a University of Tovino, Department of Clinical and B iological Sciences, S. Luigi Hospital, Regione Gonzole 10, Orbassano (Torino) 10043, Italy b Martini Ziekenhuis, Groningen, The Netherlands c Centre Hospitalier de la Cittadelle, Liège, Belgiu m d Royal Marsden Hospital, Sutton, UK e Istituto Nazionale per la Ricerca sul Cancro, Geno va, Italy f University Hospital Na Bulovce, Charles University and Postgraduate Medical School, Prague, Czech Republic g Universitaetsklinikum-Essen, Essen, Germany h Stichting Oosterschelde Ziekenhuizen, Goes, The Ne therlands i Daniel den Hoed Cancer Center of the Erasmus MC, R otterdam, The Netherlands J EORTC Data Center, Brussels, Belgium k Vrije Universiteit Medisch Centrum, Amsterdam, The Netherlands

Methods: One hundred and fifty-eight patients were randomised to receive two courses of Gemcitabine (1250 mg/m(2) days 1, 8) and Cisplatin (75 mg/m(2) day 2) prior to, or daily low-dose Cisplatin (6 mg/m(2)) concurrent with radiotherapy, consisting of 24 fractions of 2.75 Gy in 32 days, with a total dose of 66 Gy.Results: Acute haematological toxicity grade 3/4 was more pronounced in the sequential (S) (30% versus 6%), oesophagitis grade 3/4 more frequent in the concurrent (C) arm (5% versus 14%). Late oesophagitis grade 3 was 4% (S and C), pneumonitis grade 3/4 14% (S) and 18% (C). Because of the poor power of the study no significant differences in median survival (MS), overall survival (OS) and progression-free survival (PFS) could be detected. MS was 16.2 (S) and 16.5 (C) months, 2-year OS was 34% (S) and 39% (C), 3-year OS was 22% (S) and 34% (C).Conclusion: Radiotherapy 66 Gy given concurrently with daily low-dose Cisplatin or after two courses of Gemcitabine/Cisplatin was well tolerated. Due to early closure no conclusions can be reached on the relative merits; both arms showed good OS. (c) 2006 Elsevier Ltd. All rights reserved.

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 11 study with single agent pactitaxel 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 pactitaxel at a dose of 200 mg/m(2) i.v. as 3 h 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% Cl: 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: Pactitaxel 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. (c) 2005 Elsevier Ireland Ltd. All rights reserved.