MishenMed: Statistical Consulting for Clinical Trials

  1. Evaluation of target lesions: Complete Response (CR) : Disappearance of all target lesions.  Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD):   Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,  taking as reference the smallest sum diameters while on study.   Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on the study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. ( Note: the appearance of one or more new lesions is also considered...

  Tumour response evaluation: 1. Assessment of overall tumour burden and measurable disease To assess the objective response or f uture progression , it is necessary to estimate the overall tumour burden at baseline and use this as a comparator for subsequent measurements.  ' When  primary endpoint= objective tumor response Only patients with measurable disease at baseline should be included in protocols  Measurable disease is defined by the presence of at least one measurable lesion. When primary endpoint = tumour progression (either time to progression or proportion with progression at a fixed date) The protocol must specify if entry is restricted to those with measurable disease or whether patients having non-measurable disease only are also eligible. 2.  Baseline documentation of ‘target’ and ‘non-target’ lesions  ‘Target’ lesions : Wh...

  1. Background  1.1. History of RECIST criteria Important endpoints in cancer clinical trials:  Tumor shrinkage (Objective response) Time of the development of disease progression which are  useful only if based on widely accepted and readily applied standard criteria based on anatomical tumour burden.  Key features of the original RECIST: Definitions of the minimum size of measurable lesions Instructions on how many lesions to follow (up to 10; a maximum five per organ site) Use of unidimensional , rather than bidimensional, measures for the overall evaluation of tumour burden.   1.2. Why update RECIST?  To clarify those questions: whether fewer than 10 lesions can be assessed without affecting the overall assigned response for patients (or the conclusion about activity in trials);  how to apply RECIST in random...

Highlights  of revised RECIST 1.1 : Major changes include:  1. Number of lesions to be assessed : the number of lesions required to assess tumor burden for response determination has been reduced from a maximum of 10 to a maximum of 5 total (and from five to two per organ, maximum).  2. Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of >= 15 mm are considered measurable and assessable as target lesions.  The short axis measurement should be included in the sum of lesions in the calculation of tumor response.   Nodes that shrink to <10 mm short axis are considered normal.  3. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomized studies since the control arm serves as appropriate means of interpretation of data.  [What does "Confirmation of response " refer to? The main goal of confi...

  癌症（cancer）是一种疾病，指的是几乎遍布体内的细胞开始不受控制地分裂。 当实体组织（如：器官、肌肉或骨骼）里出现癌细胞增长时，我们称之为肿瘤（tumor），后者或可从血液及淋巴系统扩散到周围的组织中。 癌症治疗 旨在消除这些异常细胞，或减缓、阻止癌细胞扩散。 实体肿瘤（solid tumors）被分为两大类：恶性（malignant，具有致癌性）肿瘤和良性（benign，不具有致癌性）肿瘤。 具有致癌性的肿瘤可以侵入到身体内周围的组织中，且随着这些肿瘤的生长，有些癌细胞或许还会游离到身体的其它部位，以形成其它的 “继发性” 肿瘤（ “secondary” tumors），我们也把后者称为转移（瘤）（metastases）。 实体恶性肿瘤的例子包括癌（carcinomas）和肉瘤（sarcomas）。 1.癌（carcinomas）指的是在细胞内生成的癌症，这些细胞是组织内层器官（tissue lining organs）的组成，如：肝脏（liver）或肾脏（kidney）。 2.肉瘤（sarcomas）则是指身体结缔组织（connective tissues）中形成的癌症，例如：在肌肉、骨骼和神经中的癌症。 摘抄自： https://www.dana-farber.org/for-patients-and-families/becoming-a-patient/international-patients/chinese/inspiration/%E7%99%8C%E7%97%87%E5%92%8C%E8%82%BF%E7%98%A4%E7%9A%84%E5%8C%BA%E5%88%ABcancer-and-a-tumor/