Seminars in oncology
-
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.
-
Seminars in oncology · Dec 1995
Clinical Trial Controlled Clinical TrialA phase I/II trial of combination paclitaxel and carboplatin in advanced or metastatic non-small cell lung cancer: preliminary results of an ongoing study.
Because of paclitaxel's (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) high single-agent activity in non-small cell lung cancer we developed a study to determine the maximum tolerated dose and a dose suitable for outpatient phase II/III trials of paclitaxel combined with a fixed dose of carboplatin (area under the concentration-time curve of 6, Calvert formula). From October 1993 to November 1994, 41 patients were entered into this trial, including six at dose level I (paclitaxel 150 mg/m2), six at dose level 2 (paclitaxel 175 mg/m2), II at dose level 3 (paclitaxel 200 mg/m2), 13 at dose level 4 (paclitaxel 225 mg/m2), and five at dose level 5 (paclitaxel 250 mg/m2). Patient characteristics included 27 men and 14 women with a median age of 64 years (age range, 46 to 81 years). ⋯ The maximum tolerated dose was defined at the 250 mg/m2 dose level with three of five patients achieving grade 3 (severe toxicity. The 225 mg/m2 dose level appears to be well tolerated, but accrual at this dose level is ongoing. This appears to be a highly active regimen, with objective responses in 20 (two complete responses and 18 partial responses) of 32 patients with objectively measurable disease for an overall response rate of 62.5%.
-
Seminars in oncology · Dec 1995
Clinical TrialPhase I/II study of paclitaxel plus cisplatin as first-line chemotherapy for advanced non-small cell lung cancer: preliminary results.
From March 1993 to May 1994, 32 chemotherapy-naive patients with advanced non-small cell lung cancer entered a phase I/II study to determine the maximum tolerated dose and the activity of the paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ)/cisplatin combination. The 21 men and 11 women had a median age of 59 years (range, 25 to 72 years) and a median performance status of 1 (range, 0 to 2). Histologic types were adenocarcinoma (13 cases), squamous cell carcinoma (10), and large cell carcinoma (nine). ⋯ In conclusion, at these doses of paclitaxel and cisplatin, the dose-limiting neurologic toxicity is dose dependent and cumulative after a total paclitaxel dose of approximately 1,300 mg/m2. This combination is highly active, with a total objective response rate of 38% and an objective response rate of 47% at paclitaxel doses of 200 mg/m2 or higher. Further evaluation is warranted.
-
Seminars in oncology · Dec 1995
Multicenter Study Clinical TrialDocetaxel (Taxotere): an overview of first-line monotherapy.
Docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) has demonstrated significant activity in five phase II studies as first-line chemotherapy in the treatment of metastatic breast cancer. Overall response rates range from 55.3% to 67.7%, with responses seen at all sites of disease, including lung (40%) and liver (60%). The median duration of response was 8.3 months, and the median duration of survival was 16.4 months. ⋯ The level of activity as a single agent is comparable to that of most anthracycline and non-anthracycline combination chemotherapy regimens. Its activity does not appear to be affected by prior adjuvant chemotherapy. Further studies are ongoing to incorporate docetaxel in combination chemotherapy regimens.
-
Seminars in oncology · Dec 1995
Comparative Study Clinical TrialChemotherapy of advanced inoperable non-small cell lung cancer with paclitaxel: a phase II trial.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has demonstrated significant antineoplastic activity against different tumor types, notably ovarian and breast carcinoma. Two phase II trials of 24-hour paclitaxel infusions in chemotherapy-naive patients with stage IIIB or IV non-small cell lung cancer (NSCLC) reported response rates of 21% and 24%. Leukopenia was dose limiting: as many as 62.5% of patients experienced grade 4 leukopenia. ⋯ Nausea and vomiting were infrequent, with 14% of patients experiencing grade 1 or 2 and only 2% experiencing grade 3 or 4. Paclitaxel is thus an active single agent in this patient population, with a 3-hour infusion proving comparably effective to a 24-hour infusion and superior in terms of the incidence of hematologic and nonhematologic toxicity. Further phase II studies with paclitaxel combined with other drugs active against NSCLC are indicated, and phase III studies comparing paclitaxel with standard chemotherapy remain to be completed.