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A phase I/II study of neoadjuvant liposomal doxorubicin, paclitaxel, and hyperthermia in locally advanced breast cancer.

Publication ,  Journal Article
Vujaskovic, Z; Kim, DW; Jones, E; Lan, L; McCall, L; Dewhirst, MW; Craciunescu, O; Stauffer, P; Liotcheva, V; Betof, A; Blackwell, K
Published in: Int J Hyperthermia
2010

PURPOSE: The prognosis for locally advanced breast cancer (LABC) patients continues to be poor, with an estimated five-year survival of only 50-60%. Preclinical data demonstrates enhanced therapeutic efficacy with liposomal encapsulation of doxorubicin combined with hyperthermia (HT). Therefore this phase I/II study was designed to evaluate the safety and efficacy of a novel neoadjuvant combination treatment of paclitaxel, liposomal doxorubicin, and hyperthermia. MATERIALS AND METHODS: Eligible patients received four cycles of neoadjuvant liposomal doxorubicin (30-75 mg/m(2)), paclitaxel (100-175 mg/m(2)), and hyperthermia. They subsequently underwent either a modified radical mastectomy or lumpectomy with axillary node dissection followed by radiation therapy and then eight cycles of CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy. RESULTS: Forty-seven patients with stage IIB-III LABC were enrolled and 43 patients were evaluable. Fourteen patients (33%) had inflammatory breast cancer. Combined (partial + complete) clinical response rate was 72% and combined pathological response rate was 60%. Four patients achieved a pathologically complete response. Sixteen patients were eligible for breast-conserving surgery. The cumulative equivalent minutes (CEM 43) at T90 (tenth percentile of temperature distribution) was significantly greater for those with a pathological response. Four-year disease-free survival was 63% (95% CI, 46%-76%) and the four-year overall survival was 75% (95% CI, 58-86%). CONCLUSIONS: Neoadjuvant therapy using paclitaxel, liposomal doxorubicin and hyperthermia is a feasible and well tolerated treatment strategy in patients with LABC. The thermal dose parameter CEM 43 T90 was significantly correlated with attaining a pathological response.

Duke Scholars

Published In

Int J Hyperthermia

DOI

EISSN

1464-5157

Publication Date

2010

Volume

26

Issue

5

Start / End Page

514 / 521

Location

England

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Recurrence
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Neoadjuvant Therapy
  • Middle Aged
  • Hyperthermia, Induced
  • Humans
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Vujaskovic, Z., Kim, D. W., Jones, E., Lan, L., McCall, L., Dewhirst, M. W., … Blackwell, K. (2010). A phase I/II study of neoadjuvant liposomal doxorubicin, paclitaxel, and hyperthermia in locally advanced breast cancer. Int J Hyperthermia, 26(5), 514–521. https://doi.org/10.3109/02656731003639364
Vujaskovic, Zeljko, Dong W. Kim, Ellen Jones, Lan Lan, Linda McCall, Mark W. Dewhirst, Oana Craciunescu, et al. “A phase I/II study of neoadjuvant liposomal doxorubicin, paclitaxel, and hyperthermia in locally advanced breast cancer.Int J Hyperthermia 26, no. 5 (2010): 514–21. https://doi.org/10.3109/02656731003639364.
Vujaskovic Z, Kim DW, Jones E, Lan L, McCall L, Dewhirst MW, et al. A phase I/II study of neoadjuvant liposomal doxorubicin, paclitaxel, and hyperthermia in locally advanced breast cancer. Int J Hyperthermia. 2010;26(5):514–21.
Vujaskovic, Zeljko, et al. “A phase I/II study of neoadjuvant liposomal doxorubicin, paclitaxel, and hyperthermia in locally advanced breast cancer.Int J Hyperthermia, vol. 26, no. 5, 2010, pp. 514–21. Pubmed, doi:10.3109/02656731003639364.
Vujaskovic Z, Kim DW, Jones E, Lan L, McCall L, Dewhirst MW, Craciunescu O, Stauffer P, Liotcheva V, Betof A, Blackwell K. A phase I/II study of neoadjuvant liposomal doxorubicin, paclitaxel, and hyperthermia in locally advanced breast cancer. Int J Hyperthermia. 2010;26(5):514–521.

Published In

Int J Hyperthermia

DOI

EISSN

1464-5157

Publication Date

2010

Volume

26

Issue

5

Start / End Page

514 / 521

Location

England

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Recurrence
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Neoadjuvant Therapy
  • Middle Aged
  • Hyperthermia, Induced
  • Humans
  • Female