Is BMI a Factor in Compliance to Adjuvant Chemotherapy for Locally Advanced Rectal Cancer?

Background: Compliance to adjuvant chemotherapy (AC) for patients undergoing rectal surgery ranges from 43% to 73.6%. Reasons reported for not initiating or completing AC include onset of postoperative complications, drug toxicity, disease progression and/or patient preferences. Little is known regarding the impact of obesity on the compliance to AC in this setting. Methods: This multicenter, retrospective study analyzed compliance to AC and treatment-related morbidity in 511 patients having undergone surgery with curative intent for rectal cancer in six Italian colorectal centers between January 2013 and December 2017. Results: 70 patients were obese (BMI 30 kg/m2). The proportion of open procedures (22.9% vs. 13.4%) and conversions (14.3% vs. 4.8%) was greater in obese compared to non-obese patients (p 0.001). Median hospital stay was one day longer for obese patients (9 days vs. 10 days, p=0.038) while there was no statistically significant difference in the complication rate, whether overall (58.6% in obese vs. 52.3% in non-obese) or with a Clavien-Dindo score 3 (17.1% vs 10.9%). AC was offered to 49/70 (70%) patients in the obese group and 306/441 (69.4%) in the non-obese group (p=0.43). There was no statistically significant difference in AC compliance: 18.4% and 22.9% did not start AC, while 36.7% and 34.6%, started AC but did not complete the scheduled treatment (p=0.79) in the obese and non-obese group, respectively. Overall, 55% of patients who started AC successfully completed their adjuvant treatment. Conclusions: Obesity did not impact compliance to AC for locally advanced rectal cancer: compliance was poor in obese and non-obese patients with no statistically significant difference between the two groups. Major complication rate was not statistically significantly affected by increased BMI.

Compliance to Adjuvant Chemotherapy of Patients Who Underwent Surgery for Rectal Cancer: Report from a Multi-institutional Research Network.

INTRODUCTION: Adjuvant chemotherapy for locally advanced rectal cancer is associated with improved overall survival. However, recent evidence from randomized trials showed a compliance rate of 43 to 73%, which may affect efficacy. The aim of this multicenter retrospective analysis was to investigate the compliance rate to adjuvant treatment for patients who underwent rectal surgery for cancer. METHODS: Patients who underwent surgery with curative intent for rectal cancer in six Italian colorectal centers between January 2013 and December 2017 were retrospectively reviewed. Exclusion criteria were age less than 18 years, palliative or emergency surgery, and stage IV disease. Parameters of interest were patients' characteristics, preoperative tumor stage, neo-adjuvant chemoradiation therapy, intra-operative and postoperative outcomes. Although the participating centers referred to the same treatment guidelines for treatment, the chemotherapy regiment was not standardized across the institutions. Reasons for not starting adjuvant chemotherapy when indicated, interruption, and modification of drug regimen were collected to investigate compliance. RESULTS: A total of 572 patients were included in the analysis. Two hundred and fifty-two (44.1%) patients received neo-adjuvant chemoradiation therapy. All patients underwent high anterior rectal resection, low anterior rectal resection, or Miles' procedure. Of 399 patients with an indication to adjuvant chemotherapy, 176 (44.1%) completed the treatment as planned. Compliance for patients who started chemotherapy was 56% (95% CI 50.4-61.6%). Sixty-six patients interrupted the treatment, 76 patients significantly reduced the drug dose, and 41 patients had to switch to other therapeutic regimens. CONCLUSIONS: The present multicenter investigation reports a low compliance rate to adjuvant chemotherapy after rectal resection for cancer. Multidisciplinary teams should focus on future effort to improve compliance for these patients.

Creation of a rectal cancer registry in Italy by the Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network.

Background: The management of rectal cancer is multimodal and involves a multidisciplinary team of cancer specialists with expertise in medical oncology, surgical oncology, radiation oncology and radiology. It is crucial for highly specialized centers to collaborate via networks that aim to maintain uniformity in every aspect of treatment and rigorously gather patients' data, from the first clinical evaluation to the last follow-up visit. The Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network aims to create a rectal cancer registry. This will prospectively collect the data of patients operated on for non-metastatic rectal cancer in high volume colorectal surgical units through a well design pre-fashioned database for non-metastatic rectal cancer, in order to take all multidisciplinary aspects into consideration. Methods/Design: The protocol describes a multicenter prospective observational cohort study, investigating demographics, frailty, cancer-related features, surgical and radiological parameters, and oncological outcomes among patients with non-metastatic rectal cancer who are candidates for surgery with curative intent. Patients enrolled in the present registry will be followed up for 5 years after surgery. Discussion: Standardization and centralization of data collection for neoplastic diseases is a virtuous process for patient care. The creation of a register will allow the control of the quality of treatments provided and permit prospective and retrospective studies to be carried out on complete and reliable high quality data. Establishing data collection in a prospective and systematic fashion is the only possibility to preserve the enormous resource that each patient represents.