title: Concurrent conventionally factionated radiotherapy and weekly docetaxel in the treatment of stage IIIb non-small-cell lung carcinoma.
abstract: Docetaxel has shown remarkable radiosensitizing in vitro properties. In a previous phase I/II dose escalation study in non-small-cell lung cancer (NSCLC) we observed a high response rate after concomitant boost radiotherapy and weekly docetaxel. The maximum tolerated dose was 30 mg m(-2) week(-1). In the present phase II study we evaluated whether weekly docetaxel and conventionally fractionated radiotherapy could be better tolerated and equally effective in the treatment of locally advanced NSCLC. Thirty-five patients with T3, T4/N2, T3/M0-staged disease were recruited. Docetaxel (30 mg m(-2)) was given as a 30 min infusion once a week. Asthenia and radiation-induced oesophagitis were the main side-effects of the regimen enforcing 2-week treatment delay in 6/35 (17%) patients and minor delay (3-7 days) in another 11/35 (31%) patients. Neutrophil, platelet and haemoglobin toxicity was minimal, but pronounced lymphocytopenia was observed. Complete response (CR) of the chest disease was observed in 12/35 (34%) patients and partial response in 16/35 (46%). Although not statistically significant (P=0.19), a higher CR rate (8/18; 44%) was observed in patients who accomplished their therapy within the scheduled treatment time (44-47 days) as compared to patients that interrupted their treatment for several days due to treatment-related toxicity (CR 4/17; 23%). The overall survival and the local progression-free survival at 1 year was 48% and 60% respectively. We conclude that docetaxel combination with radiotherapy is a promising approach for the management of locally advanced NSCLC that results in high CR rate. Further trials with docetaxel-based radiochemotherapy should integrate accelerated radiotherapy together with cytoprotection.
authors.affiliation: Department of Radiotherapy and Oncology, University Hospital of Heraklion, Crete, Greece.
authors.forename: M I
authors.initials: MI
authors.lastname: Koukourakis
authors.forename: N
authors.initials: N
authors.lastname: Bahlitzanakis
authors.forename: M
authors.initials: M
authors.lastname: Froudarakis
authors.forename: A
authors.initials: A
authors.lastname: Giatromanolaki
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
authors.forename: S
authors.initials: S
authors.lastname: Koumiotaki
authors.forename: M
authors.initials: M
authors.lastname: Christodoulou
authors.forename: G
authors.initials: G
authors.lastname: Kyrias
authors.forename: J
authors.initials: J
authors.lastname: Skarlatos
authors.forename: J
authors.initials: J
authors.lastname: Kostantelos
authors.forename: K
authors.initials: K
authors.lastname: Beroukas
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D001247:Asthenia; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D000077143:Docetaxel; D019583:Dose Fractionation, Radiation; D004941:Esophagitis / Q000209:etiology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008231:Lymphopenia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011878:Radiotherapy / Q000009:adverse effects; D016019:Survival Analysis; D043823:Taxoids
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel