Epithelial Ovarian Cancer
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1 Epithelial Ovarian Cancer GYNE/ONC Practice Guideline Dr. Alex Hammond Dr. Ian Kerr Dr. Akira Sugimoto Dr. Stephen Welch Kay Faroni Christine Gawlik Kerri Thornton Approval Date: This guideline is a statement of consensus of the Gynecologic Oncology Disease Site Team regarding their views of currently accepted approaches to treatment. It is not intended to replace the independent medical judgment of the physician in the context of individual clinical circumstances to determine any patient s care or treatment. 1
2 Epithelial Ovarian Cancer Gynecologic Oncology Practice Guideline Background/Incidence Communication High Risk Individuals to Consider for Genetic Counselling Clinical Assessment of a Patient with Suspected Ovarian Cancer Staging & Pathology Considerations Surgical Management Chemotherapy Management Primary Management - (Front Line) Chemotherapy Salvage chemotherapy Monitoring & Follow-up Appendix I FIGO staging Appendix II- References 2
3 Background/Incidence Ovarian Cancer consists of several histopathological types, with Epithelial Ovarian Cancer (EOC) comprising > 90% of cases. One in 70 Canadian women is affected by Ovarian Cancer. The average age of diagnosis is 56.3 years, with >60% of cases presenting with advanced disease (Cancer Care Statistics, 2008). The majority of patients will relapse, requiring further chemotherapy. Ovarian Cancer is the fifth most common cancer among women and the fifth leading cancer causing death among women. Canadian Cancer Statistics for 2008, estimate that there will be 2,500 new cases of Ovarian Cancer with 1,700 deaths. Survival is dependent on stage of cancer at initial presentation; stage I disease has a 5 year survival rate of 85%, while stage IV, a survival rate of ~10%. Communication Twenty per cent of patients with Ovarian Cancer are expected to survive five years beyond diagnosis. The vast majority of patients with Ovarian Cancer face the lifechanging issue of a chronic disease with periods of recurrence followed by stability and control of symptoms. It is paramount for patients and their key family/support persons to receive thorough and timely provider-patient communication at critical points of care, including: diagnosis, recurrence, identification of metastasis and disease progression. Critical point of care consultations should be planned in a quiet, private place and allow enough uninterrupted time. Such discussions should include hope-giving aspects of the information, the ongoing plan of care, and an assessment of the patient s understanding of their prognosis. Key aspects discussed must be accurately documented in a timely manner to facilitate appropriate transmission of information to all caregivers involved. (Refer to Cancer Care Ontario s document Provider-Patient Communication for further information). High Risk Individuals to Consider for Genetic Counselling Hereditary Ovarian Cancer is due to mutations in the BRCA 1 and BRCA 2 genes and account for 10 % of cases of all cases of epithelial Ovarian Cancer. The presence of the mutation indicates increased risk, but the individual with the mutation might never develop a cancer. Mutations in the BRCA1 gene are estimated to confer an Ovarian Cancer risk of 30% up to age 60 years, and BRCA2 gene mutations confer a risk of 27% up to 70 years. Cancer Care Ontario has created guidelines for when to refer a patient with a family history or risk factors which would indicate the need for a referral. (Refer to Cancer Care Ontario s guideline Management Options for Women with a Hereditary Predisposition to Ovarian Cancer.) 3
4 Clinical Assessment of a Patient with Suspected Ovarian Cancer Most patients with EOC present with ascites as well as a pelvic mass. These patients should be considered to have advanced EOC until proven otherwise and should be referred to a Gynecologic Oncologist at the earliest possible moment. Occasionally patients with EOC may present with an isolated pelvic mass. These requests for consultation will be reviewed to assess whether they may be best managed by a general gynaecologist. At a primary care level testing and procedures that a patient should undergo prior to referral are: History & physical Bloodwork (CBC, Chemistry, Ca125) Pelvic ultrasound and/or CT Additional investigations that may be carried out at the discretion of the specialist are: Abdo/pelvic ultrasound and/or CT Chest x-ray Percutaneous Biopsy paracentesis or pleurocentesis for malignant cytology GI evaluation ( e.g. endoscopy) if clinically indicated 4
5 SURGICAL MANAGEMENT Pelvic Mass Clinical Radiological Assessment Apparently Isolated Mass Obvious Metastatic Disease General Gyn Surgery Referral to Gyn Oncology Frozen Section Reasonable Surgical Candidate Poor Surgical Candidate (Reason) Benign Possible Serous Borderline Malignant At least borderline Surgical Evidence of Metastases Maximal Surgical Effort Core biopsy (CA-125 Cytology) No Staging required Staging Biopsies Optimal Cytoreduction Sub- Optimal Cytoreduction Diagnostic Non Diagnostic Grade I Grades II-III Systemic Treatment Algorithm Systemic Treatment Algorithm Initiate Systemic Treatment Reconsider Surgery Stage: IA Stage: IB + Systemic Treatment Algorithm Debulking as soon as Possible No Further Treatment Systemic Treatment Algorithm Completion of Chemotherapy 5
6 Algorithm for Surgical Management of the Patient Presenting with a Pelvic Mass Legend 1. Assessment of the distribution of disease should include a history, physical examination, and imaging such as CT scan or ultrasound. Evidence of Metastatic Disease may include: Clinical evidence of ascites/omental mass/intraperitoneal carcinomatosis CT evidence of ascites, peritoneal implants, omental mass Pleural effusion Elevated CA It is at the discretion of the general gynecologist as to whether or not they decide to operate on a patient with an apparently isolated pelvic mass. If, in the opinion of the general gynecologist a patient would be better served by referral to a tertiary care center for surgery by a gynecologic oncologist, then a referral can and should be made. Specific reasons why the general gynecologist is concerned about operating in the periphery should be documented. 3. In the setting of clinical or radiologic evidence of metastatic disease, the assessment regarding whether to primarily debulk upfront versus administer primary chemotherapy upfront should be by a qualified Gynecologic Oncologist prior to any treatment decisions. The standard of care has been to proceed with primary cytoreductive surgery when feasible to decrease the volume of tumor to optimal residual disease that is less than 1 cm, or no gross residual disease. The results of a large international randomized trial comparing upfront surgery to neoadjuvant chemotherapy show similar survival and decreased morbidity for women treated by neoadjuvant chemotherapy with interval debulking. In this study, optimal cytoreduction remains the single most important prognostic factor for survival, and therefore the study addresses more the timing of surgery, than the goal and principles of cytoreductive surgery. Primary debulking should remain the goal in all women presenting with complex ovarian masses suspicious for cancer. In women with evidence of advanced disease as demonstrated by peritoneal carcinomatosis or omental "cake", the benefits of primary debulking and neoadjuvant chemotherapy followed by interval debulking surgery should be evaluated in consultation with a gynecologic oncologist. Examples of reasons why primary cytoreductive surgery may not be carried out are: 6
7 Unacceptable operative risk Radiologic suspicion of unresectable intra-abdominal disease Intra-parenchymal or pleural Severe patient debilitation/malnutrition When a decision is made to treat with primary chemotherapy, the reasons why and the discussion with the patient should be documented. 4. It is acknowledged that the accuracy of frozen section can be limited. Final treatment decision will be made on the basis of final pathology reports. Notwithstanding, where the frozen section queries a Mucinous Borderline Tumor, then full staging should be carried out ( ) due to the risk of associated foci of invasive adenocarcinoma. When the frozen section suggests a Serous Borderline tumor, and the abdominal cavity appears normal, then staging ( ) need not be carried out. 5. Intraoperatively, every effort should be made to reduce the volume of residual disease to less than 1 cm. Splenectomy, diaphragmatic resection, peritoneal stripping, diaphragmatic resection may be indicated to achieve this at the discretion of the surgeon. 6. Staging Laparotomy should include: Pelviabdominal Washings Pelvic Node Dissection Para-aortic Node Dissection Omentectomy Peritoneal Biopsies 7. In order to confirm the diagnosis of intraperitoneal carcinomatosis from a primary peritoneal or ovarian origin, ideally an elevated CA-125 combined with percutaneous or transvaginal core biopsy of tissue should be documented. It is recognized that core tissue biopsies take time to organize and therefore in accepted but the reasons why core biopsy was not pursued should be documented. 8. In the setting where the CA-125 level and peritoneal cytology are not diagnostic, then careful reconsideration should be given to surgery to ascertain the diagnosis and debulk judiciously. Caution should be exercised when administering chemotherapy to patients where the diagnosis of primary peritoneal or ovarian carcinoma has been made without tissue biopsy. Metastatic malignancies from other organs have been well described to mimic ovarian carcinoma. (For example gastrointestinal tumors, breast carcinoma, lymphomas, and soft tissue sarcomas). 7
8 9. When the decision has been made to treat with primary chemotherapy, interval debulking surgery should be performed as soon as the patient is felt to be an operative candidate. The utility of interval debulking surgery decreases with increasing numbers of cycles of chemotherapy. Patients should be assessed by a qualified gynecologic oncologist after each cycle of chemotherapy for optimal timing of interval debulking surgery. 8
9 Chemotherapy Management First Line *primary surgery *primary chemotherapy Optimally Debulked Subopitimally Debulked 1 st line Chemo** 1 st line Chemo** 1 st line Chemo** Interval Debulking Surgery NED*** Persistent or Progressive Disease NED*** Persistent or Progressive Disease Chemo NED*** Follow-up Follow-up Follow-up 2 nd line Chemo Relapse 2 nd Line Chemo Relapse Relapse 2 nd Line Chemo 2 nd line Chemo 2 nd line Chemo *See Surgical Management; **as per CCO Guidelines ***NED = no evidence of disease 9
10 Chemotherapy - First line Stage Chemotherapy Comments I-IV IA, IB grade1 Evaluate patient for clinical trial where possible No treatment IA, 1B grade2 Carboplatin IV AUC 5-6 Paclitaxel* IV 175 mg/m 2 Q21days x 3 to 6 courses IA, IB grade 3 IC-IV Carboplatin IV AUC 5-6 Paclitaxel* IV 175 mg/m 2 Q21 days x 6 courses and then reassess Other options Carboplatin AUC 5-6 Day 1- paclitaxel* IV 135mg/m 2 Day 2 cisplatin IP 100mg/m 2 Day 8 paclitaxel* IP 60 mg/m 2 Q21 days x 6 courses An option but presently not available at this centre ( for optimally debulked stage III) Or IP clinical trial or local protocol Refer to CCO guidelines for further information *premedication for prevention of hypersensitivity reactions required First line chemotherapy consists of combination therapy with platinum and taxane agents. Treatment is given every 3 weeks, based on adequate blood counts and absence of toxicities. Patients with residual disease at baseline, should be optimally treated to no evaluable disease plus 2 courses. (minimum of 6 courses total) Inadequately staged disease, grade III requires full 6 courses of chemotherapy. 10
11 Chemotherapy Management Second Line Second line Supportive Care consult Platinum sensitive > 6 months Platinum resistant < 6 months Study Platin based chemotherapy Other (table 1) Study Liposomal Doxorubicin (as per CCO guidelines) Topotecan (as per CCO guidelines) Other (table 1) All above options lead here NED Progression or unacceptable toxicity Follow-up Supportive Care Change treatment modalities (Alternate treatment modalities Table 1) Responsiveness to chemo depends on bulk of tumor burden and interval from last treatment. In recurrent patients that have a long disease free interval (>18 months) a second debulking surgery should be considered. 11
12 Chemotherapy Management Second Line Platinum Sensitive Disease (> 6 months DFI) Clinical trial where possible Comments LRCP standard Carboplatin IV AUC 5-6 Paclitaxel* IV 175 mg/m 2 Other Options Docetaxel* mg/m 2 Carboplatin AUC 5-6 Gemcitabine 1000 mg/m 2 Carboplatin AUC 4 Liposomal doxorubicin 30 mg/m 2 Carboplatin AUC 5 Carboplatin AUC 5-6 Q21days x 6 courses Q21 days x 6 courses Day 1, 8 Day 1 Q 21 days Q28 days Q 21 days Platinum resistant disease (< = 6 months DFI) or Comments Progression on first line Chemotherapy Clinical trial where possible Liposomal doxorubicin 40 mg/m 2 Topotecan 1.5mg/m 2 Q28 days x 6 courses Daily x 5 days q28 days Carboplatin AUC 5-6 Docetaxel* mg/m 2 Q21 days x 6 courses Gemcitabine mg/m 2 Weekly for 3 weeks with 1 week rest *premedication for prevention of hypersensitivity reactions required 12
13 Monitoring & Follow-up The traditional purpose of regular routine follow-up is to help determine the need for and timing of further treatment. In addition it is recognized that important goals of follow up are to provide continuous education, psycho emotional support, and reassurance. This follow-up should be consistent and created with patient s quality-of-life at the forefront of consideration. Wherever possible, opportunity for follow-up should be made available locally, with an understanding that expeditious referral back to the specialist center will be made at the first sign of symptomatic recurrence. At present there is no evidence that early treatment for relapse in those who are asymptomatic offers any benefit over waiting until the symptomatic stage. In addition, follow-up visits can provoke anxiety, worry and fear in patients. Therefore, we do not recommend a particular monitoring schedule for asymptomatic patients after treatment of their Ovarian Cancer. Rather, the follow-up strategy needs to be individualized based on each patient s specific needs. For those patients who do choose to have routine monitoring at regular intervals, no optimal strategy has been defined. The following guidelines from the National Cancer Comprehensive network (NCCN) may serve as a guide for primary care physicians: Visits every two to four months for two years, then every six months for three years, then annually CA-125 level at every visit Pelvic examination, chest radiographs, and chest/abdomen/pelvic CT scan as clinically indicated CA-125 The sensitivity of an elevated CA 125 level for recurrent/persistent disease is 79 to 95 percent. Elevations in CA 125 may precede clinical or radiographic detection by three to six months. The value of early detection of recurrent Ovarian Cancer by use of CA- 125 is controversial. As mentioned above, there is no evidence that early detection of recurrent disease improves survival. CA-125 is of much more utility after symptomatic recurrence has been identified in order to assist in assessment of treatment response. Routine testing is not recommended and is an individual decision between patient and physician. Routine imaging is not recommended. CT scans should be carried out if there is clinical or CA-125 evidence for recurrent or progressive disease. 13
14 Palliative Care For patients who have documented evidence of disease progression and are transitioning to a non-curative focus on disease management; consideration should be given to a referral for Palliative Care. This provides the opportunity to maximize symptom management, goals of care, exploration of local resources, and to begin advance care planning for the future, even while active treatment is being implemented. Radiation The role of radiation therapy in the treatment of EOC is limited, but has been used in the palliative setting in select case. 14
15 Table 1 Therapeutic Options in Special Circumstances (acceptable recurrence treatment options) Common options currently accepted Carboplatin Cisplatin Etoposide Gemcitabine Liposomal doxorubicin Paclitaxel Topotecan Options in special circumstances (Options requiring special considerations?) Capecitabine Cyclophosphamide Docetaxel Radiation Tamoxifen Vinorelbine 15
16 FIGO STAGING 16
17 17
18 Resources/References Cancer Statistics Published Guidelines Scottish Intercollegiate Guidelines Network National Comprehensive Cancer Network Genetic Services in Ontario Cancer Care Ontario Practice Guidelines/Evidence-Based Series First-line Chemotherapy for Postoperative Patients with Stage II, III or IV Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer PG: June 2004 Update The Optimal Chemotherapy Treatment for Women with Recurrent Ovarian Cancer (January 2000: This EBS replaces PG 4-2 Use of topotecan in pre-treated recurrent or relapsed Ovarian Cancer patients) 4-3 Version EBS: November 2006 Rewrite Adjuvant Care for Stage 1 Ovarian Cancer 4-13 PG: May
19 Resources/References The Role of Intraperitoneal Chemotherapy in the First-line Treatment of Women with Stage III Epithelial Ovarian Cancer 4-21 EBS: August Management Options for Women with a Hereditary Predisposition to Ovarian Cancer 4-4 ES: June 2004 Update Screening High Risk Women for Ovarian Cancer 4-6b ES: August Provider-Patient Communication EBS 19-2: March
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