Simplified gemcitabine and platin regimen in patients with advanced or metastatic non-small cell lung cancer (NSCLC) to be proposed as neoadjuvant therapy
Autor: | A. Iop, Samuela Binato, E. Colombrino, U. Fantoni, S. Cingarlini, Cosimo Sacco, Giuseppe Cartei, A. Palamidese, Simona Scalone, Renato Ceravolo, Alessandra Bearz |
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Rok vydání: | 2006 |
Předmět: |
Oncology
Adult Male medicine.medical_specialty Lung Neoplasms medicine.drug_class medicine.medical_treatment non-small cell lung cancer (NSCLC) Antimetabolite Deoxycytidine Drug Administration Schedule Internal medicine Carcinoma Non-Small-Cell Lung Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis Lung cancer Neoadjuvant therapy Aged Chemotherapy business.industry Hematology Middle Aged medicine.disease Gemcitabine Neoadjuvant Therapy Surgery Clinical trial Regimen Disease Progression Quality of Life Female Cisplatin business medicine.drug |
Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 17 |
ISSN: | 1569-8041 |
Popis: | Chemotherapy of non-small-cell lung cancer (NSCLC) has been improved by the use of cis-platin (P) and the pyrimidine antimetabolite gemcitabine (G) (2',2'-difluorodeoxycytidine). GP regimens currently used in Italy for NSCLC were and are mainly based on G day 1, 8 and 15; P on day 2, every 28 days (4 Day-Hospital admissions per cycle). However, the third G dose is frequently omitted because of myelo-toxicity, with a consistent dose decrease of both G and P in comparison with the intended dose. The 24-h lag time from 1(st) G and P has not reasonable clinical pharmacology base.To have a simplified GP regimen based on two Day-Hospital admissions per cycle, with G on day 1 and 8, P after G on day 8; every 21 days, with the goal to use it in the neoadjuvant setting.The study was designed as a controlled, prospective, multicentre investigation, based on G (1500 mg/m(2)) on day 1 and 8, and P (100 mg/m(2)) on day 8 immediately following G, administered on a 3-week cycle. Quality of life (EORTC) was valuated in 46 patients out of 95 valuable patients. Restaging procedures were repeated after the 3rd and the 6th cycle.Enrolled patients were 105 (stage IV: 63: IIIB: 29; IIIA: 13). GP cycles were 488 (1 to 6 per patient) 95 patients had at least 3 cycles and 59 of them had further 3 cycles. Myelotoxicityor= g3 was mainly neutropenia, easily amenable with symptomatic and GCSF therapies (12.6% neutropenic fever); PNS toxicity occurred in 17.9% of patients. QoL was ameliorated (P0.05). Therapy was tolerable and gave a Response Rate (RR) of 52.3% after 3 cycles (Intention-to-treat analysis) and of 57.9% in 95 valuable patients who received at least 3 therapy cycles.Present results confirm a good efficacy and/or synergism of G to P, with G on day 1 and 8 and P on day 8. This two day-hospital admissions regimen is at least as good as more complex GP regimens, and may be proposed in the neoadjuvant setting. |
Databáze: | OpenAIRE |
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