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Background: ABP 215 is a biosimilar to the reference product, bevacizumab, and was one of the first biosimilars approved by Health Canada for the first-line treatment of metastatic colorectal cancer (mCRC). This study aimed to address gaps in real-world evidence (RWE) including patient characteristics, treatment safety (primary objective), and effectiveness (secondary objective) for first-line ABP 215 therapy in Canadian patients with mCRC., Materials and Methods: Retrospective data were collected in 2 waves, at least 1 year (Wave 1) or 2 years (Wave 2) after commercial availability of ABP 215 at each participating site., Results: A total of 75 patients from Wave 1 and 164 patients from Wave 2 treated with a minimum of 1 cycle of ABP 215 were included. At least one safety event of interest (EOI) was recorded for 34.7% of Wave 1 and 42.7% of Wave 2 patients. The median progression free survival (PFS) for Wave 1 and 2 patients were 9.47 (95% confidence interval [CI]: 6.71, 11.90) and 21.38 (95% CI: 15.82, not estimable) months, respectively. Median overall survival was not estimable for Wave 1 and was 26.45 months for Wave 2., Conclusion: The safety and effectiveness of ABP 215 observed in this real-world study were comparable to clinical trial findings and to other RWE with longer PFS in the current study., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Declaration of competing interest None to declare.

Background: As surgical training is evolving and operative exposure is decreasing, new, effective, and experiential learning methods are needed to ensure surgical competency and patient safety. Video coaching is an emerging concept in surgery that needs further investigation., Design: In this randomized controlled trial conducted at a single teaching hospital, participating residents were filmed performing a side-to-side intestinal anastomosis on cadaveric dog bowel for baseline assessment. The Surgical Video Coaching (SVC) group then participated in a one-on-one video playback coaching and debriefing session with a surgeon, during which constructive feedback was given. The control group went on with their normal clinical duties without coaching or debriefing. All participants were filmed making a second intestinal anastomosis. This was compared to their first anastomosis using a 7-category-validated technical skill global rating scale, the Objective Structured Assessment of Technical Skills. A single independent surgeon who did not participate in coaching or debriefing to the SVC group reviewed all videos. A satisfaction survey was then sent to the residents in the coaching group., Setting: Department of Surgery, HôpitalMaisonneuve-Rosemont, tertiary teaching hospital affiliated to the University of Montreal, Canada., Participants: General surgery residents from University of Montreal were recruited to take part in this trial. A total of 28 residents were randomized and completed the study., Results: After intervention, the SVC group (n = 14) significantly increased their Objective Structured Assessment of Technical Skills score (mean of differences 3.36, [1.09-5.63], p = 0.007) when compared to the control group (n = 14) (mean of differences 0.29, p = 0.759). All residents agreed or strongly agreed that video coaching was a time-efficient teaching method., Conclusions: Video coaching is an effective and efficient teaching intervention to improve surgical residents' technical skills., (Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.)

Background: The phosphotidylinositol-3 kinase (PI3K)/serine-threonine kinase/mammalian target of rapamycin signaling pathway is frequently altered in colorectal cancer (CRC). PX-866 is an oral, irreversible, pan-isoform inhibitor of PI3K. This randomized phase II study evaluated cetuximab with or without PX-866 in patients with metastatic, anti-epidermal growth factor receptor-naive, KRAS codon 12 and 13 wild-type CRC., Patients and Methods: Patients with metastatic CRC who had received both oxaliplatin and irinotecan were randomized (1:1) to cetuximab (400 mg/m 2 loading then 250 mg/m 2 weekly) with or without PX-866 (8 mg orally daily; arms A and B, respectively). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate, overall survival (OS), toxicity, and correlation of relevant biomarkers with efficacy outcomes., Results: A total of 85 patients were enrolled. The median PFS was 59 days versus 104 days for arms A (cetuximab + PX-866) and B (cetuximab alone), respectively (P = .77). OS between the 2 arms (266 vs. 333 days for arm A vs. B) were similar (P = .83). Overall toxicity, including treatment-related toxicity, was higher in arm A compared with arm B, especially in terms of all-grade nausea (66% vs. 37%), vomiting (50% vs. 29%), diarrhea (64% vs. 18%), and rash (66% vs. 37%). Grade 3 diarrhea occurred in 19% of patients in Arm A and 0% in Arm B. PIK3CA mutations and PTEN loss by immunohistochemistry were infrequently seen., Conclusion: The addition of PX-866 to cetuximab did not improve PFS, objective response rate, or OS in patients with metastatic CRC. The combination arm had greater toxicity and may have been harmful in this study., (Published by Elsevier Inc.)

Background: The aim of this study was to compare functional results and quality of life (QoL) of two salvage techniques: coloanal anastomosis (CAA) or perineal reconstruction after abdominoperineal resection for very low rectal cancer., Methods: Between 1991 and 2001, 50 patients were operated for a very low rectal adenocarcinoma and analyzed after a follow-up greater than one year and because there was no relapse or no treatment, they were included in the analysis. Thirty-eight patients had a CAA, including: straight anastomosis (n=23), J pouch (n=10), coloplasty (n=2) and intersphincteric resection (n=3). Twelve patients underwent a PC., Results: Vaizey's incontinence score was equivalent for the two groups: CAA 12 (0-22) versus PC 11 (8-13). The only differences were more frequent fractioned stools for the CAA group and increased pad soiling for the PC group. Overall QoL scores (QLQ C-30) were equivalent for CAA and PC., Conclusions: For very low rectal tumors, the choice of surgical technique must be based on oncologic rather than future functional or QoL criteria, because both approaches seem to provide similar results.

The standard treatment of epidermoid carcinoma of the anal canal consists of radiotherapy or chemoradiotherapy. The recommended salvage treatment for local failures relies on abdominoperineal resection and permits a 5-year overall survival rate around 50%. However, the morbidity associated with this surgery is important with regard to delayed perineal wound healing. New techniques for perineal reconstruction offer interesting solutions to limit this morbidity. Musculocutaneous flaps permit to fill the perineal wound left after the resection and in some cases to reconstruct the posterior vaginal wall. Although less popular, the construction of a pseudocontinent perineal colostomy enables some patients to avoid a permanent iliac colostomy. The surgical excision of metastatic inguinal nodes, followed by radiotherapy, is an alternative to radiotherapy alone. Surgery can also be performed after failure of radiotherapy, at the cost of an increased morbidity.

Background: The purpose of this study was to report the pharmacokinetics (PK) and tolerance profile of intraoperative intraperitoneal chemo-hyperthermia (IPCH) with oxaliplatin and irinotecan., Patients and Methods: Thirty-nine patients with peritoneal carcinomatosis (PC) of either gastrointestinal or peritoneal origin underwent complete cytoreductive surgery followed by IPCH with a stable dose of oxaliplatin (460 mg/m(2)), plus one among seven escalating doses of irinotecan (from 300 to 700 mg/m(2)). IPCH was carried out with the abdomen open, for 30 min at 43 degrees C, with 2 l/m(2) of a 5% dextrose instillation in a closed continuous circuit. Patients received intravenous leucovorin (20 mg/m(2)) and 5-fluorouracil (400 mg/m(2)) just before IPCH to maximize the effect of oxaliplatin and irinotecan., Results: Irinotecan concentration in tumoral tissue increased until 400 mg/m(2) and then remained stable despite dose escalations. It was 16-23 times higher than in non-bathed tissues. Increasing doses of intraperitoneal irinotecan did not modify the PK of intraperitoneal oxaliplatin, and the drug concentration ratio was 17.8 higher in tumoral tissue (bathed) than in non-bathed tissues. The hospital mortality rate was 2.5% and the non-hematological complication rate was 25%. However, grade 3-4 hematological toxicity rate was 58%., Conclusion: Intraperitoneal heated oxaliplatin (460 mg/m(2)) plus irinotecan (400 mg/m(2)) presented an advantageous PK profile and was tolerated by patients, despite a high hematological toxicity rate.

Aim: This study assessed the effects of multiple therapeutic factors on quality of life (QOL) in the treatment of breast cancer., Methods: We surveyed 179 recurrence-free women with early breast cancer who had undergone a sentinel lymph node procedure, between January 1999 and June 2001. Age, tumour size, breast and axillary procedure, nodal status, chemotherapy, supra-clavicular fossa radiotherapy, and hormone therapy were tested as possible factors associated with poor QOL., Results: Information on QOL was obtained for 148 out of 179 patients. Age less than 55 years and chemotherapy were factors associated with impairment of physical well-being. Tumour size was associated with poor socio-familial well-being. Factors associated with altered arm subscale scores were age <55, axillary procedure, nodal status, chemotherapy and supra-clavicular fossa radiotherapy. Unexpectedly, sentinel lymph node (SLN) procedure delayed the onset of chemotherapy if the metastatic status of SLN was not diagnosed intra-operatively., Conclusion: Efforts are needed to improve the QOL of young patients. Axillary procedure affects only QOL related to arm morbidity.

Background: The complete resection of macroscopic colorectal peritoneal carcinomatosis (PC), followed by intraoperative intraperitoneal chemohyperthermia (IPCH) to treat residual microscopic disease, leads to cure in some patients. We report preliminary results on survival in a phase II study using oxaliplatin (LOHP)., Patients and Methods: Twenty-four patients with macroscopic colorectal PC underwent complete resection of the PC followed by IPCH with LOHP performed in an open abdominal cavity. The dose of LOHP was 460 mg/m(2) in 2 l/m(2), during 30 min at 43 degrees C, at a flow rate of 2 l/min. During the hour preceding IPCH, they received an intravenous administration of 5-fluorouracil (400 mg/m(2)) and leucovorin (20 mg/m(2))., Results: Mean peritoneal tumoral extension (Sugarbaker's Index) was 16.9 +/- 9.5, median operative duration was 490 min and median blood loss was 965 ml. There were two postoperative deaths (8%) by intracerebral hemorrhage, and morbidity rate was 41.6%. Minimal follow-up was 18 months and median follow-up was 27.4 months (range 18.3-49.6). At 1, 2 and 3 years, overall survival rates were 83%, 74% and 65%, and disease-free survival rates were 70%, 50% and 50%, respectively. Only 32% of the 22 postoperative living patients presented a peritoneal recurrence. A peritoneal index >24 influenced survival, with a 17% recurrence rate at 2 years versus 63% when it was <24 (P = 0.005)., Conclusion: This new modality of treatment, when feasible, gives encouraging preliminary results, with a promising 3-year survival rate of 65%.

Background: Intraoperative radiofrequency (RF) can be used to treat multiple small pancreatic tumours., Patients and Methods: Two patients with multiple pancreatic metastases from renal cancer were treated with RF destruction of the pancreatic tumours. The first was treated with a monopolar device and the second with a bipolar device. A high temperature (>90 degrees C) was used, and one patient underwent cooling of the intrapancreatic common bile duct., Results: The destruction of tumours was effective. However, the two patients presented post-operatively a severe necrotizing pancreatitis, with life-threatening hemorrhagic complications., Conclusion: RF destruction of pancreatic tumours is dangerous with current devices.

Background: Our aim was to study the prognostic value of the presence of lymphovascular space invasion (LVSI) in patients with stage IB and II cervical carcinoma treated by initial surgery., Patients and Methods: A retrospective analysis was performed on 193 patients who underwent, between 1985 and 1998, an initial radical hysterectomy with pelvic (+/- para-aortic) lymphadenectomy using midline laparotomy for stage IB (180 patients) or II (13 patients) cervical carcinoma. Postoperative therapy was delivered according to prognostic factors., Results: The rate of LVSI correlated significantly with tumor stage, nodal status and the location of positive nodes. Using univariate analysis, tumor size (<4 or >/= 4 cm), LVS status and nodal status were prognostic factors. At multivariate analysis, two prognostic factors were identified: LVS status and nodal status. In a subgroup of 89 patients with a small tumor (