Bexarotene improves TTP in untreated, advanced NSCLC, when given in combination with carboplatin/paclitaxel
Document Type
Article
Department
Haematology and Oncology, East Africa
Abstract
Background: Bexarotene, a specific synthetic retinoid analogue, binds to the α, β, and γ subclass of RXR, providing therapeutic specificity and reduced toxicities in pts with RXR-expressing tumors. Initial phase-I/II clinical trials in NSCLC showed that bexarotene added to chemotherapy prolonged stabilization of disease (TTP) and 1, 2, and 3 yr survival.
Methods: Stage IIIB with pleural effusion & Stage IV chemo-naïve patients, ECOG PS 0–2, were enrolled on study and treated with carboplatin IV AUC-6 d1 and paclitaxel IV 100mg/m2 d1, 8, and 15, every 28-d for 4 cycles. Pts were randomized using a 1:1 design to bexarotene PO 400mg/m2/d either concurrent (C) from Day 1 or sequential (S) at the completion of chemo, for up to a year.
Results: From a planned total of 60 patients, 48 have been enrolled thus far; median age 62.3 (range 41–86), 43 Caucasian, 41 TNM Stage IV, 33 males, 34 ECOG PS 1. To date, 44 pts are evaluable for efficacy and toxicity based on ITT; 35 were evaluated for RR: 15 (42.8%) achieved PR (C: 7 and S: 8), 15 (42.8%) exhibited SD (C: 8 and S: 7), and 5 (14.3%) had PD (C: 2 and S: 3), during the first 112 days (C1–4 chemo). TTP analysis was done in 42 pts: 19 pts showed an overall TTP of 152 days (5.06 mo) (C=10: 148.3 days and S=9: 155.5 days); in 23 pts the TTP has not been reached after a median F/U of 79 days (range 10–203). The overall 1yr S was 58.8% with no significant difference between treatment arms (p=0.7). The treatment was well tolerated; overall, AEs were reported in 48% of pts in the S arm vs. 51% in the C arm. The incidence of Gr 3–4 AEs, regardless of the treatment arm, was < 5%. There were no treatment-associated deaths.
Conclusions: so far, data suggests a comparable ORR and a potential improvement in TTP, when bexarotene is added to carboplatin/paclitaxel, compared with chemo alone. Toxicity is easily managed. Updated efficacy and toxicity data will be presented at the meeting.
Publication (Name of Journal)
Journal of Clinical Oncology
DOI
https://doi.org/10.1200/jco.2005.23.16_suppl.7270
Recommended Citation
Bordoni, R.,
Saleh, M.,
Auerbach, M.,
Steinbaum, F.,
Cuevas, J.,
Harris, S.,
Howell, B.
(2005). Bexarotene improves TTP in untreated, advanced NSCLC, when given in combination with carboplatin/paclitaxel. Journal of Clinical Oncology, 23(16).
Available at:
https://ecommons.aku.edu/eastafrica_fhs_mc_haematol_oncol/8
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Comments
This work was published before the author joined Aga Khan University.