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Abstract：
OBJECTIVE: To assess the eligibility of patients with advanced or recurrent solid malignancies presented to a molecular tumor board (MTB) at a large precision oncology center for inclusion in trials with the endpoints objective response rate (ORR) or duration of response (DOR) based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
METHODS: Prospective patients with available imaging at the time of presentation in the MTB were included. Imaging data was reviewed for objectifiable measurable disease (MD) according to RECIST v1.1. Additionally, we evaluated the patients with MD for representativeness of the identified measurable lesion(s) in relation to the overall tumor burden.
RESULTS: 262 patients with different solid malignancies were included. 177 patients (68%) had MD and 85 (32%) had non-measurable disease (NMD) at the time point of MTB presentation in accordance with RECIST v1.1. MD was not representative of the overall tumor burden in eleven patients (6%). The main reasons for NMD were lesions with longest diameter shorter than 10 mm (22%) and non-measurable peritoneal carcinomatosis (18%). Colorectal cancer and malignant melanoma displayed the highest rates of MD (> 75%). In contrast, gastric cancer, head and neck malignancies, and ovarian carcinoma had the lowest rates of MD (< 55%). In case of MD, the measurable lesions were representative of the overall tumor burden in the vast majority of cases (94%).
CONCLUSIONS: Approximately one third of cancer patients with advanced solid malignancies are not eligible for treatment response assessment in trials with endpoints ORR or DOR at the time of MTB presentation. The rate of patients eligible for trials with imaging endpoints differs significantly based on the underlying malignancy and should be taken under consideration during the planning of new precision oncology trials.
METHODS: Prospective patients with available imaging at the time of presentation in the MTB were included. Imaging data was reviewed for objectifiable measurable disease (MD) according to RECIST v1.1. Additionally, we evaluated the patients with MD for representativeness of the identified measurable lesion(s) in relation to the overall tumor burden.
RESULTS: 262 patients with different solid malignancies were included. 177 patients (68%) had MD and 85 (32%) had non-measurable disease (NMD) at the time point of MTB presentation in accordance with RECIST v1.1. MD was not representative of the overall tumor burden in eleven patients (6%). The main reasons for NMD were lesions with longest diameter shorter than 10 mm (22%) and non-measurable peritoneal carcinomatosis (18%). Colorectal cancer and malignant melanoma displayed the highest rates of MD (> 75%). In contrast, gastric cancer, head and neck malignancies, and ovarian carcinoma had the lowest rates of MD (< 55%). In case of MD, the measurable lesions were representative of the overall tumor burden in the vast majority of cases (94%).
CONCLUSIONS: Approximately one third of cancer patients with advanced solid malignancies are not eligible for treatment response assessment in trials with endpoints ORR or DOR at the time of MTB presentation. The rate of patients eligible for trials with imaging endpoints differs significantly based on the underlying malignancy and should be taken under consideration during the planning of new precision oncology trials.
摘要：
目的：根据实体肿瘤疗效评估标准（RECIST1.1版），评估晚期或复发性实体恶性肿瘤患者在大型精密肿瘤学中心分子肿瘤委员会（MTB）中纳入研究终点客观缓解率（ORR）或缓解持续时间（DOR）。
方法：包括在出现MTB时具有可用影像学的前瞻性患者。根据RECISTv1.1对影像学数据进行了客观的可测量疾病（MD）审查。此外,我们评估了MD患者确定的可测量病变相对于总肿瘤负荷的代表性.
结果：纳入262例不同实体恶性肿瘤患者。177名患者（68％）患有MD，85名患者（32％）在根据RECISTv1.1的MTB出现时间点患有不可测量的疾病（NMD）。MD不能代表11名患者(6%)的总体肿瘤负荷。NMD的主要原因是最长直径小于10mm的病变（22％）和不可测量的腹膜癌（18％）。结直肠癌和恶性黑色素瘤的MD发病率最高(>75%)。相比之下,胃癌,头颈部恶性肿瘤,卵巢癌的MD发生率最低（<55％）。如果是MD，在绝大多数病例(94%)中,可测量的病变代表了总体肿瘤负荷.
结论：在MTB出现时，在具有终点ORR或DOR的试验中，大约三分之一的晚期实体恶性肿瘤癌症患者不符合治疗反应评估的条件。根据潜在的恶性肿瘤，符合影像学终点试验资格的患者比率显着不同，在规划新的精准肿瘤学试验时，应予以考虑。
方法：包括在出现MTB时具有可用影像学的前瞻性患者。根据RECISTv1.1对影像学数据进行了客观的可测量疾病（MD）审查。此外,我们评估了MD患者确定的可测量病变相对于总肿瘤负荷的代表性.
结果：纳入262例不同实体恶性肿瘤患者。177名患者（68％）患有MD，85名患者（32％）在根据RECISTv1.1的MTB出现时间点患有不可测量的疾病（NMD）。MD不能代表11名患者(6%)的总体肿瘤负荷。NMD的主要原因是最长直径小于10mm的病变（22％）和不可测量的腹膜癌（18％）。结直肠癌和恶性黑色素瘤的MD发病率最高(>75%)。相比之下,胃癌,头颈部恶性肿瘤,卵巢癌的MD发生率最低（<55％）。如果是MD，在绝大多数病例(94%)中,可测量的病变代表了总体肿瘤负荷.
结论：在MTB出现时，在具有终点ORR或DOR的试验中，大约三分之一的晚期实体恶性肿瘤癌症患者不符合治疗反应评估的条件。根据潜在的恶性肿瘤，符合影像学终点试验资格的患者比率显着不同，在规划新的精准肿瘤学试验时，应予以考虑。
