Phase II trial of doxorubicin and paclitaxel plus granulocyte colony- stimulating factor in metastatic breast cancer: An eastern cooperative oncology group study

Journal of Clinical Oncology

Volumn 17, Issue 12, 1999, Pages 3828-3834

  Sparano, Joseph A ^a   Hu, Ping ^a   Rao, Radha M ^a   Falkson, Carla I ^a   Wolff, Antonio C ^a   Wood, William C ^a  

^a ALBERT EINSTEIN CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DOXORUBICIN; GRANULOCYTE COLONY STIMULATING FACTOR; PACLITAXEL;

ADULT; ADVANCED CANCER; AGED; ANTINEOPLASTIC ACTIVITY; ARTICLE; BLOOD TOXICITY; BREAST CARCINOMA; CANCER COMBINATION CHEMOTHERAPY; CARDIOTOXICITY; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DOSE RESPONSE; GASTROINTESTINAL TOXICITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; METASTASIS; NEUROTOXICITY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SUBCUTANEOUS DRUG ADMINISTRATION;

EID: 0032760998     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1999.17.12.3828     Document Type: Article

References (30)

1. Honig SF: Treatment of metastatic disease: Hormonal and chemotherapy, in Harris JR, Lippman ME, Morrow M, Hellman S (eds): Disease of the Breast. Philadelphia, PA, Lippincott-Raven, 1996, 669-734
2. A'Hern RPA, Smith IE, Ebbs SR: Chemotherapy and survival in advanced breast cancer: The inclusion of doxorubicin in Cooper type regimens. Br J Cancer 67:801-805, 1993
3. Sledge GW Jr, Neuberg D, Ingle J, et al: Phase III trial of doxorubicin versus paclitaxel versus doxorubicin plus paclitaxel as first-line therapy for metastatic breast cancer: An Intergroup trial. Proc Am Soc Clin Oncol 16:1a, 1997 (abstr 2)
4. Gianni L, Munzone E, Capri G, et al: Paclitaxel by 3-hour infusion in combination with bolus doxorubicin in women with untreated metastatic breast cancer: High antitumor efficacy and cardiac effects in a dose-finding and sequence-finding study. J Clin Oncol 13:2688-2699, 1995
5. Dombernowsky P, Gehl J, Boesgaard M, et al: Doxorubicin and paclitaxel: A highly active combination in the treatment of metastatic breast cancer. Semin Oncol 23:23-27, 1996 (suppl 11)
6. Von Hoff DD, Layard MW, Basa P, et al: Risk factors for doxorubicin-induced congestive heart failure. Ann Intern Med 91:710-717, 1979
7. Gianni L, Dombernowsky P, Sledge, et al: Cardiac function following combination therapy with Taxol and doxorubicin for advanced breast cancer. Proc Am Soc Clin Oncol 17:115a, 1998 (abstr 444)
8. Gianni L, Bigano L, Locatelli A, et al: Human pharmacokinetic characterization and in vitro study of the interaction between doxorubicin and paclitaxel in patients with breast cancer. J Clin Oncol 15;1906-1915, 1997
9. Holmes FA, Madden T, Newman RA, et al: Sequence-dependent alteration of doxorubicin pharmacokinetics by paclitaxel in a phase I study of paclitaxel and doxorubicin in patients with metastatic breast cancer. J Clin Oncol 14:2713-2721, 1996
10. Speyer JL, Green MD, Zeleniuch-Jacquotte A, et al: ICRh-187 permits longer treatment with doxorubicin in women with breast cancer. J Clin Oncol 10:117-127, 1992
11. Swain S, Whaley FS, Gerber MC, et al: Cardioprotection with dexrazoxane for doxorubicin-containing therapy in advanced breast cancer. J Clin Oncol 15:1318-1332, 1997
12. Swain S, Whaley FS, Gerber MC, et al: Delayed administration of dexrazoxane provides cardioprotection for patients with advanced breast cancer treated with doxorubicin-containing therapy. J Clin Oncol 15:1333-1340, 1997
13. Sparano JA, Speyer J, Gradishar WJ, et al: Phase I trial of escalating doses of paclitaxel plus doxorubicin and dexrazoxane in patients with advanced breast cancer. J Clin Oncol 17:880-886, 1999
14. Oken MM, Creech RH, Tormey DC, et al: Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982
15. Falkson G, Gelman RS, Pandya KJ, et al: Eastern Cooperative Oncology Group randomized trials of observation versus maintenance therapy for patients with metastatic breast cancer in complete remission following induction treatment. J Clin Oncol 16:1669-1679, 1998
16. Martin M, Lluch A, Ojeda B, et al: Paclitaxel plus doxorubicin in metastatic breast cancer: Preliminary analysis of cardiotoxicity. Semin Oncol 24:26-30, 1997 (suppl 17)
17. Jovtis S, Mickiewicz E, Di Notto M, et al: No clinical cardiotoxicity associated with Taxol (paclitaxel) + doxorubicin as first-line treatment for metastatic breast cancer. Proc Am Soc Clin Oncol 16:239a, 1997 (abstr 844)
18. Klein JL, Dansey R, Karanes G, et al: Induction chemotherapy with doxorubicin and paclitaxel for metastatic breast cancer. Breast Cancer Res Treat 46: 1997 (abstr 405)
19. Schwartsmann G, Menke CH, Caleffi M, et al: A phase II trial of Taxol, doxorubicin, plus G-CSF in patents with metastatic breast cancer. Proc Am Soc Clin Oncol 15:126, 1996 (abstr 168)
20. Cazap E, Ventriglia M, Rubio G, et al: Taxol plus doxorubicin in the treatment of metastatic breast cancer. Proc Am Soc Clin Oncol 15:146, 1996 (abstr 248)
21. Peretz T, Sulkes A, Chollet P, et al: A multicenter, randomized study of two schedules of paclitaxel in patients with advanced breast cancer. Eur J Cancer 31A:S75, 1995 (suppl 5) (abstr 345)
22. Henderson IC, Berry D, Demetri G, et al: Improved disease free and overall survival from the addition of sequential paclitaxel but not from the escalation of doxorubicin dose level in the adjuvant chemotherapy of patients with node-positive breast cancer. Proc Am Soc Clin Oncol 17:101a, 1998 (abstr 390a)
23. Sparano JA: Use of dexrazoxane and other strategies to prevent cardiomyopathy associated with doxorubicin-taxane combinations. Semin Oncol 25:66-71, 1998
24. Moore MR, Srinivasiah J, Feinberg BA, et al: Phase II randomized trial of doxorubicin plus paclitaxel versus doxorubicin HCL liposome injection (Doxil) plus paclitaxel in metastatic breast cancer. Proc Am Soc Clin Oncol 17:160a, 1998 (abstr 614)
25. Sparano JA, Malik UR, Einzig A, et al: Phase I trial of liposomal doxorubicin (Doxil) and docetaxel (Taxotere) in patients with advanced breast cancer. Breast Cancer Res Treat 50:264, 1998 (abstr 235)
26. Conte PF, Baldini E, Bennari A, et al: Dose-finding and pharmacokinetics of epirubicin and paclitaxel over 3 hours: A regimen with high activity and low cardiotoxicity in advanced breast cancer. J Clin Oncol 15:2510-2517, 1997
27. Sparano JA, Hu P, Schaefer PL, et al: Phase II trial of doxorubicin and docetaxel plus granulocyte-colony stimulatmg factor in metastatic breast cancer: An Eastern Cooperative Oncology Group study (E1196). Breast Cancer Res Treat 50:223, 1998 (abstr 27)
28. Nabholtz JM, Falkson G, Campos D, et al: A phase III trial comparing doxorubicin and docetaxel to doxorubicin and cyclophosphamide as first line chemotherapy for metastatic breast cancer. Proc Am Soc Clin Oncol 18:127a, 1999 (abstr 485)
29. Schuller J, Czejka M, Kletzl H, et al: Doxorubicin and Taxotere: A pharmacokinetic study of the combination in advanced breast cancer. Proc Am Soc Clin Oncol 17:205a 1998 (abstr 790)
30. Bellot R, Robert J, Dieras V, et al: Taxotere does not change the pharmacokinetic profile of doxorubicin and doxorubicinol. Proc Am Soc Clin Oncol 17:221a, 1998 (abstr 853)