Seminars in oncology
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Seminars in oncology · Dec 1995
ReviewThe role of paclitaxel in the management of coelomic epithelial carcinoma of the ovary: a review with emphasis on the Gynecologic Oncology Group experience.
Coelomic epithelial carcinoma of the ovary, the most common cause of death from cancer of the female genital tract in the United States, presents most commonly as advanced (stage III or IV) disease. Management consists of aggressive surgical cytoreduction followed by combination chemotherapy, until recently, a platinum compound plus an alkylating agent. The recent identification of the activity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) offers the potential to improve further the management of patients with advanced disease. ⋯ The results show the superiority of the paclitaxel/cisplatin regimen: overall response rate 77% versus 62%, clinical complete response 54% versus 33%, frequency of achieving a grossly disease-free state at second-look laparotomy 40% versus 22%, progression-free survival 18 versus 13 months, and overall survival 38 versus 24 months. Thus, paclitaxel/cisplatin is the new standard of care for patients with advanced ovarian carcinoma. Current phase III studies explore further the role of paclitaxel in front-line therapy: the relative merits of single-agent versus combination chemotherapy, the role of interval surgical cytoreduction combined with paclitaxel/cisplatin, the value of carboplatin-based versus cisplatin-based combinations with paclitaxel, the significance of the paclitaxel infusion length (3 v 24 v 96 hours), and the value of more dose-intense combinations.
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Seminars in oncology · Dec 1995
Comparative Study Clinical Trial Controlled Clinical TrialPaclitaxel in lung cancer: 1-hour infusions given alone or in combination chemotherapy.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given as a 1-hour infusion potentially offers its recipients reduced toxicity, demonstrated efficacy, and greater ease of administration. To confirm this hypothesis, we undertook a phase I/II study of 1-hour, single-agent paclitaxel in 164 patients' refractory malignancies; 59 patients with recurrent or stage IV non-small cell lung cancer (NSCLC) participated in the study. Our objective was to compare two paclitaxel doses (135 and 200 mg/m2) and two 1-hour infusion schedules (1 hour in 1 day, or 1 hour each day for 3 days, divided dose). ⋯ Of the 22 patients now evaluable for response (median follow-up, 8 months), 10 (six with limited and four with extensive small cell lung cancer) have achieved CRs and 11 have achieved partial remissions. The regimen is well tolerated. The final results of these and other phase II trials should help clarify optimal paclitaxel schedules and regimens for large-scale randomized trials in patients with lung cancer.
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Seminars in oncology · Dec 1995
Multicenter Study Clinical TrialSingle-agent paclitaxel by 3-hour infusion in the treatment of non-small cell lung cancer: links between p53 and K-ras gene status and chemosensitivity.
Currently available cytotoxic drugs are only moderately active in non-small cell lung cancer (NSCLC) and prolong survival only slightly. In two published trials, single-agent paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) was reported to have significant activity in NSCLC, with response rates of 21% and 24%. Treatment-limiting hypersensitivity reactions, however, were noted in a phase I trial of paclitaxel given as a 3-hour infusion at doses > or = 190 mg/m2. ⋯ Granulocytopenia was generally mild. Therapy was interrupted in only two patients because of the development of grade 3 neuropathy. In our experience, paclitaxel is one of the most active cytotoxic drugs targeting NSCLC.
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Seminars in oncology · Dec 1995
Sequential adjuvant therapy with doxorubicin/paclitaxel/cyclophosphamide for resectable breast cancer involving four or more axillary nodes.
The results of both retrospective and prospective studies suggest that the effectiveness of systemic adjuvant chemotherapy with doxorubicin and cyclophosphamide for breast cancer may be related to the dose intensity of these agents. Recent trials also have demonstrated the high activity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) against metastatic breast cancer. Clinically, paclitaxel appears to be noncross-resistant with doxorubicin, but the unique and overlapping toxicities of these three agents might preclude concurrent adjuvant administration. ⋯ The median follow-up from local control surgery in December 1994 was 448 days (range, 82 to 632 days). Three patients (7.2%) had disease relapses, one during the doxorubicin portion of treatment and two (4.9%) who had completed treatment with all three agents. Sequential dose-intensive therapy with doxorubicin/paclitaxel/cyclophosphamide has manageable toxicity and, with short follow-up, is a promising new regimen suitable for randomized testing.
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Seminars in oncology · Dec 1995
Clinical TrialA phase I/II study of paclitaxel plus cisplatin as first-line therapy for head and neck cancers: preliminary results.
Improved outcomes among patients with head and neck carcinomas require investigations of new drugs for induction therapy. Preliminary results of an Eastern Cooperative Oncology Group study of single-agent paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) reported a 37% response rate in patients with head and neck cancer, and the paclitaxel/cisplatin combination has been used successfully and has significantly improved median response duration in ovarian cancer patients. We initiated a phase I/II trial to determine the response and toxicity of escalating paclitaxel doses combined with fixed-dose cisplatin with granulocyte colony-stimulating factor support in patients with untreated locally advanced inoperable head and neck carcinoma. ⋯ No dose-limiting hematologic toxicity has been seen. Paclitaxel/cisplatin is an effective first-line regimen for locoregionally advanced head and neck cancer and continued study is warranted. Results thus far suggest no dose-response effect for paclitaxel doses above 200 mg/m2.