title: Second-line weekly paclitaxel in patients with inoperable non-small cell lung cancer who fail combination chemotherapy with cisplatin.
abstract: This phase II study was designed to assess single-agent paclitaxel (Taxol), as second-line chemotherapy.
  
  
  METHODS
  pathological diagnosis of inoperable non-small cell lung cancer (NSCLC) relapsing or refractory to standard front-line platinum (P)-based chemotherapy, performance status < or = 3, normal lab tests, informed consent. Ineligibility criteria: history of second or third cancer (unless surgically cured), mental instability or impairment, pre-existing moderate/severe peripheral neuropathy, previous chemotherapy non-including cisplatin, and previous second-line chemotherapy. Paclitaxel was given by intravenous infusion at a dose of 100 mg/m2 every week, until completion of the treatment plan of 21 weeks, disease progression, persistent toxicity, or patient refusal. Thirty-eight patients (32 males) entered the study; median age was 63 years (range 44-74); cell types were: adenocarcinoma (20), squamous (14), large cell (4). Previous chemotherapies: P and vinorelbine (31 patients) and P, mitomycin C and vinblastine (7 subjects), followed by 21 objective responses. Two patients had one course of paclitaxel; six other patients had early treatment suspensions. The median number of weekly infusions was 12 (range 1-21); median dose-intensity was 75% of projected. Toxicity was generally mild, mainly neurological and never life threatening (only 2 grade 4 toxicity out of 468 pre-chemotherapy evaluations). Six patients obtained a partial response; 7 others showed some tumor regression, 3 had tumor stabilization, and 13 disease progression. From the start of paclitaxel, the estimated median time to progression was 20 weeks, the median survival 58 weeks. Second-line treatment with single-agent paclitaxel is well-tolerated, active, and associated to long survivals.
authors.affiliation: Struttura Complessa di Pneumologia, Azienda Ospedaliera S. Croce e Carle, Cuneo I-12100, Italy. buccheri@culcasg.org
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Buccheri
authors.forename: Domenico
authors.initials: D
authors.lastname: Ferrigno
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D011336:Probability; D018570:Risk Assessment; D016879:Salvage Therapy; D016019:Survival Analysis; D019452:Terminally Ill
chemical_list: D017239:Paclitaxel