Recurrent là gì

DOI: 10.1200/JCO.năm 2016.34.15_suppl.6009 Journal of Clinical Oncology -published online before print May trăng tròn, 2016




Bạn đang xem: Recurrent là gì

Further evaluations of nivolumab (nivo) versus investigator’s choice (IC) chemotherapy for recurrent or metastatic (R/M) squamous cell carcinoma of the head & nechồng (SCCHN): CheckMate 141.


Xem thêm: Resurrect Là Gì ? Resurrect In Vietnamese

*



Xem thêm: Nghĩa Của Từ Quality Là Gì ? (Từ Điển Anh Nghĩa Của Từ Quality, Từ Quality Là Gì

Show More University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA; The University of Texas MD Anderson Cancer Center, Houston, TX; Centre Léon Bérard, Lyon, France; Centre Antoine-Lacassagne, Nice, France; Stanford Cancer Institute, Palo Allớn, CA; IRCCS Istituto lớn Nazionale Tumori, Milan, Italy; Royal Marsden NHS Foundation Trust, London, United Kingdom; University Hospital Essen, Essen, Germany; University of Chicago, Chicago, IL; Institut Gustave Roussy, Villejuif, France; University of Michigan, Ann Arbor, MI; Dana-Farber Cancer Institute, Boston, MA; Kobe University Hospital, Kobe-City, Japan; National Cancer Center Hospital East, Kashiwa, Japan; Bristol-Myers Squibb, Princeton, NJ; The Ohio State University, Columbus, OH

Abstract Disclosures


6009

Background: Patients (pts) with R/M SCCHà Nội have poor prognosis, & median OS for pts with platinum-refractory disease is ≤6 mo. We investigated if nivo, a fully human IgG4 anti-PD-1 mAb improves OS in pts with platinum-refractory R/M SCCHà Nội compared to lớn IC. Methods: Pts aged ≥18 yr with R/M SCCHN & ECOG PS 0–1 were randomized 2:1 khổng lồ nivo 3 mg/kilogam q2w (until PD or toxicity) or single-agent IC (MTX, docetaxel, or cetuximab). The primary endpoint was OS; top line data were presented at AACR. Secondary endpoints included ORR và PFS (RECIST 1.1). Here we report additional endpoints: chất lượng of life (QoL) assessments, correlative sầu biomarkers, và safety. OS, PFS, & ORR were compared between treatment arms, by PD-L1 expression (≥1%, 5%, và 10%) & HPV (p16 IHC) status. Cellular và serum biomarkers are being evaluated. Pts aged ≥18 yr with R/M SCCHà Nội & ECOG PS 0–1 were randomized 2:1 to nivo 3 mg/kg q2w (until PD or toxicity) or single-agent IC (MTX, docetaxel, or cetuximab). The primary endpoint was OS; top line data were presented at AACR. Secondary endpoints included ORR và PFS (RECIST 1.1). Here we report additional endpoints: chất lượng of life (QoL) assessments, correlative biomarkers, và safety. OS, PFS, và ORR were compared between treatment arms, by PD-L1 expression (≥1%, 5%, and 10%) & HPV (p16 IHC) status. Cellular và serum biomarkers are being evaluated. Results: 361 pts were randomized, 240 khổng lồ nivo và 121 to lớn IC. A 30% reduction in risk of death was observed for nivo-treated pts with a median OS of 7.5 mo (95% CI: 5.5–9.1) for nivo & 5.1 mo (95% CI: 4.0–6.0) for IC. Aao ước pts with PD-L1 ≥1% expression, median OS for nivo vs IC was 8.7 vs 4.6 mo in pts ≥1%, 8.8 vs 4.6 mo for ≥5%, and 8.7 vs 5.2 mo for ≥10%. Overall hazard ratio (HR) for OS of 0.70 (97.73% CI: 0.51–0.96) was consistently better for PD-L1 expression ≥1%: 0.56 (95% CI: 0.37–0.84), for ≥5%: 0.50 (95% CI: 0.30–0.83), and for ≥10%: 0.56 (95% CI: 0.31–0.99). Median PFS for nivo vs IC was 2.1 vs 2.0 mo (HR 0.64; 95% CI: 0.44–0.93) for PD-L1 ≥1%, 3.2 vs 2.0 mo (HR 0.53; 0.33–0.84) for ≥5%, và 2.1 vs 2.1 mo (HR 0.53; 0.31–0.88) for ≥10%. ORR for nivo with PD-L1 ≥1%, ≥5%, and ≥10% was 18.2%, 25.9%, and 32.6%, respectively, compared lớn 3.3%, 2.3%, & 2.9% for IC. Any grade treatment-related AEs (TRAEs) occurred in 59.3% & 77.5% of pts on nivo or IC, respectively. Grade 3/4 TRAEs occurred in 13.6% và 35.1% of pts. QoL and correlative biomarker data will be presented. Conclusions: Nivo demonstrated significant OS benefit compared to IC. OS and ORR improvement was greater with PD-L1 expression ≥1%. Nivo had a lower incidence of TRAEs compared to lớn IC. Nivo is the first immune checkpoint inhibitor to lớn demonstrate improved OS in a randomized controlled trial in R/M SCCHN. Clinical trial information: NCT02105636.


Chuyên mục: Kiến Thức