Feasibility study for biweekly administration of cisplatin plus gemcitabine as adjuvant-chemotherapy for completely resected non-small cell lung cancer.
OBJECTIVE
To evaluate the feasibility of biweekly administration of cisplatin and gemcitabine as adjuvant chemotherapy for patients with completely resected non-small cell lung cancer (NSCLC).


METHODS
This was a single-arm, single-institutional study. Patients with completely resected NSCLC (p-Stages IB-IIIA) with no previous chemotherapy or radiotherapy were eligible. Simon's optimal two-stage design was applied. Both cisplatin (50 mg/m(2)) and gemcitabine (1,000 mg/m(2)) were given on days 1 and 15, every 28 days. The primary endpoint of this study was the feasibility of this combination in the four cycles of treatment.


RESULTS
Twenty patients (19 lobectomies and 1 pneumonectomy) were enrolled in this study. Nine (45%) of patients had grade 3/4 neutropenia, and 6 (30%) had grade 3/4 anemia. Severe non-hematologic toxicities were uncommon in this series. No treatment-related death was encountered. Thirteen (65%) patients completed the planned 4 cycles of chemotherapy. The median intensity was 24 (range 21-25) mg/(m(2) week) with an average of 24.0 (21-25) mg/(m(2) week) cisplatin and 483 (range 412-500) mg/(m(2) week) with an average of 481.0 (412-500) mg/(m(2) week) gemcitabine. The median relative dose intensity of cisplatin was 100 (range 25-100) % with an average of 87.4 (25-100) % and that of gemcitabine was 100 (range 25-100) % with an average of 86.8 (25-100) %.


CONCLUSIONS
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.
Yamaguchi
Masafumi
M
Division of General Thoracic Surgery, Respiratory Center and Clinical Institute, National Hospital Organization Kyushu Medical Center, Jigyouhama 1-8-1 Chuou-ku, Fukuoka 810-8563, Japan. masafumiyamaguchi@yahoo.co.jp
Takeo
Sadanori
S
Suemitsu
Ryuichi
R
Matsuzawa
Hironori
H
D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010349:Patient Compliance; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine