Population Data Centre Profiles: Centre for Data Linkage.

The Centre for Data Linkage (CDL) was established at Curtin University, Western Australia, to develop infrastructure to enable cross-jurisdictional record linkage in Australia. The CDL's operating model makes use of the 'separation principle', with content data typically provided to researchers directly by the data custodian; jurisdictional linkage where available are used within the linkage process. Along with conducting record linkage, the team has also invested in establishing a research programme in record linkage methodology and in developing modern record linkage software which can handle the size and complexity of today's workloads. The Centre has been instrumental in the development of practical methods for privacy-preserving record linkage, with this methodology now regularly used for real-world linkages. While the promise of a nation-wide linkage system in Australia has yet to be met, distributed models provide a potential solution.

Privacy preserving linkage using multiple match-keys.

INTRODUCTION: Available and practical methods for privacy preserving linkage have shortcomings: methods utilising anonymous linkage codes provide limited accuracy while methods based on Bloom filters have proven vulnerable to frequency-based attacks. OBJECTIVES: In this paper, we present and evaluate a novel protocol that aims to meld both the accuracy of the Bloom filter method with the privacy achievable through the anonymous linkage code methodology. METHODS: The protocol involves creating multiple match-keys for each record, with the composition of each match-key depending on attributes of the underlying datasets being compared. The protocol was evaluated through de-duplication of four administrative datasets and two synthetic datasets; the 'answers' outlining which records belonged to the same individual were known for each dataset. The results were compared against results achieved with un-encoded linkage and other privacy preserving techniques on the same datasets. RESULTS: The multiple match-key protocol presented here achieved high quality across all datasets, performing better than record-level Bloom filters and the SLK, but worse than field-level Bloom filters. CONCLUSION: The presented method provides high linkage quality while avoiding the frequency based attacks that have been demonstrated against the Bloom filter approach. The method appears promising for real world use.

Evaluation of approximate comparison methods on Bloom filters for probabilistic linkage.

INTRODUCTION: The need for increased privacy protection in data linkage has driven the development of privacy-preserving record linkage (PPRL) techniques. A popular technique using Bloom filters with cryptographic analyses, modifications, and hashing variations to optimise privacy has been the focus of much research in this area. With few applications of Bloom filters within a probabilistic framework, there is limited information on whether approximate matches between Bloom filtered fields can improve linkage quality. OBJECTIVES: In this study, we evaluate the effectiveness of three approximate comparison methods for Bloom filters within the context of the Fellegi-Sunter model of recording linkage: Sørensen-Dice coefficient, Jaccard similarity and Hamming distance. METHODS: Using synthetic datasets with introduced errors to simulate datasets with a range of data quality and a large real-world administrative health dataset, the research estimated partial weight curves for converting similarity scores (for each approximate comparison method) to partial weights at both field and dataset level. Deduplication linkages were run on each dataset using these partial weight curves. This was to compare the resulting quality of the approximate comparison techniques with linkages using simple cut-off similarity values and only exact matching. RESULTS: Linkages using approximate comparisons produced significantly better quality results than those using exact comparisons only. Field level partial weight curves for a specific dataset produced the best quality results. The Sørensen-Dice coefficient and Jaccard similarity produced the most consistent results across a spectrum of synthetic and real-world datasets. CONCLUSION: The use of Bloom filter similarity comparisons for probabilistic record linkage can produce linkage quality results which are comparable to Jaro-Winkler string similarities with unencrypted linkages. Probabilistic linkages using Bloom filters benefit significantly from the use of similarity comparisons, with partial weight curves producing the best results, even when not optimised for that particular dataset.

Two-year follow-up of patients with septic shock presenting with low HDL: the effect upon acute kidney injury, death and estimated glomerular filtration rate.

BACKGROUND: Sepsis is associated with decreased levels of high-density lipoprotein (HDL) cholesterol. HDL has anti-inflammatory properties, and the use of Apo A-I mimetic peptides is associated with renal function improvement in animal models of sepsis. However, it is not known whether decreased HDL level results in impaired renal function in human sepsis. We investigated whether low levels of HDL conferred an increased risk of sepsis-associated acute kidney injury (AKI) or long-term decreased estimated glomerular filtration rate (eGFR) after sepsis. METHODS: HDL concentration (mg dL-1 ) was measured in plasma samples from 180 patients with septic shock at admission to the Emergency Department (ED). We divided the patients using median HDL as a cut-off value and assessed the frequency of sepsis-associated AKI and long-term decreased eGFR after sepsis. Univariate and multivariate analyses were performed. RESULTS: Patients with low HDL had a significantly greater frequency of KDIGO 2 or 3 sepsis-associated AKI [39/90 (43.3%) vs. 12/90 (13.3%), P < 0.001] and decreased long-term eGFR [24/58 (41.4%) vs. 11/57 (19.3%), P = 0.018] compared to those with high HDL. The adjusted OR for sepsis-associated AKI and decreased eGFR after sepsis in the lower HDL group was 2.80 (95% CI 1.08-7.25, P = 0.033) and 5.45 (95% CI 1.57-18.93, P = 0.008), respectively. CONCLUSION: Low HDL levels during sepsis are associated with increased risk of sepsis-associated AKI, and/or subsequent decreased eGFR. These results suggest that HDL may be involved and/or may be a marker of kidney injury during and after sepsis.

mRNA induces RANTES production in trophoblast cells via TLR3 only when delivered intracellularly using lipid membrane encapsulation.

BACKGROUND: Trophoblasts express Toll-like receptor 3 (TLR3). The artificial TLR3 ligand, PolyI:C, induces an inflammatory response in trophoblasts but an endogenous ligand has not been identified. Notably, inflammatory disorders of pregnancy are associated with increased circulating placenta-derived mRNA. Endogenous degraded, uncapped mRNA is recognized by TLR3 in other cell lines. OBJECTIVE: We tested the hypothesis that plasma-derived mRNA induces an inflammatory response in a trophoblast cell line via TLR3. METHODS: Experiments were performed in the human first trimester extravillous trophoblast cell line HTR-8/SV neo. Plasma-derived mRNA was amplified using modified template switching and final in vitro transcription. We compared free mRNA (which favors cell surface interaction) to liposomally encapsulated mRNA (which favors intracellular mRNA delivery). We tested for the specific requirement of TLR3 signaling using siRNA. We tested for involvement of the canonical signaling pathway downstream of TLR3 by measuring NF-κB and IFN regulatory factor transcriptional activity using firefly-luciferase constructs. RESULTS: Free mRNA did not induce RANTES production. In contrast, liposomal mRNA resulted in marked induction of RANTES production (non-stimulated control 3.4 ± 0.6 pg/mL, liposomal mRNA 169.7 ± 26.2 pg/mL, p < 0.001), and this RANTES production was abolished by siRNA for TLR3. Downstream of TLR3, liposomal mRNA-induced dose-response NF-κB and IFN regulatory factor transcriptional activity, and IFN beta production. CONCLUSION: Plasma-derived 5' uncapped mRNA delivered intracellularly signals to induce NF-κB activation and increase RANTES production via TLR3.

Toll-like receptor-3 stimulation upregulates sFLT-1 production by trophoblast cells.

BACKGROUND: Preeclampsia is characterized by a systemic inflammatory response involving cytokines, chemokines, and anti-angiogenic factors such as sFLT-1. In many other inflammatory diseases related responses are triggered by toll-like receptor (TLR) stimulation. Therefore, we tested the hypothesis that TLR stimulation of a trophoblast cell line induces inflammatory mediator production and, in particular, production of the preeclampsia-related anti-angiogenic factor sFLT-1. METHODS: We stimulated human first trimester extravillous trophoblast cells (HTR-8/SV neo cell line) with a variety of TLR ligands and measured downstream NF-kappaB and IRF signaling, inflammatory mediator (RANTES), and sFLT-1 mRNA expression and protein production. RESULTS: Of all TLR ligands, we found that TLR3 ligation with polyI:C resulted in the biggest response with 5.6-fold increased signaling via NF-kappaB and 5.8-fold increased signaling via IRF. RANTES mRNA expression increased 2900 fold and protein production increased 1600 fold in response to TLR3 ligation. sFLT-1 mRNA expression increased 1.7-fold and protein production increased 3.1-fold in response to TLR3 ligation. Inhibitors of the NF-kappaB and IRF signaling pathway decreased TLR3 ligation-induced sFLT-1 protein production by 31.8% and 24.9%, respectively. CONCLUSION: We conclude that trophoblast cells respond to TLR3 ligation by signaling through both NF-kappaB and IRF pathways resulting in expression of inflammatory mediators and, in particular, the preeclampsia-related anti-angiogenic factor sFLT-1.

Adhesion-related readmissions following gynaecological laparoscopy or laparotomy in Scotland: an epidemiological study of 24 046 patients.

BACKGROUND: Gynaecological laparotomies are associated with considerable adhesion-related burdens; however, few data are available concerning laparoscopic surgery. This study evaluated the epidemiology of adhesion-related readmissions following open and laparoscopic procedures. METHODS: Records from 24,046 patients undergoing gynaecological surgery in Scottish National Health Service hospitals during 1996 were assessed retrospectively. Cohorts comprised 15,197 patients undergoing laparoscopic surgery and 8849 patients undergoing laparotomies. Adhesion-related readmission episodes (directly and possibly related) were assessed over 4 years following initial surgery and were expressed as percentages of the number of initial procedures. RESULTS: Directly adhesion-related readmissions 1 year after initial laparoscopic surgery were: in the high-risk group (adhesiolysis and cyst drainage) 1.3%; medium-risk (therapeutic and diagnostic procedures not categorized as high- or low-risk) 1.5%; and low-risk (Fallopian tube sterilizations) 0.2%. Readmissions for laparotomy following surgery on the Fallopian tubes were 0.9%, ovaries 2.1%, uterus 0.6% and vagina 0%. Readmissions occurred at reduced rates in the second, third and fourth years after surgery. Exclusion of patients who underwent surgery within the previous 5 years resulted in reduced readmission rates following laparotomy and high-risk laparoscopy. CONCLUSIONS: With the exception of laparoscopic sterilizations, open and laparoscopic gynaecological surgery are associated with comparable risks of adhesion-related readmissions.

Seasonal fluctuation in birthweight in schizophrenia.

The birthweights of 450 schizophrenic patients born in 1971-1978 were compared with those of individually matched controls from the same birth cohort. Schizophrenics born in the second quarter of the year (April to June) had a significantly lower birthweight than their controls and this was not attributable to differences in the duration of gestation. Analogous proband/control differences were not found in 301 patients with affective psychoses, but there was a similar, much smaller, seasonal fluctuation in birthweight in the general population. These findings may be a clue both to the genesis of the "season of birth effect" and to the identity of the intrauterine influences contributing to the aetiology of schizophrenia. Folate deficiency may be implicated.

Induction paclitaxel and carboplatin for patients with head and neck carcinoma. Analysis of 62 patients treated between 1994 an 1999.

BACKGROUND: After standard therapy for advanced head and neck carcinoma, 5-year survival rate is less than 50%. Our purpose was to develop a new treatment for advanced head and neck carcinoma by using preoperative chemotherapy. Long term efficacy and toxicity of induction paclitaxel and carboplatin is reported here. METHODS: Between 1994 and 1999, 62 consecutive patients with newly diagnosed head and neck carcinoma were treated with paclitaxel and carboplatin induction chemotherapy. Chemotherapy was administered every 21 days with 3 courses of paclitaxel (150-265 mg/m(2)) and carboplatin at a dose calculated using the Calvert formula area under the curve of 7.5. Patients who achieved complete or partial response at the primary received definitive radiation to the primary tumor and those with lymph node disease received neck dissection followed by radiation to the regional lymph nodes. Nonresponders received standard resection of primary tumor and draining lymph node basin followed by radiation. RESULTS: Sixty-two consecutive patients were treated. Seventy-four percent had Stage IV (according to the 5th edition of American Joint Committee on Cancer Staging manual) disease. The median duration of follow-up from initiation of chemotherapy was 64 weeks (range, 1-272 weeks). Overall complete plus partial response rate was 41 of 62 (66%). Responses were observed at all anatomic sites: oropharynx 20 of 33 (61%); hypopharynx 8 of 12 (67%); and larynx 13 of 17 (76%). Kaplan-Meier estimates of overall survival (OS), at 230 weeks, were significantly better in Stage IV oropharynx/hypopharynx responders than nonresponders (55% vs. 27%; P = 0.04). Of the variables evaluated in multivariate models, response at the primary tumor and lymph nodes were associated with improved disease free survival and OS. Organ preservation was achieved in 28 of 62 (45%) of patients at all anatomic sites: oropharynx 39%, hypopharynx 42%, larynx 59%. Seventeen of 28 (61%) patients had their primary organ site preserved for a mean duration of 78 weeks (range, 13-238 weeks). CONCLUSIONS: Induction paclitaxel and carboplatin was well tolerated. The response rate was encouraging considering most patients were Stage IV. Chemotherapy response identified a group with improved prognosis. Organ preservation was possible at all anatomic sites.

Surveillance for recurrent head and neck cancer using positron emission tomography.

PURPOSE: Earlier detection of head and neck cancer recurrence may improve survival. We evaluated the ability of [(18)F]fluorodeoxyglucose positron emission tomography (FDG-PET) to detect recurrence in a prospective trial using sequential PET scans. PATIENTS AND METHODS: Serial posttherapy FDG-PET was prospectively performed in 44 patients with stage III or IV head and neck cancer. PET was performed twice during the first posttreatment year (at 2 and 10 months after therapy) and thereafter as needed. After therapy, patients were grouped, based on tissue biopsies, into those who achieved a complete response (CR) and those who had residual disease (RD). Patients who achieved a CR were further grouped into those without evidence of disease and those who had recurrence by 1 year after completion of therapy. Disease status as determined by physical examination (PE), PET, and correlative imaging was compared. RESULTS: Eight patients were lost to follow-up and six had RD after therapy. Of the remaining 30 patients with a CR, 16 had recurrence in the first year after therapy. Five of these 16 patients had recurrence detected by PET only, four by PET and correlative imaging only, five by PE and PET only, and two by PE, correlative imaging, and PET. Only PET detected all recurrences in the first year. PET performed better than correlative imaging (P =.013) or PE (P =.002) in the detection of recurrence. CONCLUSION: PET can detect head and neck tumor recurrence when it may be undetectable by other clinical methods. FDG-PET permits highly accurate detection of head and neck cancer recurrence in the posttherapy period.

Erythropoietin reduces anemia and transfusions: A randomized trial with or without erythropoietin during chemotherapy.

BACKGROUND: Anemia has been reported to develop during preoperative chemotherapy with paclitaxel and carboplatin. The use of recombinant human erythropoietin (EPO) has been shown to reduce anemia and subsequent packed red blood cell transfusions. The current study is a report of a Phase III, prospective, randomized trial with or without EPO that confirms the original observations of less anemia and fewer transfusions in those patients randomized to receive EPO concurrently with paclitaxel and carboplatin. METHODS: Thirty patients with advanced head and neck or lung carcinoma were treated with 2 courses of paclitaxel, 230 mg/m(2), and carboplatin, 7.5 mg/mL/minute, repeated every 21 days. The treatment group was comprised of 15 patients randomized to receive concurrent EPO, 150 U/kg, 3 times per week; in patients deemed nonresponsive the dose was increased to 300 U/kg and 450 U/kg in subsequent courses. The control group was comprised of 15 patients randomized not to receive EPO. RESULTS: Twenty-seven patients were evaluable. After 2 courses of chemotherapy the mean hemoglobin decrease was 1.2 g/dL in the EPO group versus 2.8 g/dL in the control group (P = 0.037). There was a highly significant decrease in hemoglobin over time in patients who did not receive EPO (P = 0.008). After 4 courses of chemotherapy, fewer patients were transfused in the EPO arm: 2 of 13 (15%) in the EPO treatment group versus 5 of 14 (36%) in the control group. CONCLUSIONS: There was significantly less anemia and transfusions were reduced by 50% in patients randomized to receive EPO during chemotherapy with paclitaxel and carboplatin.

Primary and recurrent early stage laryngeal cancer: preliminary results of 2-[fluorine 18]fluoro-2-deoxy-D-glucose PET imaging.

PURPOSE: To evaluate the effectiveness of 2-[fluorine 18]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET) in the identification of early stage (T1-T2) primary and recurrent laryngeal cancer. MATERIALS AND METHODS: Twelve patients with T1 or T2 laryngeal cancer underwent imaging prospectively with PET. Seven patients had new disease, and five had recurrent disease. All patients underwent imaging prior to planned therapy and tissue biopsy. PET images were evaluated by using standardized uptake ratios and visual analysis. RESULTS: Histopathologic evidence of early stage cancer was documented in the 12 patients. One had a carcinoma in situ, nine had T1 tumors, and two had T2 tumors. Of the 12 patients, 10 had vocal cord tumors, one had a hypopharyngeal tumor, and one had a preepiglottic tumor. Eleven (92%) patients with early stage cancer had standardized uptake ratios indicative of malignancy (mean, 4.6; SD, 1.8; 95% CI, 1.2; range, 2.8-7.6). One had false-negative results (standardized uptake ratio = 2.3). Nine underwent CT, and results in the larynx were normal in seven and abnormal in two. CONCLUSION: FDG PET can be used to identify primary and recurrent early stage laryngeal cancer. It may be useful for follow-up after therapy.

Fine needle aspiration biopsy of well-differentiated liposarcoma of the neck in a young female. A case report.

BACKGROUND: Well-differentiated liposarcomas are low grade, nonmetastasizing, malignant neoplasms composed primarily of mature adipose tissue. They are uncommon in the head and neck. CASE: A 24-year-old female presented to the ears, nose and throat clinic for evaluation of a recent, rapidly growing neck mass on the right side. Fine needle aspiration (FNA) biopsy of the mass showed that the smears had fragments of connective tissue with a mixture of mature-appearing fat traversed by bands of fibrous collagen and vessels. Nuclei within the fat and fibrous bands were mildly irregular, hyperchromatic and enlarged, with one or two small nucleoli. Infrequently present but readily identified, lipoblasts were scattered throughout the aspirate smears. A diagnosis of "atypical lipomatous neoplasm" was rendered. Subsequently, the mass was surgically removed. On histologic examination, the tumor was a well-differentiated liposarcoma. CONCLUSION: FNA biopsy of well-differentiated liposarcomas in the head and neck can present difficulties in the classification and diagnosis of this neoplasm.

Correlation of fine needle aspiration biopsy and fluoride-18 fluorodeoxyglucose positron emission tomography in the assessment of locally recurrent and metastatic head and neck neoplasia.

OBJECTIVE: Patients with primary head and neck neoplasia can present during follow-up with suspected recurrence, and both fine needle aspiration biopsy (FNAB) and fluoride-18 fluorodeoxyglucose positron emission tomography (FDG-PET) scan are available methodologies for evaluating these patients. Our objective was to retrospectively correlate patients who underwent both FNAB and FDG-PET scan in order to assess the possibility of recurrent neoplasia. STUDY DESIGN: The cytopathology files at Saint Louis University Health Sciences Center were retrospectively searched for patients with known primary head and neck malignancies beginning in 1995. Suspected recurrence and local metastases evaluated by both FNAB and FDG-PET scan were correlated. RESULTS: Twenty-eight patients received a combined total of 37 FNABs with concurrent FDG-PET scans. The majority of patients had primary oropharyngeal squamous cell carcinoma with intermixed, single cases of other primary head and neck neoplasms. Thirty of the 32 aspirates with recurrent or locally metastatic disease had combined positive findings by both FNAB and FDG-PET scan, yielding a sensitivity of 94%. One nonspecific and one negative FDG-PET scan came from a patient who had disease confirmed by FNAB. Five patients had negative findings by both methods that were supported by the subsequent clinical course. CONCLUSION: FNAB can provide confirmatory evidence of disease in a clinically suspicious abnormality with nonspecific FDG-PET results. FNAB and FDG-PET are highly sensitive for tumors in cases of clinically suspected recurrence and locally metastatic disease.

Intraoperative transcranial Doppler ultrasound in head and neck surgery: a preliminary report.

PURPOSE: To evaluate the possible role of intraoperative cerebral emboli in the origin of perioperative stroke during major head and neck surgical procedures. MATERIALS AND METHODS: Eleven patients undergoing major head and neck surgery that involved direct manipulation of the carotid sheath were the participants in this study. Transcranial Doppler (TCD) ultrasound was used intraoperatively to detect possible cerebral emboli. The presence or absence of intraoperative cerebral emboli in each patient was assessed by the presence or absence of typical embolic signal patterns within the TCD waveform. RESULTS: No intraoperative cerebral emboli were noted in the series, nor did any patient have a postoperative stroke. CONCLUSIONS: No intraoperative cerebral emboli were noted by using TCD ultrasound for embolus monitoring in patients undergoing major head and neck surgery involving carotid sheath manipulation. This detection system is easily used in appropriate head and neck cases and allows real-time, noninvasive intraoperative monitoring.

Maxillary sinus atelectasis with enophthalmos.

Chronic maxillary sinusitis may present as atelectasis of the sinus with changes to surrounding structures. Several mechanisms have been proposed for this problem. Chronic obstruction of the sinus ostium, with resultant retention of secretions and osteitic bone resorption, may account for these changes. Enophthalmos is one manifestation that may require corrective treatment. Titanium micromesh reconstruction of the orbital floor, with or without onlay concha cartilage, has reliably resolved the enophthalmos. Reconstruction of the orbital floor and ventilation of the obstructed sinus ostium may be carried out relatively safely in a single operation. The standard endoscopic technique of uncinate removal and middle meatal antrostomy should be modified to prevent orbital penetration. This report reviews our series of 6 patients with this problem, as well as a comprehensive review of the literature. Recommendations for management of both the obstruction and the secondary orbital manifestations are presented.

Evaluation of chemotherapy response in patients with advanced head and neck cancer using [F-18]fluorodeoxyglucose positron emission tomography.

BACKGROUND: [F-18]Fluorodeoxyglucose (FDG)-positron emission tomography (PET) can measure the metabolic activity of tissues; FDG-PET may be able to predict response to chemotherapy by identifying changes in tumor metabolism. Measurement of response to treatment may help improve survival in the management of advanced head and neck cancer. We evaluated this particular use of FDG-PET in patients participating in a neoadjuvant organ-preservation protocol using taxol and carboplatin and compared pathologic response after chemotherapy with changes in tumor metabolism measured by FDG-PET. METHODS: Serial FDG-PET studies (n = 56) were performed in patients (n = 28) with stage III/IV head and neck cancer participating in a neoadjuvant organ-preservation protocol. The FDG-PET studies were performed before and after chemotherapy. All patients had tissue biopsies before and after chemotherapy. Patients were classified as pathologic complete response (PCR) or residual disease (RD) based on tissue biopsies. Visual analysis of PET scans was performed to identify patients with complete response by PET, and these findings were compared with pathology results. Metabolic changes were also evaluated using standardized uptake ratios (SUR) of FDG. RESULTS: The sensitivity and specificity of PET for residual cancer after therapy was 90% (19/21) and 83% (5/6), respectively. Two patients had initially negative biopsies and positive PET studies for persistent disease. Pathology review and rebiospy led to confirmation of the PET results in these cases, giving a sensitivity of 90% for initial tissue biopsy. CONCLUSIONS: In this preliminary analysis, FDG-PET was accurate in classifying response to chemotherapy in most patients. Fluorodeoxyglucose-PET may identify residual viable tumor when it is otherwise undetectable.

Expression of p53 protein in advanced head and neck squamous cell carcinoma before and after chemotherapy.

BACKGROUND: The expression of p53 protein has been reported to be in the range of 35% to 67% in head and neck squamous cell carcinoma (HNSCC). Mutations of the gene for p53 protein have been associated with rapidly proliferating tumors, and p53 protein expression has been shown to be a significant predictor of worse survival in surgically resected HNSCC. To determine whether p53 protein expression in advanced (stages III and IV) HNSCC has any impact on tumor response to 2 to 3 courses of paclitaxel (Taxol) and carboplatin, we prospectively studied prechemotherapy specimens from patients with previously untreated, advanced-stage HNSCC. We also attempted to study residual tumors after chemotherapy to determine if the p53 status of the tumor changed. DESIGN: The expression of p53 protein was evaluated by immunohistochemical analysis (clone BP53-12-1; Bio-Genex, San Ramon, Calif). SETTING: Tertiary university medical center. INTERVENTION: Two to 3 courses of chemotherapy with paclitaxel and carboplatin. MAIN OUTCOME MEASURES: Pathologic complete remission or residual tumor. RESULTS: The results of p53 immunostaining were positive in 24 (67%) of 36 HNSCC specimens before chemotherapy. After chemotherapy, 8 patients achieved pathologic complete remission. Before chemotherapy, the tumor was p53 negative in 2 patients and positive in 6 patients. CONCLUSIONS: No correlation of p53 protein expression with response to chemotherapy was noted. The expression of p53 protein converted from positive to negative in 5 (42%) of 12 specimens from patients with residual tumor after chemotherapy, with no impact on clinical outcome.