Combination of vinorelbine plus gemcitabine in previously treated patients with small cell lung cancer: a multicentre phase II study.
OBJECTIVE
To evaluate the efficacy and toxicity of the gemcitabine plus vinorelbine combination in pretreated patients with small cell lung cancer (SCLC).


METHODS
Thirty-five pretreated patients (median age 59 years, PS: 0--1 in 97% and 2 in 3%) were treated with gemcitabine (1100 mg/m(2)) and vinorelbine (25mg/m(2)) on d1 and d8 every 3 weeks. Seven (20%) patients were treated with two prior regimens and 20 (57%) were refractory to front-line chemotherapy.


RESULTS
In an intention-to-treat analysis two (6%) partial responses (PR) were observed with a duration of 5.6 and 11.1 months. Stable disease (SD) was documented in 8 (23%) patients and progressive disease (PD) in 25 (71%). The overall median survival was 4.5 and the 6 months survival rate was 42.6%. Grades 3--4 neutropenia and thrombocytopenia were observed in 25 and 14% of the patients, respectively. Non-hematological toxicity consisted of grade 2 neurotoxicity occurring in 14% of the patients and grades 2--3 fatigue in 17%. Febrile neutropenia was observed in three (8.6%) patients and one of them died from sepsis.


CONCLUSIONS
The combination of gemcitabine plus vinorelbine cannot be considered as an effective salvage treatment in pretreated patients with SCLC.
Rapti
Ageliki
A
Department of Medical Oncology, University General Hospital of Heraklion, P.O. Box 1352, 71113 Heraklion, Crete, Greece.
Agelidou
Athina
A
Stergiou
Ioannis
I
Agelidou
Maria
M
Nikolakopoulos
Ioannis
I
Varthalitis
John
J
Kalykaki
Antonia
A
Chainis
Kyriakos
K
Tzanakis
Nikolaos
N
Georgoulias
Vassilis
V
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy / Q000556:secondary; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine