Archive for November, 2007.
TABLE 14. Adjuvant Chemotherapy for Stage I and Completely Resected Stage II and III Malignant Germ
Cell Tumors*
Institution Regimen No. Progression Free % of Total
GOG BEP 50 of 52 96
Stanford PVB 5 of 5 100
Cross Cancer Institute PVB 4 of 4 100
MD Anderson Cancer Center PVB 4 of 4 100
MD Anderson Cancer Center BEP 20 of 20 100
Total 83 of 85 98
*GOG indicates Gynecologic Oncology Group; BEP, cisplatin-etoposide-bleomycin combination; PVB, cisplatin-vinblastine-bleomycin combination.
Modified from Williams SD, Gershenson DM. Management of germ cell tumors of the ovary. In: Markman M, Hoskins WJ, eds. Cancer of the ovary. New York: Raven Press, 1993
TABLE 15. Chemotherapy of Patients with Incompletely Resected, Persistent, or Recurrent Malignant Germ
Cell Tumors*
Institution Regimen No. Prognosis Free % of Total
GOG PVB 47 of 89 53
Stanford PVB 4 of 4 100
Cross Cancer Institute PVB 8 of 10 80
MD Anderson Cancer Center PVB 7 of 11 64
MD Anderson Cancer Center BEP 5 of 6 83
Total 71 of 120 59
*GOG indicates Gynecologic Oncology Group; PVB, cisplatin-vinblastine-bleomycin combination; BEP, cisplatin-etoposide-bleomycin combination.
Modified from Williams SD, Gershenson DM. Management of germ cell tumors of the ovary. In: Markman M, Hoskins WJ, eds. Cancer of the ovary. New York: Raven Press, 1993
Survival is enhanced by complete cytoreduction of malignant germ cell tumors. Every effort should be made to resect the disease completely, but there is no need to remove reproductive organs not involved with the cancer. These tumors are virtually never bilateral. Thus, even patients with advanced disease who do not have involvement of the other ovary and the uterus should have those organs conserved. Because high cure rates are achieved with the use of multidrug chemotherapy, many patients will retain their reproductive capability.
Patients with malignant germ cell tumors of the ovary should undergo surgical staging similar to that for epithelial ovarian cancer. However, because most patients will require chemotherapy, reexploration for staging is not indicated unless the goal is to resect residual cancer completely. It is best to begin chemotherapy as soon as possible because tumors recur and grow rapidly.
The potential benefit of second-look laparotomy has been debated for several years. Recently, no benefit was found for second-look laparotomy except in incompletely resected immature teratomas, and its routine use in other malignant germ cell tumors cannot be justified.
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Malignant germ cell tumors of the ovary occur primarily in the second and third decades of life, although they are occasionally found in young girls and older women. The tumors are usually accompanied by abdominal pain, and almost 10% of patients will present with an acute episode of torsion, hemorrhage, or rupture of the tumor.
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Germ cell tumors may be associated with elevated serum levels of the beta subunit of human chorionic gonadotropin (b-hCG), alpha-fetoprotein, or lactic dehydrogenase. Measurement of these markers may aid in the diagnosis of germ cell tumors and may be useful in management and follow-up care. Serum markers are shown in Table 13. There is considerable variation in markers, although most endodermal sinus tumors produce alpha-fetoprotein, and most choriocarcinomas and dysgerminomas produce b-hCG and lactic dehydrogenase, respectively.
TABLE 13. Serum Markers in Malignant Germ Cell Tumors of the Ovary*
Serum Marker
Malignant Germ Cell Tumor AFP b-hCG LDH CA 125
Endodermal sinus tumor + – + +
Embryonal carcinoma + + + +
Choriocarcinoma – + + +
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Immature teratoma + – + +
Dysgerminoma – + ± ±
Mixed germ cell tumor ± ± ± ±
*AFP indicates alpha-fetoprotein; b-hCG, beta subunit of human chorionic gonadotropin; LDH, lactic dehydrogenase. t Marker depends on the type of germ cell tumors present.
Cancer treatment
Prognosis is good for most patients treated with platinum-based multidrug chemotherapy. Table 14 displays the results of adjuvant chemotherapy in stage I and completely resected stage II and stage III patients with malignant germ cell tumors. Of 85 patients given adjunctive therapy of either bleomycin, etoposide, and platinum or platinum, vinblastine, and bleomycin, 83 (98%) were progression free. In comparison, patients who had residual disease, had persistent disease, or developed recurrences had a progression-free survival rate of only 59% (71/120 patients) when treated with similar regimens (Table 15).
Patients with early-stage ovarian cancer usually have a low recurrence rate, providing they had full surgical staging and received appropriate therapy. Exceptions include patients with clear-cell cancers of the ovary. Because of the low recurrence rate, patients should be followed with a gynecologic examination and a serum CA 125 test every 3 months for the first year, every 4 months for the second year, and every 6 months for the next 3 years. After 5 years, annual examinations are recommended. Annual Pap tests are recommended. There is no proven benefit of diagnostic radiography and computed tomography in asymptomatic patients with a normal serum CA 125 level.
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Patients with advanced ovarian cancer have a very high recurrence rate, approaching 75% after a complete clinical response and 50% after a complete pathologic response (negative second-look laparotomy). For these patients, follow-up should be more intensive. They should have a gynecologic examination and a serum CA 125 test every 3 months for the first 2 years. Follow-up at 6-month intervals is recommended for the next 3 years. The use of routine computed tomographic scans is debatable, although many experts recommend scans for follow-up of patients who did not have a second-look laparotomy. The optimum frequency for such scans has not been established.
The value of the serum CA 125 test in the follow-up of patients depends in large part on whether the patient had an elevated serum level before therapy, even though CA 125 levels do not always correlate with tumor volume. The serum test does, however, appear to be the best follow-up test available.
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.