New FIGO ovarian cancer staging guidelines
The International Federation of Gynecologists and Obstetricians (FIGO) has revised the staging of ovarian cancer. The approved, new ovarian cancer staging went into effect on Jan. 1, 2014.The revision by FIGO followed a series of meetings which were concluded in Italy at the end of 2012. Representatives of several international organizations including the SGO participated in these deliberations under the leadership of Professor Lynette Denny from South Africa, the Chair of FIGO committee on Gynecologic Oncology.The proposed changes were subsequently approved by the FIGO Executive Board, The American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC). This new staging also applies to Fallopian tube cancer and primary peritoneal cancer (where feasible). The new staging is summarized in this FIGO Ovarian Cancer Staging document with changes in italics. The guidelines will be published in the January 2014 issue of the International Journal of Gynecology and Obstetrics.
SGO Postition Statement on Uterine Morcellation
Uterine morcellation is commonly performed intracorporeally by gynecologists to remove the uterus through small incisions. Most commonly, morcellation is performed to reduce the size of an enlarged uterus so that it may be removed through small laparoscopic incisions or through the vagina, thus minimizing the morbidity of a larger “open” incision. However, power morcellation or other techniques that cut up the uterus in the abdomen have the potential to disseminate an otherwise contained malignancy throughout the abdominal cavity. For this reason, the Society of Gynecologic Oncology (SGO) asserts that it is generally contraindicated in the presence of documented or highly suspected malignancy, and may be inadvisable in premalignant conditions or risk-reducing surgery. Patients being considered for minimally invasive surgery performed by laparoscopic or robotic techniques who might require intracorporeal morcellation should be appropriately evaluated for the possibility of coexisting uterine or cervical malignancy. Other options to intracorporeal morcellation include removing the uterus through a mini-laparotomy or morcellating the uterus inside a laparoscopic bag.Uterine leiomyomas are a common indication for power morcellation. Fewer than one out of 1000 women who undergo hysterectomy for leiomyomas will have an underlying malignancy. The SGO recognizes that currently there is no reliable method to differentiate benign from malignant leiomyomas (leiomyosarcomas or endometrial stromal sarcomas) before they are removed. Furthermore, these diseases offer an extremely poor prognosis even when specimens are removed intact. Patients and doctors should communicate about the risks, benefits and alternatives of all procedures so that a patient is able to make an informed and voluntary decision about accepting or declining medical care (ACOG Committee Opinion 439 Informed Consent).
Bevacizumab significantly improves survival for patients with recurrent and metastatic cervical cancer
Patients with advanced, recurrent, or persistent cervical cancer that was not curable with standard treatment who received the drug bevacizumab (Avastin) lived 3.7 months longer than patients who did not receive the drug according to findings from a large, randomized clinical trial. These results were released, based on an interim analysis, in Feb. 2013, and updates were presented as part of the American Society of Clinical Oncology annual meeting in Chicago on June 2, 2013.
The clinical trial, known as GOG240, was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the Gynecologic Oncology Group (GOG). Genentech, South San Francisco, Calif., the drug manufacturer, provided support for the trial under the Cooperative Research and Development Agreement (CRADA) with NCI for the clinical development of bevacizumab.
The study met its primary endpoint of demonstrating improved overall survival in patients who received bevacizumab, which also means that it delayed the chance of dying from the disease.
Bevacizumab delivered via I.V. drip to a vein with chemotherapy treatment
Patients, whose median age was approximately 47 years old, received a dose of 15 milligrams per kilogram (mg/kg) of body weight of bevacizumab administered in the vein with their chemotherapy treatment and continued with this dose one day every three weeks until disease progression or unacceptable toxicity occurred. Those patients lived a median 3.7 months longer than those who did not receive bevacizumab. Patients treated with chemotherapy alone had a median survival of 13.3 months while those who received chemotherapy and bevacizumab had a median survival of 17 months. This survival difference was highly statistically significant. Progression free survival, meaning that after treatment the disease did not worsen, was 8.2 months for those who received bevacizumab vs. 5.9 months for those who received chemotherapy alone.
However, patients receiving bevacizumab experienced more side effects than those who did not. These side effects were consistent with side effects previously known to be associated with bevacizumab and included hypertension, neutropenia (a low white blood cell count), and thromboembolism, or formation of blood clots. Quality of life during the trial was also measured and there was no significant difference reported by patients between those who received bevacizumab and those who received chemotherapy alone.
“The findings in this clinical trial are important because they are likely to change clinical practice and provide an opportunity to improve outcome in patients with recurrent cervical cancer who have previously had very limited treatment options,” said GOG study chair Krishnansu S. Tewari, M.D.
A total of 452 patients in the United States and Spain with metastatic, recurrent, or persistent cervical cancer not curable with standard treatment were enrolled between 2009 and 2012. The trial was designed to answer two questions: Whether topotecan in combination with paclitaxel was superior to cisplatin and paclitaxel in combination, and whether the addition of bevacizumab to either regimen improved overall survival.
Patients were randomly assigned to one of four treatment groups; two of the treatment groups received bevacizumab. In an analysis conducted in 2012, it was determined that topotecan plus paclitaxel was not superior to the standard therapy of cisplatin plus paclitaxel and investigators and patients were notified of the finding at that time.
The purpose of bevacizumab is to block the blood supply that feeds the tumor. The drug originally was approved for certain types of metastatic cancer in combination with chemotherapy and is designed to bind to and inhibit vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in tumor blood vessel growth.
“This is welcome news as progress has been very difficult against this cancer, and GOG physicians and patients who participated have made an important contribution,” said Jeff Abrams, M.D., clinical director of NCI’s Division of Cancer Treatment and Diagnosis.
It is estimated that over 12,000 women will be diagnosed with cervical cancer in the United States in 2013 and over 4,000 women will die of the disease.
The trial is GOG240, Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab for Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer, clinical trial registry number NCT00803062. It was presented as Abstract 3 at the ASCO plenary on June 2, 2013.