Seminars in oncology
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Seminars in oncology · Aug 1997
Clinical TrialWeekly paclitaxel/cisplatin with concurrent radiotherapy in patients with locally advanced non-small cell lung cancer: a phase I study.
We designed a phase I study to determine the maximum tolerated doses of weekly cisplatin and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) (doses escalated alternately) when given concurrently with standard or hyperfractionated radiotherapy (RT) and to define the nature of the dose-limiting toxicity. Chemotherapy-naive patients with locally advanced non-small cell lung cancer received weekly combination cisplatin/paclitaxel with concurrent local RT. Radiation therapy was initially given at the dose of 1.2 Gy twice daily x 5 d/wk x 5 weeks (total dose, 60 Gy). ⋯ We thus conclude that the cisplatin/paclitaxel combination given weekly can be safely administered concurrent with both standard or hyperfractionated RT. Hyperfractionation is associated with a higher incidence of severe esophagitis and required a slight reduction in cisplatin dose. To verify whether the use of a daily schedule translates into a better therapeutic index, a new phase I study is under way, testing twice-daily cisplatin/paclitaxel concurrently with hyperfractionated RT.
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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 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
Docetaxel (Taxotere) and vinorelbine in the treatment of non-small cell lung cancer.
The efficacy and safety of a combination of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) and vinorelbine were evaluated in two phase II studies including 46 and 39 chemotherapy-naive patients with non-small cell lung cancer, respectively. In the first study, vinorelbine 25 mg/m2 was given on day 1 and docetaxel 100 mg/m2 on day 2, with recombinant human granulocyte colony-stimulating factor support from day 5 until day 12, every 3 weeks. In the second study, docetaxel 75 mg/m2 was given on day 1 and vinorelbine 20 to 25 mg/m2 on days 1 and 5 in a 3-week schedule. ⋯ The overall response rates were 33% and 39%, respectively. It is concluded that combination therapy with docetaxel/ vinorelbine or with docetaxel/vinorelbine/cisplatin has antitumor activity in the treatment of non-small cell lung cancer. Granulocytopenia and febrile neutropenia are the most severe toxicities that limit the usefulness of these regimens.
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Seminars in oncology · Aug 1997
Combination treatment with docetaxel (Taxotere) and platinum compounds for non-small cell lung cancer.
There is a strong rationale for combining docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) and platinum compounds for use in the treatment of non-small cell lung cancer (NSCLC). The compounds are active as single agents and have no overlapping toxicity profiles. The first dose-finding study reported a response rate of 46%, and recommended doses of 75 mg/m2 for docetaxel and 75 to 100 mg/m2 for cisplatin, given concomitantly every 3 weeks. ⋯ Compared with monotherapy, docetaxel/platinum combinations appear to offer the potential for improved response rates in patients with NSCLC. The use of alternating schedules offers the further possible advantage of improving tolerability while retaining effective doses. Further studies are in progress or planned to elucidate optimal doses and schedules.