann Oncol 15(S3):47 (Abstr 177P)
Nole F, De Braud F, Aapro M et al (1997) 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 8:865–870
Dieras V, Extra JM, Bellissant E et al (1996) 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 14:3097–3104
Blum JL, Jones SE, Buzdar AU et al (1999) Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 17:485–494
Blum JL, Dieras V, Lorusso PM et al (2001) Multicenter phase II study of oral capecitabine in taxane-pretreated metastatic breast cancer. Cancer 92:1759–1768
O’Shaughnessy J, Blum J, Moiseyenko V et al (2001) Randomised open-label, phase II trial of oral capecitabine (xeloda) versus a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol 12:1247–1254
O’Shaughnessy J, Miles D, Vukelja S et al (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
Welt G. von Minckwitz, Oberhof C et al (2005) Phase I/II study of capecitabine and vinorelbine in pretreated patients with metastatic breast cancer. Ann Oncol 16:64–69
Jin-Hee Ahn, Sung-Bae Kim, Tae-Won Kim et al (2004) Capecitabine and Vinorelbine in patients with metastatic breast cancer previously treated with anthracycline and taxane. J Korean Med Sci 19:547–553
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(3):2451–2456
Burstein HJ, Manola J, Younger J et al (2000) Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 18:1212–1219
Gennari A, Guarneri V, Landucci E, et al., Eniu A, Palmieri FM, Perez EA et al (2005) Weekly administration of docetaxel and paclitaxel in metastatic or advanced breast cancer. Oncologist 10(9):665–685
Saintigny P, Assouad S, Gligorov J et al (2004) Dose density and dose intensity in the treatment of breast cancer. Bull du cancer 91(suppl 4):S244–S253
Rodenhuis S (2000) The status of high-dose chemotherapy in breast cancer. Oncologist 5(5):369–375
Soto C, Torrecillas L, Reyes S et al (2006) Capecitabine (X) and taxanes in patients (pts) with anthracycline-pretreated metastatic breast cancer (MBC): Sequential versus combined therapy results from a MOSG randomized phase III trial. Supplement to Journal of Clinical Oncology, 24 (18S), part I of II, p 20s, (abstract 570)
Conte PF, Guarneri V, Bruzzi P et al (2004) Concomitant versus sequential administration of epirubicin and paclitaxel as first-line therapy in metastatic breast carcinoma: results for the Gruppo Oncologico Nord Ovest randomized trial. Cancer 101(4):704–712
Alba E, Martin M, Ramos M (2004) Multicenter randomized trial comparing sequential with concomitant administration of doxorubicin and docetaxel as first-line treatment of metastatic breast cancer: a Spanish breast cancer research group (GEICAM-9903) phase III study. J Clin Oncol 22(13):2587–2593
Cresta S, Grasselli G, Mansutti M et al (2004) A randomized phase II study of combination, alternating and sequential regimens of doxorubicin and docetaxel as first-line chemotherapy for women with metastatic breast cancer. Ann Oncol 15(3):433–439
Beslija S, Obralic N, Basic H et al (2006) Randomized trial of sequence versus combination of capecitabine (X) and docetaxel (T): XT versus T followed by X after progression as first-line therapy for patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol 24(18S), part I of II, p 20s, abstract 571
Fleming TR (1982) One-sample multiple testing procedures for phase II clinical trials. Biometrics 43:143–151
Docetaxel (1999) Standard recommended dose of 100 mg/m2 is effective but not feasible for some metastatic breast cancer patients heavily pretreated with chemotherapy—a phase II single-center study. J Clin Oncol 17(4):1127–1131
Tabernero J, Climent MA, Lluch A et al (2004) A multicentre, randomised phase II study of weekly or 3-weekly docetaxel in patients with metastatic breast cancer. Ann Oncol 15:1358–1365
Riviera E, Mejia JA, Arun B et al (2006) Phase III study of docetaxel weekly (DW) versus every 3 weeks (D) in patients with metastatic breast cancer: final results. Proc Am Soc Clin Oncol 24(18S), part I of II, p 21s, abstract 574
Jones SE, Erban J, Overmoyer B et al (2005) Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. J Clin Oncol 23(24):5434–5436
O’Shaughnessy J, Miles D, Vukelja S et al (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(12):2812–2823
Moinpour C, Wu J, Donaldson G, Liepa A et al (2004) Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first-line treatment for anthracycline pre-treated metastatic breast cancer (MBC): Quality of life (QoL) and pain palliation results from the global phase III study. Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). 22(14S) (July 15 Supplement):621
Beslija S, Obralic N, Basic H et al (2006) Randomized trial of sequence versus combination of capecitabine (X) and docetaxel (T): XT versus T followed by X after progression as first-line therapy for patients (pts) with metastatic breast cancer (MBC). Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. 24(18S) (June 20 Supplement):571
Soto C, Torrecillas L, Reyes S et al (2006) Capecitabine (X) and taxanes in patients (pts) with anthracycline-pretreated metastatic breast cancer (MBC): Sequential versus combined therapy results from a MOSG randomized phase III trial. Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. 24(18S) (June 20 Supplement):570
Nole F, de Braud F, Aapro M et al (1997) 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 8(9):865–870
Fuentes H, Calderillo G, Alexander F et al (2006) Phase II study of gemcitabine plus cisplatin in metastatic breast cancer. Anticancer Drugs 17(5):565–570
Ocana A, Hortobagyi GN, Esteva FJ (2006) Concomitant versus sequential chemotherapy in the treatment of early-stage and metastatic breast cancer. Clin Breast Cancer 6(6):495–504
Hochster HS, Vogel CL, Burman SL et al (2001) Activity and safety of vinorelbine combined with doxorubicin or fluorouracil as first-line therapy in advanced breast cancer: a stratified phase II study. Oncologist 6(3):269–277
Burstein HJ, Manola J, Younger J et al (2000) Docetaxel administered on a weekly basis for metastatic breast cancer. J Clin Oncol 18(6):1212–1219
Ramaswamy B, Elias AD, Kelbick NT et al (2006) Phase II trial of bevacizumab in combination with weekly docetaxel in metastatic breast cancer patients. Clin Cancer Res 12(10):3124–3129