PMID- 10779813 OWN - NLM STAT- MEDLINE DCOM- 20000504 LR - 20181130 IS - 0007-4551 (Print) IS - 0007-4551 (Linking) VI - 87 IP - 3 DP - 2000 Mar TI - [Phase II study of docetaxel in inoperable advanced non small cell lung cancer]. PG - 253-8 AB - The purpose is to determine the response to, and toxicity of docetaxel (Taxotere) in patients with inoperable non small cell lung cancer (NSCLC), previously untreated. Seventy patients with stage IIIB or IV NSCLC were treated by 100 mg/m2/ 3 weeks of docetaxel until tumor progression or severe toxicity. Premedication with diosmine and prednisolone was given in all patients: 66/70 were eligible and 55/70 were assessable for antitumoral activity. Median age: 63 years, WHO performans status 0-1: 83%, stage IV: 96%. For eligible patients, 17/66 (26%) achieved an objective response: 1 complete response and 16 partial response (IC 95% = 15-36). With a median follow-up of 23.4 months (range 14.9-28.7), for evaluable patients, the median response duration was 8 months, the median time to progression 4 months, and the median survival time 10 months. The median number of administered cycles is 5 (range 1-12). The estimate one year survival rate was 47%. Seventy-six patients presented neutropenia (grade 3-4); febrile neutropenia was observed in 7% of cycles. Non haematological toxicities are: fluid retention related to docetaxel (2.9%), diarrhea (6%), nausea-vomiting (4%), asthenia (3%), nail changes (6%). Docetaxel (Taxotere) administered at 100 mg/m2/3 weeks has relevant clinical activity in previously untreated NSCLC with a acceptable toxicity. FAU - Robinet, G AU - Robinet G AD - Service d'oncologie thoracique, Hopital Morvan, 5, avenue Foch, 29609 Brest, France. FAU - Thomas, P AU - Thomas P FAU - Perol, M AU - Perol M FAU - Vergnenegre, A AU - Vergnenegre A FAU - Lena, H AU - Lena H FAU - Taytard, A AU - Taytard A FAU - Paillotin, D AU - Paillotin D FAU - Bessa, E H AU - Bessa EH FAU - Schuller-Lebeau, M P AU - Schuller-Lebeau MP LA - fre PT - Clinical Trial PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study TT - Etude de phase II: docetaxel dans les cancers bronchopulmonaires non a petites cellules inoperables. PL - France TA - Bull Cancer JT - Bulletin du cancer JID - 0072416 RN - 0 (Antineoplastic Agents, Phytogenic) RN - 0 (Taxoids) RN - 15H5577CQD (Docetaxel) RN - P88XT4IS4D (Paclitaxel) SB - IM MH - Adult MH - Aged MH - Antineoplastic Agents, Phytogenic/*administration & dosage/adverse effects MH - Carcinoma, Non-Small-Cell Lung/*drug therapy MH - Docetaxel MH - Female MH - Humans MH - Lung Neoplasms/*drug therapy MH - Male MH - Middle Aged MH - Paclitaxel/administration & dosage/adverse effects/*analogs & derivatives MH - *Taxoids EDAT- 2000/04/26 09:00 MHDA- 2000/05/16 09:00 CRDT- 2000/04/26 09:00 PHST- 2000/04/26 09:00 [pubmed] PHST- 2000/05/16 09:00 [medline] PHST- 2000/04/26 09:00 [entrez] PST - ppublish SO - Bull Cancer. 2000 Mar;87(3):253-8.