Paclitaxel, gemcitabine, and cisplatin in non-resectable non-small-cell lung cancer.
BACKGROUND
Paclitaxel, gemcitabine, and cisplatin are each active in non-small-cell lung cancer (NSCLC), and with different modes of action. Hence, a phase II study combining these drugs were conducted.


METHODS
Treatment was paclitaxel 110 mg/m2 and cisplatin 60 mg/m2 day 1 and 15, with gemcitabine 800 mg/m2 day 1, 8, and 15, every four weeks. Patients had previously untreated NSCLC, measurable disease, age 18-70 years, performance status < or = 2, and no brain metastases.


RESULTS
Among 49 patients, 6 (group 1) received chemotherapy as described above, while 43 patients (group 2) did not receive gemcitabine day 8. In group 1, all experienced grade 4 neutropenia and four achieved a partial response (67%). In group 2, neutropenia grade 4 occurred in 58%, with one episode of febrile neutropenia and no toxic death. No other grade 4 toxicities occurred, while grade 3 toxicity occurred with respect to thrombocytopenia (9%), nausea/vomiting (12%), neurotoxicity (12%), and nephrotoxicity (7%). There were 3 complete and 20 partial responses (response rate 54%, 95% confidence limits 38%-69%), median response duration 29 weeks (range 10-66+), median time to progression 28 weeks (range 4-66+), median survival 46 weeks (4-89+) and one-year survival rate 42%.


CONCLUSIONS
This regimen of paclitaxel, gemcitabine, and cisplatin has neutropenia as dose limiting toxicity, but septicemic episodes were rare and toxic death did not occur. Other grade 4 toxicities than neutropenia did not occur. The regimen appears safe and with a noteworthy activity both in terms of response rate, time to progression, and survival.
Sørensen
J B
JB
Department of Oncology, Finsen Centre, National University Hospital/Rigshospitalet, Copenhagen, Denmark.
Stenbygaard
L E
LE
Dombernowsky
P
P
Hansen
H H
HH
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D000093542:Gemcitabine
D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine