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T Thigpen

Publications and source records attributed to T Thigpen.

At least 19 recordsLinked to original sources
PubMed2001

Tamoxifen in the treatment of advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study.

PURPOSE: In two large Gynecologic Oncology Group studies of patients with advanced or recurrent endometrial carcinoma and no previous systemic therapy, progestins have demonstrated activity against advanced or recurrent endometrial carcinoma with response rates between 15% and 25%. Tamoxifen has been reported as variously active or inactive with or without previous systemic therapy. The purpose of this study was to determine whether tamoxifen exhibits enough activity in patients with advanced or recurrent endometrial carcinoma, who have not received systemic therapy, to warrant a phase III trial. PATIENTS AND METHODS: Sixty-eight eligible patients with advanced or recurrent endometrial carcinoma received oral tamoxifen 20 mg bid until toxicity was unacceptable or disease progressed. RESULTS: Three complete (4%) and four partial (6%) responses were observed for an overall response rate of 10% (90% confidence interval [CI], 5.7% to 17.9%). Patients with tumors that were more anaplastic tended to respond less frequently. The median progression-free survival for all 68 eligible patients was 1.9 months (90% CI, 1.7 to 3.2 months). The median survival was 8.8 months (90% CI, 7.0 to 10.1 months). CONCLUSION: Tamoxifen demonstrated modest activity at best against endometrial carcinoma and does not warrant further investigation as a single agent for this disease. Ongoing trials will assess the sequential use of tamoxifen and progestational agents.

Aged↗
PubMed2001

Initial clinical trial of substernal epicardial echocardiography: SEEing a new window to the postoperative heart.

BACKGROUND: Postoperative echocardiography windows are often of poor quality because of intervening air spaces around the heart and great vessels. We assessed the utility of a new commercially available adult chest drainage tube that has been modified with the addition of a sterile sleeve to accommodate the introduction of a nonsterile pediatric transesophageal echocardiography (TEE) probe. The TEE probe lies in a substernal epicardial position on the postoperative heart allowing one to perform substernal epicardial echocardiography (SEE). METHODS: Informed consent was obtained from 21 consecutive adult cardiac operation patients. At the completion of the operation the SEE drainage tube was inserted through the rectus muscle and into the pericardium. After chest closure, all patients underwent a full echo examination using an Acuson pediatric biplane probe in the SEE position. Views obtained and ease of insertion were judged on a 1 to 10 (worst to best) scale. RESULTS: Full SEE examinations were completed in an average of 12 minutes. Ease of probe entry and manipulation was excellent (ratings of 9.3 and 9.6, respectively). The quality of the anatomic images was also excellent. Substernal epicardial echocardiography tube positioning was integral to the orientation of the images obtained. There were no complications related to the placement of the SEE tubes or TEE probes. In 4 of 21 patients (19%) the SEE methodology was used serially in the intensive care unit to accurately assess ventricular function and filling during weaning of an intraaortic balloon and inotropic agents. CONCLUSIONS: Substernal epicardial echocardiography is a safe and highly effective methodology for the serial echocardiographic assessment of the postoperative heart.

Adult↗
PubMed1997

The role of paclitaxel in the management of patients with carcinoma of the cervix.

The major role for systemic therapy in the management of carcinoma of the cervix is to treat those patients with advanced or recurrent disease. While 19 single agents have activity, defined as a response rate > or = 15%, the agents that have attracted the greatest attention are the platinum compounds and ifosfamide. Combinations of these two drugs have produced high response rates in phase II trials. A recent randomized trial found that a combination of ifosfamide/cisplatin yielded a superior response rate to cisplatin alone (33% v 19%), although no differences in progression-free or overall survival were observed. While ongoing randomized trials continue to explore platinum/ifosfamide combinations, current attention also is directed to paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), which has demonstrated activity in a phase II trial (18% response rate). The Gynecologic Oncology Group plans to conduct a phase II trial of a platinum/paclitaxel combination and may follow it with a phase III trial of the same combination if the phase II results suggest enhanced therapeutic benefit. Randomized trials in patients with less advanced (stages IIB to IVA) disease have demonstrated superior response rates and overall survival with concomitant chemoradiation. Regimens of demonstrated efficacy in this setting include hydroxyurea plus radiation and cisplatin/5-fluorouracil plus radiation. The Gynecologic Oncology Group currently is conducting a phase I trial of concomitant paclitaxel plus radiation and may consider a paclitaxel-based regimen in future phase III trials of concomitant chemoradiation or possibly neoadjuvant chemotherapy in patients with limited disease (stages IIB to IVA).

Antineoplastic Agents↗
PubMed1996

Phase II trial of etoposide in leiomyosarcoma of the uterus: a Gynecologic Oncology Group study.

Twenty-eight patients with advanced, persistent or recurrent leiomyosarcoma of the uterus not previously exposed to cytotoxic drugs were entered into a study of single-agent intravenous etoposide 100 mg/m2 daily for 3 days every 3 weeks. No complete or partial responses were observed. Thirteen patients demonstrated stable disease, while 15 exhibited increasing disease. Median progression-free interval was 2.1 months, median survival 9.2+ months. The most frequent and severe adverse effects were the result of myelosuppression and manifested primarily as leukopenia and neutropenia. Based on the absence of activity, no further study of intravenous etoposide in leiomyosarcoma of the uterus at the dose and schedule tested is planned.

Adult↗
PubMed1996

The role of ifosfamide and systemic therapy in the management of carcinoma of the cervix.

Nineteen single agents have activity in patients with advanced or recurrent carcinoma of the cervix. The agents that have attracted the greatest attention, however, are the platinum compounds and ifosfamide. Although most phase II trials combining these agents demonstrate activity but not relative merit, a recent phase III randomized trial shows that ifosfamide/cisplatin yields a superior response rate than cisplatin alone (33% v 19%, respectively). An ongoing randomized study is evaluating cisplatin/ifosfamide with or without bleomycin on the basis of a number of phase II reports suggesting a high order of activity for the three-drug combination. Randomized trials in less advanced disease demonstrate superior response rate, progression-free interval, and overall survival for concomitant chemoradiation in patients with stage IIIB to IVA disease. Regimens with demonstrated efficacy in this setting include hydroxyurea plus radiation and cisplatin/5-fluorouracil plus radiation. Of two randomized trials of cisplatin/ifosfamide/bleomycin followed by radiation versus radiation alone, the one completed study shows no overall advantage for the combined approach but does suggest an improved 32-month survival in patients with stage IIIB disease. The other trial is ongoing, with an early observation of a superior response rate with the combined approach. Current recommendations are to use ifosfamide/cisplatin as the treatment of choice for advanced or recurrent disease and concomitant chemoradiation with either hydroxyurea or cisplatin/5-fluorouracil for stage IIIB to IVA disease.

Antibiotics, Antineoplastic↗
PubMed1995

Phase II trial of mitomycin-C in squamous cell carcinoma of the uterine cervix: a Gynecologic Oncology Group study.

Fifty-six patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix not previously exposed to cytotoxic drugs, other than as radiosensitizers, were entered into a study of single-agent 20 mg/m2 mitomycin-C every 6 weeks. The overall response rate among the 52 patients evaluable for response was 12% (three complete and three partial responses). Median response duration was 7.3 months. For the entire population, median progression-free interval was 3.0 months, and median survival was 4.9 months. Among 27 patients with pelvic disease only in previously radiated fields, two responses were observed (7%), whereas four responses were observed among 25 patients with extrapelvic disease in nonradiated fields (16%). The most frequent and severe adverse effects were the result of myelosuppression. Based on the modest level of activity observed, no further study of mitomycin-C in squamous cell carcinoma of the cervix is planned.

Adult↗
PubMed1995

The platinum compounds and paclitaxel in the management of carcinomas of the endometrium and uterine cervix.

Endometrial carcinoma and squamous cell carcinoma of the cervix are common invasive neoplasms of the female genital tract. Early diagnosis of a majority of patients has resulted in high cure rates for both diseases. In the last two decades, a growing number of active systemic drugs have been identified. Cisplatin has been extensively studied in both neoplasms and has clear activity (20% response rate in endometrial carcinoma and 23% response rate in squamous cell carcinoma of the cervix). Recently, paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been shown to be clearly active in both (35% response rate in endometrial carcinoma and 17% response rate in squamous cell carcinoma of the cervix). The apparent clinical non-cross-resistance between paclitaxel and cisplatin in other neoplasms like ovarian carcinoma makes combinations including these two agents of great interest. In endometrial carcinoma, a phase I trial of cisplatin plus doxorubicin plus escalating paclitaxel doses is being performed by the Gynecologic Oncology Group (GOG). Based on the outcome of this study, a future randomized trial will compare the current standard, doxorubicin plus cisplatin, with either a combination of cisplatin, doxorubicin, and paclitaxel or a two-drug regimen of paclitaxel plus cisplatin. In squamous cell carcinoma of the cervix, a logical approach to the incorporation of paclitaxel into front-line therapy for advanced or recurrent disease is a phase III trial of the best regimen from GOG protocol 110 (cisplatin with or without either ifosfamide or dibromodulcitol) versus the same drugs plus paclitaxel. In addition, the GOG is conducting a phase I trial of paclitaxel given concomitantly with radiation in the hope that the resulting regimen will be an arm of a future randomized study in patients with locoregionally advanced disease (stages IIB through IVA). The ultimate role of paclitaxel in the management of patients with these two neoplasms awaits the results of these efforts.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

The role of paclitaxel in the management of coelomic epithelial carcinoma of the ovary: a review with emphasis on the Gynecologic Oncology Group experience.

Coelomic epithelial carcinoma of the ovary, the most common cause of death from cancer of the female genital tract in the United States, presents most commonly as advanced (stage III or IV) disease. Management consists of aggressive surgical cytoreduction followed by combination chemotherapy, until recently, a platinum compound plus an alkylating agent. The recent identification of the activity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) offers the potential to improve further the management of patients with advanced disease. That this agent might enhance current front-line therapy is supported by its unique mechanism of action and by the significant numbers of responses reported in patients clinically resistant to the platinum compounds: more than 20% of these patients responded to paclitaxel as salvage therapy in four different phase II trials. These observations led to a phase I Gynecologic Oncology Group trial that showed that paclitaxel 135 mg/m2 over 24 hours followed by cisplatin 75 mg/m2 could be given every 3 weeks. This group then compared six cycles of the identified regimen with six cycles of standard cisplatin/cyclophosphamide chemotherapy given every 3 weeks in a phase III trial in 388 previously untreated patients with large-volume (residual nodules > 1 cm after surgery) disease. The results show the superiority of the paclitaxel/cisplatin regimen: overall response rate 77% versus 62%, clinical complete response 54% versus 33%, frequency of achieving a grossly disease-free state at second-look laparotomy 40% versus 22%, progression-free survival 18 versus 13 months, and overall survival 38 versus 24 months. Thus, paclitaxel/cisplatin is the new standard of care for patients with advanced ovarian carcinoma. Current phase III studies explore further the role of paclitaxel in front-line therapy: the relative merits of single-agent versus combination chemotherapy, the role of interval surgical cytoreduction combined with paclitaxel/cisplatin, the value of carboplatin-based versus cisplatin-based combinations with paclitaxel, the significance of the paclitaxel infusion length (3 v 24 v 96 hours), and the value of more dose-intense combinations.

Antineoplastic Agents, Phytogenic↗
PubMed1994

Chemotherapy in advanced ovarian carcinoma: current standards of care based on randomized trials.

The mainstay of the treatment of advanced (stage III or IV) ovarian carcinoma is systemic therapy. The following review bases conclusions regarding standards of care on large, randomized trials of chemotherapy in advanced ovarian carcinoma. As of 1976, "standard" chemotherapy was single alkylating agent usually with melphalan. Studies of combination chemotherapy failed to show superiority over single alkylating agent until the introduction of cisplatin. The Gynecologic Oncology Group conducted a series of two trials in patients with large-volume disease, the first randomizing patients to either single-agent melphalan or a combination of doxorubicin and cyclophosphamide and the second to doxorubicin plus cyclophosphamide with or without cisplatin. These studies demonstrated superiority for the cisplatin-based combination in terms of overall response rate, clinical complete response rate, progression-free survival, and overall survival. Subsequent randomized trials demonstrated several important facts. First, platinum-based combinations yielded results superior to single-agent cisplatin. Second, a two-drug combination of cisplatin plus cyclophosphamide provides benefit equivalent to the three-drug combination of the same two drugs plus doxorubicin. Third, substitution of carboplatin for cisplatin yields similar results. Finally, dose escalation of chemotherapy by a factor of 2 does not offer a therapeutic advantage. The next major advance after the introduction of the platinum compounds was the demonstration of the activity of taxol, a new agent with a unique mechanism of action and apparent clinical non-cross-resistance with the platinum compounds. A recently completed GOG trial of cisplatin plus cyclophosphamide versus cisplatin plus taxol in patients with large-volume disease shows that the taxol-based combination has a superior overall response rate, clinical complete response rate, rate of achieving a state of no gross residual disease at second-look laparotomy, and progression-free survival. Survival analysis awaits maturation of the data, but the control arm has already been shown to have a median survival of 23.2 months with the median not yet reached for the taxol-based arm. These data suggest that a combination of taxol plus cisplatin should be considered the standard of care for patients with advanced ovarian carcinoma. Ongoing trials seek to define further the role of taxol in frontline chemotherapy for ovarian carcinoma. In conclusion, the standard chemotherapy for advanced ovarian carcinoma should be considered a combination of taxol plus a platinum compound.

Antineoplastic Agents↗
PubMed1994

Carcinoma of the uterine cervix: current status and future directions.

Based on rigorous interpretation of current evidence, systemic therapy has two roles in the management of carcinoma of the uterine cervix. In patients with advanced or recurrent disease, single-agent chemotherapy constitutes the treatment of choice. The most extensively studied agents are the platinum compounds. Either cisplatin or carboplatin represents a reasonable choice for first-line treatment. There appears to be no significant influence of either dose or schedule on patient benefit. Other agents with clear-cut activity include ifosfamide, dibromodulcitol, and doxorubicin. At this time, there is no scientific basis for the use of combination chemotherapy in advanced or recurrent carcinoma of the cervix. In patients with locoregionally advanced disease (stages IIIB or IVA), radiation plus either hydroxyurea or a combination of cisplatin plus 5-fluorouracil offers an advantage over radiation alone in terms of progression-free interval and survival. In patients with more limited disease, there is no defined role for systemic therapy at the present time. Three goals constitute the focus for current investigational efforts: (1) continued efforts to identify additional highly active drugs are needed; (2) the development of effective combination chemotherapy depends on the use of logically designed combinations of active drugs in well-designed phase III trials with single-agent therapy as the control; and (3) phase III trials seeking more effective combinations of systemic therapy with surgery and/or radiotherapy should continue for not only locoregionally advanced disease but also for more limited carcinoma of the cervix.

Antineoplastic Agents↗
PubMed1993

Age as a prognostic factor in ovarian carcinoma. The Gynecologic Oncology Group experience.

BACKGROUND: The Gynecologic Oncology Group (GOG) has completed six major randomized trials in advanced ovarian carcinoma over the 15-year period between 1976 and 1990. This large database of 2123 patients provides a well-studied patient population with which to examine the importance of age as a prognostic factor. METHODS: The 2123 patients studied in the six GOG trials were analyzed as a group to determine important prognostic factors. Further analyses were then conducted to examine outcome by decade of life from younger than 40 years old to 70 years old and older and to evaluate the interaction of age with other significant prognostic variables. RESULTS: Three major prognostic factors were identified as exerting an influence on patient outcome in the overall patient population: age, volume of residual disease, and performance status. With regard to the effect of age, patients older than 69 years of age exhibited significantly poorer survival than those younger, even after correction for stage, residual disease, and performance status. This was not altered by variations in drugs, doses, and schedules; but there was no evidence that older patients tolerated intensive schedules less well than younger patients. CONCLUSIONS: Two practical conclusions result from this analysis. First, there is no evidence that modification of the drugs and schedules that make up the regimens used can overcome the adverse effect of older age. Second, age does not adversely affect the dose intensity that can be achieved; hence, age in itself is not reason to withhold or attenuate intensive chemotherapy, particularly in light of the fact that older patients have a poorer prognosis.

Adult↗