Observational Study in a Real-World Setting of Targeted Therapy in the Systemic Treatment of Progressive Unresectable or Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors (pNETs) in France: OPALINE Study

被引:6
作者
Smith, Denis [1 ]
Lepage, Come [2 ]
Vicaut, Eric [3 ]
Dominguez, Sophie [4 ]
Coriat, Romain [5 ]
Dubreuil, Olivier [6 ]
Lecomte, Thierry [7 ]
Baudin, Eric [8 ]
Bouvet, Laurence Venat [9 ]
Samalin, Emmanuelle [10 ]
Santos, Alexandre [11 ]
Borie, Odile [12 ]
Bisot-Locard, Segolene [11 ]
Goichot, Bernard [13 ]
Lombard-Bohas, Catherine [14 ]
机构
[1] Hop Univ Bordeaux, Ctr Medicochirurg Magellan, Oncol Digest, Hop Haut Leveque, F-33604 Pessac, France
[2] Hop Univ Le Bocage, Hepatogastroenterol, Dijon, France
[3] Hop Lariboisiere, AP HP, Unite Rech Clin, Paris, France
[4] Univ Catholique Lille, Hop St Vincent de Paul, Hop Cathol Lille, Dept Oncohematol, Lille, France
[5] Univ Paris, AP HP Ctr, Unite Gastroenterol, Hop Cochin, Paris, France
[6] Grp Hosp Diaconesses Croix St Simon, Oncol Med, Paris, France
[7] CHRU Tours, Dept Hepatogastroenterol & Oncol Digest, Tours, France
[8] Inst Gustave Roussy, Serv Med Nucl, Villejuif, France
[9] Hop Dupuytren, Dept Oncol, Limoges, France
[10] Univ Montpellier, Inst Canc Montpellier ICM, Dept Oncol Med, Montpellier, France
[11] Novartis Oncol, Rueil Malmaison, France
[12] Pfizer Oncol, Paris, France
[13] Hop Univ Hautepierre, Dept Med Interne, Strasbourg, France
[14] Hosp Civils Lyon, Hop Edouard Herriot, GHC, Serv Oncol Med, Lyon, France
关键词
Ambispective study; Everolimus; Pancreatic neuroendocrine tumor; pNET; Sunitinib; 2-Year morbi-mortality; CLINICAL-PRACTICE GUIDELINES; DIGESTIVE ENDOCRINE TUMORS; MANAGEMENT; EVEROLIMUS; DIAGNOSIS; PROGNOSIS;
D O I
10.1007/s12325-022-02103-7
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Introduction Approval of sunitinib and everolimus for the treatment of progressive, unresectable or metastatic well-differentiated pancreatic neuroendocrine tumors (pNETs) was obtained in France in 2011 and 2012, respectively. OPALINE was set up as an observational study to evaluate the efficacy of sunitinib and everolimus compared to usual pNET treatments of chemotherapies and somatostatin analogues that had been previously recommended by the health authorities. Methods The OPALINE study assessed the efficacy of everolimus and sunitinib in terms of survival, disease progression and tolerance. Patients (N = 144) were enrolled from May 2015 to September 2017, and their disease characteristics were analyzed from diagnosis to 2 years post-enrollment. Results At inclusion most patients had comorbidities, and about 95% presented metastases. Patients received on average 3.2 lines of treatment from diagnosis to inclusion and two lines throughout the 2-year follow-up. Seventy-nine patients (59.0%) received at least one targeted therapy (TT) during their care path. For these patients, the overall survival (OS) was approximatively 176.5 months (95% CI: 97.2-not evaluable), with a 2-year survival rate estimated at 93.6% (SD 2.6%). Similar survival rates were observed whether the TTs were prescribed sooner or later in the treatment path. The main reasons for discontinuation of TTs were disease progression (54 patients) and adverse events (26 patients). Most patients receiving TTs did not change their dose during the follow-up reflecting the good treatment tolerability over time. No new safety alert was reported for everolimus and sunitinib during this study. Conclusion Given their good tolerance and positive impact on estimated OS, the two TTs have an important role to play in the care path of patients with pNETs.
引用
收藏
页码:2731 / 2748
页数:18
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