Phase II study of semisynthetic paclitaxel in metastatic breast cancer Journal Article


Authors: Hudis, C.; Riccio, L.; Holmes, F.; Seidman, A.; Baselga, J.; Currie, V.; Fennelly, D.; Gilewski, T.; Moynahan, M.; Raptis, G.; Sklarin, N.; Surbone, A.; Uhlenhopp, M.; Maickel, N.; Yao, T. J.; Hellmann, S.; Usakewicz, J.; Hortobagyi, G.; Norton, L.
Article Title: Phase II study of semisynthetic paclitaxel in metastatic breast cancer
Abstract: The aim of this phase II study was to characterise the efficacy and toxicity of semisynthetic paclitaxel in patients with metastatic breast cancer. Eligible patients had measurable disease and had been treated with one prior chemotherapy regimen either as adjuvant or for metastatic disease. Semisynthetic paclitaxel was given at a dose of 175 mg/m2 over 3 h every 21 days with dexamethasone, cimetidine and diphenhydramine premedications. 31 patients were entered. All were evaluable for toxicity. 30 patients were evaluable for response because 1 patient was lost to follow-up after receiving one cycle. One patient achieved a complete response and 10 patients achieved partial responses for an overall response rate (CR+PR) of 37% (95% confidence interval 20-56%). 17 patients (55%) experienced at least one episode of grade 3 or 4 neutropenia. There were two episodes of febrile neutropenia complicating 155 cycles of therapy. One of these resulted in a treatment-related death in a patient with pulmonary metastasis. 3 patients required dose reductions for grade 3 sensory neuropathy. Our study shows that the antitumour activity and toxic effects of semisynthetic paclitaxel appear to be identical to the naturally occurring product.
Keywords: adult; clinical article; treatment outcome; aged; middle aged; clinical trial; fatigue; neutropenia; skin manifestation; paclitaxel; phase 2 clinical trial; sensory neuropathy; breast cancer; anemia; thrombocytopenia; antineoplastic agents, phytogenic; dexamethasone; breast neoplasms; fever; gastrointestinal toxicity; lung metastasis; drug response; neoplasm metastasis; metastatic breast cancer; phase ii; musculoskeletal disease; clinical trials; intravenous drug administration; oral drug administration; hematologic diseases; diphenhydramine; cimetidine; taxol; humans; human; female; priority journal; article
Journal Title: European Journal of Cancer
Volume: 33
Issue: 13
ISSN: 0959-8049
Publisher: Elsevier Inc.  
Date Published: 1997-11-01
Start Page: 2198
End Page: 2202
Language: English
DOI: 10.1016/s0959-8049(97)00254-2
PUBMED: 9470806
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 17 March 2017 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Andrew D Seidman
    244 Seidman
  2. Clifford Hudis
    840 Hudis
  3. Larry Norton
    562 Norton
  4. Nancy T Sklarin
    46 Sklarin
  5. Violante Currie
    30 Currie
  6. Jose T Baselga
    395 Baselga
  7. Antonella   Surbone
    23 Surbone
  8. George   Raptis
    21 Raptis