TY - JOUR
T1 - Hybrid (intravenous and oral) administration of vinorelbine plus cisplatinum followed by oral vinorelbine as first-line therapy of advanced non-small cell lung cancer
T2 - A phase II study
AU - Martoni, A. A.
AU - Melotti, B.
AU - Sperandi, F.
AU - Giaquinta, S.
AU - Piana, E.
AU - Pavesi, L.
AU - Da Prada, G.
AU - Lelli, G.
PY - 2008/6
Y1 - 2008/6
N2 - Background: The combination of alternate i.v./oral (hybrid) administration of vinorelbine (VNR) plus cisplatin (CDDP), followed by oral VNR, could result in a more suitable first-line regimen for patients (pts) with advanced non-small cell lung cancer (aNSCLC) in the outpatient setting. Methods: The induction treatment consisted of CDDP 80 mg/m
2 i.v. and VNR 25 mg/m
2 i.v. day 1 and VNR 60 mg/m
2 oral day 8, every 3 weeks for 4 courses. A dose escalation of VNR to 80 mg/m
2 oral from day 8 of the second course and to 30 mg/m
2 i.v. from day 1 of the third course was planned in the absence of G3-4 toxicity. Pts with disease control after 4 courses underwent consolidation treatment with oral VNR 80 mg/m
2 days 1 and 8 every 3 weeks up to intolerance or progression. Results: Fifty-three pts entered the study: 80% males; median age 63 years (range 43-71); median ECOG PS 0 (range 0-1); histotype: adenocarcinoma 59%, epidermoid 31%, undifferentiated 10%; disease stage: IIIB 22%, IV 70%, recurrent disease 8%. The objective response was as follows: 1 (2%) CR, 20 (38%) PR, 16 (30%) SD, 11 (21%) PD and 5 (9%) pts were not assessable. Median TTP and OS were 6 and 10 months, respectively. G3-4 neutropenia was observed in 23 and 24% of pts in the induction and in the consolidation phases, respectively, with febrile neutropenia in 6 pts (11%) and 2 (8%), respectively. G3-4 non-haematological toxicity was rare, being represented by nausea-vomiting and neurotoxicity in 3 pts (6%) in the induction phase. Conclusions: This combination regimen including hybrid administration of VNR plus CDDP is feasible, tolerable and effective as a first-line treatment in pts with aNSCLC.
AB - Background: The combination of alternate i.v./oral (hybrid) administration of vinorelbine (VNR) plus cisplatin (CDDP), followed by oral VNR, could result in a more suitable first-line regimen for patients (pts) with advanced non-small cell lung cancer (aNSCLC) in the outpatient setting. Methods: The induction treatment consisted of CDDP 80 mg/m
2 i.v. and VNR 25 mg/m
2 i.v. day 1 and VNR 60 mg/m
2 oral day 8, every 3 weeks for 4 courses. A dose escalation of VNR to 80 mg/m
2 oral from day 8 of the second course and to 30 mg/m
2 i.v. from day 1 of the third course was planned in the absence of G3-4 toxicity. Pts with disease control after 4 courses underwent consolidation treatment with oral VNR 80 mg/m
2 days 1 and 8 every 3 weeks up to intolerance or progression. Results: Fifty-three pts entered the study: 80% males; median age 63 years (range 43-71); median ECOG PS 0 (range 0-1); histotype: adenocarcinoma 59%, epidermoid 31%, undifferentiated 10%; disease stage: IIIB 22%, IV 70%, recurrent disease 8%. The objective response was as follows: 1 (2%) CR, 20 (38%) PR, 16 (30%) SD, 11 (21%) PD and 5 (9%) pts were not assessable. Median TTP and OS were 6 and 10 months, respectively. G3-4 neutropenia was observed in 23 and 24% of pts in the induction and in the consolidation phases, respectively, with febrile neutropenia in 6 pts (11%) and 2 (8%), respectively. G3-4 non-haematological toxicity was rare, being represented by nausea-vomiting and neurotoxicity in 3 pts (6%) in the induction phase. Conclusions: This combination regimen including hybrid administration of VNR plus CDDP is feasible, tolerable and effective as a first-line treatment in pts with aNSCLC.
KW - Cis-platin dose
KW - Consolidation treatment
KW - First-line chemotherapy
KW - NSCLC
KW - Oral chemotherapy
KW - Vinorelbine
UR - http://www.scopus.com/inward/record.url?scp=44449160004&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=44449160004&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2007.11.006
DO - 10.1016/j.lungcan.2007.11.006
M3 - Article
C2 - 18160123
AN - SCOPUS:44449160004
VL - 60
SP - 387
EP - 392
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
IS - 3
ER -