A novel biweekly schedule with cisplatin and gemcitabine in advanced non-small cell lung cancer.
A new schedule with cisplatin and gemcitabine administered biweekly was prospectively evaluated in stage IIIB or IV non-small cell lung cancer. We report the interim analysis of the safety and efficacy with the first 23 patients included. The mean age was 60. Thirteen patients (56.5%) were stage IIIB and 10 (43.5%) were stage IV The overall response rate was 47.8%: 69.2% for stage IIIB and 20% for stage IV The median survival among the 23 patients was 33 weeks and 1-year survival was 39%: 53.8% for stage IIIB and 20% for stage IV Seventy-seven cycles (154 administrations) were given. The mean number of cycles/patient was 3.3 (range: 1 to 6). Of the 154 administrations, 26 were delayed 1 week for recovery from toxicity. The dose intensity (Hryniuk criteria) was 94% of the planned dose. There was one toxic death with grade 4 thrombocytopenia and grade 4 esophagitis. In two patients, grade 3-4 vascular toxicity was observed, with distal arterial ischemic changes in the lower extremities. There were three (3.9%) episodes of grade 2 neutropenia, one (1.7%) of grade 3 and another one of grade 4. No cases of febrile neutropenia were seen. Predominant nonhematologic toxicities were asthenia and nausea/vomiting. This schedule of cisplatin and gemcitabine has a good therapeutic index and, as it is active, enrollment is ongoing to complete the second part of the study.
López-Vivanco
G
G
Department of Medical Oncology, Hospital de Cruces, Bizkaia, Spain. glvivanco@hcru.osakidetza.net
Fuente
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Barceló
R
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Rubio
I
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Muñoz
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Mañé
J M
JM
Pérez-Hoyos
T
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Viteri
A
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Ferreiro
J
J
D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy / Q000401:mortality; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D016001:Confidence Intervals; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015996:Survival Rate; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine