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Treatment section for stage IIIB, IV, recurrent and metastatic disease Expanded text under systemic therapy on second-line hormone therapy to include the ER down regulator fulvestrant, revised text on the results of prospective randomized trials that found at least equal efficacy and better tolerability for all 3 currently available aromatase inhibitors when compared to megestrol acetate (cited Henderson et al.), and to include the results of 2 randomized trials of patients who had progressed after receiving tamoxifen that demonstrated that fulvestrant yielded similar results to anastrozole in terms of its impact on disease-free survival (cited Osborns et al. and Howell et al.).
Expanded text on trastuzumab to state that women with high serum levels of HER2/neu seem to be less responsive to hormone treatment (cited Lipton et al.)
Added Harris et al. as reference #45
Added Berry et al. as reference #68.
Removed Gross et al. as a reference for the section.
Expanded text on the results of Radiation Therapy Oncology Group (RTOG) 85-01 to state that 8-year follow-up of this trial demonstrated an overall survival rate of 22% for patients receiving chemotherapy (cited Cooper et al.), to include the results of RTOG 94-05 that randomized 236 patients with localized esophageal tumors to chemoradiation with high-dose radiation therapy and 4 monthly cycles of 5-FU (cited Minsky et al.), and to note that this trial was closed in 1999 after a planned interim analysis showed that it was statistically unlikely that there would be any advantage using high-dose radiation.
Expanded the treatment option under clinical evaluation to state that the HLFP regimen (5-FU and cisplatin in combination with hydroxyurea and leucovorin) has resulted in objective response rates of 57% and a median overall survival rate of 12.7 months (cited Taieb et al.).
Replaced Sur et al.(1998) with Sur et al.(2002) as reference #3.
Editorial changes were made to the following adult treatment summaries for health professionals:
Added text to state that in one randomized trial the use of pegaspargase was associated with more rapid clearance of blast cells and a lower incidence of neutralizing antibodies than native E. coli asparaginase and that in the Children's Cancer Group trials patients receive only pegaspargase. Added Ogden et al. as reference 16.
Added text to state that patients with a t(9;11) subtype may confer an improved prognosis (cited Rubnitz et al.).
Added text to state that mediastinal disease may be monitored by combinations of imaging technologies such as MRI and PET scanning (cited Weihrauch et al.).
Added text to state that patients with NHL arising in bone have an excellent prognosis regardless of histology (cited Lones et al.).
Added text to state that the head and neck are other areas of clinical presentation in Burkitt's lymphomas. Added text to state that the clinical presentation of anaplastic large cell lymphoma is variable but that systemic symptoms are often prominent.
Added text to state that rasburicase is another drug that may be used in the initial "pre-phase" treatment.
Added text to state that there is no evidence that preradiation chemotherapy is of benefit for this tumor and that studies suggest potential benefit for postradiation chemotherapy (cited Timmerman et al.). Added text to state that in children less than 3 years of age with primitive neuroectodermal tumors, chemotherapy can be used to delay the need for radiation therapy.
Added text to state that there are other less common complications of radiation therapy such as cerebrovascular accidents (cited Bowers et al.).
Added text to state that patients who relapse within 2 years after diagnosis and those with local recurrences have the most favorable outcomes.
Added text to state that extraosseous osteosarcoma is a malignant mesenchymal neoplasm not attached to the skeletal system and that treatment should follow the guidelines of soft tissue sarcoma (cited Ahmad et al.). Added Antonescu et al. as reference 2.
Added text to state that in one study patients undergoing limb salvage procedures who had poor histologic response and close surgical margins had a high rate of local recurrence (cited Grimer et al.).
Added text to state that cyclophosphamide and etoposide have shown activity in treating recurrent osteosarcoma (cited Rodriguez-Galindo et al.).
Changes were made to the following pediatric treatment summaries for patients:
Evidence Related to the Clinical Value of Genetic Tests and Family History Information section Revised text to state that the clinical validity of a genetic test for a specific mutation may vary in different populations.
Revised definition of sporadic cancer.
Added text to state that the relationship between availability of effective medical treatment for mutation carriers and clinical validity of a given test affects the degree to which personal choice or physician recommendation is supported in counseling at-risk individuals (cited Burke et al.). Added Biesecker and Weil as references 26 and 27, respectively.
Added Shih et al. and Berry et al. as references 68 and 71, respectively.
Added text on the role of BRCA1/BRCA2 in sporadic cancer to state that a series of 221 ovarian cancers analyzed for mutations in BRCA1 identified 15 somatic mutations and 18 tumors with evidence of BRCA1 dysfunction due to hypermethylation (cited Geisler et al.) and that despite the paucity of somatic BRCA1 and BRCA2 mutations in sporadic breast and ovarian cancer, functional alterations in these genes may play a role in these cancers.
Added text on molecular correlations to state that a study of 356 families with protein-truncating BRCA1 mutations collected by the Breast Cancer Linkage Consortium reported breast cancer risk to be lower, with mutations in the central region (nucleotides 2401-4190), and ovarian cancer risk was significantly reduced with mutations 3' to nucleotide 4191 (cited Thompson et al.).
Added text on pathology/prognosis to state that the Breast Cancer Linkage Consortium found an increased frequency of high-intensity immunostaining for p53 in tumors among BRCA1 mutation carriers (cited Lakhani et al.), and that a case series report found higher rates of both ipsilateral and contralateral breast cancers among BRCA1/2 mutation carriers compared to mutation negative cases (cited Haffty et al.). Added test on a nationwide, population-based case- control study in Israel that found a survival advantage for ovarian cancer patients with BRCA founder mutations in the early years after diagnosis (cited Ben David et al.) and on a case-control study at the University of Iowa that failed to find a survival advantage for women with BRCA1 inactivation whether by germline mutation, somatic mutation, or BRCA1 promoter silencing (cited Buller et al.).
Added Chenevix-Trench, Christian, Humphries, Solh, and Scully as references 138, 146, 147, 148, and 149, respectively.
Psychosocial Issues in Inherited Breast Cancer Syndromes section Added text on anticipated and actual interest in genetic testing to state that a study of 258 individuals offered clinical genetic testing due to at least 10% risk of being a BRCA1/2 carrier found that at 26 months after the first genetic counseling session, only 26% had undergone genetic testing, and that genetic testing uptake was influenced by eligibility for free testing, prior history of breast or ovarian cancer, and Ashkenazi Jewish heritage (cited Lee et al.). Added text to state that overestimation of both breast and ovarian cancer risk has been associated with nonadherence to physician-recommended screening practices (cited Lindberg et al. and Ritvo et al.) and that targeted educational materials may be effective means of increasing knowledge about the pros and cons of genetic testing (cited Schwartz et al.).
Added text on emotional outcomes of individuals to state that studies indicate that affected individuals who undergo genetic counseling and testing experience more distress than had been expected by professionals (cited Bonadona et al. and Bish et al.); are less able to anticipate the intensity of their reactions following result disclosure (cited Dorval et al.); that women mutation carriers who had breast cancer worried more than unaffected women about developing ovarian cancer, though worry about ovarian cancer risk was found to be unrealistically low; and that some distress related to the "burden" of conveying genetic information to relatives has been noted among those who are the first in their families to be tested.
Added text on family effects to state that a study of men tested for BRCA1/2 found the majority to have low pretest distress, scores were lowest for men who were optimistic or who did not have daughters, the majority of mutation carriers had normal levels of anxiety and depression and reported no guilt, some anticipated increased distress and feelings of responsibility if their daughters developed breast or ovarian cancer, and none of the noncarriers reported feeling guilty (cited Lodder et al.)
Added text on behavioral outcomes to state that a study of screening behaviors in 216 self-referred, high-risk women members of hereditary breast cancer families found suboptimal screening practices despite the presence of known mutations in their families, 69% of women ages 50-64 and 83% of women 40-49 had had a screening mammogram in the prior year, and ovarian cancer screening rates were even lower with 20% of participants ever having a CA 125 test and 31% having had a pelvic or transvaginal ultrasound (cited Isaacs et al.). Added text on a large study that found patient compliance with screening practices was not related to general or screening-specific anxiety with the exception of BSE for which compliance is negatively associated with procedure-specific anxiety (cited Lindberg et al.).
Added text to state that colorectal cancers are predominately epithelial derived tumors (i.e., adenocarcinomas or adenomas). Revised text on genes involved in chromosome losses to include DCC/MADH2/MADH4(18q) and TP53. Added Sieber et al. as reference 43 and the Women's Health Initiative Investigators as reference 57. Added text to state that one observational study has shown that use of multivitamins and folate in women with a family history of colorectal cancer was associated with decreased relative risk of colon cancer (cited Fuchs et al.).
Added text to state that mutations that reduce rather than eliminate production of the APC protein may also lead to FAP (cited Yan et al.).
Added text to state that if FAP patients opt for a subtotal colectomy, periodic and lifelong surveillance of the rectum to remove or ablate any polyps is the standard of care, and that celecoxib has been approved by the FDA as an adjunct to endoscopic surveillance following subtotal colectomy in patients with FAP. Added text on patients with APC germline mutations to state that the degree of polyposis detected appears to correlate with risk of duodenal adenocarcinoma (cited Groves et al.).
Added text on genetic/molecular testing for HNPCC to state that clinically available tests do not currently detect large genomic deletions that may account for approximately 23% of mutations in hMSH2 (but not in hMLH1) in families in whom HNPCC was suspected but no mutations found in sequence analysis (cited Charbonnier et al.) and that deleterious mutations in the MSH6 gene have been reported in fewer than 5% of patients suspected of HNPCC (cited Berends et al.).
Added text on screening for endometrial cancer in HNPCC families to state that one observational study of 292 women has shown that all cases of endometrial cancer were detected after patients presented with signs and symptoms, suggesting that these signs should be aggressively evaluated in HNPCC family members (cited Dove-Edwin et al.).
Psychosocial Issues in Hereditary Colon Cancer Syndromes: Hereditary Nonpolyposis Colon Cancer and Familial Adenomatous Polyposis section
Added text to state that in a survey of gastroenterologists, only 16% recommended appropriate surveillance intervals for HNPCC patients (cited Batra et al.).
Added Brandi et al. as reference 13. Added text to state that misclassification of families with MEN 2A as having FMTC (due to small family size or later onset of other manifestations of MEN 2A) may result in overlooking the risk of pheochromocytoma, a disease with significant morbidity and mortality.
Revised text on prophylactic thyroidectomy to state that reimplantation of the parathyroid glands into the neck or forearm is a preventive option. Added text to state that the genotype/phenotype correlations suggest significant differences in biological aggressiveness of the medullary thyroid cancers that occur in MEN 2A, MEN 2B, and FMTC and that some authors suggest basing decisions on the timing of prophylactic thyroidectomy and the extent of surgery on these differences (cited Brandi et al.). Added text to say that surgery for MEN 2B is performed before age 1 (perhaps as early as 6 months).
Added text on treatment for those with pheochromocytoma to state that laparoscopic adrenalectomy is recommended by some authorities for the treatment of unilateral pheochromocytoma (cited Brandi et al.).
Added levels of evidence to this section.
Added text to state that the risk of lung cancer was significantly increased in smokers taking beta-carotene as part of a clinical trial. Added text to state that there was no reduction in risk of adenomatous polyps of the colon in high-risk individuals taking fiber supplements as part of a clinical trial.
Added text to clarify and specify the several potential harms that must be considered against any potential benefit of screening for cancer.
Added text describing results of an animal study that showed an interaction between ionizing radiation and the BRCA2 gene (cited Tutt et al.).
Added text on the potential harms associated with screening.
Added text stating that 85% of research volunteers in a large-scale randomized trial accepted repeat sigmoidoscopy after 3 years (cited Weissfeld et al.).
Added text on the potential harms associated with screening.
Added text describing LDCT and the detection of benign nodules (cited Diederich et al.).
Clarified text on the relation between screening for neuroblastoma and subsequent mortality.
Added text describing results from the German Neuroblastoma Screening Project (cited Schilling et al.).
Added text describing results from population-based screening studies in Canada and Germany (cited Schilling et al. and Woods et al.).
Editorial changes were made to the following screening and prevention summaries for health professionals:
Revised text to state that a retrospective review evaluating surgical palliation of malignant bowel obstruction secondary to peritoneal carcinomatosis in 63 patients with nongynecological cancer used the ability to tolerate solid food at hospital discharge as the criterion for successful palliation and that multiple logistic regression analysis identified the absence of ascites and obstruction not involving the small bowel as predictors of successful surgical palliation in this population. Added text to state that successful palliation was achieved in 45% of patients and was maintained in 76% of this group at a median follow-up of 78 days, for an overall success rate of 35% and that postoperative mortality was 15% and postoperative complications occurred in 44%. Revised text to state that for some patients with malignant obstructions of the gastrointestinal tract, the use of expandable metal stents may provide palliation of obstructive symptoms and that available stents include esophageal, biliary, gastroduodenal, and colorectal and may be placed under endoscopic guidance using fluoroscopy.
Revised text to state that octreotide given at 50 to 200 mcg three times a day may reduce the nausea, vomiting, and abdominal pain of malignant bowel obstruction and that for selected patients, the addition of an anticholinergic such as scopolamine may be helpful in reducing the associated painful colic of malignant bowel obstruction when octreotide alone is ineffective.
Revised text to state that the occurrence of the hyperactive subtype of delirium significantly correlates with opioid and steroid use, while the hypoactive subtype is associated with dehydration and that the association of hepatic failure with subtype of delirium is unclear.
Revised text to state that a critical part of cancer care is the recognition of the levels of depression present and determination of the appropriate level of intervention, ranging from brief counseling or support groups to medication and/or psychotherapy.
Added text to state that high levels of anxiety and depression may be associated with large discrepancies between perceived attainment of life values and importance of these life values (cited Nordin et al.). Added text to state that a goal of psychotherapy is to work with patients to prioritize life values to minimize discrepancies between the perceived attainment of life values and the importance of the values as a means of decreasing associated symptoms of depression and anxiety.
Revised text to state that response to fever varies with age.
Added text to state that venlafaxine, a norepinephrine and serotonin reuptake inhibitor (NSRI), has been demonstrated to produce a 60% reduction in severity and intensity of hot flashes and that the optimal dose indicated in these trials is 75 mg of the extended release formulation twice a day.
Editorial changes were made to the following supportive care summaries for health professionals:
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