Bevacizumab Treatment for Metastatic Colorectal Cancer in Real-World Clinical Practice.

Background and Objectives: Colorectal cancer (CRC) is a leading cause of cancer-related mortality and morbidity worldwide. Bevacizumab was approved for the treatment of metastatic colorectal cancer (mCRC) based on favorable benefit-risk assessments from randomized controlled trials, but evidence on its use in the real-world setting is limited. The aim of the current study is to evaluate the outcomes and safety profile of bevacizumab in mCRC in a real-world setting in Romania. Patients and Methods: This was an observational, retrospective, multicentric, cohort study conducted in Romania that included patients with mCRC treated with bevacizumab as part of routine clinical practice. Study endpoints were progression-free survival, overall survival, adverse events, and patterns of bevacizumab use. Results: A total of 554 patients were included in the study between January 2008 and December 2018. A total of 392 patients (71%) received bevacizumab in the first line and 162 patients (29%) in the second line. Bevacizumab was mostly combined with a capecitabine/oxaliplatin chemotherapy regimen (31.6%). The median PFS for patients treated with bevacizumab was 8.4 months (interquartile range [IQR], 4.7-15.1 months) in the first line and 6.6 months (IQR, 3.8-12.3 months) in the second line. The median OS was 17.7 months (IQR, 9.3-30.6 months) in the first line and 13.5 months (IQR, 6.7-25.2 months) in the second line. Primary tumor resection was associated with a longer PFS and OS. The safety profile of bevacizumab combined with chemotherapy was similar to other observational studies in mCRC. Conclusions: The safety profile of bevacizumab was generally as expected. Although the PFS was generally similar to that reported in other studies, the OS was shorter, probably due to the less frequent use of bevacizumab after disease progression and the baseline patient characteristics. Patients with mCRC treated with bevacizumab who underwent resection of the primary tumor had a higher OS compared to patients with an unresected primary tumor.

Oxaliplatin-induced neuropathy and colo-rectal cancer patient's quality of life: Practical lessons from a prospective cross-sectional, real-world study.

BACKGROUND: Colon cancer is one the most common forms of cancer in both sexes. Due to important progress in the field of early detection and effective treatment, colon and rectal cancer survivors currently account for 10% of cancer survivors worldwide. However, the effects of anti-cancer treatments, especially oxaliplatin-based chemotherapy, on the quality of life (QoL) have been less evaluated. Although the incidence of severe chemotherapy-induced neuropathy (CIPN) in clinical studies is below 20%, data from real-world studies is scarce, and CIPN is probably under-reported due to patient selection and the patients' fear that reporting side-effects might lead to treatment cessation. AIM: To determine the impact of CIPN on QoL in colorectal cancer patients with a recent history of oxaliplatin-based chemotherapy. METHODS: We performed a prospective cross-sectional study in two major Romanian oncology tertiary hospitals-the Regional Institute of Oncology Iași (Iasi, Romania) and the Fundeni Clinical Oncology Institute (Bucharest, Romania). All consecutive patients with colon or rectal cancer, undergoing Oxaliplatin-based chemotherapy that consented to enroll in the study, were assessed by means of two questionnaires-the EORTC QQ-CR29 (quality of life in colon and rectal cancer patients) and the QLQ-CIPN20 (assessment of neuropathy). Several demographical, social, clinical and treatment data were also collected. Statistical analysis was performed by means of SPSS v20. The student t test was used to assess the relationship between the QLQ-CIPN20 and QLQ-CR29 results. Kaplan Meyer-curves were used to report 3-year progression-free survival (PFS) in patients that discontinued chemotherapy vs those that completed the recommended course. RESULTS: Of the 267 patients that fulfilled the inclusion criteria in the pre-specified time frame, 101 (37.8%) agreed to participate in the clinical study. At the time of the enrolment in the study, over 50% of the patients had recently interrupted their oxaliplatin-based chemotherapy, most often due to neuropathy. Almost 85% of the responders reported having tingling or numbness in their fingers or hands, symptoms that were associated with pain in over 20% of the cases. When comparing the scores in the two questionnaires, a statistically significant relationship (P < 0.001) was found between the presence of neuropathic symptoms and a decreased quality of life. This correlation was consistent when the patients were stratified by sex, disease stage, comorbidities and the presence of stoma or treatment type, suggesting that neuropathy in itself may be a reason for a decreased quality of life. At the 3 year final assessment, median recurrence-free survival in stage III patients was 26.88 mo. When stratified by completion of chemotherapy, median recurrence free-survival of stage III patients that completed chemotherapy was 28.27 mo vs 24.33 mo in patients that discontinued chemotherapy due to toxicity, a difference that did not reach statistical significance. CONCLUSION: CIPN significantly impacts QoL in colorectal cancer patients. CIPN is also the most frequent reason for treatment discontinuation. Physicians should actively assess for CIPN in order to prevent chronic neuropathy.