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Feasibility study for biweekly administration of cisplatin plus gemcitabine as adjuvant-chemotherapy for completely resected non-small cell lung cancer
Cancer Chemotherapy and Pharmacology, 10/14/09
Yamaguchi M et al. – This regimen is feasible in the treatment of patients with completely resected NSCLC. A multicenter phase III trial is warranted to assess the efficacy of this regimen at promoting survival and preventing recurrence.
Methods- Single-arm, single-institutional study
- Patients with completely resected NSCLC with no previous chemotherapy or radiotherapy eligible
- Simon’s optimal 2-stage design applied
- Both cisplatin (50 mg/m2) and gemcitabine (1,000 mg/m2) given on days 1 and 15, every 28 days
- Primary endpoint of study was feasibility of this combination in the 4 cycles of treatment
- 20 patients (19 lobectomies and 1 pneumonectomy) enrolled
- 9 (45%) of patients had grade 3/4 neutropenia, and 6 (30%) had grade 3/4 anemia
- Severe non-hematologic toxicities uncommon in series
- No treatment-related death encountered
- Thirteen (65%) patients completed planned 4 cycles of chemotherapy
- Median intensity 24 (range 21–25) mg/(m2 week) with average of 24.0 (21–25) mg/(m2 week) cisplatin and 483 (range 412–500) mg/(m2 week) with average of 481.0 (412–500) mg/(m2 week) gemcitabine
- Median relative dose intensity of cisplatin 100 (range 25–100) % with average of 87.4 (25–100) % and that of gemcitabine 100 (range 25–100) % with average of 86.8 (25–100) %
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