Konference: 2012 37th Congress ESMO – účast ČR
Kategorie: Zhoubné nádory plic a průdušek
Téma: Poster, Poster presentation I
Číslo abstraktu: 1247P
Autoři: Eng Huat Tan; MUDr. Libor Havel; Maciej Jerzy Krzakowski; Jens Kollmeier; MD Radj Gervais; Eric Dansin; Monika Serke; Stephanie Malasse; Fabienne Biville-Hedouin; Dr. Jaafar Bennouna
Background
Individualized treatments in NSCLC are now based on molecular and/or histological data. This randomized trial (2/1) was set up to assess the efficacy of NC compared to PC for pts with nSCC. The primary end-point was disease control rate (DCR) including overall response rate (ORR) and stable disease (SD).
Methods
Pts received N60-80 mg/m2 D1, D8 + C80 mg/m2 D1 or P500 mg/m2 + C75 mg/m2 D1 for 4 cycles q3w; pts with DCR received single agent continuation maintenance (CM) until progression or toxicity.
Results
From 10/09 to 02/11, 151 pts were treated with NC or PC.
|
ITT = 151 |
NCn = 100 |
PCn = 51 |
|
Male/Stage IV (%) |
62.0/87.0 |
64.7/88.2 |
|
Median age (y, range) |
61.0 (38.4-75.1) |
63.8 (40.3-75.5) |
|
Combination: (%) ITT(95% CI) |
||
|
DCR |
75.0 (65.3-83.1) |
74.5 (60.4-85.7) |
|
ORR |
21.0 (13.5-30.3) |
23.5 (12.8-37.5) |
|
Combination + CM:(%) ITT (95% CI) |
n= 53 |
n = 33 |
|
DCR |
75 (65.3-83.1) |
76.5 (62.5-87.2) |
|
ORR |
24 (16.0-33.6) |
31.4 (19.1-45.9) |
|
Median PFS ITT (m,range) |
4.2 (3.6-4.7) |
4.2 (3.2-5.6) |
|
PFS ITT at 6/12/18m (%) |
33.0/10.3/5.5 |
27.5/7.4/2.5 |
|
Median OS ITT (m,range) |
10.6 (7.8-12.1) |
10.8 (7.0-14.5) |
Related toxicities G3/4 (%pts) NC/PC during Combination: anemia 9.0(G3)/8.2, leucopenia 26.0/10.2, neutropenia 44.0/18.3, febrile neutro 2.0/2.0, thrombocytopenia 0/6.1, fatigue(G3) 7.0/3.9, hyperglycemia 4.0/7.8, nausea(G3) 5.0/0, vomiting(G3) 7.0/2.0, stomatitis(G3) 0/2.0, pneumonia(G3) 0/2.0, deep vein thrombosis(G3) 0/2.0, pulmonary embolism(G4) 0/2.0. During Maintenance: anemia 5.0/4.1, leucopenia 2.0/10.2, neutropenia 11.0/20.4, febrile neutro 3.8/0, fatigue (G3) 3.8/0, stomatitis(G3) 1.9/ 3.0, pain 3.8/6.0, Respiratory disorders 0/4.0, deep vein thrombosis (G3)0/2.0. Deaths potentially related to CT 2/1.
Conclusions
NC and PC had similar efficacy. In the present economic context, the acquisition cost of the two platinum based doublets should be considered in the treatment decision making of pts with advanced nSCC NSCLC.
Disclosure
S. Malassé: Statistician of the study Employment for the sponsor.
F. Biville-Hedouin: Medical Project Manager of the study Employment for the sponsor.
All other authors have declared no conflicts of interest.
Datum přednesení příspěvku: 29. 9. 2012
