Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting.

BACKGROUND: There have been recent advances in chemotherapy-induced nausea and vomiting using 5-HT(3) inhibitors and dexamethasone. However, many still experience these symptoms, and expert panels encourage additional methods to reduce these symptoms. OBJECTIVES: The objective was to assess the effectiveness of acupuncture-point stimulation on acute and delayed chemotherapy-induced nausea and vomiting in cancer patients. SEARCH STRATEGY: We searched MEDLINE, EMBASE, PsycLIT, MANTIS, Science Citation Index, CCTR (Cochrane Controlled Trials Registry), Cochrane Complementary Medicine Field Trials Register, Cochrane Pain, Palliative Care and Supportive Care Specialized Register, Cochrane Cancer Specialized Register, and conference abstracts. SELECTION CRITERIA: Randomized trials of acupuncture-point stimulation by any method (needles, electrical stimulation, magnets, or acupressure) and assessing chemotherapy-induced nausea or vomiting, or both. DATA COLLECTION AND ANALYSIS: Data were provided by investigators of the original trials and pooled using a fixed effect model. Relative risks were calculated on dichotomous data. Standardized mean differences were calculated for nausea severity. Weighted mean differences were calculated for number of emetic episodes. MAIN RESULTS: Eleven trials (N = 1247) were pooled. Overall, acupuncture-point stimulation of all methods combined reduced the incidence of acute vomiting (RR = 0.82; 95% confidence interval 0.69 to 0.99; P = 0.04), but not acute or delayed nausea severity compared to control. By modality, stimulation with needles reduced proportion of acute vomiting (RR = 0.74; 95% confidence interval 0.58 to 0.94; P = 0.01), but not acute nausea severity. Electroacupuncture reduced the proportion of acute vomiting (RR = 0.76; 95% confidence interval 0.60 to 0.97; P = 0.02), but manual acupuncture did not; delayed symptoms for acupuncture were not reported. Acupressure reduced mean acute nausea severity (SMD = -0.19; 95% confidence interval -0.37 to -0.01; P = 0.04) but not acute vomiting or delayed symptoms. Noninvasive electrostimulation showed no benefit for any outcome. All trials used concomitant pharmacologic antiemetics, and all, except electroacupuncture trials, used state-of-the-art antiemetics. AUTHORS' CONCLUSIONS: This review complements data on post-operative nausea and vomiting suggesting a biologic effect of acupuncture-point stimulation. Electroacupuncture has demonstrated benefit for chemotherapy-induced acute vomiting, but studies combining electroacupuncture with state-of-the-art antiemetics and in patients with refractory symptoms are needed to determine clinical relevance. Self-administered acupressure appears to have a protective effect for acute nausea and can readily be taught to patients though studies did not involve placebo control. Noninvasive electrostimulation appears unlikely to have a clinically relevant impact when patients are given state-of-the-art pharmacologic antiemetic therapy.

Impact of a culturally appropriate intervention on breast and cervical screening among native Hawaiian women.

BACKGROUND: Native Hawaiian women have the highest breast and cervical cancer mortality rates and lowest screening rates in Hawai'i. This paper summarizes impacts of a breast and cervical cancer screening intervention spearheaded by a Native Hawaiian community. METHODS: Six hundred seventy-eight randomly selected Native Hawaiian women completed two telephone surveys assessing their cancer screening behaviors: 318 women from a community that implemented an intervention, known as a Kokua Group, to provide culturally tailored education and support in a group setting and 360 women from communities without this intervention. The surveys were conducted before intervention implementation and 3 years later, 4 to 5 months after the last intervention session. RESULTS: At posttest, intervention community women reported positive changes in 4 of 12 screening activities (P < or = 0.05), while no changes were found among controls. Some women in both communities had heard about and/or participated in Kokua Groups. Hierarchical logistic regression showed that controlling for community, demographics, and pretest scores, Kokua Group knowledge or participation was a significant predictor (P < 0.05) of 9 of 12 screening-related behaviors. CONCLUSIONS: Positive changes in screening activities among women aware of the intervention support the importance of information diffusion by community consumers. Diffusion may occur beyond the boundaries of the community as defined.

Use of complementary and alternative medicine in Hawaii cancer patients.

This research investigated complementary and alternative medicine (CAM) use by Hawaii cancer patients. Thirty-six percent of patients used CAM, most commonly religious/spiritual therapy and herbal treatments. CAM use was linked with younger age, female gender, Catholic religion, and more education. More research is needed to inform decision-making.

Participatory research in a Native Hawaiian community. The Wai'anae Cancer Research Project.

BACKGROUND: Community participation was a key component of a cancer control research project in a Native Hawaiian community. This project tested the effectiveness of a culturally appropriate intervention as a means of increasing breast and cervical cancer screening practices among Native Hawaiian women on the Wai'anae Coast of the island of O'ahu. METHODS: The Wai'anae Cancer Research project was community driven, with Native Hawaiian community representatives involved in all phases of the project, from grant proposal development to data interpretation. A community health center administered the grant award from the National Cancer Institute. The policymaking steering committee included community representatives, health professionals, and researchers to balance community and scientific quality standards. A factor in the project's success was continuous involvement over 7 years by a core of community representatives and professional staff. RESULTS: More than 500 women participated in the intervention, and outcome measures indicated that there was a community wide impact on cancer-related knowledge, attitudes, and behaviors. Important contributions of the project also included direct economic benefits, improvements in health services and systems, increased research capabilities, and dissemination of findings to other communities and researchers. CONCLUSION: Community participation in all phases of the research was essential in generating community acceptance and resulted in an innovative and effective intervention. This participatory research project has left the community richer in knowledge, skills, experience, confidence, and resources. These qualities provide a strong foundation for building future programs and research.

Barriers to mammography in a low income, multiethnic clinic population.

Breast cancer-related knowledge, attitudes, behaviors and barriers to obtaining a mammogram were assessed in women attending a primary care clinic serving a low-income minority population. Although most women believed in the value of mammograms, fewer than one in six was compliant with guidelines, and there were considerable deficits in knowledge about breast cancer risk. Ethnic and age differences in responses have implications for health program planning.

A breast and cervical cancer project in a native Hawaiian community: Wai'anae cancer research project.

BACKGROUND: This article describes a breast and cervical cancer control project in a Native Hawaiian community and presents preliminary findings from its first year. The project is community driven, with Native Hawaiian community investigators and advisors involved in all phases of the research project. Its purpose is to test the effectiveness of a culturally appropriate intervention as a means of increasing breast and cervical cancer screening practices among Native Hawaiian women. METHODS: This article discusses the process of community participation in the development of a baseline survey as well as selected findings from that survey. A baseline telephone survey was conducted to obtain an initial assessment of community knowledge, attitudes, and behavior related to cancer. Community representatives were an integral part of the research team that planned and implemented the survey. RESULTS: A total of 1,260 women drawn equally from the study and the control communities participated in the survey. A majority of those surveyed in both communities indicated adherence to cancer screening recommendations. Seventy-three percent of the women reported having obtained a Pap test during the past 2 years. Fifty-nine percent of women over 40 years of age reported having had a mammogram during the past 2 years. Twenty-eight percent reported having used Hawaiian remedies within the past year. Thirty-six percent of the women reported encouraging others to obtain cancer screening services. DISCUSSION: Though a majority of the target population are following cancer screening guidelines, a significant minority are not. While the project intervention aims to change the screening behavior of women not currently getting cancer screening, it plans to do so by enlisting the women already in compliance to reach others in their social networks who are currently not getting cancer screening. The involvement of community representatives, working alongside researchers, in baseline survey planning helped assure the survey was acceptable to the participants and the community as a whole. This process is illustrative of a participatory research commitment which underlies success in the early phase of this Native Hawaiian research project.

Polyethylene glycol conjugated interleukin-2: clinical and immunologic effects in patients with advanced renal cell carcinoma.

Recombinant interleukin-2 (rIL-2) modified with monomethoxypolyethylene glycol (PEG IL-2) was utilized in patients with metastatic renal cell carcinoma in two separate multi-institutional trials. PEG IL-2 was administered as an I.V. bolus days 1, 8, 15, and 22 with cycles repeated every six weeks. The two trials employed different dose levels: A) 20 x 10(6) I.U./m2 day 1 followed by 12 x 10(6) I.U./m2 days 8, 15, 22; and B) 12 x 10(6) I.U./m2 days 1, 8, 15, 22. Thirty-five patients were entered and 31 were evaluable for response (A-15/18, B-16/17). Two of 31 patients had partial responses. Median therapy duration was four weeks (range 1-15), and dose reduction for grade III or IV toxicity was required in 14/35 patients (A-6/18, B-8/17). Toxicity (> or = grade III) seen included: hypotension 51%, dyspnea 17%, seizures 6%, and mental status changes 11%. No differences in response or toxicity between the two schedules were noted. Hematologic changes included lymphocytosis and eosinophilia in the majority of patients. PEG IL-2 given once weekly has significant toxicity, and may produce tumor regression in patients with renal cell carcinoma.

Prospects for immunotoxin therapy in cancer.

Immunotoxins are formed by chemically linking antibodies to "toxic" polypeptides that inactivate protein synthesis. These hybrid protein molecules are guided to tumor cells by the antibody moiety, and once bound to the tumor cells, the toxic polypeptide moiety penetrates the cell membrane and enzymatically inactivates protein synthesis. A stepwise approach to identifying the potential clinical uses of immunotoxins in cancer therapy is examined in this chapter.

Radioimmunoassay for etoposide and teniposide.

A radioimmunoassay for VP-16 or VM-26 was developed by using tritiated ligand and antisera produced from rabbits immunized with succinyl-VP-16 bovine serum albumin conjugates. Separate determinations of VP-16 and its hydroxy acid, a metabolite which cross-reacted with the VP-16 antisera, could be accomplished by extracting samples with chloroform in which the metabolite was insoluble. The assay was reproducible and sensitive. Extracted standard curves were linear from 0.025 to 5 micrograms for VP-16 and 0.1 to 10 micrograms for the hydroxy acid per 0.5 ml assay mixture. Fifty percent inhibition of binding was achieved at 0.066 and 0.55 microgram for VP-16 or VM-26 and the metabolite, respectively. Preliminary disposition studies in mice and dog, and human urinary excretion support the application of the assay in pharmacologic studies.

Cell-mediated inhibition of tumor colony formation in agarose by resting and interleukin 2-stimulated human lymphocytes.

Human nonadherent peripheral blood mononuclear cells (PBMC) isolated from nonimmunized donors were preincubated for 18 h in medium alone or medium containing the lymphokine interleukin 2 and subsequently cocultured with tumor cells derived from malignant tumor cell lines or from fresh human tumors. The cell suspensions were subsequently inoculated into agarose; 14 days later, new tumor colony formation was determined. Although the different tumor cells displayed a wide range of sensitivity to the PBMC, in each instance, the number of colonies formed by the tumor cells exposed to the PBMC was consistently reduced relative to that of control cells. The inhibitory effect on the colony-forming cells was especially pronounced with PBMC preincubated with interleukin-2 and was dependent on the ratio of tumor cells to PBMC in the culture. This assay system provides an alternative to the standard 51Cr release assays in assessing the immunomodulatory effects of lymphokines and in quantitating the cytolytic or cytostatic activity of various effector cells against neoplastic stem cells from established cell lines and from heterogeneous cell preparations derived from fresh human tumors.

Mitomycin: ten years after approval for marketing.

Mitomycin was approved for marketing by the Food and Drug Administration in 1974 for use in gastric and pancreatic carcinomas when combined with other chemotherapeutic agents. Since then, mitomycin has been used extensively in combination chemotherapy for a variety of tumors, particularly in the past seven years. However, the contribution of this agent to the various drug regimens has not been adequately defined. Clear evidence of the drug's activity as a single agent has been seen in the intravesical treatment of superficial bladder carcinoma. Common toxicities include anorexia, vomiting, and myelosuppression. Less common, but potentially lethal, toxicities in the form of fibrosing alveolitis and microangiopathic hemolytic anemia with renal failure are being reported with increasing frequency. These potentially severe adverse effects, coupled with the still undefined role of mitomycin in systemic cancer chemotherapy, suggest that selection of this drug for other than investigational use should be made with care.

Clinical pharmacology of intraperitoneal cisplatin.

The clinical pharmacology of cisplatin was determined in six patients with malignant ascites secondary to ovarian cancer, and in one patient with peritoneal mesothelioma, following intraperitoneal administration of cisplatin (25-60 mg/m2). The drug was administered in 1 liter of normal saline as a 15- to 30-min infusion. Total, and in some patients free (ultrafilterable), platinum concentrations were determined in plasma, urine, and ascitic fluid by flameless atomic absorption spectrometry. The peak total platinum concentrations in ascitic fluid at the end of infusion were related to dose, a 50 mg/m2 dose producing a 20 to 80 micrograms cisplatin/ml concentration. Filterable platinum represented between 3 and 59% of total platinum in the peritoneum at 4 to 6.5 hr following its administration. Plasma platinum concentrations ranged between 0.2 to 1.6 micrograms/ml 4 hr following administration, and reached a plateau for the next 24 to 48 hr largely in the form of protein-bound platinum. The urinary excretion of cisplatin was consistent with variation in absorption from the peritoneum. Minimal gastrointestinal, bone marrow, and renal toxicities during therapy suggest that sustained free platinum concentrations in ascites may be obtained without significant toxicity and support the intraperitoneal route of administration as an effective strategy for cisplatin therapy of intra-abdominal malignancies.

Chemotherapy for advanced adenocarcinoma and squamous cell carcinoma of the lung with etoposide and cisplatin.

Forty-one patients with unselected advanced non-small cell lung cancer were treated with a combination of etoposide and cisplatin. A response rate of 19%, a 78-week median survival of responders, and a 36-week overall median survival were observed.

Mitomycin C intravesical therapy in noninvasive bladder cancer after failure on thiotepa.

Mitomycin C 40 mg in 40 ml water was administered intravesically every week for 8 consecutive weeks to 60 patients with superficial bladder cancer. All patients had failed treatment with intravesical thiotepa and had evaluable disease. An objective response of 50% or greater reduction in measured tumor mucosal involvement was obtained in 68% of patients. Forty-two percent of the patients achieved a complete response, and this included 50% of patients with Grade III disease and 70% of patients with a T1 tumor. Median response duration in complete responders was 12.2 months with a range of 3.5 to 24.3 + months. Fifty-five percent of patients are still responding. Therapy was generally well tolerated, and in contrast to thiotepa, myelosuppression was not the dose-limiting effect. One third of all patients experienced symptoms of local irritation, and skin reactions were seen in 12% of patients.

The human tumor colony-forming chemosensitivity assay: a biological and clinical review.

Over forty papers describing correlations between in vitro human tumor sensitivity to a variety of chemotherapeutic agents and the in vivo response of patients to those agents have been published since the publication in 1978 by Salmon and Hamburger of their results of a human tumor colony-forming chemosensitivity assay (CFCA). The true positive rate in over 1600 correlations is 71% and the true negative rate is 94%. The biological elements of the assay, its developmental history, its place in the spectrum of in vitro chemosensitivity assays, and its theoretical and practical limitations are discussed. The scope, design, and limitations of key clinical trials are presented and an analysis of the potential errors of statistical interpretation of the trials as well as the results of the trials is given.