New response evaluation criteria using early morphological change in imatinib treatment for patients with gastrointestinal stromal tumor.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 838-838
Author(s):  
Tomo Ishida ◽  
Tsuyoshi Takahashi ◽  
Takuro Saito ◽  
Yukinori Kurokawa ◽  
Kotaro Yamashita ◽  
...  

838 Background: While the introduction of molecularly targeted drugs, including imatinib, has greatly improved the prognosis of gastrointestinal tumor (GIST), the response evaluation criteria have not been optimized. Early morphological change (EMC) was previously reported as a predictive marker for molecularly targeted drugs in metastatic colorectal cancer. The purpose of the present study was to verify the efficacy of EMC in predicting the outcome in patients with GIST receiving imatinib. Methods: We retrospectively reviewed 55 patients. EMC in computed tomography (CT) image was evaluated, and the patients were categorized into two groups; active MR (morphologic response) (+) group and active MR (-) group, judging from the morphological features including the sharpness of the outline and the attenuation of target lesion. We investigated the association between the presence of active MR and clinical outcomes. Similarly, clinical outcomes classified by response evaluated by RECIST and Choi criteria were analyzed respectively. Results: Thirty-two patients had active MR (+). The median Progression-free survival(PFS) was 7 months vs 31 months (active MR(-) vs active MR(+), P = 0.013) and the median overall survival (OS) was 58 months vs 91 months ( P = 0.086), respectively. Although PFS of RECIST PD (progression disease) or Choi PD patients was shorter than that for PR (partial response) or SD(stable disease) patients ( P = 0.0037 for RECIST, P = 0.0058 for Choi), the number of PD patients was very small (N = 3, both in RECIST and Choi). Conclusions: The evaluation criteria based on EMC could be a sensitive method to predict the clinical outcome of imatinib treatment for patients with inoperative GIST.

2018 ◽  
Vol 36 (9) ◽  
pp. 850-858 ◽  
Author(s):  
F. Stephen Hodi ◽  
Marcus Ballinger ◽  
Benjamin Lyons ◽  
Jean-Charles Soria ◽  
Mizuki Nishino ◽  
...  

Purpose Treating solid tumors with cancer immunotherapy (CIT) can result in unconventional responses and overall survival (OS) benefits that are not adequately captured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. We describe immune-modified RECIST (imRECIST) criteria, designed to better capture CIT responses. Patients and Methods Atezolizumab data from clinical trials in non–small-cell lung cancer, metastatic urothelial carcinoma, renal cell carcinoma, and melanoma were evaluated. Modifications to imRECIST versus RECIST v1.1 included allowance for best overall response after progressive disease (PD) and changes in PD definitions per new lesions (NLs) and nontarget lesions. imRECIST progression-free survival (PFS) did not count initial PD as an event if the subsequent scan showed disease control. OS was evaluated using conditional landmarks in patients whose PFS differed by imRECIST versus RECIST v1.1. Results The best overall response was 1% to 2% greater, the disease control rate was 8% to 13% greater, and the median PFS was 0.5 to 1.5 months longer per imRECIST versus RECIST v1.1. Extension of imRECIST PFS versus RECIST v1.1 PFS was associated with longer or similar OS. Patterns of progression analysis revealed that patients who developed NLs without target lesion (TL) progression had a similar or shorter OS compared with patients with RECIST v1.1 TL progression. Patients infrequently experienced a spike pattern (TLs increase, then decrease) but had longer OS than patients without TL reversion. Conclusion Evaluation of PFS and patterns of response and progression revealed that allowance for TL reversion from PD per imRECIST may better identify patients with OS benefit. Progression defined by the isolated appearance of NLs, however, is not associated with longer OS. These results may inform additional modifications to radiographic criteria (including imRECIST) to better reflect efficacy with CIT agents.


2020 ◽  
Vol 9 (12) ◽  
pp. 4070
Author(s):  
Adriana Fonseca ◽  
Anne L. Ryan ◽  
Paul Gibson ◽  
Eleanor Hendershot ◽  
Sevan Hopyan ◽  
...  

Objective: We examined the interobserver reliability of local progressive disease (L-PD) determination using two major radiological response evaluation criteria systems (Response evaluation Criteria in Solid Tumors (RECIST) and the European and American Osteosarcoma Study (EURAMOS)) in patients diagnosed with localized osteosarcoma (OS). Additionally, we describe the outcomes of patients determined to experience L-PD. Materials and Methods: Forty-seven patients diagnosed with localized OS between 2000 and 2012 at our institution were identified. Paired magnetic resonance imaging of the primary tumor from diagnosis and post-neoadjuvant chemotherapy were blindly assessed by two experienced radiologists and determined L-PD as per RECIST and EURAMOS radiological criteria. Interobserver reliability was measured using the kappa statistic (κ). The Kaplan Meier method and log-rank test was used to assess differences between groups. Results: Of 47 patients (median age at diagnosis 12.9 years), 16 (34%) had L-PD (by RECIST or EURAMOS radiological definition). There was less agreement between the radiologists using EURAMOS radiological criteria for L-PD (80.9%, κ = 0.48) than with RECIST criteria (97.9%, κ = 0.87). Patients with radiologically defined L-PD had a 5-year progression-free survival (PFS) of 55.6%, compared to a 5 year-PFS of 82.7% in the group of patients without L-PD (n = 31) (Log rank p = 0.0185). Conclusions: The interobserver reliability of L-PD determination is higher using RECIST than EURAMOS. RECIST can be considered for response assessment in OS clinical trials. The presence of L-PD was associated with worse outcomes.


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