title: Sequential administration of docetaxel followed by cisplatin-vindesine: a pilot study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
abstract: In this phase II study, the feasibility and efficacy of sequential chemotherapy were tested with agents shown to be active as monotherapy. Patients with chemotherapy-naive, locally advanced or metastatic non-small cell lung cancer were selected for the study. Treatment involved four cycles of docetaxel (100 mg/m(2) on day 1, every 3 weeks) (sequence A), followed by four cycles of cisplatin-vindesine (cisplatin 120 mg/m(2) on day 1 and vindesine 3 mg/m(2) on days 1, 8, 15, and 22, every 4 weeks) (sequence B). Responding patients received 3 cycles of docetaxel 100 mg/m(2) (day 1, every 3 weeks) as consolidation (sequence C). Thirty-two patients entered the study with thirty being evaluable for efficacy. Four patients showed a partial response and one patient a complete response, resulting in an objective response rate of 16.7 %. The median survival time (intent-to-treat) was 11 months (95 %CI = 8.0-15.4 months) with an estimated 1-year survival rate of 47%. The median time to progression was 17.6 weeks in the evaluable population. Main grade 4 toxicity was neutropenia (21.8 % and 68.2 % of patients in sequence A and B, respectively) while grade 3 peripheral neuropathy was documented in five patients during sequence B. There were no treatment-related deaths. Sequential chemotherapy may show promise for the treatment of advanced non-small cell lung cancer. Given the feasibility of this pilot study, sequential chemotherapy concept should be investigated with newer cisplatin-based regimens using this approach in larger prospective studies.
authors.affiliation: Service d'oncologie, hôpital Pitié-Salpêtrière, 47 boulevard de l'Hôpital, 75013 Paris, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Rixe
authors.forename: Michel
authors.initials: M
authors.lastname: Gatineau
authors.forename: Eric
authors.initials: E
authors.lastname: Jauffret
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Spano
authors.forename: Brigitte
authors.initials: B
authors.lastname: Orcel
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Vannetzel
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Berille
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Derenne
authors.forename: David
authors.initials: D
authors.lastname: Khayat
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D014751:Vindesine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D014751:Vindesine