Time to progression in metastatic breast cancer patients treated with epirubicin is not improved by the addition of either cisplatin or lonidamine: Final results of a phase III study with a factorial design

Journal of Clinical Oncology

Volumn 20, Issue 20, 2002, Pages 4150-4159

  Berruti, Alfredo ^a   Bitossi, Raffaella ^a   Gorzegno, Gabriella ^a   Bottini, Alberto ^a   Alquati, Palmiro ^a   De Matteis, Andrea ^a   Nuzzo, Francesco ^a   Giardina, Giorgio ^a   Danese, Saverio ^a   De Lena, Mario ^a   Lorusso, Vito ^a   Farris, Antonio ^a   Sarobba, Maria Giuseppa ^a   DeFabiani, Enza ^a   Bonazzi, Giorgio ^a   Castiglione, Federico ^a   Bumma, Cesare ^a   Moro, Gregorio ^a   Bruzzi, Paolo ^a   Dogliotti, Luiqi ^a  

^a SAN LUIGI GONZAGA HOSPITAL   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE DERIVATIVE; CISPLATIN; EPIRUBICIN; HORMONE; LONIDAMINE; MITOXANTRONE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BLOOD TOXICITY; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG TOLERABILITY; FACTORIAL ANALYSIS; FATIGUE; FEVER; GASTROINTESTINAL SYMPTOM; HEART ARRHYTHMIA; HEPATORENAL SYNDROME; HUMAN; LIVER TOXICITY; LUNG EMBOLISM; MAJOR CLINICAL STUDY; METASTASIS; MYALGIA; NAUSEA; NEPHROTOXICITY; NEUROTOXICITY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; SEPTIC SHOCK; STOMATITIS; THROMBOEMBOLISM; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CISPLATIN; DISEASE PROGRESSION; EPIRUBICIN; FEMALE; HUMANS; INDAZOLES; LOGISTIC MODELS; MIDDLE AGED; SURVIVAL ANALYSIS;

EID: 0037108676     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2002.08.012     Document Type: Article

References (37)

1. Negri E, La Vecchia C, Decarli A: Cancer mortality in Italy, 1997: Quantifying the fall in rates in women and men. Tumori 87:290-298, 2001
2. Bonadonna G, Valagussa P, Moliterni A, et al: Adjuvant cyclophosphamide, methotrexate and 5-fluorouracil in node positive breast cancer, the results of 20 years follow-up. N Engl J Med 14:332-341, 1995
3. Fossati R, Confalonieri C, Torri E, et al: Cytotoxic and hormonal treatment for metastatic breast cancer: A systematic review of published randomized trials involving 31,510 women. J Clin Oncol 16:3439-3460, 1998
4. Bonadonna G, Gianni L, Santoro A, et al: Drugs ten years later: Epirubicin. Ann Oncol 4:359-369, 1993
5. Hortobagyi GN: Developments in chemotherapy of breast cancer. Cancer 88:3073-3079, 2000
6. Floridi A, Paggi MG, Mercante ML, et al: Lonidamine, a selective inhibitor of aerobic glycolysis of murine tumor cells. J Natl Cancer Inst 66:497-499, 1981
7. Floridi A, Paggi MG, D'Atri S, et al: Effect of lonidamine on the energy metabolism of Ehrlich ascites tumor cells. Cancer Res 41:4661-4666, 1981
8. De Martino C, Malorni W, Accinni L, et al: Cell membrane changes induced by lonidamine in human erythrocytes and T-lymphocytes, and Ehrlich ascites tumor cells. Exp Mol Pathol 46:15-30, 1987
9. Ben-Horin H, Tassini M, Vivi A, et al: Mechanism of action of the antineoplastic drug lonidamine: 31P and 31C nuclear magnetic resonance studies, Cancer Res 55:2814-2821, 1995
10. Rosbe KW, Brann TW, Holden SA, et al: Effect of Ionidamine on the cytotoxicity of four alkylating agents in vitro. Cancer Chemother Pharmacol 25:32-36, 1989
11. Silvestrini R, Zaffaroni N, Villa R, et al: Enhancement of cisplatin activity by lonidamine in human ovarian cancer cells. Int J Cancer 52:813-817, 1992
12. Del Bufalo D, Zupi G: In vitro potentiation of epirubicin activity by lonidamine in a human breast cancer cell line. Int J Oncol 4:737-740, 1994
13. Zupi G, Greco C, Laudonio N, et al: In vitro and in vivo potentiation by lonidamine of the antitumor effect of Adriamycin. Anticancer Res 6:1245-1250, 1986
14. Citro G, Cucco C, Verdina A, et al: Reversal of Adriamycin resistance by lonidamine in a human breast cancer cell line. Br J Cancer 64:534-536, 1991
15. Zupi G, Molinari A, D'Agnano I, et al: Adriamycin resistance modulation induced by lonidamine in human breast cancer cells. Anticancer Res 15:2469-2478, 1995
16. Dogliotti L, Berruti A, Buniva T, et al: Lonidamine significantly increases the activity of epirubicin in advanced breast cancer patients: Results from a multicenter prospective randomized trial. J Clin Oncol 14:1165-1172, 1996
17. Calabresi F, Marolla P, Di Lauro L, et al: Lonidamine as a potentiating agent of the FAC regimen in the treatment of advanced breast cancer: Results of a multicentric randomized clinical study. Int J Oncol 4:753-760, 1994
18. Tomirotti M, Bernardo G, Epifani C, et al: Recovery of response to Adriamycin and cyclophosphamide by lonidamine in previously treated metastatic breast cancer patients. Int J Oncol 3:213-217, 1993
19. Moraglio L, Brema F, Pastorino G, et al: Combination of epirubicin and lonidamine for treatment of advanced breast cancer. Tumori 81:107-111, 1995
20. Amadori D, Frassineti GL, De Matteis A, et al: Modulating effect of lonidamine on response to doxorubicin in metastatic breast cancer patients: Results from a multicenter prospective randomized trial. Breast Cancer Res Treat: 49:209-217, 1998
21. Smith IE, Talbot DC: Cisplatin and its analogues in the treatment of advanced breast cancer: A review. Br J Cancer 65:787-793, 1992
22. Ezzat AA, Ibrahim EM, Ajarim DS, et al: High complete pathological response in locally advanced breast cancer using paclitaxel and cisplatin. Breast Cancer Res Treat 62:237-244, 2000
23. Spielmann M, Lombart A, Zelek L, et al: Docetaxel-cisplatin combination (DC) chemotherapy in patients with anthracycline-resistant advanced breast cancer. Ann Oncol 10:1457-1460, 1999
24. Kucuk O, Pandya KJ, Skeel RT, et al: Phase II study of cisplatin and 5-fluorouracil in previously treated metastatic breast cancer: An Eastern Cooperative Oncology Group study, Breast Cancer Res Treat 57:201-206, 1999
25. Klaassen U, Wilke H, Weyhofen R, et al: Phase II study with cisplatin and paclitaxel in combination with weekly high-dose 24 h infusional 5-fluorouracil/leucovorin for first-line treatment of metastatic breast cancer. Anticancer Drugs 9:203-207, 1998
26. Cocconi G, Bisagni G, Bacchi M, et al: Cisplatin and etoposide as first-line chemotherapy for metastatic breast carcinoma: A prospective randomized trial of the Italian Oncology Group for Clinical Research. J Clin Oncol 9:664-669, 1991
27. Nielsen D, Dombernowsky P, Larsen SK, et al: Epirubicin or epirubicin and cisplatin as first-line therapy in advanced breast cancer: A phase III study. Cancer Chemother Pharmacol 46:459-466, 2000
28. Creagan ET, Green SJ, Ahmann DL, et al: A phase III clinical trial comparing the combination cyclophosphamide, Adriamycin, cisplatin with cyclophosphamide, 5-fluorouracil, prednisone in patients with advanced breast cancer. J Clin Oncol 2:1260-1265, 1984
29. Kolaric K, Roth A, Vukas D, et al: CAP (cyclophosphamide, Adriamycin, platinum) vs CMFVP (cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, prednisone) combination chemotherapy in untreated metastatic breast cancer. Cancer Chemother Pharmacol 13:142-144, 1984
30. Kolaric K, Vukas D, Potrebica V: Combination of cyclophosphamide, Adriamycin and platinum (CAP) versus 5-fluorouracil, Adriamycin and cyclophosphamide (FAC) as primary treatment in metastatic breast cancer: Results of a prospective randomized study. Tumori 75:132-136, 1989
31. Silvestrini R, Gornati D, Zaffaroni N, et al: Modulation by lonidamine on the combined activity of cisplatin and epidoxorubicin in human breast cancer cells. Breast Cancer Res Treat 42:103-122, 1997
32. Dogliotti L, Danese S, Berruti A, et al: Cisplatin, epirubicin, and lonidamine combination regimen as first-line chemotherapy for metastatic breast cancer: A pilot study. Cancer Chemother Pharmacol 41:333-338, 1998
33. Miller AB, Hoogstraten B, Staquet M, Winkler A: Reporting results of cancer treatment. Cancer 47:207-214, 1981
34. Sun J: Variance estimation of a survival function for interval-censored survival data. Stat Med 20:1249-1257, 2001
35. Michelotti A, Venturini M, Tibaldi C, et al: Single agent epirubicin as first line chemotherapy for metastatic: Breast cancer patients. Breast Cancer Res Treat 59:133-139, 2000
36. Ormrod D, Holm K, Goa K, et al: Epirubicin: A review of its efficacy as adjuvant therapy and in the treatment of metastatic disease in breast cancer. Drugs Aging 15:389-416, 1999
37. Venturini M, Bruzzi P, Del Mastro L, et al: Effect of adjuvant chemotherapy with or without anthracyclines on the activity and efficacy of first line CEF regimen in patients with metastatic breast cancer. J Clin Oncol 14:764-773, 1996