title: Gemcitabine combined with cisplatin as neoadjuvant chemotherapy in stage IB-IIIA non-small cell lung cancer.
abstract: This single-arm, multicenter, phase II study examined the objective response rate and toxicity after neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with stage IB-IIIA non-small cell lung cancer. Treatment consisted of three 21-day cycles of gemcitabine (1000 mg/m(2)) on days 1 and 8 and cisplatin (75 mg/m(2)) on day 1 of each cycle. Surgery was performed 4-5 weeks after day 1 of the last cycle of study therapy. A total of 52 patients from five investigative sites in Russia were enrolled in the study, of which 50 (96.2%) received study therapy. Of the 49 patients who were evaluable for response, six (12.2%) had a complete response and 16 (32.7%) had a partial response, resulting in an overall response rate of 44.9%. Disease progression occurred in four out of the 49 (8.2%) patients. Radical tumor resection was performed in 38 out of the 49 (77.6%) patients. A total of 41 patients were assessed for a pathological complete response, of which four (9.8%) patients had pathological complete tumor regression. Postsurgical restaging was performed in 36 out of the 41 (87.8%) patients. Tumor downstaging occurred in 16 out of the 36 (44.4%) patients. Grade 3/4 neutropenia and thrombocytopenia were experienced by 28.0%/6.0% patients and 6.0%/2.0% patients, respectively. Grade 3 anemia occurred in 4.0% of the patients. Nonhematological toxicity was mild. Overall mortality was 30.0% (15 out of 50 patients), predominantly from progressive disease. The 1-year overall survival rate was 74.4% (95% confidence interval: 61.3-87.6%). Neoadjuvant chemotherapy with gemcitabine and cisplatin showed a good safety profile with an encouraging possibility of curative surgery in patients with early-stage non-small cell lung cancer.
authors.affiliation: Memorial NN Blokhin Russian Cancer Research Center RAMS, Moscow, Russia.
authors.forename: Mikhail I
authors.initials: MI
authors.lastname: Davidov
authors.forename: Boris E
authors.initials: BE
authors.lastname: Polotzky
authors.forename: Aleksander F
authors.initials: AF
authors.lastname: Marenich
authors.forename: Sergey V
authors.initials: SV
authors.lastname: Orlov
authors.forename: Aleksander F
authors.initials: AF
authors.lastname: Lazarev
authors.forename: Lyudmila S
authors.initials: LS
authors.lastname: Skryabina
authors.forename: Eugeniy V
authors.initials: EV
authors.lastname: Pavlushkov
authors.forename: Vladimir A
authors.initials: VA
authors.lastname: Semenchenya
authors.forename: Olga Y
authors.initials: OY
authors.lastname: Brichkova
authors.forename: Vera V
authors.initials: VV
authors.lastname: Karaseva
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001772:Blood Cell Count; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D049268:Positron-Emission Tomography; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D055815:Young Adult; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine