title: Multicenter Phase II trial of intermediate dose cisplatin and vinorelbine in inoperable non-small cell lung cancer patients.
abstract: Vinorelbine (VNB) and cisplatin (CDDP) combination regimen was found active in the treatment of advanced non-small cell lung cancer (NSCLC) patients, but significant toxicity was observed. We evaluated the activity and toxicity of this combination administered at lower doses than previously reported. From March 1992 to March 1994, 99 patients (pts) were enrolled in a multicentric Phase II study and received intravenous CDDP at 80 mg/m2 on day 1, associated with intravenous VNB at 25 mg/m2 on days 1 and 8. Cycles were repeated every 3 weeks. The reduced doses led to a consistently lower myelotoxicity (8% Grade III-IV leukopenia) in comparison to two related Phase III studies, recently published. Conversely, the incidence of neurological toxicity was superimposable. Considering all eligible patients, the overall response rate was 28.3%, and this is similar to the results commonly observed employing the most active CDDP containing regimens. In conclusion, CDDP and VNB combination chemotherapy at the schedule performed in the present study led to a reduction of hematologic toxicity, while an appreciable activity was maintained.
authors.affiliation: Oncologia Medica, Ospedale San Giovanni Antica Sede, Turin, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Bretti
authors.forename: A
authors.initials: A
authors.lastname: Berruti
authors.forename: G
authors.initials: G
authors.lastname: Gorzegno
authors.forename: P
authors.initials: P
authors.lastname: La Ciura
authors.forename: E
authors.initials: E
authors.lastname: Pazè
authors.forename: A
authors.initials: A
authors.lastname: Celano
authors.forename: G
authors.initials: G
authors.lastname: Grecchi
authors.forename: D
authors.initials: D
authors.lastname: Perroni
authors.forename: C
authors.initials: C
authors.lastname: Bumma
authors.forename: L
authors.initials: L
authors.lastname: Dogliotti
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* / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine