Seminars in oncology
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Seminars in oncology · Jun 1999
Clinical TrialDocetaxel (Taxotere) in combination with vinorelbine in non-small cell lung cancer.
Following encouraging preclinical evidence suggesting anticancer synergy when docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) and vinorelbine are administered together, a clinical trial was designed to determine the maximum tolerated dose of the combination when given with granulocyte colony-stimulating factor support to 27 patients with advanced non-small cell lung cancer. Doses were escalated in stages to a maximum of 45 mg/m2 vinorelbine and 60 mg/m2 docetaxel, both administered on day 1 of a 2-week cycle. Hematologic toxicity was mild, with febrile neutropenia complicating only four of the 209 cycles delivered. ⋯ Major response was seen in 37% of patients. The median survival was 9 months and 1-year survival was approximately 35%. The combination of 45 mg/m2 vinorelbine and 60 mg/m2 docetaxel has now moved into a phase II trial.
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Seminars in oncology · Jun 1999
ReviewPhase I-II studies of docetaxel as a single agent in the treatment of metastatic breast cancer.
Docetaxel (Taxotere, Rhône-Poulenc Rorer, Antony, France) is highly effective in the first-line treatment of metastatic breast cancer, achieving an objective response rate of 61% (95% confidence interval, 52% to 69%). This rate of response is seen in patients with poor prognostic factors such as liver metastases and multiple organ involvement. ⋯ Phase II data suggest that docetaxel is the most active agent yet available in the treatment of advanced breast cancer; this conclusion is now supported by the results of randomized phase III trials. These data justify the further investigation of docetaxel alone and in combination chemotherapy.
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Seminars in oncology · Jun 1999
ReviewPhase III randomized trials of docetaxel in patients with metastatic breast cancer.
In a randomized phase III trial in which docetaxel was compared with doxorubicin in metastatic breast cancer patients who had failed prior alkylating chemotherapy, docetaxel proved more active, achieving responses at a significantly higher rate (complete + partial responses, 48% v 33%). The risk to benefit ratio favors docetaxel. The higher response rate was achieved without the risk of potentially fatal cardiac toxicity evident in patients who received doxorubicin and with a lower risk of infection and febrile neutropenia. ⋯ Those assigned to docetaxel lived significantly longer (median survival, 11.4 v 8.7 months), experienced a longer time before disease progression (19 weeks v 11 weeks), and achieved a higher overall response rate (30% v 11.6%). The toxicity profile of both regimens was manageable. These phase III studies confirmed the activity observed with docetaxel in the phase II trials and support the view point that docetaxel is one of the most active agents available for the treatment of breast cancer.
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Seminars in oncology · Jun 1999
ReviewEmerging role of docetaxel (Taxotere) in advanced non-small cell lung cancer.
In the first-line treatment of advanced non-small cell lung cancer (NSCLC), phase II trials of single-agent docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) at a dose of 100 mg/m2 every 3 weeks have reported encouraging results, with an overall response rate of 29% and a median survival duration of 9 months. Neutropenia is the dose-limiting toxicity but, even when severe, is usually of brief duration. Docetaxel also is active against NSCLC at doses of 60 to 75 mg/m2, which are associated with a lower incidence of neutropenia and other side effects. ⋯ In a large multicenter trial of 80 platinum-treated patients, the response rate was 16%, median survival was 7 months, and the 1-year survival rate was 25%. In conclusion, single-agent docetaxel appears to be one of the most active agents in the therapy of advanced NSCLC, with response and survival data in chemonaive patients comparable to that reported for combination chemotherapy regimens and activity in platinum-refractory NSCLC superior to that reported with other agents studied to date. Further studies designed to optimize the therapeutic index of docetaxel and docetaxel-based combination chemotherapy of NSCLC are clearly indicated.
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Seminars in oncology · Jun 1999
ReviewDocetaxel (Taxotere) and neoadjuvant chemotherapy for non-small cell lung cancer.
In locally advanced non-small cell lung cancer with ipsilateral (N2) or contralateral (N3) mediastinal node involvement, the presence of micrometastases results in a poor outcome when patients are treated by surgery alone. The prognosis is also bad in inoperable locally advanced disease (T4) treated solely by radiotherapy. Compared with surgery or radiotherapy alone, the additional use of cisplatin-based induction chemotherapy has been shown to significantly increase the prospects of long-term survival in these patients. ⋯ Several ongoing phase I/II studies are investigating neoadjuvant regimens in which docetaxel is combined with agents such as cisplatin and carboplatin. In preliminary results from a study of docetaxel plus cisplatin, an objective response was seen in 70% of 20 evaluable patients. It is hoped that the use of docetaxel in single-agent or combination induction regimens will prove to prolong patient survival.