A phase II study of induction chemotherapy with gemcitabine (G) and cisplatin (P) in locally advanced non-small cell lung cancer: interim analysis

Autor: Felice Pasini, M. V. Oletti, N. Panza, R. Pedersini, Giuseppe Cartei, Antonio Santo, A. Maiorino, S. Maluta, Annamaria Molino, F. Pari, Gianluigi Cetto, F. Calabrò, A. Sibau, Alberto Terzi
Rok vydání: 2001
Předmět:
Zdroj: Lung Cancer. 34:15-20
ISSN: 0169-5002
DOI: 10.1016/s0169-5002(01)00400-7
Popis: Background: Gemcitabine–cisplatin (GP) combination is one of the most active and well tolerated regimens in advanced non-small cell lung cancer (NSCLC). The aim of this study is to evaluate the activity and toxicity of the GP regimen as a 21-day schedule in patients (pts) with stage IIIAN2–IIIB NSCLC. Patients and methods: From October 1997 to July 2000, 47 pts entered the study: 43 were eligible (40 men and three women); median age was 61 years (range 45–73); ECOG PS 0–1; histology was squamous (20 pts), adenocarcinoma (12 pts), large cell (five pts), and undifferentiated (six pts); stage was IIIAN2 (14 pts, 32.56%), and IIIB (29 pts, 67.44%). Malignant pleural effusion or superior vena cava syndrome was criteria of exclusion. Induction treatment consisted of three cycles of GP (G 1250 mg/m2 i.v. on days 1 and 8, and P 100 mg/m2 on day 8 every 3 weeks). Responding and stable pts underwent surgery (S) and/or radiotherapy (RT). Results: Following a minimum of two cycles, 39 pts were evaluable for response and 42 for toxicity. Two pts had complete responses (CR; 5.2%), 24 had partial response (PR; 61.5%), eight had stable disease (SD; 20.5%), and five had progressive disease (PRO; 12.8%). WHO grades 3 and 4 anaemia, neutropenia and thrombocytopenia were observed in two, four and two pts, respectively; non-haematological toxicity was moderate. After induction, stable and responding pts received either RT (18 pts) or S+RT (13 pts). Among the 16 resected pts, a radical complete resection was possible in 13 cases (81.3%), whereas tumour down-staging was observed in nine pts (56.2%). Conclusion: GP, as a 3-week neoadjuvant schedule, appears a safe and active regimen.
Databáze: OpenAIRE