Combination of bevacizumab and 2-weekly pegylated liposomal doxorubicin as first-line therapy for locally recurrent or metastatic breast cancer. A multicenter, single-arm phase II trial (SAKK 24/06)

Annals of Oncology

Volumn 22, Issue 1, 2011, Pages 80-85

  Rochlitz, C ^a   Ruhstaller, T ^b   Lerch, S ^c   Spirig, C ^b   Huober, J ^b   Suter, T ^d   Buhlmann M ^d   Fehr, M ^e   Schonenberger A ^f   von Moos, R ^g   Winterhalder, R ^h   Rauch, D ⁱ   Muller A ^j   Mannhart Harms, M ^k   Herrmann, R ^a   Cliffe, B ^c   Mayer, M ^c   Zaman, K ^l  

^a UNIVERSITY HOSPITAL BASEL   (Switzerland)

^b CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^c SWISS GROUP FOR CLINICAL CANCER RESEARCH SAKK   (Switzerland)

^d UNIVERSITY OF BERN   (Switzerland)

^e UNIVERSITÄTSSPITAL ZÜRICH   (Switzerland)

^f CANTONAL HOSPITAL AARAU   (Switzerland)

^g KANTONSSPITAL GRAUBÜNDEN   (Switzerland)

^h LUZERNER KANTONSSPITAL   (Switzerland)

ⁱ Regionalspital Thun ^*  (Switzerland)

^j CANTONAL HOSPITAL WINTERTHUR   (Switzerland)

^k Department of Internal Medicine   (Switzerland)

^l LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

more..

Author keywords

Bevacizumab; Breast cancer; Liposomal doxorubicine; Phase II; Toxicity

Indexed keywords

BEVACIZUMAB; DOXORUBICIN;

ADULT; ARTICLE; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CARDIOTOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEART FAILURE; HUMAN; HYPERTENSION; METASTASIS POTENTIAL; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; TREATMENT DURATION; TREATMENT RESPONSE;

EID: 78650413401     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdq319     Document Type: Article

References (35)

1. Ferlay J, Autier P, Boniol M et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol 2007; 18: 581-592.
2. Coleman MP, Gatta G, Verdecchia A et al. EUROCARE-3 summary: cancer survival in Europe at the end of the 20th century. Ann Oncol 2003; 14 (Suppl 5): 128-149.
3. Mosconi P, Colozza M, De Laurentiis M et al. Survival, quality of life and breast cancer. Ann Oncol 2001; 12 (Suppl_3): S15-S19.
4. Drummond DC, Meyer O, Hong K et al. Optimizing liposomes for delivery of chemotherapeutic agents to solid tumors. Pharmacol Rev 1999; 51: 691-743.
5. Allen TM, Martin FJ. Advantages of liposomal delivery systems for anthracyclines. Semin Oncol 2004; 31 (Suppl 13): 5-15.
6. O'Brien MER, Wigler N, Inbar M et al. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol 2004; 15(3): 440-449.
7. Sandler A, Gray R, Perry MC et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006; 355(24): 2542-2550.
8. Hurwitz H, Fehrenbacher L, Novotny W et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350(23): 2335-2342.
9. Escudier B, Pluzanska A, Koralewski P et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007; 370(9605): 2103-2111.
10. Miller K, Wang M, Gralow J et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007; 357(26): 2666-2676.
11. Pivot X, Verma S, Thomssen C et al. Clinical benefit of bevacizumab (BV) plus first-line docetaxel (D) in elderly patients (pts) with locally recurrent (LR) or metastatic breast cancer (mBC): AVADO study. J Clin Oncol 2009; 27(15S): 1094.
12. Robert NJ, Dieras V, Glaspy J et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab (B) for first-line treatment of HER2-negative locally recurrent or metastatic breast cancer (MBC). J Clin Oncol 2009; 27(15S): 1005.
13. D'Adamo DR, Anderson SE, Albritton K et al. Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas. J Clin Oncol 2005; 23: 7135-7142.
14. Haddad P, Skubitz K. Combination of bevacizumab (A) and pegylated-liposomal doxorubicin (PLD) (PLD-A) in sarcoma (SAR). J Clin Oncol 2006; 24(18S): 9556.
15. Wedam SB, Low JA, Yang SX et al. Antiangiogenic and antitumor effects of bevacizumab in patients with inflammatory and locally advanced breast cancer. J Clin Oncol 2006; 24(5): 769-777.
16. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92(3): 205-216.
17. Herndon JE. A design alternative for two-stage, phase II, multicenter cancer clinical trials. Control Clin Trials 1998; 19(5): 440-450.
18. Beslija S, Bonneterre J, Burstein HJ et al. Third consensus on medical treatment of metastatic breast cancer. Ann Oncol 2009; 20: 1771-1785.
19. Cardoso F, Castiglione M. ESMO Guidelines Working Group. Locally recurrent or metastatic breast cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2009; 20 (Suppl 4): 15-18.
20. Carrick S, Parker S, Thornton CE et al. Single agent versus combination chemotherapy for metastatic breast cancer. Cochrane Database Syst Rev 2009; Issue 2. Art. No.: CD003372. doi: 10.1002/14651858.CD003372.pub3.
21. Cardoso F, Bedard PL, Winer EP et al. International guidelines for management of metastatic breast cancer: combination vs sequential single-agent chemotherapy. J Natl Cancer Inst 2009; 101: 1174-1181.
22. Sparano JA, Makhson AN, Semiglazov VF et al. Pegylated liposomal doxorubicin plus docetaxel significantly improves time to progression without additive cardiotoxicity compared with docetaxel monotherapy in patients with advanced breast cancer previously treated with neoadjuvant-adjuvant anthracycline therapy: results from a randomized phase III study. J Clin Oncol 2009; 27: 4522-4529.
23. Batist G, Ramakrishnan G, Rao CS et al. Reduced cardiotoxicity and preserved antitumor efficacy of liposome-encapsulated doxorubicin and cyclophosphamide compared with conventional doxorubicin and cyclophosphamide in a randomized, multicenter trial of metastatic breast cancer. J Clin Oncol 2001; 19(5): 1444-1454.
24. Ewer MS, Vooletich MT, Durand J-B et al. Reversibility of trastuzumab-related cardiotoxicity: new insights based on clinical course and response to medical treatment. J Clin Oncol 2005; 23(31): 7820-7826.
25. Chu TF, Rupnick MA, Kerkela R et al. Cardiotoxicity associated with tyrosine kinase inhibitor sunitinib. Lancet 2007; 370(9604): 2011-2019.
26. Schmidinger M, Zielinski CC, Vogl UM et al. Cardiac toxicity of sunitinib and sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 2008; 26(32): 5204-5212.
27. Ranson MR, Carmichael J, O'Byrne K et al. Treatment of advanced breast cancer with sterically stabilized liposomal doxorubicin: results of a multicenter phase II trial. J Clin Oncol 1997; 15: 3185-3591.
28. Al-Batran SE, Bischoff J, von Minckwitz G et al. Clinical benefit of pegylated liposomal doxorubicin in patients with metastatic breast cancer previously treated with conventional anthracyclines: a multicentre phase II trial. Br J Cancer 2006; 94: 1615-1620.
29. Coleman RE, Biganzoli L, Canney P et al. A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993). Eur J Cancer 2006; 42: 882-887.
30. Jacobi U, Waibler E, Schulze P et al. Release of doxorubicin in sweat: first step to induce the palmar-plantar erythrodysesthesia syndrome? Ann Oncol 2005; 16(7): 1210-1211.
31. Keller AM, Mennel RG, Georgoulias VA et al. Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer. J Clin Oncol 2004; 22(19): 3893-3901.
32. Salzberg M, Thurlimann B, Hasler U et al. Pegylated liposomal doxorubicin (caelyx) in metastatic breast cancer: a community-based observation study. Oncology 2007; 72(3-4): 147-151.
33. Huober J, Fett W, Nusch A et al. A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer. BMC Cancer 2010; 10: 2; doi: 10.1186/1471-2407-10-2.
34. Azad NS, Aragon-Ching JB, Dahut WL et al. Hand-foot skin reaction increases with cumulative sorafenib dose and with combination anti-vascular endothelial growth factor therapy. Clin Cancer Res 2009; 15(4): 1411-1416.
35. Azad NS, Posadas EM, Kwitkowski VE et al. Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity. J Clin Oncol 2008; 26(22): 3709-3714.