A phase II study of paclitaxel in advanced bronchioloalveolar carcinoma (EORTC trial 08956).

Abstract

PURPOSE:

The incidence of bronchioloalveolar carcinoma (BAC) has risen steadily over the last decades along with the increasing frequency of adenocarcinomas. BAC is relatively resistant to commonly used chemotherapy regimens. A phase II study with single agent paclitaxel in patients with stages IIIB, IV or recurrent BAC was performed.

EXPERIMENTAL DESIGN:

Patients with BAC with at least one target bidimensionally measurable lesion staged as unresectable stages IIIB, IV or recurrent disease, not previously irradiated; ECOG performance status 0-2; life expectancy greater than 3 months; age range between 18 and 75, received paclitaxel at a dose of 200 mg/m2 i.v. as 3h continuous infusion on day 1 every 21 days. Treatment was continued until progression or up to a maximum of six cycles.

RESULTS:

Nineteen patients were eligible. Median number of cycles was 3 (range 0-6); 35% of patients received the planned six cycles of chemotherapy. One patient died of unrelated cause before the start of treatment. Both hematological and non-hematological toxicities were generally mild. Only one partial response (PR) was observed among the 18 eligible patients who started protocol treatment, with a response rate of 5.6% (95% CI: 0.1-27.3%). After an independent review, two PR were confirmed, for a response rate of 11.1% (95% CI: 1.4-34.7%); nine patients had stable disease (50.0%), three patients had progressive disease (11.1%) and four patients were not assessable (22.2%). Median survival was 8.6 months (95% CI: 5.8-14.5) and 1-year survival was 35.0% (95% CI: 14.1-55.8). Median progression free survival for all patients was 2.2 months (95% CI: 1.5-6.0). The study was terminated due to the low response rate.

CONCLUSIONS:

Paclitaxel as single agent in stages IIIB-IV BAC was well tolerated and manageable but of limited efficacy. BAC should not be excluded from trials of new forms of chemotherapy.

• Authors: Giorgio V Scagliotti, Egbert Smit, Lionel Bosquee, Mary O'Brien, Andrea Ardizzoni, Peter Zatloukal, Wilfried Eberhardt, Maartje Smid-Geirnaerdt, Hein G de Bruin, Sonia Dussenne, Catherine Legrand, Giuseppe Giaccone, European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Group (LCG)
• Journal: Lung cancer (Amsterdam, Netherlands) (Lung Cancer) Vol. 50 Issue 1 Pg. 91-6 (Oct 2005) ISSN: 0169-5002 [Print] Ireland
• PMID: 16019107 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Antineoplastic Agents, Phytogenic
• Paclitaxel

Topics

• Adenocarcinoma, Bronchiolo-Alveolar (drug therapy, pathology)
• Adult
• Aged
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects, therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, pathology)
• Disease Progression
• Female
• Humans
• Infusions, Intravenous
• Lung Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Paclitaxel (administration & dosage, adverse effects, therapeutic use)
• Survival Analysis
• Treatment Outcome