Gemcitabine-cisplatin given on day 1 every 3 weeks in advanced non-small cell lung cancer.
OBJECTIVE
To determine the activity and toxicity of a higher dose intensity of the gemcitabine plus cisplatin combination in patients with non-small cell lung cancer (NSCLC).


METHODS
Between June 2001-June 2003, patients with locally advanced or metastatic NSCLC and ECOG performance status 0-2 entered prospectively the study. Cisplatin dose was 80 mg/m(2) and gemcitabine 2 g/m(2). Both drugs were given on day 1 and cycles were repeated every 3 weeks. Three-four chemotherapy cycles were given, followed by thoracic radiotherapy, followed by another 2-3 chemotherapy cycles post radiotherapy.


RESULTS
35 patients (34 males, 1 female) with a median age of 65 years (range 42-75) were enrolled. NSCLC histological subtypes were: adenocarcinoma 3, large cell carcinoma 3, and squamous cell carcinoma 29. Twenty patients had stage IIIB and 15 stage IV. A median of 6 cycles (range 4-6) were administered. Grade 2 nausea (11/35) and vomiting (6/35) and grade 1 alopecia (23/35) were the most common nonhematological side effects. No patient needed dose reduction because of toxicity. Grade 2 hematological toxicity was seen in 10/35 patients. Only one case developed grade 4 hematological toxicity after the 4th cycle (febrile neutropenia). No patient achieved complete response. The partial response (PR) rate was 27.5% and stable disease (SD) rate was 28.5%. Median overall survival (OS) was 12.5 months (range 3-20) and progression-free survival (PFS) 5 months (range 0-13).


CONCLUSIONS
This regimen allows the delivery of higher dose of gemcitabine with cisplatin, has favorable toxicity profile and good antitumor activity.
Karacetin
D
D
Department of Radiation Oncology, Sisli Etfal Hospital, Istanbul,Turkey. didem@efereks.com
Incekara
O
O
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D000093542:Gemcitabine
D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine