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Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine : The TREAT study
- Publication Year :
- 2013
-
Abstract
- BackgroundAdjuvant chemotherapy is beneficial in non-small-cell lung cancer (NSCLC). However, balancing toxicity and efficacy mandates improvement.Patients and methodsPatients with completely resected stages IB-pT3N1 NSCLC were randomly assigned to either four cycles cisplatin (C: 50 mg/m(2) day (d)1 + 8) and vinorelbine (V: 25 mg/m(2) d1, 8, 15, 22) q4 weeks or four cycles cisplatin (75 mg/m(2) d1) and pemetrexed (Px: 500 mg/m(2) d1) q3 weeks. Primary objective was the clinical feasibility rate (no grade (G)4 neutropenia/thrombocytopenia or thrombocytopenia with bleeding, no G3/4 febrile neutropenia or non-hematological toxicity; no premature withdrawal/death). Secondary objectives were drug delivery and efficacy.ResultsOne hundred and thirty two patients were randomized (stages: 38% IB, 10% IIA, 47% IIB, 5% pT3pN1; histology: 43% squamous, 57% non-squamous). The feasibility rates were 95.5% (cisplatin and pemetrexed, CPx) and 75.4% (cisplatin and vinorelbine, CVb) (P = 0.001); hematological G3/4 toxic effects were 10% (CPx) and 74% (CVb) (P
- Subjects :
- Adult
Male
Oncology
medicine.medical_specialty
Guanine
Lung Neoplasms
Drug-Related Side Effects and Adverse Reactions
medicine.medical_treatment
Medizin
Pemetrexed
Neutropenia
Vinblastine
Vinorelbine
Disease-Free Survival
03 medical and health sciences
0302 clinical medicine
Glutamates
Carcinoma, Non-Small-Cell Lung
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Lung cancer
Survival rate
Aged
030304 developmental biology
Cisplatin
0303 health sciences
Chemotherapy
business.industry
Hematology
Middle Aged
medicine.disease
3. Good health
Survival Rate
Chemotherapy, Adjuvant
030220 oncology & carcinogenesis
Female
business
Febrile neutropenia
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....024b94e67fa998b081d31394a0670719