John F. Boggess

Phase III Study of Cisplatin With or Without Paclitaxel in Stage IVB, Recurrent, or Persistent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

PURPOSE To determine whether cisplatin plus paclitaxel (C+P) improved response rate, progression-free survival (PFS), or survival compared with cisplatin alone in patients with stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix. PATIENTS AND METHODS Eligible: patients with measurable disease, performance status (PS) 0 to 2, and adequate hematologic, hepatic, and renal function received either cisplatin 50 mg/m2 or C+P (cisplatin 50 mg/m2 plus paclitaxel 135 mg/m2) every 3 weeks for six cycles. Tumor measurements and quality-of-life (QOL) assessments were obtained before each treatment cycle. RESULTS Of 280 patients entered, 6% were ineligible. Among 264 eligible patients, 134 received cisplatin and 130 received C+P. Groups were well matched with respect to age, ethnicity, PS, tumor grade, disease site, and number of cycles received. The majority of all patients had prior radiation therapy (cisplatin, 92%; C+P, 91%). Objective responses occurred in 19% (6% complete plus 13% partial) of patients receiving cisplatin versus 36% (15% complete plus 21% partial) receiving C+P (P = .002). The median PFS was 2.8 and 4.8 months, respectively, for cisplatin versus C+P (P < .001). There was no difference in median survival (8.8 months v 9.7 months). Grade 3 to 4 anemia and neutropenia were more common in the combination arm. There was no significant difference in QOL scores, although a disproportionate number of patients (cisplatin, n = 50; C+P, n = 33) dropped out of the QOL component, presumably because of increasing disease, deteriorating health status, or early death. CONCLUSION C+P is superior to cisplatin alone with respect to response rate and PFS with sustained QOL.

A comparative study of 3 surgical methods for hysterectomy with staging for endometrial cancer: robotic assistance, laparoscopy, laparotomy

OBJECTIVE The purpose of this study was to compare outcomes in women who underwent endometrial cancer staging by different surgical techniques. STUDY DESIGN Three hundred twenty-two women underwent endometrial cancer staging: 138 by laparotomy (TAH); 81 by laparoscopy (TLH) and 103 by robotic technique (TRH). RESULTS The TRH cohort had a higher body mass index than the TLH cohort (P = .0008). Lymph node yield was highest for TRH (P < .0001); hospital stay (P < .0001) and estimated blood loss (P < .0001) were lowest for this cohort. Operative time was longest for TLH (213.4 minutes) followed by TRH (191.2 minutes) and TAH (146.5 minutes; P < .0001. Postoperative complication rates were lower for TRH, compared with TAH (5.9% vs 29.7%; P < .0001). Conversion rates for the robotic and laparoscopic groups were similar. CONCLUSION TRH with staging is feasible and preferable over TAH and may be preferable over TLH in women with endometrial cancer. Further study is necessary to determine long-term oncologic outcomes.

What is the optimal minimally invasive surgical procedure for endometrial cancer staging in the obese and morbidly obese woman

OBJECTIVE Thirty-three percent of U.S. women are either obese or morbidly obese. This is associated with an increased risk of death from all causes and is also associated with an increased risk of endometrial carcinoma. We sought to compare minimally invasive surgical techniques for staging the obese and morbidly obese woman with endometrial cancer. MATERIALS AND METHODS Consecutive robotic endometrial cancer staging procedures were collected from 2005-2007 and were compared to consecutive laparoscopic cases (2000-2004). Demographics including age, weight, body mass index (BMI), operative time, estimated blood loss, lymph node retrieval, hospital stay and complications were collected and compared. RESULTS During the study period, there were 36 obese and 13 morbidly obese women who underwent surgery with the DaVinci robotic system and 25 obese and 7 morbidly obese women who underwent traditional laparoscopy. For both the obese and morbidly obese patient, robotic surgery was associated with shorter operative time (p=0.0004), less blood loss (p<0.0001), increased lymph node retrieval (p=0.004) and shorter hospital stay (p=0.0119). CONCLUSIONS Robotic surgery is a useful minimally invasive tool for the comprehensive surgical staging of the obese and morbidly obese woman with endometrial cancer. As this patient population is at increased risk of death from all causes, including post-operative complications, all efforts should be made to improve their outcomes and minimally invasive surgery provides a useful platform by which this can occur.

A case-control study of robot-assisted type III radical hysterectomy with pelvic lymph node dissection compared with open radical hysterectomy

OBJECTIVE The purpose of this study was to compare robotically assisted hysterectomy (RAH) with open (ORH) type III radical hysterectomy in the treatment of early-stage cervical cancer. STUDY DESIGN The outcomes of 51 consecutive patients who underwent RAH were compared with the outcomes of 49 patients who underwent ORH. RESULTS There were no differences with regard to patient demographics. There were significant differences between the groups with regard to operative blood loss (P < .0001), operative time (P = .0002), and lymph node retrieval (P = .0003), all of which were in favor of the RAH cohort. All patients with RAH were discharged on postoperative day 1, compared with a 3.2-day average hospitalization for the cohort with ORH. The incidence of postoperative complications was 7.8% and 16.3% for the RAH and ORH cohorts, respectively (P = .35). CONCLUSION Robotic type III radical hysterectomy with pelvic node dissection is feasible and may be preferable over open radical hysterectomy in patients with early-stage cervical cancer. Further study will determine procedure generalizability and long-term oncologic outcomes.

Survival outcomes for women undergoing type III robotic radical hysterectomy for cervical cancer: A 3-year experience ☆

OBJECTIVES.: To assess progression-free (PFS) and overall survival (OS) for women with cervical cancer who underwent type III robotic radical hysterectomy (RRH). METHODS.: A retrospective analysis of women who underwent RRH from 2005 to 2008 was performed. The data analyzed included patient demographics, histology, clinical stage, surgical margins, lymph node and disease status. Comparison was made to a group of historical open radical hysterectomies. Survival statistics were analyzed using the Kaplan-Meier method. RESULTS.: Seventy-one women underwent attempted RRH during the study period. Eight were excluded from analysis, 4 for non-cervical primary and 4 cases aborted due to extent of disease. Squamous was the most common histology (62%) followed by adenocarcinoma (32%). Median patient age was 43 years. There was one intraoperative complication (asystole after induction) and two postoperative complications (ICU admission to rule out myocardial infarction and reoperation for cuff dehiscence). Of the patients who underwent RRH, 32% received whole-pelvis radiation with chemo sensitization. The median follow-up was 12.2 months (range 0.2-36.3 months). Kaplan-Meier survival analysis demonstrated 94% PFS and OS at 36 months due to the recurrence and death of one patient. Compared with a historical cohort at our institution, there was no statistically significant difference in PFS (P=0.27) or OS (P=0.47). CONCLUSIONS.: RRH is safe and feasible and has been shown to be associated with improved operative measures. This study shows that at 3 years, RRH appears to have PFS and OS equivalent to that of traditional laparotomy. Longer follow-up is needed, but early data are supportive of at least equivalent oncologic outcomes compared with other surgical modalities.

A Prospective Study of Risk-Reducing Salpingo-oophorectomy and Longitudinal CA-125 Screening among Women at Increased Genetic Risk of Ovarian Cancer: Design and Baseline Characteristics: A Gynecologic Oncology Group Study

Background: Women who are genetically predisposed to ovarian cancer are at very high risk of developing this disease. Although risk-reducing salpingo-oophorectomy (RRSO) and various screening regimens are currently recommended to reduce ovarian cancer risk, the optimal management strategy has not been established nor have multiple additional issues been adequately addressed. We developed a collaboration among the Clinical Genetics Branch (National Cancer Institutes Intramural Research Program), the Gynecologic Oncology Group (GOG), and the Cancer Genetics Network to address these issues. Methods: This is a prospective, international, two-cohort, nonrandomized study of women at genetic risk of ovarian cancer, who chose either to undergo RRSO or screening, at study enrollment. Primary study objectives include quantifying and comparing ovarian and breast cancer incidence in the two study groups, assessing feasibility and selected performance characteristics of a novel ovarian cancer screening strategy (the Risk of Ovarian Cancer Algorithm), evaluating various aspects of quality of life and nononcologic morbidity related to various interventions in at-risk women, and creating a biospecimen repository for subsequent translational research. Results: Study accrual is complete as of November 2006; 2,605 participants enrolled: 1,030 (40%) into the surgical cohort and 1,575 (60%) into the screening cohort. Five years of prospective follow-up ends in November 2011. Verification of BRCA mutation carrier status is under way, either through patient-provided reports from clinical genetic testing done before enrollment or through research-based genetic testing being conducted as part of the protocol. Patient eligibility is currently under evaluation and baseline, surgical, pathology, and outcome data are still being collected. The study design and selected baseline characteristics of cohort members are summarized. Conclusion: This National Cancer Institute intramural/extramural collaboration will provide invaluable prospectively collected observational data on women at high familial ovarian cancer risk, including substantial numbers of women carrying BRCA1/2 mutations. These data will aid in elucidating the effect of RRSO on breast/ovarian cancer risk and the effects of two management strategies, on quality of life and other issues that may influence patient care, as well as providing preliminary estimates of test specificity and positive predictive value of a novel ovarian cancer screening strategy. (Cancer Epidemiol Biomarkers Prev 2008;17(3):594–604)

Robotic-assisted surgery in gynecologic oncology: A Society of Gynecologic Oncology consensus statement: Developed by the Society of Gynecologic Oncology's Clinical Practice Robotics Task Force

The Society of Gynecologic Oncologys (“SGO”) Clinical Practice Committee has developed a series of Clinical Documents designed to improve the overall quality of womens cancer care; reduce the use of unnecessary, ineffective or harmful interventions; as well as facilitate the optimal treatment of patients with a goal to maximize the therapeutic benefit, and minimize the risk of harm, at acceptable cost. In developing clinical documents, SGO follows a rigorous process to assure that any conflicts of interest are disclosed and appropriately addressed and that relationships with manufacturers and other third parties do not influence the development process. More specifically, SGO adheres to the principles adopted by the Council of Medical Specialty Societies (“CMSS”) in developing, adopting and promulgating clinical guidelines and consensus statements. Consistent with CMSS principles, SGO received no funding from any manufacturer to support the development of this Consensus Statement nor any other clinical consensus statement or practice guideline developed and published by SGO. In accordance with CMSS principles, SGO requires that its clinical documents be subject to multiple levels of review beginning with a review by SGOs full Clinical Practice Committee. After review and approval by the Clinical Practice Committee, Consensus Statements are submitted to the SGO Council which is SGOs governing body which reviewed and approved the Consensus Statement for submission to SGOs Journal. None of the members of the SGO Council has a financial or other relationship with Intuitive. In accordance with those principles, each member of the Robotics Clinical Task Forcewhich developed the Consensus Statement executed a detailed disclosure statement prior to participating in the Task Force. There is currently only one manufacturer of robotic gynecology technology, Intuitive Surgical Inc., of Sunnyvale, California (“Intuitive”). Onemember of the thirteenmembers of the Robotics Clinical Task Force has a consulting relationship with Intuitive and receives honoraria from Intuitive for teaching advanced courses at his institution. SGO has received unrestricted educational grants from Intuitive to provide educational support for its annual and winter meetings at approximately

A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study

25,000 a year over 5 years. All content for these educational programs was developed in accordance with ACCME standards. Clinical Documents are intended to be educational devices that provide information that may assist healthcare providers in caring for patients. This Clinical Document is not a rule and should not be construed as establishing a legal standard of care or as encouraging,

Robotic surgery in gynecologic oncology: evolution of a new surgical paradigm

BACKGROUND Sentinel-lymph-node mapping has been advocated as an alternative staging technique for endometrial cancer. The aim of this study was to measure the sensitivity and negative predictive value of sentinel-lymph-node mapping compared with the gold standard of complete lymphadenectomy in detecting metastatic disease for endometrial cancer. METHODS In the FIRES multicentre, prospective, cohort study patients with clinical stage 1 endometrial cancer of all histologies and grades undergoing robotic staging were eligible for study inclusion. Patients received a standardised cervical injection of indocyanine green and sentinel-lymph-node mapping followed by pelvic lymphadenectomy with or without para-aortic lymphadenectomy. 18 surgeons from ten centres (tertiary academic and community non-academic) in the USA participated in the trial. Negative sentinel lymph nodes (by haematoxylin and eosin staining on sections) were ultra-staged with immunohistochemistry for cytokeratin. The primary endpoint, sensitivity of the sentinel-lymph-node-based detection of metastatic disease, was defined as the proportion of patients with node-positive disease with successful sentinel-lymph-node mapping who had metastatic disease correctly identified in the sentinel lymph node. Patients who had mapping of at least one sentinel lymph node were included in the primary analysis (per protocol). All patients who received study intervention (injection of dye), regardless of mapping result, were included as part of the assessment of mapping and in the safety analysis in an intention-to-treat manner. The trial was registered with ClinicalTrials.gov, number NCT01673022 and is completed and closed. FINDINGS Between Aug 1, 2012, and Oct 20, 2015, 385 patients were enrolled. Sentinel-lymph-node mapping with complete pelvic lymphadenectomy was done in 340 patients and para-aortic lymphadenectomy was done in 196 (58%) of these patients. 293 (86%) patients had successful mapping of at least one sentinel lymph node. 41 (12%) patients had positive nodes, 36 of whom had at least one mapped sentinel lymph node. Nodal metastases were identified in the sentinel lymph nodes of 35 (97%) of these 36 patients, yielding a sensitivity to detect node-positive disease of 97·2% (95% CI 85·0-100), and a negative predictive value of 99·6% (97·9-100). The most common grade 3-4 adverse events or serious adverse events were postoperative neurological disorders (4 patients) and postoperative respiratory distress or failure (4 patients). 22 patients had serious adverse events, with one related to the study intervention: a ureteral injury incurred during sentinel-lymph-node dissection. INTERPRETATION Sentinel lymph nodes identified with indocyanine green have a high degree of diagnostic accuracy in detecting endometrial cancer metastases and can safely replace lymphadenectomy in the staging of endometrial cancer. Sentinel lymph node biopsy will not identify metastases in 3% of patients with node-positive disease, but has the potential to expose fewer patients to the morbidity of a complete lymphadenectomy. FUNDING Indiana University Health, Indiana University Health Simon Cancer Center, and the Indiana University Department of Obstetrics and Gynecology.

Perioperative Outcomes of Robotically Assisted Hysterectomy for Benign Cases With Complex Pathology

Robotic surgical platforms were first developed with telesurgery in mind. Conceptualized by NASA and the military to provide surgical expertise to remote locations, some telesurgical success has been documented, but progress has been held back by communication bandwidth limitations. Telepresence surgery, where the surgeon is in proximity to the patient but is provided with an ergonomic console equipped with three-dimensional vision and autonomous control of wristed laparoscopic surgical instruments and energy sources, has shown efficacy first in cardiac and then urologic cancer surgery. Interest is currently focused on the application of this technology in the field of gynecology, with techniques being described to perform simple hysterectomy, myomectomy, tubal anastomosis, and pelvic reconstruction procedures. This article will review the application of robotic- and computer-assisted surgery in the specialty of gynecologic oncology.