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Research Reports |
VG Marchese, PT, PhD, is a faculty member, Department of Physical Therapy, College of Allied Health Sciences, Health Science Center, University of Tennessee, Memphis, Tenn, and Department of Physical Therapy, Lebanon Valley College, 101 N College Ave, Annville, PA 17003 (USA)
BH Connolly, PT, DPT, EdD, FAPTA, is Chair, Department of Physical Therapy, College of Allied Health Sciences, Health Science Center, University of Tennessee
C Able, PT, is Staff Physical Therapist, Department of Physical Therapy, Momentum Physical Rehabilitation, Memphis, Tenn
AR Booten, PT, is Staff Physical Therapist, Baptist Hospital, Nashville, Tenn
P Bowen, PT, is Staff Physical Therapist, White County Community Hospital, Sparta, Tenn
BM Porter, PT, is Staff Physical Therapist, Henry County Medical Center, Paris, Tenn
SN Rai, PhD, is a faculty member, Department of Biostatistics, St Jude Children's Research Hospital, Memphis, Tenn
ML Hancock, MS, is a staff member, Department of Biostatistics, St Jude Children's Research Hospital
CH Pui, MD, is a faculty member, Division of Hematology-Oncology, St Jude Children's Research Hospital
S Howard, MD, is an assistant faculty member and Director of Clinical Trials, International Outreach Program, St Jude Children's Research Hospital, and Associate Professor, College of Medicine, Health Science Center, University of Tennessee
MD Neel, MD, is an assistant faculty member, Department of Surgery, Orthopedics, St Jude Children's Research Hospital
SC Kaste, DO, is a faculty member, Division of Diagnostic Imaging, St Jude Children's Research Hospital, and Department of Radiology, Health Science Center, University of Tennessee
Address all correspondence to Dr Marchese at: marchese{at}lvc.edu
Submitted April 5, 2007;
Accepted November 15, 2007
 | Abstract |
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Subjects: Thirty-three subjects aged 5 to 27 years with ALL and osteonecrosis participated.
Methods: The extent of osteonecrosis was determined by magnetic resonance imaging (MRI) of the hip and knee according to 2 classification systems, including the Association Research Circulation Osseous (ARCO) and a knee staging scale. Pain, hip and knee ROM, and the Timed Up and Down Stairs (TUDS) Test were used as measures.
Results: Correlations were observed between ARCO and hip pain (r=.34), between hip flexion ROM and hip pain (r=–.34), and between knee pain and time on the TUDS Test (r=–.35).
Discussion and Conclusion: Physical therapists should consider that people with ALL may have hip or knee osteonecrosis without clinical symptoms. This notion supports the need for MRI in addition to a comprehensive examination of functional mobility.
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Dexamethasone and prednisone are known to cause osteonecrosis in people with ALL.2–4 Osteonecrosis occurs in 15% to 38% of children with ALL2,5 and is more common in children aged 10 years or older.2,3,5 The onset of osteonecrosis occurs as early as 2 months and up to 5 years after the diagnosis of ALL.3 Dose intensity is thought to increase the risk of developing osteonecrosis.2,3 In one study,3 osteonecrosis was diagnosed within 3 years of the start of treatment in all but 1 of 111 children with ALL. These researchers postulated that the maturing bone of adolescents is more susceptible to the development of osteonecrosis than that of younger children because epiphyseal closure and corticosteroid-induced marrow fat cell hypertrophy result in increased intraosseous pressure. The latter leads to reduced intramedullary blood flow, marrow ischemia and, ultimately, necrosis in the bones of adolescents. In contrast, immature bone may buffer increased pressure at the epiphyseal plate.3 However, children younger than 10 years of age are still at risk for developing osteonecrosis.
Considering that people with ALL are at risk for developing osteonecrosis, there has been extensive study into what radiological methods provide the most appropriate assessment for early detection. Although radiography, computed tomography, and magnetic resonance imaging (MRI) have all been used to identify osteonecrosis in both children and adults,2,3,8 MRI is the most sensitive and specific method, allowing for the earliest diagnosis.9 There are many methods for quantifying osteonecrosis in the hip and knee for children and adults, such as the international classification system of the Association Research Circulation Osseous (ARCO) and that of Ficat and Arlet.5,8–13 Cherian et al11 reported that ARCO is a reliable and acceptable method for classifying the size of the necrotic area, as demonstrated by MRI, and Karimova et al10 found that an MRI staging system was a reliable method for identifying and interpreting osteonecrosis of the knee.
The anterior-lateral region of the femoral head, the distal femur, and the proximal tibia are the most frequently involved sites for osteonecrosis.3,4 Although clinical symptoms of osteonecrosis are rare for people with osteonecrosis in the knees, it is common for people with osteonecrosis of the hip to present with mild aching, lateral hip pain with activity, stiffness, and decreased range of motion (ROM), primarily in flexion, abduction, and medial rotation.3–5 These clinical symptoms may lead to a decrease in activities such as walking and stair climbing because these functions require ROM in joints and in the planes that are commonly affected by osteonecrosis.14–16
We used the International Classification of Functioning, Disability and Health (ICF),17 a health classification system, as the framework for this study. The ICF classifies functioning at the level of body part (body function/structure), whole person (activity), whole person in social context (participation), and contextual factors (external and internal). Body functions are physiological functions, and body structures are anatomical parts of the body. Activity includes the execution of a task or action by an individual. Participation is involvement in a life situation. Contextual factors include environmental factors that constitute the physical, social, and attitudinal environments in which people conduct their lives and personal factors (including sex, age, coping styles, social background, education, profession, past and current experience, overall behavior pattern, character, and other factors) that influence how disability is experienced by an individual. This article focuses primarily on the body function/structure and activity components.
Impairments in body function/structure and activity limitations in people with ALL may be caused by a variety of reasons, such as prolonged inactivity, vincristine-related peripheral neuropathy, or osteonecrosis.2–7,18–20 To our knowledge, no studies have been conducted to objectively evaluate the relationship between body function/structure (degree of osteonecrosis, pain, and ROM) and activity (stair climbing). It is not known whether clinical symptoms (such as decreased ROM and pain) and decreased activity (such as stair climbing) are related to the severity of osteonecrosis. Knowledge of such relationships could lead to justification of the need for the early diagnosis of osteonecrosis by having all children with ALL receive routine MRI screening. This information could assist physical therapists with examination and intervention development for children with ALL.
The purpose of this study was to explore the relationships among specific measures of body function/structure, as measured by the stage of osteonecrosis in the hips and knees, pain, ROM, and activity (Timed Up and Down Stairs [TUDS] test). We hypothesized that pain would increase with the severity of osteonecrosis whereas joint ROM and activity would decrease, leading to increased time required to ascend and descend stairs.
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±SD) years old (range, 5–27 years). The inclusion criteria consisted of the following: diagnosis of osteonecrosis by MRI, either in the hip (femoral head) or knee (distal femur, proximal tibia or fibula, or both), within 4 weeks of study enrollment; age of at least 5 years; and signed informed consent or assent of the participant or parent. Potential participants were excluded if they had a history of a neuromuscular disease, such as cerebral palsy or Down syndrome, or had undergone a surgical intervention for osteonecrosis (eg, core decompression or arthroplasty). At the time of this study, 860 subjects who were enrolled in 3 consecutive clinical trials for newly diagnosed ALL (Total Therapy 13, 14, and 15 trials*) were monitored, and 176 of them had MRI-documented osteonecrosis: 24 in the hips only, 121 in the knees only, and 31 in both hips and knees. Six of these subjects were not eligible because of previous arthroplasty or joint resurfacing procedures for hip or knee osteonecrosis, and 11 subjects were not eligible because of a neuromuscular disease, specifically Down syndrome. Of the 159 potentially eligible participants, 33 had medical appointments during the study period, and all of them agreed to participate. In the 33 participants (1 from the Total Therapy 14 trial, 27 from the Total Therapy 15 trial, and 5 from the Total Therapy 13 trial), the hip was involved bilaterally in 5 participants and unilaterally in 5 participants, whereas the knee was affected bilaterally in 29 participants and unilaterally in 2 participants. Eight participants had osteonecrosis of both hip and knee joints (Tab. 1). Ficat and Arlet scores for the knees were not available for 1 participant. The mean length of time from the diagnosis of ALL to enrollment in this study was 3.2 years (SD=2.8 years, range=5 months–10 years). None of the participants in this study was receiving physical therapy services, used an assistive device, or wore ankle-foot orthoses. Five participants were taking some type of pain medication.
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Instrumentation
The ARCO classification system was used to characterize the extent of osteonecrosis in the participants' hips. This method classifies the disease into the following stages11,12: stage 0—diagnostic imaging results are normal; stage 1—conventional radiography and computed tomography results are normal, but MRI, scintigraphy, or both indicate the presence of osteonecrosis; stage 2—radiography demonstrates regions of irregularity, such as mottling, osteolysis, and sclerosis, but the femoral head is spherical on anterior-posterior and lateral views; stage 3—the "crescent sign," a fine radiolucent subchondral fracture line, is apparent on radiographs, and the femoral head mechanically fails; and stage 4—flattening of the femoral articular surface, narrowing of the joint space, and changes in the acetabulum are evident.
The Ficat and Arlet knee staging method of classification was used to describe the extent of osteonecrosis in the participants' knees. The stages are as follows: stage 1—the knee is normal; stage 2—cystic or osteosclerotic lesions are apparent; stage 3—the knee has a fine radiolucent subchondral fracture line, referred to as the crescent sign, or subchondral collapse; and stage 4—narrowing of the joint space is evident.8,10 Ficat and Arlet scores are radiographic criteria; for the present study, we extrapolated these changes from MRI. There were no modifications of the Ficat and Arlet staging method other than the use of MRI instead of radiographs. The advantage of the use of MRI is the identification of the development of osteonecrosis before it becomes evident on conventional radiographs.5
Pain was measured with the Wong-Baker Faces Scale21 for participants 5 to 13 years old and the point box pain scale22 for those more than 13 years old. The Wong-Baker Faces Scale allows people to rate pain by choosing 1 of 6 faces (from a very happy face, representing no pain, to a very sad face, representing the worst pain imaginable) with corresponding numbers from 0 to 10. Participants were asked to point to the face that corresponded to the level of pain in each joint.21,22 The point box pain scale allows people to identify the level of pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable.22 Participants were asked to choose the number that best represented their level of pain.
Active hip flexion, active knee flexion, and passive knee extension ROM were measured with a large full-circle goniometer with 1-degree intervals.16 These motions were selected because they are typically affected by osteonecrosis and are required for an individual to perform activities of daily living such as walking and stair climbing.
The TUDS Test was used to measure functional mobility. The TUDS Test requires an individual to ascend and descend stairs while the time (in seconds) is recorded with a stopwatch.18,23 The TUDS Test was selected as a functional activity because it requires movement of the knees and hips, joints commonly affected by osteonecrosis.
Procedure
Before data collection began, the physical therapist researchers performed intrarater and interrater reliability testing of the ROM measurements with a group of subjects who were healthy. They achieved good intrarater and interrater reliability for the measurements: r=.97 and r=.96 for active hip flexion ROM, r=.94 and r=.90 for active knee flexion ROM, and r=.93 and r=.91 for passive knee extension ROM. The physical therapist researchers collected data on ROM, TUDS Test score, and pain score for each participant during the study.
A single experienced pediatric radiologist scored the extent of osteonecrosis from MRI of the hips and knees according to the ARCO or Ficat and Arlet classifications systems or both.
The physical therapist researchers who obtained the outcome measures kept the order of the outcome measures consistent for all participants (pain score, ROM, and TUDS Test score). No physical therapy intervention was performed before or after the subjects participated in this study because the primary aim of this study was to examine the correlations of the severity of osteonecrosis with ROM, pain, and stair climbing and not the effects of physical therapy intervention. The participants were asked to rate the pain in each joint (hips and knees) by using the Wong-Baker Faces Scale21 or the point box pain scale.22
To obtain ROM measurements of active hip flexion, active knee flexion, and passive knee extension, the examiner first took the participant passively through the desired motion. The participant then was asked to perform the movement for hip and knee flexion, and the examiner obtained the measurement with the goniometer. To measure active hip flexion ROM, the examiner placed the participant in a supine position with the fulcrum of the goniometer over the lateral aspect of the hip joint and used the greater trochanter as a reference. The proximal arm of the goniometer was aligned with the lateral midline of the pelvis. The distal arm of the goniometer was aligned with the lateral midline of the femur, and the examiner used the lateral epicondyle as a reference. To measure active knee flexion ROM and passive knee extension ROM, the examiner placed the participant in a supine position with the fulcrum of the goniometer aligned over the lateral epicondyle of the femur. The proximal arm of the goniometer was aligned with the lateral midline of the femur, and the examiner used the greater trochanter as a reference. The distal arm of the goniometer was aligned with the lateral midline of the fibula, and the lateral malleolus was used as a reference.16 The participant's passive rather than active full knee extension was measured because bony changes in the knee might result in subtle changes in knee extension that would not be evident with active movements only.
The stairs used for the TUDS Test were located in a stairwell near a physical therapy gymnasium. Each of the 12 stairs measured 16.5 cm high, 31 cm deep, and 104.4 cm wide. Participants began the TUDS Test from a standing position, with feet together, approximately 15 cm (6 in) from the first step. An examiner stood near the first step within clear view of the participant's body. As a safety measure, a spotter closely monitored each participant throughout the entire procedure. The participant was instructed to go up and down 12 stairs "as fast as possible while being safe" and was instructed to use the railing if desired. The examiner said, "On your mark, get set, go," at which time the participant ascended and descended the set of 12 stairs as quickly as possible. Timing began when the participant's first foot lifted off the ground at the bottom of the stairs. Timing ended when both feet were back on the ground at the bottom of the stairs. The physical therapy measurements (pain score, ROM, and TUDS Test score) took approximately 20 minutes to complete.
Data Analysis
Because enrollment was restricted to a small number of participants available during the 6 months of data collection, the results of this study should be considered descriptive. Before the initiation of the study, we used a one-tailed test for correlations at an alpha level of .05 and a large effect size (r=.45) to determine that 30 subjects were required for 80% power.24
Intrarater and interrater reliability was estimated with intraclass correlation coefficients. Descriptive statistics were calculated for all variables. We calculated Spearman correlation coefficients (95% confidence intervals) for the 2 methods used to classify the extent of osteonecrosis in the hips and knees (ARCO and Ficat and Arlet scores), the pain score for the involved hip or knee, hip and knee ROM, and TUDS Test time (n=33).25 The Holm procedure was applied to account for P values generated from multiple significance tests of correlation coefficients.26
We analyzed the joints independently because we obtained both left and right hip and knee pain scores and ROM measurements (66 hips and 66 knees). Ficat and Arlet scores for the knees were lacking for one participant because no MRI of the knees was available, but this participant did have MRI of the hips and ARCO scores, resulting in 64 analyzable knees in 32 participants. For analysis of TUDS Test scores for which there was only one value per participant, data from the hip or the knee with the highest ARCO or Ficat and Arlet score, respectively, were used. The most severely involved joint was selected because the entire body and not just a single extremity performs a functional activity. The most severely involved joint is likely to be the most important factor in limiting a functional activity.
The Jonckheere-Terpstra test27 for trend was used to determine whether the distributions of ROM were shifted on the basis of the ordered ARCO and Ficat and Arlet scores and to test for a linear association between the ARCO and Ficat and Arlet scores and pain scores in order to account for the correlated nature of the data, such as left and right knees and hips in the same participant. All P values were generated from 2-sided exact Monte Carlo simulations of the exact distribution of P values.25 P values of less than .05 were considered significant unless otherwise noted. Statistical analyses were performed with SAS (version 9.1) statistical software.
,28
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There was an inverse correlation between TUDS Test time and knee pain score (r=–.35, P=.05). We used the pain score of the joint that had the highest Ficat and Arlet score for the assessment of TUDS Test time. We observed no significant differences between the TUDS Test times of participants with osteonecrosis in the hips and knees (n=8) and those of participants with osteonecrosis in the knees only (n=23).
| Discussion |
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5 on the pain scale from 0 to 10. Our finding of a correlation between hip pain and the MRI-confirmed severity of osteonecrosis is supported by the findings of several previous studies that examined the association between pain and osteonecrosis.2,29 Ribeiro et al2 reported pain in 11 of the 17 subjects who had MRI-documented osteonecrosis and who were receiving chemotherapy for either ALL or non-Hodgkin lymphoma. Pain was the primary symptom leading to the diagnosis of osteonecrosis in 35 young adults who had undergone bone marrow transplantation.29 In contrast, another group of authors reported that among 28 children who reported joint or limb pain following organ transplantation, only 7 had MRI-diagnosed osteonecrosis when referred for imaging.30
The data also supported our hypothesis that there would be a relationship between specific measures of body function (knee pain) and activity (TUDS Test), as demonstrated by the inverse correlation between knee pain score and TUDS Test time. This finding suggests that unless an individual is experiencing pain in the knees, functional mobility may not be affected. Six of the 31 participants (7 knees) in the present study reported knee pain scores of less than 4 (scale from 0 to 10), and none of the 31 participants reported pain scores of greater than 5. Although the data failed to support our hypothesis that there would be a relationship between the other measures of body function (knee osteonecrosis and knee ROM) and activity (TUDS Test), our findings are consistent with those of Karimova et al,5 who found that more than half of the knees with osteonecrosis in children with leukemia and lymphoma were asymptomatic. These results suggest that people may have osteonecrosis involving the knees but show minimal clinical symptoms.
Clinical Implications
Physical therapists should be prepared to examine and develop an intervention program while taking into consideration that any child or adolescent with a diagnosis of ALL is at risk for osteonecrosis, even if MRI was not performed and the patient does not report clinical symptoms. Therapists should understand that clinical symptoms are unreliable predictors of the presence, size, and stage of osteonecrosis. In addition, the clinical management of ALL is complex, and children with ALL experience many short- and long-term body function impairments, activity limitations, and participation restrictions during treatment and for years following the cessation of chemotherapy.20,31–34
Children with ALL receive a variety of chemotherapy agents that often have mild to severe secondary complications that affect the neuromuscular and musculoskeletal systems. A primary focus of research has been on the neuromuscular toxic side effects of vincristine. Children receiving vincristine are susceptible to developing peripheral neuropathy as early as 1 month following the initiation of treatment,7 with symptoms continuing even after chemotherapy has been completed.20 Symptoms may include decreased deep-tendon reflexes, paresthesia, pain or muscle cramps, decreased ankle ROM, and impaired gross and fine motor performance.7,18,19,33–35 In addition, weakness in dorsiflexion of the toes and ankles19,36 and weakness in hand grip strength (force-generating capacity)36 may be observed. However, other chemotherapy agents used in the treatment of ALL also may have toxic side effects. Methotrexate, another chemotherapy agent commonly used for the treatment of ALL, may interfere with skeletal growth and cause bone mineral density deficits and fractures, primarily in the lower extremities.37,38 Dexamethasone or prednisone may cause osteonecrosis as well as myopathy, primarily in the proximal muscles.39 Additionally, children with ALL are at risk for increased energy expenditure (requiring more energy to perform a task)40 and may experience cardiac toxicity attributable to agents such as daunorubicin.41 Thus, when performing an examination or developing an intervention program for patients with ALL, physical therapists should take into consideration all of these factors in addition to environmental and personal factors of individual patients.
Physical therapy intervention programs for people with ALL have typically included ankle ROM exercises and strengthening exercises to prevent limitations in ROM attributable to vincristine-related peripheral neuropathy.18,34 In addition, clinical practice has indicated that ankle-foot orthoses may be recommended to assist with foot drop, prevent damage to the ankle structures, and decrease the risk of falls. Strengthening exercises have been recommended to assist with weakness from inactivity, steroid-induced myopathy, and vincristine-related peripheral neuropathy.18 Aerobic exercises have been recommended to assist with overall health and wellness. Furthermore, balance and high-level coordination activities, such as single-limb stance and running speed and agility activities, may be suggested.20
Physical therapy interventions for people with ALL are complex because there must be a balance between interventions that promote bone mineral deposition and decreased weight-bearing activities for people with osteonecrosis. Unfortunately, such interventions for people with ALL and, more specifically, osteonecrosis have not been well studied.
Marchese et al18 examined physical therapy interventions for 27 children (4–15 years old) with ALL. The intervention group received 5 sessions of physical therapy, and the children were instructed to perform an individualized exercise program consisting of ankle dorsiflexion stretching, lower-extremity strengthening, and aerobic exercise; the control group received no physical therapy intervention until the end of the study. After 4 months, the children in the intervention group had significantly improved (P=.01) ankle dorsiflexion active ROM and knee extension strength. That study did not find significant differences between the groups in values measured before and after the intervention for ankle dorsiflexion strength, TUDS Test time, and 9-minute run-walk. However, that study did not examine the effects of the intervention on osteonecrosis.
Neumayr et al42 compared physical therapy alone with core decompression and physical therapy for femoral head osteonecrosis in 38 people with sickle cell disease (17 received hip core decompression with physical therapy and 21 received physical therapy alone). The physical therapy protocol included the weight-bearing restriction of toe-touch weight bearing on the affected hip for all participants for the initial 6 weeks of the study. If the participants had osteonecrosis in one hip, then an assistive device, such as crutches or a walker, was provided, and if both hips were involved, then the participants used a wheelchair for all mobility. Physical therapy services were performed once or twice per week for stretching, for strengthening, and to assist with the home exercise program. The participants continued to receive physical therapy for 3 months, once or twice a week, including weight bearing as tolerated, stretching, strengthening, gait training, and home exercise program instruction. That study reported that physical therapy alone appeared to be as effective as hip core decompression followed by physical therapy in improving hip function. Even though that study is helpful, there are many differences between children with sickle cell disease and children with ALL. Therefore, one must be cautious when making generalizations regarding the 2 different participant populations in terms of the implications for physical therapy intervention for children with ALL. That study did not document the efficacy of physical therapy versus no physical therapy. We are not aware of any study documenting the efficacy of physical therapy for people with osteonecrosis, regardless of their underlying conditions.
For people with ALL and osteonecrosis that is not severe (ARCO or Ficat and Arlet stage I or II), a physical therapist may recommend the use of crutches to maintain a non-weight-bearing position of the lower extremity to attempt to decrease pain and perhaps slow the progression of the osteonecrosis. Instructing people on how to perform active and passive ROM exercises may help preserve joint motion. A clinician may recommend limiting an individual's physical activity level to minimize clinical symptoms in order to slow the progression of the condition or to delay the need for surgical intervention until the individual has completed chemotherapy. However, the efficacy of these recommendations remains to be demonstrated and remains an important area for future studies. Physicians may decrease the dose of steroids in people with osteonecrosis or discontinue their use altogether in cases of severe osteonecrosis, although there are no studies to document the efficacy of this approach.
Study Limitations
The small sample size in the present study limits our ability to find some correlations between the variables and precludes additional analyses, such as comparing TUDS Test times between subjects with bilateral joint involvement and those with a single involved joint. For a sample of 33 participants to detect a correlation of r=.35 at an alpha level of .05 with a one-tailed test, the power was 63%. Thus, with a larger sample, we may have found more correlations between the variables. The relationships between the severity of hip osteonecrosis, hip pain scores, and hip ROM and the TUDS Test times also were not assessed because of the small sample size. We did not measure quality of life or restrictions in participation (school and sports), nor did we account for any environmental factors, such as family support or other family constraints. We do not have information on the length of time between the original diagnosis of osteonecrosis and enrollment in the present study.
The relationships among osteonecrosis, pain, and use of pain medication have not been studied; additional research is required to examine the implications of the use of pain medication (frequency, dose, and pain intensity) for the progression of osteonecrosis, ROM, and activity limitations. In addition, further examination is needed to understand the implications of pain in areas of the body without osteonecrosis and to determine the causes of the pain. Two participants in the present study reported pain in joints without osteonecrosis (one in the hip and one in the knee). The pain may have been associated with a variety of factors that were not specifically identified.
Future studies are needed to establish differences in functional outcomes, such as walking long distances, climbing stairs, balancing, and transitioning movements, while considering the number of joints involved and the severity of osteonecrosis. No participant in the present study had the most severe stage (stage 4) of osteonecrosis in the knees. Further analyses are needed to determine whether people with stage 4 osteonecrosis in the knees have increased symptoms, such as higher pain scores, decreased ROM, and increased time to perform the TUDS Test. In addition, studies are needed to examine whether the length of time from the diagnosis of osteonecrosis affects the severity of pain, ROM, and activity (eg, stair climbing) limitations. Studies are also needed to further identify risk factors for developing osteonecrosis (age, gender, or prior activity level). Prospective longitudinal studies will determine the efficacy of physical therapy intervention for minimizing deficits in body function/structure, activity, and participation resulting from osteonecrosis in children with ALL.
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| Footnotes |
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The study was approved by the institutional review boards of St Jude Children's Research Hospital and the University of Tennessee.
This study was supported, in part, by the American Lebanese Syrian Associated Charities (ALSAC), Cancer Center CORE grant 2U54CA055727–12, and grants P30 CA-21765 and P01 CA-20180 from the National Institutes of Health.
* Total Therapy 13, 14, and 15 are St Jude Children's Research Hospital's specific research protocols for patients with ALL. 
SAS Institute Inc, PO Box 8000, Cary, NC 27511.
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