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A randomized study of doxorubicin versus doxorubicin plus cisplatin in endocrine-unresponsive metastatic prostatic carcinoma.

Thirty-seven patients with hormonally refractory prostatic carcinoma entered a randomized trial comparing doxorubicin and doxorubicin plus cisplatin. All patients had failed prior hormonal treatment. Mean Karnofsky performance status (76% doxorubicin versus 75% combination), percent of patients with prior palliative irradiation (40% doxorubicin versus 35% combination), and hemoglobin levels of less than or equal to 12 g/dl (30% doxorubicin versus 24% combination) were roughly equivalent in the two treatment groups. More patients treated with doxorubicin than the combination treatment had an elevated acid phosphatase level at study entry (90% versus 65%). Measurable bidimensional tumors were present in 13 patients in 16 sites in the doxorubicin arm and in 10 patients in 11 sites in the combination arm. Partial responses were seen in 1 of 13 patients in the doxorubicin arm and 2 (20%) of 10 patients in the combination arm. Improvement in Karnofsky performance status of 20% or greater was rarely observed with either treatment (7% doxorubicin versus 8% combination). Acid phosphatase levels normalized or improved by 50% in 39% of patients who received doxorubicin and 27% of patients who received the combination. The overall response rate by National Prostatic Cancer Project Criteria was 53% for doxorubicin and 59% for doxorubicin plus cisplatin. Myelotoxicity and gastrointestinal toxicity were severe, particularly in the combination arm, and required discontinuation of treatment in some patients who responded to treatment. Moderate renal dysfunction (creatinine value 2.0-3.0 mg/dl) occurred only in the combination arm at an incidence of 23%. Time to progression and survival were similar for the two treatment groups. In this small group of 37 patients, the combination of cisplatin and doxorubicin showed no improvement over doxorubicin alone in response, response duration, or survival, and was difficult to administer in this patient population.

Adenocarcinoma↗

[Prognosis and documentation of the disease course in severe craniocerebral injuries].

35 survivors of severe head injury were consecutively admitted to the Neurological Department, University of Vienna for early rehabilitation. The outcome after a mean observation periods of 19 months was compared with clinical signs (best motor response, pupillary light reaction, pupil size) in the acute stage. The clinical signs were graded semiquantitatively. The outcome was assessed using the Glasgow Outcome Scale and compared with alternatives, the Karnofsky Performance Status and a self-designed neuropsychological rating scale. Both indexes appeared to possess certain advantages which included additional information and sensitivity to change. A significant correlation was established between the long-term outcome after severe head injury on the one hand and the "best motor response" and changes in pupillary light reaction in the acute stage on the other hand. However, the clinical parameter of pupil size in the acute stage does not provide a prognostic indicator of the disability status at the end of the observation period. There was good agreement between the outcome scores derived by means of the 3 rating scales. Solely with respect to the items "orientation and memory function" and "emotions" of the neuropsychological rating scale was no significant correlation obtained with the clinical sign "best motor response" in the acute stage. Our results indicate that it seems possible to assess the outcome after severe head injury not only be means of the widely-adopted Glasgow Outcome Scale, but also using the Karnofsky Performance Status and our neuropsychological rating scale without any marked loss of reliability. The clinical signs - "best motor response" and pupillary light reaction - are excellent prognostic indicators of the long-term outcome after severe head injury.

Adolescent↗

Results of radiotherapy with curative intent in non-small cell lung cancer. An analysis of 130 patients.

Between 1970 and 1985, 130 patients were irradiated with curative intent at the Center of Oncology in Kraków. The histological diagnosis was squamous-cell carcinoma in 60.8% of patients, adenocarcinoma in 25.4% of patients and other non-small cell cancer in 13.8% of patients. Out of 130 irradiated patients 21.5% refused surgery, 26.2% were inoperable for medical reasons, and 52.3% had unresectable tumors. According to the UICC TNM 1987 classification, 62 (47.7%) patients had early (stages I and II) disease. The remaining 68 (52.3%) patients had stage III A cancer. Additional criteria for patients selection to radiotherapy with curative intent were: Karnofsky performance status > or = 50, and no respiratory insufficiency. All patients were treated with megavoltage radiation. Patients with stage I were treated by three isocentric beams. Tumor dose was 6000 cGy in 24 fractions over five weeks. In patients with stage II and III A disease the radiotherapy was started with two parallel opposed beams encompassing primary lesion and mediastinum. The dose of 4000 cGy was given in 20 fractions over four weeks, followed by a "boost" dose of 2000 cGy in the fractions over two weeks, delivered with three isocentric beams. 54% of patients were disease-free at the twelfth month, 24.6% at the 36th month, and 18.5% of patients survived five years without evidence of cancer. A significantly better survival has been observed in patients with stages I and II, with Karnofsky performance status > or = 70, and with complete radiological regression eight weeks after radiation therapy. The main cause of failure of the treatment were distant metastases.

Adenocarcinoma↗

Quality of life during chemotherapy in non-small cell lung cancer patients.

To evaluate the usefulness of chemotherapy in non-small cell lung cancer, objective response, length of remission and survival have been considered the main yardsticks. Subjective improvement and gain in Karnofsky performance status have attracted very little attention. Thirty-one patients with stages III and IV underwent combination chemotherapy with high-dose cisplatin, and were assessed with categorical scales and 100 mm visual analogue scales used by patients themselves to report on several symptoms of their illness. After chemotherapy 17 of 19 patients (89%) gained weight; 20 presented anorexia, 10 of those (50%) improved; 15 had pain, 7 of those (47%) were alleviated; cough was reported in 22, in 10 (45%) it was ameliorated; hemoptysis disappeared in 10 of 11 patients (91%); of the 9 patients who had dyspnea, 7 improved (78%); and astenia was attenuated in 8 of 16 patients (50%). Quality of life was reported improved in 75% of those patients who had considered themselves seriously affected prior to the treatment. When compared with Karnofsky performance status, no relationship was found (r = 0.31). It is concluded that, apart from the objective response achieved, a significant proportion of patients did benefit from treatment as demonstrated by a marked relief of symptoms.

Antineoplastic Agents↗

Dose-volume modeling of salivary function in patients with head-and-neck cancer receiving radiotherapy.

PURPOSE: We investigated the factors that affect salivary function after head-and-neck radiotherapy (RT), including parotid gland dose-volume effects, potential compensation by less-irradiated gland tissue, and functional recovery over time. METHODS AND MATERIALS: Sixty-five patients with head-and-neck tumors were enrolled in a prospective salivary function study. RT was delivered using intensity-modulated RT (n = 45), forward-planning three-dimensional conformal RT (n = 14), or three-dimensional conformal RT with an intensity-modulated RT boost (n = 6). Whole salivary flow was measured before therapy and at 6 months (n = 61) and 12 months (n = 31) after RT. A wide variety of dose-volume models to predict post-RT salivary function were tested. Xerostomia was defined according to the subjective, objective, management, analytic (SOMA) criteria as occurring when posttreatment salivary function was < 25% of the pretreatment function. Multivariate logistic regression analysis was used to assess the combined effect of dose-volume, patient-, and treatment-related factors. RESULTS: A significant correlation was observed between the relative quality-of-life scores and relative stimulated saliva values at 6 months after RT (Spearman's correlation coefficient [R(s)] = 0.46, p < 0.001). The dose-volume factors were by far the strongest correlates with stimulated saliva flow, although other factors showed modest significance in multimetric models (chemotherapy, gender, and Karnofsky performance status). Several fitted dose-volume models provided a good mathematical description of the data. Significant noise in the salivary measurements (repeated measurement coefficient of variation was 27% in normal subjects) precluded selection of any one of the models presented solely on the basis of the objective fit criteria. Nevertheless, the mean dose-exponential model, in which each parotid gland's relative salivary gland function equaled exp(-A x mean gland dose), with A equal to 0.054/Gy (68% confidence interval 0.052-0.059), provided a good representation of the data and was incorporated into our multimetric analysis. Using that model, we estimated that a mean parotid dose of 25.8 Gy, on average, was likely to reduce a single parotid gland's flow to 25% of its pretreatment value, regardless of the treatment delivery method. Significant correlations were observed between a logistic multivariate model (incorporating the mean dose-exponential equation, gender, and Karnofsky performance status) and stimulated saliva flow at 6 months (R(s) = 0.73), stimulated saliva flow at 12 months (R(s) = 0.54), and quality-of-life score at 6 months (R(s) = 0.35) after RT. CONCLUSION: Stimulated parotid salivary gland dose-volume models strongly correlated with both stimulated salivary function and quality-of-life scores at 6 months after RT. The mean stimulated saliva flow rates improved from 6 to 12 months after RT. Salivary function, in each gland, appeared to be lost exponentially at a rate of approximately 5%/1 Gy of mean dose. Additional research is necessary to distinguish among the models for use in treatment planning. The incidence of xerostomia was significantly decreased when the mean dose of at least one parotid gland was kept to < 25.8 Gy with conventional fractionation. However, even lower mean doses imply increased late salivary function.

Adult↗

Biochemical modulation of doxorubicin by high-dose tamoxifen in the treatment of advanced hepatocellular carcinoma.

BACKGROUND/AIMS: In vitro data have indicated that tamoxifen (> 2.5 uM) significantly enhances the cytotoxic effect of doxorubicin in hepatocellular carcinoma (HCC) cells. This clinical study was conducted to examine whether tamoxifen, at a dose sufficient to result in a plasma concentration of more than 2.5 uM, may improve the therapeutic efficacy of doxorubicin in patients with advanced HCC. METHODOLOGY: A prospective phase II study was conducted. Eligible patients had unresectable and non-embolizable HCC, objectively measurable tumors, adequate neogram with absolute granulocyte count > 2,000/mm3 and platelet count > 1 x 10/mm3, total serum bilirubin < 3.0 mg/dl, age > or = 75 year, and a Karnofsky performance status < or = 50%. The treatment included oral tamoxifen 40 mg/m2, q.i.d, Day 1 to 7, and intravenous doxorubicin 60 mg/m2, Day 4, repeated every 3 weeks. RESULTS: Between May 1994 and December 1996, a total of 38 patients were enrolled in the study. Thirty-six patients were evaluable for tumor response and treatment-related toxicities. There were 32 men and 4 women, with a median age of 49 years. They received an average of 3.8 (range:1-12) courses of chemotherapy. ECOG (Eastern Cooperative Oncology Group) Grade 3-4 leucopenia and Grade 3-4 thrombocytopenia developed in 27.2% and 12.5% courses given, respectively. Gastrointestinal toxicity was generally mild. Three patients developed symptomatic cardiac toxicity. Twelve patients (33.3%, 95% confidence interval 17-51%) had achieved a partial remission (PR), with a median progression-free survival of 7 months. Median survivals of the responders and non-responders were 10 and 3 months, respectively (p<0.05). The median Karnofsky performance status of the responders improved from 74.0+/-6.3% to a post-chemotherapy value of 93.2+/-4.6% (p<0.05) CONCLUSIONS: High dose tamoxifen appears to be an effective biochemical modulator of doxorubicin in the treatment of HCC. Prospective randomized phase III studies comparing doxorubicin alone versus doxorubicin plus high-dose tamoxifen are needed.

Adult↗

GliaSite brachytherapy for treatment of recurrent malignant gliomas: a retrospective multi-institutional analysis.

OBJECTIVE: To review the cumulative experience of 10 institutions in treating recurrent malignant gliomas with the brachytherapy device, GliaSite Radiation Therapy System. METHODS: The patient population consisted of 95 patients with recurrent grade 3 or 4 gliomas, a median age of 51 years, and a median Karnofsky performance status score of 80. All patients had previously undergone resection and had received external beam radiotherapy as part of their initial treatment. After recurrence, each patient underwent maximal surgical debulking of their recurrent lesion and placement of an expandable balloon catheter (GliaSite) in the tumor cavity. The balloon was afterloaded with liquid I (Iotrex) to deliver a median dose of 60 Gy to an average depth of 1 cm with a median dose rate of 52.3 Gy/hr. Patients were carefully followed with serial magnetic resonance imaging and monthly examinations for tumor progression, side effects, and survival. RESULTS: The median survival for all patients, measured from date of GliaSite placement, was 36.3 weeks with an estimated 1 year survival of 31.1%. The median survival was 35.9 weeks for patients with an initial diagnosis of glioblastoma multiforme and 43.6 weeks for those with non- glioblastoma multiforme malignant gliomas. Analysis of the influence of various individual prognostic factors on patient survival demonstrated that only Karnofsky performance status significantly predicted for improved survival. There were three cases of pathologically documented radiation necrosis. CONCLUSION: Reirradiation of malignant gliomas with the GliaSite Radiation Therapy System after reresection seems to provide a modest survival benefit above what would be expected from surgery alone. This report not only confirms the initial results of the feasibility study but provides evidence that similar outcomes can be obtained outside of a clinical trial.

Adult↗

Benign meningiomas: primary treatment selection affects survival.

PURPOSE: To examine the effect of primary treatment selection on outcomes for benign intracranial meningiomas at the University of Florida. METHODS AND MATERIALS: For 262 patients, the impact of age, Karnofsky performance status, pathologic features, tumor size, tumor location, and treatment modality on local control and cause-specific survival was analyzed (minimum potential follow-up, 2 years; median follow-up, 8.2 years). Extent of surgery was classified by Simpson grade. Treatment groups: surgery alone (n = 229), surgery and postoperative radiotherapy (RT) (n = 21), RT alone (n = 7), radiosurgery alone (n = 5). Survival analysis: Kaplan-Meier method with univariate and multivariate analysis. RESULTS: At 15 years, local control was 76% after total excision (TE) and 87% after subtotal excision plus RT (SE+RT), both significantly better (p = 0.0001) than after SE alone (30%). Cause-specific survival at 15 years was reduced after treatment with SE alone (51%), compared with TE (88%) or SE+RT (86%) (p = 0.0003). Recurrence after primary treatment portended decreased survival, independent of initial treatment group or salvage treatment selection (p = 0.001). Atypical pathologic features predicted reduced 15-year local control (54 vs. 71%) and cause-specific survival rates (57 vs. 86%). Multivariate analysis for cause-specific survival revealed treatment group (SE vs. others; p = 0.0001), pathologic features (atypical vs. typical;p = 0.0056), and Karnofsky performance status (> or = 80 vs. < 80; p = 0.0153) as significant variables. CONCLUSION: Benign meningiomas are well managed by TE or SE+RT. SE alone is inadequate therapy and adversely affects cause-specific survival. Atypical pathologic features predict a poorer outcome, suggesting possible benefit from more aggressive treatment. Because local recurrence portends lower survival rates, primary treatment choice is important.

Adolescent↗

Results of a policy of surveillance alone after surgical management of pediatric low grade gliomas.

PURPOSE: To document the incidence of tumor progression in pediatric patients with low-grade gliomas (LGGs), with particular emphasis on those patients who did not receive postoperative chemotherapy or radiotherapy (RT). METHODS AND MATERIALS: A database of 128 patients with histologically confirmed LGGs (World Health Organization Grade I-II), age <or=18 years, who had been referred to the London Regional Cancer Center and Dalhousie University between 1979 and 1995, was compiled. RESULTS: The median follow-up for the 128 patients was 7.3 years. Of the 128 patients, 63 were male and 65 female. The median age was 7.0 years (range 0-18). Twenty-five patients underwent gross complete resection, 63 subtotal resection, and 40 patients biopsy. Ninety-one percent (n = 117) of the tumors were astrocytomas, of which 22 were pilocytic, 3 were oligodendrogliomas, 7 were mixed gliomas, and 1 was a ganglioglioma. Of the 103 subtotally resected patients, 48 received postoperative RT (median dose 59 Gy in 25 fractions) and 10 patients were irradiated at the time of tumor progression. The 5-year overall survival was 86%, cause-specific survival 88%, and 5-year progression-free survival 79%. The results of the univariate analysis of the overall survival by the Wilcoxon model were statistically significant for Karnofsky performance status (p = 0.03), RT timing (i.e., postoperative vs. deferred; p = 0.05), and tumor location (p = 0.02). The analysis of progression-free survival confirmed the statistical significance of the extent of surgical resection (i.e., complete vs. subtotal resection; p = 0.02). None of the patients who underwent gross complete resections received postoperative RT and none developed tumor recurrence. Of the 103 patients who had subtotal resections, 33 had progression, with a median postprogression survival of 39 months. The rate of tumor progression among the subtotally resected LGG patients who did not receive immediate postoperative RT was 42%. The timing of RT and tumor location lost statistical significance for overall survival when the completely resected patients were excluded from the analysis. CONCLUSIONS: The extent of surgical resection was prognostically significant for progression-free survival but lost significance as a prognostic factor once the complete resection patients were excluded from the analysis. At a median survival of 7.3 years, 42% of the subtotally resected LGG patients who did not receive immediate postoperative RT had tumor progression. No statistically significant difference in survival was seen between the postoperative and deferred RT groups, even though the postoperative RT group was a group with poorer prognostic features (bulky residual tumor postoperatively, Karnofsky performance status <70, and nonhemispheric, noncerebellar tumors), indicating that RT may be beneficial for this particular subset of patients.

Analysis of Variance↗

The national practice for patients receiving radiation therapy for carcinoma of the esophagus: results of the 1996-1999 Patterns of Care Study.

PURPOSE: A Patterns of Care Study (PCS) was conducted to evaluate the standards of practice for patients receiving radiation therapy for esophageal cancer from 1996 to 1999. This study examined the evaluation and treatment schemes used during this time and compared these results to the PCS data obtained between 1992 and 1994 to identify any fundamental changes in national practice. METHODS: A national survey was conducted using a two-stage cluster sampling technique. Specific information was collected on 414 patients with esophageal cancer who received radiotherapy (RT) as part of definitive or adjuvant management at 59 institutions. Patients were staged according to the 1983 AJCC. Eligibility criteria for case review included RT between 1996 and 1999, no evidence of distant metastasis (including CT evidence of either supraclavicular or celiac nodes >1 cm), squamous cell or adenocarcinoma histology, Karnofsky performance status >60, tumors in the thoracic esophagus with <2 cm extension into the stomach, and no prior malignancies within the last 5 years. Statistical analysis was performed on the database using SUDAAN software to accurately reflect the type of sampling technique used by PCS. For the purpose of this analysis, institutions were stratified as either large or small based on the number of new cases seen each year. For the purposes of comparison, the 1992-1994 PCS esophageal survey results were subjected to the same statistical procedures and tests. RESULTS: The median age of patients was 64 years. Seventy-seven percent were male, and 23% were female. Karnofsky performance status was >or=80% in 85% of patients. The racial profile mirrors the previous survey with 75% Caucasian, 21% African-American, 3% Asian, and <1% Hispanic. A review of the histology revealed a nearly 50:50 split between squamous cell and adenocarcinoma. Sixteen percent were clinical Stage I, 39% clinical Stage II, and 33% clinical Stage III according to the 1983 AJCC system. Workup included endoscopy (96%), CT of the chest (87%), CT of the abdomen (75%), and esophagram (64%). Endoscopic ultrasound (EUS) was used in 18% of cases as compared to <2% in the original survey (p < 0.0001). Patients treated at large centers were more likely to undergo EUS than those treated at small centers (23% vs. 12%, p = 0.047). Fifty-six percent of patients received concurrent chemoradiation as definitive treatment. There was a significant increase in the use of concurrent chemoradiation before planned surgical resection as compared to the original survey (27% vs. 10%, p = 0.007). Other schemes included RT alone (10%), postoperative RT (1%), and postoperative chemoradiation (5%). Forty-six percent of patients with adenocarcinoma underwent trimodality therapy as compared to 19% with squamous cell carcinomas (p = 0.0002). Patients undergoing preoperative chemoradiation were more likely to have had an EUS. The median total dose of external RT was 50.4 Gy, and the median dose per fraction was 1.8 Gy. Brachytherapy was used in 6% of cases. The chemotherapy agents most commonly used included 5-fluorouracil (82%), cisplatin (67%), and paclitaxel (22%). Paclitaxel was more commonly employed as part of a preoperative chemoradiation regimen than in the setting of definitive chemoradiation (46% vs. 12%, p = 0.03). Compared to the original survey, paclitaxel use significantly increased between 1996 and 1999 (0.2% vs. 22%, p = 0.001). CONCLUSIONS: The Patterns of Care Survey confirms the use of concurrent chemoradiation as part of the national standards of practice for the management of esophageal cancer patients. A comparison with the previous study documents the significant rise in the use of EUS, preoperative chemoradiation followed by surgery, and the increasing use of paclitaxel as part of a combined modality regimen.

Adenocarcinoma↗

Chronic oral etoposide and tamoxifen in the treatment of far-advanced hepatocellular carcinoma.

BACKGROUND: Hepatocellular carcinoma (HCC) is a chemoresistant tumor that frequently expresses a high level of p 170 glycoprotein of the multidrug-resistance (MDR) gene. Preliminary data suggested that VP-16 showed modest activity in HCC. Recently, schedule-dependent cytotoxicity of VP-16 has been demonstrated. In this study, we tested the therapeutic efficacy of chronic oral VP-16 plus tamoxifen, a potential MDR-reversing agent, in patients with far-advanced HCC. METHODS: A prospective single-arm study was conducted in the National Taiwan University Hospital. To be eligible, patients must have had unresectable and non-embolizable HCC, objectively measurable tumors, adequate hemogram with absolute granulocyte count greater than or equal to 2,000/mm3, and platelet count greater than or equal to 1x10 (5)/mm3, total serum bilirubin less than or equal to 3.0 mg/dl, age less than or equal to 75 years, and a Karnofsky performance status of greater then or equal to 50%. The treatment included VP-16 (Bristol-Myers-Squibb, Princeton, NJ), 50 mg/m2/day, orally, Days 1 to 21, and tamoxifen (Pharmachemie B.V. Haarlem, Netherlands), 40 mg/day, orally, Days 1 to 21; repeated every 5 weeks. RESULTS: Between December 1990 and December 1993, a total of 33 patients were enrolled in the study. There were 28 men and 5 women, with a median age of 51 years. They received an average of 3.2 (range: 1-10) courses of chemotherapy. ECOG (Eastern Cooperative Oncology Group) Grade 3 and Grade 4 leucopenia developed in 6 patients (18.2%) and 4 (12.1%) patients, respectively. Grade 3 and 4 thrombocytopenia developed in 2 patients (6.1%). Treatment-related death occurred in one patient due to sepsis. Mild gastrointestinal toxicities were common with Grade 1 and 2 nausea. Grade 1 and 2 vomiting, Grade 1 and 2 diarrhea, and Grade 1 and 2 stomatitis, developed in 13 (39.4%), 7 (21.2%), 12 (36.4%), and 16 (48.5%) patients, respectively. Grade 3 and 4 gastrointestinal toxicities were rare. Deep vein thrombosis occurred in one patient (3.0%). Eight patients (24.2%, 95% confidence interval 11%-42%) had achieved a partial remission, with a median time-to-progression of 6 months (2-11). Median survivals of the responders and non-responders were 8.0 and 3.0 months, respectively (P < 0.05). The median Karnofsky performance status of the responders improved from 70% to 80%. CONCLUSIONS: Chronic oral VP-16 and tamoxifen has modest activity and acceptable toxicity in far-advanced HCC, and is a useful palliative treatment in about a quarter of such patients.

Administration, Oral↗

High stromal versican expression predicts unfavourable outcome in oral squamous cell carcinoma.

BACKGROUND: Versican, an extracellular matrix proteoglycan, has been noted to be expressed in several malignant tumours and has been suggested to play an important role in cancer development and tumour growth. AIMS: To investigate whether the versican expression level in the peritumoural stromal tissue of primary oral squamous cell carcinoma (OSCC) predicts relapse-free or disease-specific survival. Also, to study the associations between versican expression and several other clinicopathological variables, as well as tumour cell proliferation. METHODS: Immunohistochemistry was used to study the expression of versican and tumour cell proliferative activity in 139 OSCCs. All pertinent clinical data were collected retrospectively from the hospital records. RESULTS: In this cohort, versican expression did not correlate with the clinicopathological factors or tumour cell proliferation. In univariate analyses, higher risk for disease recurrence was associated with higher stromal versican expression score (p = 0.02), positive neck node status (p = 0.02), lower Karnofsky performance status (p = 0.03) and higher tumour cell proliferation index (p = 0.04). Increased disease-specific risk of death was associated with high stromal versican expression score (p = 0.005) higher T class (p = 0.002), positive neck node status (p<0.001), higher stage (p<0.001), poorer histological differentiation (p = 0.005), worse general condition of the patient (p = 0.049) and increased tumour cell proliferative index (p = 0.02). In multivariate disease-specific survival analysis, high stromal versican expression score (p = 0.048), poorer histological differentiation (p = 0.047) and higher stage (p = 0.002) independently predicted poorer disease outcome. CONCLUSIONS: In this cohort, increased stromal versican expression correlated with both increased risk for disease recurrence and shortened survival. High stromal versican expression may thus be considered an independent and adverse prognostic marker in OSCC.

Adolescent↗

Measuring the quality of life before and after bilateral lung transplantation in patients with cystic fibrosis.

Lung transplantation is an important topic today in healthcare policy because the technique is new and costly. One of the important issues in the evaluation of lung transplantation is quality of life. The quality of life after lung transplantation must be relatively high compared with other forms of medical care to legitimize the high costs of transplantation. Quantifying the quality of life after lung transplantation and other medical therapies is possible with general measurements of quality of life. In a pilot study of six patients with cystic fibrosis, the quality of life, both before and after lung transplantation, was measured by the following five instruments: (1) standard gamble, (2) time trade-off, (3) the Karnofsky performance status, (4) the EuroQol visual analog scale, and (5) the Nottingham health profile. This pilot study demonstrates that the introduced methodology is feasible. The preliminary results suggest that the improvement in quality of life for patients with cystic fibrosis after bilateral lung transplantation is comparable to the improvement in quality of life after heart transplantation.

Adult↗

A structural model of the relationships among self-efficacy, psychological adjustment, and physical condition in Japanese advanced cancer patients.

We made detailed research for relationships among physical condition, self-efficacy and psychological adjustment of patients with advanced cancer in Japan. The sample consisted of 85 (42 males and 43 females) advanced cancer patients. Interviews were conducted with some measurement scales including the Self-efficacy scale for Advanced Cancer (SEAC), and the Hospital Anxiety and Depression Scale (HADS). Karnofsky Performance Status (KPS) and medication status were also recorded from the evaluation by physicians. We used structural equation modeling (SEM) for statistical analysis. The analysis revealed that the model, including three self-efficacy subscales, depression, anxiety, KPS, meal-, liquid-intake, prognosis and three latent variables: 'Self-efficacy', 'Emotional Distress', and 'Physical Condition,' fit the data (chi-square(24)=28.67, p=0.23; GFI=0.93; CFI=0.98; RMSEA=0.05). In this model, self-efficacy accounted for 71% of the variance in emotional distress and physical condition accounted for 8% of the variance in self-efficacy. Overall, our findings suggest clearly that close relationships existed among physical condition, self-efficacy and emotional distress. That is, patients in good physical condition had a high self-efficacy, and patients with high self-efficacy were less emotionally distressed. These results imply that psychological intervention which emphasizes self-efficacy would be effective for advanced cancer patients.

Adaptation, Psychological↗

Quality of life and performance in advanced head and neck cancer patients on concomitant chemoradiotherapy: a prospective examination.

PURPOSE: To prospectively evaluate performance and quality of life (QOL) in advanced-stage head and neck cancer (HNC) patients on a curative-intent, concomitant-chemoradiotherapy (CT/XRT) (twice-daily radiation, fluorouracil, hydroxyurea, and cisplatin) regimen aimed at improving locoregional control, survival, and QOL. PATIENTS AND METHODS: Sixty-four patients were assessed before, during, and at 3-month intervals after treatment. Standardized measures of QOL (Functional Assessment of Cancer Therapy-Head and Neck), performance (Performance Status Scale for Head and Neck Cancer Patients and Karnofsky Performance Status Rating Scale), and patient-reported symptoms (McMaster University Head and Neck Radiotherapy Questionnaire) were administered. RESULTS: Acute treatment toxicities were severe, with declines in virtually all QOL and functional domains. Marked improvement was seen by 12 months; general functional and physical measures returned to baseline levels of good to excellent. Although up to a third of the patients continued to report problems with swallowing, hoarseness, and mouth pain, these difficulties were present in similar magnitudes before treatment. The following symptoms were more frequent at 12 months: dry mouth (58% v 17%), difficulties tasting (32% v 8%), and soft food diet (82% v 42%). Twelve-month diet was not related to pretreatment functioning, disease, treatment, or patient characteristics. Twelve-month QOL was best predicted by pretreatment QOL, with very little relationship to residual side effects or functional impairments. Small numbers of patients in four of the five disease sites precluded examination of outcome by site. CONCLUSION: These data support the feasibility of intense CT/XRT as primary treatment for advanced HNC. Results confirm acute toxicity but indicate that many of the treatment-related performance and QOL declines resolve by 12 months. The persistent inability to eat a full range of foods warrants further attention and monitoring.

Adolescent↗

Prognostic factors derived from recursive partition analysis (RPA) of Radiation Therapy Oncology Group (RTOG) brain metastases trials applied to surgically resected and irradiated brain metastatic cases.

PURPOSE: (a) To identify the prognostic factors that determine survival after surgical resection and irradiation of tumors metastatic to brain. (b) To determine if the prognostic factors used in the recursive partition analysis (RPA) of brain metastases cases from Radiation Therapy Oncology Group (RTOG) studies into three distinct survival classes is applicable to surgically resected and irradiated patients. METHOD: The medical records of 125 patients who had surgical resection and radiotherapy for brain metastases from 1985 to 1997 were reviewed. The patients' disease and treatment related factors were analyzed to identify factors that independently determine survival after diagnosis of brain metastasis. The patients were also grouped into three classes using the RPA-derived prognostic parameters which are: age, performance status, state of the primary disease, and presence or absence of extracranial metastases. Class 1: patients < or = 65 years of age, Karnofsky performance status (KPS) of > or =70, with controlled primary disease and no extracranial metastases; Class 3: patients with KPS < 70. Patients who do not qualify for Class 1 or 3 are grouped as Class 2. The survival of these patients was determined from the time of diagnosis of brain metastases to the time of death. RESULTS: The median survival of the entire group was 9.5 months. The three classes of patients as grouped had median survivals of 14.8, 9.9, and 6.0 months respectively (p=0.0002). Age of < 65 years, KPS of > or = 70, controlled primary disease, absence of extracranial metastases, complete surgical resection of the brain lesion(s) were found to be independent prognostic factors for survival; the total dose of radiation was not. CONCLUSION: Based on the results of this study, the patients and disease characteristics have significant impact on the survival of patients with brain metastases treated with a combination of surgical resection and radiotherapy. These parameters could be used in selecting patients who would benefit most from such treatment.

Adult↗

Longitudinal follow-up of body composition in hematopoietic stem cell transplant patients.

Patients with hematological malignancies are well nourished prior to allogeneic hematopoietic stem cell transplantation (HSCT). HSCT and associated complications can affect body composition. The study evaluated cross-sectionally the prevalence and longitudinally the changes in lean body mass index (LBMI) in HSCT patients. Patients (n=82) were classified as normal or low LBMI. Logistic regression analyses were used to estimate odds ratios (OR) for low vs normal LBMI, between healthy volunteers and patients; for limited or extensive vs no chronic graft-versus-host-disease (GVHD); and for decreased (Karnofsky <80) vs normal functional status (>80). Patients were significantly more likely to have low LBMI at 6, 12 months, 2-3, 4-6 and >6 years than volunteers. In all, 38% of patients were below pre-HSCT LBMI at 4-6 years post-HSCT. Low LBMI was significantly associated with steroid treatment (OR 2.6, confidence intervals (CI) 1.3-5.2, P=0.008); limited (OR 5.5, CI 1.7-18.5, P=0.005) or extensive chronic GVHD (OR 20.3, CI 5.7-71.6, P<0.001); and decreased performance status (Karnofsky scores of < or =80) (OR 2.7, CI 1.3-5.9, P=0.01). Patients were more likely to have low LBMI than volunteers. Chronic GVHD and low performance status were associated with low LBMI; thus, complications and/or treatment increase the likelihood of low LBMI.

Body Composition↗

Reoperation for malignant astrocytomas: personal experience and a review of the literature.

All patients in a randomized study comparing chemotherapy with chemotherapy plus radiotherapy for patients with astrocytomas grade 3 and 4, were considered for reoperation when tumour progression was established. Fifty-eight patients were reoperated and 85 were not. Different prognostic factors, such as age, sex, Karnofsky performance status and reoperation were evaluated univariately and simultaneously in a multivariate model. The Karnofsky index and age were found to be independent prognostic factors, while re-operation could not be demonstrated to prolong life when controlled for age and the Karnofsky index. We review the literature on re-operation of malignant astrocytomas.

Analysis of Variance↗