Quality of life, effectiveness, and safety of aflibercept plus FOLFIRI in older patients with metastatic colorectal cancer: An analysis of the prospective QoLiTrap study

被引：1

作者：

Piringer, Gudrun ^{[1
,2
]}

Thaler, Josef ^{[1
]}

Anchisi, Sandro ^{[3
]}

Geffriaud-Ricouard, Christine ^{[4
]}

Gueldner, Max ^{[5
]}

Scholten, Felicitas ^{[6
]}

Derigs, Hans-Guenter ^{[6
]}

Bohanes, Pierre ^{[7
]}

Gruenberger, Birgit ^{[8
]}

Schwarz, Leonora ^{[9
]}

von Moos, Roger ^{[10
]}

Hofheinz, Ralf-Dieter ^{[11
]}

机构：

[1] Wels Grieskirchen Hosp, Dept Internal Med 4, Grieskirchner Str 42, A-4600 Wels, Austria

[2] Johannes Kepler Univ Linz, Altenberger Str 69, A-4040 Linz, Austria

[3] Valais Hosp, Valais Romand Hosp Ctr, Dept Oncol, Ave Grand Champsec 86, CH-1951 Sion, Switzerland

[4] Sanofi, Global Med Oncol, 46 Ave Grande Armee, F-75017 Paris, France

[5] Sanofi Aventis Deutschland GmbH, Luetzowstr 107, D-10785 Berlin, Germany

[6] Frankfurt Hochst Clin, Dept Internal Med Hematol Oncol Palliat Med & Pneu, Gotenstr 6-8, D-65929 Frankfurt, Germany

[7] Ctr Chemotherapy, Dept Oncol & Internal Med, CH-1004 Lausanne, Switzerland

[8] Hosp Wiener Neustadt, Dept Internal Med Hematol & Oncol, Corvinusring 3-5, A-2700 Wiener Neustadt, Austria

[9] Alcedis, Dept Biometry, Winchesterstr 3, D-35394 Giessen, Germany

[10] Cantonal Hosp Graubuenden, Dept Oncol, Loestr 170, CH-7000 Chur, Switzerland

[11] Univ Hosp Mannheim, Dept Oncol, Theodor Kutzer Ufer 1, D-68167 Mannheim, Germany

来源：

JOURNAL OF GERIATRIC ONCOLOGY | 2023年 / 14卷 / 08期

关键词：

Aflibercept; Antiangiogenics; Colorectal cancer; Older adults; EGFR inhibitors; Quality of life; Safety; VEGF inhibitors; Bevacizumab; INTERNATIONAL SOCIETY; ELDERLY-PATIENTS; MANAGEMENT; ADULTS;

D O I：

10.1016/j.jgo.2023.101638

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Introduction: Colorectal cancer (CRC) mainly affects older patients. The pivotal VELOUR phase III trial of aflibercept plus FOLFIRI in metastatic CRC (mCRC) included only 5.9% of patients aged >= 75 years. Herein, we report a preplanned analysis from QoLiTrap, a large prospective observational study evaluating the impact of age on quality of life (QoL), effectiveness, and safety of aflibercept plus FOLFIRI in daily clinical practice in Europe.Materials and Methods: Enrolled patients had progressive mCRC, had failed a prior oxaliplatin-based regimen, and had received aflibercept (4 mg/kg) plus FOLFIRI every two weeks until disease progression, death, unacceptable toxicity, or physician/patient decision. Analyses were performed by age classes (<60, 60-64, 65-69, 70-74, and >= 75 years). The primary endpoint was the percentage of patients whose global health status (GHS) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was maintained (i.e., no worsening from baseline by at least 5% over a 12-week treatment). Secondary endpoints included tumor objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.Results: Overall, 1277 patients (<60 years, n = 327; 60-64 years, n = 231; 65-69 years, n = 227; 70-74 years, n = 259; and >= 75 years, n = 233) were treated, of whom 872 were evaluable for QoL. GHS was maintained in 36.5%, 41.6%, 38.9%, 41.8%, and 44.8% of patients aged <60, 60-64, 65-69, 70-74, and >= 75 years, respec-tively. Age did not influence PFS (median 7.8 months), OS (median 14.4 months), or ORR (20.8%). Number of cycles, dose delays for any cause, and dose reductions for adverse events (AEs) were comparable between age classes. Grade >= 3 AEs occurred in 47.7%, 51.9%, 51.5%, 55.2%, and 55.8% of patients aged <60, 60-64, 65-69, 70-74, and >= 75 years, respectively. The main grade >= 3 AEs were hypertension (11.2%) and diarrhea (9%) in patients aged >= 75 years.Discussion: The results suggest that aflibercept plus FOLFIRI maintains QoL and retains its activity, including a high objective tumor response, regardless of age and treatment line. In fit older patients, the safety profile seems manageable, with no new safety signals.

引用

页数：10

共 35 条

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