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PubMed1982

Cyclosporin A in renal transplantation: a prospective randomized trial.

Cyclosporin A combined with prednisone was compared with standard immunosuppressive therapy (antilymphoblast globulin, prednisone, and azathioprine) in a prospective randomized trial of 100 mismatched, living related donor and cadaveric renal transplants. The results demonstrated cyclosporin A plus prednisone to be an effective immunosuppressive regimen for renal transplantation. The actuarial graft survival at 1 year was 93% for patients treated with cyclosporin A and 81% for patients treated with conventional immunosuppression. Patient survival was 98% for the cyclosporin A group and 100% for the conventional group. Cyclosporin A-treated patients had fewer rejection episodes and fewer infections complications including a marked decrease in the incidence of posttransplant cytomegalovirus infection. The side effects of cyclosporin A were mild, but nephrotoxicity caused by cyclosporin A was frequent and significant. Nephrotoxicity was reversible and managed by decreasing the daily cyclosporin A dose. It is concluded that the combination of cyclosporin A plus prednisone provides an excellent alternate immunosuppressive regimen for renal transplants as compared with conventional therapy. The consequences of long-term administration of cyclosporin A are at present unknown.

Adolescent↗
PubMed1996

Long-term results of a prospective randomized trial of adjuvant brachytherapy in soft tissue sarcoma.

PURPOSE: This trial was performed to evaluate the impact of adjuvant brachytherapy on local and systemic recurrence rates in patients with soft tissue sarcoma. PATIENTS AND METHODS: In a single-institution prospective randomized trial, 164 patients were randomized intraoperatively to receive either adjuvant brachytherapy (BRT) or no further therapy (no BRT) after complete resection of soft tissue sarcomas of the extremity or superficial trunk. The adjuvant radiation was administered by iridium-192 implant, which delivered 42 to 45 Gy over 4 to 6 days. The two study groups had comparable distributions of patient and tumor factors, including age, sex, tumor site, tumor size, and histologic type and grade. RESULTS: With a median follow-up time of 76 months, the 5-year actuarial local control rates were 82% and 69% in the BRT and no BRT groups (P = .04), respectively. Patients with high-grade lesions had local control rates of 89% (BRT) and 66% (no BRT) (P = .0025). BRT had no impact on local control in patients with low-grade lesions (P = .49). The 5-year freedom-from-distant-recurrence rates were 83% and 76% in the BRT and no BRT groups (P = .60), respectively. Analysis by histologic grade did not demonstrate an impact of BRT on the development of distant metastasis, despite the improvement in local control noted in patients with high-grade lesions. The 5-year disease-specific survival rates for the BRT and no BRT groups were 84% and 81% (P = .65), respectively, with no impact of BRT regardless of tumor grade. CONCLUSION: Adjuvant brachytherapy improves local control after complete resection of soft tissue sarcomas. This improvement in local control is limited to patients with high-grade histopathology. The reduction in local recurrence in patients with high-grade lesions is not associated with a significant reduction in distant metastasis or improvement in disease-specific survival.

Brachytherapy↗
PubMed1989

Prevention of deep vein thrombosis in potential neurosurgical patients. A randomized trial comparing graduated compression stockings alone or graduated compression stockings plus intermittent pneumatic compression with control.

In a randomized trial of neurosurgical patients, groups wearing graduated compression stockings alone (group 1) or graduated compression stockings plus intermittent pneumatic compression (IPC) (group 2) were compared with an untreated control group in the prevention of deep vein thrombosis (DVT). In both active treatment groups, the graduated compression stockings were continued for 14 days or until hospital discharge, if earlier. In group 2, IPC was continued for seven days. All patients underwent DVT surveillance with iodine 125-labeled fibrinogen leg scanning and impedance plethysmography. Venography was carried out if either test became abnormal. Deep vein thrombosis occurred in seven (8.8%) of 80 patients in group 1, in seven (9.0%) of 78 patients in group 2, and in 16 (19.8%) of 81 patients in the control group. The observed differences among these rates are statistically significant. The results of this study indicate that graduated compression stockings alone or in combination with IPC are effective methods of preventing DVT in neurosurgical patients.

Clinical Trials as Topic↗
PubMed2005

Randomized trials stopped early for benefit: a systematic review.

CONTEXT: Randomized clinical trials (RCTs) that stop earlier than planned because of apparent benefit often receive great attention and affect clinical practice. Their prevalence, the magnitude and plausibility of their treatment effects, and the extent to which they report information about how investigators decided to stop early are, however, unknown. OBJECTIVE: To evaluate the epidemiology and reporting quality of RCTs involving interventions stopped early for benefit. DATA SOURCES: Systematic review up to November 2004 of MEDLINE, EMBASE, Current Contents, and full-text journal content databases to identify RCTs stopped early for benefit. STUDY SELECTION: Randomized clinical trials of any intervention reported as having stopped early because of results favoring the intervention. There were no exclusion criteria. DATA EXTRACTION: Twelve reviewers working independently and in duplicate abstracted data on content area and type of intervention tested, reporting of funding, type of end point driving study termination, treatment effect, length of follow-up, estimated sample size and total sample studied, role of a data and safety monitoring board in stopping the study, number of interim analyses planned and conducted, and existence and type of monitoring methods, statistical boundaries, and adjustment procedures for interim analyses and early stopping. DATA SYNTHESIS: Of 143 RCTs stopped early for benefit, the majority (92) were published in 5 high-impact medical journals. Typically, these were industry-funded drug trials in cardiology, cancer, and human immunodeficiency virus/AIDS. The proportion of all RCTs published in high-impact journals that were stopped early for benefit increased from 0.5% in 1990-1994 to 1.2% in 2000-2004 (P<.001 for trend). On average, RCTs recruited 63% (SD, 25%) of the planned sample and stopped after a median of 13 (interquartile range [IQR], 3-25) months of follow-up, 1 interim analysis, and when a median of 66 (IQR, 23-195) patients had experienced the end point driving study termination (event). The median risk ratio among truncated RCTs was 0.53 (IQR, 0.28-0.66). One hundred thirty-five (94%) of the 143 RCTs did not report at least 1 of the following: the planned sample size (n = 28), the interim analysis after which the trial was stopped (n = 45), whether a stopping rule informed the decision (n = 48), or an adjusted analysis accounting for interim monitoring and truncation (n = 129). Trials with fewer events yielded greater treatment effects (odds ratio, 28; 95% confidence interval, 11-73). CONCLUSIONS: RCTs stopped early for benefit are becoming more common, often fail to adequately report relevant information about the decision to stop early, and show implausibly large treatment effects, particularly when the number of events is small. These findings suggest clinicians should view the results of such trials with skepticism.

Clinical Trials Data Monitoring Committees↗
PubMed2022

Systems Analysis Reveals Contraceptive-Induced Alteration of Cervicovaginal Gene Expression in a Randomized Trial.

Hormonal contraceptives (HCs) are vital in managing the reproductive health of women. However, HC usage has been linked to perturbations in cervicovaginal immunity and increased risk of sexually transmitted infections. Here, we evaluated the impact of three HCs on the cervicovaginal environment using high-throughput transcriptomics. From 2015 to 2017, 130 adolescent females aged 15-19 years were enrolled into a substudy of UChoose, a single-site, open-label randomized, crossover trial (NCT02404038) and randomized to injectable norethisterone-enanthate (Net-En), combined oral contraceptives (COC), or etonorgesterol/ethinyl-estradiol-combined contraceptive vaginal ring (CCVR). Cervicovaginal samples were collected after 16 weeks of randomized HC use and analyzed by RNA-Seq, 16S rRNA gene sequencing, and Luminex analysis. Participants in the CCVR arm had a significant elevation of transcriptional networks driven by IL-6, IL-1, and NFKB, and lower expression of genes supporting epithelial barrier integrity. An integrated multivariate analysis demonstrated that networks of microbial dysbiosis and inflammation best discriminated the CCVR arm from the other contraceptive groups, while genes involved in epithelial cell differentiation were predictive of the Net-En and COC arms. Collectively, these data from a randomized trial represent the most comprehensive "omics" analyses of the cervicovaginal response to HCs and provide important mechanistic guidelines for the provision of HCs in sub-Saharan Africa.

HIV↗
PubMed1985

Saphenous vein or PTFE for femoropopliteal bypass. A prospective randomized trial.

To evaluate the patency of PTFE (Gore-tex) as a femoropopliteal bypass, a prospective randomized trial was performed between PTFE and saphenous vein. Forty-nine consecutive patients with intermittent claudication, rest pain, or tissue loss due to an occlusion of the superficial femoral artery entered the study. Randomization between PTFE and saphenous vein was performed at the time of operation after assessment of the quality of the latter. The two groups did not differ significantly regarding stage of peripheral ischemia, outflow tract, or localization of the distal anastomosis. The patency rate 6 weeks after operation was 92% for each group. After a mean follow-up of 54 months, the patency rate for the PTFE group was 37% and 70% for the saphenous vein group (p less than 0.001). In the PTFE group, there were eight major amputations. No amputations were performed in the saphenous vein group. It is concluded from this study that the saphenous vein is by far superior to PTFE as a femoropopliteal bypass.

Aged↗
PubMed1983

A prospective randomized trial to compare mezlocillin and metronidazole with cefuroxime and metronidazole as prophylaxis in elective colorectal operations.

A prospective randomized trial has compared a broad spectrum ureidopenicillin with a broad spectrum cephalosporin for prophylaxis against the aerobic organisms encountered during elective colonic surgery. Even though only two doses of antibiotics were administered the incidence of severe sepsis was low. Severe wound infection occurred in three of the patients receiving mezlocillin and metronidazole (6 per cent) compared with six in the group receiving cefuroxime and metronidazole (13 per cent). Minor wound sepsis was recorded in 24 per cent of patients receiving mezlocillin and metronidazole compared with only 11 per cent after cefuroxime and metronidazole. There were two episodes of septicaemia, one in each group, and three abscesses, all of which occurred in patients receiving metronidazole and mezlocillin. The total number of surgically related infections was, however, significantly less with cefuroxime and metronidazole (N = 13) compared with mezlocillin and metronidazole (N = 23; P less than 0.03). Escherichia coli was the principal organism responsible for surgically-related postoperative sepsis: (22 isolates: 14 mezlocillin and eight cefuroxime) all of which sensitive to the agents used. Pseudomonas aeruginosa was recovered from 10 patients (three mezlocillin and seven cefuroxime), all of the isolates were resistant to both antibiotics and were associated with severe morbidity. There were 11 isolates of Staphylococcus spp. (nine mezlocillin and two cefuroxime: P less than 0.03). Postoperative diarrhoea occurred in six patients, all were in the group receiving cefuroxime and metronidazole. (Clostridium difficile was recovered from the stool in three of which one was associated with Cl. difficile cytotoxin.)

Adolescent↗
PubMed1999

Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain.

STUDY DESIGN: A prospective double-blind randomized trial in 31 patients. OBJECTIVES: To assess the clinical efficacy of percutaneous radiofrequency denervation of the lumbar zygapophysial joints in reducing pain, functional disability, and physical impairment in patients with back pain originating from the lumbar zygapophysial joints. SUMMARY OF BACKGROUND DATA: Chronic low back pain is a major health problem in the industrialized world. A treatment option is percutaneous radiofrequency denervation of the lumbar zygapophysial joints. Its clinical efficacy has never been formally tested in a controlled trial. METHODS: Thirty-one patients with a history of at least 1 year of chronic low back pain were selected on the basis of a positive response to a diagnostic nerve blockade and subsequently randomly assigned to one of two treatment groups. Each patient in the radiofrequency treatment group (15 patients) received an 80 C radiofrequency lesion of the dorsal ramus of the segmental nerve roots L3, L4, and L5. Patients in the control group (n = 16) underwent an the same procedure but without use of a radiofrequency current. Both the treating physician and the patients were blinded to the group assignment. Before treatment, physical impairment, rating of pain, the degree of disability, and quality of life were assessed by a blinded investigator. RESULTS: Eight weeks after treatment, there were 10 success patients in the radiofrequency group (n = 15) and 6 in the sham group (n = 16). The unadjusted odds ratio was 3.3 (P = 0.05, not significant), and the adjusted odds ratio was 4.8 (P < 0.05, significant). The differences in effect on the visual analog scale scores, global perceived effect, and the Oswestry disability scale were statistically significant. Three, 6, and 12 months after treatment, there were significantly more success patients in the radiofrequency group compared with the sham group. CONCLUSIONS: Radiofrequency lumbar zygapophysial joint denervation results in a significant alleviation of pain and functional disability in a select group of patients with chronic low back pain, both on a short-term and a long-term basis.

Adult↗
PubMed2001

Sociodemographic and clinical predictors of participation in two randomized trials: findings from the Collaborative Ocular Melanoma Study COMS report no. 7.

Collecting sociodemographic and clinical data concerning patients who choose not to enroll in a randomized clinical trial can be useful in assessing the feasibility of attaining sample size goals during the course of a trial. It can also aid in addressing the extent of generalizability of trial findings after a trial has ended. The Collaborative Ocular Melanoma Study (COMS) consists of two multicenter randomized clinical trials to evaluate the effectiveness of radiotherapy in comparison to standard enucleation (removal of the affected eye) in prolonging survival of patients with choroidal melanoma. One trial is for patients with large tumors and the other trial is for patients with medium-sized tumors. The same baseline sociodemographic and clinical data were collected for both enrolled patients and eligible patients who did not enroll in the randomized trials during the first 3 years of patient recruitment. Partial information on nonrandomized patients was collected thereafter. Recruitment ended in the large tumor and medium tumor trials on December 31, 1994, and July 31, 1998, respectively. From November 1986 through July 1998, 6906 patients with choroidal melanoma were evaluated for the randomized trials, of whom 4191 (61%) were eligible for enrollment. Logistic regression methods were used to identify factors predictive of trial participation. Sociodemographic factors that appeared to be associated (p < 0.15) with participation in the univariable models in the medium tumor trial were age 60 years or older, less than college education, nonmanagerial occupation, current smoking, and residing in the same state as a COMS clinical center. In the large tumor trial, males, individuals who were not college-educated, and individuals residing in the same state as a COMS clinical center were more likely to enroll. In both trials, clinical determinants of participation were larger tumor dimensions and initial visual acuity worse than 20/20 in the study eye. In multivariable regression models, the variables that were significantly predictive of enrollment (p < 0.05) in at least one of the trials were older age, residence in the same state, larger tumor basal diameter, and worse initial visual acuity in the study eye. Knowledge of possible sociodemographic and clinical predictors of differentials in patient participation for nonenrolled patients may help to refine patient education and recruitment strategies for future trials. Patient enrollment in clinical trials may be increased by heightened physician awareness of such predictors, strategies for addressing these differences, and enhanced communication between physicians and patients.

Aged↗
PubMed2002

Late complications following treatment for severe aplastic anemia (SAA) with high-dose cyclophosphamide (Cy): follow-up of a randomized trial.

High-dose cyclophosphamide (Cy) has been promoted as curative therapy for severe aplastic anemia (SAA). However, our randomized trial comparing antithymocyte globulin (ATG) and Cy was terminated early because of excess morbidity/early mortality in the Cy arm. We now report analysis of secondary endpoints at a median of 38 months. Relapse occurred in 6 (46%) of 13 responders in the ATG arm versus 2 (25%) of 8 in the Cy arm (P =.38). Five (31%) of 16 patients in the ATG arm and 4 (27%) of 15 patients in the Cy arm had evidence of paroxysmal nocturnal hemoglobinuria (PNH) at diagnosis, with no substantial change in the overall percentage of glycophosphatidyl inositol (GPI)-anchored protein-deficient neutrophils over extended follow-up in individual patients in either arm. Bone marrow cytogenetic abnormalities have been observed among surviving patients in both arms (2 of 14 ATG versus 1 of 12 Cy, P =.70). High-dose Cy does not prevent relapse or clonal evolution in SAA.

Anemia, Aplastic↗
PubMed1985

A randomized trial to compare single with multiple phenol injection treatment for haemorrhoids.

One hundred and twenty consecutive patients were entered into a randomized trial of single versus multiple phenol injection for the treatment of haemorrhoids. Follow-up at 3 and 12 months was available in 105 patients (56 in the single group and 49 in the multiple group). The results have shown that injection therapy, whether this be single or multiple, is an extremely effective form of therapy for patients with first or second degree haemorrhoids.

Adult↗
PubMed1993

Preoperative or postoperative irradiation in adenocarcinoma of the rectum: final treatment results of a randomized trial and an evaluation of late secondary effects.

From 1980 to 1985, 471 patients with resectable rectal and rectosigmoid cancer were randomly allocated to receive either preoperative short-term high-dose irradiation (25.5 Gy in one week) for all patients or prolonged postoperative radiotherapy (60 Gy in seven to eight weeks) only for patients with a Dukes B or C lesion. After a minimum follow-up of five years, the local recurrence rate was statistically significantly lower after preoperative than after postoperative radiotherapy (13 percent vs. 22 percent; P = 0.02). No difference in overall survival was noted (P = 0.5). To evaluate possible late side effects on the bowel, urinary bladder, or skin after surgery and additional preoperative or postoperative radiotherapy, all patients included in the randomized trial, together with 58 patients from a preceding pilot study with the same preoperative regimen, were studied in a prolonged follow-up program. The hospital files of all patients were re-examined. Of the patients who were carefully examined, 176 had a survival exceeding five years and 19 had a survival exceeding 10 years. Overall, 7 percent (33/464) either were operated upon or have had a radiologic diagnosis of small bowel obstruction: 14/255 (5 percent) after preoperative irradiation, 14/127 (11 percent) after postoperative irradiation, and 5/82 (6 percent) after surgery alone. The cumulative risk of developing a bowel obstruction was significantly increased after postoperative radiotherapy. Among the 98 patients alive after preoperative irradiation, significant morbidity from the bowel was noted in 11 patients, from the urinary bladder in two, and from the skin in six. In the postoperatively treated group of 34 patients, the bowel, urinary bladder, and skin morbidity were significant in five, two, and five patients, respectively. Corresponding morbidity in 44 nonirradiated patients was seen in five, one, and two patients, respectively. It is concluded that preoperative, short-term, high-dose radiotherapy decreases the local recurrence rate relative to postoperative radiotherapy, with no indications of increased late morbidity after a follow-up of 5 to 10 years.

Adenocarcinoma↗
PubMed1991

Prospective randomized trial of sequential compression devices vs low-dose warfarin for deep venous thrombosis prophylaxis in total hip arthroplasty.

A prospective randomized trial compared the effectiveness of low-dose warfarin (LDW) to sequential compression devices (SCD) for deep venous thrombosis (DVT) prophylaxis in 95 patients after total hip arthroplasty (THA). Patients were 39 years of age or older, with no history of previous venous disease. Bilateral lower-extremity venography was used for thrombi detection. Venous thrombi occurred in 12 patients (all calf) on LDW (26.6%) and 3 patients with SCDs (one calf, two thigh) (6.0%). The incidence of DVT was significantly higher in the LDW group (P less than .006). In this study of average-risk patients, the use of SCDs significantly outperformed LDW as a prophylactic agent. However, the thrombi that did occur with SCDs were more critical.

Adult↗
PubMed2002

T-cell responses against tyrosinase 368-376(370D) peptide in HLA*A0201+ melanoma patients: randomized trial comparing incomplete Freund's adjuvant, granulocyte macrophage colony-stimulating factor, and QS-21 as immunological adjuvants.

We conducted a randomized trial in HLA*A0201+ patientswith American Joint Committee on Cancer stage III or IV melanoma immunized with tyrosinase 368-376(370D) peptide and gp100 209-217(210M) peptide to compare the potency of three different adjuvants. Patients received 3 monthly immunizations with 500 microg of each peptide either with incomplete Freund's adjuvant (IFA), QS-21, or granulocyte macrophage colony-stimulating factor (GM-CSF). The primary end point was induction of IFN-gamma release by CD8+ T cells against tyrosinase and gp100 peptides measured by enzyme-linked immunospot assays without in vitro prestimulation measured pretreatment, 2 and 8 weeks after the third vaccination. Four of 9 and 4 of 8 patients immunized using QS-21 and GM-CSF, respectively, developed increased frequencies of CD8+ T cells against tyrosinase 370D peptide compared with 0 of 9 patients immunized using IFA (P = 0.045). T-cell responses against a gp100-related peptide showed similar results, but their relevance to T-cell reactivity against native gp100 209-217 is uncertain. These results show that: (a) QS-21 and GM-CSF are superior to IFA as immunological adjuvants for vaccination against tyrosinase 370D peptide; and (b) with appropriate adjuvants, increased frequencies of peptide-specific T cells after vaccination can be detected by enzyme-linked immunospot without prolonged prestimulation in vitro.

Adult↗
PubMed2004

Sickness behavior of rats with abdominal sepsis can be improved by antibiotic and G-CSF prophylaxis in clinic modeling randomized trials.

BACKGROUND AND AIM: In clinical sepsis research nearly all immune-modulators have demonstrated no benefit in regard to the 28-day mortality rate. Other endpoints such as quality of life have become more attractive, but clinically relevant animal models analyzing an equivalent to quality of life by measurement of sickness behavior are extremely rare. The concept of clinic modeling randomized trials was used in an animal trial to model clinical complexity and conditions of a randomized clinical trial. METHODS: 80 adult male Wistar rats were randomly assigned to (1) control: anesthesia and sham operation, (2) sepsis: laparotomy and peritoneal infection with human stool bacteria, (3) sepsis with antibiotic prophylaxis: cefuroxime/metronidazole and (4) sepsis with antibiotic plus a cytokine prophylaxis with granulocyte-colony stimulating factor (GCSF). Endpoints were physiological and behavioral parameters. RESULTS: The combination of antibiotics plus G-CSF was most effective in reducing mortality. All infected animals showed reduced open field activity acutely after infection, and recovery was improved during the 9 day follow-up in rats with prophylactic treatments. In the social interaction test, but not in the elevated plus-maze anxiety test, prophylaxis was also efficient, especially with antibiotics and G-CSF. CONCLUSIONS: The results show that improving sickness behavior in septic rats with G-CSF plus antibiotics may be a promising approach.

Animals↗
PubMed2006

A randomized trial of blood donor recruitment strategies.

BACKGROUND: Improvement in donor return rates, especially among first-time donors, may significantly improve the blood supply. There are few rigorous studies of the effectiveness of various approaches to donor recruitment, however. STUDY DESIGN AND METHODS: By use of a single-blind, randomized trial design, 6919 post-September 11, 2001, first-time donors were randomly assigned into the following intervention arms: T-shirt incentive versus none, recruitment scripts with a patient story (Script A) versus a complimentary message including the donor's blood type (Script B), and telephone versus e-mail recruitment. Our primary outcome was a second donation within 6 months. Rate ratios (RRs) and 95 percent confidence intervals (95% CIs) were calculated with Taylor series methods. RESULTS: A total of 1421 (20.5%) first-time donors returned within the 6 months, including 1252 with a second and 169 with both second and third donations. The T-shirt incentive was not effective in increasing returns compared to no incentive (20.5% vs. 20.6%; RR, 0.99; 95% CI, 0.91-1.09). Script A was significantly more effective than Script B (22.2% vs. 18.9%; RR, 1.18; 95% CI, 1.07-1.29). E-mail was substantially less effective than telephone recruitment (13.2% vs. 27.8%; RR, 0.48; 95% CI, 0.40-0.57). CONCLUSIONS: A T-shirt incentive had no apparent effect, but an empathetic message significantly improved the return donation rate. E-mail recruitment was substantially less effective than telephone recruitment, perhaps due to technical problems. The study illustrates the utility of the randomized clinical trial study design for testing donor recruitment strategies.

Blood Banking↗
PubMed2003

Prognosis after rectal cancer in blacks and whites participating in adjuvant therapy randomized trials.

PURPOSE: National health statistics indicate that blacks have lower survival rates from colorectal cancer than do whites. This disparity has been attributed to differences in stage at diagnosis and other disease features, extent and quality of treatment, and socioeconomic factors. We evaluated outcomes for blacks and whites with rectal cancer who participated in randomized clinical trials of the National Surgical Adjuvant Breast and Bowel Project (NSABP). The randomized trial setting enhances uniformity in disease stage and treatment plan among all participants. PATIENTS AND METHODS: The study included black (N = 104) or white (N = 1,070) patients from two serially conducted NSABP randomized trials for operable rectal cancer. Recurrence-free survival and survival were compared using statistical modeling to account for differences in patient and disease characteristics between the groups. RESULTS: Blacks and whites had largely similar disease features at diagnosis. After adjustment for patient and tumor prognostic covariates, the black/white recurrence hazard ratio (HR) was 1.25 (95% confidence interval [CI], 0.94 to 1.66). The mortality HR was somewhat larger at 1.45 (95% CI = 1.09 to 1.93). Outcomes were improved for both groups in the more recent trial, which employed systemic adjuvant chemotherapy in all treatment arms. CONCLUSION: Recurrence-free survival was modestly less favorable for blacks, whereas overall survival was more disparate. Outcomes between groups were more comparable than those noted in national health statistics surveys and other studies. Adequate treatment access and the identification of new prognostic factors that can identify patients at high risk of recurrence are needed to ensure optimal outcomes for rectal cancer patients of all racial/ethnic backgrounds.

Aged↗