Background and objectives: Improving early diagnosis and advances in colorectal cancer (CRC) treatment leads to longer survival of these patients. The purpose of this study was to identify the main surgical factors affecting long-term Quality of life (QoL) among colorectal cancer patients after surgery. Materials and Methods: QoL was prospectively evaluated in patients undergoing elective colorectal cancer resection operations in three CRC surgery centers of Lithuania using EORTC generic (QLQC-30) and disease-specific (QLQ-CR29) questionnaires at the time of preoperative admission and 1, 24, and 72 months after surgery. QoL was evaluated among different patient groups, diagnostic and treatment modalities, disease, and postoperative complications. Non-parametric tests and multivariate logistic regression models were used for statistical analysis. Results: Eighty-eight consecutive CRC patients from three institutions were included in the study over a three-month inclusion period, 42 (47.73%) women and 46 (52.27%) men, mean age 64.2 ± 11.5 years. Most tumors were localized in the sigmoid colon and rectum. The largest number of patients had stage III cancer. Twenty-nine patients died—a 6-year survival rate was 67%. 50 of 59 live patients (84.8%) responded to the questionnaire 6 years after their operation. Evaluating changes in quality of life 72 months after surgery with assessments before surgery, both questionnaire responses revealed good long-term CRC surgical treatment results: improved general and functional scale estimates and decreased symptom scale ratings. The multivariate analysis found that age, stoma formation, and rectal cancer were independent risk factors for having worse QoL six years after surgical intervention. Conclusions: Six years after surgery, QoL returns to preoperative levels. Age, stoma formation, adjuvant treatment, and rectal cancer reduce long-term QoL.
Background and objectives: Teverelix drug product (DP) is a gonadotropin-releasing hormone antagonist in development for the treatment of patients with prostate cancer in whom androgen deprivation therapy is indicated. The aim of this paper is to present the results of five Phase 2 studies that assessed the pharmacokinetics, pharmacodynamics, efficacy and safety of different loading dose regimens of teverelix DP. Methods: Five single-arm, uncontrolled clinical trials were conducted in patients with advanced prostate cancer. The five different loading dose regimens of teverelix DP tested were (a) a single 90 mg subcutaneous (SC) injection of teverelix DP given on 3 consecutive days (Days 0, 1 and 2); (b) a single 90 mg intramuscular (IM) injection of teverelix DP given 7 days apart (Days 0 and 7); (c) a single 120 mg SC injection of teverelix DP given on 2 consecutive days (Days 0 and 1); (d) 2 × 60 mg SC injections of teverelix DP given on 3 consecutive days (Days 0, 1 and 2), and (e) 2 × 90 mg SC injections of teverelix DP given on 3 consecutive days (Days 0, 1 and 2). The primary efficacy parameter was the duration of action of an initial loading dose regimen in terms of suppression of testosterone to below the castration level (0.5 ng/mL). Results: Eighty-two patients were treated with teverelix DP. Two regimens (90 mg and 180 mg SC on 3 consecutive days) had a mean duration of castration of 55.32 days and 68.95 days with >90% of patients having testosterone levels < 0.5 ng/mL at Day 28. The mean onset of castration for the SC regimens ranged from 1.10 to 1.77 days, while it was slower (2.4 days) with IM administration. The most common adverse event (AE) was injection site reaction. No AEs of severe intensity were reported. Conclusions: Teverelix DP is safe and well tolerated. Castrate levels of testosterone can be rapidly achieved following the subcutaneous injection of teverelix DP on 3 consecutive days. Streamlining of the administration of the loading dose and identifying a suitable maintenance dose will be investigated in future trials.