Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis.

PURPOSE: To determine whether a chlorhexidine mouthwash could alleviate radiation-induced oral mucositis. PATIENTS AND METHODS: Patients scheduled to receive radiation therapy to include greater than one third of the oral cavity mucosa were selected for study. Following stratification, they were randomized in a double-blind manner to receive a chlorhexidine mouthwash or a placebo mouthwash. Both groups were then similarly evaluated for mucositis and mouthwash toxicity. RESULTS: Twenty-five patients were randomized to receive the chlorhexidine mouthwash, while 27 received the placebo mouthwash. Treatment arms were well balanced. There was a trend for more mucositis and there was substantially more toxicity (eg, mouthwash-induced discomfort, taste alteration, and teeth staining) on the chlorhexidine arm. CONCLUSION: In contrast to the prestudy hypothesis that a chlorhexidine mouthwash might provide benefit for patients receiving radiation therapy to the oral mucosa, this study provides strong evidence suggesting that a chlorhexidine mouthwash is detrimental in this clinical situation.

Marrow transplantation for stable-phase chronic granulocytic leukemia.

Ten patients with chronic granulocytic leukemia in the stable phase underwent marrow transplantation from HLA-identical siblings (nine cases) or an identical twin (one case) following preparation with cytarabine, cyclophosphamide, and total body irradiation. Marrow cytogenetics on all patients prior to transplantation revealed the Philadelphia chromosome without other evidence of aneuploidy. The immediate posttransplant course was in most cases relatively uncomplicated with only two serious infections and one death. All patients recovered with cytogentically normal marrow and leukemia has recurred only in the syngeneic transplant recipient. At present, nine patients are surviving from 358 to 961 days (median 597 days) after bone marrow transplantation. Bone marrow transplantation is capable of eliminating the abnormal clone of myeloid cells in patients with stable-phase chronic granulocytic leukemia and can be performed relatively safely in this "healthy" group of patients.

A clinical review of seventeen patients with ovarian dysgerminoma.

This is a retrospective evaluation of 17 patients with the diagnosis of ovarian dysgerminoma who were treated at the University of Iowa Hospitals from January 1938, to December 1976. Not a single patient was lost to follow-up. The majority of patients were between 11 to 30 years old. Seven patients died with disease, 3 during the 1st year, 3 during the 2nd year and 1 during the 4th year after diagnosis. In this series we have 10 patients with no evidence of disease (NED). The duration of follow-up of that group is from 51 months to 444 months with a median of 102 months. Postoperative radiation therapy is a valuable adjuvant to surgical treatment for dysgerminoma.

Multimodality therapy of favorable prognosis non-Hodgkin's lymphoma.

Twenty-seven previously untreated patients with favorable prognosis non-Hodgkin's lymphoma were treated with a combination of total body irradiation followed by cyclophosphamide - vincristine - prednisone (CVP). The dose of total body irradiation was planned to be 150 rad followed by 6 cycles of chemotherapy. The complete response rate was 59%; the complete plus partial response rate, 93%. The 50% disease-free survival was 8 months. The actuarial projected 5 year survival was 60% and the disease-free survival at 5 years was 27%. The program was well tolerated by the majority of patients. It is possible for some patients with favorable non-Hodgkin's lymphomas to achieve prolonged periods of disease-free survival when treated with combinations of irradiation plus chemotherapy.

Plasma prostaglandin levels in radiation-induced enteritis.

Increased prostaglandin synthesis has been implicated as a causative factor in the production of radiation induced enteritis. Seventeen patients selected to begin pelvic irradiation for treatment of gynecological cancer had plasma Prostaglandin E, Prostaglandin F, and 13, 14 dihydro 15 keto PGF2 alpha metabolite determined by radioimmunoassay, prior to initiation of radiotherapy, at weekly intervals during treatment and at six weeks following completion of radiotherapy. A total of 362 prostaglandin determinations were performed. Thirteen patients (76%) developed significant diarrhea consisting of three or more watery bowel movements per day. Nine patients (53%) had intermittent colicky pain and six patients (35%) had nausea and vomiting during treatment. Statistical evaluation revealed no significant elevation of plasma prostaglandins during radiotherapy.

Para-aortic lymph node irradiation in carcinoma of the cervix after exploratory laparotomy and biopsy-proven positive aortic nodes.

From July 1970 to January 1977, 23 patients with previously untreated cancer of the cervix (CA CX), mostly Stage IIIB, were included in this study. The para-aortic lymph nodes (PALN) were histologically documented to have metastatic disease in all 23 patients. External radiation treatment (RT) was delivered using a Cobalt--60 machine to a spade-shaped field to treat the pelvic cavity and para-aortic area. The majority of the patients received 4000-6000 rad to the pelvic cavity and from 5000-5500 rad to the PALN's by external RT. In addition, intracavitary radium was used in 21 patients. Five patients are alive and free of disease at 115, 110, 90, 73 and 45 months after completion of RT. One survivor had clinical Stage IB, one had Stage IIB, and three had Stage IIIB cervical carcinoma. Two of 15 patients with clinically enlarged and suspicious para-aortic nodes are alive, while 3 of 8 patients with clinically normal appearing nodes survived. Three (60%) of the survivors developed late bowel radiation damage. Eighteen patients died--10 during the first year, 3 during the second year, 2 during the third year, 1 during the fourth year and 2 during the eighth year of the follow-up. Five (27.8%) of the patients who died had developed late bowel radiation damage. Fifteen of the 18 died with disease at an average of 21 months. Three patients died of intercurrent disease. Their average survival was 40 months, double that of patients dying of disease. This report suggests that in cancer of the cervix, radiation therapy can control some PALN metastatic disease, but the risk of complications is rather high. In the absence of better methods of management, this risk of complications is justifiable because the alternative is to leave known disease untreated.

Olsalazine is contraindicated during pelvic radiation therapy: results of a double-blind, randomized clinical trial.

PURPOSE: A randomized clinical trial from Great Britain suggested a possible beneficial effect of acetylsalicylate in the prevention of radiation-induced bowel toxicity. Olsalazine is an orally administered drug designed to deliver 5-aminosalicylate to the large bowel with minimal systemic absorption. A randomized clinical trial was undertaken to assess the effectiveness of olsalazine in preventing acute diarrhea in patients receiving pelvic radiation therapy. METHODS AND MATERIALS: Patients receiving pelvic radiation therapy were randomized, in double-blind fashion, to olsalazine 250 mg, two capsules twice daily, or an identical appearing placebo, two capsules twice daily. Patients were then evaluated weekly during radiation therapy for the primary study endpoint, diarrhea, as well as rectal bleeding, abdominal cramping, and tenesmus. RESULTS: The study was closed early, after entry of 58 evaluable patients, when a preliminary analysis showed excessive diarrhea in patients randomized to olsalazine. The incidence and severity of diarrhea were worse in patients randomized to olsalazine (p = 0.0036). Sixty percent of the patients randomized to olsalazine experienced Grade 3 or 4 diarrhea compared to only 14% randomized to placebo. There was also a trend toward higher incidence and greater severity of abdominal cramping in patients who were randomized to olsalazine (p = 0.084). CONCLUSION: Administration of olsalazine during pelvic radiation therapy resulted in an increased incidence and severity of diarrhea. Olsalazine is contraindicated in patients receiving pelvic radiation therapy.

The use of partially matched, unrelated donors in clinical bone marrow transplantation.

It is estimated that 60-70% of patients who might benefit from a bone marrow transplant will not have a suitably matched, related donor. We have, therefore, designed a clinical experiment to test the safety and feasibility of using marrow from partially matched, unrelated donors. This paper details our transplant experience in the first eight patients with leukemia. The first four patients had advanced leukemia at the time of transplantation. Each showed hematopoietic recovery, but all died from septic complications largely related to extended neutropenia encompassing both the pre-marrow-grafting and the post-marrow-grafting period. The next four patients were in remission at the time of transplantation. Each showed prompt and sustained hematopoiesis with variable graft-versus-host disease (GVHD). No acute or chronic GVHD was seen in two patients, grade II (skin only) was seen in one patient, and grade IV (skin, liver, and gut) was seen in one patient. One patient has died from sepsis five-and-one-half months following transplantation, and three are alive and well six-and-one-half to nine-and-one-half months postengraftment. This preliminary experience, together with several case reports in the literature, leads us to conclude that bone marrow transplantation with partially matched, unrelated marrow is a safe and feasible approach. If these results are confirmed by longer follow-up in a larger group of patients, the development of marrow donor pools would appear to be justified.

Accuracy of lymphangiography in the diagnosis of paraaortic lymph node metastases from carcinoma of the cervix.

A study was undertaken to evaluate the use of lymphograms as a method of diagnosing cancer of the cervix metastatic to the paraaortic lymph nodes. Twenty-one patients underwent lymphograms, surgical biopsy, and histologic examination of the paraaortic nodes. The specificity of lymphangiographic examinations is not accurate enough to be of clinical significance in the detection of paraaortic lymph node metastasis from carcinoma of the cervix. Lymphangiography can be of assistance in locating suspicious lymph nodes. These nodes should then be biopsied. The final therapeutic decisions should be based on tissue diagnosis.

Anxiety and cancer treatment: response to stressful radiotherapy.

Previous research with individuals undergoing surgery or diagnostic procedures provided a conceptual framework for analysis of radiation therapy, a common form of cancer treatment. The present investigation was designed to document the magnitude of anxiety patients experience in response to one particularly stressful form of radiation treatment. In addition, the change in anxiety responses with repeated exposures and individual differences among patients that may affect their adjustment were explored. In Part 1, gynecologic cancer patients receiving their first internal radiotherapy application were studied. As the time for treatment neared, subjective and physiologic indicants of anxiety and distress among the patients significantly increased. By 24 hours post-treatment, anxiety for all patients remained elevated. These post-treatment data are convergent with other investigations of post-treatment distress among cancer patients, but contrast with data obtained from those receiving treatment for benign conditions. A subset of the women who required two applications of radiotherapy participated in Part 2. These patients continued to respond negatively during the second treatment. Data on individual differences in anxiety responses (i.e., low vs. high anxiety) were obtained in both investigations and suggest that those with low levels of pre-treatment anxiety experience considerable disruption post-treatment.

Psychological reactions to radiation therapy: reconsideration of the adaptive aspects of anxiety.

A common form of cancer treatment is radiation therapy. In this investigation individual differences in the psychological reactions of 45 patients undergoing external treatment were examined in the context of the Janis (1958) and linear decline models (e.g., Spielberger, Auerbach, Wadworth, Dunn, & Taulbee, 1973) of medical stressor anxiety. Evaluation included pre- and postradiation assessments of the subjects' state and trait anxiety, somatic complaints, and treatment side effects. Technologists administering the daily treatments assessed behavioral indicants of affective distress. Data analyses revealed that increases in complaints and side effects were reported by all patients at treatment conclusion. More interesting, significant changes in state anxiety were obtained from pre- to posttreatment: (a) Patients with an initial high level of anxiety reported a significant reduction, although they remained the most anxious subgroup; (b) patients with a moderate level of pretreatment anxiety reported no change; and (c) patients with low levels of anxiety reported significant increases in state anxiety. No change in trait anxiety was found for any group, suggesting that the foregoing changes in state anxiety were not simply attributable to regression. Data trends suggested that patients who were either low or high in state anxiety were also characterized by more anger or hostility than patients moderate in anxiety. The findings are consistent with the Janis model, which posits that in threatening situations the level of fear can potentially determine the adequacy of adaptation.

A comparison of bone marrow transplantation with maintenance chemotherapy for patients with acute nonlymphoblastic leukemia in first complete remission.

Twenty patients treated with maintenance chemotherapy for acute nonlymphoblastic leukemia after achieving complete remission were compared with 13 patients who underwent bone marrow transplantation from an HLA-identical sibling. The median age was 27 years for both maintenance chemotherapy patients (range 17-42 years) and for patients undergoing bone marrow transplantation (range 16-42 years). The 1-year survival for maintenance chemotherapy was 80% vs. 54% with bone marrow transplantation (p = NS). Complete remission durability was 70% at 1 year for maintenance chemotherapy (34% projected for 5 years) compared with no relapses in the first year with bone marrow transplantation (p = 0.01). Patients on maintenance chemotherapy were hospitalized for an average of 22 days (range 0-171 days) during the first 12 months of treatment. Patients undergoing bone marrow transplantation were hospitalized for an average of 82 days (range 41-113 days) in the same time period. Severe hematologic toxicity was seen in 13/13 bone marrow transplantation patients and 6/20 maintenance chemotherapy patients. Chronic graft-vs.-host disease occurred in 3/7 surviving bone marrow transplantation patients. Maintenance chemotherapy had an average first year cost of +3,076.00 for patients who did not relapse and +48,827.00 for patients that relapsed. The first year costs for bone marrow transplantation averaged +84,102.00. Thus, maintenance chemotherapy was associated with a better early survival, less toxicity, and lower cost than bone marrow transplantation in the first year after initiating therapy. However, fewer relapses with bone marrow transplantation suggest that it will yield a higher long-term survival rate.

Bifurcation level of the aorta: landmark for pelvic irradiation.

The position of the aortic bifurcation in women in relation to the lumbar vertebral bodies was determined in 100 pelvic arteriograms to provide some help in teleradiation therapy planning for pelvic malignancies. It was found that in order to cover the area of the aortic bifurcation, the radiation field should extend to the top of the body of the fourth lumbar vertebra.

Metastases to the cavernous sinus from primary carcinoma of the larynx.

Distant metastases from late stages of carcinoma of the vocal cords can occur. Such metastatic deposit can occur in unusual sites. In this report, we are presenting a patient with spread to the cavernous sinus. Radiation therapy was of palliative value.