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Predictors of quality of life in rural patients with cancer.

Quality of life (QOL) as an outcome for cancer treatment has been studied primarily in urban populations. Yet, descriptions of rural dwellers suggest that their perception of QOL may differ from that of their urban counterparts. The purpose of this study was to examine QOL in people with a cancer diagnosis of at least 1 month duration in two similar rural northeastern states. The Functional Assessment of Cancer Therapy General (FACT G) scale was completed by 344 respondents. The mean QOL score was 89.41 +/- 16.55. State of residence, gender, known recurrence, and marital status were significant predictors of QOL, explaining 18.3% of the variance in this study. Age, education level, income, type of cancer, living arrangements, and time since diagnosis were not predictive. The QOL scores in this rural sample were higher than those reported earlier for predominantly urban dwellers. Future research is needed to understand these differences.

Adult↗

Prognostic significance of positive surgical margins in patients with extraprostatic carcinoma after radical prostatectomy.

BACKGROUND: A significant number of prostate adenocarcinoma patients undergoing radical prostatectomy are found to have microscopic extraprostatic disease extension. A majority of these patients have focal extraprostatic extension limited to one or both sides of the prostate. In addition, positive surgical margins are a common pathologic finding in this patient subgroup. In the current study, the authors evaluated the impact of positive surgical margins as an independent predictive factor for prostate specific antigen (PSA) progression in patients with pT3a/b N0M0 carcinoma. METHODS: The Mayo Clinic prostate cancer registry list provided 1202 patients with pT3a/b NO prostate carcinoma (no seminal vesicle or regional lymph node involvement) who underwent a radical prostatectomy between 1987-1995. To reduce confounding variables, patients who received preoperative therapy or adjuvant therapy were excluded, resulting in 842 patients who were eligible for analysis. RESULTS: A total of 354 patients (42%) had > or = 1 positive surgical margins whereas 488 patients (58%) demonstrated no margin involvement. The sites of margin positivity were as follows: apex (n = 163), base (n = 47), posterior prostate (n = 227), and anterior prostate (n = 11). A total of 111 patients had > or = 2 positive surgical margins. The 5-year survival free of clinical recurrence and/or biochemical failure (postoperative PSA level > 0.2 ng/mL) for patients with no positive surgical margins was 76% and was 65% for patients with 1 positive surgical margin (P = 0.0001). There was no significant difference in biochemical disease progression between patients with 1 versus those with > or = 2 surgical margins (65% vs. 62%). Multivariate analysis revealed that positive surgical margins were a significant predictor (P = 0.0017) of clinical disease recurrence and biochemical failure (relative risk, 1.55; 95% confidence interval, 1.18-2.04) after controlling for preoperative PSA, Gleason score, and DNA ploidy. CONCLUSIONS: In the current study, positive surgical margins were found to be a significant predictor of disease recurrence in patients with pT3a/b NO prostate carcinoma, a finding that is independent of PSA, Gleason score, and DNA ploidy. The benefit of adjuvant therapy in optimizing recurrence-free survival remains to be tested.

Aged↗

The modified Gait Abnormality Rating Scale for recognizing the risk of recurrent falls in community-dwelling elderly adults.

BACKGROUND AND PURPOSE: The purpose of this study was to determine the reliability and validity of measurements obtained with a seven-item modified version of the Gait Abnormality Rating Scale (GARS-M), an assessment of gait designed to predict risk of falling among community-dwelling, frail older persons. SUBJECTS: Fifty-two community-dwelling, frail older persons, with a mean age of 74.8 years (SD = 6.75), participated. METHODS: A history of falls was determined from self-report or by proxy report. The GARS-M was scored from videotapes of subjects walking at self-selected paces. Gait characteristics were recorded during a timed walk on a 6-m brown-paper walkway. RESULTS: Scores obtained by three raters for 23 subjects demonstrated moderate to substantial intrarater and interrater reliability. Concurrent validity, as assessed by Spearman rank-order correlation coefficients, was demonstrated for the relationship between GARS-M scores and stride length (r = -.754) and for the relationship between GARS-M scores and walking speed (r = -.679). Mean GARS-M scores distinguished between frail older persons with and without a history of recurrent falls (mean GARS-M scores of 9.0 and 3.8, respectively). CONCLUSION AND DISCUSSION: The GARS-M is a reliable and valid measure for documenting gait features associated with an increased risk of falling among community-dwelling, frail older persons and may provide a clinically useful alternative to established quantitative gait-assessment methods.

Accidental Falls↗

Triage of patients with acute gastrointestinal bleeding for intensive care unit admission based on risk factors for poor outcome.

This study's aim was to determine the prognostic factors and to develop a triage system for intensive care unit (ICU) admission of patients with gastrointestinal bleeding (GIB). This prospective, observational study included 411 adults consecutively hospitalized for GIB. Each patient's selected clinical findings and laboratory values at presentation were obtained. The Acute Physiology and Chronic Health Evaluation (APACHE) II scores were calculated from the initial findings in the emergency department. Poor outcome was defined as recurrent GIB, emergency surgery, or death. The role of hepatic cirrhosis, APACHE II score, active GIB, end-organ dysfunction, and hypotension in predicting outcome was evaluated. Chi-square, Student's t, Mann-Whitney U, and logistic regression analysis tests were used for statistical comparisons. Poor outcome developed in 81 (20%) patients; 39 died, 23 underwent emergency surgery, and 47 rebled. End-organ dysfunction, active bleeding, hepatic cirrhosis, and high APACHE II scores were independent predictors of poor outcome with odds ratios of 3:1, 3:1, 2:3, and 1:1, respectively. The ICU admission rate was 37%. High APACHE II score, active bleeding, end-organ dysfunction, and hepatic cirrhosis are independent predictors of poor outcome in patients with GIB and can be used in the triage of these patients for ICU admission.

APACHE↗

Pretreatment serum testosterone level as a predictive factor of pathological stage in localized prostate cancer patients treated with radical prostatectomy.

OBJECTIVE: Pretreatment serum level of testosterone (T) is a potential prognostic factor for prostate cancer. The present study was conducted to evaluate the clinical significance of pretreatment serum T level in patients with clinically localized prostate cancer. MATERIALS AND METHODS: The subjects were 82 clinically localized prostate cancer patients treated with radical prostatectomy, whose pretreatment T levels were recorded. We investigated clinical and pathological factors such as pretreatment serum T level, age, pretreatment PSA or pathological Gleason score concerning the association with pathological stage and biochemical recurrence. RESULTS: The mean pretreatment T level was significantly lower in patients with non-organ-confined prostate cancer (pT3-T4, N1; 3.44+/-1.19 ng/ml) than in patients with organ-confined cancer (pT2; 4.33+/-1.42 ng/ml) (p=0.0078). Multivariate analysis demonstrated that pathological Gleason score, pretreatment serum T level and pretreatment PSA were significant predictors of extraprostatic disease. When the patients were divided into high and low T level groups according to the median value, pretreatment T levels were not significantly associated with PSA recurrence rates (p=0.7973). CONCLUSIONS: A lower pretreatment T level appears to be predictive of extraprostatic disease in patients with localized prostate cancer.

Age Factors↗

Fractionation sensitivity and dose response of late adverse effects in the breast after radiotherapy for early breast cancer: long-term results of a randomised trial.

BACKGROUND AND PURPOSE: Unlike squamous carcinomas, breast adenocarcinoma may be as sensitive to fraction size as late dose-limiting normal tissues. If so, fewer larger fractions would be as safe and effective as regimens based on 2.0 Gy fractions. The first step is to test the effects of radiotherapy fractions >2.0 Gy on late normal tissue responses in the breast after tumour excision and radiotherapy for early breast cancer. PATIENTS AND METHODS: One thousand four-hundred and ten women with T1-3 N0-1 M0 invasive breast cancer were randomised between 1986-98 into one of three radiotherapy regimens after local tumour excision of early stage breast cancer; 50 Gy in 25 fractions (F) vs two dose levels of a test schedule giving 39 or 42.9 Gy in 13 F over 5 weeks. Fraction sizes were 2.0, 3.0 and 3.3 Gy, respectively. The primary endpoint was late change in breast appearance compared to post-surgical appearance scored from annual photographs blinded to treatment allocation. Secondary endpoints included palpable breast induration (fibrosis) and ipsilateral tumour recurrence. RESULTS: After a minimum 5-year follow up, the risk of scoring any change in breast appearance after 50 Gy/25 F, 39 Gy/13 F and 42.9 Gy/13 F was 39.6, 30.3 and 45.7%, from which an alpha/beta value of 3.6 Gy (95% CI 1.8-5.4) is estimated. The alpha/beta value for palpable breast induration was 3.1 Gy (95% CI 1.8-4.4). CONCLUSIONS: An alpha/beta value of around 3 Gy for late normal tissue changes in the breast is derived from the estimated equivalence of 41.6 Gy in 13 fractions and 50 Gy in 25 fractions over 5 weeks, in line with trial predictions.

Adenocarcinoma↗

An integrated clinical approach to predicting the benefit of tirofiban in non-ST elevation acute coronary syndromes. Application of the TIMI Risk Score for UA/NSTEMI in PRISM-PLUS.

AIMS: We evaluated the TIMI Risk Score for Unstable Angina and Non-ST Elevation Myocardial Infarction for predicting clinical outcomes and the efficacy of tirofiban in non-ST elevation acute coronary syndromes. METHODS AND RESULTS: Developed in TIMI 11B, the risk score is calculated as the sum of seven presenting characteristics (age > or =65 years, > or =3 cardiac risk factors, documented coronary disease, recent severe angina, ST deviation > or =0.5 mm, elevated cardiac markers, prior aspirin use). The risk score was validated in the PRISM-PLUS database (n=1915) and tested for interaction with the efficacy of tirofiban+heparin vs heparin alone. The risk score revealed an increasing gradient of risk for death, myocardial infarction or recurrent ischaemia at 14 days ranging from 7.7-30.5% (P<0.001). Dichotomized at the median, patients with a score > or =4 derived a greater relative risk reduction with tirofiban (P((Interaction))=0.025). Among patients with normal creatine kinase myocardial bands, the risk score showed a 3.5-fold gradient of risk (P<0.001) and identified a population that derived significant benefit from tirofiban (RR 0.73, P=0.027). CONCLUSION: The TIMI Risk Score is a simple clinical tool for risk assessment that may aid in the early identification of patients who should be considered for treatment with potent antiplatelet therapy.

Acute Disease↗

Milnacipran efficacy in the prevention of recurrent depression: a 12-month placebo-controlled study. Milnacipran recurrence prevention study group.

To compare the efficacy and assess the tolerability of milnacipran 50mg p.o. b.i.d. to placebo in the prevention of recurrence in depressed patients who had responded an acute treatment and had remained in remission during a 4-month continuation phase. Remission criteria were: a Hamilton Depression Rating Scale (HDRS) (21-item) < or = 8, improvement or disappearance of the initial symptoms, and an assessment of 'very much improved' or 'much improved' on the Clinical Global Impression (CGI) Subscale: Global Improvement. Recurrence was defined by a major depressive episode according to DSM-III-R criteria and a minimum score of 18 on the HDRS, with the need to treat the recurrence. The primary analysis was the rate of recurrence as a function of time in the intent-to-treat population. Groups were compared using the Cox model. Absolute recurrence rates were 16.3% (17/104) in milnacipran-treated patients and 23.6% (26/110) in placebo-treated patients, with a significant difference in the reduction of recurrence as a function of time (Kaplan Meier Survival Analysis analysis, P < 0.05). There was no difference in tolerability between groups. This study demonstrates that milnacipran is effective with good tolerability in preventing recurrence in major depressive disorder over 1 year in patients with recurrent depression who responded to acute treatment with milnacipran and continued their response for 18 weeks.

Adult↗

The role of perineural invasion and other biopsy characteristics as prognostic markers for localized prostate cancer.

The presence of perineural invasion and the finding of Gleason score 7 cancer on three cores in this case signifies a high likelihood of extraprostatic extension. However, the presence of perineural invasion on prostate biopsy does not independently influence the likelihood of prostate-specific antigen recurrence following radical prostatectomy when matched for preoperative Gleason score, prostate-specific antigen, and clinical stage. This is because cases with perineural invasion on needle biopsy are often associated with other adverse preoperative features such as high biopsy Gleason score, multiple cores involved, and high serum prostate-specific antigen levels. The finding of perineural invasion on needle biopsy may aid urologists in deciding whether to resect the neurovascular bundle on the side of perineural invasion. Excising the neurovascular bundle in cases with perineural invasion will reduce the incidence of positive margins by 17.5% of cases. The remaining cases not benefiting from neurovascular bundle excision are equally divided between extremely aggressive tumors with positive margins outside the neurovascular bundle region or positive seminal vesicles and lymph nodes, and less aggressive tumors that are either organ-confined or have very limited extraprostatic extension.

Biopsy, Needle↗

Genome-wide linkage survey for genetic loci that affect the risk of suicide attempts in families with recurrent, early-onset, major depression.

We previously described the results of a genome-wide linkage survey for genetic loci that influenced the development of unipolar mood disorders in 81 families identified by individuals with Recurrent, Early-Onset, Major Depressive Disorder (RE-MDD) [Zubenko et al. 2003b; Am J Med Genet (Neuropsychiatr Genet) 123B:1-18]. In the current study, we extended this linkage analysis by including the history of a suicide attempt as a covariate to identify chromosomal regions that harbor genes that influence the risk of this behavior in the context of mood disorders. This approach identified six linkage peaks with maximum multipoint DeltaLOD scores that reached genome-wide adjusted levels of significance (2p, 5q, 6q, 8p, 11q, and Xq). Four of these (2p, 6q, 8p, and Xq) exceeded the criterion for "highly-significant linkage" (genome-wide adjusted P < 0.001) recommended by Lander and Kruglyak [1995; Nat Genet 11:241-246]. The strongest evidence for linkage was observed in analyses employing affected relative pairs (ARPs) with the most severe and disabling Mood Disorders: Depression Spectrum Disorder and RE-MDD. The highest DeltaLOD score that emerged from this linkage analysis, 5.08, occurred for ARPs with Depression Spectrum Disorder at D8S1145 (37.0 cM, 18.2 Mbps, P < 0.0001) at cytogenetic location 8p22-p21. Significant linkage results on Xq arose from analyses of ARPs with RE-MDD at DXS1047 (143 cM, 127.8 Mbps, DeltaLOD = 3.87, P < 0.0001), a finding that may contribute to the higher rate of suicide attempts among women than men. These findings provide evidence for suicide risk loci that are independent of susceptibility loci for Mood Disorders, and suggest that the capacity for suicide risk loci to affect the development of suicidal behavior depends on the psychiatric disorder or subtype with which they interact.

Age of Onset↗

Determination of discriminatory power of prognostic factors for recurrence of breast cancer.

Vascular and lymphatic invasion of cancer cells, type of histology, histopathological TNM classification, level of tumor invasion, menopausal status, and age were reported as prognostic factors for breast cancer. We determined the discriminatory power of these prognostic factors for predicting breast cancer recurrence in 98 patients with the method of quantification theory type II, using a computer, model Hi-TAC M-150. The discriminatory rate of these combined seven factors for recurrence was 82.609%. We calculated the probability of breast cancer recurrence using the method of quantification theory type II. The probability of breast cancer recurrence (P) was given as follows. P = 1/1 + 7.333e5.468X. The score X is given by the sum of category weight of seven prognostic factors. Averages of P values of patients with recurrence and without recurrence were statistically different (p less than 0.01). The rate of having more than 30% of P values was 78% in 23 patients with breast cancer recurrence, and it was only 3% in 75 patients without breast cancer recurrence. The difference was statistically significant (X2 = 61.83, p less than 0.001). These results suggest that we can discriminate a high-risk patient with breast cancer recurrence using this method.

Age Factors↗

Social adjustment and the course of affective illness: a one-year controlled longitudinal study involving bipolar and unipolar outpatients.

The association between social adjustment and recurrent affective episodes was examined in 27 recovered bipolar patients and 24 recovered unipolar patients who had been receiving maintenance treatment for at least 1 year. Social adjustment variables and psychiatric status were assessed by bimonthly interviews over the 1-year period using the Social Adjustment Scale (SAS) and the Research Diagnostic Criteria (RDC). Variations in the social adjustment scores were analyzed in the 2 months preceding the onset of a recurrent affective episode. Furthermore, social adjustment variables at entry into the study were assessed to investigate whether there was any association between these and the potential timing of a recurrent episode. Results revealed no significant deterioration in social adjustment during the 2 months preceding a recurrent affective episode. However, it was demonstrated that there was a relationship between a patient's overall social adjustment score at entry into the study and the onset of recurrent affective episodes, independent of any residual depressive symptomatology. Specifically, impaired work adjustment in bipolar and unipolar patients was associated with recurrent episodes. Impaired social and leisure activities adjustment in bipolar patients was also associated with recurrent episodes, and impaired marital adjustment in unipolar patients was associated with recurrent episodes. These results suggest that social maladjustment could be a risk factor for both unipolar and bipolar recurrent affective episodes and that impairment in specific areas of social functioning could be used to predict outcome.

Adult↗

Limitations of biopsy Gleason grade: implications for counseling patients with biopsy Gleason score 6 prostate cancer.

PURPOSE: We examined the implications of underestimating Gleason score by prostate biopsy in patients with biopsy Gleason 6 prostate cancer with respect to adverse pathological findings and biochemical recurrence after radical prostatectomy. MATERIALS AND METHODS: We retrospectively reviewed clinical and pathological data on a cohort of 531 patients with Gleason score 6 on prostate biopsy who underwent radical retropubic prostatectomy between June 1992 and January 2002. Patients were excluded if they received neoadjuvant androgen deprivation. Concordance between biopsy and radical prostatectomy Gleason score was examined. A comparison was made with respect to final radical prostatectomy specimen pathology and the risk of biochemical recurrence between cases that remained Gleason 6 and those with a final grade of 7 or greater. RESULTS: A total of 451 patients were included in the analysis. Mean followup was 55.1 months (range 12 to 123.4). Of the patients 184 (41%) had a Gleason score of 7 or greater after a review of the entire prostate, while 37 (8%) had a score of less than 6 and 230 remained with Gleason 6. Patients who were under graded were more likely to have extraprostatic extension (22% vs 4%, p <0.01), seminal vesicle invasion (9% vs 2%, p <0.01) and biochemical recurrence (10% vs 3%, p <0.01) compared to those who remained with Gleason score 6. CONCLUSIONS: Gleason grade on needle biopsy is an inexact predictor of the final grade following radical prostatectomy. Patients with biopsy Gleason score 6 who are under graded are at significantly higher risk for adverse pathological features and biochemical recurrence than patients who remain with Gleason score 6 or less on final pathology findings.

Aged↗

The 2002 AJCC pT2 substages confer no prognostic information on the rate of biochemical recurrence after radical prostatectomy.

INTRODUCTION: We examined the prognostic value of AJCC pT2 substages in prediction of biochemical recurrence (BCR) after radical prostatectomy (RP), in European patients. METHODS: A cohort of 1726 RP patients with pT2N0 prostate cancer (PCa) was studied. Multivariate Cox regression models addressed the association between either the 1997 or 1992/2002 pT2 substages after controlling for total PSA, primary and secondary pathologic Gleason scores and surgical margin status and time to PSA recurrence (PSA >0.1 and rising) after RP. Regression coefficients were then used to test the predictive accuracy of multivariate models in a nomogram setting. RESULTS: PSA recurrence occurred in 80 (4.6%) patients. Mean and median times to recurrence were respectively 28.9 and 24.4 months. In univariate analyses, neither the 1997 (p = 0.48) nor the 1992/2002 pT2 substages (p = 0.054) were predictive of recurrence. In multivariate analyses the lack of significance persisted (1997 p = 0.709; 1992/2002 p = 0.124). When either the 1997 or 1992/2002 pT2 substages were added to a multivariate nomogram without pT2 substage information, its accuracy respectively decreased by 0.8% and 1.1%. CONCLUSION: Our data indicate that pT2 substages offer no incremental value relative to pre-treatment total PSA, surgical margin status and pathologic Gleason scores. Therefore, it might be postulated that it is sufficient to confirm organ confinement according to Partin's pathologic staging.

Analysis of Variance↗

Clinical results of thoracoscopic Heller's myotomy in the treatment of achalasia.

OBJECTIVES: Ideal treatment for achalasia permanently eliminates the dysfunctional lower oesophageal sphincter, relieving dysphagia and regurgitation. The aim of this study was to review the results in a series of patients undergoing video-imaged thoracoscopic Heller's myotomy (THM). METHODS: Records of all patients undergoing THM by a single surgeon at one institution were analysed. Follow-up was conducted using a structured questionnaire together with oesophageal manometry and/or 24 h pH monitoring when clinically indicated. RESULTS: Twenty-five consecutive patients (13 males, 12 females, mean age 40.3+/-19.9 years) suffering from grade 4 dysphagia underwent THM between 1993 and 2001. Preoperative mean lower oesophageal sphincter (LOS) pressure was 42.6+/-6.3 mmHg. Seven patients (28%) had undergone previous pneumatic dilatations. There were no hospital deaths and no oesophageal perforations. Length of hospital stay was 4.3+/-1.8 days. One patient died 3 years after surgery from unrelated causes. At follow-up of 5.4+/-2.1 years, freedom from any reintervention was 95.8% (23/24). Eleven patients (45.8%) were asymptomatic. In patients with residual or recurrent symptoms (n=13), their severity was significantly reduced from the preoperative period (dysphagia score 1.7+/-0.8 versus 4+/-0; P</=0.05). Four patients (16%) with troublesome residual or recurrent grade 3-4 dysphagia underwent repeat oesophageal manometric study, showing a mean reduction in LOS pressure from their baseline values of 46.8+/-6.1 to 30+/-5.4 mmHg (P</=0.01). One of these patients (4.2%) required repeat Heller's myotomy 1.5 years after THM. Six patients complained of troublesome postoperative heartburn; distal oesophageal acid exposure was shown to be abnormal in 3 (12.5%) of these patients and all enjoyed symptomatic relief with medical therapy. CONCLUSIONS: THM is a safe and effective procedure in the treatment of achalasia. Some patients do experience recurrence of symptoms; however, these are significantly less severe. The incidence of postoperative heartburn is acceptably low and can be controlled with oral medications, making the addition of an anti-reflux procedure not necessary. Longer-term follow up and randomised studies comparing THM to other therapeutic modalities are needed to ascertain respectively the durability of this approach and its relative advantages.

Adolescent↗

Radioablation and suture fixation of advance grades of hemorrhoids. An effective alternative to staplers and Doppler guided ligation of hemorrhoids.

BACKGROUND: for advance grades of symptomatic hemorrhoids (grade III and IV) the author has innovated a procedure called radiofrequency ablation and fixation of hemorrhoids. The procedure is performed as a day care surgery. PATIENTS AND METHODS: the surgical technique and clinical follow-up of patients operated by this technique are presented. An Ellman dual frequency radiofrequency generator was used for ablation, which was followed by suture fixation of the hemorrhoids. Patient satisfaction score was assessed using a visual analogue scale. The results of this procedure are presented and are compared with the results of published data of stapled hemorrhoidopexy and Doppler guided hemorrhoidal artery ligation procedures. RESULTS: between 1998 and 2005, 2,376 patients were operated with this technique. Patient s mean age was 34 years and 1,438 patients were males. The postoperative complication rate was 3.5%, which included secondary bleeding, retention of urine and perianal thrombosis. The recurrence rate was less than 1.5%. The satisfaction score was 9.2 on VAS. CONCLUSIONS: radiofrequency ablation and fixation of hemorrhoids is a technique that results in less postoperative pain, shorter hospital stay, and early return to normal activity. It seems to be a better alternative to stapled hemorrhoidopexy or Doppler guided hemorrhoidal artery ligation with regard to effectiveness and symptomatic relief on long term.

Adult↗

Psychosocial adjustment to recurrent cancer.

This descriptive study of the perceptions and needs of people with recurrent malignancies asks three questions: How do patients describe the meaning of a recurrence of cancer? Do individuals perceive the diagnosis of recurrence and the initial diagnosis of cancer differently? What are the key psychosocial problems associated with recurrent cancer? The theoretical framework was based on Lazarus and Folkman's theory of stress, appraisal, and coping. Subjects completed the Impact of Event Scale (IES), the Psychosocial Adjustment to Illness Scale--Self-Report (PAIS), and a semistructured qualitative interview. The interview elicited perceptions of the event of recurrence and differences between the diagnosis of recurrence and the initial diagnosis. The convenience sample included 40 patients diagnosed with recurrent cancer within the last 30 days. Many subjects (78%) reported that the recurrence was more upsetting than the initial diagnosis. Scores on both the IES and the PAIS were high when compared to normative samples of patients with cancer suggesting that this sample of patients experienced a lot of psychological distress as well as problems at home, work, and in their social lives. These concerns often were unknown to caregivers. Although more research is needed, the authors propose that, with more accurate assessment, more effective intervention could be implemented and the quality of life improved for patients with recurrent cancer.

Adaptation, Psychological↗

Methotrexate or total lymphoid radiation for treatment of persistent or recurrent allograft cellular rejection: a comparative study.

BACKGROUND: Methotrexate and total lymphoid irradiation (TLI) have been used successfully for treatment of recurrent and persistent rejection in orthotopic heart transplant recipients; however, there has been no comparison of these two modalities. METHODS: We retrospectively compared the efficacy of methotrexate (n = 29) versus TLI (n = 28) in heart transplant recipients with recurrent or persistent rejection. All patients received induction therapy (rabbit anti-thymocyte globulin or OKT3) and standard triple immunosuppressive therapy. Methotrexate (7.5 mg to 22.5 mg per wk) or TLI (80 cGy x 10 fractions) was used for the treatment of recurrent or persistent rejection on the basis of clinical indications. Average biopsy scores (International Society of Heart and Lung Transplantation biopsy score/total number of biopsies performed) calculated over 3-month periods, daily maintenance prednisone dose before and after methotrexate or TLI treatment, and actuarial survival and freedom from angiographic coronary artery disease and infection were compared. To control for the general decrease in prednisone with increased time from transplantation, a control group matched for time from transplantation was selected. RESULTS: Recipient sex and age at transplant, donor age, and donor ischemic time were similar in both groups. Days after transplantation to start of therapy was longer in patients receiving methotrexate; however, this did not reach statistical significance. Patients receiving TLI had received more cumulative corticosteroids and OKT3 before the start of TLI therapy (p < 0.001). There were no differences in actuarial freedom from infection or coronary artery disease between the two groups and between the treatment groups and the control group. Actuarial survival was reduced in patients receiving TLI 3 years after transplantation (p < 0.05). Maintenance prednisone doses from 3 months before until 9 months after therapy (mg/kg) were not different between patients receiving TLI and methotrexate and were significantly greater than the prednisone doses in the control group. Four months after treatment initiation, the prednisone dose was significantly reduced in both treatment groups compared with the pretherapy dose (methotrexate 0.28 +/- 0.16 to 0.22 +/- 0.13, p = 0.05; TLI 0.36 +/- 0.16 to 0.22 +/- .07, p < 0.001). The average biopsy score was significantly reduced by both methotrexate and TLI therapy (methotrexate 1.8 +/- 0.7 to 0.83 +/- 0.9, p = 0.0001; TLI 2.1 +/- 0.8 to 1.0 +/- 0.9, p = 0.0001). CONCLUSION: Methotrexate and TLI are both effective for the treatment of recurrent or persistent rejection after heart transplantation, reducing average biopsy scores and daily maintenance prednisone doses. There was a reduction in actuarial survival rates in patients treated with TLI, possibly reflecting the greater rejection therapy received before TLI initiation. Because both agents are effective, the choice of methotrexate or TLI may be based on clinical indications, as well as other issues, such as cost, compliance, and availability.

Actuarial Analysis↗