Impact of age and gender on the efficacy and safety of upfront therapy with panitumumab plus FOLFOX followed by panitumumab-based maintenance: a pre-specified subgroup analysis of the Valentino study

ESMO Open

article

A. Raimondi¹  G. Fuc๠ A.G. Leone¹  S. Lonardi²  C. Antoniotti³  V. Smiroldo⁴  A. Amatu⁵  M. Tampellini⁶  G. Ritorto⁷  R. Murialdo⁸  M. Clavarezza⁹  A. Zaniboni⁹  R. Berenato⁹  M. Ratti^1,10  S. Corallo¹  F. Morano¹  M. Di Bartolomeo¹  M. Di Maio^1,11  F. Pietrantonio¹ 

[1] Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori;Medical Oncology Unit 3, Department of Oncology, Istituto Oncologico Veneto—IRCCS;Unit of Medical Oncology, Azienda Ospedaliero-Universitaria Pisana;Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital;Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda;Department of Oncology, AOU San Luigi di Orbassano, University of Torino;SSD ColoRectal Cancer Unit, Oncology Department, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza;Department of Internal Medicine, University of Genoa and IRCCS AOU San Martino-IST;Medical Oncology Unit;Medical Oncology Unit, ASST Ospedale di Cremona;Department of Oncology, University of Turin, Ordine Mauriziano Hospital

关键词: colorectal cancer;    metastasis;    age;    gender;    anti-EGFR;   

DOI  :  10.1016/j.esmoop.2021.100246

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Background The safety and efficacy outcome of elderly metastatic colorectal cancer (mCRC) patients fit enough to receive combination chemotherapy plus biological agents is an issue of growing interest. Also, gender-specific differential toxicity and efficacy of anti-epidermal growth factor receptor (EGFR)-based upfront treatments need to be explored.Patients and methods Valentino was a multicenter, randomized, phase II trial, investigating two panitumumab-based maintenance strategies following first-line panitumumab plus FOLFOX in RAS wild-type mCRC patients. We carried out a subgroup analysis, aimed at assessing the differences in efficacy, safety and quality of life (QoL) according to age (<70 versus ≥70 years) and gender (male versus female). Efficacy endpoints were progression-free survival (PFS), overall survival (OS) and overall response rate (ORR); safety endpoints were rates of any grade and grade 3/4 adverse events (AEs).Results No significant differences in terms of PFS, OS and ORR were observed between patients aged <70 or ≥70 years and the effect of the maintenance treatment arm on survival outcomes was similar in the two subgroups. The safety profile of both induction and maintenance treatment and the impact on QoL were similar in elderly and younger patients. No significant differences in PFS, OS, ORR or clinical benefit rate were observed according to gender. A significantly higher rate of overall grade 3/4 AEs (P = 0.008) and of grade 3/4 thrombocytopenia (P = 0.017), any grade and grade 3/4 neutropenia (P < 0.0001) and any grade conjunctivitis (P = 0.033) was reported in female as compared to male patients. Conversely, we reported a significantly higher incidence of any grade skin rash (P = 0.0007) and hypomagnesemia (P = 0.029) in male patients.Conclusions The upfront choice of an anti-EGFR-based doublet chemotherapy followed by a maintenance strategy represents a valuable option in RAS wild-type mCRC irrespective of gender and age, though a careful evaluation of patients to maximize the risk/benefit ratio is warranted.

【 授权许可】

CC BY|CC BY-NC-ND