HIPEC after neoadjuvant chemotherapy is associated with acceptable toxicity and favorable quality of life in newly diagnosed advanced ovarian cancer patients.

OBJECTIVE: To evaluate toxicity, quality of life and PFS in patients with advanced ovarian cancer who underwent neoadjuvant chemotherapy (NAC) followed by CRS and HIPEC with carboplatin. METHODS: Patients with stage IIIC or IVA epithelial ovarian cancer, who were not candidates for primary CRS, were enrolled in this phase two trial. Patients received 3-6 cycles of NAC with an IV carboplatin doublet followed by CRS with HIPEC (carboplatin 800 mg/m2 for 90 min). They were followed for at least 12 months to assess for adverse events, quality of life (QOL) and disease progression. QOL was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaires prior to CRS and post-operatively at 6 weeks, 3 months, and 6 months after CRS. RESULTS: Twenty patients were enrolled. HIPEC was completed successfully in all twenty patients, and there was no peri-operative mortality. Twelve (70.6%) patients experienced a grade 3 or 4 toxicity; most commonly anemia (59%), thrombocytopenia (29%), and hypokalemia (24%). There was no significant change between the pre-operative and postoperative 6 weeks, 3 month, and 6 month FACT-O, NTX, and AD scores. Nine (45%) patients have experienced disease recurrence to date. The median progression free survival in this cohort is 11.2 months (2.5-23.7 months). CONCLUSION: The addition of HIPEC with carboplatin to interval CRS was well tolerated in patient population. Myelosuppression was the most common adverse event. CRS with HIPEC did not adversely impact these patients' QOL indices. The efficacy of this regimen should be further evaluated in a larger clinical trial.

Comparing Surgical Experience and Skill Using a High-Fidelity, Total Laparoscopic Hysterectomy Model.

OBJECTIVE: To evaluate differences in standardized scores and surgical confidence in the completion of a standardized total laparoscopic hysterectomy and bilateral salpingo-oophorectomy (TLH-BSO) among obstetrician-gynecologists (ob-gyns) with different levels of training, and to assess a TLH-BSO model for validity. METHODS: We conducted a prospective cohort study of 68 participants within four categories of ob-gyns: 1) graduating or recently graduated residents (n=18), 2) minimally invasive gynecologic surgery graduating or recently graduated fellows (n=16), 3) specialists in general obstetrics and gynecology (n=15), and 4) fellowship-trained minimally invasive gynecologic surgery subspecialists (n=19) who completed a TLH-BSO simulation. Participants completed presimulation questionnaires assessing laparoscopic confidence. Participants performed a video-recorded TLH-BSO and contained specimen removal on a standardized 250-g biological model in a simulated operating room and completed a postsimulation questionnaire. RESULTS: Randomized videos were scored by blinded experts using the validated OSATS (Objective Structured Assessment of Technical Skills). The surgery was divided into five standardized segments: 1) adnexa, 2) dissection and pedicles, 3) colpotomy, 4) cuff closure, and 5) tissue extraction. Minimally invasive gynecologic surgery subspecialists averaging 8.9 years in practice scored highest in all categories (overall median score 91%, P<.001), followed by fellows (64%, P<.001), specialists in obstetrics and gynecology averaging 19.7 years in practice (63%, P<.001), and residents (56%, P<.001). Residents, fellows and specialists in obstetrics and gynecology were comparable overall. Fellows scored higher on cuff closure (63% vs 50%, P<.03) and tissue extraction (77% vs 60%, P<.009) compared with specialists in obstetrics and gynecology. Minimally invasive gynecologic surgery subspecialists were fastest overall and on each individual component. Residents were slowest in almost all categories. CONCLUSION: When performing a TLH-BSO of a standardized 250-g uterus on a simulation model, fellowship-trained minimally invasive gynecologic surgery subspecialists achieved higher OSATS in all areas and completed all components faster. Similar performances were noted between residents, fellows, and specialists in obstetrics and gynecology in practice an average of 19.7 years. FUNDING SOURCE: Support from Applied Medical, Medtronic, CooperSurgical, and Karl Storz in the form of in-kind equipment was obtained through unrestricted educational grants.