A multicenter randomized phase II study of the irinotecan/gemcitabine doublet versus irinotecan monotherapy in previously treated patients with extensive stage small-cell lung cancer

• Published in: Lung cancer (Amsterdam, Netherlands) Netherlands), 2009-08, Vol.65 (2), p.187-191
• Main Authors: Pallis, Athanasios G, Agelidou, Athina, Agelaki, Sofia, Varthalitis, Ioannis, Pavlakou, Georgia, Gerogianni, Aleka, Papakotoulas, Pavlos, Rapti, Ageliki, Chandrinos, Vassilis, Christophyllakis, Charalampos, Georgoulias, Vassilis
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - adverse effects; Camptothecin - analogs & derivatives; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Female; Gemcitabine; Hematology, Oncology and Palliative Medicine; Humans; Irinotecan; Kaplan-Meier Estimate; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Pneumology; Pulmonary/Respiratory; SCLC; Second-line therapy; Small Cell Lung Carcinoma - drug therapy; Small Cell Lung Carcinoma - pathology; Tumors; Tumors of the respiratory system and mediastinum
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/j.lungcan.2008.11.002

Abstract Objectives To compare the efficacy and safety profile of irinotecan (I) versus the combination of irinotecan/gemcitabine (IG) as second-line treatment of patients with extensive stage small-cell lung cancer (SCLC). Treatment Patients with SCLC who have received at least one chemotherapy regimen were randomized to receive either the IG regimen (gemcitabine 1000 mg/m2 intravenous (i.v.) on days 1 and 8 and irinotecan 300 mg/m2 i.v. on day 8) or I monotherapy (300 mg/m2 i.v. on day 1) both every 3 weeks. Results Thirty-eight patients were enrolled in the IG and 31 in the I arm. Due to slow accrual an early closure of the study was decided. Response rate was significantly higher in the IG than in I arm (23.7% vs. 0%; p = 0.004). The median time to progression (TTP) was 3.9 months (range: 0.5–14.5 months; 95% CI: 1.4–6.6) and 1.7 months (range: 0.5–9.9 months; 95% CI: 1.2–2.3) ( p = 0.010) for the IG and I arms, respectively. There was no difference in terms of median overall survival between the two arms (6.8 months and 4.6 months for the IG and I arm, respectively). The most frequent toxicities were grade III/IV neutropenia and grade III/IV diarrhea. Conclusions Although the IG regimen seems to be more active than the I monotherapy, the premature closure of the study prevents the drawing of definitive conclusions.