Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial.

Importance: Patients with platinum-resistant or platinum-refractory ovarian cancer (PRROC) have limited therapeutic options, representing a considerable unmet medical need. Objective: To assess antitumor activity and safety of intraperitoneal (IP) olvimulogene nanivacirepvec (Olvi-Vec) virotherapy and platinum-based chemotherapy with or without bevacizumab in patients with PRROC. Design, Setting, and Participants: This open-label, nonrandomized multisite phase 2 VIRO-15 clinical trial enrolled patients with PRROC with disease progression following their last prior line of therapy from September 2016 to September 2019. Data cutoff was on March 31, 2022, and data were analyzed between April 2022 and September 2022. Interventions: Olvi-Vec was administered via a temporary IP dialysis catheter as 2 consecutive daily doses (3 × 109 pfu/d) followed by platinum-doublet chemotherapy with or without bevacizumab. Main Outcomes and Measures: Primary outcomes were objective response rate (ORR) via Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) and cancer antigen 125 (CA-125) assay, and progression-free survival (PFS). Secondary outcomes included duration of response (DOR), disease control rate (DCR), safety, and overall survival (OS). Results: Twenty-seven heavily pretreated patients with platinum-resistant (n = 14) or platinum-refractory (n = 13) ovarian cancer were enrolled. The median (range) age was 62 (35-78) years. The median (range) prior lines of therapy were 4 (2-9). All patients completed both Olvi-Vec infusions and chemotherapy. Median follow-up duration was 47.0 months (95% CI, 35.9 months to NA). Overall, ORR by RECIST 1.1 was 54% (95% CI, 33%-74%), with a DOR of 7.6 months (95% CI, 3.7-9.6 months). The DCR was 88% (21/24). The ORR by CA-125 was 85% (95% CI, 65%-96%). Median PFS by RECIST 1.1 was 11.0 months (95% CI, 6.7-13.0 months), and the PFS 6-month rate was 77%. Median PFS was 10.0 months (95% CI, 6.4-NA months) in the platinum-resistant group and 11.4 months (95% CI, 4.3-13.2 months) in the platinum-refractory group. The median OS was 15.7 months (95% CI, 12.3-23.8 months) in all patients, with a median OS of 18.5 months (95% CI, 11.3-23.8 months) in the platinum-resistant group and 14.7 months (95% CI, 10.8-33.6 months) in the platinum-refractory group. Most frequent treatment-related adverse events (TRAEs) (any grade, grade 3) were pyrexia (63.0%, 3.7%, respectively) and abdominal pain (51.9%, 7.4%, respectively). There were no grade 4 TRAEs, and no treatment-related discontinuations or deaths. Conclusions and Relevance: In this phase 2 nonrandomized clinical trial, Olvi-Vec followed by platinum-based chemotherapy with or without bevacizumab as immunochemotherapy demonstrated promising ORR and PFS with a manageable safety profile in patients with PRROC. These hypothesis-generating results warrant further evaluation in a confirmatory phase 3 trial. Trial Registration: ClinicalTrials.gov Identifier: NCT02759588.

Clear cell carcinoma of the pelvic side wall arising from endometriosis.

Endometriosis is a condition wherein an ectopic layer of endometrial tissue arises in an extra-uterine location, often effecting significant pelvic pain and infertility. While very uncommon, there have been reported cases of endometriosis undergoing malignant transformation, frequently involving the ovaries and seldom in extra-gonadal regions. We recount a case depicting a 63 year-old woman who presented with an apparent inguinal hernia in 2017; she was ultimately diagnosed with a pelvic side wall clear cell carcinoma and attendant metastatic disease to the medial groin, which emanated from endometriosis. Malignant transformation of endometriosis identified in the pelvic side wall is a very rare finding. Nevertheless, oncologists should maintain a high index of suspicion in patients with a history of endometriosis or pelvic surgery.

The incidence of occult malignancy following uterine morcellation: A ten-year single institution experience retrospective cohort study.

INTRODUCTION: When the Food and Drug Administration (FDA) initially reported on the parlous incidence (0.28%) of occult malignancy identified following uterine power morcellation, investigations thereafter documented their particular experience with this surgical procedure. Nevertheless, the precise risk of identifying a sarcoma following uterine morcellation remains indeterminate, primarily due to varying study patient risk factors, diagnostic criteria and operative approach. METHOD: We retrospectively evaluated subjects who underwent an endoscopic hysterectomy and uterine power morcellation for the treatment of a presumptive, benign indication from January 2006 until December 2015. The primary outcome was the incidence of an occult malignancy. Secondarily, we were interested in characterizing the patients' specific clinical (age, menopausal status, body mass index (BMI)) risk factors within the context of a confirmed malignant or pre-malignant pathology. RESULTS: We identified 281 patients who underwent endoscopic surgery that incorporated uterine morcellation. During the study period, one subject was ultimately diagnosed with a uterine leiomyosarcoma; the overall incidence of occult malignancy was 0.36%. There were also 3 cases of uterine premalignant disease on final pathology (2 patients had complex hyperplasia with or without atypia and 1 subject was diagnosed with a smooth muscle tumor of uncertain malignant potential (an incidence of 1.1%)). We were unable to establish any relationship between patient age, uterine weight, menopausal status or BMI and the incidence of a malignant or pre-malignant pathology (P > 0.05). CONCLUSION: The rate of occult malignancy in the present investigation was similar to previously documented studies and that which has been reported by the FDA. Additional study of methods in which to enhance preoperative work-up and mitigate the surgical risk for tumor cell dissemination is warranted.

The safety and feasibility of minimally invasive sentinel lymph node staging using indocyanine green in the management of endometrial cancer.

OBJECTIVES: The purpose of this study was to report on the feasibility of laparoscopic sentinel lymph node (SLN) staging using indocyanine green (ICG) in the management of endometrial cancer. STUDY DESIGN: We retrospectively evaluated the charts of presumed, clinical stage I endometrial cancer patients who underwent robotic-assisted surgery that incorporated mapping with ICG and SLN dissection from January 2016 until February 2017. Patient demographics, operative characteristics (e.g., complications, lymph node counts) and pathology data were evaluated. RESULTS: There were 87 patients who were included in the study. A total of 370 lymph nodes were removed, of which 245 were SLNs; unilateral and bilateral mapping of the SLNs was achieved in 84 (96.5%) and 71 (81.6%) of subjects, respectively. There were 10 (11.5%) patients who had metastatic disease identified within 22 (5.9%) of the total (n = 370) lymph nodes extracted, 19 (7.7%) of which were sentinel lymph nodes. We did not observe any intraoperative complications. CONCLUSION: The results from our study suggest that minimally invasive SLN staging using ICG is a feasible procedure that is potentially effective at detecting metastases, which may ultimately attenuate the incidence of surgical morbidity.

Consolidation hyperthermic intraperitoneal chemotherapy for the treatment of advanced stage ovarian carcinoma: a 3 year experience.

PURPOSE: Hyperthermic intraperitoneal chemotherapy (HIPEC) potentially confers significant survival benefits in the management of ovarian cancer although the long-term data remain scant. We sought to compare the survival rates of advanced stage ovarian cancer patients who were treated with primary induction therapy alone or in conjunction with consolidation HIPEC. METHODS: 69 ovarian cancer patients who underwent surgery and completed their primary induction chemotherapy were treated with consolidation carboplatin (AUC 10) based HIPEC and compared to a historical cohort that received surgery and primary chemotherapy alone (n = 69). The demographic and clinical characteristics on which we were primarily focused, included patient age, body mass index, surgery and pathology data, chemotherapy regimen, toxicity, and progression free/overall survival. RESULTS: The two patient groups' demographic and clinical characteristics were similar (P > 0.05). Progression-free survival was significantly more pronounced in the HIPEC (25.1 months) patients compared to the control group (20 months) (P = 0.024) and there was a decreased risk of disease progression accorded to the patients treated with HIPEC (HR 2.1028; 95% CI 1.2941-3.4167; P = 0.0027). However, we did not discern any HIPEC related overall survival advantages (P = 0.29). CONCLUSIONS: The results from our ovarian cancer study suggest that adjunctive HIPEC proffers a significant progression-free survival advantage and a decreased risk for disease progression. There was, however, no overall survival advantage discerned by the HIPEC group. We also recognize that HIPEC remains controversial, and thus randomized studies evaluating HIPEC compared to standard chemotherapy in the management of ovarian cancer are warranted.

The impact of total parenteral nutrition on postoperative recovery in patients treated for advanced stage ovarian cancer.

OBJECTIVES: Total parenteral nutrition (TPN) presumably benefits cancer patients although reports have disputed the significance of this nutritional intervention. We sought to compare the postoperative outcomes of ovarian cancer patients treated with either TPN or conservative management. METHODS: We retrospectively evaluated the impact of TPN and conservative management in ovarian cancer patients who underwent debulking surgery and a bowel resection. The primary study variables encompassed patient time until restoration of bowel function, number of postoperative complications and duration of hospital stay. RESULTS: There were 147 subjects who were selected for this study. The patients who were treated with TPN (n = 69) demonstrated a longer time until restoration of bowel function (5.77 vs. 4.70 days; P < 0.001), experienced lower pre-operative albumin levels (2.22 vs. 2.97 g/dL; P < 0.001) and endured a significantly longer hospital stay (11.46 vs. 7.14 days; P < 0.001) compared to the conservative management (n = 78) cohort. CONCLUSIONS: Postoperative TPN in ovarian cancer patients may be inadvisable because of the increased risk for complications. Moreover, in the hypoalbuminemic patients, TPN may have not only delayed their postoperative recovery and increased hospital stay duration, but further precipitated the manifestation of nosocomial sequelae.

Lower-extremity lymphedema following management for endometrial and cervical cancer.

BACKGROUND: Despite the alleged benefits conferred by a lymphadenectomy in the management of gynecologic malignancies, there are concerns regarding the development of postoperative lower-extremity lymphedema. The purpose of this study was to identify the incidence of lymphedema and associated risk factors in accordance with surgical staging during the management of endometrial and cervical cancer. METHOD: We conducted a 5-year review of all endometrial and cervical cancer patients who underwent a lymphadenectomy. The subjects' demographics, medical co-morbidities, diagnosis, surgical treatment, inclusion of adjuvant radiotherapy and incidence of lower-extremity lymphedema were noted. RESULTS: We identified 165 (135 endometrial cancer and 30 cervical cancer) subjects. Positive pelvic and para-aortic lymph nodes were present in 21 (12.7%) and 10 patients (6.1%), respectively. In the entire population, 6 (3.6% incidence) subjects developed post-operative lymphedema. Supplementary analyses revealed that a BMI >35 kg/m(2) and possessing numerous (≥3) co-morbidities significantly correlated with the manifestation of lower-extremity lymphedema. CONCLUSION: In the current investigation, we observed a reasonably low, overall incidence of postoperative lower-extremity lymphedema. Nevertheless, when evaluating the potential for lymphedema in patients for whom a lymphadenectomy is indicated, specific risk factors should be considered in an effort to attenuate the development of this morbid condition.

A Randomized Controlled Pilot Study Comparing the Impact of Aprepitant and Fosaprepitant on Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecologic Cancer.

OBJECTIVE: The purpose of this pilot study was to compare the response rates and daily living activities of patients with newly diagnosed gynecologic cancer treated with fosaprepitant or aprepitant in the management of chemotherapy-induced nausea and vomiting. METHODS AND MATERIALS: Eligible participants were randomized to either intravenous fosaprepitant (150 mg, day 1) or oral aprepitant (125 mg on day 1 and 80 mg on days 2-3) before undergoing weekly paclitaxel (80 mg/2)(2) and monthly carboplatin (AUC 6)-based chemotherapy. In addition, standard premedications (eg, ranitidine, dexamethasone, and diphenhydramine) were administered intravenously on day 1. Response evaluation and impact on daily life were measured throughout the acute phase (0-24 hours), delayed period (days 2-4), and overall phase (0-120 hours) of the patients' initial chemotherapy cycle via the Functional Living Index-Emesis. RESULTS: In the current investigation, 20 gynecologic cancer subjects were treated with either fosaprepitant (n = 10) or aprepitant (n = 10) before their first chemotherapy cycle. We observed 7 overall complete responses (70%, no emetic episodes or rescue medications) in the aprepitant group and 6 (60%) in the fosaprepitant cohort (P = 0.660). In addition, both treatment groups reported similarly, favorable rates of daily living activities throughout the acute (P = 0.626) and delayed (P = 0.648) phases of cycle 1 chemotherapy. CONCLUSIONS: The findings from the current analysis suggest that intravenous fosaprepitant and oral aprepitant confer beneficial antiemetic prevention. Moreover, the 2 medications theoretically afford a favorable impact on daily living, thereby potentially facilitating the completion of a patient's clinically prescribed chemotherapy regimen.

Survival rate comparisons amongst cervical cancer patients treated with an open, robotic-assisted or laparoscopic radical hysterectomy: A five year experience.

BACKGROUND: The purpose of this retrospective study was to assess the 5-year survival outcomes of cervical cancer patients who underwent an, open radical hysterectomy (ORH), robotic-assisted radical hysterectomy (RRH) or laparoscopic radical hysterectomy (LRH) for the treatment of their disease. METHOD: We conducted a review of all cervical cancer patients who were managed with an ORH, RRH or LRH. RESULT: Forty-nine patients were treated with LRH, 58 were managed via RRH and 39 patients underwent an ORH. The LRH (1.78 h) patients had a significantly shorter operative duration than the RRH (2.88 h) and ORH (2.39 h) subjects (p < 0.001). Blood loss was the highest in the ORH (475 cc) group (RRH = 207 cc and LRH = 312 cc) (P < 0.001). Moreover, the ORH (5.04 days) patients had a significantly longer hospital stay than the LRH (2.95 days) and RRH (2.50 day) subjects (P < 0.001). Kaplan-Meier survival analysis revealed a progression free survival (PFS) rate of 84.6% for the ORH group, 89.8% for the LRH group and 89.7% for the RRH patients (P = 0.271) at 60 months; overall survival was 92.3% for the ORH group, 95.9% for the LRH group and 96.6% for the RRH patients (P = 0.80). CONCLUSION: The results from this study suggest that, irrespective of operative approach, patients who underwent a radical hysterectomy for early stage cervical cancer attained similar 5-year disease free and overall survival outcomes.

Dramatically reduced incidence of vaginal cuff dehiscence in gynecologic patients undergoing endoscopic closure with barbed sutures: A retrospective cohort study.

INTRODUCTION: This retrospective study documented the rate of vaginal cuff dehiscence (VCD) in a large series of gynecologic patients who were treated with an endoscopic (robotic-assisted or laparoscopic) hysterectomy that incorporated either delayed absorbable monofilament barbed or vicryl running sutures. METHOD: We sought to discern any prognostic associations between operative variables (e.g., closure type (barbed or vicryl sutures), endoscopic approach (robotic-assisted or laparoscopic), and energy source (Harmonic Ace Shears or monopolar/bipolar electro-surgery)) and the risk for VCD via patient chart review. Statistical evaluation was comprised of univariate analyses and multiple regression. RESULTS: We identified 1876 subjects; there were 14 cases (0% with barbed suture and 0.99% with vicryl suture) of VCD (an overall incidence of 0.75%), nearly all of which were associated with a robotic-assisted hysterectomy involving vicryl sutures (p = 0.034). However, the type of endoscopic surgery (P = 0.11) and energy source (P = 0.28) were not significant prognostic factors. The VCD patients' exhibited a median duration of 47 days (range, 14-116) until the development of their condition. CONCLUSION: Vaginal cuff separation subsequent to laparoscopic closure is a rare occurrence. While our incidence of VCD was low and comparable to other reported rates in the literature, we did not observe any cases of VCD following laparoscopic hysterectomy performed with barbed suture closure.

A comparison of open surgery, robotic-assisted surgery and conventional laparoscopic surgery in the treatment of morbidly obese endometrial cancer patients.

BACKGROUND AND OBJECTIVES: The intent of this retrospective study was to assess the operative outcomes of morbidly obese endometrial cancer patients who were treated with either open surgery (OS) or a minimally invasive procedure. METHODS: Morbidly obese (body mass index [BMI] > 40 kg/m(2)) patients with endometrial cancer who underwent OS, robotic-assisted laparoscopic surgery (RS), or conventional laparoscopic surgery (LS) were eligible. We sought to discern any outcome differences with regard to operative time, perioperative complications, and hospital stay. RESULTS: Sixteen patients were treated with LS (BMI = 47.9 kg/m(2)), 13 were managed via RS (BMI = 51.2 kg/m(2)), and 24 underwent OS (BMI = 53.7 kg/m(2)). The OS (1.35 hours) patients had a significantly shorter operative duration than the LS (1.82 hours) and RS (2.78 hours) patients (P < .001); blood loss was greater in the OS (250 mL) group in comparison with the RS (100 mL) and LS (175 mL) patients (P = .002). Moreover, the OS (4 days) subjects had a significantly longer hospital stay than the LS (2 days) and RS (2 days) patients (P = .002). CONCLUSION: In the present study, we ascertained that minimally invasive surgery was associated with longer operative times but lower rates of blood loss and shorter hospital stay duration compared with treatment comprising an open procedure.

Consolidation hyperthermic intraperitoneal chemotherapy and maintenance chemotherapy following laparoscopic cytoreductive surgery in the treatment of ovarian carcinoma.

PURPOSE: Hyperthermic intraperitoneal chemotherapy (HIPEC) is an intriguing method of delivery wherein the cytotoxic agent is continuously heated and circulated throughout the peritoneum in an attempt to improve efficacy. Despite the potential of HIPEC in the treatment of ovarian cancer, there are limited safety, feasibility and survival data involving this procedure, particularly in conjunction with maintenance chemotherapy. PATIENTS AND METHODS: We retrospectively evaluated ovarian cancer patients who underwent laparoscopic debulking surgery, attained a complete response to their primary chemotherapy and subsequently received consolidation HIPEC with carboplatin area under the curve of 10 (AUC of 10) and a planned 12 cycles of paclitaxel (135 mg/m(2)) maintenance chemotherapy. The following demographic and clinical characteristics were abstracted: patient age, body mass index, surgery and pathology data, chemotherapy regimen, intra-operative results, toxicity, post-operative complications, length of hospital stay and disease-free/overall survival. RESULTS: We identified 37 patients who were the subject of this study. There were no intra-operative complications during the administration of HIPEC; median estimated blood loss was 50 mL and length of hospital stay was 1.25 days. In the overall study population, six patients developed grade 3/4 anaemia and 24 patients exhibited grade ≤ 2 thrombocytopenia and neutropenia. Ten patients developed grade ≤ 2 nausea on postoperative day 1; there were no hospital readmissions. Median disease-free survival and overall survival was 13 months and 14 months, respectively. CONCLUSION: The results from this ovarian cancer treatment evaluation suggest that the combination of consolidation HIPEC and maintenance chemotherapy is feasible and reasonably well tolerated.

The feasibility of administering varying high-dose consolidation hyperthermic intraperitoneal chemotherapy with carboplatin in the treatment of ovarian carcinoma.

OBJECTIVES: Hyperthermic intraperitoneal chemotherapy (HIPEC) is an intriguing method of delivery wherein the cytotoxic agent is continuously heated and circulated throughout the peritoneum in an attempt to bolster drug efficacy. Despite HIPEC's potential, ascertaining the optimal dose without compromising patient tolerability remains indeterminate. METHODS: We retrospectively evaluated 52 advanced stage ovarian cancer patients who were treated with consolidation HIPEC with carboplatin at varying doses (e.g., AUC 6, 8 or 10) subsequent to optimal debulking surgery and the attainment of a clinical complete response to their primary chemotherapy regimen. The following patient and operative characteristics were abstracted: demographics, surgery and pathology data, chemotherapy regimen, intraoperative results, toxicity, postoperative complications, length of hospital stay and survival data. RESULTS: Twelve patients received HIPEC carboplatin at an AUC 6, 15 subjects were treated with carboplatin at an AUC 8 and 25 underwent carboplatin at an AUC 10. There were no intraoperative complications during the administration of HIPEC; mean estimated blood loss was 50 mL and length of hospital stay was 1.65 days. In the overall study population, 5 patients developed grade 3/4 anemia and 33 subjects exhibited grade ≤2 thrombocytopenia and neutropenia. Thirteen patients also developed grade ≤2 nausea on postoperative day 1, which was successfully addressed with anti-emetic therapy; there were no hospital readmissions. CONCLUSIONS: The results from the current evaluation suggest that consolidation hyperthermic intraperitoneal chemotherapy with carboplatin is both feasible and reasonably tolerated, even at an AUC of 10. However, additional, randomized study of this procedure incorporating chemotherapy dose escalation with a more extensive patient population is warranted.

The safety and feasibility of robotic-assisted lymph node staging in early-stage ovarian cancer.

OBJECTIVES: The purpose of this study was to report on the safety and feasibility of robotic-assisted systematic lymph node staging in the management of early-stage ovarian cancer. METHODS: We retrospectively reviewed the charts of presumed early-stage (International Federation of Gynecology and Obstetrics (FIGO) stages I and II) ovarian cancer patients who underwent robotic-assisted surgery that incorporated a systematic pelvic and para-aortic lymphadenectomy from January 2009 until December 2013. Patient demographics, operative characteristics, pathology, lymph node counts, surgical complications, and hospital stay were evaluated. RESULTS: A total of 26 early-stage ovarian cancer patients were identified. The mean operating time was 2.90 hours, and the estimated blood loss was 63 mL; there were no intraoperative complications although 1 patient's surgery was significantly prolonged due to pelvic adhesions. The mean number of pelvic and para-aortic lymph nodes removed was 14.6 (2.3% incidence of pelvic lymph node metastases) and 5.8 (3.3% incidence of para-aortic lymph node metastases), respectively. The patients' mean duration of hospital stay was 18.4 hours, and 2 patients were readmitted for either a postoperative wound infection or vaginal dehiscence. CONCLUSIONS: The results from this study suggest that robotic-assisted surgical staging in the management of presumed early-stage ovarian cancer is both feasible and associated with a minimal patient complication rate. We encountered a low incidence of lymph node metastases, and the readmission rate was favorable. Nevertheless, because the prevalence of lymph node metastases can approach 20% in select patients, physicians should consider a systematic lymph node resection to confer an optimal clinical assessment.

The incidence of postprandial nausea and nutritional regression in gynecologic cancer patients following intestinal surgery: a retrospective cohort study.

INTRODUCTION: We sought to evaluate the impact of defined intestinal surgeries on postprandial nausea, nutritional regression (i.e., a soft diet that was altered to clear liquids) and hospital stay duration in a population of gynecologic cancer patients. METHOD: The following study variables were evaluated: age, intestinal surgery type: 1) small bowel resection (SBR) 2) proximal colectomy alone (Col) 3) rectosigmoid resection (RSR) and 4) rectosigmoid resection with proximal colectomy (RSR + Col), initiation of postoperative feeding (period 1 = days 1 or 2, period 2 = days 3 or 4, or period 3 ≥ day 5), development of postprandial nausea, incidence of nutritional regression and hospital stay duration. RESULTS: There were 218 patients who were the subject of this study. Patients who initiated early feeding (i.e., period 1) were at significantly greater risk for developing postprandial nausea (P = 0.005); the subjects in the RSR and RSR + Col groups had the highest incidence of postprandial nausea (P = 0.008). Also, in the combined group of patients, those who were fed the latest (i.e., period 3 or ≥5 days) had the longest hospital stay (P < 0.001). CONCLUSION: Early postoperative feeding is presumably safe but postprandial nausea and nutritional regression may be a concern in these patients who have undergone an extensive intestinal surgery. Delayed feeding may mitigate the incidence of postprandial nausea and nutritional regression although potentially at the expense of increased hospital stay duration.

The incidence of genitourinary and gastrointestinal complications in open and endoscopic gynecologic cancer surgery.

OBJECTIVES: The purpose of this study was to examine the incidence of genitourinary and intestinal tract injuries in an effort to identify which factors might predispose a patient to developing one of these surgical complications. METHODS: We retrospectively evaluated the charts of gynecologic cancer patients who were treated at a single medical institution from January 2002 to February 2011. The following study variables were noted for evaluation: age, BMI, cancer origin, disease recurrence, a history of pelvic surgery, surgery type, operative approach and injury classification (genitourinary or gastrointestinal). RESULTS: In our group of 1,618 patients, a total of 47 (2.9%) gastrointestinal and 18 (1.1%) genitourinary tract injuries were encountered. There were no intraoperative-related deaths but 2 patients expired 1 month after surgery. Logistic regression indicated that surgery type, undergoing an open procedure, cancerous involvement of the bowel or genitourinary tract and a history of pelvic surgery were significant predictors of operative injury occurrence [χ(2) (28) = 167.22; p < 0.001]. CONCLUSIONS: We ascertained a relatively low incidence of gastrointestinal and genitourinary complications. Nevertheless, undergoing an open procedure, a history of pelvic surgery and surgical involvement of the bowel or genitourinary tract were predictive of an increased risk for these aforementioned injuries.

Systemic and local hormone therapy for endometrial hyperplasia and early adenocarcinoma.

OBJECTIVE: To estimate disease regression, persistence, and progression in women with complex endometrial hyperplasia and stage I endometrial carcinoma treated with a levonorgestrel-releasing-intrauterine system or oral progesterone. METHODS: Records of all patients who received progestin therapy for endometrial hyperplasia or early-stage endometrioid cancer between January 1999 and July 2011 were reviewed. Demographic data (age, body mass index), presentation, treatment modality and rationale, rates of response, recurrence, and salvage surgery were collected and compared using Student's t and χ tests. Fertility outcomes when available were analyzed. RESULTS: One hundred eighty-six women received primary hormone therapy for endometrial hyperplasia or cancer. Of these, 153 had adequate follow-up without surgery or radiation as part of primary treatment. Average age at diagnosis was 49.6 years (range 22-92 years). The most common reasons cited for hormone therapy were medical comorbidities (46%) and fertility (21%). Patients with hyperplasia compared with cancer had significantly different complete response (66-70% compared with 6-13%), initial response with recurrence (11-23% compared with 19-30%), and no response rates (11-19% compared with 57-75%), respectively (P<.001). Outcomes were not significantly different between the levonorgestrel-releasing intrauterine system and oral progesterone among patients with cancer at all time points. In patients with hyperplasia, outcomes were not significantly different except during the 9-month to 12-month assessment where those who received systemic hormones were less likely to have disease persistence or progression compared with patients who had levonorgestrel-releasing intrauterine systems. Three patients achieved pregnancy. CONCLUSIONS: Hormone therapy has varied response rates among women with endometrial hyperplasia or cancer who do not undergo surgery. Close patient monitoring remains paramount given the high recurrence and high percentage of patients who will not respond.

A phase II study of modified dose-dense paclitaxel and every 4-week carboplatin for the treatment of advanced-stage primary epithelial ovarian, fallopian tube, or peritoneal carcinoma.

PURPOSE: Traditional dose-dense chemotherapy regimens for advanced stage ovarian cancer incorporate weekly paclitaxel on a 21-day cycle and are associated with favorable efficacy but high rates of neutropenia, thrombocytopenia, and anemia. The purpose of this phase II study was to assess the response rate and toxicity of modified dose-dense paclitaxel and every 4-week carboplatin for the treatment of advanced-stage ovarian, fallopian tube, and primary peritoneal carcinoma. METHODS: All eligible patients were treated with 6 cycles of intravenous dose-dense paclitaxel (80 mg/m²) days 1, 8, and 15 and carboplatin (AUC 5 or 6) Day 1 during a 28-day cycle in accordance with an IRB-approved protocol. Patients who had clinically defined stable disease or better with a CA-125 ≤ 35 U/ml following the completion of primary induction therapy were subsequently administered a planned 12 cycles of paclitaxel (135 mg/m²; every 21 days) consolidation therapy. RESULTS: Eighty-eight patients received at least 3 cycles of induction dose-dense chemotherapy, of whom 76 completed 6 cycles of chemotherapy; the overall response rate was 84.2 % (56.6 % complete response). Fifty-three patients received an aggregate 473 cycles (median = 9; range 1-12) of consolidation chemotherapy. Grade 3-4 hematological toxicity included neutropenia (22.7 %), thrombocytopenia (7.9 %), and anemia (1.1 %). Further, grade 3 neuropathy developed in one (1.1 %) patient. The patients' median disease-free survival and overall survival were 22.5 and 31.5 months, respectively. CONCLUSIONS: This phase II study suggests that first-line treatment comprising modified dose-dense paclitaxel and monthly carboplatin chemotherapy with paclitaxel consolidation therapy preserves the efficacy of traditional dose-dense chemotherapy, while minimizing hematologic toxicity.

Increased incidence of severe gastrointestinal events with first-line paclitaxel, carboplatin, and vorinostat chemotherapy for advanced-stage epithelial ovarian, primary peritoneal, and fallopian tube cancer.

OBJECTIVES: We sought to assess the response rate and toxicity of paclitaxel, carboplatin, andvorinostat primary induction therapy for the treatment of advanced-stage ovarian carcinoma. METHODS: Patients were treated with 6 cycles of weekly paclitaxel (80 mg/m), carboplatin (6 times area under the curve), and vorinostat (200 mg) every 28 days according to an institutional review board-approved protocol. The subjects were eligible for response evaluation; in patients who achieved stable disease or better following the conclusion of primary induction chemotherapy, they were subsequently treated with a planned 12 cycles of paclitaxel (135 mg/m) and vorinostat (400 mg) maintenance chemotherapy every 28 days. RESULTS: Eighteen patients received a combined 90 cycles (median, 6 cycles; range, 1-6 cycles) of primary induction chemotherapy. Of the 18 subjects, 7 demonstrated a complete response, and 2 subjects exhibited a partial response (a total response rate of 50.0%). Eight patients also received a combined total of 50 cycles (median, 5 cycles; range, 1-12 cycles) of consolidation therapy. Grade 3/4 neutropenia and thrombocytopenia were observed in 9 (56.3%) and 2 (12.5%) patients. One patient (6.3%) developed grade 3 anemia, and another (6.3%) manifested a grade 3 neuropathy. Remarkably, we observed a significant gastrointestinal event (eg, bowel anastomotic perforation) in 3 patients, which effectuated the study's closure. CONCLUSIONS: Because the current study was prematurely terminated, we cannot derive a conclusive assessment regarding the efficacy of this treatment. Nevertheless, the high incidence of severe gastrointestinal toxicity warrants further consideration when using vorinostat in the adjuvant setting for patients who have undergone a bowel resection as part of their initial tumor debulking.

Robotic-assisted surgery for the treatment of pelvic masses in pregnant patients: a series of four cases and literature review.

The purpose of this study was to assess the safety and feasibility of robotic-assisted surgery for the treatment of a pelvic mass in gravid patients. We retrospectively reviewed the charts of all pregnant women who were diagnosed with a pelvic mass by individual obstetric physicians and referred to our gynecologic oncology service from January 2009 until March 2012; four patients were identified and treated with robotic-assisted surgery by the same group of gynecologic oncologists. The following patient data were collected: age, disease origin, histology, tumor size, gravid status at surgery, surgical procedure, intra- and postoperative surgical complications, and both maternal and fetal outcomes. The gynecologic lesions comprised an immature teratoma, a mucinous cystadenoma, a hemorrhagic cyst and an ovarian endometrioma; in each case, blood loss was minimal and no maternal or fetal intra-operative complications were encountered. All patients had normal, spontaneous vaginal deliveries at term. Robotic-assisted surgery for the treatment of pelvic masses in pregnant patients is ostensibly feasible and associated with favorable outcomes for both the patient and fetus.