Seminars in oncology
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Seminars in oncology · Aug 1997
Clinical TrialPaclitaxel/carboplatin plus ifosfamide in non-small cell lung cancer.
Chemotherapy has a positive role in managing patients with stage IV non-small cell lung cancer. Randomized studies and meta-analyses comparing chemotherapy with best supportive care have confirmed a significant prolongation of survival for chemotherapy-treated patients. In recent years, several new active agents have been identified. ⋯ Although the three-drug regimens used in the 1980s appeared to be no more active than two-drug combinations, the advent of additional active compounds with novel mechanisms of action allows this question to be readdressed. Based on this background, we have initiated a phase I/II study of carboplatin and paclitaxel with escalating doses of ifosfamide. The study design and dosing schedule are discussed in this report.
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Seminars in oncology · Aug 1997
Clinical TrialChemoradiotherapy for poor-risk stage III non-small cell lung cancer.
Cisplatin-based chemoradiotherapy is becoming a standard treatment for patients with stage III non-small cell lung cancer (NSCLC). However, a significant proportion of patients with lung cancer also present with co-morbid conditions that indicate a poor prognosis and poor tolerance of treatment. We have completed a phase I/II study to evaluate the tolerability and efficacy of carboplatin-based chemoradiotherapy for patients with poor-risk stage III NSCLC. ⋯ The median survival was 12 months, and the 2- and 3-year survival rates were 30% and 20%, respectively. In conclusion, this treatment regimen was relatively well tolerated, with promising response and survival in patients with poor-risk stage III NSCLC. This pilot study provides a basis for further investigation of this treatment regimen.
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Seminars in oncology · Aug 1997
Clinical TrialInduction therapy with carboplatin/paclitaxel followed by concurrent carboplatin/paclitaxel and dose-escalating conformal radiotherapy in the treatment of locally advanced, unresectable non-small cell lung cancer: preliminary report of a phase I trial.
Locally advanced non-small cell lung cancer is optimally managed with chemotherapy and thoracic irradiation, although the most appropriate strategy is not yet defined. In this phase I trial, we use two 21-day cycles of induction chemotherapy with paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) (225 mg/m2 over 3 hours) and carboplatin (area under the concentration-time curve = 6) followed by concurrent weekly paclitaxel (45 mg/m2/wk x 6) and carboplatin (area under the concentration-time curve = 2/wk x 6) and thoracic irradiation. Patients undergo three-dimensional treatment planning (conformal radiotherapy) to define the cancer target volume precisely. ⋯ No grade 3 or 4 nonhematologic toxicity has been seen. The trial data are not yet mature enough to report on survival. Accrual and treatment is continuing at the 66 Gy radiation dose level.
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Seminars in oncology · Aug 1997
Clinical TrialIfosfamide/carboplatin/etoposide/paclitaxel in advanced lung cancer: update and preliminary survival analysis.
The primary objective of this study was to define the maximum tolerated dose and toxicity profile of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), given as a 24-hour infusion, in conjunction with ifosfamide/carboplatin/etoposide (ICE) chemotherapy in patients with advanced lung cancer. Paclitaxel was escalated from 75 to 225 mg/m2 in 25-mg/m2 increments. All patients received granulocyte colony-stimulating factor 5 microg/kg/d from day 4 until the neutrophil count was > or = 10,000/microL. ⋯ Survival was almost identical between stage IIIA and stage IV subsets. We conclude that it is possible to safely administer full-dose single-agent paclitaxel with granulocyte colony-stimulating factor support in conjunction with full-dose ifosfamide/carboplatin/etoposide chemotherapy. While response rates observed were not particularly notable, median survival is considerably longer than that usually achieved with combination chemotherapy in advanced lung cancer.
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Seminars in oncology · Aug 1997
Clinical TrialPostoperative bronchopulmonary complications in stage III lung cancer patients treated with preoperative paclitaxel-containing chemotherapy and concurrent radiation.
We previously observed encouraging results and acceptable toxicity in phase II trials testing preoperative split-course thoracic radiation and simultaneous cisplatin, etoposide, and 5-fluorouracil in stage III non-small cell lung cancer patients. We decided to delete 5-fluorouracil and to incorporate paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) into our combined-modality treatment. The first group of patients received carboplatin dosed at an area under the concentration-time curve of 4 on day 2, etoposide 50 mg orally days 1 to 5 and 8 to 12, cisplatin 50 mg/m2 on day 21, and paclitaxel 35 mg/m2 escalated to 45 mg/m2 on days 1 and 8. ⋯ Postoperative complications included bronchopleural fistula in one patient each in groups 1 and 3, hypoxia in one patient in group 1, pulmonary hypertension in one patient in group 2, pneumonia in one patient in group 2, and adult respiratory distress syndrome in one patient in group 3, which proved lethal. Thus, six of 16 patients had serious postoperative complications. The relatively high incidence of postoperative bronchopulmonary complications suggests that the use of preoperative paclitaxel-containing chemotherapy and simultaneous thoracic radiation may not be feasible.