Konference: 2014 50th ASCO Annual Meeting - účast ČR
Kategorie: Gastrointestinální nádory
Téma: Gastrointestinal (Noncolorectal) Cancer
Číslo abstraktu: 4057
Autoři: M.D. Charles S. Fuchs, MPH; MUDr. Jiří Tomášek, Ph.D.; Jae-Yong Cho, M.D., Ph.D.; Gianluca Tomasello; M.D. Chanchal Goswami, Pl; M.D. Lucas Vieira dos Santos; Dott. Giuseppe Aprile; Prof. M.D. David R. Ferry, Ph.D.; prof. MUDr. Bohuslav Melichar, Ph.D.; Mustapha Ali Tehfe; M.D. Eldar Topuzov, Ph.D.; Prof. M.D. John Raymond Zalcberg, MB BS, PhD, FRACP, FRACMA FAICD; M.D. Ian Chau; Josep Tabernero, MD; Yanzhi Hsu, Ph.D.; Jonathan D. Schwartz; Minori Koshiji; Prof. Dr. Howard Safran
The REGARD trial demonstrated significant improvements in overall survival (OS), progression free survival (PFS), and disease control rates in pts receiving RAM, a human IgG1 receptor targeted antibody. We examined outcomes by age (<65 and ≥65 years [yrs]).
Methods: Pts were randomized 2:1 to receive RAM (8 mg/kg IV) plus BSC or PL plus BSC every 2 wks until PD, unacceptable toxicity, or death. Eligible patients had PD within 4 months (m) after 1st-line therapy for metastatic disease or within 6 m after adjuvant therapy. The primary endpoint was OS. Secondary endpoints included PFS, 12-wk PFS rate, overall response rate (ORR) and safety.
Results: 355 pts. were randomized; 227 were age <65 yrs (RAM 156; PL 71) and 128 were ≥ 65 yrs (RAM 82; PL 46).Baseline characteristics were well balanced between the treatment arms and subgroups. RAM efficacy was similar in younger and older patients. Median OS was 5.3 vs 4.1 m in the RAM:PL arms for pts <65 yrs and 5.2 vs 3.8 m in the RAM:PL arms for pts ≥65 yrs. The OS HR was 0.846 (95% CI, 0.611-1.171) in pts <65 years and 0.722 (95% CI 0.471-1.106) in pts ≥65 yrs (treatment-by-age group interaction p = 0.5569). Median PFS was 1.9 vs 1.3m in the RAM:PL arm for pts <65 yrs and 2.8 vs 1.4 m for Ram:PL for pts ≥65 yrs. The PFS HR was 0.450 (95% CI, 0.327-0.620) <65 yrs and 0.490 (95% CI, 0.319-0.752) (interaction p=0.9445). The incidence of Grade ≥3 adverse events was comparable between treatment arms for both age groups (55% vs 57% pts <65 yrs; 60% pts ≥65 yrs in both arms). The most frequent grade ≥ 3 AEs in ≥ 5% of pts RAM arm were: hypertension (7.8% RAM; 1.4% PL [<65 yrs] and 7.3% RAM; 4.4% PL [≥65 yrs]), abdominal pain (7.1% RAM; 4.3% PL [<65 yrs]), fatigue (7.3% RAM; 2.2% PL ≥ 65 yrs) and anemia (9.1% RAM; 7.1% PL [<65 yrs]. No specific AE was observed at grade ≥ 3 in > 10% of patients.
Conclusions:When compared to placebo, RAM conferred similar improvements for OS and PFS between pts age < 65 yrs and those age ≥ 65; AE profiles were also similar for pts ≥ 65 and <65 yrs. Clinical trial information: NCT00917384.
J Clin Oncol 32:5s, 2014 (suppl; abstr 4057)
Datum přednesení příspěvku: 31. 5. 2014