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PubMed2006

Prognostic stratification of patients with anaplastic gliomas according to genetic profile.

BACKGROUND: There is a need to improve the current, controversial, and poorly reproducible classification of anaplastic gliomas, which represent a highly heterogeneous entity in terms of survival. METHODS: The impact of the most common genetic alterations on survival was investigated based on 156 anaplastic gliomas: Among the patients who were included, the gender ratio was 1.32, the median age was 45.5 years (range, 20-83 years), and the median Karnofsky performance status was 70 (range, 40-100). Genetic analysis included a search for loss of heterozygosity (LOH) on chromosomes 1p and 19q; amplification of chromosomes 9p and 10q and of the epidermal growth factor receptor (EGFR), cyclin-dependent kinase 4 (CDK4) and mouse double-minute (MDM2) genes; and p53 expression. RESULTS: The median survival was 33.5 months, and the median progression-free survival was 15.8 months. In a univariate analysis, LOH on 1p and 19q was correlated with longer survival, whereas p53 expression, LOH on 9p, LOH on 10q, amplified EGFR, and deleted CDKN2A were correlated with shorter survival. LOH on 1p and 19q were associated with oligodendrogliomas, LOH on 10q was related to EGFR amplification, and LOH on 1p and 19q was mutually exclusive with EGFR amplification and LOH on 10q. In a multivariate analysis, the significant prognostic factors were age, histology, LOH on 1p and 19q, and P16/CDKN2A deletion. Recursive partitioning analysis (RPA) divided the whole group hierarchically into 3 distinct prognostic subgroups: Group A with 1p19q codeletion (median survival, 98 months), Group B with EGFR amplification (median survival, 17 months), and Group CC (median survival, 31 months), providing a basis for a genetically based prognostic subclassification for patients with Grade III gliomas. CONCLUSIONS: The search for 1p19q codeletion and EGFR receptor amplification provides a simple, clinically relevant prognostic subclassification of grade III gliomas.

Adult↗
PubMed2007

Extended safety and efficacy data on S-1 plus cisplatin in patients with untreated, advanced gastric carcinoma in a multicenter phase II study.

BACKGROUND: S-1 is a promising oral fluoropyrimidine. The authors obtained extended Phase II safety and efficacy data in a multicenter setting for the S-1 plus cisplatin combination: The experimental arm of the global Phase III First-Line Advanced Gastric Cancer Study (FLAGS) is being compared with 5-fluorouracil/cisplatin. METHODS: Eligible patients had untreated, histologically confirmed advanced gastric cancer (AGC), a Karnofsky performance status (KPS) > or =70%, adequate organ function, and provided written consent. Patients received S-1 (25 mg/m(2) twice daily on Days 1 through 21) plus cisplatin (75 mg/m(2) on Day 1) every 28 days. The confirmed overall response rate (CORR) also was designated by an external review. The time to progression (TTP), median survival (MS), and safety were assessed. RESULTS: All 72 patients were assessed for safety and survival, and 64 patients were assessed for CORR. The median KPS was 90%. The median number of treatment cycles was 4. The CORR was 55% (95% confidence interval [95% CI], 42-67%). The median duration of response was >5 months. At 6 months, only an estimated 38% of patients had cancer progression. The estimated MS was 10.4 months (95% CI, 8.6-12.9 months). At least 1 serious adverse event occurred in 44% of patients. The frequent grade 3 or 4 toxicities (using the National Cancer Institute Common Toxicity Criteria), which occurred in >10% of patients, included fatigue/asthenia (24%), emesis (17%), nausea (15%), diarrhea (13%), and neutropenia (19%). Complicated neutropenia (1.4%) and grade 4 diarrhea (1.4%) were rare. CONCLUSIONS: The current extended data confirmed that S-1 combined with cisplatin had a highly desirable safety profile. The efficacy against AGC, according to an external review, was encouraging. FLAGS is expected to complete its accrual of 1050 patients by December 2007.

Adult↗
PubMed2002

Elevated serum vascular endothelial growth factor and decreased survival in advanced laryngeal carcinoma.

PURPOSE: The purpose of this study was to determine whether serum vascular endothelial growth factor (s-VEGF) levels at the time of diagnosis correlate with any known tumor variables and overall survival in patients with advanced laryngeal squamous cell carcinoma. Comparisons with a cohort of normal healthy controls were also performed to determine the potential usefulness of s-VEGF as a screening tool. EXPERIMENTAL DESIGN: Serum from patients enrolled in the VA Laryngeal Cooperative Study #258 (n = 183), as well as normal healthy controls (n = 40) was used in this analysis. Quantitative enzyme-linked immunosorbent assays (ELISA) for VEGF were performed in duplicate on each serum sample. Demographic and survival data were available for each patient enrolled in the study. Univariate analyses, multivariate Cox regression analyses, and Kaplan-Meier survival analysis were used. RESULTS: The mean serum concentration of s-VEGF for the healthy control group was 47.83 +/- 0.13 pg/mL. For all patients enrolled in the VA Cooperative Study, regardless of treatment group, the mean s-VEGF level was 317.22 +/- 25.46 pg/mL. The patients randomly assigned to the surgical arm (n = 97) had a mean value of 315.44 +/- 30.44 pg/mL. Those randomly assigned to the induction chemotherapy arm (n = 86) had a mean s-VEGF level of 319.22 +/- 42.11 pg/mL. Serum VEGF levels were significantly elevated in patients with laryngeal carcinoma compared with healthy controls (p < .001). The serum VEGF levels in each arm of the trial were also elevated versus the healthy controls (p < .001, surgery arm plus radiotherapy; p < .001, chemotherapy plus radiotherapy). In a univariate analysis, elevated s-VEGF correlated with poor Karnofsky performance status for all patients with advanced laryngeal carcinoma (p < .008). High s-VEGF levels also correlated with a poor performance score in patients on the chemotherapy arm of the VA Laryngeal Trial (p < .004). Elevated s-VEGF levels in the surgical plus radiotherapy arm correlated with node-positive disease (p = .047) and supraglottic location of the tumor (p = .022). In a multivariate analysis using all known tumor variables and s-VEGF levels, elevated s-VEGF levels and infiltrating growth pattern correlated with decreased survival for all evaluated patients with advanced laryngeal carcinoma (p = .065, and p = .018, respectively). CONCLUSIONS: Serum VEGF levels are significantly elevated in patients with advanced laryngeal carcinoma versus healthy controls. Elevated pretreatment s-VEGF levels tended to indicate a more aggressive disease state and a poorer overall survival in advanced laryngeal carcinoma.

Biomarkers, Tumor↗
PubMed2006

Concomitant low-dose cisplatin and three-dimensional conformal radiotherapy for locally advanced squamous cell carcinoma of the head and neck: Analysis of survival and toxicity.

BACKGROUND: Our center sought to implement a simple chemoradiotherapy schedule for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) with minimal toxicity to achieve rates of overall survival comparable to other schedules. METHODS: The chemoradiotherapy schedule consisted of daily radiation to 70 Gy over 7 weeks with concurrent cisplatin 20 mg/m(2) during days 1 to 4 of weeks 1 and 5. Acute and late toxicities were recorded according to the Radiation Therapy Oncology Group (RTOG) and common toxicity criteria (CTC) grading. The overall, disease-specific, and locoregional recurrence-free survival were calculated using the STATA statistics package. Possible factors influencing these endpoints were analyzed. RESULTS: Fifty-seven patients were treated, and 56 patients were evaluable for follow-up. Median follow-up of alive patients was 16.1 months. There was an 82% complete response rate to chemoradiotherapy. The 2-year Kaplan-Meier overall, disease-specific, and locoregional recurrence-free survival rates were 62%, 67%, and 63%. Acute grade 3 and 4 radiation toxicity was noted in 61% and 2%, respectively. Grade 3 or 4 hematologic toxicity was noted in 7% of patients. Factors influencing overall survival included: Karnofsky performance status, receiving more than 50% of planned chemotherapy, age, and initial hemoglobin level. CONCLUSION: This regimen is tolerable and achieves overall survival and locoregional control rates comparable to other chemoradiotherapy schedules.

Age Factors↗
PubMed1979

The L1210 assay for immune complexes: application in cancer patients and correlation with disease progress.

Immune complexes (ICs) were determined by the non-complement-dependent L1210 radioimmune assay on 132 serum samples collected from 53 patients with a variety of cancers. Both the mean IC levels and frequency of positive tests were significantly greater in cancer patients (mean = 96 +/- 100 microgram/ml, 46% positive) than in a control group of 67 normal healthy blood donors (mean = 39 +/- 15, 3% positive). When cancer patients were assorted into groups by disease progress, those with large or progressing tumors had significantly higher mean values (136 +/- 129) and frequency of positives (75%) than those with small or regressing tumors (58 +/- 18, 22% positive). In lung cancer patients, IC levels showed a strong inverse correlation (rs = -0.903) with survival time in patients who died, and appeared to be a better prognostic indicator than performance status (Karnofsky scale) at time of diagnosis. Serial IC measurements taken on several patients showed a decrease in levels concomitant with a favorable response to cytoreductive therapy, sustained normal levels during periods of prolonged remission, and a rise to elevated levels with (and sometimes preceding) documentation of new metastases.

Animals↗
PubMedDate not supplied

Quality of life in patients with metastatic colorectal cancer receiving chemotherapy: a randomized, double-blind trial comparing 5-FU versus 5-FU with leucovorin.

We compared health-related quality of life (HQL) measures in 210 patients with metastatic colorectal cancer who were receiving equitoxic regimens of weekly 5-fluorouracil (5-FU) plus leucovorin (LV) or 5-FU alone in a multicenter, placebo-controlled, double-blind, randomized trial. The HQL was assessed during the first 120 days of treatment by the patient-generated functional living index-cancer (FLIC) questionnaire. Also assessed were clinician-generated measures to evaluate physical functioning and suffering: Karnofsky performance status (KPS), body weight, disease symptoms, and hospitalization. No significant difference was detected between treatment groups in HQL or in any measurement of efficacy or toxicity. The number of patients hospitalized was similar in both groups, 35 patients receiving 5-FU-LV, 32 receiving 5-FU-placebo, but those receiving 5-FU-LV were hospitalized longer (450 vs 315 total days). The KPS improved or stabilized in 23% and 37% of patients, respectively. Overall, FLIC scores significantly improved in 27% or remained stable in 62% of all patients; disease symptoms improved in 19-49%; a weight increase of 2 kg or more occurred in 27%. A change in FLIC was not associated with tumor response or improvement in pain, but a decline in FLIC was associated with improved survival. An improvement in KPS or weight was associated with tumor response and strongly correlated with survival. Improvement of pain was associated with a stable or increase in weight, and worsening of pain correlated with lack of tumor response.

Adenocarcinoma↗
PubMed2002

Comparison of 5-aminolaevulinic acid and porphyrin photosensitization for photodynamic therapy of malignant bronchial stenosis: a clinical pilot study.

BACKGROUND AND OBJECTIVES: Photosan, a mixture of porphyrin oligomers as sensitizer for photodynamic therapy (PDT), carry the risk of prolonged photosensitivity of the skin. New sensitizer such as 5-aminolaevulinic acid (ALA) with low rates of skin phototoxicity appear to be promising alternatives. The aim of this study was to evaluate the efficacy of ALA compared to Photosan for PDT in malignant tracheo-bronchial stenosis. Reduction of tumor stenosis, increase in quality of life, and phototoxicity were considered as primary objectives. Improvement in clinical symptoms due to reduction of tumor stenosis, for example hemotysis, dyspnea, and poststenotic pneumonia were considered as secondary objectives. PATIENTS AND METHODS: After diagnostic work-up, photosensitization was done in 16 patients with ALA (60 mg/kg BW, oral, 6-8 hours prior to PDT) and in 24 patients with Photosan (2 mg/kg BW, i.v., 48 hours before PDT). The light dose was calculated as 100 J/cm(2) tumor length. Light at 630 nm was applied using a pumped dye laser. In both groups, additional hyperbaric oxygenation was applied at a level of 2 absolute atmospheric pressure. RESULTS: Stenosis diameter and Karnofsky performance status showed a significant improvement in favor of the Photosan-group, P = 0.00073 and 0.00015, respectively. In both groups no sunburn occurred due to phototoxicity of the sensitizer. CONCLUSION: Despite the limitations of a non-randomized study, photosensitization with Photosan seems to be more effective in PDT of malignant tracheo-bronchial stenosis compared to ALA.

Adenocarcinoma↗
PubMed1986

Photodynamic therapy of endobronchial tumors.

After presensitization with IV hematoporphyrin derivative (HpD), neoplasms in the tracheobronchial tree of 18 patients were treated by photodynamic therapy (PDT) with 630-nm light from a tunable dye argon laser system delivered through quartz fibers passed through the biopsy channel of a flexible bronchoscope under local anesthesia. Tumor effect was measured by complete response (CR)--no visible tumor in area treated, partial response (PR)--tumor size or degree of obstruction reduced by more than 50% and some response (SR)--tumor or degree of obstruction reduced by more than 20% but less than 50%. One month or less after 30 treatments to 26 areas in 18 patients, there was 40% CR, 57% PR, and 3% SR. All tumors showed at least some response. Since many of these patients had end-stage disease, the effect on the clinical condition and symptoms were evaluated using the Karnofsky Performance Status (KPS), oxygen requirements, and the presence or absence of respiratory symptoms. One month after treatment, 61% were clinically improved, with an increase of the average KPS from 48 to 61. Three patients with stage III primary lung cancer improved from being severely disabled requiring hospitalization to normal activity with effort and lived an average of 3.5 months. One patient with metastatic colon cancer was palliated from bedrest with continuous oxygen to normal activity with no oxygen for 12 months. A patient with hemoptysis and carcinoma in situ remains biopsy- and symptom-free for 34 months. A patient with hemoptysis and cough from breast cancer metastases maintained CR, biopsy- and symptom-free for 7 months. A patient with hemoptysis from recurrence at the bronchial stump maintained CR, biopsy- and symptom-free for 13 months. Six patients with Stage III primary lung cancer with average KPS of 27 (severe) died in the hospital and lived an average of 5 weeks (two CR, two PR, two SR). One patient with atelectasis of the right lower lobe re-expanded 14 days after treatments began.

Bronchial Neoplasms↗
PubMed2005

The Chronic Fatigue Syndrome Activities and Participation Questionnaire (CFS-APQ): an overview.

Chronic fatigue syndrome (CFS) is characterized by severe fatigue and a reduction in activity levels. The purpose of this study was to provide an overview of design, reliability, and validity of the CFS Activities and Participation Questionnaire (CFS-APQ). The CFS-APQ was constructed based on a retrospective analysis of the Karnofsky Performance Status Questionnaire and the Activities of Daily Living Questionnaire (n = 141). In a reliability study of 34 participants the test-retest reliability coefficient of the CFS-APQ was 0.95. In two different studies, the Cronbach alpha coefficient for internal consistency varied between 0.87 (n = 88) and 0.94 (n = 47). The CFS-APQ was administered to 47 patients who listed 183 activities that had become difficult due to their chronic symptoms, and 157 (85.8%) answers matched the content of the CFS-APQ. The outcome of a cross-sectional study (n = 88) studying the correlations between the Medical Outcomes Short Form 36 Health Status Survey subscale scores and the CFS-APQ supported the validity of the CFS-APQ. The CFS-APQ scores correlated with a behavioural assessment of the patients' performance of activities encompassed by the questionnaire (r = 0.29-0.55; n = 63), and correlated with exercise capacity parameters (r = 0.26-0.39; n = 77) obtained during a maximal exercise capacity stress test. Finally, the CFS-APQ correlated with visual analogue scales for pain (r = 0.51) and fatigue (r = 0.50; n = 47). It is concluded that the CFS-APQ generates reliable and valid data, and can be used as a clinical measure of disease severity in patients with CFS. Future studies should aim at examining the sensitivity of the CFS-APQ.

Fatigue Syndrome, Chronic↗
PubMedDate not supplied

Considerations of psychosocial illness phase in cancer survival.

Rarely are biomedical, clinical and psychosocial data considered simultaneously as influences on cancer patient outcomes. This study utilized medical record and interview data from 152 adult cancer patients with various tumor types in a model of survival estimation. Predictors included disease stage of the neoplasm (TNM stage), clinical functioning of the patient (Karnofsky performance status), and psychosocial demands of the disease course (psychosocial illness phase). Psychosocial illness phase captures developmental time phases of illness (i.e. 'crisis', 'early chronic', 'late chronic' and 'terminal'), essentially locating patients along the disease course relative to treatment and treatment response. The analysis utilized the Kaplan-Meier (product-limit) method to estimate stratum specific survival functions. Model comparisons employed the differences in the likelihood ratio chi-squares between nested models, and Cox proportional hazard models assisted in explaining the effects of the predictors on survival times. Results indicate that psychosocial illness phase makes an independent contribution to survival time estimation (p<0.05) when all three dimensions are considered simultaneously.

Adaptation, Psychological↗
PubMed2004

Prognostic value of depressive coping and depression in survival of lung cancer patients.

The aim of this investigation was to determine whether depressive coping and depression predict shorter survival among lung cancer patients. We conducted a prospective study using an inception cohort with a 3-5-year follow-up. The sample consisted of n = 59 (of n = 69 invited to participate) patients (mean age 65 years, S.D. = 9.7; 81% male) newly diagnosed with small cell lung cancer or non-small cell lung cancer Stage III or IV who were scheduled for later chemotherapy and/or radiotherapy at a tertiary care centre. Patients were investigated after their diagnosis and before the beginning of treatment. Depressive coping and depression were assessed using standardized self-report questionnaires (Freiburg Questionnaire of Coping with Illness; Hospital Anxiety and Depression Scale). Depressive coping was associated with shorter survival (hazard ratio 1.75, 95% confidence interval 1.04-2.93, p = 0.034) after adjusting for age, sex, stage, histological classification, and Karnofsky performance status but not treatment type, using the Cox proportional hazards regression. Depression, however, was not linked with survival (hazard ratio 1.05, 95% confidence interval 0.98-1.13, p = 0.18). To conclude, the prognostic value of depressive coping was partially confirmed, warranting further examination of the robustness of this relationship.

Adaptation, Psychological↗
PubMed2003

Response of patients with advanced prostatic cancer to administration of somatostatin analog RC-160 (vapreotide) at the time of relapse.

BACKGROUND: The aim of this study was to evaluate the effects of administration of the somatostatin analog RC-160 (vapreotide) at the time of relapse in patients with androgen independent prostate cancer. METHODS: Our study included 13 patients with biopsy-proven prostate cancer, stage D3. Eight patients had been treated with a depot formulation of the agonist D-Trp-6-LH-RH, with a median remission time of 68 (range 48-102 months). Five patients were initially treated by surgical orchiectomy, but relapsed after a median time of 33 months (range 17-91 months). A new remission period with a median duration of 10 months (range 2-29 months) was induced with Ketoconazole in the orchiectomy group. At the relapse time, all the patients received 1 mg of vapreotide t.i.d., by subcutaneous route, in addition to D-Trp-6-LH-RH, or Ketoconazole in the orchiectomy group. RESULTS: Eight of 13 patients demonstrated clinical improvement after 3 months of therapy with vapreotide, six showing a decrease in serum prostate specific antigen (PSA) from 234.5 +/- 308.5 to 68.2 +/- 60.5 ng/ml (mean decline 71 +/- 8%; P < 0.05). Two additional patients presented a fall in serum prostatic acid phosphatase (PAP). Responding patients showed a decrease in the bone pain score from 2.62 +/- 0.48 to 0.37 +/- 0.69 and an increase in the Karnofsky performance status from 72.3 +/- 4.21 to 83.6 +/- 23.2 (P < 0.05). In accord with the ECOG criteria, two patients had a complete response; four had partial response, and two had a stable response. Four patients did not respond and one was not evaluable. Two patients died in remission, one at 16 months due to myocardial infarction and the other at 24 months due to pneumonia. Three patients relapsed at 5, 17, and 19 months respectively. Three patients who have been followed-up for more than 3 years continued in remission (79, 45, and 45 months) respectively. Vapreotide was well tolerated, only three patients having transitory mild diarrhea. CONCLUSIONS: Our results indicate that therapy with the somatostatin analog vapreotide at the time of relapse can induce objective clinical responses in some patients with prostate cancer who are refractory to androgen ablation induced by LH-RH analogs or orchiectomy.

Adult↗
PubMed1982

Estramustine phosphate (Estracyt) treatment of T3-T4 prostatic carcinoma.

From September, 1978, to November, 1980, 69 consecutive patients with locally advanced (T3-T4) prostatic adenocarcinoma, with or without distant metastases, were treated with oral estramustine phosphate. Dosage was 15 mg/kg/day for 2 months, followed by 5 mg/kg/day until progression. In the 48 evaluable patients with progressive disease that entry in the study, 1 complete response, 7 partial responses, 31 disease stabilizations, and 9 progressions were encountered (81.2% NPCP response rate). Karnofsky performance status equal to or less than 50 was predictive of poor response to estramustine phosphate. In the 10 evaluable patients with stabilized disease at entry in the study after orchiectomy, 2 complete responses, 4 partial responses, 3 disease stabilization, and 1 progression were noted. The major side effects observed were gynecomastia, nausea, and vomiting.

Adenocarcinoma↗
PubMedDate not supplied

Adjuvant treatment of brain metastases.

With an incidence of 15/10(5) in the general population, brain metastases constitute a serious, debilitating complication in cancer patients. The majority of those patients suffer from more than one metastasis, but up to 30% to 40% present with a solitary lesion. Whole-brain radiotherapy (WBRT) extends median survival from 1 to 2 months for treatment with steroids only, to 4 to 6 months in most series. However, long-term survival (>1-2 years) is observed in up to 10% of patients with favorable prognostic factors, such as solitary lesions, good Karnofsky performance status, and absence of extracranial disease. For those patients, individually optimized treatment is worthwhile. For good-prognosis patients with controlled extracranial disease, surgery in combination with postoperative WBRT should be considered, especially when fast relief of symptoms is mandated. For surgically inaccessible solitary lesions below a size threshold of approximately 30 ccm, stereotactic radiosurgery (RS), although never compared to surgery in a randomized fashion, seems to yield comparable results and is the treatment of choice for more than one lesion in appropriately selected patients. Nevertheless, a number of questions concerning the optimal treatment regimens for brain metastases remain. These mainly concern the radiation dose, need for a combination of RS and WBRT, relative timing of different treatment modalities, and maximum number of brain metastases that can reasonably be treated with RS when long-term progression-free survival is the goal. However, RS is definitely an excellent option for salvage and palliation in patients with short life expectancy, as it is simultaneously noninvasive and cost-effective, with short hospitalization times.

Brain Neoplasms↗
PubMed2002

Leptin role in advanced lung cancer. A mediator of the acute phase response or a marker of the status of nutrition?

Leptin is an anorexia inductor peptide produced by adipocytes and related to fat mass. Leptin is also produced by fat under proinflammatory cytokine action. Our objective is to study serum leptin levels in relation to nutritional status and acute phase response in advanced-stage non-small cell lung cancer.Seventy-six patients newly diagnosed of non surgical non-small cell lung cancer before chemotherapy treatment and 30 healthy controls were included. BMI, serum leptin and cholesterol levels and lymphocyte count were decreased in lung cancer patients. Cytokine IL-6, TNF-alpha, sTNF-RII, sIL-2R, IL-12, IL-10 and IFN-gamma, and other acute phase reactants as alpha1 antitrypsin, ferritin, CRP and platelets were all raised in patients, whereas the IL-2 was decreased. We found a direct relationship between leptin and other indicators of the status of nutrition, especially total fat mass. We also found a close relationship between the status of nutrition and the performance status (Karnofsky index). However, serum leptin and nutritional status were inversely correlated with acute phase proteins and proinflammatory cytokines, suggesting a stress-type malnutrition. Although serum leptin levels, nutritional status and Karnofsky index are related to survival, at multivariate analysis they all were displaced by the acute phase reaction markers. These results suggest that cancer anorexia and cachexia are not due to a dysregulation of leptin production. Circulating leptin concentrations are not elevated in weight-losing cancer patients and are inversely related to the intensity of the inflammatory response. In advanced lung cancer patients serum leptin concentrations only depend on the total amount of fat.

Acute-Phase Reaction↗
PubMed1998

High-dose-rate brachytherapy for medically inoperable stage I endometrial cancer.

PURPOSE: The objective of this study was to determine the efficacy of high-dose-rate (HDR) brachytherapy in 36 medically inoperable patients with stage I endometrial cancer. METHODS AND MATERIALS: From October 1989 to August 1997, 36 patients presented with clinical stage I inoperable endometrial cancer. Surgery was precluded because of obesity and/or poor cardio-pulmonary reserve. Obesity was assessed using the body mass index (BMI) scale (kg/m2). Patients received 5 weekly HDR outpatient brachytherapy applications while under intravenous conscious sedation. Three-year clinical endpoints were calculated using the Kaplan and Meier method. Grade 3 and above complications were scored using the Radiation Therapy Oncology Group system. RESULTS: The median age, Karnofsky performance status, BMI, and weight were 65 years old, 80%, 47 kg/m2, and 268 lbs, respectively. Nineteen patients were inoperable due to morbid obesity (median weight and BMI: 316 lbs and 56 kg/m2) while the remaining patients had other significant medical problems. Two patients died from acute cardiovascular events within 30 days of the last insertion. With a median follow-up of 32 months the 3-year uterine control, disease-free survival, survival, and complications were 88, 85, 65, and 21%, respectively. CONCLUSION: Excellent uterine control rates (88%) were achieved using HDR brachytherapy for patients with medically inoperable endometrial cancer, but with significant acute and late morbidities. These toxicities were observed in a previous interim analysis that resulted in major modifications of the HDR program. No severe complications have developed since these changes were implemented. The current approach used for these challenging inoperable patients is a viable alternative to observation or hormonal therapy.

Adult↗
PubMed1994

Gamma knife radiosurgery of a series of only minimally selected metastatic brain tumours.

From December 1991 to October 1992, 77 lesions in 25 consecutive patients were treated with Gamma Knife radiosurgery. Thirteen patients (52%) had multiple metastases up to sixteen lesions and twelve patients had a single metastasis. The volume of the largest tumour treated was 12.5 cm3. Karnofsky performance status (KPS) of the patients was 20-90% (mean 70). Marginal tumour dose given was 18 to 35 Gy (mean 26.1 Gy) in 30 to 90% isodose line according to the tumour volume and site. All but two patients were followed by MRI or CT scan repeatedly for a minimum of 6 month or to death. All but one of the tumours were locally controlled. Seventeen patients died during follow up and in four death was due to remote CNS metastases. The median survival for this minimally selected group of patients was 8.5 months, and the median survival for the patients with a single metastasis was 10.5 months. In patients with multiple metastases the median survival reached only 2.5 months but in 11 patients out of 13 patients neurological symptoms and signs improved or stabilized shortly after radiosurgery.

Adult↗
PubMed1985

A phase II trial of aclacinomycin-A in advanced squamous cell carcinoma of the head and neck.

Sixteen patients with advanced squamous cell carcinoma of the head and neck were entered into a phase II trial of Aclacinomycin-A (ACM), 100 mg/M2 administered by brief infusion every three weeks. All patients had received prior radiation therapy and prior non-anthracycline containing chemotherapy. No clinically significant disease regression was observed in fourteen patients having adequate trials. The major toxicity was myelosuppression; leukopenia occurred in 93% of patients. Gastro-intestinal toxicity was mild and included two patients with transient liver function test abnormalities. No antitumor activity was observed in this patient population which was heavily pre-treated and had a median Karnofsky performance status of only 60%. The results of other phase II trials of ACM-A have been similarly disappointing suggesting that it is not a clinically useful agent in the treatment of solid tumors.

Aclarubicin↗