Seminars in oncology
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Seminars in oncology · Oct 1997
Clinical TrialA phase II study of repetitive cycles of dose-intense carboplatin plus paclitaxel chemotherapy and peripheral blood stem cells in metastatic breast cancer.
To assess the feasibility of administering sequential cycles of dose-intensive therapy, 14 patients without prior chemotherapy for metastatic breast cancer were registered to be treated with paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) at an initial dose of 250 mg/m2 over 24 hours (day 1), followed by carboplatin dosed to an area under the concentration-time curve of 16 (calculated according to the Calvert formula), every 3 weeks for four cycles. This combination was supported with peripheral blood stem cells collected following granulocyte colony-stimulating factor with or without cyclophosphamide and paclitaxel. One patient failed to peripheralize CD34 cells after cyclophosphamide/paclitaxel therapy and was taken off protocol. ⋯ Of the nine patients who entered the paclitaxel/carboplatin phase and were evaluable for response, five achieved a complete remission. This doublet of high-dose therapy can be given in an entirely ambulatory setting and is associated with modest hematologic toxicity. The value of this option in the treatment of metastatic breast cancer compared with more conventional approaches to high-dose therapy will require a greater number of patients evaluable for response and longer follow-up.
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Seminars in oncology · Oct 1997
Clinical TrialPhase II study of paclitaxel and epirubicin as first-line therapy in patients with metastatic breast cancer.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), the first taxane used in routine clinical practice, has aroused considerable interest for its high single-agent activity against breast cancer and for its novel mechanism of action. Epirubicin, the 4' epimer of doxorubicin, is another agent with a high activity against breast cancer and is known for its lower rate of toxic side effects, especially toxic cardiac events, compared with its mother compound. The combination of paclitaxel and doxorubicin yielded response rates between 63% and 93% in phase I/II studies. ⋯ The median cumulative epirubicin dose was 420 mg/m2 in group A and 630 mg/m2 in group B. The combination of paclitaxel 175 mg/m2 and epirubicin 60 or 90 mg/m2 can be administered safely to patients with metastatic breast cancer. Although response was not the primary end point of this trial, the response data are nonetheless encouraging and suggest that further evaluation of this combination-line treatment of metastatic breast cancer is warranted.
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Seminars in oncology · Oct 1997
Clinical TrialPaclitaxel plus doxorubicin in metastatic breast cancer: preliminary analysis of cardiotoxicity.
This ongoing phase II trial was designed to determine the antitumor activity and cardiotoxicity of a combination of doxorubicin (50 mg/m2) and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) (175 to 225 mg/m2 over 3 hours) as first-line chemotherapy for metastatic breast cancer. Of 76 patients entered so far, 57 who had received at least three courses of chemotherapy are assessable for efficacy and cardiac toxicity. A slight majority (57%) of the patients entered had prior adjuvant chemotherapy, including 33% with anthracycline-containing combinations. ⋯ The remaining five patients had LVEF decreases that fell below the lower limits of normal (33% to 48%). None of the patients developed clinically evident heart failure. Our results indicate that the combination of doxorubicin (50 mg/m2) plus paclitaxel (175 to 225 mg/m2) is effective and does not induce a clinically relevant cardiotoxicity.