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PubMed2004

Intrapleural staphylococcal superantigen induces resolution of malignant pleural effusions and a survival benefit in non-small cell lung cancer.

BACKGROUND: Malignant pleural effusion (MPE) may occur in up to 50% of patients with non-small cell lung cancer (NSCLC). The majority of these patients have a poor performance status and a dismal prognosis, with survival duration ranging from 2 to 3 months. Since these patients are typically symptomatic from their MPE, prompt treatment is required. Patients with symptomatic MPE from NSCLC and poor performance scores (Eastern Cooperative Oncology Group [ECOG] score >/= 2, Karnofsky performance status [KPS] score < 50) are generally not offered systemic chemotherapy. Treatment is palliative and includes intrapleural catheter drainage or chemical pleurodesis with talc, doxycycline, or bleomycin. None of the latter modalities prolong survival. OBJECTIVE: Our goal was to investigate the toxicity and therapeutic effect of a new therapeutic agent, Staphylococcus aureus superantigen (SSAg), a powerful T-cell stimulant administered intrapleurally to unselected, consecutive patients with MPE from NSCLC (stage IIIb with pleural effusion) and a poor performance status. By providing direct access of the SSAg to the bronchial and mediastinal lymphatics, we predicted that intrapleural administration of SSAg would induce resolution of MPE and prolong survival in this population with advanced NSCLC and a limited prognosis. METHODS: Fourteen consecutive, unselected patients with MPE from NSCLC and a median pretreatment KPS score of 40 (range, 10 to 60) received pleural instillation of SSAg, 100 to 400 pg, once or twice weekly (mean, 3.7 +/- 1.3 treatments [+/- SD]) until the pleural effusions resolved. They were evaluated for drug toxicity, resolution, duration of MPE, and survival. RESULTS: Other than mild fever (maximum grade 2), toxicity of SSAg treatment was trivial and notably devoid of respiratory distress or hypotension. Eleven patients had a complete response (CR), and 3 patients had a partial response of their MPE. In 12 patients, the response endured for > 90 days, with a median time to recurrence of 5 months (range, 3 to 23 months). The median survival for the SSAg-treated group was 7.9 months (range, 2 to 36 months; 95% confidence interval [CI], 5.9 to 11.4 months), compared to a median survival of 2.5 months (range, 0.1 to 57 months; 95% CI, 1.3 to 3.4 months) for 18 consecutive, unselected patients with MPE from NSCLC (stage IIIb) treated with talc poudrage (p = 0.044). Survival duration of all 14 SSAg-treated cases and 13 talc-poudrage-treated patients with comparable pretreatment KPS (range, 10 to 60; median, 40 and 30, respectively), and distribution (p = 0.5) was 7.9 months (95% CI, 5.9 to 11.4 months) and 2.0 months (95% CI, 0.4 to 2.9 months), respectively (p = 0.0023). Nine of 14 patients treated with SSAg survived > 6 months, 4 patients survived > 9 months, and 3 patients survived > 350 days. One of the patients in the CR group has survived 36 months. None of the 13 talc-treated patients survived > 6 months. INTERPRETATION: In 14 unselected, consecutive patients with MPE from NSCLC and poor pretreatment performance (median KPS of 40), the intrapleural administration of SSAg was efficacious in resolving the MPE without any clinically important adverse effects. SSAg-treated patients with a median KPS of 40 (range, 10 to 60) had a median survival that exceeded that with talc poudrage, and was comparable to current systemic chemotherapy used in patients with KPS >/= 70 status. SSAg treatment is simple to perform, minimally invasive, and does not require hospital time. It may be an attractive alternative to existing palliative modalities for stage IIIb patients with MPE and poor performance who are not candidates for systemic chemotherapy.

Aged↗
PubMed2006

Donor quality of life before and after adult-to-adult right liver live donor liver transplantation.

Donor right hepatectomy for adult-to-adult live donor liver transplantation (ALDLT) is a major surgical operation for the benefit of the recipient. Justification of procedure mandates knowledge of the possible physical and psychological negative effects on the donor. We prospectively and longitudinally quantified donor quality of life using generic and condition-specific questionnaires up to 1 year. The generic questionnaires were the Karnofsky Performance Status scale and the Chinese (Hong Kong) version of the Medical Outcomes Study 36-Item Short-Form Survey, which measures 8 health concepts: 4 physical components and 4 mental components. Within 1 year, 30 consecutive donors were included. These 11 male and 19 female donors (36.7% and 63.3%, respectively) had a median age of 35 years (range, 21-56 years). There was no donor mortality or major complications. Donor quality-of-life worsening was most significant in the first 3 postoperative months, particularly among the physical components. The physical and mental components returned to the previous levels in 6 to 12 months' time, though the Karnofsky performance scores were slightly lower at 1 year (P = 0.011). Twenty-six (86.7%) donors declared that they would donate again if there were such a need and it were technically possible. It was noticed that older donors were more likely to express unwillingness to donate again. In conclusion, the temporary worsening of donor quality of life substantiates ALDLT as an acceptable treatment modality.

Adult↗
PubMedDate not supplied

Phase II trial of uracil/tegafur (UFT) plus leucovorin in patients with advanced hepatocellular carcinoma.

UNLABELLED: Although UFT 300 mg/m2/day and leucovorin 90 mg/day administered orally in divided doses administered every 8 hours for 28 days repeated every 35 days could be administered safely to patients with advanced hepatomas and good performance status, this combination and schedule has limited activity in treating advanced hepatoma. BACKGROUND/PURPOSE: Biochemical modulation of 5-fluorouracil has yielded higher response rates in hepatoma when compared to treatment with 5-fluorouracil as a single agent, although the impact on survival has been negligible. This study was conducted to determine the activity and evaluate the toxicity of uracil and tegafur in a 4:1 molar concentration ratio (UFT; Bristol-Myers Squibb, Wallingford, CT) plus oral calcium leucovorin in the treatment of patients with advanced hepatocellular carcinoma (hepatoma). PATIENTS AND METHODS: Sixteen patients with advanced measurable hepatocellular carcinoma were enrolled onto the trial. All patients had a Karnofski performance status > or = 60%, platelet count > or = 75,000/micro L, total bilirubin < or = 2.0 x institutional upper limit of normal but otherwise normal liver and kidney function profile and bidimensionally measurable disease by CT or ultrasound examination. None of these patients received prior cytotoxic chemotherapy or radiation therapy for advanced disease. Fourteen patients received 300 mg/m2/d UFT plus 90 mg/d leucovorin administered orally in divided daily doses every 8 hours for 28 days repeated every 35 days. Two patients registered for the trial but did not receive study medication. Objective tumor response, the primary purpose of this trial, was evaluated after two courses of therapy. Other end-points included toxicity, time to progression, and overall survival. RESULTS: Fourteen patients were evaluable for response and toxicity, respectively. No complete or partial responders were observed in this trial. Three patients had stable disease lasting 17 to 22 weeks. Toxicity was mild with severe (grade 3 or 4) liver pain, diarrhea, anorexia/nausea, fatigue, dyspnea, hyperbilirubinemia, anemia, and edema seen in 3 (21%), 2 (14%), 3 (21%), 2 (14%), 1 (7%), 1 (7%), 1 (7%) and 1 (7%) patients, respectively. The most frequent grade I and 2 toxic effects included fever of unknown origin, dyspnea, nausea, vomiting and diarrhea. CONCLUSION: UFT 300 mg/m2/d plus oral leucovorin 90 mg/d administered for 28 days did not demonstrate antitumor activity against advanced hepatomas. Further treatment using this regimen is not recommended for this disease.

Adult↗
PubMed1988

Treatment of stomach cancer, a national experience.

A total of 1165 patients with stomach cancer were entered into a prospective, observational national study. They represented 54 per cent of all stomach cancer patients reported to the Cancer Registry in Norway during the study period, and data are analysed for three hospital levels (local, county and university hospitals). The median age was 71 years (range 18-96 years). The median pretreatment delay was 113 days, and 46 per cent of patients had a performance status (Karnofsky index) of less than or equal to 80. The diagnosis was confirmed by pre-operative histology in 88 per cent of cases. In all, 88 per cent of patients underwent surgery, the resectability rate was 67 per cent and 50 per cent had a potential curative operation. Total gastrectomy was most commonly performed. Lymph node dissection was performed in 14 per cent of those undergoing a curative resection. The postoperative complication rate was 27 per cent but varied with the type of operation, being highest in proximal resection (55 per cent) and lowest after distal resection (19 per cent). A total of 7 per cent of the patients died postoperatively. Most patients had advanced disease at the time of treatment and only 6 per cent had stage I tumours. There were significant differences in patient and treatment characteristics between the three hospital levels. In conclusion, patient selection bias which will influence results does occur. A fairly aggressive attitude towards local disease was found, but the low proportion of patients undergoing lymph node dissection not only leads to questions regarding the efficacy of this treatment policy, but also casts doubt on the validity of staging of stomach cancer. Morbidity and mortality rates are still high. The consequences of the differences revealed between hospital groups are difficult to interpret. Proponents of both regionalization of treatment and small hospital care may find arguments for their case in the data.

Adult↗
PubMed1994

A prospective study of short-course radiotherapy in poor prognosis glioblastoma multiforme.

PURPOSE: Older age and poor performance status at presentation are unfavorable prognostic factors for patients with glioblastoma multiforme. Some studies suggest a shorter, palliative course of radiotherapy may confer similar benefits as compared to a radical course in such patients. We report a prospective, single arm trial, describing the use of a short-course of radiation in patients with glioblastoma and poor prognostic features. METHODS AND MATERIALS: Twenty-nine patients with pathologically confirmed glioblastoma and age > or = 65 years or with initial KPS < or = 50 were treated with a short-course of whole brain radiotherapy (30 Gy/10 fractions/2 weeks). Computer tomography tumor volume, dexamethasone requirements, Spitzer quality of life index, and Karnofsky performance status were measured pre and 1 month postradiation. Overall survival for the study patients was compared with that of radically treated and supportive care only historical controls. RESULTS: Indices of tumor response were stable or improved in 60% of patients evaluable 1 month postradiotherapy. Median survival for all study patients was 6 months. Median survivals in similar groups of radically treated and supportive care only patients were 10 and 1 month(s), respectively. A survival advantage for the radical vs. short-course treatment was observed for the subset of patients with a pretreatment KPS > 50. CONCLUSION: Elderly patients with a low pretreatment KPS (< or = 50) may be treated adequately with a short, palliative course of radiotherapy. Elderly patients with a higher pretreatment KPS (> 50), however, may benefit from a higher dose radiotherapy regimen.

Aged↗
PubMedDate not supplied

Ifosfamide containing regimen for non-small cell lung cancer.

BACKGROUND: Combination chemotherapy has been demonstrated as one of the best active regimens in patients with non-small cell lung cancer (NSCLC). METHODS: A total of 206 patients with advanced unresectable NSCLC stage III B or stage IV were enrolled to receive combination chemotherapy with mitomycin, ifosfamide and cisplatin. About a third of them (n=63) did not continue therapy after the first course either because of toxicity, lack of affordability, or death. The remaining 143 patients (121 males) received two or more cycles of chemotherapy. RESULTS: Nearly half of all followed-up patients showed a partial or complete radiological response. Overall performance status (Karnofsky scale) worsened in 28 (19.6%) and improved in 44 (30.8%). While 50 patients (35%) gained weight, 65 (45.5%) lost weight during follow-up. Overall median survival was 20 weeks [95% confidence interval (CI), 16 to 24 weeks]. However, overall survival improved progressively with the number of chemotherapy cycles administered. Median survival in patients receiving at least three, four and five chemotherapy cycles was 23 (95% CI, 19-27); 27 (95% CI, 24-30) and 35 (95% CI, 28-42) weeks respectively. Survival at the end of three, six, nine and 12 months was 64.3%, 29.4%, 14.7% and 9.8%) respectively. Survival had no association with age of the patient, but was significantly correlated with baseline performance status (Pearson's correlation coefficient 0.29 p<0.01). The cost of each course of chemotherapy was a little over 100 US dollars. The side effects were minimal and acceptable, and the regimen was tolerated well by all the patients. CONCLUSION: Ifosfamide regimen containing mitomycin and cisplatin is a chemotherapeutic combination for treating patients with advanced NSCLC.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1997

[Effectiveness and tolerance of tramadol in cancer pain. A comparative study with respect to buprenorphine].

Opioid analgesics represent one of the most important tools in a sequential pharmacological approach to oncological pain relief. They are recommended by the WHO when nonsteroidal anti-inflammatory drugs (NSAIDs) no longer provide adequate analgesia. However, the use of opioids is limited because of their numerous and often severe adverse effects. This aspect of opioids has motivated continuous research projects aimed at discovering drugs that can provide maximum pain relief but with improved tolerability. Tramadol is a new, centrally acting analgesic with a dual mechanism of action. It shows a selective interaction with mu receptors, which are responsible for nociception, and has weak pharmacodynamic activity on other opioid receptors. At the same time, it acts synergistically on neuroamine transmission by inhibiting synaptic noradrenaline (norepinephrine) reuptake and inducing intrasynaptic serotonin (5-hydroxytryptamine; 5-HT) release. From a pharmacokinetic standpoint, tramadol offers high bioavailability, with similar patterns after oral or parenteral administration (half-life 5 to 7 hours, time to peak plasma concentration 3.1 hours, and approximately 20% plasma protein binding). Although the efficacy of tramadol is comparable to that of other drugs with similar modes of action, the incidence of side effects such as constipation and respiratory depression is lower. The frequency of euphoria and dysphoria is negligible, resulting in little risk of abuse or dependence. It therefore seemed appropriate to further investigate the efficacy and tolerability of tramadol, defined as having only weak potency, in comparison with a widely used opioid, in oncological pain. Buprenorphine was selected as an opioid with a potency equivalent to half that of morphine, but with tolerability that is partially limited by the fact that it frequently gives rise to adverse reactions considered typical of stronger opioids. To compare the analgesic effect and tolerability of tramadol and buprenorphine, 60 patients (44 men, 16 women; average age 61.4 years), all presenting with advanced tumours, were treated orally in a controlled crossover trial with randomised sequences. Patients took both drugs, each for a week, with a 24-hour washout period between treatments. Tramadol was prescribed at the daily dose of 300mg, orally, and buprenorphine at 0.6 mg/day, as a sublingual preparation. Assessments were made of Karnofsky performance status and severity of pain before and during the 4 hours after taking the 2 drugs. Each patient also completed a daily diary recording the severity of pain 1 hour after the dose, the evolution of pain during the day and its severity compared with that on the previous day. They also assessed the duration and quality of sleep. The Karnofsky index changed little with either treatment, but all other variables showed worthwhile improvement, indicating the significant analgesic effect of both drugs. Buprenorphine and tramadol had a similar analgesic effect, although the improvement with the test drug was significant within 1 hour of administration (p < 0.05 compared with baseline) and more marked (p < 0.05 on day 2 compared with buprenorpine). At the end of tramadol treatment, sleep had also improved, both quantitatively and qualitatively (both p < 0.05). The final assessment was significantly in favour of tramadol as regards efficacy (p < 0.05) and patient acceptability (p < 0.01). Thus, tramadol was better tolerated than buprenorphine, and caused fewer and milder adverse reactions. Only 1 patient discontinued tramadol, compared with 18 using reference therapy. Tramadol, although theoretically less potent, nevertheless brought about as much pain relief as the comparator opioid. In conclusion, for this class of drug, tramadol provides an excellent balance between efficacy and tolerability, confirming preliminary studies.

Aged↗
PubMed2005

Lung cancer symptoms and pulse oximetry in the prognostic assessment of patients with lung cancer.

BACKGROUND: Medical oncologists continue to use performance status as a proxy for quality of life (QOL) measures, as completion of QOL instruments is perceived as time consuming, may measure aspects of QOL not affected by cancer therapy, and interpretation may be unclear. The pulse oximeter is widely used in clinical practice to predict cardiopulmonary morbidity after lung resection in cancer patients, but little is known on its role outside the surgical setting. We evaluated whether the Lung Cancer Symptom Scale and pulse oximetry may contribute to the evaluation of lung cancer patients who received standard anticancer therapy. METHODS: We enrolled forty-one consecutive, newly diagnosed, patients with locally advanced or metastatic lung cancer in this study. We developed a survival model with the variables gender, age, histology, clinical stage, Karnofsky performance status, wasting, LCSS symptom scores, average symptom burden index, and pulse oximetry (SpO2). RESULTS: Patient and observer-rated scores were correlated, except for the fatigue subscale. The median SpO2 was 95% (range: 86 to 98), was unrelated to symptom scores, and was weakly correlated with observer cough scores. In a multivariate survival model, SpO2 > 90% and patient scores on the LCSS appetite and fatigue subscales were independent predictors of survival. CONCLUSION: LCSS fatigue and appetite rating, and pulse oximetry should be studied further as prognostic factors in lung cancer patients.

Adult↗
PubMed1997

Is the time interval between surgery and radiotherapy important in operable nonsmall cell lung cancer? A retrospective analysis of 340 cases.

PURPOSE: To evaluate the influence of prognostic factors in postoperative radiotherapy of NSCLC with special emphasis on the time interval between surgery and start of radiotherapy. METHODS AND MATERIALS: Between January 1976 and December 1993, 340 cases were treated and retrospectively analyzed meeting the following criteria: complete follow-up; complete staging information including pathological confirmation of resection status; maximum interval between surgery (SX) and radiotherapy (RT) of 12 weeks (median 36 days, range 18 to 84 days); minimum dose of 50 Gy (R0), and maximum dose of 70 Gy (R2). Two hundred thirty patients (68%) had N2 disease; 228 patients were completely resected (R0). One hundred six (31%) had adenocarcinoma, 172 (51%) squamous cell carcinoma. RESULTS: In univariate analysis, Karnofsky performance status (90+ >60-80%; p = 0.019 log rank), resection status stratified for nodal disease (R+ <R0; p = 0.046), and the time interval between SX and RT were of significant importance. Patients with a long interval (37 to 84 days) had higher 5-year survival rates (26%) and a median survival time (MST: 21.9 months, 95% C.I. 17.2 to 28.6 months) than patients with a short interval (18 to 36 days: 15%; 14.9 months, 13 to 19.9 months; p = 0.013). A further subgroup analysis revealed significant higher survival rates in patients with a long interval in N0/1 disease (p = 0.011) and incompletely resected NSCLC (p = 0.012). In multivariate analysis, the time interval had a p-value of 0.009 (nodal disease: p = 0.0083; KPI: p = 0.0037; sex: p = 0.035). CONCLUSION: Shortening the time interval between surgery and postoperative radiotherapy to less than 6 weeks even in R+ cases is not necessary. Survival of patients with a long interval between surgery and start of radiotherapy was better in this retrospective analysis as compared to patients with a short interval.

Adult↗
PubMed1985

Fast neutrons and misonidazole for malignant astrocytomas.

Twenty-five patients with biopsy proven malignant supratentorial astrocytomas were entered into a Phase I/II study of misonidazole combined with neutron radiation at Fermilab Neutron Therapy Facility (NTF) between August 1979 and April 1981. The main objectives were to determine tissue tolerance in terms of acute and late effects, and to estimate tumor clearance and survival rates. The total dose was 18.0 Gy given in weekly fractions of 3.0 Gy over 39 days. Four hours before each irradiation, 2.5 gm/m2 misonidazole was administered orally. Patients' ages ranged from 28-69 years. Karnofsky status for most patients was 80 or 90; the lowest grade was 60. The majority of patients had glioblastoma multiforms. Most were already on steroids prior to initiation of therapy. The median survival for the whole group was 12.0 months; 25% were alive at 18 months with some neurological compromise. The median survival remained unchanged for subgroups of patients with ages between 40-60 years and with Karnofsky performance status above 80. Among the 19 patients with glioblastoma multiforme, the median survival was 10 months. Acute toxicity was within tolerable limits. Details of toxicity and tissue analysis from post mortems and second craniotomy samples are presented.

Adult↗
PubMed1996

Adenocarcinoma of the lung--clinical features and survival.

Four thousand patients were registered by the Edinburgh Lung Cancer Group in 1981-1987; 9.5% had adenocarcinoma. Of these, 102 patients with pathological confirmation of the diagnosis, presenting to one hospital group in Edinburgh, were reviewed. Two cases were excluded after case note review. Of the remaining 100, 64 were male and 36 were female, with a mean age of 73 years. The majority (89%) were smokers or ex-smokers, and 52% had a poor performance status (Karnofsky Index 10-70). Significantly, more adenocarcinoma patients underwent surgery compared to other cell types (39 vs. 19%, P < 0.01), and less were treated with radiotherapy (19 vs. 31%). The 5-yr survival rate for the adenocarcinoma patients was 19 vs. 7% in the remainder of patients. Of 39 patients referred for surgery, 37 had lung resections and their 5-yr survival rate was 42%. Post-operative staging showed 48% in Stage I, 27% in Stage II and 24% in Stage III. The majority of the long-term survivors had Stage I disease (64%). Forty-two percent of the patients received palliative therapy alone (all died within 10 months). Ten percent of patients receiving radiotherapy survived for 5 yr. Review of these cases suggested two patterns of presentations: (1) patients with poor performance status, extensive disease and often pleural involvement (16%); and (2) patients with more localized disease (39%), many of whom were suitable for surgical resection with surprisingly good prognosis.

Adenocarcinoma↗
PubMed2004

Randomised phase III study of intravenous vinorelbine plus hormone therapy versus hormone therapy alone in hormone-refractory prostate cancer.

BACKGROUND: Vinorelbine (VRL) has been shown to be active in hormone-refractory prostate cancer (HRPC) in phase II studies, alone or in combination. Its moderate toxicity profile is well tolerated in elderly patients. PATIENTS AND METHODS: Patients with metastatic prostate cancer, progressive after primary hormonal therapy, were randomised to receive intravenous VRL 30 mg/m2 on days 1 and 8 every 3 weeks, and hydrocortisone 40 mg/day or hydrocortisone alone until disease progression. Centres could choose to add aminoglutethimide 1000 mg/day to hydrocortisone as second-line hormone therapy (HT) for all their patients. Randomisation was stratified by centre. Further chemotherapy was allowed after progression. The primary end point was progression-free survival (PFS). The final analysis was performed on a total of 414 patients. Reported results were all based on intention-to-treat analyses. All progressions and responses were reviewed by an independent panel. RESULTS: PFS was significantly prolonged in the VRL plus HT arm compared with the HT alone arm, according to the statistical hypothesis of the protocol (P=0.055 in the two-sided log-rank test with a pre-specified significance level of 10%). The 6-month PFS rates were 33.2% versus 22.8%, and the median durations of PFS were 3.7 versus 2.8 months. In the multivariate Cox analysis, which included age, Karnofsky performance status (PS), haemoglobin, alkaline phosphatase at study entry and number of prior hormonal treatments, the P value was decreased to 0.005. The prostate-specific antigen (PSA) response rate (> or =50% decline sustained for at least 6 weeks) was significantly higher for VRL plus HT compared with HT (30.1% versus 19.2%; P=0.01). Clinical benefit, defined as a decrease in pain intensity or analgesic consumption or an improvement of Karnofsky PS for at least 9 weeks, and at least stable assessment in the other two, was also more frequently observed in patients who received VRL plus HT versus HT alone (30.6% and 19.2%; P=0.008). There was no statistical difference in overall survival. Forty-three per cent of patients in the HT arm received at least one line of further chemotherapy after progression, compared with 28% of patients in the VRL-based arm. Aminoglutethimide did not seem to result in better efficacy for either arm. VRL plus HT was well tolerated, with a median administered relative dose intensity of 90%; grade 4 neutropenia occurred in 6.5% of patients and non-haematological toxicity was rare. CONCLUSIONS: The combination of VRL and hydrocortisone compared with hydrocortisone alone resulted in improved clinical benefit, PFS and PSA response rate. This therapeutic gain is similar to that previously reported with mitoxantrone in combination with low-dose corticosteroids. There was no gain in survival; however, the combination is well tolerated in this elderly group of patients, who often present cardiac co-morbidities, and therefore offers an active and safe therapeutic option for patients with hormone-refractory prostate cancer.

Aged↗
PubMed2001

The role of palliative radiotherapy in locally advanced non-small cell lung cancer.

The aim of this study was to evaluate retrospectively the treatment results of non-small cell lung cancer (NSCLC) patients treated with palliative intent in Dokuz Eylul University Hospital, Radiation Oncology Department. One hundred and fifteen inoperable, non-metastatic and symptomatic NSCLC patients were treated with palliative radiotherapy (PRT) between July 1991 and May 2000. PRT was used in patients with low performance status, weight loss more than 10% within last 6 months, secondary malignancies, co-morbid diseases and socio-economic problems. Parallelly opposed isocentric antero-posterior fields including both the parenchymal and mediastinal masses were used. 10-55 Gy total doses were delivered in 1-23 fractions with a median of 30 Gy. Nineteen patients received systemic chemotherapy before PRT. Survival analysis was made from the treatment beginning date, and subjective palliation rates were assessed according to clinical improvements in symptomatology evaluated 1-6 weeks after PRT. The median follow-up time was 28 weeks (1-234 weeks). Totally, 245 disease-related symptoms were detected in 115 patients. Overall "improvement" in symptomatology was found to be 90% (221/245) with a "near-total response" rate of 46% (113/245). Hemoptysis was the best palliated symptom. Median survival time was 30 weeks. Karnofsky performance status (KPS) (p=0.015), weight loss (p=0.0015), histologic tumor type (p=0.0024) and tumor size (p=0.02) were found to effect overall survival rates significantly in uni-variant analysis. Multi-variant analysis revealed statistically significant effect with histological tumor type and weight loss status. Only 16% of patients (3/19) showed partial and 5% (1/19) complete response to systemic treatment. Median survival time was 46 weeks in this group. In conclusion, this retrospective study of patients with poor prognostic factors confirms that PRT is an effective treatment modality in symptomatic locally advanced NSCLC patients resulting in 90% symptomatic improvement rate and a median survival of 30 weeks.

Adult↗
PubMed2002

The systemic inflammatory response, weight loss, performance status and survival in patients with inoperable non-small cell lung cancer.

The relationship between the magnitude of systemic inflammatory response and the nutritional/functional parameters in patients with inoperable non-small cell lung cancer were studied. The extent of weight loss, albumin, C-reactive protein, performance status and quality of life was measured in 106 patients with inoperable non-small cell lung cancer (stages III and IV). Survival analysis was performed using the Cox proportional hazard model. The majority of patients were male and almost 80% had elevated circulating C-reactive protein concentrations (>10 mg x l(-1)). On multivariate analysis, age (P=0.012), tumour type (0.002), weight loss (P=0.056), C-reactive protein (P=0.047), Karnofsky performance status (P=0.002) and fatigue (P=0.046) were independent predictors of survival. The patients were grouped according to the magnitude of the C-reactive protein concentrations (< or =10, 11-100 and >100 mg x l(-1)). An increase in the magnitude of the systemic inflammatory response was associated with increased weight loss (P=0.004), reduced albumin concentrations (P=0.001), reduced performance status (P=0.060), increased fatigue (P=0.011) and reduced survival (HR 1.936 95%CI 1.414-2.650, P<0.001). These results indicate that the majority of patients with inoperable non-small cell lung cancer have evidence of a systemic inflammatory response. Furthermore, an increase in the magnitude of the systemic inflammatory response resulted in greater weight loss, poorer performance status, more fatigue and poorer survival.

Adult↗
PubMed1996

[Primary cerebral non-Hodgkin's lymphomas. The results of radiotherapy].

BACKGROUND: In the last years many therapeutic attempts were made to improve the poor prognosis of primary cerebral non Hodgkin's lymphoma. The aim of this study was to report on own experiences concerning this rare disease. PATIENTS AND METHODS: In 1986 to 1994 26 patients were treated for primary cerebral non Hodgkin's lymphoma. 15% were HIV-positive. High-grade non-Hodgkin's lymphomas were diagnosed in 62%. 46% of all cases showed multiple lesions. 23% of our patients received a dose less than 25.5 Gy, 27% received 37.5 Gy (whole brain) and 39% were treated with 51 Gy (37.5 Gy whole brain and 13.5 Gy boost dose). Radiation technique included regular and irregular fields (single dose: 1.5 Gy). RESULTS: 62% of patients achieved a complete or partial remission directly after irradiation, in 4% no change or progression was seen. 31% could not be examined due to their bad status or death. The mean follow-up time for all patients was 19.6 months, the median survival was 3.6 months. The 1-year-survival rate was 41%, 3-year survival rate was 28%. Patients who received a tumor dose of 51 Gy had better survival times in comparison to patients who received less (p = 0.01). Prognostic parameters (Cox regression analysis) were: tumor dose, grading and local result after irradiation. The Karnofsky performance status was not an independent parameter (p = 0.12). Side effects were low. Long-term survivors had relatively good quality of life. CONCLUSION: Taking into consideration the small numbers of patients in all studies all results or conclusions have to be made with great reservations. Despite the high proportion of HIV-positive patients our results are in compliance with other authors using similar therapy protocols. Reports dealing with combined radio-chemotherapy have published good results concerning survival time. But long-term morbidity due to these protocols needs further investigation and has to be awaited.

Adult↗
PubMed2006

Astragalus-based Chinese herbs and platinum-based chemotherapy for advanced non-small-cell lung cancer: meta-analysis of randomized trials.

PURPOSE: Systemic treatments for advanced non-small-cell lung cancer have low efficacy and high toxicity. Some Chinese herbal medicines have been reported to increase chemotherapy efficacy and reduce toxicity. In particular, Astragalus has been shown to have immunologic benefits by stimulating macrophage and natural killer cell activity and inhibiting T-helper cell type 2 cytokines. Many published studies have assessed the use of Astragalus and other Chinese herbal medicines in combination with chemotherapy. We sought to evaluate evidence from randomized trials that Astragalus-based Chinese herbal medicine combined with platinum-based chemotherapy (versus platinum-based chemotherapy alone) improves survival, increases tumor response, improves performance status, or reduces chemotherapy toxicity. METHODS: We searched CBM, MEDLINE, TCMLARS, EMBASE, Cochrane Library, and CCRCT databases for studies in any language. We grouped studies using the same herbal combinations for random-effects meta-analysis. RESULTS: Of 1,305 potentially relevant publications, 34 randomized studies representing 2,815 patients met inclusion criteria. Twelve studies (n = 940 patients) reported reduced risk of death at 12 months (risk ratio [RR] = 0.67; 95% CI, 0.52 to 0.87). Thirty studies (n = 2,472) reported improved tumor response data (RR = 1.34; 95% CI, 1.24 to 1.46). In subgroup analyses, Jin Fu Kang in two studies (n = 221 patients) reduced risk of death at 24 months (RR = 0.58; 95% CI, 0.49 to 0.68) and in three studies (n = 411) increased tumor response (RR = 1.76; 95% CI, 1.23 to 2.53). Ai Di injection (four studies; n = 257) stabilized or improved Karnofsky performance status (RR = 1.28; 95% CI, 1.12 to 1.46). CONCLUSION: Astragalus-based Chinese herbal medicine may increase effectiveness of platinum-based chemotherapy when combined with chemotherapy. These results require confirmation with rigorously controlled trials.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2004

Postoperative residual tumour imaged by contrast-enhanced computed tomography and 201Tl single photon emission tomography: can they predict progression-free survival in high-grade gliomas?

AIMS: To evaluate if postoperative residual tumour imaged by either computed tomography or 201Tl single photon emission tomography (SPECT) carried out postoperatively could predict progression-free survival (PFS) in high-grade malignant gliomas. MATERIALS AND METHODS: Thirty-three patients with high-grade malignant gliomas underwent both contrast-enhanced CT scan and 201Tl-SPECT postoperatively before receiving radiotherapy. The PFS was evaluated against the individual reports of the above two imaging studies by univariate analysis. RESULTS: CT and 201Tl-SPECT were carried out within a median interval of 17 days after surgery. Of the 33 patients, CT and 201Tl-SPECT were reported as positive for residual tumours in 23 (69.7%) and 30 (91%) patients, respectively. Sensitivity, specificity and overall accuracy were 71.4%, 40% and 66.6% for CT, and 96.4%, 40% and 87.8% for 201Tl-SPECT, respectively, and were based on their last follow-up status (P = 0.627 for CT; P = 0.053 for 201Tl-SPECT). The median PFS for patients reported to be positive or negative on CT scan was 4 and 5 months, respectively (P = 0.202). With 201Tl-SPECT, although the median PFS for patients with a positive 201Tl uptake was also 4 months, it had not even reached for those reported having a negative 201Tl uptake (cumulative survival 66.7% at last follow-up) (P = 0.198). However, Karnofsky performance status (KPS) was the only significant predictor on univariate analysis (KPS: < 80 vs. > or = 80; P < 0.001) for PFS. CONCLUSIONS: Although both the imaging modalities have a poor specificity, postoperative 201Tl-SPECT had a significantly better accuracy to predict the status at last follow-up than contrast-enhanced CT. Nevertheless, KPS remained the most significant outcome predictor for PFS in high-grade malignant gliomas.

Adult↗
PubMed1995

Concomitant chemoradiotherapy, neutron boost, and adjuvant chemotherapy for anaplastic astrocytoma and glioblastoma multiforme.

The survival rate for patients with malignant gliomas is poor. We describe the results of a prospective study using concomitant chemoradiotherapy, neutron boost, and adjuvant chemotherapy for patients with malignant gliomas. Forty-two patients with anaplastic astrocytoma (AA) and glioblastoma multiforme (GBM) were treated with postoperative photon radiation 45 Gy/25 fraction (fxs) with concomitant continuous intravenous infusion of 5-fluorouracil at 300 mg/m2/day x 5 days and hydroxyurea 0.5 g orally every 12 hr for 6 days for 5 consecutive weeks, followed by a neutron boost of 450 N cGy/6 fxs delivered twice weekly. Adjuvant chemotherapy with procarbazine, CCNU, and vincristine (PCV) was given up to 1 year or until tumor progression. Thirty-four patients (81%) had GBM and 8 patients (19%) had AA. Sixteen patients (38%) were ineligible for the neutron boost because of large tumors or poor performance status and instead received a photon boost with concomitant chemotherapy for a total dose of 60-65 Gy to the tumor. The overall median survival is 68 weeks at a median follow-up of 203 weeks (range 166-302 weeks for the 11 patients remaining alive); 7/8 patients with AA are alive, 2 of these with progressive disease. For AA the median survival is not reached at a median follow-up of 203 weeks (range 166-302 weeks for the 7 patients alive with AA). Time to tumor progression for the 1 dead patient with AA was 35 weeks and the other 2 patients failed at 171 weeks and 179 weeks following treatment. The median survival for the 34 patients with GBM was 62 weeks; 4/34 patients with GBM are alive at 285, 238, 216, and 206 weeks. Multivariate survival analysis in the 34 patients with GBM revealed age and Karnofsky performance status as important prognostic factors. Extent of surgery and neutrons did not affect survival. Concomitant chemoradiotherapy was well tolerated by all patients. The only toxicities observed were mucositis < or = grade II in 3 patients (7%) and mild myelosuppression in 1 patient (2.4%). Adjuvant PCV was well tolerated. Continuous concomitant chemoradiotherapy was well tolerated by all patients with acceptable side effects. The survival rate for the patients with GBM suggests no significant impact on the prognosis for these patients. Patients with AA did well; however, the patient numbers are small.

Adolescent↗