PMID- 10812192
OWN - NLM
STAT- MEDLINE
DCOM- 20000727
LR  - 20190921
IS  - 0169-5002 (Print)
IS  - 0169-5002 (Linking)
VI  - 28
IP  - 3
DP  - 2000 Jun
TI  - Amifostine plus cisplatin plus vinorelbine in the treatment of advanced non small 
      cell lung cancer: a multicenter phase II study.
PG  - 237-44
AB  - PURPOSE: to evaluate the activity and toxicity of the combination cisplatin plus 
      vinorelbine plus amifostine in advanced non small cell lung cancer (NSCLC). 
      PATIENTS AND METHODS: a two-stage Simon design was applied. To proceed after the 
      first stage, responses from seven of 19 patients were needed. Overall, 17 
      responses from 40 treated patients were required to comply with the design 
      parameter. Inclusion criteria were cyto-histologically proven stage IIIB-IV 
      NSCLC; age of 70 years or less; Eastern Cooperative Oncology Group (ECOG) 
      performance status of 2 or less; normal cardiac, hepatic, renal and bone marrow 
      functions; and no previous chemotherapy. Patients were staged by physical 
      examination, biochemistry, chest radiograph, brain, thoracic and abdominal 
      computed tomographic (CT) scans, and bone scan. All patients received cisplatin 
      100 mg/m(2) intravenously (iv) day 1, vinorelbine 25 mg/m(2) iv days 1-8-15-22, 
      amifostine 740 mg/m(2) iv day 1 every 4 weeks up to six cycles. Eleven of 40 
      enrolled patients were stage IIIB and 29 stage IV, with a median age of 57 years 
      (range, 38-70 years). RESULTS: all patients were evaluable for response and 
      toxicity (intention to treat analysis). We observed 20 (50%) objective responses, 
      with four (10%) complete responses. Median time to progression was 20 weeks, and 
      median survival was 45 weeks. The toxicity was manageable. The reported main 
      toxicities were neutropenia grade 4 in 10% of patients, grade 1 and grade 3 
      nephrotoxicity both in 5% of patients and grade 1 amifostine-related hypotension 
      in 15% of patients. CONCLUSION: these data show that cisplatin plus vinorelbine 
      plus amifostine is an active and feaseable regimen in stage IIIB-IV NSCLC. A 
      phase III trial comparing cisplatin plus vinorelbine versus cisplatin plus 
      vinorelbine plus amifostine in advanced NSCLC is warranted.
FAU - Gridelli, C
AU  - Gridelli C
AD  - Divisione di Oncologia Medica B, Istituto Naizonale Tumori, via M. Semmola 3, 
      80131, Naples, Italy. cgridelli@sirio-oncology.it
FAU - Cigolari, S
AU  - Cigolari S
FAU - Maiorino, A
AU  - Maiorino A
FAU - Ianniello, G P
AU  - Ianniello GP
FAU - Brancaccio, L
AU  - Brancaccio L
FAU - Rossi, A
AU  - Rossi A
FAU - De Cataldis, G
AU  - De Cataldis G
FAU - Pedicini, T
AU  - Pedicini T
FAU - Maiorino, L
AU  - Maiorino L
FAU - Barletta, E
AU  - Barletta E
FAU - Di Lanno, M
AU  - Di Lanno M
FAU - Bilancia, D
AU  - Bilancia D
FAU - Crispino, C
AU  - Crispino C
FAU - Barzelloni, M L
AU  - Barzelloni ML
FAU - Masullo, P
AU  - Masullo P
FAU - D'Aniello, R
AU  - D'Aniello R
FAU - Manzione, L
AU  - Manzione L
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 5V9KLZ54CY (Vinblastine)
RN  - M487QF2F4V (Amifostine)
RN  - Q20Q21Q62J (Cisplatin)
RN  - ACV protocol
SB  - IM
MH  - Adult
MH  - Aged
MH  - Amifostine/administration & dosage/therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & 
      dosage/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/diagnosis/*drug therapy/mortality
MH  - Cisplatin/administration & dosage/therapeutic use
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Lung Neoplasms/diagnosis/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Survival Rate
MH  - Tomography, X-Ray Computed
MH  - Treatment Outcome
MH  - Vinblastine/administration & dosage/therapeutic use
EDAT- 2000/05/17 09:00
MHDA- 2000/08/01 11:00
CRDT- 2000/05/17 09:00
PHST- 2000/05/17 09:00 [pubmed]
PHST- 2000/08/01 11:00 [medline]
PHST- 2000/05/17 09:00 [entrez]
AID - S0169500299001312 [pii]
AID - 10.1016/s0169-5002(99)00131-2 [doi]
PST - ppublish
SO  - Lung Cancer. 2000 Jun;28(3):237-44. doi: 10.1016/s0169-5002(99)00131-2.