Cervical Cancer

GlaxoSmithKline Submits BLA for Cervarix HPV Vaccine

In its second annual "Clinical Cancer Advances" report, the American Society of Clinical Oncology (ASCO) selected six notable developments in clinical cancer research as most important in 2006.

Hospitalized oncology patients are at particular risk for acute venous thromboembolism (VTE); however, more often than not, a standard for VTE prophylaxis does not exist, according to Jerelyn Osoria, RN, OCN, of Memorial Sloan-Kettering Cancer Center. Ms. Osoria reported at the Oncology Nursing Society 31st Annual Congress (abstract 113) that an electronic medical orders system and better nursing documentation have helped improve this situation at her institution's Gynecology (GYN) oncology inpatient nursing unit.

Trials in the past decade offer the first evidence that some of the most prevalent cancers in the population are preventable, and a host of ongoing trials are testing new prevention strategies, Peter Greenwald, MD, DrPH, director of the National Cancer Institute's Division of Cancer Prevention, said at the 50th Annual Meeting of the Southwest Oncology Group (SWOG).

This article summarizes the current management of patients with newly diagnosed cervical cancer. The topics range from the management of early-stage disease to the phase III randomized studies that have established the current standard of care for patients with locally advanced cancer of the cervix. New approaches to combined-modality therapy with the goal of improving outcomes and decreasing complications are also described.

This article summarizes the current management of patients with newly diagnosed cervical cancer. The topics range from the management of early-stage disease to the phase III randomized studies that have established the current standard of care for patients with locally advanced cancer of the cervix. New approaches to combined-modality therapy with the goal of improving outcomes and decreasing complications are also described.

This article summarizes the current management of patients with newly diagnosed cervical cancer. The topics range from the management of early-stage disease to the phase III randomized studies that have established the current standard of care for patients with locally advanced cancer of the cervix. New approaches to combined-modality therapy with the goal of improving outcomes and decreasing complications are also described.

This article summarizes the current management of patients with newly diagnosed cervical cancer. The topics range from the management of early-stage disease to the phase III randomized studies that have established the current standard of care for patients with locally advanced cancer of the cervix. New approaches to combined-modality therapy with the goal of improving outcomes and decreasing complications are also described.

African-American women with uterine cancer have worse survival rates than white women who received similar treatment even though they had similar prognostic factors

xAdvaxis, Inc. has conducted a pre-IND meeting with the FDA regarding its two planned phase II studies for its lead product Lovaxin C, a live Listeria vaccine for the treatment of cervical and head and neck cancers. The IND will be filed once phase I/II studies have been completed. In a separate news release, Advaxis announced that its breast cancer vaccine Lovaxin B, Listeria monocytogenes modified to deliver HER2/neu to immune cells, is in preclinical testing.

 I read with great interest the paper by Michael Brave and colleagues from the US Food and Drug Administration (FDA). The authors describe the FDA's review supporting this first approval of a chemotherapeutic drug for advanced cervical cancer. This decision was made after a Gynecologic Oncology Group trial (GOG-0179) conducted at 94 American study centers demonstrated a survival benefit in patients with stage IVB, recurrent, or persistent carcinoma of the cervix who received cisplatin plus topotecan (Hycamtin) compared with those who received cisplatin alone.

Topotecan, a camptothecin analog previously approved for the treatment of ovarian cancer and small-cell lung cancer, was granted regular approval by the US Food and Drug Administration (FDA) on June 14, 2006, for use in combination with cisplatin to treat women with stage IVB, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. The purpose of this summary is to review the database supporting this approval.

Topotecan, a camptothecin analog previously approved for the treatment of ovarian cancer and small-cell lung cancer, was granted regular approval by the US Food and Drug Administration (FDA) on June 14, 2006, for use in combination with cisplatin to treat women with stage IVB, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. The purpose of this summary is to review the database supporting this approval.

Astudy conducted by researchers from the Medical University of South Carolina (MUSC) and University of South Carolina shows that the cancer rate among blacks living in South Carolina is nearly twice as great as it is for whites in the state.

Topotecan, a camptothecin analog previously approved for the treatment of ovarian cancer and small-cell lung cancer, was granted regular approval by the US Food and Drug Administration (FDA) on June 14, 2006, for use in combination with cisplatin to treat women with stage IVB, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. The purpose of this summary is to review the database supporting this approval.

Although most American adults can identify mammography, the Pap test, and colonoscopy as cancer screening tests, they are generally ill informed about the age at which screening should begin and how often they should undergo the examinations.

The FDA has approved Hycamtin (topotecan, GlaxoSmithKline) in combination with cisplatin for the treatment of women with late-stage (IVB) cervical cancer that surgery or radiation appears unlikely to cure. The agency acted on the basis of a single phase III trial that showed a significant 2.9-month survival advantage in women treated with the combination vs whose who received cisplatin alone.

The FDA has approved Merck's Gardasil (quadrivalent human papillomavirus recombinant vaccine) for the prevention of cervical cancer and cervical, vulvar, and vaginal precancers caused by human papillomarvirus (HPV).

The Food and Drug Administration (FDA) has announced the approval of the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16, and 18. The vaccine, which carries the brand name Gardasil, is approved for use in females 9 to 26 years of age. Gardasil was evaluated and approved in 6 months under FDA's priority review process. This month, "Closing Thoughts" shares comments about the vaccine from leaders in the oncology community.

The US Food and Drug Administration (FDA) has approved topotecan HCl (Hycamtin) in combination with cisplatin, for the treatment of stage IVB, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy. Following a 6-month priority review by the FDA, the expanded indication is based on phase III results that demonstrated a survival advantage by using topotecan in combination with cisplatin compared to cisplatin alone.

Childbearing is one of the most important life goals for many women, and fertility preservation is a very important factor in the overall quality of life of cancer survivors. Cervical cancer frequently affects young women; because some women tend to delay childbearing, fertility preservation must be considered when treatment options are discussed. Over the past decade, the radical trachelectomy procedure has become a well established fertility-preserving option for young women with early-stage cancer; this procedure is associated with low morbidity, good oncologic outcome, and a high proportion of pregnancies that reach the third trimester and babies that are delivered at term. This article will review available literature on the vaginal radical trachelectomy procedure and data from other surgical approaches, such as the abdominal radical trachelectomy. In addition, the potential future application of neoadjuvant chemotherapy followed by fertility-preserving surgery in patients with locally advanced cervical cancer will be examined. Finally, ultraconservative surgical approaches (eg, conization alone with or without laparoscopic lymphadenectomy) in very early-stage disease will be discussed.

Childbearing is one of the most important life goals for many women, and fertility preservation is a very important factor in the overall quality of life of cancer survivors. Cervical cancer frequently affects young women; because some women tend to delay childbearing, fertility preservation must be considered when treatment options are discussed. Over the past decade, the radical trachelectomy procedure has become a well established fertility-preserving option for young women with early-stage cancer; this procedure is associated with low morbidity, good oncologic outcome, and a high proportion of pregnancies that reach the third trimester and babies that are delivered at term. This article will review available literature on the vaginal radical trachelectomy procedure and data from other surgical approaches, such as the abdominal radical trachelectomy. In addition, the potential future application of neoadjuvant chemotherapy followed by fertility-preserving surgery in patients with locally advanced cervical cancer will be examined. Finally, ultraconservative surgical approaches (eg, conization alone with or without laparoscopic lymphadenectomy) in very early-stage disease will be discussed.

Childbearing is one of the most important life goals for many women, and fertility preservation is a very important factor in the overall quality of life of cancer survivors. Cervical cancer frequently affects young women; because some women tend to delay childbearing, fertility preservation must be considered when treatment options are discussed. Over the past decade, the radical trachelectomy procedure has become a well established fertility-preserving option for young women with early-stage cancer; this procedure is associated with low morbidity, good oncologic outcome, and a high proportion of pregnancies that reach the third trimester and babies that are delivered at term. This article will review available literature on the vaginal radical trachelectomy procedure and data from other surgical approaches, such as the abdominal radical trachelectomy. In addition, the potential future application of neoadjuvant chemotherapy followed by fertility-preserving surgery in patients with locally advanced cervical cancer will be examined. Finally, ultraconservative surgical approaches (eg, conization alone with or without laparoscopic lymphadenectomy) in very early-stage disease will be discussed.

A 46-year-old multiparous (gravida 3, para 3) woman presented to her primary care provider with a palpable vulvar polypoidal mass, measuring 7 cm in greatest dimension. The mass was painless and had been growing in size over the past 2 years. Her medical history was remarkable for obesity, hypothyroidism, and an appendectomy at age 17. Her family history was significant for a sister with breast cancer, diagnosed at age 34. A core biopsy was performed.

SAN FRANCISCO-In a large phase III study, a prophylactic human papillomavirus (HPV) vaccine prevented 100% of high-grade cervical precancers and noninvasive adenocarcinomas associated with HPV types 16 and 18. Laura Koutsky, PhD, of the University of Washington, Seattle, presented the results for the FUTURE II Steering Committee at a late-breaking abstract session of the Infectious Diseases Society of America annual meeting.

Granulocyte-macrophage colony-stimulating factor (GM-CSF,sargramostim [Leukine]) is a powerful cytokine that is able to stimulatethe generation of dendritic cells. Adjuvant treatment with continuous lowdoseGM-CSF has been shown to prolong survival of stage III/IV melanomapatients. Data on continuous low-dose GM-CSF therapy in tumorsother than prostate cancer are still lacking.

Over the past four decades, the incidence and mortality rates for uterine cervical carcinoma have decreased in the United States by as much as 70% to 75% [1]. This improvement is among the largest seen for any cancer site and has been attributed to the use of cervical cytologic screening [2].

Pemetrexed (Alimta) is a novel antimetabolite that inhibits the folatedependentenzymes thymidylate synthase, dihydrofolate reductase, andglycinamide ribonucleotide formyltransferase. Pemetrexed has demonstratedactivity in clinical trials in a variety of tumor types, includinglung, breast, colon, mesothelioma, pancreatic, gastric, bladder, headand neck, and cervix. Pemetrexed is rapidly metabolized into activepolyglutamate forms that are potent inhibitors of several tetrahydrofolatecofactor-requiring enzymes critical to the synthesis of purines and thymidine.Functionally, pemetrexed acts as a prodrug for its polyglutamateforms. Two different transporters are known to take extracellular folates,and some antifolates, into the cell. These are the reduced folate carrierand the folate receptor. One of the many attributes that make pemetrexedunique is that methodology has been developed to eliminate and controlmany of its associated clinical toxicities. Multivariate analyses demonstratedthat pretreatment total plasma homocysteine levels significantlypredicted severe thrombocytopenia and neutropenia, with orwithout associated grade 3/4 diarrhea, mucositis, or infection. Routinevitamin B12 and folic acid supplementation have resulted in decreasedfrequency/severity of toxicities associated with pemetrexed without affectingefficacy, making this novel antifolate a safe and efficaciousanticancer agent.

Pemetrexed (Alimta) is active in a variety of solid tumors, includingbreast and gynecologic cancers. Phase II trials of pemetrexed at a doseof 600 mg/m2 without vitamin B12 and folic acid supplementation inlargely pretreated metastatic breast cancer patients demonstrated objectiveresponse rates of 21% and 28%, with generally manageableneutropenia constituting the primary toxicity. In phase II trials using500 mg/m2 with or without vitamin supplementation in anthracyclineandtaxane-pretreated patients, response rates were lower (approximately9%) and treatment was generally well tolerated irrespective ofvitamin supplementation status. A phase II trial is currently comparingpemetrexed doses of 600 and 900 mg/m2 with vitamin B12 supplementationin patients with previously untreated advanced breast cancer. In aphase II trial in patients with advanced cervical cancer, pemetrexed at600 mg/m2 without vitamin supplementation and 500 mg/m2 with supplementationproduced similar response rates, with the frequency of neutropeniabeing somewhat lower among patients receiving the lower doseand vitamin supplementation. Preliminary results in an ongoing phaseII trial indicate activity of the regimen of gemcitabine (Gemzar) at1,000 mg/m2 plus pemetrexed at 500 mg/m2 with vitamin supplementationin patients with ovarian cancer. Ongoing and future studies willestablish optimal dosing regimens of pemetrexed and potential benefitsof vitamin supplementation in the settings of metastatic breastcancer and gynecologic malignancies.

The 14 reports in this special supplement discuss theuse of the cytoprotectant amifostine in patients withcancer of the head and neck, esophagus, lung, andcervix, as well as those with lymphoma and acutemyelogenous leukemia. Discussions focus on thepotential of this agent to both reduce radiation sideeffects such as xerostomia and permit doseescalation of chemotherapy and/or radiotherapy.Improvements in treatment outcome and quality oflife as a result of cytoprotection are examined.