Τίτλος:
First-line treatment of advanced non-small-cell lung cancer with
docetaxel and cisplatin: A multicenter phase II study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Purpose: To evaluate the efficacy and safety of the docetaxelcisplatin
combination in patients with advanced non-small-cell lung cancer
(NSCLC).
Patients and methods: Chemotherapy-naive patients with histologically
confirmed, measurable stage IIIB or IV NSCLC, a World Health
Organization (WHO) performance status of 0-2 and adequate bone marrow
renal, hepatic and cardiac function were eligible for the study.
Patients received docetaxel (100 mg/m(2)) as an one-hour infusion on day
1 and cisplatin (80 mg/m(2)) as a 30-min infusion with appropriate
hydration on day 2. Granulocyte colony-stimulating factor (G-CSF; 150 mu
g/m(2), SC) was given on days 3 to 13. Treatment was repeated every
three weeks.
Results. Fifty-three patients were enrolled (25 with stage IIIB and 25
with stage IV). One complete and 23 partial responses were observed
(overall response rate (OR): 45%; 95% CI: 34.1%-61.8%). The response
rate was 57% and 32% in patients with stages IIIB and IV disease (P =
NS). The median time to progression was 36 weeks and the median survival
45 weeks; the one-year survival was 48%. Grade 3-4 neutropenia occurred
in 23 patients, 15 of whom were hospitalized for neutropenic fever; two
patients died of sepsis. Grade 2 neurotoxicity was observed in six
patients and grade 3 in five patients; grade 3 fatigue occurred in seven
patients, grade 3-4 mucositis in four patients and grade 3-4 diarrhea in
six patients. Mild allergic reactions and oedema were observed in five
and four patients, respectively. The median dose intensity was 30
mg/m(2)/week for docetaxel and 24 mg/m(2)/week for cisplatin,
corresponding to 91% and 89% of the specified protocol doses,
respectively.
Conclusions: The docetaxel-cisplatin combination is an active regimen in
advanced NSCLC, but hematologic toxicity remains high despite the
prophylactic use of G-CSE.
Συγγραφείς:
Georgoulias, V
Androulakis, N
Dimopoulos, AM
Kourousis, C
and Kakolyris, S
Papadakis, E
Apostolopoulou, F and
Papadimitriou, C
Vossos, A
Agelidou, M
Heras, P
Tzannes,
S
Vlachonicolis, J
Mavromanolakis, E
Hatzidaki, D
Περιοδικό:
Annals of Oncology
Εκδότης:
KLUWER ACADEMIC PUBL
Λέξεις-κλειδιά:
chemotherapy; cisplatin; docetaxel; non-small-cell lung cancer
DOI:
10.1023/A:1008278103446
