Weekly paclitaxel plus capecitabine in advanced breast cancer patients: Dose-finding trial of GOIRC and GOL

Annals of Oncology

Volumn 17, Issue 1, 2006, Pages 79-84

  Di Costanzo, F ^a   Gasperoni, S ^a   Papaldo, P ^b   Bilancia, D ^c   Manzione, L ^c   Landucci, E ^a   Mazzoni, F ^a   Cognetti, F ^b  

^a CAREGGI UNIVERSITY HOSPITAL   (Italy)

^b Oncologia Medica   (Italy)

^c UO Oncologia Medica   (Italy)

Author keywords

Capecitabine; Metastatic breast cancer; Weekly paclitaxel

Indexed keywords

ANTHRACYCLINE; CAPECITABINE; DEXAMETHASONE; ORPHENADRINE; PACLITAXEL; RANITIDINE;

ADULT; AGED; ANEMIA; ARTICLE; BLOOD TOXICITY; BONE MARROW SUPPRESSION; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; DIARRHEA; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG RESPONSE; DRUG SAFETY; FATIGUE; HAND FOOT SYNDROME; HUMAN; HYPERBILIRUBINEMIA; HYPERPIGMENTATION; LEUKOPENIA; LIVER TOXICITY; MAXIMUM TOLERATED DOSE; METASTASIS; MUCOSA INFLAMMATION; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; SKIN TOXICITY; THROMBOCYTOPENIA; TOXICITY TESTING; VOMITING;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CARCINOMA, DUCTAL, BREAST; CARCINOMA, LOBULAR; DEOXYCYTIDINE; FEMALE; HUMANS; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 29844448860     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdj033     Document Type: Article

References (30)

1. Hamilton A, Hortobagyi G. Chemotherapy: What progress in the last 5 years? J Clin Oncol 2005; 23: 1760-1775.
2. Miwa M, Ura M, Nishida M et al. Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 1998; 34: 1274-1281.
3. Blum JL, Dieras V, Lo Russo PM et al. Multicenter, phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma. Cancer 2001; 92: 1759-1768.
4. Reichardt P, von Minckwitz G, Luck HJ et al. Capecitabine: The new standard in metastatic breast cancer failing anthracycline- and taxane-containing chemotherapy? Mature results of a large, multicenter phase II trial. Eur J Cancer 2001; 37 (Suppl 6): 19.
5. Fumoleau P, Largillier R, Trillet-Lenoir V et al. Phase II study of capecitabine (Xeloda®) in pts with advanced breast cancer (ABC), previously treated with anthracyclines and taxanes. Breast Cancer Res Treat 2001; 69: 285.
6. O'Shaughnessy JA, Blum J, Moiseyenko V et al. Randomized, open-label, phase II trial of oral capecitabine (Xeloda®) vs. a reference arm of intravenous CMF (cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for advanced/metastatic breast cancer. Ann Oncol 2001; 12: 1247-1254.
7. Talbot DC, Moiseyenko V, Van Belle S et al. Randomised, phase II trial comparing oral capecitabine (Xeloda®) with paclitaxel in patients with metastatic/advanced breast cancer pretreated with anthracyclines. Br J Cancer 2002; 86: 1367-1372.
8. Seidman AD, Tiersten A, Hudis C et al. Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer. J Clin Oncol 1995; 13: 2575-2581.
9. Gianni L, Munzone E, Capri G et al. Paclitaxel in metastatic breast cancer: A trial of two doses by 3-hour infusion in patients with disease recurrence after prior therapy with anthracyclines. J Natl Cancer Inst 1995; 87: 1169-1175.
10. Zimatore M, Danova M, Vassallo E et al. Weekly taxanes in metastatic breast cancer. Oncol Rep 2002; 9: 1047-1052.
11. Perez EA, Irwin DH, Patel R et al. A large phase II trial of paclitaxel administered as a weekly one hour infusion in patients with metastatic breast cancer. Proc Am Soc Clin Oncol 1999; 18: 480a.
12. Mickiewicz E, Alvarez AM, Brosio C et al. A promising second line treatment with weekly Taxol (T) in anthracycline recurrent, advanced breast cancer (ABC) patients (PTS). Proc Am Soc Clin Oncol 1999; 18: 135a (Abstr 515).
13. Waintraub SE, Cantwell S, DeVries J et al. Phase II study to evaluate the efficacy of weekly paclitaxel (WP) in patients with metastatic breast cancer (MBC) who have failed prior anthracycline (A) +/ taxane (T) therapy. Proc Am Soc Clin Oncol 2000; 19: 121a (Abstr 470).
14. Villalona-Calero MA, Weiss GR, Burris HA et al. Phase I and pharmacokinetic study of the oral fluoropyrimidine capecitabine in combination with paclitaxel in patients with advanced solid malignancies. J Clin Oncol 1999; 17: 1915-1925.
15. Sawada N, Ishikawa T, Fukase Y et al. Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by taxol/ taxotere in human cancer xenografts. Clin Cancer Res 1998; 4: 1013-1019.
16. Kano Y, Akutsu M, Tsunoda S et al. Schedule-dependent interaction between paclitaxel and 5-fluorouracil in human carcinoma cell lines in vitro. Br J Cancer 1996; 74: 704-710.
17. Collichio FA, Amamoo MA, Fogleman J et al. Phase II study of low-dose infusional 5-fluorouracil and paclitaxel (Taxol) given every 2 weeks in metastatic breast cancer. Am J Clin Oncol 2002; 25: 194-197.
18. Cortesi E, Grifalchi F, Ramponi S et al. Weekly paclitaxel and 5-fluorouracil in pretreated patients with metastatic breast cancer: A phase I study. Anticancer Res 2003; 23: 1961-1966.
19. Schüller J, Cassidy J, Dumont E et al. Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 2000; 45: 291-297.
20. Reigner B, Blesch K, Weidekamm E. Clinical pharmacokinetics of capecitabine. Clin Pharmacokinet 2001; 40: 85-104.
21. Pasquier E, Carre M, Pourroy B et al. Antiangiogenic activity of paclitaxel is associated with its cytostatic effect, mediated by the initiation but not completion of a mitochondrial apoptotic signaling pathway. Mol Cancer Ther 2004; 3: 1301-1310.
22. Seidman AD, Clifford AH, Albanel J et al. Dose-dense therapy with weekly 1-hour paclitaxel infusion in the treatment of metastatic breast cancer. J Clin Oncol 1998; 16: 3353-3361.
23. Seidman AD, Berry D, Cirrincione C et al. CALGB 9840: Phase III study of weekly (W) paclitaxel (P) via 1-hour (h) infusion versus standard (S) 3h infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC. Proc Am Soc Clin Oncol 2000; 22: 14s (Abstr 512).
24. Green MC, Budzar AU, Smith T et al. Weekly paclitaxel improves pathologic complete remission in operable breast cancer compared with paclitaxel once every 3 weeks. J Clin Oncol 2005; 23: 5983-5992.
25. Del Mastro L, Perrone F, Repetto L et al. Gruppo Italiano di Oncologia Geriatrica (GIOGer). Weekly paclitaxel as first-line chemotherapy in elderly advanced breast cancer patients: A phase II study of the Gruppo Italiano di Oncologia Geriatrica (GIOGer). Ann Oncol 2005; 16: 253-258.
26. Batista N, Perez-Manga G, Costenla M et al. Phase II study of capecitabine in combination with paclitaxel in patients with anthracycline-pretreated advanced/metastatic breast cancer. Br J Cancer 2004; 90: 1740-1746.
27. Gradishar WJ, Meza LA, Amin B et al. Capecitabine plus paclitaxel as front-line combination therapy for metastatic breast cancer: A multicenter phase II study. Clin Oncol 2004; 22: 2321-2327.
28. O'Shaughnessy JA, Blum J. A retrospettive evaluation of impact of dose reduction in patients treated with Xeloda (capecitabine). Proc Am Soc Clin Oncol 2000; 22: 14s (Abstr 400).
29. Michaud L, Gauthier M, Wojdylo J et al. Improved therapeutic index with lower dose capecitabine in metastatic breast cancer (MBC) patients (pts). Proc Am Soc Clin Oncol 2000; 22: 14s (Abstr 402).
30. Johnson DH, Paul D, Handle KR. Paclitaxel, 5-fluorouracil, and folinic acid in metastatic breast cancer: BRE-26, a phase II trial. Semin Oncol 1997; 24 (1 Suppl 3): S22-S25.