PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer.

BACKGROUND: Cetuximab improves progression-free survival (PFS) and overall survival (OS) in patients with KRAS wild type (wt) metastatic colorectal cancer (mCRC). Few data are available on factors impacting both efficacy and compliance to cetuximab treatment, which is, in combination with chemotherapy, a standard-of-care first-line treatment regimen for patients with KRAS wt mCRC. PATIENTS AND METHODS: PREMIUM is a prospective, French multicenter, observational study that recruited patients with KRAS wt mCRC scheduled to receive cetuximab, with or without first-line chemotherapy, as part of routine clinical practice, between October 28, 2009 and April 5, 2012 (ClinicalTrials.gov Identifier: NCT01756625). The main endpoints were the factors impacting on efficacy and compliance to cetuximab treatment. Predefined efficacy endpoints were PFS and safety. RESULTS: A total of 493 patients were recruited by 94 physicians. Median follow-up was 12.9 months. Median progression-free survival was 11 months [9.6-12]. In univariate analyses, ECOG performance status (PS), smoking status, primary tumor location, number of metastatic organs, metastasis resectability, surgery, folliculitis, xerosis and paronychia maximum grade, and acne preventive treatment were statistically significant. In multivariate analysis (Hazard Ratios of multivariate stepwise Cox models), ECOG PS, surgery, xerosis and folliculitis were positive prognostics factors for longer PFS. Among all patients, 69 (14%) were non-compliant. In multivariate analysis, no variables were statistically significant. The safety profile of cetuximab was consistent with previous studies. CONCLUSIONS: ECOG PS <2, surgical treatment performed, and maximum grade xerosis or folliculitis developed were predictive factors of cetuximab efficacy on KRAS wt mCRC patients. Unfortunately, we failed in identifying predictive factors for compliance in these patients.

Fine-needle aspiration cytology guided by endoscopic ultrasonography: results in 141 patients.

BACKGROUND AND STUDY AIMS: Diagnosis of submucosal lesions, pancreatic tumors, and mediastinal or celiac lymph nodes or masses is possible using endoscopic ultrasonography (EUS), but histological confirmation to differentiate between benign and malignant lesions is still required. The aim of this study was to evaluate the efficacy of a new method of EUS-guided fine-needle aspiration biopsy of intramural and paramural lesions. PATIENTS AND METHODS: From October 1991 to September 1994, EUS-guided fine-needle aspiration biopsy was carried out in 141 patients with findings of mediastinal masses (18 cases), mediastinal lymph nodes (24 cases), submucosal tumors (seven cases), celiac lymph nodes (26 cases), large gastric folds with negative endoscopic biopsy (13 cases), pancreatic tumors (43 cases), a small liver metastasis (five cases), retrorectal tumors (four cases), and an adrenal metastasis (one case). The EUS examination was performed using a Pentax-Hitachi FG 32-UA system. RESULTS: A malignant tumor was diagnosed in 110 of the 141 patients. EUS-guided fine-needle aspiration was positive in 85 cases. In 15 cases, an adequate specimen could not be obtained (10.6%). The sensitivity and specificity of the diagnosis of malignancy were 77.0% and 100%, respectively. Results were better for mediastinal masses (sensitivity 88%), mediastinal lymph nodes (81%), and celiac lymph nodes (80%) than for pancreatic tumors (75%) or submucosal tumors (60%). CONCLUSIONS: These results suggest that EUS-guided fine-needle biopsy using a curved-array transducer represents a step forward in the tissue diagnosis of gastrointestinal lesions.

[Linear electronic intrarectal ultrasonography and cancer of the rectum. Results in 45 patients]. / Echographie endo-rectale électronique linéaire et cancer du rectum. Résultats chez 45 patients.

The aim of this study was to evaluate the preoperative staging of rectal carcinoma by intrarectal ultrasonography using linear probe or curved array transducer. Between October 1991 and July 1993, preoperative staging with endoscopic ultrasound was performed in 45 patients with rectal carcinoma. Twenty-four received preoperative radiation therapy. For carcinoma of the middle and the lower part of rectum, the distance between the inferior pole of the tumour and the levator ani muscle was systematically measured. The ultrasound results were compared with histological and surgical findings. The staging was accurately predicted in 82.2% of cases. The depth of cancer invasion was correct in 93.3% (95.2% when preoperative radiation therapy was not applied and 79.1% after radiation therapy). Presence or absence of lymph nodes metastasis was correctly determined in 84.4% (90.5% when preoperative radiation therapy was not applied and 79.1% after radiation therapy). The distance between the inferior pole of the tumour and the levator ani muscle was correctly determined in 29/31 carcinoma of the middle and the lower part of rectum. While the linear and sectorial technique is more difficult when the tumour was circular, the staging of the lower part of rectum carcinoma and anal canal was easier.