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The article reports a study whose purpose was to develop and test the Patient Record Pain Management Assessment Tool, an instrument to evaluate compliance with the American Pain Society's quality assurance standards on acute pain and cancer pain in chart documentation. Content validity, overall validity, and interrater reliability were all found to be acceptable. The instrument is therefore a useful tool for documenting the level of pain management practice in institutional settings.

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Proglumide, a cholecystokinin (CCK) antagonist, has been shown to have agonist effects at extremely low doses on both endogenous and exogenous opioid systems. To determine the effectiveness and the side effects of proglumide as an opioid agonist, a double-blind crossover study was conducted in 60 patients with cancer pain who were treated with opioid analgesics. Forty-three patients completed both treatment arms: (a) full analgesic dose plus placebo (the patient's usual analgesic dose, individualized to drug dose and route) and (b) one-half analgesic dose plus 50 mg of proglumide. An analysis of eight pain descriptors was performed to determine whether or not these treatments were associated with a difference in patients' pain perception. The level of patient anxiety differed between the two arms, but was inconsistent over time. There were no side effects detected with proglumide, as determined by clinical monitoring and patient questionnaire. No differences in pain perception were detected between the study arms. The latter finding is consistent with an augmentation of morphine analgesia, but without additional controls, the equivalency of the two arms cannot be determined with certainty. Nonetheless, this study suggests that proglumide may have use as an opioid adjunct in patients with cancer pain.

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PURPOSE: To evaluate the diagnostic usefulness of positron emission tomography (PET) with fluorine-18 fluorodeoxyglucose (FDG) in patients with primary colorectal carcinomas. MATERIALS AND METHODS: Forty-eight patients with biopsy-proved (n = 44) or high clinical suspicion for (n = 4) colorectal cancer underwent whole-body PET after intravenous administration of 10 mCi (370 MBq) of FDG. FDG PET results were correlated with computed tomographic (CT), surgical, and histopathologic findings. RESULTS: PET depicted all known intraluminal carcinomas in 37 patients (including two in situ carcinomas) (sensitivity, 100%), but findings were false-positive in four of seven patients without cancer (three with inflammatory bowel conditions, one who had undergone polypectomy). Specificity was 43% (three of seven patients); positive predictive value, 90% (37 of 41 patients); and negative predictive value, 100% (three of three patients). No FDG accumulation was noted in 35 hyperplastic polyps. FDG PET depicted lymph node metastases in four of 14 patients (sensitivity, 29%). Results were similar to those obtained with CT (true-positive, two of seven patients [sensitivity, 29%]; true-negative, 22 of 26 patients [specificity, 85%]). FDG PET depicted liver metastases in seven of eight patients and was superior to CT, which depicted liver metastases in three patients (sensitivity of 88% and 38%, respectively). FDG PET and CT, respectively, correctly depicted the absence of liver metastases in 35 and 32 patients (specificity, 100% and 97%; negative predictive value, 97% and 86%). CONCLUSION: FDG PET has a high sensitivity and specificity for detection of colorectal carcinomas (primary and liver metastases) and appears to be superior to CT in the staging of primary colorectal carcinoma.

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PURPOSE: In 1984, the Department of Veterans Affairs Cooperative Studies Program began a trial in which patients with resectable squamous cell carcinoma of the larynx were randomized to receive standard surgery followed by radiation therapy or to receive neoadjuvant therapy with cisplatin and fluorouracil (5-FU) followed by radiation therapy for those achieving a greater than 50% tumor response to chemotherapy. This analysis reviews the tumor responses, toxicity, compliance, and long-term survival for those patients randomized to the chemotherapy arm. PATIENTS AND METHODS: One hundred sixty-six patients were randomized to the chemotherapy arm. Standard tumor response data, chemotherapy toxicity, and survival have been examined using standard statistical methods. RESULTS: The high response rates and acceptable toxicity to cisplatin and 5-FU of previously untreated patients were confirmed. Long-term disease-free survival was more likely to occur in patients who achieved a complete response to chemotherapy, particularly in those who had a confirmed histologic response to chemotherapy. Pretreatment histologic growth patterns were highly predictive of responses to chemotherapy. CONCLUSION: Neoadjuvant chemotherapy was well tolerated and did not negatively affect the definitive treatment that followed. The survival of nonresponding patients who underwent prompt salvage surgery was also not impaired. The role of organ preservation should be explored in other head and neck sites.

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Two patients with extensive small cell lung cancer developed unilateral, spontaneous pneumothoraces while receiving chemotherapy. Both pneumothoraces wee asymptomatic, required no special procedure, and resolved with continued chemotherapy. Development of spontaneous pneumothorax during chemotherapy in patients with known small cell lung cancer may represent a response to treatment.

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We reviewed the results of standard therapy (surgery +/- radiation therapy) in 66 patients with advanced resectable head and neck cancer treated between 1984 and 1988 and compared them with a "historical" group of similar resectable patients treated between 1978 and 1984, by induction chemotherapy followed by standard therapy. The median disease-free survival of patients treated by surgery was 18 months, whereas it had not been reached in those receiving chemotherapy. When 2-year disease-free survival was compared according to stage and site, patients receiving chemotherapy fared better. The recurrence rate of all patients receiving chemotherapy was less than half of those receiving standard treatment only. A higher percentage of patients receiving chemotherapy survived their original tumor, only to die of second malignancies, most of these occurring elsewhere in the aerodigestive tract.

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Piritrexim (PTX) is a newly developed lipid-soluble folate antagonist that crosses the cell membrane by a simple, rapid, carrier-independent diffusion process. A Phase II study was conducted to evaluate the activity of PTX in 34 patients with previously chemotherapy-naive squamous cell cancer of the head and neck area (SCCHN). Among them, 30 patients had received previous radiation therapy and/or surgery. Of 33 patients who could be examined, 3 had a complete response (CR), 6 had a partial response (PR), 11 had no change, and 13 had disease progression. The overall response rate (CR + PR) was 27% (9 of 33; 95% confidence interval, 13% to 46%). The response duration ranged from 36 to 360 + days (median, 162) and was similar to the best studies reported with methotrexate. The three most severe side effects (Grades 3 and 4 by World Health Organization criteria) were leukopenia, thrombocytopenia, and mucositis. These occurred in 41%, 26%, and 15% of the 34 patients, respectively. This study established PTX as an agent with some activity in SCCHN. The use of PTX in combination chemotherapeutic regimens needs to be explored.

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The safety and clinical utility of repeated administrations of 111In-ZCE 025 were evaluated in 25 patients who have undergone colorectal carcinoma resection. Fifteen patients were clinically and radiologically free of recurrences and asymptomatic while 10 had rising CEA and/or symptoms. We repeatedly imaged the patients following intravenous administrations of 40 mg ZCE 025, every 4 to 6 mo. Side effects occurred in 16% of patients who received two or more infusions. Sixteen lesions were detected by immunoscintigraphy in 11 patients who were free of disease by CT scans or other imaging modalities. Ten recurrences were surgically confirmed in seven patients. Radiographic and clinical follow-up confirmed the remaining 6 Mab-positive lesions. Elevated human anti-mouse antibody (HAMA) titers were detectable in the sera of 30% and 64% of patients following the 1st and 2nd Mab injection respectively, but did not interfere with successful immunoscintigraphy nor correlated with the occurrence of side effects. This study suggests that a negative Mab scan indicates that a patient will remain free of recurrence; conversely, a positive scan was associated with recurrences of disease.

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A perfluorocarbon blood substitute, Fluosol, is undergoing clinical trials as an adjunct to chemotherapy. The adverse effects associated with its administration have been postulated to result from complement activation. When gel electrophoresis and Western blotting of Fluosol are used after its incubation with serum, activated C3 and factors Bb and H are bound to the Fluosol particles in a time-dependent fashion, which suggests that complement activation with Fluosol, as does that with zymosan, occurs on the surface of the particles. Paradoxically, it is found, both by the measurement of Fluosol-bound C3d and by fluid-phase C5a, that lower concentrations of Fluosol cause greater amounts of complement activation, which suggests a complex interaction of activators and inhibitors that changes as the available surface area is decreased. Studies performed with bystander red cell-bound C3d demonstrated in vivo complement activation occurring in six patients receiving Fluosol as an adjunct to chemotherapy for colon cancer. In two patients, there was a marked increase in red cell-bound C3d after Fluosol infusion; these two patients also developed adverse reactions during Fluosol infusion. These studies suggest that the Fluosol surface plays a major role in the initiation and regulation of complement activation that is seen during Fluosol infusion.

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Laboratory abnormalities in blood coagulation factors are common in patients with cancer but the significance is unknown. Twenty-eight patients with head and neck cancer were studied at the time of diagnosis. Twenty-five were advanced-stage (III or IV) patients. Levels of clotting factors, antithrombin III, and plasminogen were normal. Levels of von Willebrand factor (vWF), both antigenic and functional (ristocetin cofactor), were elevated. This group of patients were followed for a minimum of 41 months (median, 48 months). Fifteen patients died within the follow-up period. von Willebrand factor levels were significantly higher in these 15 than the 13 survivors. Extreme elevation of ristocetin cofactor (greater than 300 U/dl) was seen in six of the 15 patients who died and in none of the survivors. Plasma vWF is elevated in head and neck cancer and the level measured at the time of diagnosis may have prognostic and potentially therapeutic implications.

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Detailed records were maintained prospectively of all medications taken by 719 patients with advanced carcinoma of the lung or colon. Of this total, a cohort of 19 patients was identified who had ingested incidentally either nifedipine, diltiazem, verapamil, or trifluoperazine in standard therapeutic doses for a minimum of one month and a mean of 5.8 months and median of three months. Treatment with these calcium antagonists was well tolerated and, upon comparison with otherwise comparable patients who did not ingest a calcium antagonist, appeared to be associated with certain favorable outcomes, including delayed tumor progression and prolonged survival. These preliminary findings suggest that beneficial effects of such drugs observed with chronic treatment in experimental animal tumor models may occur in human disease and that definitive prospective, randomized, clinical trials of calcium antagonists administered continuously in ordinary therapeutic doses are both feasible and justified.

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The effect of cis-diamminedichloroplatinum (DDP) on plasma and urinary zinc was studied in fifteen patients with squamous cell carcinoma. A decrease in plasma zinc accompanied by an increase in urinary zinc excretion was observed. Pretreatment plasma or urinary zinc did not correlate with tumor size or site, nor was there a correlation between changes in these measurements and a response to therapy. The enhanced excretion of urinary zinc may be related to a decrease in amino acid resorption in the proximal tubule. It is concluded that DDP administration may result in hyperzincuria and could potentially precipitate a symptomatic zinc deficiency state.

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We treated 94 patients with advanced head and neck cancer with a combined-modality protocol that included induction chemotherapy followed by surgery with and without radiotherapy. With a minimum follow-up of 3 1/2 years, 33 (35%) of the patients were alive and disease free. Thirty (32%) of the patients died of recurrent head and neck cancer. Complete response to chemotherapy and initial tumor bulk correlated with prolonged disease-free survival. Site of disease had no effect. There appeared to be no advantage to the use of routine postoperative radiotherapy in these advanced tumors.

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In a five-year study of medical students who had participated in a first-year elective course on cancer, the authors found that 47 percent of all participants subsequently became involved in other cancer programs. A sample (n = 40) of the participants was interviewed and studied in depth. Their subsequent expressed and overt interests in cancer were related to their achievement on neoplasm-related test items contained in second-year systemic pathology examinations and to their perception of transfer of learning from the cancer course. Neither expressed nor overt interest in cancer was significantly related to test scores on neoplasm items; but perceived transfer of learning was positively related to scores on neoplasm items, and perceived transfer and overt interest, combined, significantly related to test scores on neoplasm items in systemic pathology.

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A variety of adjuvant chemotherapy programs have been described for advanced head and neck cancer. The protocol described herein is nontoxic and particularly appropriate for patients with advanced tumors who cannot, because of severe pulmonary disease, tolerate bleomycin sulfate. Eighty percent of patients treated with this combination responded with more than 50% tumor shrinkage. Chemotherapy was followed by either surgery, radiation therapy, or both. Long-term control with this combined modality therapy was better in oral cavity and oropharyngeal lesions than in tumors from the hypopharynx.

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Twenty patients with advanced squamous cell carcinoma of the hypopharynx received two courses of chemotherapy with cisplatinum, vincristine and bleomycin before undergoing surgery. The chemotherapy was well tolerated, with minimal toxicity and no intra or postoperative complications attributable to it. The response to the chemotherapy was dramatic with all but 2 patients exhibiting a greater than 50% tumor shrinkage. Only 3 patients, all with positive surgical margins, received postoperative radiation therapy. Surgical salvage of recurrent lesions was performed on 2 patients who are now free of disease. With a median follow-up of 20 months, 1 patient has died of recurrent disease, 3 have died of other causes, all others remain free of disease.

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Two courses of triple-agent chemotherapy were given to 47 patients with advanced head and neck cancer. All but one patient with a nasopharyngeal carcinoma had resectable stage III and IV squamous cell carcinoma. Eighty-eight percent of the patients responded to the chemotherapy with a 50 percent or greater decrease in tumor size. Forty-three patients underwent surgical resection and 19 were histologically upgraded to stage II or better (T less than 2 cm, N0). None of these 19 patients have relapsed, with follow-up ranging from 12 to 42 months. In 12 of the 47 patients, recurrent tumor developed within the first 18 months of follow-up.

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A painless lateral neck mass in an otherwise healthy 58-year-old man is a frequent diagnostic problem. We have recently seen such a patient with a cervical neck mass whose preoperative evaluation findings were normal. Excisional biopsy revealed a lymph node exhibiting changes compatible with extramedullary hematopoiesis. This becomes an additional unusual cause of enlarged lateral neck nodes.

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