Seminars in oncology
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Seminars in oncology · Aug 1997
Clinical TrialPreliminary results of neoadjuvant paclitaxel and carboplatin in the treatment of early stage non-small cell lung cancer.
The purpose of this study is to determine the feasibility of delivering neoadjuvant paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin to patients with clinical early stage (stage I and II) non-small cell lung cancer. Although neoadjuvant chemotherapy appears to prolong survival in patients with stage IIIA non-small cell lung cancer, several studies have demonstrated an increase in perioperative mortality associated with this approach. This study is designed to address whether three cycles of paclitaxel (200 mg/m2/3 hour, day 1) and carboplatin (area under the concentration-time curve 5, day 2) can be given preoperatively to patients with clinical stage I and II non-small cell lung cancer and to assess the associated toxicities, pathologic response rate, disease-free survival, and overall survival of this group of patients. ⋯ Three have successfully undergone resection, with no perioperative complications noted. One patient had a pathologic complete remission and two had pathologic partial remissions. Preliminary results indicate that this approach is well tolerated and results in major tumor response.
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Seminars in oncology · Aug 1997
Clinical TrialWeekly paclitaxel in patients with advanced lung cancer: preliminary data from a phase II trial.
We conducted a phase II trial in chemotherapy-naive patients with advanced non-small cell lung cancer to determine the efficacy of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) delivered at a maximum tolerated dose of 175 mg/m2 on an extended weekly schedule. Patients with stage IIIB/IV non-small cell lung cancer were eligible if they had an Eastern Cooperative Oncology Group performance status of 0 to 2, had received no previous chemotherapy, demonstrated normal hematologic and hepatic function, and could provide informed consent. Paclitaxel 175 mg/m2 was administered as an intravenous infusion weekly over 3 hours with standard premedication, for 6 weeks of an 8-week cycle. ⋯ Median duration of response was 6.5 months, and the 1-year survival rate was 53%. The extended weekly paclitaxel schedule results in enhanced dose intensity, marked activity, and acceptable toxicity. Paclitaxel given weekly at maximum dose intensity may be more effective than conventional paclitaxel administration schedules.
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Seminars in oncology · Aug 1997
Clinical TrialThe development of docetaxel (Taxotere) in non-small cell lung cancer--docetaxel in new combinations and new schedules: an overview of ongoing and future developments.
Non-small cell lung cancer is the most common cause of cancer death in the western world. Non-small cell lung cancer is modestly sensitive to chemotherapy with a small survival benefit in locally advanced and metastatic disease. Newer agents such as docetaxel are yielding encouraging response rates both as single agents and in combination. ⋯ These preliminary results suggest that the combination of docetaxel, ifosfamide, and cisplatin, with lenograstim support, is well tolerated in the doses evaluated. Preliminary efficacy results show a response rate of 67% (six of nine patients). The study continues to determine the maximum tolerated dose of this regimen in preparation for a phase II evaluation.
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Seminars in oncology · Aug 1997
Randomized Controlled Trial Clinical TrialA randomized study of etoposide and carboplatin with or without paclitaxel in the treatment of small cell lung cancer.
Small cell lung cancer accounts for 20% to 25% of all lung cancer cases and is initially responsive to combination chemotherapy. However, the majority of patients relapse, and at that point their disease is highly resistant to chemotherapy. The combination of etoposide with either cisplatin or carboplatin is regarded as the standard of care for these patients. ⋯ The study compares EP (carboplatin area under the concentration-time curve of 6 intravenously [IV] over 30 to 60 minutes on day 1, with etoposide 120 mg/m2 IV days 1 to 3) versus EP plus paclitaxel (paclitaxel 200 mg/m2 IV 1-hour infusion on day 1, carboplatin area under the concentration-time curve of 6 IV over 30 to 60 minutes on day 1, and etoposide 50/100 mg orally on alternating days 1 to 10). The design, inclusion criteria, and staging of patients in this study will be presented with initial accrual and patient characteristics. Randomized studies of this type are essential if the true role of this new combination is to be fully evaluated.
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Seminars in oncology · Aug 1997
Randomized Controlled Trial Multicenter Study Clinical TrialCarboplatin plus paclitaxel as first-line chemotherapy in previously untreated advanced ovarian cancer. German AGO Study Group Ovarian Cancer. Arbeitsgemeinschaft Gynäkologische Onkologie.
Since publication of the results of the Gynecologic Oncology Group (GOG) III study, the combination of cisplatin and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been adopted widely as the new standard for treating advanced ovarian cancer. Further attempts to optimize first-line chemotherapy with platinum and taxanes include substituting carboplatin for cisplatin, individualizing the carboplatin dose by calculating it according to the area under the concentration-time curve, and reducing the length of the paclitaxel infusion. Attempts to optimize platinum/paclitaxel combinations have led to the initiation of several small phase I/II trials evaluating the carboplatin/paclitaxel combination. ⋯ Retrospective comparison with the GOG results reveals no significant difference in response rates between patients in the cisplatin/paclitaxel arm of GOG III and those in the AGO study: the GOG study reported a 73% response rate, compared with a preliminary 75% response rate in the AGO study, resulting in a relative risk of 1.03 (95% confidence interval, 0.83 to 1.27). Overall, this interim analysis did not reveal any reason to terminate this study early. Accrual is ongoing and is expected to be completed in 1997.