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CCTG IND.236: A Phase 1b trial of combined CFI-402257 and weekly paclitaxel in patients with HER2-negative (HER2-) advanced breast cancer (aBC) Philippe L. Bedard, Mihaela Mates, John Hilton, Nathalie Levasseur, Arif Awan, Amirrtha Srikanthan, David Cescon, Karen Gelmon, Andrew Robinson, Nancy Drummond-Ivars, Irene Li, Laleh Rastgou, Jackie Edwards, Linda Hagerman, Siwei Zhang, Mark Bray, Lesley Seymour, Moira Rushton-Marovac, Pierre-Olivier Gaudreau Background: CFI-402257 is a selective oral inhibitor of TTK protein kinase, a critical regulator of the mitotic spindle assembly checkpoint overexpressed in breast cancer (BC). CFI-402257 monotherapy has anti-proliferative and cytotoxic activity and enhances antitumor activity of paclitaxel in BC xenograft models. Material and methods: Primary objectives were to establish safety and Recommended Phase 2 dose (RP2D) of CFI-402257 combined with weekly paclitaxel (Phase 1b) and Overall Response Rate (ORR) as per RECIST 1.1 (Phase 2). Patients with HER2- aBC with adequate organ function, PS 0-1, previously treated with >1 non-taxane chemotherapy, were eligible. A 3+3 design was used for Phase 1b, with dose limiting toxicities (DLTs) assessed during cycle 1 (28 days). Starting dose CFI-402257 was 84mg (DL1 = 84mg, DL2 = 112mg, DL3 = 168mg, DL4 = 210mg and DL5 = 252mg) on a 2-day on, 5-day off schedule with paclitaxel 80mg/m2 day 1, 8, 15. Safety assessments were performed weekly (CTCAE v5.0) and response every 2 cycles. A Simon 2-stage design was used for Phase 2 (stage 2 required ≥4 responses in 17 evaluable patients from stage 1). Results: 37 patients received a total of 260 cycles including all 5 dose levels. Median age was 59; 92% ER+/HER2-; 49% PS1; 22% 3 prior chemotherapy lines; 41% 4 sites of metastatic disease, and 81% had received prior CDK4/6 inhibitors. Grade 3 hematological adverse events (AEs, all dose levels) were neutropenia (70%), lymphopenia (41%) and anemia (14%). Six DLTs occurred: 5 dose-related grade 4 neutropenia and 1 febrile neutropenia. Three DLTs occurred at DL3, two at DL4, and one at DL5. Three serious AEs (two at DL3, and one at DL4) at least possibly related to treatment were seen: 2 febrile neutropenia and 1 skin infection (all grade 3). Frequent AEs (˃5%; all dose levels) considered at least possibly related to treatment were: diarrhea (38%), nausea (30%), fatigue (27%), vomiting (16%), anorexia (14%), maculo-papular rash (14%), oral mucositis (11%), alopecia (11%) and pruritus (8%). DL3 (168mg) was selected as RP2D. ORR was 3/36=8% and 1/17=5.9% in all vs Phase 2 evaluable patients, respectively. Clinical Benefit Rate (CBR; defined as complete response, partial response or stable disease ˃16 weeks in duration) was 18/33=54.6% and 10/17=58.8% in all vs Phase 2 evaluable patients, respectively. During Phase 2, the 17 evaluable patients from stage 1 did not meet pre-specified threshold for anti-tumor activity to proceed to stage 2. Conclusions: CFI-402257 and paclitaxel was well tolerated, with neutropenia as the main toxicity. DL3 (168mg) was selected as RP2D. Phase 2 ORR and CBR was 5.9% and 58.8%, respectively; during Phase 2, the 17 evaluable patients from stage 1 did not meet the pre-specified threshold for anti-tumor activity to proceed to stage 2 and the trial was closed to accrual on April 7, 2022. Final analysis and correlative analyses are ongoing. Acknowledgements: Coordinated by the CCTG. Funding supported by SU2C Canada - Canadian Cancer Society Breast Cancer Dream Team Research Funding (SU2C-AACR-DT-18-15) and OICR. CFI-402257 provided by Treadwell Therapeutics. Citation Format: Philippe Bedard, Mihaela Mates, John Hilton, Nathalie Levasseur, Arif Awan, Amirrtha Srikanthan, David W. Cescon, Karen Gelmon, Andrew Robinson, Nancy Drummond-Ivars, Irene Li, Laleh Rastgou, Jackie Edwards, Linda Hagerman, Siwei Zhang, Mark Bray, Lesley Seymour, Moira Rushton, Pierre-Olivier Gaudreau. CCTG IND.236: A Phase 1b trial of combined CFI-402257 and weekly paclitaxel in patients with HER2-negative (HER2-) advanced breast cancer (aBC) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-07-10.

Purpose: The purpose of this study is to better understand fear of cancer (FCR) through the experience of ovarian and fallopian tube cancer survivors. Methods: This study used a descriptive qualitative design. Twelve participants in remission from ovarian or fallopian tube cancer were recruited. Researchers conducted face-to-face, semi-structured interviews and the content, transcribed verbatim, underwent content analysis. Results: FCR has been identified as a significant concern for women in remission from ovarian cancer. Four themes emerged from the participants’ FCR experience: (a) uncertainty surrounding recurrence; (b) varied beliefs and sources of worry; (c) perceived risk of recurrence; (d) management of FCR. Implications: Survivorship support can be optimized by nurses by screening for FCR, offering psychosocial support for women at risk for FCR, teaching and reinforcing adaptive coping strategies.

Strengths-Based Nursing (SBN) is an integrated value-driven approach based on a philosophy of care to guide actions. It consists of eight values which guide nursing practice to promote care of the whole person and family. SBN promotes empowerment, collaborative partnership, innate health and healing, authentic relationships while focusing on enhancing and developing strengths to cope with challenges and minimize, contain or circumvent that which is not working.Our poster will illustrate the basics of SBN and how it can be utilized in the promotion of whole person care.Conclusion: SBN has enlarged our perspective, broadened our skilled-know how, and opened us to new ways of caring for persons and families dealing with cancer. It has also given us insights into our nursing practices and illustrates the importance these eight values have in supporting development of whole person care.

Robotic surgery has been rapidly adopted in many specialties, yet barriers remain. The current manuscript outlines a gynecologic oncology division’s experience with robotic surgery and breaks down results from its robotic surgery program into three parts: (I) clinical outcomes, (II) patient-reported outcomes, and (III) hospital outcomes. Published articles, manuscripts in submission, and internal data from various studies within our division were collated. Clinical outcomes were collected from patients’ electronic health records, patient-reported outcome measures [e.g., satisfaction, quality of life (QOL), pain] were summarized from questionnaires, and hospital outcomes (e.g., resource utilization, workflow, costs) were gathered from internal hospital systems. The current review focuses on all surgeries performed for gynecologic cancers (uterine, cervical, and epithelial ovarian cancer) in the Division of Gynecologic Oncology at the Jewish General Hospital, McGill University, Montreal, Canada. In comparison to open surgery, robotic surgery was associated with fewer complications, less blood loss, and less postoperative analgesic use, without compromising recurrence rates or survival. Overall, patients reported being satisfied with the procedure and reported a relatively rapid return to daily activities and to baseline QOL. From the surgeon’s perspective, the robotic system’s user interface enabled performing minimally invasive surgeries in complex surgical cases that were performed by laparotomy prior to the introduction of robotics. From an institutional perspective, the robotic surgery cases were associated with cost savings and entailed operational efficiencies. A division of gynecologic oncology could reap a variety of benefits with the implementation of a robotic surgery program if used carefully and within a setting conducive to such technological change. The overarching implications of a computer-assisted robotic interface in the operating room extend beyond the conventional outcomes measured in healthcare.

Background: Postoperative pain is frequently undermanaged in spite of advancements in pharmacologic and non-pharmacologic therapies for pain. Minimally invasive surgery is a promising surgical technique associated with reduced postoperative pain. The current study evaluates satisfaction following robotically-assisted surgery and its impact on short-term and long-term patient-rated pain. Methods: Prospective study on all consecutive patients (n=367) undergoing robotic surgery in the division of gynecologic oncology from December 2009 to December 2012. Patients were invited to complete questionnaires before surgery and at 1 week, 3 weeks, 3, 6, and 12 months after surgery. The brief pain inventory (BPI) was used to evaluate patient-rated pain severity, interference of pain with daily life, and treatments taken for pain. Results: After controlling for preoperative factors, both pain severity and pain interference with daily life returned to pre-surgery levels within three weeks of surgery. Patients using opioids for pain relief remained very low, varying from 2% at baseline to 11% during the first week, returning to 5% by the third week. By the first week post-surgery, the vast majority of patients expressed high satisfaction with an average score of 91%. Conclusions: Robotic surgery for the treatment of gynecologic cancers results in a minimal impact on short- and long-term patient-rated pain. The majority of patients (~90%) did not require the use of opioids and were very satisfied with their surgery.

IntroductionVaginal vault dehiscence following robotic-assisted hysterectomy for gynecologic cancer may be attributed to surgical techniques and postoperative therapeutic interventions. We searched for risk factors in patients with gynecologic cancers and complemented this with a literature review.MethodsEvaluation of prospectively gathered information on all consecutive robotic surgeries for gynecologic cancers was performed in a tertiary academic cancer center between December 2007 and March 2012. The literature was reviewed for articles relevant to “gynecologic oncology” and “robotics” with “vaginal cuff dehiscence” in the English and French languages. Respective authors were contacted to complete relevant information.ResultsSeven dehiscences were identified of 441 cases with established gynecologic cancers. The closures in these 7 were performed using interrupted 1-Vicryl (Ethicon Inc) (3/167; 1.8%), combination of interrupted 1-Vicryl and 1-Biosyn (Covidien Inc) (3/156, 1.9%), and V-Loc (Covidien Inc) (1/118, 0.8%) sutures. Associated risk factors included adjuvant chemotherapy and/or brachytherapy, early resumption of sexual activity, and low body mass index (mean, 23 ± 3.23 kg/m2). Dehiscences occurred regardless of suturing by staff or trainees. Review of operative videos did not reveal a detectable etiologic factor, such as excessive cautery damage to the vaginal cuff or shallow tissue sutured. All 7 colporrhexis repairs were performed through a vaginal approach without the need of laparoscopy or laparotomy.ConclusionsPostoperative chemotherapy, brachytherapy, and early resumption of sexual activities are risk factors for vaginal vault dehiscence. Surgical technique, particularly the use of delayed absorbable sutures, deserves further evaluation

Women undergoing minimally invasive robotic-assisted surgery for a gynecologic malignancy have many questions and concerns related to the cancer diagnosis and surgery. The provision of information enhances coping with such illness-related challenges. A lack of print materials for these patients prompted the creation of a written teaching tool to improve informational support. A booklet was developed using guidelines for the design of effective patient education materials, including an iterative process of collaboration with healthcare providers and women who had undergone robotic-assisted surgery, as well as attention to readability. The 52-page booklet covers the trajectory of the woman's experience and includes the physical, psychosocial, and sexual aspects of recovery.

Objective:This is a prospective evaluation of the outcome of minimal invasive surgery using robotics in function of the body mass index (BMI) of patients.Methods:This is a prospective cohort study of consecutive women undergoing surgery for endometrial cancer at a tertiary care facility since the initiation of a robotic program in December 2007. Surgical and personal outcome variables as well as quality of life and postoperative recovery were assessed using a combination of objective and subjective/self-report questionnaires. Women were divided into 3 groups based on their BMI. Comparative analyses among nonobese (n = 52), obese (n = 33) and morbidly obese (n = 23) women were performed on the outcome measures after surgery.Results:The mean BMI and the range in each of the BMI categories was 25 kg/m2 (18.7-29.4 kg/m2), 34 kg/m2 (30.1-38.4 kg/m2), and 46 kg/m2 (40.0-58.8 kg/m2). Women with higher BMI tended to be more frequently affected with comorbidities such as diabetes (15.4%, 26.0%, and 27.3%, respectively; P = 0.32) and hypertension (55.8%, 69.6%, and 69.7%, respectively; P = 0.19). Despite these differences, surgical console time (P = 0.20), major postoperative complications (P = 0.52), overall wound complications (P = 0.18), and median length of hospitalization in days (P = 0.17) were not statistically different among the 3 groups. Only 5.6% of women needed a mini laparotomy all of which were performed for the removal of their enlarged uterus, which could not be delivered safely via the vagina, at the end of the surgical procedure. There was no increased conversion to laparotomy due to increased BMI. Women in all 3 groups reported rapid resumption of hygiene regimens and chores, little need for narcotic analgesia, and high satisfaction with the procedure.Conclusions:Obese and morbidly obese patients with endometrial cancer are also good candidates for robotic surgery. These women benefit considerably from minimal invasive surgery and have little perioperative complications.

Objective: This pilot study aimed to provide supportive evidence for the acceptability and usefulness of the Meaning-Making intervention (MMi) in patients newly diagnosed with Stage III or IV ovarian cancer, and to provide estimates of parameters needed to design a full-scale study. Methods: A randomized controlled trial with 24 patients (12 experimental and 12 control) was conducted. Existential well-being (primary outcome), overall quality of life, distress, anxiety, depression and self-efficacy were measured. Results: Compared to the control group, patients in the experimental group had a better sense of meaning in life at one and three months post-intervention. Conclusion: The MMi seems a promising intervention for advanced cancer patients, and a full randomized controlled trial is warranted to further investigate its efficacy. Copyright © 2010 John Wiley & Sons, Ltd.

Objectives To determine the relationship between BMI, age, and the physical, functional, and psychosocial areas of health-related quality of life (HRQoL) and patient satisfaction in women with endometrial cancer undergoing robotic-assisted surgery. Methods During the first two years of the robotic surgery program, we prospectively collected data concerning patient demographics and surgical outcomes. At the first postoperative visit (21 to 28days after surgery), all participants completed a HRQoL questionnaire. We examined the association between BMI and age, as well as the different areas of HRQoL, using chi-square and ANOVA. Results Of 109 participants, 41 were 70years of age or older, and 51 had a BMI of 30kg/m 2 or more. Following surgery, the mean (±SD) duration of hospital stay was 1.9±1.5days, and reported pain level was highest on the second postoperative day, with a mean score of 3.4±2.1 on a seven-point scale. Moreover, two thirds of women reported no pain by the first postoperative visit, and only 18.2% of women aged 70years or older used any narcotic for pain control. These results indicated that there was little influence of the surgery on HRQoL, and women resumed typical activities within an average of 11days after surgery. Lastly, participants' average rating of satisfaction was 6.7 on a seven-point scale. Conclusion This pilot study has demonstrated the advantages for HRQoL of robotic-assisted surgery in the management of endometrial cancer. Women with endometrial cancer benefited from use of robotic surgery regardless of age or BMI.

Objective The objective of this study is to evaluate the detection rate and diagnostic accuracy of sentinel lymph node (SLN) mapping using intra-operative cervical injection of filtered 99mTc-sulfur colloid (99mTc-SC) and patent blue in patients with endometrial cancer. Methods Prospective evaluation of the first 100 endometrial cancer patients undergoing SLN mapping using cervical injection of patent blue combined with filtered 99mTc-SC in the operating room was done. Patients underwent robotic-assisted lymphatic mapping with frozen section, hysterectomy, BSO, and completion bilateral lymphadenectomy (including para-aortic nodes in grade 2 and 3 tumors). Results At least one SLN was detected in 92% of patients; in 66 of these (72%) bilateral SLN were detected, and in 15 cases the SLN was in the para-aortic area. Eleven percent of all patients had lymph node metastases, and 4 of which had pre-operative grade 1 tumor. The SLN was the only positive node in 44% of the cases with positive nodes. Sensitivity was 89% with 1 false negative result, yielding a negative predictive value of 99% (95% CI 93–100). Specificity was 100% (95% CI 94–100), and positive predictive value was 100% (95% CI 60–100). No complications or anaphylactic reactions were noted. Conclusions Intra-operative SLN biopsy, using cervical injection of patent blue and filtered 99mTc-SC in endometrial cancer patients is feasible and yields adequate detection rates.

Evaluation of surgical outcomes, including quality of life, in patients with endometrial cancer in the early phase of implementation of a robotic surgery program, comparing elderly with younger patients.Prospective evaluation of perioperative data and a postoperative quality-of-life survey of the first 100 robotic surgeries for endometrial cancer performed in the Division of Gynecologic Oncology at a tertiary cancer center. Women were divided in 2 groups based on age, allowing comparison of outcomes between the elderly (≥70 years) and younger groups (70 years).Of the first 100 patients, 41 were elderly (mean age, 78 years). The elderly group had significantly higher number of comorbidities and more advanced disease when compared with the younger women. Despite this, elderly women had similar mean operative times (252 vs 243 minutes), mean console times (171 vs 175 minutes), and mean blood loss (83 vs 81 mL) as compared with the younger group. Conversion rate to minilaparotomy was 6%, all of which were performed at the end of surgery for the removal of enlarged uteri that could not be delivered vaginally. The overall perioperative complication rates were not statistically different between the age groups. Median hospital stay tended to be longer for the elderly women (2 vs 1 day) but was not statistically significant. The postoperative quality-of-life assessment revealed that patients young and old alike were highly satisfied with the procedure.Prospective evaluation indicates that even in the early phases of implementation of a robotic surgical program for endometrial cancer, the procedure seems safe and confers an excellent quality of life for elderly patients.