PMID- 16870542
OWN - NLM
STAT- MEDLINE
DCOM- 20060921
LR  - 20191110
IS  - 1699-048X (Print)
IS  - 1699-048X (Linking)
VI  - 8
IP  - 7
DP  - 2006 Jul
TI  - Cisplatin plus continuous infusion vinorelbine for the treatment of advanced 
      non-small cell lung cancer: a phase I-II study.
PG  - 519-24
AB  - BACKGROUND: In this Phase I/II trial, the maximumtolerated dose (MTD) and 
      activity of cisplatin plus vinorelbine (VRL) administered in continuous infusion 
      as first-line treatment of advanced non small cell lung cancer (NSCLC) was 
      determined in 12 consecutive chemotherapy-naive patients with advanced NSCLC. 
      PATIENTS AND METHODS: The dose of cisplatin was 100 mg/m(2) in all patients, and 
      vinorelbine was administered as an initial intravenous (iv) bolus of 8 mg/m(2) on 
      day 1 followed by a 4-day continuous iv infusion at 4 different 24 h dose levels 
      (DLs) to be repeated every 21 days. All 12 patients (47 cycles) were evaluable 
      for response and toxicity. RESULTS: The MTD was 8 mg/m(2) bolus followed by a 
      continuous iv infusion of 8 mg/m(2) per day over 4 days. The dose limiting 
      toxicities (DLT) were febrile neutropenia in 4 patients and grade 3 mucositis in 
      1 patient. There was less neuro-toxicity and compared to the weekly bolus scheme. 
      There was no significant cumulative toxicity after 3 cycles. Partial responses 
      were observed in 6 patients; an overall response rate of 50% (95% CI: 30-65%). 
      Median time to progression was 5,5 months (95% CI: 1,5-11 months) and median 
      survival was 11 months (95% CI: 5-20 months). CONCLUSIONS: The results 
      demonstrate that, in this setting of first-line treatment of NSCLC, cisplatin 
      plus vinorelbine at 8 mg/m(2) bolus followed by a continuous infusion of 8 
      mg/m(2) per day over 4 days is the recommended schedule. Further trials would be 
      useful to establish activity of this combination.
FAU - Cobo-Dols, M
AU  - Cobo-Dols M
AD  - Medical Oncology Section, Hospital Regional Universitario Carlos Haya, Malaga, 
      Spain. manuelcobodols@yahoo.es
FAU - Gil-Calle, S
AU  - Gil-Calle S
FAU - Villar-Chamorro, E
AU  - Villar-Chamorro E
FAU - Ales-Diaz, I
AU  - Ales-Diaz I
FAU - Carabantes-Ocon, F
AU  - Carabantes-Ocon F
FAU - Alcalde-Garcia, J
AU  - Alcalde-Garcia J
FAU - Gutierrez-Calderon, V
AU  - Gutierrez-Calderon V
FAU - Montesa-Pino, A
AU  - Montesa-Pino A
FAU - Breton-Garcia, J J
AU  - Breton-Garcia JJ
FAU - Benavides-Orgaz, M
AU  - Benavides-Orgaz M
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PL  - Italy
TA  - Clin Transl Oncol
JT  - Clinical & translational oncology : official publication of the Federation of 
      Spanish Oncology Societies and of the National Cancer Institute of Mexico
JID - 101247119
RN  - 5V9KLZ54CY (Vinblastine)
RN  - Q20Q21Q62J (Cisplatin)
RN  - Q6C979R91Y (Vinorelbine)
SB  - IM
MH  - Adult
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Cisplatin/*administration & dosage
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Lung Neoplasms/*drug therapy
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Survival Analysis
MH  - Vinblastine/administration & dosage/*analogs & derivatives
MH  - Vinorelbine
EDAT- 2006/07/28 09:00
MHDA- 2006/09/22 09:00
CRDT- 2006/07/28 09:00
PHST- 2006/07/28 09:00 [pubmed]
PHST- 2006/09/22 09:00 [medline]
PHST- 2006/07/28 09:00 [entrez]
AID - 834 [pii]
AID - 10.1007/s12094-006-0052-6 [doi]
PST - ppublish
SO  - Clin Transl Oncol. 2006 Jul;8(7):519-24. doi: 10.1007/s12094-006-0052-6.