Publications by authors named "Steven E Waggoner"

Objective: To evaluate the safety, tolerability, and efficacy of topical artesunate ointment for treatment of biopsy-confirmed Human papillomavirus (HPV)-associated Vulvar intraepithelial neoplasia (VIN) 2/3.

Methods: Participants were enrolled on a prospective, IRB-approved, dose-escalation phase I trial testing either 1, 2 or 3 treatment cycles (5 days), every other week, as applicable. Clinical assessments were completed prior to each dose cycle and included exam and review of adverse event (AE) diary cards.

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Accurate coregistration of computed tomography (CT) and magnetic resonance (MR) imaging can provide clinically relevant and complementary information and can serve to facilitate multiple clinical tasks including surgical and radiation treatment planning, and generating a virtual Positron Emission Tomography (PET)/MR for the sites that do not have a PET/MR system available. Despite the long-standing interest in multimodality co-registration, a robust, routine clinical solution remains an unmet need. Part of the challenge may be the use of mutual information (MI) maximization and local phase difference (LPD) as similarity metrics, which have limited robustness, efficiency, and are difficult to optimize.

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Purpose: Platinum-based chemotherapy is the standard of care for platinum-sensitive ovarian cancer, but complications from repeated platinum therapy occur. We assessed the activity of two all-oral nonplatinum alternatives, olaparib or olaparib/cediranib, versus platinum-based chemotherapy.

Patients And Methods: NRG-GY004 is an open-label, randomized, phase III trial conducted in the United States and Canada.

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Purpose: The Sedlis criteria define risk factors for recurrence warranting post-hysterectomy radiation for early-stage cervical cancer; however, these factors were defined for squamous cell carcinoma (SCC) at an estimated recurrence risk of ≥30%. Our study evaluates and compares risk factors for recurrence for cervical SCC compared with adenocarcinoma (AC) and develops histology-specific nomograms to estimate risk of recurrence and guide adjuvant treatment.

Methods: We performed an ancillary analysis of GOG 49, 92, and 141, and included stage I patients who were surgically managed and received no neoadjuvant/adjuvant therapy.

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Background: On Aug 14, 2014, the US Food and Drug Administration approved the antiangiogenesis drug bevacizumab for women with advanced cervical cancer on the basis of improved overall survival (OS) after the second interim analysis (in 2012) of 271 deaths in the Gynecologic Oncology Group (GOG) 240 trial. In this study, we report the prespecified final analysis of the primary objectives, OS and adverse events.

Methods: In this randomised, controlled, open-label, phase 3 trial, we recruited patients with metastatic, persistent, or recurrent cervical carcinoma from 81 centres in the USA, Canada, and Spain.

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Background: We conducted a phase I trial to determine the safety of systemic chemotherapy prior to abdominopelvic robotic stereotactic ablative radiotherapy (SABR) in women with persistent or recurrent gynecologic cancers.

Methods: Patients were assigned to dose-finding cohorts of day 1 carboplatin (AUC 2 or 4) and gemcitabine (600 or 800 mg/m(2)) followed by day 2 to day 4 Cyberknife SABR (8 Gy × three consecutive daily doses). Toxicities were graded prospectively by common terminology criteria for adverse events, version 4.

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Objective: To determine the maximum tolerated dose (MTD) of a modified paclitaxel/doxorubicin/cisplatin (TAP) regimen which incorporated intraperitoneal (IP) paclitaxel or IP paclitaxel/cisplatin in advanced endometrial cancer.

Methods: Patients (pts) with FIGO (1998) Stage IIIA/IIIC with positive cytologic washings/ascites, adnexa, or serosa or Stage IV (intraperitoneal disease spread), histologically confirmed endometrial cancer were eligible. The study was designed as a phase I, 3+3 dose escalation study evaluating 5 dose levels (DL).

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Objective: To define the maximum tolerated dose (MTD) and assess the feasibility of intravenous (IV) docetaxel, intraperitoneal (IP) carboplatin and IP paclitaxel in women with stage II-IV untreated ovarian, fallopian tube or primary peritoneal carcinoma.

Methods: Patients received docetaxel (55-75 mg/m(2)) IV and carboplatin (AUC 5-7) IP on day 1 and paclitaxel 60 mg/m(2) IP on day 8. A standard 3+3 design was used in the dose escalation phase.

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The aim of this study was to determine the dose of weekly oral topotecan that allows safe administration and to evaluate the pharmacokinetics of this dose in patients with recurrent gynecologic malignancies. The first cohort of patients received oral topotecan 6 mg/week administered orally on days 1, 8, and 15 of a 28-day regimen. A standard 3+3 dose-escalating phase design was used for dose levels II-V (8, 10, 12 and 14 mg/week).

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Objective: To estimate the prevalence of sleep disturbances, and to determine if there is an association between sleep disturbances with quality of life (QOL), depression or clinical demographic variables.

Methods: Patients diagnosed with ovarian, fallopian tube or primary peritoneal cancer during the last 5years completed questionnaires regarding sleep patterns and disturbances [Pittsburgh Sleep Quality Index (PSQI)], depression [Beck Depression inventory (BDI)], and QOL [The Functional Assessment of Cancer Therapy-Ovarian (FACT-O), fatigue module (-F)]. Data were analyzed by Student's t-test or Pearson correlation coefficient to determine if there were differences between PSQI score with QOL, depression or clinical demographic variables.

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Objectives: This study aimed to assess the feasibility of a lifestyle intervention for promoting physical activity (PA) and diet quality during adjuvant chemotherapy for ovarian cancer.

Methods: Patients were enrolled post-operatively and received PA and nutrition counseling, at every chemotherapy visit for six cycles. Quality of life (QoL) was measured with the Functional Assessment of Cancer Therapy (FACT-G), PA with the Leisure Score Index (LSI), dietary intake with 3-day food records, and symptom severity/distress by the Memorial Symptom Assessment Scale (MSAS).

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Objective: To examine lifestyle behaviors that may contribute to endometrial cancer survivor morbidity and to identify associations with quality of life.

Methods: Patients with early-stage (I or II) endometrial cancer with a body mass index of at least 25 kg/m2 completed questionnaires on smoking, physical activity, fruit and vegetable intake, and the Functional Assessment of Cancer Therapy (FACT) and Short-Form medical outcomes (SF-36) quality-of-life surveys. Behaviors were compared with American Cancer Society 2006 guidelines for cancer survivors (150 min/wk of moderate-to-vigorous physical activity; five servings fruit and vegetables per day; no smoking).

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Objectives: The aim of this study was to determine the maximum tolerated dose and dose-limiting toxicity (DLT) of whole abdomen radiation as a chemosensitizer of weekly docetaxel for women with recurrent epithelial ovarian fallopian tube, or peritoneal cancers.

Patients And Methods: Women were enrolled on one of three dose levels of docetaxel (20, 25, or 30 mg/m(2)) administered weekly with concurrent low-dose whole abdominal radiation given as 60 cGy bid 2 days weekly for a total of 6 weeks.

Results: Thirteen women were enrolled and received 70 weekly treatments of docetaxel in combination with radiation therapy.

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Objective: The purpose of this study was to assess cigarette use and environmental smoke exposure in women with cervical cancer.

Study Design: Smoking behavior was recorded prospectively in a clinical trial of women with locally advanced cervical carcinoma.

Results: Of 315 participants, 133 women (42%) were current smokers; 72 women (23%) were former smokers, and 110 women (35%) were never smokers.

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Purpose: To estimate the antitumor activity of pemetrexed in patients with persistent or recurrent platinum-resistant epithelial ovarian or primary peritoneal cancer and to determine the nature and degree of toxicities.

Patients And Methods: A phase II trial was conducted by the Gynecologic Oncology Group. Patients must have had cancer that had progressed on platinum-based primary chemotherapy or recurred within 6 months.

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Objective: The majority of endometrial cancer survivors (ECS) are obese and at risk for premature death. The purpose of this study was to assess feasibility of a lifestyle intervention program for promoting weight loss, change in eating behaviors, and increased physical activity in obese ECS.

Study Design: Early stage ECS (n=45) were randomized to a 6-month lifestyle intervention (LI; n=23) or usual care (UC; n=22).

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Objective: To determine if smoking, a known risk factor for a number of cancers including cervical cancer, is associated with poor prognosis in patients with locally advanced cervical carcinoma treated with chemoradiation.

Methods: Patients with primary, previously untreated, histologically confirmed stage II-B, III-B or IV-A cervical carcinoma participated in a Gynecologic Oncology Group (GOG) phase III study (GOG 165) and were randomly allocated to receive radiation plus either cisplatin or 5-fluorouracil. Smoking behavior was ascertained using an administered questionnaire and by quantifying urine cotinine concentration.

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Objective: To determine the maximum tolerated dose (MTD) of vinorelbine in combination with weekly cisplatin and pelvic radiation therapy (RT).

Methods: Eligible patients included those with bulky or locally advanced cervical cancer. Women with other advanced gynecologic malignancies were also eligible.

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Purpose: The purpose of this study was to determine whether amifostine (WR-2721) prevents or ameliorates clinically significant (grade 2 to 4) neurotoxicity associated with cisplatin and 3-hour paclitaxel chemotherapy.

Materials And Methods: The chemotherapy program consisted of intravenous paclitaxel 175 mg/m2 over 3 hours followed by amifostine 740 mg/m2 and cisplatin 75 mg/m2 administered over 90 minutes beginning 15 minutes after amifostine administration. At baseline, before each treatment cycle, and for 3 months after completing chemotherapy, patients were evaluated for evidence of neurotoxicity and other treatment-related adverse effects using three methods: standard clinical evaluation (National Cancer Institute common toxicity criteria [CTC] grading), a neurotoxicity questionnaire to assess symptoms and limitations imposed by peripheral neuropathy, and vibration perception threshold (VPT) testing.

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Objectives: Platinum-containing chemotherapeutic drugs have high response rates yet are known to cause hypersensitivity reactions. Attempts have been made to rechallenge allergic patients with prolonged desensitization infusion regimens.

Case: A female with advanced peritoneal cancer went into remission after six cycles of paclitaxel/cisplatin.

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Cervical cancer is a serious health problem, with nearly 500000 women developing the disease each year worldwide. Most cases occur in less developed countries where no effective screening systems are available. Risk factors include exposure to human papillomavirus, smoking, and immune-system dysfunction.

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Background: Treatment with chemotherapeutic agents, after initial ovarian tumor debulking, and during recurrence, results in extended chemotherapy. When ovarian cancer recurs, chemotherapy is continued when patients respond to therapy. However, the disease may become stable.

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Objective: To estimate the antitumor activity of topotecan in women with advanced, persistent, or recurrent endometrial carcinoma previously treated with chemotherapy, and to determine the nature and degree of toxicity of topotecan in this cohort of patients.

Materials And Methods: Eligible patients were those who had failed one prior chemotherapy regimen. Topotecan 0.

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