Archive for the Ovarian Cancer category.
For patients with small-volume persistent or recurrent disease confined to the peritoneal cavity, intraperitoneal chemotherapy may be a reasonable regimen. With large tumors (> 1 cm) or with disease located outside the peritoneal cavity, systemic chemotherapy should be considered. Patients who respond to platinum often can be retreated with one of the platinum compounds alone or in combination with other agents. The longer the disease-free interval from their primary chemotherapy, the better their chances of response; patients who have a disease-free interval of 2 years or more respond at a rate similar to that of newly diagnosed patients.
Patients who are platinum resistant and have not received paclitaxel should be treated with systemic paclitaxel. Administration of paclitaxel has resulted in a 30-35% response rate as salvage therapy and a 25-30% response rate as salvage therapy in patients resistant to platinum therapy. Other drugs for which modest response rates have been reported are topotecan, ifosfamide, hexamethylmelamine, and low-dose oral etoposide (VP-16). All patients who require salvage therapy for epithelial ovarian cancer should be considered for clinical trials.
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Radiation Therapy. The role of irradiation in the management of ovarian cancer remains controversial. There is little doubt that patients with early-stage ovarian cancer or microscopic residual advanced epithelial ovarian cancer can be cured with whole-abdominal radiation therapy. A review of the literature demonstrates survival rates that are not substantially different from those obtained with modern multidrug chemotherapy (Table 12). Although there has never been a randomized trial of modem multidrug chemotherapy and whole abdominal radiotherapy, few centers use radiotherapy as primary treatment for epithelial ovarian cancer. Most specialists believe that the complication rates are higher with irradiation; however, the lack of a randomized trial does not allow that conclusion to be established.
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Radiation therapy may be used as palliative therapy for selected patients who are symptomatic from localized disease and for whom conventional chemotherapy has failed. Examples of such palliative therapy are the control of vaginal bleeding for cancer metastatic to the vagina and temporary control of persistent pelvic disease in an attempt to avoid a colostomy. Such therapy is palliative, however, because the spread pattern of the disease makes it unlikely that there are no metastases outside of the pelvis.
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TABLE 12. Long-Term (5-10-Year) Survival in Ovarian Carcinoma Patients Treated with Whole Abdominal
Irradiation: Correlation of Survival with the Size of Tumor After Initial Surgery
No. with No. with Minimal No. with Large
Residual Tumor Residual Tumor Residual Tumor
Author Year (% Surviving) (% Surviving) (% Surviving)
Dembo 1985 46 (48) 55 (43) 71 (18)
Martinez et al 1985 30 (68) 42 (54) 54 (20)
Fuller et al 1987 20 (77) 12 (62) 10 (0)
Macbeth et al 1988 57 (57) – -
Goldberg and Peschel 1988 60 (77) 14 (7) -
van Bunningen et al 1988 85 (75) – -
Weiser 1988 37 (59) 24 (42) 23 (10)
Lindner et al 1990 63 (65) 10 (40) -
Mean survival 65% 41% 12%
PALLIATIVE SURGERY
Most patients who are not cured of ovarian cancer develop intestinal obstruction as the terminal event of their disease process. It appears that 50-75% of these patients can undergo some type of palliative resection or bypass surgery. These patients will survive 4-6 months with the ability to eat. The mortality of surgery is 12-30%, and the rate of developing serious complications is 15-49%.
The patient and her family should be informed of the serious nature of the surgery and the limited success rate. However, for some patients, the ability to live at home for 4-6 months with the ability to eat a limited diet is sufficient reason to undertake the procedure. The recent improvements in the use of percutaneous gastrostomy make this surgery an acceptable alternative for many patients because they can have limited oral intake supplemented by intravenous fluids administered at home.
CHEMOTHERAPY
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Although surgery is an important aspect in the management of ovarian cancer, surgery alone is rarely curative and by itself will provide only brief palliation of advanced disease. Most patients with ovarian cancer require adjunctive chemotherapy. Fortunately, 75-80% of patients will respond to chemotherapy. Unfortunately, many patients develop resistance to chemotherapy before complete eradication of the cancer. For these patients, secondary or salvage chemotherapy is an important part of their treatment.
Primary Chemotherapy. In the 1960s, single alkylating agents were the chemotherapy of choice for epithelial ovarian cancer. The most commonly used drugs were melphalan and chlorambucil. Overall response rates were 45-55%, and complete clinical response was seen in 1520% of cases. In the 1970s, multidrug regimens resulted in an improvement in overall response rates as well as in complete clinical responses. The introduction of cisplatin in the late 1970s resulted in combination chemotherapy regimens that achieved overall response rates of 70-80% with complete clinical response rates of approximately 50%. The addition of cisplatin to multidrug regimen improves response rates and survival. Because of the ease of administration, most patients are treated with the combination of carboplatin and cyclophosphamide.
The Gynecologic Oncology Group recently reported the results of a randomized trial of cisplatin and paclitaxel in advanced epithelial ovarian cancer. In the trial, patients with stage III disease (tumors >1 cm) or stage IV disease received either cisplatin and cyclophosphamide or cisplatin and paclitaxel. There was a significant improvement in complete response rate, overall response rate, and disease-free survival for patients who received paclitaxel. Based on this study, the standard primary chemotherapy regimen for advanced ovarian cancer is cisplatin and paclitaxel. Several clinical trials are under way to define the best dose and duration of administration for paclitaxel. Other studies are evaluating the complications of carboplatin and paclitaxel. The Gynecologic Oncology Group has recently begun a trial of high-dose chemotherapy using paclitaxel, carboplatin, and melphalan with peripheral progenitor stem cell support.
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Salvage Chemotherapy. About 15-20% of patients with advanced epithelial ovarian cancer will be “cured” by initial surgery and primary chemotherapy. Most patients, however (75-80%), either will have residual disease at the conclusion of initial therapy or will develop recurrent disease. For these patients, salvage therapy will be required. The most important issues to consider are the size and location of the persistent disease and whether the patient responded to primary chemotherapy. The definition of “platinum or paclitaxel responder” requires the patient to have had an initial response to chemotherapy drugs and to have not developed regrowth of disease within 6 months.
The technique of second-look laparotomy has been described in multiple publications. It involves the use of a generous upper and lower midline incision and a thorough evaluation of the entire pelvic and abdominal cavity. Biopsies from the pelvic sidewalls, the serosal surfaces of the rectum and bladder, and the cul-de-sac are required for adequate evaluation of the pelvis. In the upper abdomen, sites to be biopsied include both abdominal gutters, both diaphragmatic surfaces, and any residual omentum. Lymph node sampling should include the right and left paraaortic nodes and the right and left pelvic nodes. Washings for cytologic analysis should include the pelvis, both abdominal gutters, and both diaphragmatic surfaces. In addition to the above, it is important to biopsy adhesions and any suspicious areas in the abdomen or pelvis. Most experts would recommend a minimum of 25 biopsies, and often 40-50 samples are necessary to evaluate the patient adequately at second-look laparotomy. Some investigators are evaluating laparoscopic second-look surgical reassessment. When small-volume unresectable disease is discovered, the patient may be spared a full laparotomy. The reliability of a negative second-look laparoscopy has yet to be determined.
The chances of a patient having residual disease at second-look laparotomy is directly related to a variety of prognostic factors. The fate of patients who have a negative second-look laparotomy has been evaluated by several investigators, who concluded that 17% of patients (ranging from 5% to 57% with a weighted mean of 17%) with a negative second-look laparotomy will develop recurrent cancer. If one considers only patients with stage III and stage IV cancer who have grade 2 or 3 histologic features, the recurrence rate approaches 50%.
Second-look laparotomy is not accepted as standard therapy by all physicians who treat ovarian cancer. Some authorities have argued that second-look laparotomy has never been proven to improve survival, whereas others have pointed out the lack of effective second-line therapy as a contraindication to second-look laparotomy. Although the first statement is true in that no randomized trial has addressed the question of survival benefit in epithelial ovarian cancer, there are reports of success with salvage therapy (covered later in this section). The major benefit appears to be in patients diagnosed with minimal disease.
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Secondary Cytoreductive Surgery. Although there is wide acceptance of the concept of primary cytoreductive surgery, few publications have addressed the concept of secondary cytoreductive surgery. A review of the literature indicated that 32-74% of patients could have their disease secondarily cytoreduced to a microscopic level at second-look laparotomy. The review also revealed that an even greater number of patients could have their disease reduced to an optimal level. Two groups of researchers found improved survival in patients whose ovarian cancer was secondarily cytoreduced to small-volume disease at second-look laparotomy. A 50% 5-year survival rate was reported in patients who either were found to have microscopic disease or whose disease was cytoreduced to a microscopic level at second-look laparotomy.
Surgical removal of epithelial cancer that is confined to the ovary, followed by a full surgical staging procedure, may be adequate therapy. In other early-stage patients, some type of adjunctive treatment may be required. Epithelial ovarian cancer is categorized as early disease (stages I and II with no residual cancer) and advanced disease (stage II with residual cancer and stage III and stage IV cancer).
Table 10 provides a classification system for patients within broad categories. Early ovarian cancer can be divided into low-risk and high-risk disease. For properly staged low-risk epithelial ovarian cancer, survival is approximately 95% and no therapy has been shown to be more effective than surgical removal of the cancer. For patients who wish to continue childbearing, unilateral salpingo-oophorectomy is acceptable providing they had a full surgical staging procedure. Most authorities would recommend removal of the retained ovary when childbearing is complete.
High-risk cancer, however, requires adjuvant treatment with either irradiation or chemotherapy. With adjunctive therapy, survival rates for patients with high-risk cancer are 75-95%. In these patients, the role of conservative surgery is more controversial, although some oncologists will preserve childbearing capability in these women despite the requirement for adjunctive chemotherapy. These patients do not have the option of choosing irradiation as a therapeutic option because such therapy would destroy the retained ovary.
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Primary Cytoreductive Surgery. Reports in the late 1960s indicated improved survival in patients who had extensive surgical resection followed by whole-abdomen radiation. In a 1975 study, the exact residual diameter of tumors was recorded, and size was related to duration of survival. All of the study patients had been treated postoperatively with a single alkylating agent. The study reported a survival time of 39 months for patients with no residual tumors, 29 months for patients with residual tumors smaller than 0.5 cm in diameter, 18 months for patients whose tumors were 0.6-1.5 cm in diameter, and 11 months for patients with residual tumors larger than 1.5 cm. Since that report, many other reports have confirmed that patients whose tumors are reduced to small-volume disease are more likely to have a response to chemotherapy and the frequency of complete responses is greater. Overall response rates were 66.8% in patients with optimal residual disease compared with 53.3% in patients with suboptimal residual disease. The complete response rate was 42.7% in patients with optimal residual disease compared with 24% for patients with suboptimal residual disease.
A group of researchers evaluated 324 patients who had been entered in a Gynecologic Oncology Group study for patients with optimal (<1 cm) disease in an effort to define the benefit of cytoreductive surgery in relation to a variety of other prognostic factors. These investigators found that although cytoreductive surgery was an important factor in determining outcome, it was not the only significant factor. Also important was the age of the patient, the number of residual tumor nodules, and the grade of the tumor.
Treatment
Treatment of ovarian cancer usually involves several types of therapy. Surgical therapy is the initial form of intervention, but it is curative in only a small percentage of cases. Usually, adjunctive chemotherapy, radiation therapy, or both are necessary. Surgical reassessment after adjunctive therapy
is necessary for most patients with advanced disease. In a large percentage of patients, some type of salvage therapy is important. Table 10 outlines current therapies and therapeutic options for epithelial ovarian cancer.
• TABLE 8. Gynecologic and Nongynecologic
Cancers That May Have Serum Elevations of CA 125
Gynecologic Cancers Nongynecologic Cancers
Epithelial ovarian cancer Pancreatic cancer
Some germ cell tumors Lung cancer
Some stromal tumors Breast cancer
Fallopian tube cancer Colon cancer
Endometrial cancer
Endocervical cancer
• TABLE 9. Gynecologic and Nongynecologic Benign Conditions That May Have Serum Elevations of CA 125
Gynecologic Conditions Nongynecologic Conditions
Endometriosis Pancreatitis
Adenomyosis Cirrhosis
Leiomyomata uteri Passive liver congestion
Ectopic pregnancy Peritonitis
Normal pregnancy Peritoneal tuberculosis
Pelvic inflammatory disease Peritoneal sarcoidosis
Menses Recent laparotomy
TABLE 10. Optional Therapy for Epithelial Ovarian Cancer*
Category of Ovarian Cancer Recommended (Standard) Therapy
Early ovarian cancer
Low risk (stages IA & B, grade 1) TAH, BSO, full surgical staging
High risk (stages IA & B, grades 2 & 3, TAH, BSOt, full surgical staging
stages IC, IIA, B & C, no residual} Adjunctive therapy with combination platinum-based chemotherapy
Second look: Not recommended
Alternative: Whole abdominal radiation therapy
Investigational: Paclitaxel in combination with a platinum compound
Advanced ovarian cancer
Optimal§ Maximal surgical cytoreduction
Combination chemotherapy with a platinum compound and paclitaxel
Second look: Recommended
Alternative: Whole abdominal radiation therapy for patients with no gross residual
Investigational: High-dose chemotherapy with stem cell rescue
Suboptimal Maximal surgical cytoreduction
Combination chemotherapy with cisplatin and paclitaxel
Second look: Recommended
Alternative: None
Investigational: High-dose chemotherapy with stem cell rescue
Recurrent or persistent ovarian cancer Investigational therapy or topotecan, ifosfamide, or hexamethylmelamine
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*TAH indicates total abdominal hysterectomy; BSO, bilateral salpingo-oophorectomy. Some investigators include grade 2 in the low-risk category. t Unilateral salpingo-oophorectomy permissible in patients who desire further childbearing. §Optimal (stage III, <1 cm residual).
I I Suboptimal (stage III, >1 cm residual, or stage IV).
Staging of ovarian carcinoma is based on findings at clinical examination and by surgical exploration. The histologic findings are to be considered in the staging, as are the cytologic findings as far as effusions are concerned. It is desirable that a biopsy be taken from suspicious areas outside of the pelvis.
Stage I Growth is limited to the ovaries.
Stage IA Growth is limited to one ovary; no ascites present containing malignant cells. There is no tumor on the external surface; capsule is intact.
Stage lB Growth is limited to both ovaries; no ascites present containing malignant cells. There is no tumor on the external surfaces; capsules are intact.
Stage IC* Tumor is classified as either stage IA or lB but with tumor on the surface of one or both ovaries; or with ruptured capsule(s); or with ascites containing malignant cells present or with positive peritoneal washings.
Stage II Growth involves one or both ovaries, with pelvic extension.
Stage IIA There is extension and/or metastases to the uterus and/or tubes.
Stage lIB There is extension to other pelvic tissues.
Stage IIC* Tumor is either stage IIA or lib but with tumor on the surface of one or both ovaries; or with capsule(s) ruptured; or with ascites containing malignant cells present or with positive peritoneal washings.
Stage Ill Tumor involves one or both ovaries with peritoneal implants outside the pelvis and/or positive retroperitoneal or inguinal nodes. Superficial liver metastasis equals stage III. Tumor is limited to the true pelvis but with histologically proven malignant extension to small bowel or overturn.
Stage IlIA Tumor is grossly limited to the true pelvis with negative nodes but with histologically confirmed microscopic seeding of abdominal peritoneal surfaces.
Stage IIIB Tumor involves one or both ovaries with histologically confirmed implants of abdominal peritoneal surfaces, none exceeding 2 cm in diameter; nodes are negative.
Stage IIIC There are abdominal implants greater than 2 cm in diameter and/or positive retroperitoneal or inguinal nodes.
Stage IV Growth involves one or both ovaries, with distant metastases. If pleural effusion is present, there must be positive cytologic findings to assign a case to stage IV. Parenchymal liver metastasis equals stage IV.
*To evaluate the impact on prognosis of the different criteria for assigning cases to stage IC or IIC, it would be of value to know whether the rupture of the capsule was spontaneous or caused by the surgeon and if the source of malignant cells detected was peritoneal washings or ascites.
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