Current Quality of Gynecologic Cancer Care in North America.

Evaluating the quality of care received by gynecologic cancer patients in the real world is essential for excellent outcomes. The recent population-based literature looking at quality of care was reviewed for all gynecologic malignancies. Outcomes are generally highest when care is provided by high-volume providers in high-volume cancer centers. Provision of care according to clinical practice guidelines has also been demonstrated to improve outcomes in many situations. Disparities exist for marginalized groups in terms of the care they receive and subsequent outcomes. Health systems need to improve care for these populations.

An organizational guideline for gynecologic oncology services.

OBJECTIVES: Documented variations in practice compelled the need to establish a network that would facilitate the flow of patients through the care continuum of a provincial health care system in accordance with best practices. Therefore, a guideline was developed to provide recommendations for the optimal organization of gynecologic oncology services in this higher resource location to improve access to multidisciplinary care and appropriate treatment. METHODS: A systematic review was conducted of Web sites of international guideline developers, relevant cancer agencies, and Medline and EMBASE from 1996 to 2011 using search terms related to gynecologic malignancies, combined with organization of services, patterns of care, and various facility and physician characteristics. The results of the review were combined with expert consensus and stakeholder consultation to develop a gynecologic oncology services organizational guideline. RESULTS: The evidence review yielded a lower quality evidence base; therefore, recommendations were determined through consensus, including guidance for physician and hospital specialization, and other domains including human and physical resources. Definitive surgical treatment of most invasive cancers by subspecialist gynecologic oncologists is recommended. In addition, it is recommended that these subspecialists provide care within designated gynecologic oncology centers. The recommendations also outline which services, such as radiation therapy, may be provided in other affiliated centers. Multidisciplinary team management is also endorsed. CONCLUSIONS: These recommendations are intended to allow a collaborative community of practice, supported by formal interorganizational processes, to evolve to facilitate adherence to guidelines and best practices at a system-wide level.

Management of advanced or recurrent cervical cancer: chemotherapy and beyond.

Metastatic or recurrent cervical cancer has a survival duration of approximately 12 months. Thus, we review the outcomes of chemotherapy and/or novel agents for women who present in this situation. Included were studies in women with advanced or recurrent cervical cancer where at least response rate, survival or toxicity were reported. Platinum alone chemotherapy at 50 mg/m(2) is superior to other single-agent platinum or nonplatinum regimens in terms of efficacy and toxicity profile. Platinum with either paclitaxel, gemcitibine, topotecan or vinorelbine has equivalent efficacy but differ with respect to toxicity profile and convenience of treatment regimen. Bevacizumab in addition to combination chemotherapy provides a duration of survival that is 3.7 months longer than that provided by combination chemotherapy alone. EGF receptor (EGFR) tyrosine kinase inhibitor agents did not provide promising efficacy. Bevacizumab in addition to combination chemotherapy provides superior efficacy with acceptable toxicity. Evaluation of other novel targeted antiangiogenic agents, either alone or in combination with chemotherapy is ongoing.

Dalteparin low molecular weight heparin (LMWH) in ovarian cancer: a phase II randomized study.

OBJECTIVE: Low molecular weight heparin reduces the risk of venous thromboembolism (VTE) and may have antineoplastic effects by interfering with angiogenesis and with tumor growth and metastasis. A multicentre phase II randomized trial was done to evaluate the antineoplastic potential of dalteparin in ovarian cancer (OC). MATERIALS AND METHODS: Women with newly-diagnosed epithelial OC were randomized to receive standard chemotherapy (CT) and one of 3 doses of dalteparin (50 IU/kg, 100 IU/kg, or 150 IU/kg) subcutaneously once daily during the first 3 of 6 cycles of 3-weekly CT. Blood was drawn on day 1 of each cycle for CA125 and, in a substudy of randomized patients, for markers of coagulation activation and angiogenesis. The primary outcome was tumor response defined by ≥ 50% reduction in serum CA125 from baseline sustained for at least 28 days. Patients were followed until the end of CT. RESULTS: The study was terminated early due to poor recruitment. Seventy-seven women were evaluable for the primary outcome. A 50% drop in CA125 at the end of cycle 3 was seen in 85% of the 50 IU/kg group, 92% of the 100 IU/kg group, and 85% of the 150 IU/kg group. There were no symptomatic VTE or major bleeding events while on dalteparin. Two patients experienced VTE several days after discontinuing study drug. Women on dalteparin had lower levels of D-dimer and thrombin-antithrombin, and higher levels of tissue factor pathway inhibitor, relative to baseline. CONCLUSION: Dalteparin is safe and well tolerated in women receiving CT for newly-diagnosed epithelial OC. A dose-response effect was not identified. The lack of control group precluded any inference on the antineoplastic effect of dalteparin.

Surgical management of a suspicious adnexal mass: a systematic review.

OBJECTIVE: To systematically review the existing literature in order to determine the optimal recommended protocols for the surgical management of adnexal masses suspicious for apparent early stage malignancy. METHODS: A review of all systematic reviews and guidelines published between 1999 and 2009 was conducted as a first step. After the identification of two systematic reviews on the topic, searches of MEDLINE for studies published since 2004 were also conducted to update and supplement the evidentiary base. RESULTS: The updated literature search identified 31 studies that met the inclusion criteria. A bivariate random effects analysis of 15 frozen section diagnosis studies yielded an overall sensitivity of 89.2% (95% CI, 86.3 to 91.5%) and specificity of 97.9% (95% CI, 96.6 to 98.7%). The surgical evidence suggests that systematic lymphadenectomy and proper surgical staging improve survival. Conservative fertility-preserving surgical approaches are an acceptable option in women with low malignant potential tumours. The accuracy and the adequacy of surgical staging by laparotomy or laparoscopic approaches appear to be comparable, with neither approach conferring a survival advantage. Intraoperative tumour rupture was indeed reported to occur more frequently in patients undergoing laparoscopy versus laparotomy in two retrospective cohort studies. CONCLUSIONS: The best available evidence was collected and included in this rigorous systematic review. The abundant evidentiary base provided the context and direction for the surgical management of adnexal masses suspicious for apparent early stage malignancy.

Preoperative identification of a suspicious adnexal mass: a systematic review and meta-analysis.

OBJECTIVE: To systematically review the existing literature in order to determine the optimal strategy for preoperative identification of the adnexal mass suspicious for ovarian cancer. METHODS: A review of all systematic reviews and guidelines published between 1999 and 2009 was conducted as a first step. After the identification of a 2004 AHRQ systematic review on the topic, searches of MEDLINE for studies published since 2004 was also conducted to update and supplement the evidentiary base. A bivariate, random-effects meta-regression model was used to produce summary estimates of sensitivity and specificity and to plot summary ROC curves with 95% confidence regions. RESULTS: Four meta-analyses and 53 primary studies were included in this review. The diagnostic performance of each technology was compared and contrasted based on the summary data on sensitivity and specificity obtained from the meta-analysis. Results suggest that 3D ultrasonography has both a higher sensitivity and specificity when compared to 2D ultrasound. Established morphological scoring systems also performed with respectable sensitivity and specificity, each with equivalent diagnostic competence. Explicit scoring systems did not perform as well as other diagnostic testing methods. Assessment of an adnexal mass by colour Doppler technology was neither as sensitive nor as specific as simple ultrasonography. Of the three imaging modalities considered, MRI appeared to perform the best, although results were not statistically different from CT. PET did not perform as well as either MRI or CT. The measurement of the CA-125 tumour marker appears to be less reliable than do other available assessment methods. CONCLUSION: The best available evidence was collected and included in this rigorous systematic review and meta-analysis. The abundant evidentiary base provided the context and direction for the diagnosis of early-staged ovarian cancer.

Teaching cervical cancer surgery in low- or middle-resource countries.

BACKGROUND: With the widespread implementation of screening programs internationally, there will be an increase in early stage cervical cancer cases. In response to this, the Ministry of Health in each country will need to plan strategies to provide care such as radical surgery or radiation for this potentially curable group of women. METHODS: The Gynaecologic Oncologists of Canada created a teaching module to intensively train a small number of locally identified gynecologists to perform radical hysterectomy and pelvic lymphadenectomy. The process was based on adult learning principles; it involved a Canadian gynecologic oncologist working in the low- or middle-resource country with the gynecologists and problem-solving local issues in health care delivery. RESULTS: The teaching process included a pretest and a posttest on the basis of the objectives of the module. There were 7 modules including preoperative evaluation of the patient, cone biopsy, radical hysterectomy, pelvic lymphadenectomy, ureteric injury, vascular injury, and follow-up after surgery. Each module was divided into background information, techniques, and complications. There were video clips imbedded in the modules. After the educational modules had been reviewed, the learners were walked through the surgical procedures repeatedly including a detailed assessment of performance after each case. Participants had the opportunity to provide feedback on the training program. The module was reviewed in Mongolia and implemented in Kenya. CONCLUSIONS: In low- and middle-resource countries where there is an urgent need to provide a curative surgical option for the management of early cervical cancer, a focused high-intensity curriculum delivered by a trained surgeon can translate into immediate change in clinical and surgical practice.

Surgical outcomes in women with ovarian cancer.

OBJECTIVE: We sought to assess whether the specialty of the surgeon or the hospital involved in the initial management of women with ovarian cancer determined the likelihood of unnecessary repeated abdominal surgery and long-term patient survival. METHODS: We conducted a population-based study involving women in Ontario, Canada, who had epithelial ovarian cancer treated initially with abdominal surgery between January 1996 and December 1998. We documented incident surgical cases using hospital contact data and the Ontario Cancer Registry. We obtained data on patient characteristics, clinical findings, surgical techniques and perioperative care from electronic administrative data records and patient charts. We performed regression analyses to assess the influence of surgeon and hospital specialization and of case volumes on the likelihood of repeat surgery and survival. We controlled for stage of disease and other factors associated with these outcomes. We also examined the relation between the adequacy of surgery and adjuvant chemotherapy with survival. RESULTS: A total of 1341 women met our inclusion criteria. Our analysis showed that repeat surgery was associated with the surgeon's discipline, younger patient age, well-differentiated tumours and early stage of disease. However, survival was not associated with the surgeon's discipline; rather, it was associated with advanced patient age, increasing comorbidities, advanced stage of disease, poorly differentiated tumours, urgent surgery and adjuvant chemotherapy. We observed a trend between inadequate surgery and a decreased likelihood of survival. CONCLUSION: Further study is needed to understand patterns of repeat surgery for ovarian cancer. Improved quality of operative reporting is required to classify surgical adequacy.

Evaluation of postoperative pain control for women undergoing surgery for gynaecologic malignancies.

OBJECTIVES: (1) To compare the benefits of epidural analgesia and patient-controlled analgesia (PCA) in the management of postoperative pain in women with gynaecologic malignancies,and (2) to understand issues related to the delivery of pain control strategies. METHODS: A retrospective cohort study, based on chart review, was conducted of all women with gynaecologic malignancies who received either PCA or epidural analgesia at the Henderson Division of Hamilton Health Sciences, Hamilton, Ontario, from May 20, 1999, to July 17, 2001. Both objective (i.e., daily pain scores) and subjective (i.e., nursing progress notes) concerns were captured in the data collection instrument. RESULTS: Ninety-seven women had PCA and 122 had epidural analgesia as their primary form of postoperative analgesia. Pain scores were excellent (<2, range 0-10) in both groups. The nausea score was superior for the epidural group. Twenty percent of women experienced motor blocks and 17% had sensory blocks, which impeded their ability to walk for the first 3 days after surgery. Pruritus, rash, and Benadryl use were seen in more than 20% of the epidural group. Prolonged catheterization and a 3-fold increased risk of urinary tract infections were seen in the epidural group. Epidural catheter leaks occurred in 12.3% of the women on epidural analgesia. CONCLUSIONS: Postoperative pain management was excellent both in women who received PCA and in those who received epidural analgesia. Problems related to the delivery of pain control were more common in the epidural group.

Pitfalls in the diagnosis of cervical intraepithelial neoplasia 1.

OBJECTIVE: This review article outlines the issues involved in (1) the cytologic diagnosis of low-grade squamous intra-epithelial lesion (cervical intraepithelial neoplasia [CIN] 1), (2) histologic diagnosis of CIN 1, (3) the advantages and disadvantages of various management strategies for CIN 1 confirmed by biopsy, and (4) the evolving technology that may be useful for predicting the course of the disease. MATERIALS AND METHODS: A MEDLINE search was conducted using the search terms cervical intraepithelial neoplasia, low-grade dysplasia, mild dysplasia, low-risk squamous intraepithelial lesion, mild dyskaryosis, HPV, colposcopy, histology, and cytology. RESULTS.: Using a loop electrosurgical excision procedure or cone biopsy assessment of the cervix as the gold standard, a cytologic assessment of CIN 1 alone results in a high false-positive rate (51.5%) and a false-negative rate (24%) for CIN 3. The appropriate second test after low-grade squamous intraepithelial lesion (CIN 1) cytologic results includes repeat cervical cytologic analysis. Subsequent human papillomavirus testing provides no advantage and increases the cost of care. Immediate referral to colposcopy is costly but minimizes the percent of women lost to follow-up. Using a loop electrosurgical excision procedure or cone biopsy assessment of the cervix as the gold standard, the colposcopically directed biopsy may give a false-positive result (11.7%) or false-negative result (up to 31%) for CIN 3. One contributing issue is the moderate interobserver reliability of histologic analysis (kappa= 0.46). There are advantages and disadvantages to both the immediate and expectant management strategies. The most crucial concern for immediate treatment is overtreatment, and that for expectant management the high rate of patients lost to follow-up. Novel technologies, including MIB-1, p16(INK)4a, and genetic assessments, may be helpful in predicting those CIN 1 lesions destined to progress or to persist. CONCLUSIONS: The cytologic and histologic diagnosis of CIN 1 is fraught with problems related to the subjectivity of the diagnosis. Both management options are also fraught with concerns. Any technique that can better predict disease course would be an advantage to the care of women with this abnormality.