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1.
Curr Oncol ; 24(6): e540-e546, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29270064

ABSTRACT

OBJECTIVE: The purpose of this guideline is to recommend systemic therapy options for women with recurrent epithelial ovarian cancer, including fallopian tube and primary peritoneal cancers. METHODS: This document updates the recommendations published in the 2011 Optimal Chemotherapy for Recurrent Ovarian Cancer guideline from Cancer Care Ontario. Draft recommendations were formulated based on evidence obtained through a systematic review of phase ii and iii randomized controlled trials (rcts). The draft recommendations underwent internal review by clinical and methodology experts, and external review by clinical practitioners through a survey assessing the clinical relevance and overall quality of the guideline. Feedback from the internal and external reviews was integrated into the clinical practice guideline. RESULTS: The primary literature search yielded thirty-six primary research papers representing thirty rcts that met the eligibility criteria. The guideline provides recommendations for patients with serous tumour histologies and with recurrent, platinum-resistant, and platinum-sensitive ovarian cancer. CONCLUSIONS: The body of evidence from trials that included olaparib and bevacizumab consistently shows a benefit in progression-free survival (pfs) without a corresponding benefit in overall survival (os). The Working Group for this guideline designated pfs, which is associated with symptom control, as a critical outcome. A finding of net benefit can therefore be concluded based on significant differences in pfs. However, that benefit is not without identified harms. Given the identified harms, patient involvement in the decision-making process must take into consideration the side effect profiles of olaparib and bevacizumab within the context of improved pfs but minimal change in os.

2.
Curr Oncol ; 23(5): 343-350, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27803599

ABSTRACT

BACKGROUND: A need for follow-up recommendations for survivors of fallopian tube, primary peritoneal, or epithelial ovarian cancer after completion of primary treatment was identified by Cancer Care Ontario's Program in Evidence-Based Care. METHODS: We searched for existing guidelines, conducted a systematic review (medline, embase, and cdsr, January 2010 to March 2015), created draft recommendations, and completed a comprehensive review process. Outcomes included overall survival, quality of life, and patient preferences. RESULTS: The Cancer Australia guidance document Follow Up of Women with Epithelial Ovarian Cancer was adapted for the Ontario context. A key randomized controlled trial found that the overall survival rate did not differ between asymptomatic women who received early treatment based on elevated serum cancer antigen 125 (ca125) alone and women who waited for the appearance of clinical symptoms before initiating treatment (hazard ratio: 0.98; 95% confidence interval: 0.80 to 1.20; p = 0.85); in addition, patients in the delayed treatment group reported good global health scores for longer. No randomized studies were found for other types of follow-up. We recommend that survivors be made aware of the potential harms and benefits of surveillance, including a discussion of the limitations of ca125 testing. Women could be offered the option of no formal follow-up or a follow-up schedule that is agreed upon by the woman and her health care provider. Education about the most common symptoms of recurrence should be provided. Alternative models of care such as nurse-led or telephone-based follow-up (or both) could be emerging options. CONCLUSIONS: The recommendations provided in this guidance document have a limited evidence base. Recommendations should be updated as further information becomes available.

3.
Curr Oncol ; 23(2): 109-18, 2016 Apr.
Article in English | MEDLINE | ID: mdl-27122975

ABSTRACT

BACKGROUND: In 2009, the Program in Evidence-based Care (pebc) of Cancer Care Ontario published a guideline on the follow-up of cervical cancer. In 2014, the pebc undertook an update of the systematic review and clinical practice guideline for women in this target population. METHODS: The literature from 2007 to August 2014 was searched using medline and embase [extended to 2000 for studies of human papillomavirus (hpv) dna testing]. Outcomes of interest were measures of survival, diagnostic accuracy, and quality of life. A working group evaluated the need for changes to the earlier guidelines and incorporated comments and feedback from internal and external reviewers. RESULTS: One systematic review and six individual studies were included. The working group concluded that the new evidence did not warrant changes to the 2009 recommendations, although hpv dna testing was added as a potentially more sensitive method of detecting recurrence in patients treated with radiotherapy. Comments from internal and external reviewers were incorporated. RECOMMENDATIONS SUMMARY: Follow-up care after primary treatment should be conducted and coordinated by a physician experienced in the surveillance of cancer patients. A reasonable follow-up strategy involves visits every 3-4 months within the first 2 years, and every 6-12 months during years 3-5. Visits should include a patient history and complete physical examination, with elicitation of relevant symptoms. Vaginal vault cytology examination should not be performed more frequently than annually. Combined positron-emission tomography and computed tomography, other imaging, and biomarker evaluation are not advocated; hpv dna testing could be useful as a method of detection of recurrence after radiotherapy. General recommendations for follow-up after 5 years are also provided.

4.
Curr Oncol ; 22(4): 287-96, 2015 Aug.
Article in English | MEDLINE | ID: mdl-26300667

ABSTRACT

OBJECTIVE: The purpose of this guideline is to help ensure the provision of high-quality colposcopy practices in the province of Ontario, including those conducted as diagnostic procedures in follow-up to an abnormal cervical screening test. METHODS: This document updates the recommendations published in the 2008 colposcopy guideline from Cancer Care Ontario, The Optimum Organization for the Delivery of Colposcopy Service in Ontario. A systematic review of guidelines was conducted to evaluate the existing evidence and recommendations concerning these key aspects of colposcopy: □ Training, qualification, accreditation, and maintenance of competence□ Practice setting requirements□ Operational practice□ Quality indicators and outcomes. RESULTS: This guideline provides recommendations on training and maintenance of competence for colposcopists in the practice settings in which colposcopic evaluation and treatments are conducted. It also provides recommendations on operational issues and quality indicators for colposcopy. CONCLUSIONS: This updated guideline is intended to support quality improvement for colposcopy for all indications, including the follow-up of an abnormal cervical screening test and work-up for lower genital tract lesions that are not clearly malignant. The recommendations contained in this document are intended for clinicians and institutions performing colposcopy in Ontario, and for policymakers and program planners involved in the delivery of colposcopy services.

5.
Curr Oncol ; 22(4): e282-93, 2015 Aug.
Article in English | MEDLINE | ID: mdl-26300679

ABSTRACT

BACKGROUND: A system-level organizational guideline for gynecologic oncology was identified by a provincial cancer agency as a key priority based on input from stakeholders, data showing more limited availability of multidisciplinary or specialist care in lower-volume than in higher-volume hospitals in the relevant jurisdiction, and variable rates of staging for ovarian and endometrial cancer patients. METHODS: A systematic review assessed the relationship of the organization of gynecologic oncology services with patient survival and surgical outcomes. The electronic databases medline and embase (ovid: 1996 through 9 January 2015) were searched using terms related to gynecologic malignancies combined with organization of services, patterns of care, and various facility and physician characteristics. Outcomes of interest included overall or disease-specific survival, short-term survival, adequate staging, and degree of cytoreduction or optimal cytoreduction (or both) for ovarian cancer patients by hospital or physician type, and rate of discrepancy in initial diagnoses and intraoperative consultation between non-specialist pathologists and gyne-oncology-specialist pathologists. RESULTS: One systematic review and sixteen additional primary studies met the inclusion criteria. The evidence base as a whole was judged to be of lower quality; however, a trend toward improved outcomes with centralization of gynecologic oncology was found, particularly with respect to the gynecologic oncology care of patients with advanced-stage ovarian cancer. CONCLUSIONS: Improvements in outcomes with centralization of gynecologic oncology services can be attributed to a number of factors, including access to specialist care and multidisciplinary team management. Findings of this systematic review should be used with caution because of the limitations of the evidence base; however, an expert consensus process made it possible to create recommendations for implementation.

6.
Curr Oncol ; 22(3): 211-9, 2015 Jun.
Article in English | MEDLINE | ID: mdl-26089720

ABSTRACT

BACKGROUND: Systemic therapy options are needed for women with recurrent, metastatic, or persistent cervical cancer. This systematic review and clinical practice guideline were developed to address that need, and to update a 2007 guideline from Cancer Care Ontario's Program in Evidence-Based Care. METHODS: The literature between 2006 and April 2014 in the medline and embase databases, the Cochrane Database of Systematic Reviews (Issue 4, 2014), the Cochrane Central Register of Controlled Trials (Issue 3, 2014), relevant guideline databases, and conference proceedings of the American Society of Clinical Oncology (2007-2013) was searched. A working group developed draft guidelines and incorporated comments and feedback from internal and external reviewers. RESULTS: Four phase iii randomized controlled trials met the inclusion criteria for the review and provided the basis for draft recommendations. Feedback was obtained from Ontario practitioners and others abroad, which led to modifications to the draft recommendations. Three key recommendations were developed. CONCLUSIONS: The working group concluded that all patients should be offered the opportunity to participate in appropriate randomized clinical trials. Cisplatin-paclitaxel, cisplatin-vinorelbine, cisplatin-gemcitabine, and cisplatin-topotecan are recommended combinations for this patient population. The substitution of carboplatin for cisplatin in the foregoing combinations can also be recommended because carboplatin is associated with fewer adverse effects and greater ease of administration. Selection of combination chemotherapy will depend on the toxicity profile, patient preference, and other factors. Finally, bevacizumab in combination with cisplatin-paclitaxel or carboplatin-paclitaxel is recommended for a specific subset of the target population as outlined in Gynecologic Oncology Group study 0240.

8.
Gynecol Oncol ; 128(1): 95-100, 2013 Jan.
Article in English | MEDLINE | ID: mdl-23085459

ABSTRACT

INTRODUCTION: A cervical cytology based screening program is effective if there is regular screening of the 'at risk' population and close follow-up of those labeled abnormal. METHODS: This is a population cohort study of women between 20-69 year old who were eligible in Ontario from 2008-2010. We used administrative data to evaluate the rates of cervical cancer screening and follow-up of high grade Pap tests. Variation in cervical cytology coverage and follow-up of high grade abnormal results are associated with age, area level income and health region. Multivariate logistic regression was used to identify independent factors associated with screening and followup. RESULTS: 3.7million women were eligible for screening of which 72% had a Pap smear in the prior 3years. These rates varied by age, income and region (p<0.0001). Women residing in the lowest income neighborhoods were half as likely to be screened (p<0.0001). 83% of those with an high grade intraepithelial lesion Pap test result had follow-up with colposcopy or treatment within 6months and this varied by year, age, income and region (p<0.0001). CONCLUSIONS: Despite universal health coverage, cervical cancer screening rates are suboptimal with older and low income women being at greatest risk. Follow-up among women with high grade abnormal tests is mediocre at 3months and acceptable at 6months. Novel models of cervical cancer screening program implementation are needed to address these inadequacies.


Subject(s)
Early Detection of Cancer/statistics & numerical data , Papanicolaou Test , Uterine Cervical Neoplasms/diagnosis , Vaginal Smears/statistics & numerical data , Adult , Age Factors , Aged , Cohort Studies , Colposcopy , Female , Follow-Up Studies , Humans , Logistic Models , Middle Aged , Retrospective Studies , Uterine Cervical Neoplasms/pathology
9.
Curr Oncol ; 19(4): e244-57, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22876153

ABSTRACT

QUESTIONS: What is the optimal strategy for preoperative identification of the adnexal mass suspicious for ovarian cancer? What is the most appropriate surgical procedure for a woman who presents with an adnexal mass suspicious for malignancy? PERSPECTIVES: In Canada in 2010, 2600 new cases of ovarian cancer were estimated to have been diagnosed, and of those patients, 1750 were estimated to have died, making ovarian cancer the 7th most prevalent form of cancer and the 5th leading cause of cancer death in Canadian women. Women with ovarian cancer typically have subtle, nonspecific symptoms such as abdominal pain, bloating, changes in bowel frequency, and urinary or pelvic symptoms, making early detection difficult. Thus, most ovarian cancer cases are diagnosed at an advanced stage, when the cancer has spread outside the pelvis. Because of late diagnosis, the 5-year relative survival ratio for ovarian cancer in Canada is only 40%. Unfortunately, because of the low positive predictive value of potential screening tests (cancer antigen 125 and ultrasonography), there is currently no screening strategy for ovarian cancer. The purpose of this document is to identify evidence that would inform optimal recommended protocols for the identification and surgical management of adnexal masses suspicious for malignancy. OUTCOMES: Outcomes of interest for the identification question included sensitivity and specificity. Outcomes of interest for the surgical question included optimal surgery, overall survival, progression-free or disease-free survival, reduction in the number of surgeries, morbidity, adverse events, and quality of life. METHODOLOGY: After a systematic review, a practice guideline containing clinical recommendations relevant to patients in Ontario was drafted. The practice guideline was reviewed and approved by the Gynecology Disease Site Group and the Report Approval Panel of the Program in Evidence-based Care. External review by Ontario practitioners was obtained through a survey, the results of which were incorporated into the practice guideline. PRACTICE GUIDELINE: These recommendations apply to adult women presenting with a suspicious adnexal mass, either symptomatic or asymptomatic. IDENTIFICATION OF AN ADNEXAL MASS SUSPICIOUS FOR OVARIAN CANCER: Sonography (particularly 3-dimensional sonography), magnetic resonance imaging (mri), and computed tomography (ct) imaging are each recommended for differentiating malignant from benign ovarian masses. However, the working group offers the following further recommendations, based on their expert consensus opinion and a consideration of availability, access, and harm: Where technically feasible, transvaginal sonography should be the modality of first choice in patients with a suspicious isolated ovarian mass.To help clarify malignant potential in patients in whom ultrasonography may be unreliable, mri is the most appropriate test.In cases in which extra-ovarian disease is suspected or needs to be ruled out, ct is the most useful technique.Evaluation of an adnexal mass by Doppler technology alone is not recommended. Doppler technology should be combined with a morphology assessment.Ultrasonography-based morphology scoring systems can be used to differentiate benign from malignant adnexal masses. These scoring systems are based on specific ultrasound parameters, each with several scores base on determined features. All evaluated scoring systems were found to have an acceptable level of sensitivity and specificity; the choice of scoring system may therefore be made based on clinician preference.As a standalone modality, serum cancer antigen 125 is not recommended for distinguishing between benign and malignant adnexal masses.Frozen sections for the intraoperative diagnosis of a suspicious adnexal mass is recommended in settings in which availability and patient preference allow. SURGICAL PROCEDURES FOR AN ADNEXAL MASS SUSPICIOUS FOR MALIGNANCY: To improve survival, comprehensive surgical staging with lymphadenectomy is recommended for the surgical management of patients with early-stage ovarian cancer. Laparoscopy is a reasonable alternative to laparotomy, provided that appropriate surgery and staging can be done. The choice between laparoscopy and laparotomy should be based on patient and clinician preference. Discussion with a gynecologic oncologist is recommended. Fertility-preserving surgery is an acceptable alternative to more extensive surgery in patients with low-malignant-potential tumours and those with well-differentiated surgical stage i ovarian cancer. Discussion with a gynecologic oncologist is recommended.

10.
Ann Oncol ; 23(5): 1185-1189, 2012 May.
Article in English | MEDLINE | ID: mdl-21976386

ABSTRACT

BACKGROUND: To perform a subset analysis of patients with partially platinum-sensitive recurrent ovarian cancer (ROC) who received either CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) in the CALYPSO trial. PATIENTS AND METHODS: CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy. Patients were randomized to CD or CP. Patients with a treatment-free interval of >6 and ≤ 12 months were evaluated for progression-free survival (PFS), the primary end point of CALYPSO trial, and safety. RESULTS: A total of 344 partially platinum-sensitive patients were included (N = 161, CD and N = 183, CP). The hazard ratio for PFS was 0.73 (95% confidence interval: 0.58-0.90; P = 0.004 for superiority) in favor of CD. Median PFS times were 9.4 months (CD) and 8.8 months (CP). Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions. Hand-foot syndrome was more common with CD; however, grade 3/4 reactions were low (one patient in each arm). CONCLUSION: Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.


Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carboplatin/administration & dosage , Doxorubicin/analogs & derivatives , Ovarian Neoplasms/drug therapy , Paclitaxel/administration & dosage , Polyethylene Glycols/administration & dosage , Adenocarcinoma/pathology , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carboplatin/adverse effects , Disease-Free Survival , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Drug Resistance, Neoplasm/drug effects , Female , Humans , Middle Aged , Ovarian Neoplasms/pathology , Paclitaxel/adverse effects , Platinum Compounds/therapeutic use , Polyethylene Glycols/adverse effects , Recurrence , Treatment Outcome , Young Adult
11.
Ann Oncol ; 23(1): 238-244, 2012 Jan.
Article in English | MEDLINE | ID: mdl-21447615

ABSTRACT

BACKGROUND: The purpose of the study was to assess the safety, tolerability, recommended phase II dose (RPTD), and preliminary antitumor activity of the combination of carboplatin-paclitaxel (Taxol)-temsirolimus. MATERIALS AND METHODS: Patients with solid malignancies suitable for carboplatin-paclitaxel (CP) chemotherapy and two or less prior lines of chemotherapy received 15, 20, or 25 mg of temsirolimus per week with CP given every 21 days. Thirty-eight eligible patients were entered into six dose levels with the first two levels administering temsirolimus on days 8 and 15 and the subsequent four dose levels switching to days 1 and 8 temsirolimus administration. RESULTS: Days 8 and 15 administration of temsirolimus was not feasible due to myelosuppression on day 15. CP on day 1 with temsirolimus on days 1 and 8 was well tolerated. Dose-limiting toxicity (DLT) was grade 4 thrombocytopenia (n=2) and grade 3 fatigue (n=1). Relative dose intensities for carboplatin, paclitaxel, and temsirolimus at the RPTD were 92%, 82%, and 56%, respectively. Non-DLT treatment-related adverse events occurring in >20% of patients included fatigue, mucositis, alopecia, neuropathy, nausea, neutropenia, thrombocytopenia, and infection. Grade 3/4 non-hematological toxicity was rare. Partial responses (PRs) and disease stabilization were seen in 46% and 49% of patients, respectively. Nine of 11 (82%) endometrial cancer patients had objective PRs. CONCLUSION: Carboplatin-paclitaxel-temsirolimus is well tolerated and the RPTD is carboplatin area under the curve 5 mg/ml/min, paclitaxel 175 mg/m2, both given on day 1 with temsirolimus 25 mg on days 1 and 8.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Neoplasms/drug therapy , Adult , Aged , Carboplatin/administration & dosage , Carboplatin/adverse effects , Dose-Response Relationship, Drug , Female , Humans , Male , Maximum Tolerated Dose , Middle Aged , Paclitaxel/administration & dosage , Paclitaxel/adverse effects , Sirolimus/administration & dosage , Sirolimus/adverse effects , Sirolimus/analogs & derivatives
12.
Ann Oncol ; 22(11): 2417-2423, 2011 Nov.
Article in English | MEDLINE | ID: mdl-21402619

ABSTRACT

BACKGROUND: CALYPSO (CAeLYx in Platinum Sensitive Ovarian) patients compared carboplatin-pegylated liposomal doxorubicin (C-PLD) with carboplatin-paclitaxel (C-P) in patients with late-relapsing recurrent ovarian cancer (ROC). We analyzed outcomes in patients ≥70 years. PATIENTS AND METHODS: Nine hundred and seventy-six patients with taxane-pretreated ROC relapsing >6 months after first- or second-line platinum-based therapy were randomly assigned to 4-weekly C area under the curve (AUC) 5 plus PLD 30 mg/m(2) or 3-weekly C AUC 5 plus P 175 mg/m(2) for six or more cycles. RESULTS: One hundred and fifty-seven (16%) patients ≥70 years (median: 74 years, C-PLD; 73 years, C-P; range 70-82 years) were included (n = 71, C-PLD; n = 86, C-P). In comparing elderly and younger, elderly patients experienced fewer grade ≥2 allergic reactions (P = 0.005) but more grade ≥2 sensory neuropathy (P = 0.007). Myelosuppression did not differ with age. Elderly patients completed planned treatment as frequently as younger (79%, C-PLD; 82%, C-P). In comparing arms within elderly patients, C-P was associated with more grade ≥2 alopecia, sensory neuropathy, arthralgia/myalgia (P < 0.001 for all), severe leukopenia plus febrile neutropenia; C-PLD was associated with more grade ≥2 hand-foot syndrome (P = 0.005). Median progression-free survival was 11.6 months (C-PLD) and 10.3 months (C-P; P = 0.44). CONCLUSIONS: Patients ≥70 years experienced more neuropathy, with a higher incidence in the C-P arm. Similar to all study patients, C-PLD provided a better therapeutic index with less toxicity than C-P in elderly women with platinum-sensitive ROC.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Neoplasm Recurrence, Local/drug therapy , Ovarian Neoplasms/drug therapy , Age Factors , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carboplatin/administration & dosage , Carboplatin/adverse effects , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Doxorubicin/analogs & derivatives , Female , Humans , Paclitaxel/administration & dosage , Paclitaxel/adverse effects , Polyethylene Glycols/administration & dosage , Polyethylene Glycols/adverse effects , Quality of Life , Treatment Outcome
13.
Gynecol Oncol ; 121(1): 163-8, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21216453

ABSTRACT

OBJECTIVE: Prophylactic salpingo-oophorectomy is recommended to women who carry a BRCA1 or BRCA2 mutation to reduce the risks of breast, ovarian and fallopian tube cancer. We measured the impact of prophylactic salpingo-oophorectomy on menopausal symptoms and sexual functioning in women with a BRCA mutation. METHODS: Women who underwent prophylactic salpingo-oophorectomy between October 1, 2002 and June 26, 2008 for a known BRCA1 or BRCA2 mutation were invited to participate. Participants completed questionnaires before prophylactic surgery and again one year after surgery. Measures of sexual functioning and menopausal symptoms before and after surgery were compared. Satisfaction with the decision to undergo prophylactic salpingo-oophorectomy was evaluated. RESULTS: 114 women who underwent prophylactic surgery completed questionnaires before and one year after surgery. Subjects who were premenopausal at the time of surgery (n=75) experienced a significant worsening of vasomotor symptoms (hot flashes, night sweats and sweating) and a decline in sexual functioning (desire, pleasure, discomfort and habit). The increase in vasomotor symptoms and the decline in sexual functioning were mitigated by HRT, but symptoms did not return to pre-surgical levels. HRT decreased vaginal dryness and dyspareunia; however, the decrease in sexual pleasure was not alleviated by HRT. Satisfaction with the decision to undergo prophylactic salpingo-oophorectomy remained high regardless of increased vasomotor symptoms and decreased sexual function. CONCLUSIONS: Women who undergo prophylactic salpingo-oophorectomy prior to menopause experience an increase in vasomotor symptoms and a decrease in sexual functioning. These symptoms are improved by HRT, but not to pre-surgical levels.


Subject(s)
Fallopian Tube Neoplasms/prevention & control , Genes, BRCA1 , Genes, BRCA2 , Germ-Line Mutation , Ovarian Neoplasms/prevention & control , Ovariectomy , Salpingostomy , Adult , Aged , Fallopian Tube Neoplasms/genetics , Female , Genetic Predisposition to Disease , Hormone Replacement Therapy , Humans , Menopause , Middle Aged , Ovarian Neoplasms/genetics , Patient Satisfaction , Quality of Life , Sexual Dysfunction, Physiological/etiology , Surveys and Questionnaires
14.
J Natl Cancer Inst ; 102(20): 1547-56, 2010 Oct 20.
Article in English | MEDLINE | ID: mdl-20937992

ABSTRACT

BACKGROUND: Topotecan has single-agent activity in recurrent ovarian cancer. It was evaluated in a novel combination compared with standard frontline therapy. METHODS: Women aged 75 years or younger with newly diagnosed stage IIB or greater ovarian cancer, Eastern Cooperative Oncology Group Performance Status of 1 or less, were stratified by type of primary surgery and residual disease, treatment center, and age; then randomly assigned to one of the two 21-day intravenous regimens. Patients in arm 1 (n = 409) were administered four cycles of cisplatin 50 mg/m(2) on day 1 and topotecan 0.75 mg/m(2) on days 1-5, then four cycles of paclitaxel 175 mg/m(2) over 3 hours on day 1 followed by carboplatin (area under the curve = 5) on day 1. Patients in arm 2 (n = 410) were given paclitaxel plus carboplatin as in arm 1 for eight cycles. We compared progression-free survival (PFS), overall survival, and cancer antigen-125 normalization rates in the two treatment arms. A stratified log-rank test was used to assess the primary endpoint, PFS. All statistical tests were two-sided. RESULTS: A total of 819 patients were randomly assigned. At baseline, the median age of the patients was 57 years (range = 28-78); 81% had received debulking surgery, and of these, 55% had less than 1 cm residual disease; 66% of patients were stage III and 388 (47.4%) patients had measurable disease. After a median follow-up of 43 months, 650 patients had disease progression or died without documented progression and 406 had died. Patients in arm 1 had more hematological toxicity and hospitalizations than patients in arm 2; PFS was 14.6 months in arm 1 vs 16.2 months in arm 2 (hazard ratio = 1.10, 95% confidence interval = 0.94 to 1.28, P = .25). Among patients with elevated baseline cancer antigen-125, fewer in arm 1 than in arm 2 had levels return to normal by 3 months after random assignment (51.6% vs 63.3%, P = .007) CONCLUSIONS: Topotecan and cisplatin, followed by carboplatin and paclitaxel, were more toxic than carboplatin and paclitaxel alone, but without improved efficacy. Carboplatin plus paclitaxel remains the standard of care for advanced epithelial ovarian cancer.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma/drug therapy , Ovarian Neoplasms/drug therapy , Adult , Aged , Carboplatin/administration & dosage , Carcinoma/secondary , Cisplatin/administration & dosage , Cisplatin/adverse effects , Disease-Free Survival , Drug Administration Schedule , Drug Resistance, Neoplasm , Female , Humans , Middle Aged , Neoplasm Staging , Odds Ratio , Ovarian Neoplasms/pathology , Paclitaxel/administration & dosage , Topotecan/administration & dosage , Topotecan/adverse effects , Treatment Failure
15.
Curr Oncol ; 17(3): 65-9, 2010 Jun.
Article in English | MEDLINE | ID: mdl-20567627

ABSTRACT

QUESTION: What is the most appropriate follow-up strategy for patients with cervical cancer who are clinically disease-free after receiving primary treatment? PERSPECTIVES: For women with cervical cancer who have been treated with curative intent, follow-up includes identification of complications related to treatment and intervention in the event of recurrent disease. Most women who recur with cervical cancer are not curable; however, early identification of recurrence can alter disease management or treatment-planning options, and for those with a central pelvic recurrence and no evidence of distant disease, there is a potential for cure with additional therapy. Follow-up protocols in this population are variable, using a number of tests at a variety of intervals with questionable outcomes. OUTCOMES: Outcomes of interest included recurrence, survival, and quality of life. METHODOLOGY: The Gynecology Cancer Disease Site Group (DSG) conducted a systematic review of the literature and a narrative review of emerging clinical issues to inform the most appropriate follow-up strategy for patients with cervical cancer. The evidence was insufficient to specify a clinically useful recommended follow-up schedule, and therefore, the expert consensus opinion of the Gynecology Cancer DSG was used to develop recommendations on patient surveillance. The resulting recommendations were reviewed and approved by the Gynecology Cancer DSG and by the Program in Evidence-Based Care Report Approval Panel. An external review by Ontario practitioners completed the final phase of the review process. Feedback from all parties was incorporated to create the final practice guideline. RESULTS: The systematic review of the literature identified seventeen retrospective studies. The Gynecology Cancer DSG used a consensus process to develop recommendations based on the available evidence from the systematic review, the narrative review, and the collective clinical experience and judgment of the DSG members. PRACTICE GUIDELINE: The recommendations in this practice guideline are based on the expert consensus opinion of the Gynecology Cancer DSG, informed by evidence from retrospective studies. These are some general features of an appropriate follow-up strategy: 1. At a minimum, follow-up visits with a complete physical examination, including a pelvic-rectal exam and a patient history, should be conducted by a physician experienced in the surveillance of cancer patients. 2. There is little evidence to suggest that vaginal vault cytology adds significantly to the clinical exam in detecting early disease recurrence. 3. Routine use of various other radiologic or biologic follow-up investigations in asymptomatic patients is not advocated, because the role of those investigations has yet to be evaluated in a definitive manner. 4. A reasonable follow-up schedule involves follow-up visits every 3-4 months in the first 2 years and every 6-12 months in years 3-5. Patients should return to annual population-based general physical and pelvic examinations after 5 years of recurrence-free follow-up.

16.
Gynecol Oncol ; 118(2): 196-201, 2010 Aug 01.
Article in English | MEDLINE | ID: mdl-20466411

ABSTRACT

BACKGROUND: Little is known about patterns of end of life (EOL) care in gynecologic cancer patients. This paper reports on five EOL quality indicators: (1) chemotherapy in last 2 weeks of life (2) death in an acute care bed (3) emergency department visits in last 2 weeks of life (4) home care (nursing) visits in last 6 months of life (5) physician house calls in last 2 weeks of life. METHODS: A population-based, retrospective cohort study using administrative sources of health care data which was conducted as part of the Project for an Ontario Women's Health Report Card. It describes five health services received near the EOL by women who died of ovarian, uterine or cervical cancer in 2003-2004 in Ontario, Canada. Measures were stratified by age, income and region. RESULTS: The cohort included 2040 women. Four percent received chemotherapy, 34% visited the emergency department; 27% received a physician house call; 73% received a home care visit; and 51% died in an acute care bed. Older age was associated with lower use of each service. Living in a lower income neighborhood was associated with lower physician home visits. Regional variation across the province was observed for 3 indicators. INTERPRETATION: Observations made in this study can be used to inform interventions to improve EOL care for women with gynecological cancers. Tracking indicators over time serves to monitor response to improvement interventions. Reporting on the specific needs of this population helps assure that gaps in this domain of care are addressed.


Subject(s)
Genital Neoplasms, Female/therapy , Palliative Care/methods , Terminal Care/methods , Cohort Studies , Emergency Medical Services , Female , Genital Neoplasms, Female/drug therapy , Home Care Services , Humans , Retrospective Studies
17.
Psychooncology ; 19(3): 318-25, 2010 Mar.
Article in English | MEDLINE | ID: mdl-19319830

ABSTRACT

OBJECTIVE: This research explores the treatment decision-making (TDM) experiences of women with recurrent ovarian cancer (ROC) with regard to treatment options; their understanding of risks and benefits of various treatment options; the decision-making role they want for themselves and for their oncologist; and the social context of the consultation as it pertains to the decision. METHODS: We conducted semi-structured interviews with 26 women at the time of first recurrence. Through inductive data analysis key themes were identified. RESULTS: Many women describe self-identifying the cancer recurrence fairly quickly due to new symptoms. Many feel that the goal for treating their recurrence is to control versus cure the cancer. They describe the subsequent process of diagnosis and TDM for ROC as quick and straightforward with all women accepting the oncologists' treatment recommendation. They feel that the type and number of treatment options are limited. They have a strong desire for physician continuity in their care. Participants feel that their doctor's recommendations as well as their previous experience with ovarian cancer are strong factors influencing their current TDM process. CONCLUSIONS: Shared decision making is based on a simultaneous participation of both the physician and patient in TDM. When faced with ROC, women feel that their doctor's recommendation and their past experience with treatment and TDM are prominent factors influencing the current TDM process.


Subject(s)
Ovarian Neoplasms/therapy , Adult , Aged , Decision Making , Female , Humans , Interviews as Topic , Middle Aged , Ovarian Neoplasms/psychology , Patient Acceptance of Health Care/psychology , Patient Participation/psychology , Physician-Patient Relations , Recurrence , Social Support
18.
Eur J Gynaecol Oncol ; 30(5): 493-6, 2009.
Article in English | MEDLINE | ID: mdl-19899398

ABSTRACT

OBJECTIVE: To facilitate the planning of resources for cancer services in Ontario, Cancer Care Ontario commissioned an evaluation of operative services delivered for cervical cancer. METHODS: Women with an incident diagnosis of cervical cancer were identified from 1 April, 2003 to 31 March, 2004 using the Ontario Cancer Registry. Record linkages were created to other provincial health databases such as the Ontario Health Insurance Plan. RESULTS: There were 513 incident cases. Disease-specific rates of cancer were higher in rural areas and those from lower income quintiles. Forty-three percent of women had no surgery. Use of surgery did not appear to vary by SEC, urban/rural residence or LHIN. Women of younger age were more like to receive surgery for cervical cancer. Gynecologists conducted 63% of the operations. Gynecologics were most likely to complete a lymphadenectomy (70.3%). All women were assessed by CXR. Only 22% of women had a CT scan of the abdomen and pelvis. Radiation consults were performed in half of the women with cervix cancer but treatment was only delivered to half of those seen. Medical oncologists saw about 10% of women with cervical cancers. CONCLUSIONS: There appear to be variations in incidence rates of cervical cancer, with cancers being more frequent in rural areas. In two-thirds of the population, surgery is performed in the region where the patient lives. Subspecialty care from gynecologic oncologists was provided to one-third of women. These preliminary data would be enhanced with further information such as comorbidity, treatment intent (palliative/curative), histology, grade and stage.


Subject(s)
Health Services Accessibility , Uterine Cervical Neoplasms/surgery , Women's Health Services , Adult , Aged , Conization , Female , Humans , Incidence , Middle Aged , Ontario/epidemiology , Rural Population , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/epidemiology , Vaginal Smears
19.
Eur J Gynaecol Oncol ; 30(5): 503-5, 2009.
Article in English | MEDLINE | ID: mdl-19899401

ABSTRACT

BACKGROUND: To facilitate the planning of future resources for cancer services in Ontario, Cancer Care Ontario commissioned an evaluation of operative services delivered for vulvar cancer. METHODS: Women with an incident diagnosis of vulvar malignancy were identified from 1, April 2003 to 31 March, 2004 using the Ontario Cancer Registry. Record linkages were created to other provincial health databases such as the Ontario Health Insurance Plan. RESULTS: Vulvar cancers affected 148 women. Disease specific rates of cancer were higher in rural areas and in women in the lower income quintiles. No surgery occurred in 17.6% of women. Use of surgery did not appear to vary by urban/rural residence or LHIN. Ontario's 17 gynecologic oncologists performed 75% of the surgeries. Groin lymphadenectomy rate was 52.8%. Surgery was performed in the LHIN of residence for 41% of women. All women were assessed by CXR. CT scan of the abdomen and pelvis occurred in 77%. MRIs were done infrequently. Radiation consults were preformed in half of the women with vulvar cancer but treatment was only delivered in half of those seen. Medical oncologists saw about 10% of women with gynecologic cancers. CONCLUSIONS: There appear to be variations in incidence rates of vulvar cancer with disease being more frequent in rural areas. Subspecialty care from gynecologic oncologists was provided to 75% of women. Rates of lymphadenectomy as part of a surgical attempt occurred in 52.8% of women. These data would be enhanced with further information such as comorbidity, treatment intent (palliative/curative), histology, grade and stage.


Subject(s)
Health Services Accessibility , Lymph Node Excision , Vulvar Neoplasms/surgery , Adult , Aged , Female , Groin/surgery , Humans , Middle Aged , Ontario , Perioperative Care , Waiting Lists , Young Adult
20.
Eur J Gynaecol Oncol ; 30(4): 361-4, 2009.
Article in English | MEDLINE | ID: mdl-19761122

ABSTRACT

BACKGROUND: To facilitate the planning of future resources for cancer services in Ontario, Cancer Care Ontario commissioned an evaluation of operative services delivered for ovarian cancers. The affected population was characterized in terms of age, location of residence, and SES. Operative care delivery was described in terms of inpatient verses outpatient access, LHIN of treatment, surgical specialist providing treatment, and specific operative procedures. The investigations and consults around the time of diagnosis are described. METHODS: Women with an incident diagnosis of an ovarian malignancy were identified from 1 April 2003 to 31 March 2004 using the Ontario Cancer Registry. Record linkages were created to other provincial health databases such as the Ontario Health Insurance Plan. RESULTS: We report on 963 women with ovarian cancer. The incidence of disease was related to increasing age. Access to surgery correlated with the highest income quintile, urban residence and LHIN. Twenty-seven percent of women did not have surgery for their ovarian cancer. Women of younger age were more like to receive surgery for ovarian cancer. Use of a laparotomy for biopsy was most common in community hospital (40%). Lymphadenectomy rates were low overall; rates for gynecologic oncologists were 13.2%. All women were assessed by CXR. CT scan of abdomen and pelvis occurred in 77% of women. MRIs were done infrequently. Medical oncology were involved in 26.6% of the patients. CONCLUSIONS: These pilot data would be enhanced with further information such as comorbidity, treatment intent (palliative/curative), histology, grade and stage. However, there are clear referral patterns to academic centres which means a need for manpower and hospital resources to deal with this population.


Subject(s)
Ovarian Neoplasms/surgery , Adult , Aged , Female , Gynecologic Surgical Procedures/methods , Health Services Accessibility , Humans , Middle Aged , Ontario , Ovarian Neoplasms/diagnosis , Specialties, Surgical , Waiting Lists , Young Adult
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