医学
卡培他滨
内科学
胃肠病学
化疗
进行性疾病
化疗方案
实体瘤疗效评价标准
神经内分泌肿瘤
外科
结直肠癌
癌症
作者
Ángela Lamarca,Jorge Barriuso,Lynne McCallum,George Papaxoinis,Magdy Nasralla,Christina Nuttall,Melissa Frizziero,Zoe Kordatou,Mairéad G. McNamara,Richard Hubner,Was Mansoor,Juan W. Valle
标识
DOI:10.1093/annonc/mdx368.024
摘要
Background: TemCap is an option for treatment of NENs; benefit of treatment until progression rather than a fixed 6-month (mo) course remains unclear. Methods: Patients (pts) diagnosed with advanced NEN (pathology-confirmed), treated with TemCap with follow-up and available radiological response data were eligible for this retrospective study. Efficacy was assessed by RECIST v1.1. Results: Of 62 pts identified (Jan’12-Jan’17), 60 were eligible. Median (med) age at starting TemCap was 63.6 yrs; 50% were male; Performance Status (PS) 0-1 (83.3%), 2 (16.7%); with NEN of lung (33.3%), pancreas (21.7%), small bowel (16.7%), colorectal (3.3%) and other (25.0%) origin. The med Ki-67 was 12% (range 1-29); most (83.3%) were well-differentiated [grade (G)1/typical (18.3%); G2/atypical (65%); G3 (16.7%)], non-functional (75.0%) and metastatic (90.0%). Pts received TemCap as first- (33.3%) or second- (35.0%) line, for a med of 5.58 mo (95%CI 5.33-5.78). After 6 cycles, 38 pts (63.3%) were progression-free (i.e. eligible for maintenance TemCap [mTemCap]); 11 received mTemCap, 27 did not. Rationale for mTemCap was good response (n = 7), good tolerance (n = 3) or pts’ wishes (n = 1). Overall, 29 pts (48.3%) had stable disease and 14 pts (23.3%) achieved a partial response (PR); med reduction in responding pts was -56.7% (95%CI -76.4 to -33.3); 4 additional pts (6.67%) achieved a reduction >20% but <30%. Time to PR was 3.9 mo (95%CI 2.45-15.24); time to maximum response was 10.7 mo (7.2-11.8). By the end of follow-up, 95% and 75% of pts had stopped TemCap and progressed, respectively; estimated med PFS and overall survival (OS) were 10.1 mo (95%CI 6.7-14.2) and 27.3 mo (95%CI 16.35-NR), respectively. Achieving a PR was an independent factor (multivariable Cox regression) impacting on PFS (HR 0.2 (95%CI 0.1-0.6); p = 0.001); landmark analysis (excluding pts with early (3 mo) progression; n = 10) confirmed such findings. Conclusions: Achieving a PR impacts on PFS in pts treated with TemCap. Although PR is an early event, maximum response is not achieved until later in pts’ treatment/follow-up; mTemCap until progression is appropriate for pts who are progression-free at 6 mo and have good tolerance to treatment. Legal entity responsible for the study: N/A Funding: None Disclosure: All authors have declared no conflicts of interest.
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