MATERIALS AND METHODS: Between April 2020 and July 2021, 118 patients participated in this prospective study. Patients' data were collected from medical records. Harris hip score (HHS) was used to evaluate the functional recovery six months after fractures. The obtained data were analysed using a univariate and multivariate model.

RESULTS: The mean age of the participants was 79.5±9.4 years and 68.6% of the patients were female. The six-month mortality rate was 5.9% and independently associated with age (odds ratio (OR): 3.512, 95% confidence interval (CI) 1.538 - 8.019; P<0.001, patients aged >80 years vs those aged ≤80 years) and hypoproteinemia (OR: 2.859, 95% CI: 1.001 - 8.166, P=0.049). Among 111 survivors there were 66 (59.5%) of patients with a good functional recovery. Patients aged >80 years had a higher risk of poor functional outcome (OR: 3.167, 95% CI: 1.386 - 7.235, P: 0.006) compared to those aged ≤ 80 years. No significant correlations between other clinical (gender, body mass index, comorbidities, type of fractures or surgery, time until surgery) or laboratory parameters (anaemia, hyperglycemia, marked elevation of C reactive protein level, electrolyte abnormalities, elevated urea) and mortality or functional outcome were found.

METHODS: OPTIM1SE was a prospective, open-label, observational study. Patients with untreated KRAS wild-type mCRC and distant metastases were treated per locally approved labels and monitored for 3 years via electronic medical records. The primary endpoint was the overall response rate (ORR). Secondary endpoints included safety, progression-free survival (PFS), and overall survival (OS).

RESULTS: From November 19, 2013, to June 30, 2016, 520 patients were enrolled in 51 sites. Patients were mostly male (61.2%), with a mean age of 58.5 (±12.0) years; 420 patients received leucovorin, 5-FU, and irinotecan-based regimens and 94 received leucovorin, 5-FU, and oxaliplatin. The most common primary tumor site was the rectum (38.8%), with liver metastases (65.0%). ORR was 45.4% (95% CI, 41.1%-49.7%), including 26 patients (5.0%) with a complete response. Median PFS was 9.9 months (95% CI, 8.2-11.0); median OS (mOS) was 30.8 months (95% CI, 27.9-33.6). Higher mOS was associated with tumors of left compared with right-sided origin (hazard ratio, 0.69 [95% CI, 0.49-0.99]); higher ORR was also associated with liver metastases compared with all other metastases (55.4% vs. 40.2%). Adverse events were consistent with the known safety profile of cetuximab.