Ovarian Cancer Summary

Epidemiology
·         5th most common cancer among women.
·         Leading cause of gynecologic cancer death.
·         4% of cancers among women in the U.S.
·         Epithelial ovarian cancer accounts for 90% of all cases.
·         Fallopian tube cancer and primary peritoneal cancer are much rare, but share histologic, prognostic and treatment response features with epithelial ovarian cancer.
·         25% of women presents with stage I, 15% with stage II, 42% with stage III and 17% with stage IV.
·         10% of cancers of the ovary are non-epithelial. They are classified as either sex cord stromal cell tumors or germ cell tumors
Risk factors and presentation
·         Non-specific discomfort, Urinary frequency, persistent bloating and constipation.
·         Mean age at diagnosis of ovarian cancer in 59.
·         Increasing age is one of the strongest risk factor for developing ovarian cancer.
·         Family history is the next strongest risk factor.
·         A woman with a 1st degree relative with ovarian cancer has a lifetime risk of 5%.
·         Families with multiple cases of breast and/or ovarian cancer should consider genetic testing.
·         Deleterious BRCA1  or BRCA2 mutation carriers have a lifetime risk of ovarian cancer estimated at 16% to 60%, with the higher risk among BRCA1 mutation heterozygous women with strong family histories of the disease
·         Women with genetic mutations that are part of the HNPCC syndrome also have an increased risk of ovarian cancer.
·         Other risk factors include white race, diets high in animal fat, nulliparity or first birth after age 35 yrs, involuntary infertility, late menopause and early menarche.
·         Oral contraceptive use is associated with a decreased risk.
Screening
·         No data to support the routine use of ovarian cancer screening of any type in the general population
·         A randomized trial of screening with Ca125 and transvaginal sonogram compared with usual care enrolled 78,216 women age 55 to 74. Screening did not decrease mortality, and there was evidence of harm from interventions required for women with false positive screening results.
·         No prospective data to demonstrate longer survival with screening of women at high risk for developing ovarian cancer, however the prevalence of the disease in these populations makes screening a reasonable choice for women who wish to preserve fertility
Risk reduction
·         Prophylactic BSO may substantially reduce the risk of ovarian cancer for women who are carries of deleterious BRCA1 or BRCA2 mutations
·         Approximately 80% lower risk of ovarian and fallopian tube cancers with follow up of less than 10 yrs from surgical procedure.
·         A meta-analysis of 10 studies confirmed this level of risk reduction across a large population of high risk women.
Diagnosis and surgical staging
·         Transvaginal ultrasound can assist in the differential diagnosis.
·         CT scan chest, abdomen and pelvis are helpful for staging.
·         CA 125 is elevated in more than 80% of patients with advanced ovarian cancer but only 50% of patients with early stage.
·         Definitive diagnosis by surgical exploration
·         Prognosis is linked to the amount of residual tumor after surgical cytoreduction.
·         Optimal cytoreduction is defined as no residual tumor measuring > 1cm.
·         In patients whom there is clear evidence that optimal cytoreduction will not be possible, neoadjuvant chemotherapy should be used but a biopsy of accessible tissue may be performed to confirm diagnosis prior.
o   One phase III randomized trial showed equivalent outcomes for patients with stage III or IV ovarian cancer whether treated with neoadjuvant chemotherapy followed by surgery or with cytoreductiove surgery followed by Chemotherapy. (NEJM 2010;363;943)
·         Patients who have a complete resection of all macroscopic disease have superior survival outcomes with patients in whom the disease cannot be completely resected.
·         Ctyoreduction surgery includes TAH BSO, pelvic & para-aortic lymph node sampling, infra-colic omentectomy, pelvic and peritoneal biopsies, and pelvic and peritoneal washings.
Treatment overview and estimates of overall survival
Stage
Definition
Treatment overview
5 yr survival
I
Tumor confined to the ovaries
Complete surgical resection/staging + see below
85-90%
IA
Limited to 1 ovary, capsule intact, no tumor on surface, no malignant cells in ascites or washing
·   No adjuvant chemotherapy for grade 1 or 2.
·   Adjuvant chemotherapy for grade 3 and clear cell.
IB
Limited to both ovaries, rest as 1A
1C
Limited to 1 or both ovaries but with capsule rupture or tumor on ovarian surface or malignant cells in ascites or peritoneal washing
Adjuvant chemotherapy
II
Involves 1 or both ovaries with pelvic extension
Adjuvant chemotherapy
80%
IIA
Extension and/or implants on uterus and/or fallopian tubes, no malignant cells in ascites or peritoneal washings
IIB
Extension to other pelvic tissue, rest as IIA
IIC
Pelvic extension with malignant cells in ascites or peritoneal washing
III
Involves 1 or both ovaries with peritoneal metastasis outside the pelvis and/or retroperitoneal or inguinal LNs
Adjuvant chemotherapy
15-50%
IIIA
Microscopic peritoneal metastasis beyond the pelvis
IIIB
Macroscopic peritoneal metastasis beyond the pelvis, measuring <2 cm
IIIC- optimally debulked
Macroscopic peritoneal metastasis beyond the pelvis measuring > 2 cm and/or regional LN metastases;
No residual disease >1 cm at completion of cytoreductive surgery
Intraperitoneal cisplatin plus intraperitoneal and intravenous paclitaxel
30-50%
IIIC- suboptimally debulked
Same as above but residual disease > 1 cm at completion of cytoreductive surgery
IV platinum + taxane chemotherapy
10-20%
IV
Distant metastases (excluding peritoneal) to liver or malignant pleural effusion
IV adjuvant chemtherapy
5-10 %

Chemotherapy for early stage ovarian cancer
·         Stage IA or IB grade 1 or 2 are considered favorable prognostic group.
·         2 randomized trials for this favorable group failed to show a DFS or OS benefit from chemotherapy. (NEJM 1990;322;1021)
·         Stage IA or IB grade 3, all stage IC, All clear cell tumors and Stage II have a less favorable prognosis.
·         A number of randomized trials have demostrated that adjuvant chemotherapy can prolong the time to progression for women with high risk early stage ovarian cancer.
·         An analysis of data from more than 900 patients with high risk, early stage disease showed that adjuvant platinum based chemotherapy administered postoperatively led to 11% improvement in 5 yr PFS and 8% improvement in 5 yr OS, compared with a strategy of observation until evidence of recurrent disease. (J Natl Cancer Inst. 2003;95;105)
·         The optimal duration of therapy for early stage disease has not been defined.
·         A large phase III trial showed that adding 24 weeks of maintenance paclitaxel after 3 cycles of IV paclitaxel plus carboplatin did not improve PFS or OS.
Chemotherapy for advanced ovarian cancer
·         Standard 1st line therapy is Platinum + Taxane combination chemotherapy.
·         Patients with optimally cytoreduced, stage III ovarian cancer have a significant survival advantage when receiving a combination of IP Cisplatin + IP & IV Paclitaxel.
·         Carboplatin and Cisplatin are equally efficacious when delivered IV for advanced ovarian cancer but important differences in adverse effect profiles.
·         Systematic review of 1st line chemotherapy for stage II, III or IV Ovarian cancer: (Gynecal Oncol;2002;85;71)
o   A published meta-analysis found that, compared with non-platinum-based regimens, platinum, alone or in combination with other agents, improved survival.
o   The meta-analysis did not detect a difference in efficacy between cisplatin and carboplatin.
o   Carboplatin is more myelosuppressive, but Cisplatin has a greater risk of nausea, vomiting, neurotoxicity, and nephrotoxicity.
o   In 2 randomized trials, treatment with paclitaxel + cisplatin resulted in improved OS compared with cyclophosphamide + cisplatin.
o   Conclusion is IV carboplatin + paclitaxel is the recommended postoperative regimen. IV cisplatin + paclitaxel may be considered a treatment option.
o   Single agent carboplatin can be considered in patients whom paclitaxel is contraindicated.
·         GOG 132 trial: (JCO 2000; 18;106)
o   Phase III Randomized Study of Cisplatin Versus Paclitaxel Versus Cisplatin and Paclitaxel in Patients with Suboptimally debulked Stage III or IV Ovarian Cancer.
o   Cisplatin alone or in combination yielded superior response rates and PFS relative to paclitaxel. However, OS was similar in all three arms, and the combination therapy had a better toxicity profile. Therefore, the combination of cisplatin and paclitaxel remains the preferred initial treatment option
·         Approximately 60-80% of patients with advanced ovarian cancer experience objective response.
·         Median PFS is about 26 months, and OS is about 60 months, for women with advanced disease who had optimal debulking.
·         Median PFS is about 18 months, and OS is about 38 months, for women with advanced disease who had suboptimal debulking.
·         Bevacizumab was tested for 1st line therapy in stage III & IV ovarian cancer:
o   GOG 218 trial: (JCO 2010;28;18s)
§  Phase III trial of 1873 patients with advanced ovarian cancer
§  Paclitaxel + Carboplatin with bevacizumab followed by bevacizumab maintenance had a PFS of 14.1 months compared to 10.3 months for patients assigned to chemotherapy without bevacizumab.
§  OS didn’t seem to be improved.
o   ICON7 trial: (JCO 2011;29; suppl;LBA5006)
§  European similarly designed study of 1528 patients with advanced ovarian cancer
§  Employed a lower dose and shorter duration of bevacizumab
§  Showed a similar PFS advantage and trend towards improvement of OS.
·         Weekly Paclitaxel + every 3 weeks Carboplatin was compared with standard every 3 weeks Paclitaxel + Carboplatin in a phase III trial of 637 women with stage II-IV ovarian cancer, and it was associated with an OS advantage of 72% vs 65% at 3 years. (Lancet;2009;374;9698;1331)
·         Liposomal doxorubicin +Carboplatin were not superior to Paclitaxel + Carboplatin as 1st line therapy in patients with stage IC to IV disease in terms of survival outcomes or quality of life.
·         Intraperitoneal chemotherapy for stage III disease with optimal cytoreduction:
o   Because drug delivery is by diffusion, intraperitoneal therapy is limited to patients with small volume residual disease.
o   GOG 172 trial: (NEJM;2006;354;34)
§  Phase III trial of 429 patients with optimally debulked stage III patients randomized to receive IV Cisplatin + Paclitaxel or IP Cisplatin + IV & IP Paclitaxel.
§  Patients assigned to the IP treatment had significantly longer PFS (23.8 months vs 18.3 months) and OS (65.6 months vs 49.7 months)
§  Toxicity was greater in the IP arm with initial decrease in quality of life, however at 1 year; there were no quality of life differences.
·         Early vs delayed treatment of relapsed ovarian cancer:
o   MRC OV05/EORTC 55955 trial (Lancet;2010;376;9747;1155)
§  A randomized trial of Women with ovarian cancer in complete remission after first-line platinum-based chemotherapy and a normal CA125 concentration.
§  Clinical examination and CA125 measurement were done every 3 months. 
§   If CA125 concentration exceeded twice the upper limit of normal, patients were randomly assigned (1:1) to early treatment group which starts within 28 days of the CA125 elevation or the delayed group which starts treatment only at clinical or symptomatic relapse.
§  All patients were treated according to standard local practice. 265 women in early group and 264 women in the delayed one.
§   there was no evidence of a difference in overall survival between early and delayed treatment
§  The value of routine measurement of CA125 in the follow-up of patients who attain a complete response after first-line treatment is not proven.
·         Secondary surgical procedures:
o   GOG 152 trial: (NEJM;2004;351;24;2489)
§  Randomized phase III trial of 550 women with residual tumor >1 cm after primary cytoreduction surgery.
§  Patients who were stable or improved after 3 cycles of Cisplatin + Paclitaxel we randomly assigned to continue with chemotherapy or to have a 2nd attempt at cytoreduction followed by additional chemotherapy.
§  Patients didn’t benefit from a 2nd attempt at cytoreduction in terms of PFS or OS; rather treatment with chemotherapy should continue.
·         Consolidation therapy:
o   Disease will recur in almost 70% of women with advanced disease who have a clinically defined complete response to standard chemotherapy with a platinum agent and a taxane.
o   GOG 178 trial: (JCO;2003;21;13;2460)
§  Phase III trial of 277 women with advanced ovarian cancer after complete response to platinum and Taxol based chemotherapy randomly assigned to 12 vs 3 months of maintenance Paclitaxel.
§  Patients assigned to receive 12 cycles of consolidation Paclitaxel had a markedly improved PFS of 28 months vs 21 months for patients receiving 3 cycles only.
§  The study was early closed. As of the date of study closure, there was no difference in OS.
Treatment of recurrent or resistant disease
·         20% of women with advanced ovarian cancer do not respond to 1st line platinum/taxane therapy.
·         Platinum refractory:
o   Progressing during treatment with platinum based regimen.
o   Very poor prognosis.
·         Platinum resistant:
o   Progressing within 6 months of completing 1st line platinum based regimen.
o   Objective response can be achieved in a minority of patients (10-20%)
o   Liposomal doxorubicin, topotecan, gemcitabine, docetaxel, weekly Paclitaxel, oral Etoposide, irinotecan and vinorelbine can be used.
o   Bevacizumab as a single agent can achieve objective responses.
·         Potentially/intermediate platinum sensitive:
o   Progressing >6 months but <12 months from completing 1st line platinum based regimen.
o   Response rate to platinum based regimen is higher than 20%.
o   Treatment with platinum or nonplatinum single agents is appropriate.
·         Platinum sensitive:
o   Recurrence > 12 months from completion of 1st line platinum based therapy.
o   Platinum sensitive patients have a high likelihood of response to retreatment with platinum based therapy.
o   2 randomized trials have shown that platinum based combination therapy (carbo/gemzar) or (carbo/Taxol) is superior to single agent platinum.
o   Liposomal doxorubicin + Carboplatin were superior to Paclitaxel + Carboplatin in terms of PFS (11.3 months vs 9.4 months) and toxicity profile in a large phase III randomized trial. ( JCO 2010;28;3323)
o   Another phase III trial comparing gemzar + Carboplatin with or without bevacizumab, showed PFS advantage in the group assigned to receive bevacizumab (12.4 months vs 8.4 months). (JCO 2012;30;2039)
·         Patients with recurrent ovarian cancer who receive 2nd line chemotherapy, in general the median time for disease control with any given agent in approximately 4 months.
Low malignant potential tumors of the ovary (LMP)
·         Patients with LMP who wish to preserve fertility can undergo fertility sparing surgery.
·         Most women with LMP have early stage disease.
·         5 yr OS rates exceed 95%, and PFS exceeds 80%.
·         There is no evidence that adjuvant therapy (chemo or RT) is beneficial in any stage if pathology review confirms there is no evidence of invasive implants.
·         5 yr OS rates for patients with stage III or IV are around 90%, and PFS > 65%.
Sex-cord stromal cell tumors of the ovary
·         Subclassifed as granulosa cell tumors, and the androgen producing tumors such as Sertoli-Leyding cell tumors
·         Granulosa cell tumors:
o   Generally stage I at diagnosis.
o   Diagnosed in women age 40-70.
o   Produce estrogen which may cause abnormal uterine bleeding, endometrial hyperplasia and even endometrial cancer.
o   Endometrial cancers that are found concurrently with granulosa cell tumors are typically early stage and low grade.
o   The treatment is surgical resection
o   If patient desire fertility preservation and fertility sparing surgery was done. Then an endometrial biopsy should be done to rule out a concurrent endometrial cancer
o   Routine lymphadenectomy is not routinely recommended
o   Adjuvant chemotherapy is not routinely recommended.
o   There are some data supporting the use of combination platinum based chemotherapy for patients with recurrent or unresectable disease. (JCO;2007;25;20;2944)
·         Sertoli-Leydig tumors:
o   Commonly present before age 40.
o   More than 90% of cases are stage I at diagnosis.
o   Androgen leads to virilization.
o   5 yr survival rates are 70-90% depending on stage and degree of tumor differentiation
o   Platinum based chemotherapy may be considered for patients with poorly differentiated tumors and for patients with advanced or recurrent disease.
Germ cell tumors of the ovary
·         Affect adolescent girls and young women
·         Fertility sparing surgery is appropriate for most patients.
·         50% of germ cell tumors are dysgerminomas.
·         Other histologies included yolk sac tumors, immature teratomas, embryonal cell, nongestational choriocarcinomas, and mixed tumors.
·         HCG and AFP may be elevated in some germ cell tumors at diagnosis and can be used in follow up monitoring.
·         Dysgerminomas are likely to be confined to 1 ovary at diagnosis (stage I), and carry a favorable prognosis
·         Patients with stage I dysgerminoma and stage I, grade I immature teratomas can be treated with surgery alone.
·         All other nondysgerminomas and high stage dysgerminomas should be treated with chemotherapy after surgical resection.
·         Standard treatment is combination platinum/etoposide-based chemotherapy, with most data supporting 3 to 4 cycles of bleomycin, etoposide and cisplatin.
o   GOG 78 trial: (JCO;1994;12;4;701)
§  93 patients with completely resected germ cell tumors nondysgerminoma, received 3 cycles of bleomycin, etoposide and cisplatin
§  Disease free survival was 96%



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