Gemcitabine/carboplatin in a modified 21-day administration schedule for advanced-stage non-small-cell lung cancer.
OBJECTIVE
Gemcitabine/carboplatin is active for advanced-stage non-small-cell lung cancer. Although it has a better toxicity profile than gemcitabine/cisplatin, severe thrombocytopenia can be a problem. We conducted a phase II study of gemcitabine/carboplatin on a 21-day schedule with administration of carboplatin delayed until day 8, intending to decrease the severity of thrombocytopenia and evaluate the feasibility and efficacy of this schedule.


METHODS
Thirty-one patients with stage IIIB or stage IV non-small cell lung cancer received gemcitabine 1000 mg/m(2) on days 1 and 8 and carboplatin at an area under the curve of 5 mg capital ZE, Cyrillic minute/mL on day 8, every 21 days.


RESULTS
The response rate was 22.6%, including 1 complete response. The median time to progression was 161 days, and the median survival was 454 days. Grade 3/4 thrombocytopenia, according to the National Cancer Institute Common Toxicity Criteria, version 3.0, was observed in 2 patients (6.5%) in the first 2 cycles. Nonhematologic toxicity included rash, depression, fever, nausea/vomiting and increased hepatic transaminase. The median courses of delivery were 3, and 13 patients (42%) received the first 3 courses without treatment delay. Dose intensity for each drug was 638 mg/m(2) per week for gemcitabine and 1.56 mg capital ZE, Cyrillic minute/mL per week for carboplatin area under the curve, respectively.


CONCLUSIONS
This study suggests that gemcitabine/carboplatin with a day-8 administration of carboplatin in a 21-day schedule reduces the severity of thrombocytopenia without having a detrimental effect on efficacy.
Yoshimura
Mana
M
Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.
Imamura
Fumio
F
Ueno
Kiyonobu
K
Uchida
Junji
J
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine