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Biomedical subjects

L D Roman

Publications and source records attributed to L D Roman.

At least 19 recordsLinked to original sources
PubMed2005

The impact of anti HPV vaccination on cervical cancer incidence and HPV induced cervical lesions: consequences for clinical management.

Cervical cancer is the second most common cause of cancer-related deaths in women worldwide. Screening for cervical cancer is accomplished utilizing a Pap smear and pelvic exam. While this technology is widely available and has reduced cervical cancer incidence in industrialized nations, it is not readily available in third world countries in which cervical cancer incidence and mortality is high. Development of cervical cancer is associated with infection with high risk types of human papillomavirus (HPV) creating a unique opportunity to prevent or treat cervical cancer through anti-viral vaccination strategies. Several strategies have been examined in clinical trials for both the prevention of HPV infection and the treatment of pre-existing HPV-related disease. Clinical trials utilizing prophylactic vaccines containing virus-like particles (VLPs) indicate good vaccine efficacy and it is predicted that a prophylactic vaccine may be available within the next five years. But, preclinical research in this area continues in order to deal with issues such as cost of vaccination in underserved third world populations. A majority of clinical trials using therapeutic agents which aim to prevent the progression of pre-existing HPV associated lesions or cancers have shown limited efficacy in eradicating established tumors in humans possibly due to examining patients with more advanced-stage cancer who tend to have decreased immune function. Future trends in clinical trials with therapeutic agents will examine patients with early stage cancers or pre-invasive lesions in order to prevent invasive cervical cancer. Meanwhile, preclinical studies in this field continue and include the further exploration of peptide or protein vaccination, and the delivery of HPV antigens in DNA-based vaccines or in viral vectors. Given that cervical cancers are caused by the human papillomavirus, the prospect of therapeutic vaccination to treat existing lesions and prophylactic vaccination to prevent persistent infection with the virus are high and may be implemented in the near future. The consequences for clinical management may include a significant reduction in the frequency of Pap smear screening in the case of prophylactic vaccines, and the availability of less invasive and disfiguring treatment options for women with pre-existing HPV associated lesions in the case of therapeutic vaccines. Implementation of both prophylactic and therapeutic vaccine regimens could result in a significant reduction of health care costs and reduction of worldwide cervical cancer incidence.

Female↗
PubMed2004

[Comparative clinical evaluation of the effectiveness of modified radical mastectomy and organ-preserving therapy in localized breast cancer (pT1-2N0M0)].

The outcome of 320 patients with breast tumors was followed. Modified total mastectomy with subsequent irradiation, chemo- and/or hormone therapy was given to 164 patients. Limb-saving surgery was performed in 156. Incidence of locally advanced recurrences did not differ significantly in the two groups--3.7 and 5.5%, respectively. Nor did 5-year overall (90 +/- 1.4% and 88.4% +/- 1.6%, respectively) and relapse-free survival (88.4 +/- 1.2% and 83.5 +/- 1.4%, respectively) (p < 0.05). Hence, mastectomy is not worth more than sparing treatment.

Breast Neoplasms↗
PubMed2000

A phase II study of gemcitabine and cisplatin in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix.

OBJECTIVE: The aim of this study was to determine the response rate and toxicity of cis-platinum and gemcitabine in advanced, recurrent, or persistent squamous cell carcinoma of the cervix. METHODS: From July 1997 to January 1999, we conducted a Phase II trial in patients with advanced, persistent, or recurrent carcinoma of the cervix. The schedule employed 1250 mg/m(2) of gemcitabine on days 1 and 8 and 50 mg/m(2) of cis-platinum on day 1 in a 21-day cycle. Eligibility criteria were a GOG performance status of 0-2, adequate bone marrow reserve, serum creatinine less than 1.8 mg%, and a lesion which could be measured in two dimensions. None of the patients had received prior chemotherapy other than radiation sensitizers. Standard GOG toxicity and response criteria were used. RESULTS: Nineteen patients were enrolled into the trial. Two patients were inevaluable because of inadequate trial of drug. Seventeen patients were evaluable for response and toxicity. The median age of the patients was 47 years (range 24-72). The median number of cycles delivered was 5 (range 2-8). The incidence of grade 4 neutropenia and anemia was 2.4 and 1.2%, respectively. Two patients developed a single episode of grade 3 gastrointestinal toxicity. The overall response rate was 41% (7/17). There was 1 complete response of 14 months duration and 6 partial responses. Among those patients not previously irradiated, the response rate was 57% (4/7). Among the radiated patients, the response rate was 30% (3/10) with all responses occurring in the radiation field. CONCLUSION: This combination of cis-platinum and gemcitabine is a well-tolerated regimen which exhibits high activity in advanced, recurrent, or persistent squamous cell cervical cancer.

Adult↗
PubMed2000

The use of a pelvic displacement prosthesis to exclude the small intestine from the radiation field following radical hysterectomy.

OBJECTIVE: The goal of this study was to develop a device which will elevate the small intestine out of the pelvic cavity during radiation after radical surgery. METHODS: A prosthetic device of silicone plastic was designed which conforms to the pelvis. This device is filled with saline and renograffin for X-ray visualization. The capacity of the device is between 750 and 1500 cc. A small bowel contrast radiograph is performed prior to radiation to document exclusion from the radiation field. The device remains in place throughout radiation therapy and is then removed through a small incision after draining the contents of the prosthesis. RESULTS: Seven devices have been placed to date. The patients' age ranged from 35 to 65 years. All women had stage Ib1 carcinoma of the cervix and all underwent a type III radical hysterectomy with bilateral pelvic and common iliac lymphadenectomy. The indication for placement of the device was deep invasion of tumor in five patients, close margin in one patient, and positive pelvic lymph nodes in one patient. The amount of fluid instilled in the device ranged from 960 to 1200 cc. All patients had a return to normal bowel function within 3 days of surgery. All had radiologically documented exclusion of the small intestine from the radiation field prior to beginning radiation. In the postoperative period there was one major complication: a pulmonary embolism documented by pulmonary angiogram on postoperative day 2. All seven patients completed planned radiotherapy. The devices have been removed, with no adhesions to the prosthesis. CONCLUSIONS: The results of this study determine that the feasibility, safety, and efficacy of a prosthetic device in displacing the small bowel from the radiation field following radical surgery are sufficient to warrant a large-scale study. The device should be applicable to any and all tumors that require high dose pelvic radiation. It is expected that displacement of the small intestine from the radiation field will diminish overall complications and may allow delivery of radiation doses that approach colon and bladder tolerance.

Adult↗
PubMed2000

[Long-term outcome of surgical treatment of patients with esophageal cancer].

Under study were the results of surgical treatment of 185 patients with esophageal carcinoma. One-year survival was 75.4%, 2-year survival was 49.6%, 3-year--43.4%, and 4-year survival--33.3%. Among the patients with tumors with the invasion degree T1, T2, T3 and having no metastases to the regional lymph nodes the resection of the esophagus in combination with the extended lympho dissection resulted in 4-year survival in more than 50% of the patients operated upon. In patients with tumors T3N1, T4N1 and especially with the simultaneous involvement of several lymph collectors the 4-year survival was 21.4%. The operative intervention at this stage of the disease should be considered as a palliative means in the greater part of the patients.

Adenocarcinoma↗
PubMed1999

Cold-knife conization versus conization by the loop electrosurgical excision procedure: a randomized, prospective study.

OBJECTIVE: Our purpose was to compare the diagnostic ability and treatment efficacy of conization by the loop electrosurgical excision procedure with cold-knife conization. STUDY DESIGN: One hundred eighty women who required conization for diagnosis and treatment of cervical dysplasia or microinvasive cervical carcinoma were prospectively enrolled in a randomized clinical trial to receive either cold-knife conization or conization by the loop electrosurgical excision procedure. Conization complications, rate of lesion clearance, and therapeutic outcome were assessed for the 2 study groups. RESULTS: There were no statistically significant differences in the complication rate (P = 1.00), the rate of lesion clearance (P =.18), or the rate of disease recurrence (P =.13) between the 2 study groups. The mean follow-up was 11.2 months in the cold-knife conization group and 10.4 months in the loop-excision conization group. CONCLUSION: Cold-knife conization and loop-excision conization yield similar diagnostic and therapeutic results.

Adenocarcinoma↗
PubMed1999

[Lymph node dissection in esophageal cancer].

Results of surgical treatment of 70 patients with carcinoma of the thoracic part of the oesophagus were analyzed. The extended two-levels (intraabdominal and intrathoracic) lymphodissection is the necessary part of the operation. Postoperative lethality was 2.9%, one year and 2 years survival was 85.8 and 69% correspondingly. The data obtained show that it is expedient to introduce the extended two-levels lymphodissection into clinical practice.

Adenocarcinoma↗
PubMed1998

Detection of ovarian cancer cells: comparison of a telomerase assay and cytologic examination.

BACKGROUND: Telomerase is an enzyme essential for the normal replication of chromosomes. Telomerase activity is absent in most somatic cells in adults, but it is usually expressed in cancer cells, including ovarian carcinoma cells. Our principal goal was to compare the sensitivity of a telomerase assay, i.e., the telomeric repeat amplification protocol (TRAP) assay, with that of cytologic examination in detecting cancer cells in the peritoneal cavity of patients with ovarian carcinoma. METHODS: TRAP assays and cytologic examinations were performed on peritoneal washings and ascitic fluids from 42 patients with active ovarian carcinoma. Control specimens included washings from 29 patients with benign ovarian diseases and ascitic fluids from 14 patients with liver failure. We also evaluated the stability of telomerase in ascitic fluids left unprocessed at room temperature as well as the ability of the TRAP assay to detect cancer cells in mixtures containing large numbers of normal cells. RESULTS: Specimens from 37 (88%) of the 42 patients with ovarian carcinoma tested positive for telomerase. Cytologic examination detected cancer cells in only 27 of the telomerase-positive specimens (i.e., in specimens from 64% of the 42 patients). This difference of 24% (95% confidence interval = 17%-30%) in sensitivity between the two tests was statistically significant (two-sided P = .002). Specimens from five of the patients with ovarian carcinoma were cytologically negative and telomerase negative. All 43 control specimens were cytologically negative, but the TRAP assay detected telomerase in two of them. Telomerase activity was detected in unprocessed samples left at room temperature for 5 days and in mixtures containing a small number of cancer cells and a 2000- to 10000-fold excess of normal cells. CONCLUSIONS: Assaying for telomerase is more sensitive than cytologic examination in detecting cancer cells in the peritoneal cavity of patients with ovarian carcinoma.

Ascitic Fluid↗
PubMed1998

Influence of quantity of lymph-vascular space invasion on the risk of nodal metastases in women with early-stage squamous cancer of the cervix.

OBJECTIVE: To determine if the quantity of lymph-vascular space invasion influences the risk of pelvic nodal metastases in women with early-stage cervical squamous carcinoma. METHODS: Between 1991 and 1997, 105 women with stages IA2, Ib, and IIa squamous carcinoma of the cervix underwent radical hysterectomy and pelvic lymphadenectomy. The histopathology slides were prospectively reviewed. If lymph-vascular space invasion (LVSI) was present, the amount was quantified in four ways: percentage of cervical histopathologic sections containing LVSI, percentage of sections with tumor containing LVSI, total number of foci of LVSI, and maximal number of foci of LVSI in 10 high-powered fields. These measures of LVSI were correlated with the risk of nodal metastases. RESULTS: Seventy-three (70%) women had tumors with LVSI. Of these, 23 had pelvic nodal metastases. All women with nodal metastases had tumors with LVSI. Using logistic regession, independent predictors of nodal metastases were depth of cervical stromal invasion (P = 0.01) and tumor size (P = 0.04). LVSI was also a significant predictor of nodal metastases based on the Mantel-Haenszel test (P = 0.01). In women whose tumors contained LVSI, logistic regression identified tumor size (P = 0.004) and LVSI in > 45% of all cervical histopathologic sections (P = 0.002) as significant predictors of nodal metastases. CONCLUSION: The quantity of LVSI, as defined by the percentage of all cervical histopathologic sections containing LVSI, correlates significantly with the risk of nodal metastases in women with early-stage squamous carcinoma of the cervix.

Adult↗
PubMed1998

A phase II trial of CPT-11 in recurrent squamous carcinoma of the cervix: a gynecologic oncology group study.

OBJECTIVE: To determine the response rate and associated toxicity of weekly CPT-11 in squamous carcinoma of the cervix. METHODS: From October 1994 to May 1996, the Gynecologic Oncology Group (GOG) conducted a Phase II trial in patients with recurrent squamous cervix carcinoma. The schedule employed weekly x4 intravenous CPT-11 at 125 mg/m2 followed with a 2-week rest, to be repeated until disease progression or unacceptable toxicity. Eligibility criteria were a GOG performance status of 0-2, adequate bone marrow reserve, adequate liver function, and serum creatinine <2 mg%. None of the patients had received prior chemotherapy other than radiation sensitizers. Standard GOG toxicity and response criteria were used. RESULTS: Fifty-four patients were entered into the trial. Three patients were ineligible because of wrong cell type (N = 2) or inadequate pathology material (N = 1). Two were inevaluable because of inadequate trial of drug. An additional 4 patients were inevaluable for response. Thus, 49 were evaluable for toxicity and 45 were evaluable for response. The median age of patients was 45 years (range, 29-71 years). The median number of weekly doses delivered was 7 (range, 1-46). The incidence of grade 4 neutropenia and anemia was 6.1 and 4.1%, respectively. Nineteen patients (38.8%) developed gastrointestinal (GI) toxicity including 8 with grade 3 and 11 with grade 4 severity. The overall response rate was 13.3% (6/45). There was 1 patient death from GI toxicity. There was one complete response of 8.8 months duration and 5 partial responses. CONCLUSION: OFFis schedule of CPT-11 exhibits modest activity with moderate toxicity in patients with recurrent squamous carcinoma of the cervix.

Adult↗
PubMed1998

Carcinoembryonic antigen in women with isolated pelvic masses. Clinical utility?

OBJECTIVE: To determine the usefulness of serum carcinoembryonic antigen (CEA) determination in predicting the nature of an isolated pelvic mass. STUDY DESIGN: Two hundred twenty-six women with an isolated pelvic mass had a serum CEA determination preoperatively. The results were correlated with the histopathologic findings. RESULTS: CEA was elevated in 19 of the 226 women. Twelve of the 183 (7%) women with benign masses, 2 of the 17 (12%) women with tumors of low malignant potential and 5 of the 15 (33%) women with a frankly invasive epithelial ovarian cancer had elevated CEA. None of the women with a malignant germ cell or stromal tumor had elevated CEA (P = .06 for prediction of malignancy.) There were no cases of metastatic gastrointestinal malignancies in the study group. The sensitivity, specificity, positive predictive value and negative predictive value of serum CEA were 16%, 93%, 37% and 83%, respectively. The corresponding figures for serum CA-125 were 67%, 71%, 35% and 90%. There was no statistically significant correlation between elevated CEA and mucinous histology. CONCLUSION: Preoperative serum CEA determination in women with isolated pelvic masses is not useful.

Adolescent↗
PubMed1997

Carboplatin as a radiation sensitizer in locally advanced cervical cancer: a pilot study.

Radiation therapy is the mainstay in treatment of locally advanced cervical carcinoma. Several chemotherapeutic agents have been used as radiation sensitizers in the treatment of cervical cancer in an effort to improve local response and survival. A prospective study was designed to evaluate carboplatin as a radiosensitizer in advanced cervical cancer. Standard radiotherapy techniques were used to treat patients with Stage IIA-IIIB cervical cancer. Intravenous carboplatin was administered twice weekly concurrent with external beam radiation. Of 22 evaluable patients, there were 19 complete responders of whom 15 remain alive: 11 patients were alive and disease free at last visit for a median duration of 15 months follow-up (range, 4-43 months) and 4 patients remain alive with disease for a median duration of 17 months (range, 3-55 months). Seven have died, one of whom was without evidence of disease. There were no treatment-related deaths and no grade 4 toxicity. The most significant adverse effect was hematologic resulting in four patients with grade 3 neutropenia or anemia. There were no fistulae or late gastrointestinal or genitourinary complications. This pilot study suggests that carboplatin administered with standard radiation is safe, well-tolerated, and thus may be useful as a radiation sensitizer in the treatment of locally advanced cervical cancer.

Adult↗
PubMed1997

Pelvic examination, tumor marker level, and gray-scale and Doppler sonography in the prediction of pelvic cancer.

OBJECTIVE: To determine the ability of pelvic examination, tumor marker assessment, and transvaginal ultrasonography, with selected use of Doppler ultrasonography, to predict pelvic malignancy. METHODS: Two hundred twenty-six women scheduled for operative removal of a pelvic mass were entered in the study prospectively. Each woman underwent pelvic examination, tumor marker assessment, and transvaginal ultrasonography preoperatively. Women whose gray-scale findings were suspicious for malignancy underwent Doppler ultrasonography. Suspicious findings included masses that were fixed or irregular on pelvic examination; CA 125 level greater than 35 U/mL; elevations in serum lactic dehydrogenase, alpha-fetoprotein, or hCG; and the presence of a substantial solid component on gray-scale ultrasonography. Suspicious Doppler findings included intratumoral color flow, pulsatility index less than 1.0, or resistance index 0.4 or lower. The findings were correlated with the presence of malignancy. RESULTS: If all three indicators (examination, tumor marker assessment, and gray-scale ultrasound findings) were nonsuspicious, 99% of premenopausal women and 100% of postmenopausal women had benign masses. If all three indicators were suspicious, 77% of premenopausal women and 83% of postmenopausal women had malignant tumors. Logistic regression identified ultrasound impression and tumor size to be significant predictors of malignancy in premenopausal women, whereas CA 125 level and ultrasound impression were significant in postmenopausal women. In patients with suspicious gray-scale findings, recategorization based on Doppler findings resulted in inferior diagnostic indices. CONCLUSIONS: Ultrasonographic tumor size and appearance are the best predictors of pelvic malignancy in premenopausal women, whereas CA 125 level and ultrasonographic appearance are the best predictors in postmenopausal women. Neither color nor spectral Doppler is useful in this setting.

Biomarkers, Tumor↗
PubMed1997

Risk of residual invasive disease in women with microinvasive squamous cancer in a conization specimen.

OBJECTIVE: To quantify the risk of residual invasion when cervical conization reveals microinvasive squamous carcinoma and to determine whether any factors affect this risk. METHODS: We reviewed the charts and histopathology slides of 87 women who underwent a conization that contained microinvasive squamous carcinoma, followed by either a repeat conization or hysterectomy. Depth of invasion, number of invasive foci, and status of the internal margin and post-conization endocervical curettage (ECC) were assessed. The findings were correlated with the presence of residual invasion. RESULTS: Significant predictors of residual invasion included status of the internal margin (residual invasion present in 22% of women with an involved margin versus 3% with a negative margin; P < .03) and the combined status of the internal margin and post-conization ECC (residual invasion in 4% of patients if both negative, 13% if one positive, and 33% if both positive; P < .015). Depth of invasion and number of invasive foci in the conization specimen were not significant. The power of this study to detect a 25% difference in the risk of residual invasion was 73% for depth of invasion and 75% for number of invasive foci. CONCLUSION: Women with microinvasive squamous carcinoma in a conization specimen in which both the internal conization margin and post-conization ECC are negative have a low risk of residual invasion and are candidates for follow-up or simple hysterectomy. If either the internal margin or the post-conization ECC contains dysplasia or carcinoma, the risk of residual invasion is high and warrants repeat conization before definitive treatment planning.

Carcinoma, Squamous Cell↗