- Email: [email protected]
neu product in sera of ovarian cancer patients
108
SOCIETY
OF GYNECOLOGIC
The Madison system defines doses to the paracervical, myometrial, and upper vaginal tissues. This schedule gives five weekly treatments of 9.2 Gy/fraction to point M. Eight patients treated with 40 HDR-ICR insertions have been followed for 6-20 months from completion of therapy. Seven of eight patients had Stage I disease, one with Stage II. All patients had multiple significant medical problems. The average weight was 275 pounds. All patients were treated as outpatients with IV sedation. All patients are alive without evidence of disease. No adverse effects occurred during the procedures or periprocedural period. Acute and late effects include Grade 1 or 2 vaginal or rectal events in four patients. No Grade 3 or 4 acute or late toxicity has occurred. Presenting symptoms of bleeding have been controlled in all patients. Avoiding hospitalization, bed rest, and general anesthesia in this high-risk patient group by using HDR-ICR can decrease treatment morbidity while maintaining local disease control. 132. Short-Term, Treatment
for
Single-Agent Cisplatin Chemotherapy as First-Line Stage III Ovarian Carcinoma, E. SURWIT, J. CHILD-
ERS, K. HATCH, AND D. ALBERTS, University of Arizona, Tuscan, Arizona 85724.
Twenty-nine patients with stage III epithelial ovarian carcinoma received cisplatin, 80 mg/m* IV infusion, on Days 1 and 8 monthly for 3 months (i.e., six doses over 9 weeks). CA-125 tumor markers were positive in 24 patients prior to initiation of chemotherapy and normalized (i.e., less than 35 U/ml) in 22 patients (92%). Twenty patients have undergone restaging laparotomy following completion of cisplatin therapy. Seven patients had histopathologically proven complete responses (35%). The median follow-up and survival for all patients is 23 months. Grade 3 or 4 toxicity was observed as follows: (1) peripheral neuropathy in 2% of patients; (2) ototoxicity in 14% of patients; (3) nausea and vomiting in 10%; (4) nephrotoxicity in none; (5) anemia in none; (6) leukopenia in 10%; (7) granulocytopenia in 14%; (8) thrombocytopenia in none; and (9) alopecia in none. We conclude that dose-intensive cisplatin is safe and less toxic than the traditional combination of cyclosphosphamide and cisplatin. The overall response rate, negative second-look rate, and survival compare favorably with the traditional regimen of cisplatin and cyclophosphamide in ovarian cancer. 133. Phase II Trial of Menogaril (NSC 269148) in Chemotherapy-Naive Patients with Advanced Squamous Carcinoma of the Cervix. G. SUTTON, J. BLESSING, D. GALLUP, AND H. HOMESLEY, Indiana
University Medical Center, Indianapolis,
Indiana 46202.
A phase II trial of the semisynthetic anthracycline menogaril (methylnogarol, 7-OMEN) was conducted by the GOG in patients with recurrent or advanced squamous carcinoma of the cervix who had not received prior chemotherapy. A starting dose of 200 mg/m’ over 2 hr intravenously every 4 weeks was given. Patients who had prior radiotherapy were given 160 mg/m’. Twenty-three patients were entered and 22 are evaluable (one with inadequate data). Age range was 30-73 years (median 44.5 years), and GOG performance status was O-1 for 17 patients and 2 for the remaining 5. Twenty-one patients had prior radiotherapy. One patient developed GOG grade 4 granulocytopenia, and none developed more than grade 1 thrombocytopenia. There was one instance of grade 3 gastrointestinal toxicity and no cardiotoxicity. There were no responses to menogaril therapy. Ten patients (45.5%) had stable disease and the remainder progressed on therapy. This drug appears to be inactive in this group of patients in the dose studied. The lack of significant toxicity suggests that more intensive therapy may be considered. 134. Management
and Outcome Second-Look.
of Recurrent
Epithelial
Ovarian
Cancer
after Negative L. VACCARELLO,S. RUBIN, W. JONES, J. LEWIS, J. CUR~N, R. BARAKAT, T. HAKES, M. MARKMAN, B.
ONCOLOGISTS-ABSTRACTS REICHMAN, AND W. HOSKINS, Memorial Center, New York, New York 10021.
Sloan-Kettering
Cancer
Fifty-seven ovarian cancer patients with recurrence after complete response to platinum-based chemotherapy documented by negative second-look laparotomy were retrospectively analyzed. The diagnosis of recurrence was made on physical exam 45% of the time, with CA 125, imaging techniques, and signs and symptoms leading to diagnosis with decreasing frequencies. Recurrences occurred in the abdomen/pelvis (40 pts), lymph nodes (7) liver (4), lungs (3), and vagina (3) and were diagnosed a mean of 20 months after second-look surgery. Thirty-nine patients (68%) underwent laparotomy at the time of recurrence, with 37/39 (95%) having >0.5 cm disease found. Twelve of these 37 were resected to CO.5 cm, so that at the end of laparotomy 14/39 (36%) had minimal disease. There were no operative mortalities and there was one major surgical complication of small bowel obstruction. Intestinal resection or bypass was performed on lo/39 patients (26%) with one requiring a colostomy. Treatment after recurrence consisted mainly of platinum-based chemotherapy (88%), with a small number of patients receiving irradiation or hormonal therapy. With a mean follow-up of 20 months from recurrence for the entire group, 18/57 patients (32%) are alive. None survived when the recurrence was ouside of the pelvis or abdomen. All 18 nonexplored patients died with a mean survival time from recurrence of 8.8 months. Patients in whom residual disease was 60.5 cm at the completion of surgery had a significant survival advantage over those with larger volume disease (D/14, 79% vs 7/25, 28%, P = 0.0038). Recurrent ovarian cancer after platinum-based therapy carries a grave prognosis, particularly when deemed inoperable or diagnosed outside of the abdominal/pelvic cavity. Operable patients, and especially those whose disease could be resected to ~0.5 cm, showed a significant survival advantage. 135. Expression
of Interleukin-1 Cervix. F.
Receptor
Antagonist
in the Normal
and
A. VALEA, L. VAN LE, S. HASKILL, J. A. ANNERS, AND W. C. FOWLER,University of North Carolina, Chapel Hill, North Carolina 27599. Carcinomatous
Interleukin-I (IL-l), an important regulator of inflammation, can also promote growth and cellular differentiation in certain cells. An IL-l receptor antagonist (IL-lra) that blocks IL-l-mediated activities has been identified. Although IL-lra activity has been studied in other tissues, its role in cervical cancer is not clear. To determine whether IL-lra may play a role in the pathogenesis of cervical cancer, 22 cervical specimens (18 cancers and 4 normals) were stained for IL-lra using an avidin-biotin immunohistochemical technique. An alkaline phosphatase anti-alkaline phosphatase (APAAP) technique against cytokeratin was used to identify the cancer cells. RNA was extracted from 4 normal and 8 cancer samples and amplified using polymerase chain reaction (PCR) with specific primers for IL-lra to detect IL-lra transcripts. Although IL-lra mRNA was uniformly present in both normals and cancers, IL-lra protein expression was not consistently found in all the cancers. The explanation for this is not readily apparent but may indicate that regulation of IL-lra synthesis occurs at the level of translation in cervicai cancer. We conclude that IL-lra protein and mRNA are found in the normal cervix and that the regulation and function in cervical carcinoma may be complex. 136. HER-2/neu
Product in Sera of Ovarian Cancer Patients. S. WAGH. FUCHS,A. SCHARL, AND J. A. HOLT, The University of Chicago Lying-in Hospital, 5841 Maryland Avenue, Chicago, IIlinois 60637. GONER,
The overexpression of the protein product from the c-erbB-2 (HERZ/neu) oncogene, which occurs in approximately 30% of the epithelial ovarian cancers (OvCA) seen clinically, is a robust independent risk factor for poor prognosis. Serum levels of a shed fragment of the c-
SOCIETY
OF GYNECOLOGIC
erbB-2 protein can be measured by an enzyme immunoassay that makes use of monoclonal antibodies directed against two epitopes on its extracellular domain. Elevated serum levels of c-erbB-2 protein have been found in some patients with breast cancer. With this precedent and the high incidence of c-erbB-2 protein overexpression in OvCA as partial rational, we tested the hypothesis that measuring serum levels of cerbB-2 protein might identify a high-risk subset of OvCA patients. To this end, we studied 66 serum samples from 44 OvCA patients, aged 24-81 years (stage I, II, III, and IV; n = 5,5,20, and 14, respectively). Sera from 17 patients before primary surgery (mean CA-125 = 3281 U/ml), had a mean c-erbB-2 protein level of 10 U/ml. Forty-nine samples obtained from patients with clinically persistent or recurrent disease (n = 42, mean CA-125 = 769 U/ml) or collected just prior to positive second look laparotomy (n = 7, mean CA-125 = <5 U/ml) had a mean c-erbB-2 protein level of 15 U/ml. When using the threshold (>30 U/ml) provided by the manufacturer of the assay, we found that only 2 of 44 patients (4.5%) had an elevated level of c-erbB-2 protein (95% confidence limit, up to 13%). There was no discernable correlation between the level of c-erbB-2 protein and the tumor stage or CA-125 concentration. One patient, with bulky disease and a normal c-erbB-2 protein level, had an elevated level after tumor resection, suggesting poor assay specificity. Our data document that c-erbB-2 product can be detected in sera of selected OvCA patients, but that elevated levels are infrequent and therefore offer only rare potential clinical use to identify or monitor high-risk groups. Sexual Issues Confronting Gestational Patients. L. WENZEL, R. BERKOWITZ, S. ROBINSON,D. GOLDSTEIN,AND M. BERNSTEIN,Memorial Cancer Institute, Long Beach, California 90801; Harvard Medical School, Boston, Massachusetts 02115; and Arizona State University, Tempe, Arizona 85287.
137. Psychological, Trophoblastic
Social, Disease
and (GTD)
We evaluated the presence, type, and magnitude of psychological, social, and sexual stressors following the diagnosis and treatment of GTD. Seventy-six women diagnosed with GTD from 1985 to 1989 completed questionnaires evaluating their status on mood disturbance, marital satisfaction, sexual functioning, psychosocial response to illness, and report of the most stressful event occurring within the past year. Multivariate analyses of variance were conducted on dependent measures to examine differences between diagnostic groups (partial mole, complete mole, persistent disease), time from diagnosis (cl year, l-2 years, or 3-5 years from diagnosis), and follow-up status (active disease or remission). MANOVA’s revealed no significant differences on the dependent measures based on time from diagnosis, type of medical treatment received, or the type of molar disease. However, significant differences were observed between patients with metastatic vs nonmetastatic disease (Ffll, 56) = 2.25, P < 0.03). Follow-up ANOVA’s indicated that the metastatic disease group displayed significantly greater mood disturbance (F(1, 66) = 17.63, P < O.OOOl), reported suffering clinically significant levels of distress, and significantly greater levels of distress in response to the illness (F(33, 39) = 2.32, P < 0.006). Women with active disease also reported significantly greater levels of distress in response to the illness as compared to those in remission (F(33, 39) = 2.76, P < 0.001). Descriptive analyses suggest that across disease types, a substantial proportion of GTD patients experience clinically significant levels of anxiety, anger, fatigue, and confusion, with sexual problems identified among all disease groups, More than 20% in each disease group did indicate that the problem was attributable to GTD. Across disease groups, women appeared to be significantly impacted by pregnancy concerns for protracted periods of time as a result of GTD. Although few differences exist between disease diagnostic groups, study results suggest that patients with active or metastatic disease do experience significant levels of distress, while
109
ONCOLOGISTS-ABSTRACTS others continue remission. 138. Connectivity University
to adjust to certain disease stressors even after
between Hospital
the Gynecologic IBM Mainframe
Oncology Database and the Computer. L. WILLIAMS,
I. BENJAMLN, K. SMITH, AND H. JONESIII, Vanderbilt University Medical Center, Nashville, Tennessee 37232; and University of Pennsylvania Medical Center, Philadelphia, Pennsylvania 19104. Since August 1990, the Gynecologic Oncology Division, under the auspices of the Society of Gynecologic Oncologists, has been one of 16 institutions to serve as a /3 test site for the Gynecologic Oncology Database (GODB), a customized software package designed to track the activity of a busy Gynecologic Oncology Service. Soon after the system was implemented, it became apparent that its use as a clinical research tool would be greatly enhanced if data stored on gynecologic oncology patients on the University Hospital IBM Mainframe computer could be imported directly into the database. Since 1980, the tumor registrar has entered 65 separate coded fields of information on each patient with a diagnosis of malignancy into Mainframe DB2 software. Of these 65 fields, we identified 21 corresponding fields in the GODB. A total of 1895 different patients with gynecologic malignancies were identified in the mainframe database. Twenty-one coded fields of information on each patient were downloaded to a floppy diskette in space-delimited ASCII format. The space-delimited ASCII file was converted to a comma-delimited ASCII file by a program written in Basic language. This space-delimited file was imported into commercially available personal computer softward, where Mainframe alphanumeric codes were replaced with appropriate GODB terminology. The 189.5 patients, each with 21 fields of information, were imported directly into the GODB. From August 15, 1990 to May 15, 1991, 2635 records of patient demographics, tumors, and therapies were entered prospectively into the GODB on 316 different patients treated on the Gynecologic Oncology Service. Following the import on May 15, the database contained 9388 records on 2101 different patients. The ability to download data stored on the IBM Mainframe computer markedly enhances the clinical research capabilities of the GODB. 139.
Human tected
Papillomavirus in Adenocarcinomas Using the Polymerase Chain
of the Endocervix DeReaction. T. WRIGHT,
M. MITCHELL, AND R. RICHART, Columbia University, New York, New York 10027; and M. D. Anderson Cancer Center, Houston, Texas 77030. Although it is now well recognized that invasive carcinomas of the cervix are associated with specific types of human papillomaviruses (HPV), the clinical implications of these associations are not yet known. Recently, it has been suggested that there is a preferential association between specific types of HPV and specific types of cervical carcinoma. For example, HPV 18 has been preferentially associated with adenocarcinomas of the endocervix and with more aggressive tumors that occur in younger women. In order to better assessassociations between specific types of HPV and clinical outcome, we have analyzed a series of 165 paraffin-embedded endocervical adenocarcinomas for the presence of HPV DNA using the polymerase chain reaction (PCR). For this study two different sets of type-specific primers for detecting HPV 16 or 18 DNA were used. One set amplifies a portion of the E6 region of HPV 16/18 and the other set amplifies a portion of the late region of HPV 16/18. Out of 165 cases analyzed for HPV 16/18 DNA, 114 (69%) contained either HPV 16 or HPV 18 DNA. HPV 18 was more frequently detected in adenocarcinomas of the endocervix since 42% of the cases contained HPV 18 DNA whereas 27% contained HPV 16 DNA. Associations between HPV status and various clinicopathological features and clinical outcome for a subset of these cases are being assessed.
SOCIETY
OF GYNECOLOGIC
The Madison system defines doses to the paracervical, myometrial, and upper vaginal tissues. This schedule gives five weekly treatments of 9.2 Gy/fraction to point M. Eight patients treated with 40 HDR-ICR insertions have been followed for 6-20 months from completion of therapy. Seven of eight patients had Stage I disease, one with Stage II. All patients had multiple significant medical problems. The average weight was 275 pounds. All patients were treated as outpatients with IV sedation. All patients are alive without evidence of disease. No adverse effects occurred during the procedures or periprocedural period. Acute and late effects include Grade 1 or 2 vaginal or rectal events in four patients. No Grade 3 or 4 acute or late toxicity has occurred. Presenting symptoms of bleeding have been controlled in all patients. Avoiding hospitalization, bed rest, and general anesthesia in this high-risk patient group by using HDR-ICR can decrease treatment morbidity while maintaining local disease control. 132. Short-Term, Treatment
for
Single-Agent Cisplatin Chemotherapy as First-Line Stage III Ovarian Carcinoma, E. SURWIT, J. CHILD-
ERS, K. HATCH, AND D. ALBERTS, University of Arizona, Tuscan, Arizona 85724.
Twenty-nine patients with stage III epithelial ovarian carcinoma received cisplatin, 80 mg/m* IV infusion, on Days 1 and 8 monthly for 3 months (i.e., six doses over 9 weeks). CA-125 tumor markers were positive in 24 patients prior to initiation of chemotherapy and normalized (i.e., less than 35 U/ml) in 22 patients (92%). Twenty patients have undergone restaging laparotomy following completion of cisplatin therapy. Seven patients had histopathologically proven complete responses (35%). The median follow-up and survival for all patients is 23 months. Grade 3 or 4 toxicity was observed as follows: (1) peripheral neuropathy in 2% of patients; (2) ototoxicity in 14% of patients; (3) nausea and vomiting in 10%; (4) nephrotoxicity in none; (5) anemia in none; (6) leukopenia in 10%; (7) granulocytopenia in 14%; (8) thrombocytopenia in none; and (9) alopecia in none. We conclude that dose-intensive cisplatin is safe and less toxic than the traditional combination of cyclosphosphamide and cisplatin. The overall response rate, negative second-look rate, and survival compare favorably with the traditional regimen of cisplatin and cyclophosphamide in ovarian cancer. 133. Phase II Trial of Menogaril (NSC 269148) in Chemotherapy-Naive Patients with Advanced Squamous Carcinoma of the Cervix. G. SUTTON, J. BLESSING, D. GALLUP, AND H. HOMESLEY, Indiana
University Medical Center, Indianapolis,
Indiana 46202.
A phase II trial of the semisynthetic anthracycline menogaril (methylnogarol, 7-OMEN) was conducted by the GOG in patients with recurrent or advanced squamous carcinoma of the cervix who had not received prior chemotherapy. A starting dose of 200 mg/m’ over 2 hr intravenously every 4 weeks was given. Patients who had prior radiotherapy were given 160 mg/m’. Twenty-three patients were entered and 22 are evaluable (one with inadequate data). Age range was 30-73 years (median 44.5 years), and GOG performance status was O-1 for 17 patients and 2 for the remaining 5. Twenty-one patients had prior radiotherapy. One patient developed GOG grade 4 granulocytopenia, and none developed more than grade 1 thrombocytopenia. There was one instance of grade 3 gastrointestinal toxicity and no cardiotoxicity. There were no responses to menogaril therapy. Ten patients (45.5%) had stable disease and the remainder progressed on therapy. This drug appears to be inactive in this group of patients in the dose studied. The lack of significant toxicity suggests that more intensive therapy may be considered. 134. Management
and Outcome Second-Look.
of Recurrent
Epithelial
Ovarian
Cancer
after Negative L. VACCARELLO,S. RUBIN, W. JONES, J. LEWIS, J. CUR~N, R. BARAKAT, T. HAKES, M. MARKMAN, B.
ONCOLOGISTS-ABSTRACTS REICHMAN, AND W. HOSKINS, Memorial Center, New York, New York 10021.
Sloan-Kettering
Cancer
Fifty-seven ovarian cancer patients with recurrence after complete response to platinum-based chemotherapy documented by negative second-look laparotomy were retrospectively analyzed. The diagnosis of recurrence was made on physical exam 45% of the time, with CA 125, imaging techniques, and signs and symptoms leading to diagnosis with decreasing frequencies. Recurrences occurred in the abdomen/pelvis (40 pts), lymph nodes (7) liver (4), lungs (3), and vagina (3) and were diagnosed a mean of 20 months after second-look surgery. Thirty-nine patients (68%) underwent laparotomy at the time of recurrence, with 37/39 (95%) having >0.5 cm disease found. Twelve of these 37 were resected to CO.5 cm, so that at the end of laparotomy 14/39 (36%) had minimal disease. There were no operative mortalities and there was one major surgical complication of small bowel obstruction. Intestinal resection or bypass was performed on lo/39 patients (26%) with one requiring a colostomy. Treatment after recurrence consisted mainly of platinum-based chemotherapy (88%), with a small number of patients receiving irradiation or hormonal therapy. With a mean follow-up of 20 months from recurrence for the entire group, 18/57 patients (32%) are alive. None survived when the recurrence was ouside of the pelvis or abdomen. All 18 nonexplored patients died with a mean survival time from recurrence of 8.8 months. Patients in whom residual disease was 60.5 cm at the completion of surgery had a significant survival advantage over those with larger volume disease (D/14, 79% vs 7/25, 28%, P = 0.0038). Recurrent ovarian cancer after platinum-based therapy carries a grave prognosis, particularly when deemed inoperable or diagnosed outside of the abdominal/pelvic cavity. Operable patients, and especially those whose disease could be resected to ~0.5 cm, showed a significant survival advantage. 135. Expression
of Interleukin-1 Cervix. F.
Receptor
Antagonist
in the Normal
and
A. VALEA, L. VAN LE, S. HASKILL, J. A. ANNERS, AND W. C. FOWLER,University of North Carolina, Chapel Hill, North Carolina 27599. Carcinomatous
Interleukin-I (IL-l), an important regulator of inflammation, can also promote growth and cellular differentiation in certain cells. An IL-l receptor antagonist (IL-lra) that blocks IL-l-mediated activities has been identified. Although IL-lra activity has been studied in other tissues, its role in cervical cancer is not clear. To determine whether IL-lra may play a role in the pathogenesis of cervical cancer, 22 cervical specimens (18 cancers and 4 normals) were stained for IL-lra using an avidin-biotin immunohistochemical technique. An alkaline phosphatase anti-alkaline phosphatase (APAAP) technique against cytokeratin was used to identify the cancer cells. RNA was extracted from 4 normal and 8 cancer samples and amplified using polymerase chain reaction (PCR) with specific primers for IL-lra to detect IL-lra transcripts. Although IL-lra mRNA was uniformly present in both normals and cancers, IL-lra protein expression was not consistently found in all the cancers. The explanation for this is not readily apparent but may indicate that regulation of IL-lra synthesis occurs at the level of translation in cervicai cancer. We conclude that IL-lra protein and mRNA are found in the normal cervix and that the regulation and function in cervical carcinoma may be complex. 136. HER-2/neu
Product in Sera of Ovarian Cancer Patients. S. WAGH. FUCHS,A. SCHARL, AND J. A. HOLT, The University of Chicago Lying-in Hospital, 5841 Maryland Avenue, Chicago, IIlinois 60637. GONER,
The overexpression of the protein product from the c-erbB-2 (HERZ/neu) oncogene, which occurs in approximately 30% of the epithelial ovarian cancers (OvCA) seen clinically, is a robust independent risk factor for poor prognosis. Serum levels of a shed fragment of the c-
SOCIETY
OF GYNECOLOGIC
erbB-2 protein can be measured by an enzyme immunoassay that makes use of monoclonal antibodies directed against two epitopes on its extracellular domain. Elevated serum levels of c-erbB-2 protein have been found in some patients with breast cancer. With this precedent and the high incidence of c-erbB-2 protein overexpression in OvCA as partial rational, we tested the hypothesis that measuring serum levels of cerbB-2 protein might identify a high-risk subset of OvCA patients. To this end, we studied 66 serum samples from 44 OvCA patients, aged 24-81 years (stage I, II, III, and IV; n = 5,5,20, and 14, respectively). Sera from 17 patients before primary surgery (mean CA-125 = 3281 U/ml), had a mean c-erbB-2 protein level of 10 U/ml. Forty-nine samples obtained from patients with clinically persistent or recurrent disease (n = 42, mean CA-125 = 769 U/ml) or collected just prior to positive second look laparotomy (n = 7, mean CA-125 = <5 U/ml) had a mean c-erbB-2 protein level of 15 U/ml. When using the threshold (>30 U/ml) provided by the manufacturer of the assay, we found that only 2 of 44 patients (4.5%) had an elevated level of c-erbB-2 protein (95% confidence limit, up to 13%). There was no discernable correlation between the level of c-erbB-2 protein and the tumor stage or CA-125 concentration. One patient, with bulky disease and a normal c-erbB-2 protein level, had an elevated level after tumor resection, suggesting poor assay specificity. Our data document that c-erbB-2 product can be detected in sera of selected OvCA patients, but that elevated levels are infrequent and therefore offer only rare potential clinical use to identify or monitor high-risk groups. Sexual Issues Confronting Gestational Patients. L. WENZEL, R. BERKOWITZ, S. ROBINSON,D. GOLDSTEIN,AND M. BERNSTEIN,Memorial Cancer Institute, Long Beach, California 90801; Harvard Medical School, Boston, Massachusetts 02115; and Arizona State University, Tempe, Arizona 85287.
137. Psychological, Trophoblastic
Social, Disease
and (GTD)
We evaluated the presence, type, and magnitude of psychological, social, and sexual stressors following the diagnosis and treatment of GTD. Seventy-six women diagnosed with GTD from 1985 to 1989 completed questionnaires evaluating their status on mood disturbance, marital satisfaction, sexual functioning, psychosocial response to illness, and report of the most stressful event occurring within the past year. Multivariate analyses of variance were conducted on dependent measures to examine differences between diagnostic groups (partial mole, complete mole, persistent disease), time from diagnosis (cl year, l-2 years, or 3-5 years from diagnosis), and follow-up status (active disease or remission). MANOVA’s revealed no significant differences on the dependent measures based on time from diagnosis, type of medical treatment received, or the type of molar disease. However, significant differences were observed between patients with metastatic vs nonmetastatic disease (Ffll, 56) = 2.25, P < 0.03). Follow-up ANOVA’s indicated that the metastatic disease group displayed significantly greater mood disturbance (F(1, 66) = 17.63, P < O.OOOl), reported suffering clinically significant levels of distress, and significantly greater levels of distress in response to the illness (F(33, 39) = 2.32, P < 0.006). Women with active disease also reported significantly greater levels of distress in response to the illness as compared to those in remission (F(33, 39) = 2.76, P < 0.001). Descriptive analyses suggest that across disease types, a substantial proportion of GTD patients experience clinically significant levels of anxiety, anger, fatigue, and confusion, with sexual problems identified among all disease groups, More than 20% in each disease group did indicate that the problem was attributable to GTD. Across disease groups, women appeared to be significantly impacted by pregnancy concerns for protracted periods of time as a result of GTD. Although few differences exist between disease diagnostic groups, study results suggest that patients with active or metastatic disease do experience significant levels of distress, while
109
ONCOLOGISTS-ABSTRACTS others continue remission. 138. Connectivity University
to adjust to certain disease stressors even after
between Hospital
the Gynecologic IBM Mainframe
Oncology Database and the Computer. L. WILLIAMS,
I. BENJAMLN, K. SMITH, AND H. JONESIII, Vanderbilt University Medical Center, Nashville, Tennessee 37232; and University of Pennsylvania Medical Center, Philadelphia, Pennsylvania 19104. Since August 1990, the Gynecologic Oncology Division, under the auspices of the Society of Gynecologic Oncologists, has been one of 16 institutions to serve as a /3 test site for the Gynecologic Oncology Database (GODB), a customized software package designed to track the activity of a busy Gynecologic Oncology Service. Soon after the system was implemented, it became apparent that its use as a clinical research tool would be greatly enhanced if data stored on gynecologic oncology patients on the University Hospital IBM Mainframe computer could be imported directly into the database. Since 1980, the tumor registrar has entered 65 separate coded fields of information on each patient with a diagnosis of malignancy into Mainframe DB2 software. Of these 65 fields, we identified 21 corresponding fields in the GODB. A total of 1895 different patients with gynecologic malignancies were identified in the mainframe database. Twenty-one coded fields of information on each patient were downloaded to a floppy diskette in space-delimited ASCII format. The space-delimited ASCII file was converted to a comma-delimited ASCII file by a program written in Basic language. This space-delimited file was imported into commercially available personal computer softward, where Mainframe alphanumeric codes were replaced with appropriate GODB terminology. The 189.5 patients, each with 21 fields of information, were imported directly into the GODB. From August 15, 1990 to May 15, 1991, 2635 records of patient demographics, tumors, and therapies were entered prospectively into the GODB on 316 different patients treated on the Gynecologic Oncology Service. Following the import on May 15, the database contained 9388 records on 2101 different patients. The ability to download data stored on the IBM Mainframe computer markedly enhances the clinical research capabilities of the GODB. 139.
Human tected
Papillomavirus in Adenocarcinomas Using the Polymerase Chain
of the Endocervix DeReaction. T. WRIGHT,
M. MITCHELL, AND R. RICHART, Columbia University, New York, New York 10027; and M. D. Anderson Cancer Center, Houston, Texas 77030. Although it is now well recognized that invasive carcinomas of the cervix are associated with specific types of human papillomaviruses (HPV), the clinical implications of these associations are not yet known. Recently, it has been suggested that there is a preferential association between specific types of HPV and specific types of cervical carcinoma. For example, HPV 18 has been preferentially associated with adenocarcinomas of the endocervix and with more aggressive tumors that occur in younger women. In order to better assessassociations between specific types of HPV and clinical outcome, we have analyzed a series of 165 paraffin-embedded endocervical adenocarcinomas for the presence of HPV DNA using the polymerase chain reaction (PCR). For this study two different sets of type-specific primers for detecting HPV 16 or 18 DNA were used. One set amplifies a portion of the E6 region of HPV 16/18 and the other set amplifies a portion of the late region of HPV 16/18. Out of 165 cases analyzed for HPV 16/18 DNA, 114 (69%) contained either HPV 16 or HPV 18 DNA. HPV 18 was more frequently detected in adenocarcinomas of the endocervix since 42% of the cases contained HPV 18 DNA whereas 27% contained HPV 16 DNA. Associations between HPV status and various clinicopathological features and clinical outcome for a subset of these cases are being assessed.