Paclitaxel as second and subsequent therapy for metastatic breast cancer: Activity independent of prior anthracycline response Journal Article


Authors: Seidman, A. D.; Reichman, B. S.; Crown, J. P. A.; Yao, T. J.; Currie, V.; Hakes, T. B.; Hudis, C. A.; Gilewski, T. A.; Baselga, J.; Forsythe, P.; Lepore, J.; Marks, L.; Fain, K.; Souhrada, M.; Onetto, N.; Arbuck, S.; Norton, L.
Article Title: Paclitaxel as second and subsequent therapy for metastatic breast cancer: Activity independent of prior anthracycline response
Abstract: Purpose: Two phase II clinical trials were performed to determine efficacy and tolerability of paclitaxel (Taxol; Bristol-Myers Squibb Co, Wallingford, CT) and granulocyte colony-stimulating factor ([G-CSF] Neupogen; Amgen, Inc, Thousand Oaks, CA) as second or subsequent therapy for metastatic breast cancer. Patients and Methods: Paclitaxel plus G-CSF was administered as a second stage IV regimen to 25 patients with metastatic breast cancer at a dose of 250 mg/m2 intravenously over 24 hours. Fifty-two patients received paclitaxel plus G-CSF at 200 mg/m2 as a third or subsequent regimen (no restriction on number of prior regimens or on prior high-dose chemotherapy). All patients had received prior anthracycline treatment, and ultimately had progressive bidimensionally measurable disease. Results: Twenty-five of 76 patients (32.8%) had a major objective response (95% confidence interval [CI], 14% to 37%). The median duration of response was 7 months (range, 1 to 20+). Responses were as likely in patients with disease demonstrated to be unresponsive to anthracycline, ie, de nova resistance (11 of 37, or 30%) as in those with disease that once exhibited anthracycline sensitivity, ie, acquired resistance, (10 of 31, or 32%). G-CSF administration was associated with febrile neutropenic episodes in 36 of 402 cycles (9%) in 16 of 76 patients (21%). Conclusion: Paclitaxel's clinically significant activity against metastatic breast cancer extends to patients with many prior chemotherapy regimens. The lack of impact of prior doxorubicin therapy on the likelihood of subsequent response to paclitaxel suggests an important role for this agent in the treatment of refractory metastatic breast cancer.
Keywords: adult; cancer chemotherapy; controlled study; aged; major clinical study; clinical trial; neutropenia; dose response; paclitaxel; cancer staging; drug megadose; controlled clinical trial; phase 2 clinical trial; breast cancer; drug resistance; disease duration; recombinant granulocyte colony stimulating factor; anthracycline; breast metastasis; granulocyte colony stimulating factor; refractory period; human; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 13
Issue: 5
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1995-05-01
Start Page: 1152
End Page: 1159
Language: English
DOI: 10.1200/jco.1995.13.5.1152
PUBMED: 7537798
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 28 August 2018 -- Source: Scopus
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MSK Authors
  1. Andrew D Seidman
    244 Seidman
  2. Clifford Hudis
    840 Hudis
  3. Larry Norton
    562 Norton
  4. Tzy-Jyun Yao
    42 Yao
  5. Violante Currie
    30 Currie
  6. Jose T Baselga
    395 Baselga
  7. Linda Marks
    2 Marks