RECIST 1.1-Update and clarification: From the RECIST committee.

The Response Evaluation Criteria in Solid Tumours (RECIST) were developed and published in 2000, based on the original World Health Organisation guidelines first published in 1981. In 2009, revisions were made (RECIST 1.1) incorporating major changes, including a reduction in the number of lesions to be assessed, a new measurement method to classify lymph nodes as pathologic or normal, the clarification of the requirement to confirm a complete response or partial response and new methodologies for more appropriate measurement of disease progression. The purpose of this paper was to summarise the questions posed and the clarifications provided as an update to the 2009 publication.

Variability in response assessment in solid tumors: effect of number of lesions chosen for measurement.

PURPOSE: This study was performed to systematically evaluate the variability in tumor response assessments that occurs depending on how many tumor deposits are selected for measurement at imaging. EXPERIMENTAL DESIGN: The two largest perpendicular diameters of all tumor deposits in 36 patients were measured on computed tomography scans obtained at baseline and first posttherapy follow-up. A computerized modeling analysis of those data was performed to determine each patient's therapeutic response category assignment for every possible number of lesions in a grouping. The variance in the sum of measurements of these lesion groupings was calculated, and the frequency of response assessment categories was plotted against the number of lesions. RESULTS: The computerized analysis of the resultant 1,833,821 possible combinations of tumor deposits showed that when six lesions were measured bidimensionally and four lesions were measured undimensionally, the average variance decreased by 90%. The number of different response assessment categories into which a patient was assigned decreased with increasing lesion grouping size. When six or more lesions were measured bidimensionally, 9% of all possible lesion groupings still fell into a second response category, reflecting the effect of which particular lesions are chosen for measurement. CONCLUSIONS: Measuring larger numbers of lesions will decrease the variance. In this population, the variance decreased by at least 90% when six or more lesions were measured bidimensionally. Further confirmatory studies with larger series of patients are warranted before adopting this number as a criterion in clinical trials for assessing the activity of antineoplastic therapies.

Diagnosis, management, and outcomes of 115 patients with hepatic hemangioma.

BACKGROUND: Hepatic hemangiomas are congenital vascular malformations and are the most common benign hepatic tumors. Because the use of cross-sectional imaging has increased, benign hepatic tumors, especially hemangiomas, are encountered more frequently, so clinicians should be familiar with the most appropriate diagnostic tests, management, and outcomes of patients with hepatic hemangioma. STUDY DESIGN: All patients with a primary diagnosis of hepatic hemangioma referred for surgical evaluation at our institution between January 1992 and December 2000 were identified from a prospective database. Demographics, presentation, tumor characteristics, diagnostic studies, surgical procedures, and outcomes were analyzed. RESULTS; Of 115 patients in the study, nearly half were asymptomatic. In symptomatic patients, abdominal pain or discomfort was the most common presenting symptom. At our institution, the diagnosis of hemangioma was established by ultrasonographic studies in 57% of patients tested, by CT scan in 73%, and by MRI in 84%. In patients with large tumors considered for resection, direct angiography or, more recently, CT angiography, confirmed the diagnosis in 27 of 29 patients (93%). Enucleation was performed in 31 (60%) of the 52 patients who underwent surgical resection; 63 patients were observed. Postoperative complications occurred in 13 patients (25%), and there were no perioperative deaths. Of the patients with symptoms before resection, 96% had resolution of symptoms after operation. CONCLUSIONS: Hepatic hemangioma can be diagnosed in most patients using noninvasive studies, particularly MRI. Hepatic hemangiomas can be removed safely if patients become symptomatic or when malignancy cannot be excluded. CT angiography can be a valuable preoperative study in patients with large tumors, and enucleation is the procedure of choice. In asymptomatic or minimally symptomatic patients, hepatic hemangiomas usually have a benign course and can be observed.

Predictors of a true complete response among disappearing liver metastases from colorectal cancer after chemotherapy.

BACKGROUND: During chemotherapy, some colorectal liver metastases (LMs) disappear on serial imaging. This disappearance may represent a complete response (CR) or a reduction in the sensitivity of imaging during chemotherapy. The objective of the current study was to determine the fate of disappearing LMs (DLMs) and the factors that predict a true CR. METHODS: Between 2000 and 2003, 435 patients who were evaluated by hepatobiliary surgeons received chemotherapy before they were considered for resection. Inclusion criteria were <12 LMs before chemotherapy, at least 1 DLM on a computed tomography (CT) scan, and either surgical resection or 1 year of clinical follow-up after the disappearance of LMs. A true CR was defined as either a pathologic CR (no tumor detected in the resection specimen) or a durable clinical CR (did not reappear on follow-up imaging). Clinical and pathologic factors were analyzed to identify those associated with a true CR. RESULTS: During chemotherapy, 39 patients (9%) had a total of 118 DLMs on follow-up CT scans. Sixty-eight DLMs were resected, and 50 were followed clinically. Overall, 75 DLMs (64%) were true CRs, including 44 pathologic CRs and 31 durable clinical CRs. On multivariate analysis, the use of hepatic arterial infusion (HAI) chemotherapy (odds ratio [OR], 6.2; P = .02), the inability to observe the DLM on a magnetic resonance image (OR, 4.7; P = .005), and normalization of serum carcinoembryonic antigen levels (OR, 4.6; P = .006) were associated independently with a true CR. CONCLUSIONS: Approximately 66% of DLMs represented a true CR according to assessment by resection or radiologic follow-up. Predictive factors may help to stratify patients who are likely to harbor residual disease.

Conversion to resectability using hepatic artery infusion plus systemic chemotherapy for the treatment of unresectable liver metastases from colorectal carcinoma.

PURPOSE To determine the conversion to resectability in patients with unresectable liver metastases from colorectal cancer treated with hepatic arterial infusion (HAI) plus systemic oxaliplatin and irinotecan (CPT-11). PATIENTS AND METHODS Forty-nine patients with unresectable liver metastases (53% previously treated with chemotherapy) were enrolled onto a phase I protocol with HAI floxuridine and dexamethasone plus systemic chemotherapy with oxaliplatin and irinotecan. Results Ninety-two percent of the 49 patients had complete (8%) or partial (84%) response, and 23 (47%) of the 49 patients were able to undergo resection in a group of patients with extensive disease (73% with > five liver lesions, 98% with bilobar disease, 86% with > or = six segments involved). For chemotherapy-naïve and previously treated patients, the median survival from the start of HAI therapy was 50.8 and 35 months, respectively. The only baseline variable significantly associated with a higher resection rate was female sex. Variables reflecting extensive anatomic disease, such as number of lesions or number of vessels involved, were not significantly associated with the probability of resection. CONCLUSION The combination of regional HAI floxuridine/dexamethasone and systemic oxaliplatin and irinotecan is an effective regimen for the treatment of patients with unresectable liver metastases from colorectal cancer, demonstrating a 47% conversion to resection (57% in chemotherapy-naïve patients). Future randomized trials should compare HAI plus systemic chemotherapy with systemic therapy alone to assess the additional value of HAI therapy in converting patients with hepatic metastases to resectability.