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Biomedical subjects

S Kramer

Publications and source records attributed to S Kramer.

At least 73 records · Page 4Linked to original sources

The Patterns of Care Outcome Studies: results of the National practice in carcinoma of the larynx.

The Patterns of Care Study conducted a survey of patients with glottic and supraglottic carcinomas treated in 1973 and 1974. Patients for this study were randomly selected from all types of treatment facilities, including those with full and part-time therapists and large and small institutions. Detailed evaluation and treatment parameters were recorded for a total of 707 patients. Overall three-year recurrence free survival for glottic carcinoma was: Stage I, 90%; Stage II, 78%; Stage III, 65%; and Stage IV, 23%. For supraglottic carcinoma the rates are: Stage I 78%, Stage II, 60%, Stage III, 34% and Stage IV, 30%. The use of surgery in this study for advanced lesions varied among different departments. For advanced lesions, those treated with combined radiation and surgery had improved survival; this was also related to completeness of work-up and departmental equipment.

Carcinoma, Squamous Cell

Quality assurance in radiation therapy: clinical and physical aspects. Consensus of best current management: the starting point for clinical quality assessment.

Consensus of best current management developed by a rational and deliberative process can provide the basis for clinical quality assessment. Unfortunately, it is not always possible to arrive at a consensus at all cancer sites, and this generally indicates areas where clinical research is needed. Assessing the quality of care in these situations presents special problems. When it is possible to arrive at consensus in a specific disease, this consensus should detail appropriate pretreatment evaluation and the details of the treatment. Committees of experts for each specific disease site can formulate the consensus and must document their decisions based on information from the current world literature. A carefully thought out and documented consensus can then provide the basis for the development of process based questionnaires in assessing quality. We have observed that individuals formulating consensus of best current management do not strictly follow their own criteria, and that compliance in various strata of practice throughout the United States shows a greater deviation from consensus than anticipated and indeed this deviation crosses all types of practice. It was then necessary to conduct outcome surveys in the same patients to validate the processes of care by showing a correlation of process performance with outcome or indeed to change our concepts of best current management. We recognize from these outcome studies that relatively few processes have direct association with outcome and the majority of our consensus points relate to either good general patient management or items important to individual patients but not to large groups of patients. In addition to validating processes through outcome correlations, we have found that process verification is important. We have observed quite different outcomes for two groups of patients with Hodgkin's disease treated with the same processes (i.e., mantle field technology and adequate radiation dose, etc.). We were unable to identify the reason for an increased failure rate in one group of these patients until we looked at each individual mantle port film from the two groups of patients. We then identified that one facility was not including the Hodgkin's disease in the treatment portal due to poor technical performance. We believe that this program of process verification may be important in evaluating quality for any disease site. Data will be presented that illustrates the above problems.

Adult

The efficacy of random digit dialing in selecting matched controls for a case-control study of pediatric cancer.

A study of random digit dialing as a method of control selection was conducted as part of a matched case-control study of risk factors for neuroblastoma. The study was conducted in 1981-1982 in the Greater Delaware Valley region. Participation involved parents submitting to a 2-4-hour telephone interview. Potential control telephone numbers were selected by substituting the last two digits of the case family's telephone number with randomly selected digits. Successive random telephone numbers were called until a family with a child matching the case by year of birth plus or minus three years and race who agreed to participate was identified. A total of 3,245 telephone numbers were dialed to select controls for 101 cases, an average of 32.1 telephone numbers per case. Among 1,908 residential households contacted, 25.5% refused to give information about household characteristics. Of households with known characteristics, 45% had children under 25 years of age and 14.9% had a child eligible for the study. Among 181 households invited to participate, 101 agreed. For 18.6% of all calls, residential respondents were randomly offered $10 as an inducement to participate. This inducement did not significantly influence participation rates among families invited to participate.

Adult

Influence of place of treatment on diagnosis, treatment, and survival in three pediatric solid tumors.

This study examines differences between cancer centers (CC) and noncancer centers (NCC) in terms of management procedures and outcomes for three pediatric solid tumors: Wilms' tumor (N = 147), rhabdomyosarcoma (N = 87), and medulloblastoma (N = 76). Data were derived for the period 1970-1979 from the population-based Greater Delaware Valley Pediatric Tumor Registry maintained at the Children's Cancer Research Center, which routinely collects data on all childhood neoplasms that occur in a 31-county region. Management measures reviewed included the degree to which important pretreatment evaluations were performed, types of therapy used, and extent of follow-up examinations conducted. Outcome variables were three-year disease-free survival and frequency of deaths related to complications of therapy. Differences in three-year disease-free survival between CC and NCC were noted for medulloblastoma (52% v 24%) and rhabdomyosarcoma (48% v 10%), but not for Wilms' tumor (79% v 68%). Among medulloblastoma patients, differences were detected in the frequency of pretreatment evaluations and in the therapy used. The principal management contrast found in rhabdomyosarcoma was that multiagent chemotherapy was used less often in NCC. Wilms' tumor patients were evaluated and treated similarly in the community versus the CC, except for some contrasts in the surgical approach and the frequency of follow-up for the detection of late complications.

Adolescent

"Masked" Ph1 chromosome abnormalities in CML: a report of two unique cases.

Two patients with chronic myeloid leukemia (CML) showed previously undescribed variants of a "masked" Ph1 abnormality. The first patient had the karyotype 46,XY, + 21, -9, -22, +mar9,mar18 at presentation in the chronic phase. The dicentric marker 9 was interpreted as representing the usual translocation of 22q11 to 9q34, followed by translocation of the Ph1 chromosome (the deleted 22) to 9p and probable translocation of 9p to the distal long arm of the marker. The patient developed clones containing 2 and 3 copies of the "Ph1-containing" marker 9 concomitant with the metamorphosis of his disease to a more aggressive phase. The second case presented with the karyotype 46,XY,-9,-22,+two D-group markers. A complex rearrangement of chromosomes 9 and 22 is postulated, with interstitial insertion of either 9p or distal 9q into chromosome 22q11. This patient is still in the chronic phase of his disease 9 mo after presentation. The common denominator in these unusual "masked" cases is the 22q11 breakpoint. The paucity of published reports of duplication of 9q + without concurrent duplication of the Ph1 chromosome, supported by the findings in our first case, leads us to conclude that the amplification of genes on the Ph1 chromosome are more important for the evolution of the abnormal stem cell in CML than the chromosome 9 derivative.

Adult

Patterns of care study: Hodgkin's disease relapse rates and adequacy of portals.

The Patterns of Care Study (PCS) has noted differences in stage adjusted relative relapse rates for Hodgkin's disease in four large facilities; the rates vary from 0% to 11% for infield or marginal recurrence (P = 0.003), and from 10% to 39% for any relapse (P = 0.0006) among these facilities. These differences in outcome were not attributable to variation in patient workup, treatment method, or radiation dose. A resurvey of 181 of these records of patients treated with radiation therapy for cure, in which portal films were available for review, indicates that treatment portal films did not encompass the disease adequately in 66 patients. When this occurred, there was a 50% overall relapse rate with 32% recurrence either infield or marginal. Chemotherapy tended to obscure the effect of inadequate technology, and when the 26 patients receiving chemotherapy as part of their initial treatment were excluded, inadequate margins were followed by even higher rates of relapse. For the subgroup of patients treated with radiation therapy alone, inadequate margins were associated with a 54% overall relapse rate, of which 33% were infield or marginal recurrence. When the portal films for patients treated with radiation therapy only were judged to be adequate, the total rate of any relapse was 14%, with 7% infield or marginal recurrence. PCS data indicate there is a critical need for accurate inclusion of Hodgkin's disease in the treatment portals; that marked facility differences exist in this technical process; and that skilled independent observers can reliably identify inaccurate technical performance.

Evaluation Studies as Topic

Comparison of postoperative radiotherapy and combined postoperative radiotherapy and chemotherapy in the multidisciplinary management of malignant gliomas. A joint Radiation Therapy Oncology Group and Eastern Cooperative Oncology Group study.

Recently, the RTOG and ECOG concluded a joint randomized study on malignant gliomas that was in progress for the past five years. A total of 626 patients entered this protocol. Sixty-seven percent of the 535 evaluable patients have died and thus this represents a preliminary report of a major joint clinical trial. The objective of this study was to evaluate the efficacy after neurosurgery of three new treatment options as compared with control treatment of radiotherapy alone. The four options were: (1) control radiation; 6000 rad/6-7 weeks to whole brain; (2) a higher radiation dose; Control dose plus a booster dose of 1000 rad/1-2 weeks to the tumor; (3) control radiation dose plus BCNU (80 mg/m2/day IV X 3 and repeat BCNU every 8 weeks); (4) Control radiation dose plus combination methyl-CCNU (125 mg/m2/day orally X 1 and repeat methyl-CCNU every 8 weeks), and DTIC (150 mg/m2/day IV X 5 and repeat DTIC every 4 weeks). All pertinent patient characteristics were studied and several important prognostic factors have been identified. Notably, age, histologic type (Astrocytoma with anaplastic foci, versus glioblastoma multiforme), initial performance status, time since first symptoms and presence or absence of seizure. At this time, it appeared that there was no treatment option which was significantly better than the control. The study identified that age was the most important prognostic factor. Patients who were younger than age 40 years had an 18-month survival of 64%, patients who were age 40-60 years had an 18-month survival of 20%, and patients who were older than age 60 had an 18-month survival of 8%. The study also demonstrated that a modified histologic classification of anaplastic astrocytoma versus glioblastoma provided better prognostic information than the astrocytoma grading system of Kernohan. Patients with anaplastic astrocytoma had a median survival of 27 months as compared to 8 months for patients with glioblastoma. In further evaluation of any beneficial effect of chemotherapy, it was identified that only among the 40-60-year-old groups, BCNU treated patients appeared to have significantly increased survival than patients in the control groups (P = 0.01, one-sided). Similarly, methyl-CCNU + DTIC was suggestively better than the control (P = 0.08, one-sided). The higher radiation dose, 7000 rad/8-9 weeks appeared to give no significantly better survival over the control dose option. Both BCNU and methyl-CCNU + DTIC produced some toxicity. The combination of methyl-CCNU + DTIC was more toxic than BCNU, producing severe or worse thrombocytopenia in 23% of the patients as compared to 6% on BCNU.

Adult

Delayed onset of overt porphyria cutanea tarda in a patient on long-term haemodialysis. A case report.

After 7 years on haemodialysis, a 37-year-old anephric man developed cutaneous lesions of the hands, arms and face, shown by skin biopsy to be compatible with porphyria cutanea tarda (PCT) (symptomatic porphyria). Elevated levels of plasma uroporphyrin and 7-COOH porphyrin were detected alongside a predominant isocoproporphyrin fraction in the faeces by means of quantitative thin-layer chromatography, confirming the diagnosis of overt PCT. The plasma uroporphyrin did not pass into the dialysate, even after chloroquine therapy. There was no evidence of hereditary PCT, chronic liver disease or iron overload, although the patient had a history of excessive alcohol consumption. The overt PCT developed after 8 months of home dialysis using softened water with high aluminium concentrations and subsided clinically and biochemically when the softened water was replaced by deionized water.

Adult

Patterns of care outcome studies. Results of the national practice in cancer of the cervix.

This report summarizes the national data collected by the Patterns of Care Study in the process and outcome of care in the treatment of carcinoma of the cervix. Substantial variation was found from a consensus of best current management, although training facilities tended to score higher than nontraining on a compliance measure. Four year national averages for control of cervical cancer are: Stage I, 87%, Stage II, 66%, Stage III, 28%. Factors relating to recurrences include failure to use intracavitary irradiation, the type of equipment, the central dose, and Karnofsky Score. The presence of complications is associated with daily dose, lateral dose and central dose, among other factors, and was shown to be unacceptably high in Stage I.

Adult

Patterns of care outcome studies. Results of the national practice in Hodgkin's disease.

The outcome of treatment for Hodgkin's disease has been determined for 407 patients treated in 1973. A two-level random sampling assures that these results are representative of the national practice. Actuarial analysis of recurrence-free survival at four years is: Stage IA, 80%; Stage IIA, 75%; Stage IIIA, 60%; combined Stages IB, IIB, and IIIB, 50%. Factors significantly associated with recurrence include stage, histology, age, chemotherapy, new patient load, part-time practice, treatment technique, treatment machine, treatment simulation, work up score, treatment score, and facility of treatment. Major treatment complications by stage ranged from 4-12%; complications are significantly associated with disease location, patient age, and the presence of coexisting disease.

Actuarial Analysis

Childhood craniopharyngioma: survival, local control, endocrine and neurologic function following radiotherapy.

Between 1961 and 1978, 19 patients with a diagnosis of childhood or teenage craniopharyngioma received supervoltage radiotherapy. All patients had previously undergone either partial surgical resection (10 patients), total gross resection (3 patients), or aspiration and biopsy (6 patients). Fourteen patients were treated primarily and five were treated for recurrence. The five-year survival was 73% with a 10-year survival of 64%. Sixteen percent developed a recurrence following radiotherapy. Long term effects were assessed in terms of neurologic, intellectual, psychological and endocrine function. Seventy-nine percent had none or minimal neurologic disability. The mean full scale IQ for the group was 90. There were no additional endocrine deficiencies that could be directly attributed to radiation. Behavioral disorders occurred in 50%. These results are at least comparable, if not superior, to those of surgery.

Adolescent

Radiation therapy technology manpower needs 1982.

A shortage of radiation therapy technologists has existed in the United States for many years. This report analyzes the data from the third manpower survey of ACR/ASTR carried out in 1981 to 1982, using the Patterns of Care master facility list. Of 1106 questionnaires mailed, 77% were returned. The survey identified 3757 technologists performing radiation therapy technology duties. Of these, 2537 of these were Registered Technologists (Therapy) American Registry of Radiologic Technologists RTT (ARRT), 1220 were not. There has been a good growth in the total number of RTT (ARRT) members as indicated by the 1982 ARRT Annual Report (1148 in May, 1977, 2878 in May, 1982). Using the "Blue Book" Criteria of 1981 of 2 RTT/megavoltage unit or 2 RTT/300 new patients, the technology need (2900) would appear filled. However, 860 of the RTT were performing supervisory or dosimetry duties and 42% of the 2897 staff technologists were non RTT personnel. At the time of the survey, 597 funded vacancies existed (241 in 1977). A trend toward a changing standard of 3 RTT/megavoltage unit, reflecting the increased complexity of modern radiation therapy techniques, especially in Patterns of Care Strata A1, A2, C1 institutions was identified. While great progress has been made, there is a continuing need for recruitment into the 113 existing educational programs to try to stabilize the supply of technologists. Attention should also be given to measures for upgrading the skills and knowledge of the non RTT personnel in the field and retention of the RTT personnel.

Health Facilities

Tumor regression and other prognosticators in advanced head and neck cancers: a sequel to the RTOG methotrexate study.

The randomized Radiation Therapy Oncology Group (RTOG) Methotrexate trial in advanced squamous cancers of the head and neck has reported no control or survival benefits when the chemotherapy adjuvant was administered to patients just prior to definitive irradiation. The required data collection and outcome reporting among 146 patients bearing oral cavity primaries and 354 patients with oropharyngeal cancers has allowed a multi-variate approach seeking answers to many unresolved questions. As anticipated, the ability to control these squamous cancers is largely a function of size (T & N stage) with a superior clearance among T3-4 primaries of the oropharynx (66%) contrasted to identically staged oral cavity tumors (48%). Adjusted median survival is more than doubled to 26.6 months or 19.8 months among oral cavity and oropharynx patients respectively, when compared to the 8 month median survival when neither primary nor cervical nodes are controlled. Lymph node deposits also impact upon survival, especially among oropharynx patients where the 17.6 month adjusted median survival among N0 patients declines to 11.0 months when the primaries are associated with N3 nodes. Surprisingly, the ability to control nodel deposits of all sizes (N1, N2, or N3) is superior among oropharynx patients when compared with identical oral cavity metastases (e.g. 71.4% adjusted clearance in N3 oropharyngeal deposits versus 46.1% in N3 nodes secondary to oral cavity primaries). Adjustments for maldistribution of advanced N-stages in association with T-4 primary stage eliminated an apparent T-stage effect upon nodal clearance within both anatomic regions. Finally, the association of T and N-stage upon distant metastases was investigated, with the surprising conclusion that neither initial T nor N-stage exerts any apparent influence on the observed 10-12% occurrence. The interrelationship of these various prognostic variables is explored using the Cox and logistic models.

Carcinoma, Squamous Cell

The dissemination of cancer by transurethral resection of locally advanced prostate cancer.

In 1973 a study was done on 443 patients treated with radiation therapy for cancer of the prostate. An actuarial analysis was done on survival comparing patients whose cancer was diagnosed by transurethral resection of the prostate to those diagnosed by needle biopsy. This analysis indicated a doubling of recurrence and of deaths of patients diagnosed by transurethral resection of the prostate. This effect of transurethral resection of the prostate was observed in patients with T3 and T4 cancer of intermediate, poor or unstated differentiation. It was not observed in those with well differentiated cancer. The effect was not caused by a difference in the extent of cancer or a distribution of histologic subtypes between the 2 diagnostic groups. Therefore, it appears that transurethral resection of the prostate causes dissemination on locally advanced prostatic cancer and clinical studies are suggested to avoid or minimize this effect.

Biopsy

Assessment of the quality of life in long-term survivors after definitive radiotherapy.

An interview questionnaire was developed to assess quality of life both in objective and subjective terms in cancer patients. Standardized measures were employed and allowed for comparison with a national baseline. Three hundred thirty-nine patients who were alive without evidence of disease 3 or more years following initial treatment were interviewed. There was no difference in terms of educational level, marital status, or satisfaction with local government, family, job, friends, community, health, recreation, or activities when compared to the age-adjusted national baseline. The patients were more satisfied with region, self, and life as a whole. There was no evidence of a diminished quality of life in these patients.

Adolescent