448 results on '"DiSilvestro, Paul A."'
Search Results
2. Phase II trial of pembrolizumab and epacadostat in recurrent clear cell carcinoma of the ovary: An NRG oncology study GY016
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Gien, Lilian T., Enserro, Danielle M., Block, Matthew S., Waggoner, Steven, Duska, Linda R., Wahner-Hendrickson, Andrea E., Thaker, Premal H., Backes, Floor, Kidd, Michael, Muller, Carolyn Y., DiSilvestro, Paul A., Covens, Allan, Gershenson, David M., Moore, Kathleen N., Aghajanian, Carol, and Coleman, Robert L.
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- 2024
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3. Health-related quality of life in patients with newly diagnosed advanced ovarian cancer treated with niraparib vs placebo: Results from the phase 3 randomized PRIMA/ENGOT-OV26/GOG-3012 trial
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Pothuri, Bhavana, Han, Sileny, Chase, Dana M., Heitz, Florian, Burger, Robert A., Gaba, Lydia, Van Le, Linda, Guerra, Eva, Bender, David, Korach, Jacob, Cloven, Noelle, Churruca, Cristina, Follana, Philippe, DiSilvestro, Paul, Baurain, Jean-François, Jardon, Kris, Pisano, Carmela, Peen, Ulla, Mäenpää, Johanna, Gupta, Divya, Bacqué, Emeline, Li, Yong, Compton, Natalie, Antonova, Jenya, Monk, Bradley J., and González-Martín, Antonio
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- 2024
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4. Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial
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Powell, Matthew A, Filiaci, Virginia L, Hensley, Martee L, Huang, Helen Q, Moore, Kathleen N, Tewari, Krishnansu S, Copeland, Larry J, Secord, Angeles A, Mutch, David G, Santin, Alessandro, Warshal, David P, Spirtos, Nick M, DiSilvestro, Paul A, Ioffe, Olga B, and Miller, David S
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Cancer ,Clinical Trials and Supportive Activities ,Clinical Research ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Adult ,Antineoplastic Combined Chemotherapy Protocols ,Carboplatin ,Carcinosarcoma ,Disease-Free Survival ,Female ,Humans ,Ifosfamide ,Ovarian Neoplasms ,Paclitaxel ,Uterine Neoplasms ,Clinical Sciences ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
PurposeThis phase III randomized trial (NCT00954174) tested the null hypothesis that paclitaxel and carboplatin (PC) is inferior to paclitaxel and ifosfamide (PI) for treating uterine carcinosarcoma (UCS).Patients and methodsAdults with chemotherapy-naïve UCS or ovarian carcinosarcoma (OCS) were randomly assigned to PC or PI with 3-week cycles for 6-10 cycles. With 264 events in patients with UCS, the power for an overall survival (OS) hybrid noninferiority design was 80% for a null hazard ratio (HR) of 1.2 against a 13% greater death rate on PI with a type I error of 5% for a one-tailed test.ResultsThe study enrolled 536 patients with UCS and 101 patients with OCS, with 449 and 90 eligible, respectively. Primary analysis was on patients with UCS, distributed as follows: 40% stage I, 6% stage II, 31% stage III, 15% stage IV, and 8% recurrent. Among eligible patients with UCS, PC was assigned to 228 and PI to 221. PC was not inferior to PI. The median OS was 37 versus 29 months (HR = 0.87; 90% CI, 0.70 to 1.075; P < .01 for noninferiority, P > .1 for superiority). The median progression-free survival was 16 versus 12 months (HR = 0.73; P = < 0.01 for noninferiority, P < .01 for superiority). Toxicities were similar, except that more patients in the PC arm had hematologic toxicity and more patients in the PI arm had confusion and genitourinary hemorrhage. Among 90 eligible patients with OCS, those in the PC arm had longer OS (30 v 25 months) and progression-free survival (15 v 10 months) than those in the PI arm, but with limited precision, these differences were not statistically significant.ConclusionPC was not inferior to the active regimen PI and should be standard treatment for UCS.
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- 2022
5. Patient reported outcomes for cisplatin and radiation followed by carboplatin/paclitaxel versus carboplatin/paclitaxel for locally advanced endometrial carcinoma: An NRG oncology study.
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Matulonis, Ursula A, Huang, Helen Q, Filiaci, Virginia L, Randall, Marcus, DiSilvestro, Paul A, Moxley, Katherine M, Fowler, Jeffrey M, Powell, Matthew A, Spirtos, Nick M, Tewari, Krishnansu S, Richards, William E, Nakayama, John M, Mutch, David G, Miller, David S, Matei, Daniela, and Wenzel, Lari B
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Humans ,Endometrial Neoplasms ,Gastrointestinal Diseases ,Peripheral Nervous System Diseases ,Cisplatin ,Paclitaxel ,Carboplatin ,Neoplasm Staging ,Disease-Free Survival ,Chemotherapy ,Adjuvant ,Quality of Life ,Female ,Chemoradiotherapy ,Adjuvant ,Patient Reported Outcome Measures ,Functional Status ,Chemotherapy ,Combined radiation therapy ,Endometrial cancer ,Patient reported outcomes ,Quality of life ,Patient Safety ,Cancer ,Clinical Trials and Supportive Activities ,Clinical Research ,Digestive Diseases ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Oncology and Carcinogenesis ,Paediatrics and Reproductive Medicine ,Oncology & Carcinogenesis - Abstract
IntroductionChemotherapy plus radiation (Cis-RT + CP) did not demonstrate superiority in prolonging relapse-free survival compared to chemotherapy alone in patients with stage III or IVA endometrial carcinoma. The impact of treatment on quality of life (QOL), neurotoxicity (NTX) and psychometric properties of the gastrointestinal (GI) symptoms subscale during treatment and up to 1 year are described herein.MethodsQOL assessments were scheduled at baseline, 6 weeks (post completion of RT (Cis-RT + CP) or prior to cycle 3 (CP)), then 18 weeks (end of treatment) and 70 weeks (1 year after the end of treatment) after starting treatment. QOL instruments included the FACT-En TOI, FACT/GOG-neurotoxicity (Ntx) subscale (short), and the gastrointestinal (GI) symptoms subscale.ResultsAt the end of treatment, patients receiving Cis-RT + CP reported a statistically significant decreased QOL when compared to CP. The decline in QOL was reflected in physical well-being, functional well-being, and endometrial cancer specific concerns, but the minimally important differences (MID) were not considered clinically meaningful. Patients in both groups reported increased chemotherapy-induced Ntx symptoms with the CP group having worse scores and reaching peak symptoms at the time of chemotherapy completion. Patients on Cis-RT + CP reported statistically significantly worse GI symptoms after radiation therapy compared to patients on CP, this occurred across assessment intervals, though the MID was not meaningful. Psychometric evaluations indicated that the GI symptom scale is reliable, valid, and responsive to change.ConclusionsPROs indicate that the chemoradiotherapy group experienced worse HRQoL and GI toxicity compared to patients randomized to chemotherapy alone for locally advanced endometrial cancer though based on the MID, these were not clinically meaningful differences. The GI symptom subscale was a reliable and valid scale that has value for future trials.Trial registrationNCT00942357.
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- 2022
6. Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II
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Oonk, Maaike HM, Slomovitz, Brian, Baldwin, Peter JW, van Doorn, Helena C, van der Velden, Jacobus, de Hullu, Joanne A, Gaarenstroom, Katja N, Slangen, Brigitte FM, Vergote, Ignace, Brännström, Mats, van Dorst, Eleonora BL, van Driel, Willemien J, Hermans, Ralph H, Nunns, David, Widschwendter, Martin, Nugent, David, Holland, Cathrine M, Sharma, Aarti, DiSilvestro, Paul A, Mannel, Robert, Boll, Dorry, Cibula, David, Covens, Al, Provencher, Diane, Runnebaum, Ingo B, Luesley, David, Ellis, Patricia, Duncan, Timothy J, Tjiong, Ming Y, Cruickshank, Derek J, Kjølhede, Preben, Levenback, Charles F, Bouda, Jiri, Kieser, Katharina E, Palle, Connie, Spirtos, Nicola M, O'Malley, David M, Leitao, Mario M, Geller, Melissa A, Dhar, Kalyan, Asher, Viren, Tamussino, Karl, Tobias, Daniel H, Borgfeldt, Christer, Lea, Jayanthi S, Bailey, Jo, Lood, Margareta, Eyjolfsdottir, Brynhildur, Attard-Montalto, Stephen, Tewari, Krishnansu S, Manchanda, Ranjit, Jensen, Pernille T, Persson, Par, Van Le, Linda, Putter, Hein, de Bock, Geertruida H, Monk, Bradley J, Creutzberg, Carien L, and van der Zee, Ate GJ
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Biomedical and Clinical Sciences ,Clinical Sciences ,Oncology and Carcinogenesis ,Clinical Trials and Supportive Activities ,Clinical Research ,Cancer ,Evaluation of treatments and therapeutic interventions ,6.5 Radiotherapy and other non-invasive therapies ,Aged ,Female ,Humans ,Lymph Node Excision ,Lymphatic Metastasis ,Middle Aged ,Neoplasm Micrometastasis ,Neoplasm Staging ,Prospective Studies ,Radiation Dosage ,Sentinel Lymph Node ,Time Factors ,Treatment Outcome ,Vulvar Neoplasms ,Oncology & Carcinogenesis ,Oncology and carcinogenesis - Abstract
PurposeThe Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN).MethodsGROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences.ResultsFrom December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL.ConclusionInguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.
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- 2021
7. Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209).
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Miller, David S, Filiaci, Virginia L, Mannel, Robert S, Cohn, David E, Matsumoto, Takashi, Tewari, Krishnansu S, DiSilvestro, Paul, Pearl, Michael L, Argenta, Peter A, Powell, Matthew A, Zweizig, Susan L, Warshal, David P, Hanjani, Parviz, Carney, Michael E, Huang, Helen, Cella, David, Zaino, Richard, and Fleming, Gini F
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Clinical Research ,Cancer ,Clinical Trials and Supportive Activities ,Mind and Body ,6.5 Radiotherapy and other non-invasive therapies ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Antineoplastic Combined Chemotherapy Protocols ,Carboplatin ,Cisplatin ,Endometrial Neoplasms ,Female ,Filgrastim ,Humans ,Middle Aged ,Paclitaxel ,Progression-Free Survival ,Quality of Life ,Treatment Outcome ,Clinical Sciences ,Oncology and Carcinogenesis ,Oncology & Carcinogenesis - Abstract
PurposeLimitations of the paclitaxel-doxorubicin-cisplatin (TAP) regimen in the treatment of endometrial cancer include tolerability and cumbersome scheduling. The Gynecologic Oncology Group studied carboplatin plus paclitaxel (TC) as a noninferior alternative to TAP.MethodsGOG0209 was a phase III, randomized, noninferiority, open-label trial. Inclusion criteria were stage III, stage IV, and recurrent endometrial cancers; performance status 0-2; and adequate renal, hepatic, and marrow function. Prior radiotherapy and/or hormonal therapy were permitted, but chemotherapy, including radiosensitization, was not. Patients were treated with doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 (day 1), followed by paclitaxel 160 mg/m2 (day 2) with granulocyte colony-stimulating factor or paclitaxel 175 mg/m2 and carboplatin area under the curve 6 (day 1) every 21 days for seven cycles. The primary endpoint was overall survival (OS; modified intention to treat). Progression-free survival (PFS), health-related quality of life (HRQoL), and toxicity were secondary endpoints.ResultsFrom 2003 to 2009, 1,381 women were enrolled. Noninferiority of TC to TAP was concluded for OS (median, 37 v 41 months, respectively; hazard ratio [HR], 1.002; 90% CI, 0.9 to 1.12), and PFS (median, 13 v 14 months; HR, 1.032; 90% CI, 0.93 to 1.15). Neutropenic fever was reported in 7% of patients receiving TAP and 6% of those receiving TC. Grade > 2 sensory neuropathy was recorded in 26% of patients receiving TAP and 20% receiving TC (P = .40). More grade ≥ 3 thrombocytopenia (23% v 12%), vomiting (7% v 4%), diarrhea (6% v 2%), and metabolic (14% v 8%) toxicities were reported with TAP. Neutropenia (52% v 80%) was more common with TC. Small HRQoL differences favored TC.ConclusionWith demonstrated noninferiority to TAP, TC is the global first-line standard for advanced endometrial cancer.
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- 2020
8. Circulating Tumor Cells In Advanced Cervical Cancer: NRG Oncology—Gynecologic Oncology Group Study 240 (NCT 00803062)
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Tewari, Krishnansu S, Sill, Michael W, Monk, Bradley J, Penson, Richard T, Moore, David H, Lankes, Heather A, Ramondetta, Lois M, Landrum, Lisa M, Randall, Leslie M, Oaknin, Ana, Leitao, Mario M, Eisenhauer, Eric L, DiSilvestro, Paul, Van Le, Linda, Pearl, Michael L, Burke, James J, Salani, Ritu, Richardson, Debra L, Michael, Helen E, Kindelberger, David W, and Birrer, Michael J
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Cervical Cancer ,Clinical Research ,Cancer ,Adult ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Biomarkers ,Tumor ,Disease Management ,Female ,Humans ,Kaplan-Meier Estimate ,Middle Aged ,Molecular Targeted Therapy ,Neoplastic Cells ,Circulating ,Prognosis ,Treatment Outcome ,Uterine Cervical Neoplasms ,Oncology and Carcinogenesis ,Pharmacology and Pharmaceutical Sciences ,Oncology & Carcinogenesis - Abstract
To isolate circulating tumor cells (CTC) from women with advanced cervical cancer and estimate the impact of CTCs and treatment on overall survival and progression-free survival (PFS). A total of 7.5 mL of whole blood was drawn pre-cycle 1 and 36 days post-cycle 1 from patients enrolled on Gynecologic Oncology Group 0240, the phase III randomized trial that led directly to regulatory approval of the antiangiogenesis drug, bevacizumab, in women with recurrent/metastatic cervical cancer. CTCs (defined as anti-cytokeratin+/anti-CD45- cells) were isolated from the buffy coat layer using an anti-EpCAM antibody-conjugated ferrofluid and rare earth magnet, and counted using a semiautomated fluorescence microscope. The median pre-cycle 1 CTC count was 7 CTCs/7.5 mL whole blood (range, 0-18) and, at 36 days posttreatment, was 4 (range, 0-17). The greater the declination in CTCs between time points studied, the lower the risk of death [HR, 0.87; 95% confidence interval (CI), 0.79-0.95)]. Among patients with high (≥ median) pretreatment CTCs, bevacizumab treatment was associated with a reduction in the hazard of death (HR, 0.57; 95% CI, 0.32-1.03) and PFS (HR, 0.59; 95% CI, 0.36-0.96). This effect was not observed with low (< median) CTCs. CTCs can be isolated from women with advanced cervical cancer and may have prognostic significance. A survival benefit conferred by bevacizumab among patients with high pretreatment CTCs may reflect increased tumor neovascularization and concomitant vulnerability to VEGF inhibition. These data support studying CTC capture as a potential predictive biomarker.
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- 2020
9. Adjuvant Therapy in Node-Positive Endometrial Cancer: A Focus on Chemotherapy
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Dexter, Julia, Lips, Erin, and DiSilvestro, Paul
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- 2022
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10. Bevacizumab plus fosbretabulin in recurrent ovarian cancer: Overall survival and exploratory analyses of a randomized phase II NRG oncology/gynecologic oncology group study
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Tewari, Krishnansu S, Sill, Michael W, Coleman, Robert L, Aghajanian, Carol, Mannel, Robert, DiSilvestro, Paul A, Powell, Matthew, Randall, Leslie M, Farley, John, Rubin, Stephen C, and Monk, Bradley J
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Biomedical and Clinical Sciences ,Clinical Sciences ,Oncology and Carcinogenesis ,Clinical Research ,Rare Diseases ,Cancer ,Ovarian Cancer ,6.2 Cellular and gene therapies ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adult ,Antineoplastic Combined Chemotherapy Protocols ,Bevacizumab ,Female ,Follow-Up Studies ,Humans ,Middle Aged ,Neoplasm Recurrence ,Local ,Ovarian Neoplasms ,Ovary ,Progression-Free Survival ,Stilbenes ,Time Factors ,Tumor Burden ,Fosbretabulin ,Vascular disrupting agent ,Ovarian cancer ,Paediatrics and Reproductive Medicine ,Oncology & Carcinogenesis ,Clinical sciences ,Oncology and carcinogenesis ,Reproductive medicine - Abstract
ObjectiveTo explore the relationship between tumor size and response to combined anti-vascular targeted therapy using the anti-angiogenesis inhibitor, bevacizumab, and the tubulin-binding vascular disrupting agent, fosbretabulin.MethodsAn exploratory, post-hoc analysis of the randomized phase II trial, Gynecologic Oncology Group-0186I, was performed. One hundred and seven patients with recurrent ovarian carcinoma, treated with up to 3 prior regimens, were randomized to bevacizumab 15 mg/kg body weight with or without intravenous fosbretabulin 60 mg/m2 body surface area every 21 days until progression or unacceptable toxicity. The primary analysis favored the combination (HR 0.69; 95% CI, 0.47-1.00; p = .049) [Monk BJ, et al. J Clin Oncol 2016;34:2279-86]. The Cox proportional hazards model was used to estimate the treatment effect in various subpopulations.ResultsWith extended follow-up, the median PFS for bevacizumab plus fosbretabulin was 7.6 months as compared to 4.8 months with bevacizumab alone (HR 0.74; 90% CI, 0.54-1.02). Overall survival was similar in the experimental and control arms (25.2 vs 24.4 mos, respectively, HR 0.85; 90% CI, 0.59-1.22; p = .461). Eighty-one patients had measurable disease and median tumor size was 5.7 cm. In the ≤5.7 cm subgroup, the HR for progression or death was 0.77 (90% CI 0.45-1.31). Patients with tumors >5.7 cm (n = 40) had a HR for progression or death of 0.55; 90% CI, 0.32-0.96; p = .075).ConclusionsAlthough no significant survival benefit was observed, the trend showing a reduced HR for progression or death with increasing tumor size when fosbretabulin is added to bevacizumab compared to bevacizumab alone warrants further study.
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- 2020
11. Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer.
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Coleman, Robert, Spirtos, Nick, Enserro, Danielle, Herzog, Thomas, Sabbatini, Paul, Armstrong, Deborah, Kim, Jae-Weon, Park, Sang-Yoon, Kim, Byoung-Gie, Nam, Joo-Hyun, Fujiwara, Keiichi, Walker, Joan, Casey, Ann, Alvarez Secord, Angeles, Rubin, Steve, Chan, John, DiSilvestro, Paul, Davidson, Susan, Cohn, David, Basen-Engquist, Karen, Huang, Helen, Brady, Mark, Mannel, Robert, and Tewari, Krishnansu
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Aged ,Antineoplastic Combined Chemotherapy Protocols ,Bevacizumab ,Carboplatin ,Combined Modality Therapy ,Cytoreduction Surgical Procedures ,Female ,Humans ,Middle Aged ,Neoplasm Recurrence ,Local ,Neoplasms ,Glandular and Epithelial ,Ovarian Neoplasms ,Paclitaxel ,Quality of Life ,Reoperation ,Survival Analysis - Abstract
BACKGROUND: Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube (ovarian) cancer is widely practiced but has not been evaluated in phase 3 investigation. METHODS: We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival. RESULTS: A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery. CONCLUSIONS: In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).
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- 2019
12. Lifestyle intervention in ovarian cancer enhanced survival (LIVES) study (NRG/GOG0225): Recruitment, retention and baseline characteristics of a randomized trial of diet and physical activity in ovarian cancer survivors
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Thomson, Cynthia A., Crane, Tracy E., Miller, Austin, Gold, Michael A., Powell, Matthew, Bixel, Kristin, Van Le, Linda, DiSilvestro, Paul, Ratner, Elena, Lele, Shashikant, Guntupalli, Saketh, Huh, Warner, Robertson, Sharon E., Modesitt, Susan, Casey, A. Catherine, Basen-Engquist, Karen, Skiba, Meghan, Walker, Joan, Kachnic, Lisa, and Alberts, David S.
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- 2023
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13. Contributors
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Backes, Floor J., primary, Beffa, Lindsey B., additional, Billingsley, Caroline C., additional, Birrer, Michael J., additional, Bixel, Kristin, additional, Boitano, Teresa K.L., additional, Brewster, Wendy R., additional, Chase, Dana M., additional, Bruce, Shaina, additional, Crown, Angelena, additional, Chu, Christina S., additional, Clarke-Pearson, Daniel L., additional, Ross, Robert A., additional, Crosland, Brian, additional, Cohen, Joshua G., additional, Coleman, Robert L., additional, DiSilvestro, Paul A., additional, Dorigo, Oliver, additional, Duska, Linda R., additional, Eskander, Ramez Nassef, additional, Gemignani, Mary L., additional, Gunderson, Camille Catherine, additional, Hagemann, Andrea R., additional, Herzog, Thomas J., additional, Korenaga, Travis R., additional, Huh, Warner K., additional, Kuroki, Lindsay, additional, Kurnit, Katherine, additional, Mannel, Robert S., additional, Massad, L. Stewart, additional, Mathews, Cara A., additional, Miller, David S., additional, Monk, Bradley J., additional, Mutch, David G., additional, Nikam, Rachita, additional, Pinkerton, JoAnn V., additional, Powell, Matthew, additional, Rash, Dominique L., additional, Landrum, Lisa M., additional, Ring, Kari L., additional, Renz, Malte, additional, Roane, Brandon, additional, Rubin, Stephen C., additional, Salani, Ritu, additional, Satero, Jane, additional, Sood, Anil K., additional, Soper, John T., additional, Stock, Elizabeth Christina, additional, Sung, C. James, additional, Tewari, Krishnansu Sujata, additional, Toboni, Michael D., additional, Tucker, Katherine, additional, Walker, Joan L., additional, Wall, Jaclyn A., additional, Washington, Christina, additional, Wenzel, Lari B., additional, Westin, Shannon N., additional, Yashar, Catheryn M., additional, Creasman, William T., additional, and Zuna, Rosemary E., additional
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- 2023
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14. Germ cell, stromal, and other ovarian tumors
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Beffa, Lindsey B., primary, Sung, C. James, additional, and DiSilvestro, Paul A., additional
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- 2023
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15. Phase I and Randomized Phase II Study of Ruxolitinib With Frontline Neoadjuvant Therapy in Advanced Ovarian Cancer: An NRG Oncology Group Study
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Landen, Charles N., primary, Buckanovich, Ronald J., additional, Sill, Michael W., additional, Mannel, Robert S., additional, Walker, Joan L., additional, DiSilvestro, Paul A., additional, Mathews, Cara A., additional, Mutch, David G., additional, Hernandez, Marcia L., additional, Martin, Lainie P., additional, Bishop, Erin, additional, Gill, Sarah E., additional, Gordinier, Mary E., additional, Burger, Robert A., additional, Aghajanian, Carol, additional, Liu, Joyce F., additional, Moore, Kathleen N., additional, and Bookman, Michael A., additional
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- 2024
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16. Adjuvant Chemotherapy plus Radiation for Locally Advanced Endometrial Cancer.
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Matei, Daniela, Filiaci, Virginia, Randall, Marcus, Mutch, David, Steinhoff, Margaret, DiSilvestro, Paul, Moxley, Katherine, Kim, Yong, Powell, Matthew, OMalley, David, Spirtos, Nick, Small, William, Richards, William, Nakayama, John, Matulonis, Ursula, Huang, Helen, Miller, David, and Tewari, Krishnansu
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Adult ,Aged ,Aged ,80 and over ,Antineoplastic Combined Chemotherapy Protocols ,Chemoradiotherapy ,Adjuvant ,Chemotherapy ,Adjuvant ,Disease-Free Survival ,Endometrial Neoplasms ,Female ,Humans ,Kaplan-Meier Estimate ,Middle Aged ,Neoplasm Recurrence ,Local ,Neoplasm Staging ,Neoplasm ,Residual ,Prognosis ,Quality of Life ,Recurrence ,Statistics ,Nonparametric ,Treatment Outcome - Abstract
BACKGROUND: Stage III or IVA endometrial cancer carries a significant risk of systemic and locoregional recurrence. METHODS: In this randomized phase 3 trial, we tested whether 6 months of platinum-based chemotherapy plus radiation therapy (chemoradiotherapy) is associated with longer relapse-free survival (primary end point) than six cycles of combination chemotherapy alone in patients with stage III or IVA endometrial carcinoma. Secondary end points included overall survival, acute and chronic toxic effects, and quality of life. RESULTS: Of the 813 patients enrolled, 736 were eligible and were included in the analysis of relapse-free survival; of those patients, 707 received the randomly assigned intervention (346 received chemoradiotherapy and 361 received chemotherapy only). The median follow-up period was 47 months. At 60 months, the Kaplan-Meier estimate of the percentage of patients alive and relapse-free was 59% (95% confidence interval [CI], 53 to 65) in the chemoradiotherapy group and 58% (95% CI, 53 to 64) in the chemotherapy-only group (hazard ratio, 0.90; 90% CI, 0.74 to 1.10). Chemoradiotherapy was associated with a lower 5-year incidence of vaginal recurrence (2% vs. 7%; hazard ratio, 0.36; 95% CI, 0.16 to 0.82) and pelvic and paraaortic lymph-node recurrence (11% vs. 20%; hazard ratio, 0.43; 95% CI, 0.28 to 0.66) than chemotherapy alone, but distant recurrence was more common in association with chemoradiotherapy (27% vs. 21%; hazard ratio, 1.36; 95% CI, 1.00 to 1.86). Grade 3, 4, or 5 adverse events were reported in 202 patients (58%) in the chemoradiotherapy group and 227 patients (63%) in the chemotherapy-only group. CONCLUSIONS: Chemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone in patients with stage III or IVA endometrial carcinoma. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00942357.).
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- 2019
17. Randomized Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study.
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Walker, Joan, Brady, Mark, Fleming, Gini, Huang, Helen, DiSilvestro, Paul, Fujiwara, Keiichi, Alberts, David, Zheng, Wenxin, Cohn, David, Powell, Matthew, Van Le, Linda, Davidson, Susan, Gray, Heidi, Rose, Peter, Aghajanian, Carol, Myers, Tashanna, Alvarez Secord, Angeles, Rubin, Stephen, Mannel, Robert, Wenzel, Lari, and Tewari, Krishnansu
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Adult ,Aged ,Aged ,80 and over ,Antineoplastic Combined Chemotherapy Protocols ,Bevacizumab ,Carboplatin ,Disease Progression ,Drug Administration Schedule ,Female ,Humans ,Infusions ,Intravenous ,Infusions ,Parenteral ,Middle Aged ,Neoplasm Staging ,Ovarian Neoplasms ,Paclitaxel ,Progression-Free Survival ,Time Factors ,United States - Abstract
PURPOSE: To evaluate the impact of two different intraperitoneal (IP) chemotherapy regimens on progression-free survival (PFS) among women with newly diagnosed advanced ovarian carcinoma. METHODS: Eligible patients were randomly assigned to six cycles of IV paclitaxel 80 mg/m2 once per week with intravenous (IV) carboplatin area under the curve 6 (IV carboplatin) versus IV paclitaxel 80 mg/m2 once per week with IP carboplatin area under the curve 6 (IP carboplatin) versus once every 3 weeks IV paclitaxel 135 mg/m2 over 3 hours day 1, IP cisplatin 75 mg/m2 day 2, and IP paclitaxel 60 mg/m2 day 8 (IP cisplatin). All participants received bevacizumab 15 mg/kg IV every 3 weeks in cycles 2 to 22. RESULTS: A total of 1,560 participants were enrolled and had 84.8 months of follow-up. The median PFS duration was 24.9 months in the IV carboplatin arm, 27.4 months in the IP carboplatin arm, and 26.2 months in the IP cisplatin arm. For the subgroup of 1,380 patients with stage II/III and residual disease of 1 cm or less, median PFS was 26.9 (IV-carboplatin), 28.7 (IP-carboplatin), and 27.8 months (IP cisplatin), respectively. Median PFS for patients with stage II/III and no residual disease was 35.9, 38.8, and 35.5 months, respectively. Median overall survival for all enrolled was 75.5, 78.9, and 72.9 months, respectively, and median overall survival for stage II/III with no gross residual disease was 98.8 months, 104.8 months, and not reached. Mean patient-reported Functional Assessment of Cancer Therapy neurotoxicity scores (Gynecologic Oncology Group) were similar for all arms, but the mean Trial Outcome Index of the Functional Assessment of Cancer Therapy-Ovary scores during chemotherapy were statistically worse in the IP cisplatin arm. CONCLUSION: Compared with the IV carboplatin reference arm, the duration of PFS was not significantly increased with either IP regimen when combined with bevacizumab and was better tolerated than IP cisplatin.
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- 2019
18. GOG 8020/210: Risk stratification of lymph node metastasis, disease progression and survival using single nucleotide polymorphisms in endometrial cancer: An NRG oncology/gynecologic oncology group study
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Brooks, Rebecca A, Tritchler, David S, Darcy, Kathleen M, Lankes, Heather A, Salani, Ritu, Sperduto, Paul, Guntupalli, Saketh, DiSilvestro, Paul, Kesterson, Joshua, Olawaiye, Alexander B, Moxley, Katherine, Waggoner, Steven, Santin, Alessandro, Rader, Janet S, Kizer, Nora T, Thaker, Premal H, Powell, Matthew A, Mutch, David G, Birrer, Michael J, and Goodfellow, Paul J
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Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Human Genome ,Cancer ,Clinical Research ,Genetics ,Patient Safety ,Uterine Cancer ,2.1 Biological and endogenous factors ,Aetiology ,Aged ,Biomarkers ,Tumor ,Case-Control Studies ,Disease Progression ,Endometrial Neoplasms ,Endometrium ,ErbB Receptors ,Female ,Humans ,Lymphatic Metastasis ,Middle Aged ,NM23 Nucleoside Diphosphate Kinases ,Neoplasm Staging ,Polymorphism ,Single Nucleotide ,Prognosis ,Progression-Free Survival ,Risk Assessment ,Endometrial cancer ,Risk stratification ,SNP association ,Node positivity ,Paediatrics and Reproductive Medicine ,Oncology & Carcinogenesis ,Clinical sciences ,Oncology and carcinogenesis ,Reproductive medicine - Abstract
ObjectivesThe ability to stratify a patient's risk of metastasis and survival permits more refined care. A proof of principle study was undertaken to investigate the relationship between single nucleotide polymorphisms (SNPs) in literature based candidate cancer genes and the risk of nodal metastasis and clinical outcome in endometrioid endometrial cancer (EEC) patients.MethodsSurgically-staged EEC patients from the Gynecologic Oncology Group or Washington University School of Medicine with germline DNA available were eligible. Fifty-four genes represented by 384 SNPs, were evaluated by Illumina Custom GoldenGate array. Association with lymph node metastases was the primary outcome. Progression-free survival (PFS) and overall survival (OS) was also evaluated.Results361 SNPs with high quality genotype data were evaluated in 337 patients with outcome data. Five SNPs in CXCR2 had an odds ratio (OR) between 0.68 and 0.70 (p-value ≤ 0.025). The A allele rs946486 in ABL had an OR of 1.5 (p-value = 0.01) for metastasis. The G allele in rs7795743 in EGFR had an OR for metastasis of 0.68 (p-value = 0.02) and hazard ratio (HR) for progression of 0.66 (p-value = 0.004). Importantly, no SNP met genome wide significance after adjusting for multiple test correcting and clinical covariates. The A allele in rs2159359 SNP in NME1 and the G allele in rs13222385 in EGFR were associated with worse OS. Both exhibited genome wide significance; rs13222385 remained significant after adjusting for prognostic clinical variables.ConclusionSNPs in cancer genes including rs2159359 SNP in NME1 and rs13222385 in EGFR may stratify risk in EEC and are prioritized for further investigation.
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- 2019
19. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial
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Banerjee, Susana, Moore, Kathleen N, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Friedlander, Michael, Lisyanskaya, Alla, Floquet, Anne, Leary, Alexandra, Sonke, Gabe S, Gourley, Charlie, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William H, Holmes, Eileen, Lowe, Elizabeth S, and DiSilvestro, Paul
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- 2021
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20. Population-adjusted indirect treatment comparison of the SOLO1 and PAOLA-1/ENGOT-ov25 trials evaluating maintenance olaparib or bevacizumab or the combination of both in newly diagnosed, advanced BRCA-mutated ovarian cancer
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Vergote, Ignace, Ray-Coquard, Isabelle, Anderson, Daniel M., Cantuaria, Guilherme, Colombo, Nicoletta, Garnier-Tixidre, Claire, Gilbert, Lucy, Harter, Philipp, Hettle, Robert, Lorusso, Domenica, Mäenpää, Johanna, Marth, Christian, Matsumoto, Koji, Ouwens, Mario, Poveda, Andrés, Raspagliesi, Francesco, Rhodes, Kirsty, Rubio Pérez, María J., Shapira-Frommer, Ronnie, Shikama, Ayumi, Sikorska, Magdalena, Moore, Kathleen, and DiSilvestro, Paul
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- 2021
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21. Overall Survival With Maintenance Olaparib at a 7-Year Follow-up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial
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DiSilvestro, Paul, Banerjee, Susana, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Friedlander, Michael, Lisyanskaya, Alla, Floquet, Anne, Leary, Alexandra, Sonke, Gabe S., Gourley, Charlie, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William, Mathews, Cara, Liu, Joyce, McNamara, John, Lowe, Elizabeth S., Ah-See, Mei-Lin, and Moore, Kathleen N.
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- 2023
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22. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial
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Friedlander, Michael, Moore, Kathleen N, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Lisyanskaya, Alla, Sonke, Gabe S, Gourley, Charlie, Banerjee, Susana, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William H, Liu, Joyce, Mathews, Cara, Selle, Frédéric, Lortholary, Alain, Lowe, Elizabeth S, Hettle, Robert, Flood, Emuella, Parkhomenko, Elena, and DiSilvestro, Paul
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- 2021
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23. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial.
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Coleman, Robert L, Brady, Mark F, Herzog, Thomas J, Sabbatini, Paul, Armstrong, Deborah K, Walker, Joan L, Kim, Byoung-Gie, Fujiwara, Keiichi, Tewari, Krishnansu S, O'Malley, David M, Davidson, Susan A, Rubin, Stephen C, DiSilvestro, Paul, Basen-Engquist, Karen, Huang, Helen, Chan, John K, Spirtos, Nick M, Ashfaq, Raheela, and Mannel, Robert S
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Humans ,Neoplasms ,Glandular and Epithelial ,Peritoneal Neoplasms ,Ovarian Neoplasms ,Fallopian Tube Neoplasms ,Neoplasm Recurrence ,Local ,Paclitaxel ,Carboplatin ,Antineoplastic Combined Chemotherapy Protocols ,Disease-Free Survival ,Survival Rate ,Adult ,Aged ,Aged ,80 and over ,Middle Aged ,Female ,Young Adult ,Cytoreduction Surgical Procedures ,Bevacizumab ,Carcinoma ,Ovarian Epithelial ,Neoplasms ,Glandular and Epithelial ,Neoplasm Recurrence ,Local ,and over ,Carcinoma ,Ovarian Epithelial ,Oncology & Carcinogenesis ,Oncology and Carcinogenesis - Abstract
BackgroundPlatinum-based chemotherapy doublets are a standard of care for women with ovarian cancer recurring 6 months after completion of initial therapy. In this study, we aimed to explore the roles of secondary surgical cytoreduction and bevacizumab in this population, and report the results of the bevacizumab component here.MethodsThe multicentre, open-label, randomised phase 3 GOG-0213 trial was done in 67 predominantly academic centres in the USA (65 centres), Japan (one centre), and South Korea (one centre). Eligible patients were adult women (aged ≥18 years) with recurrent measurable or evaluable epithelial ovarian, primary peritoneal, or fallopian tube cancer, and a clinical complete response to primary platinum-based chemotherapy, who had been disease-free for at least 6 months following last infused cycle of platinum. Patients were randomly assigned (1:1) to standard chemotherapy (six 3-weekly cycles of paclitaxel [175 mg/m2 of body surface area] and carboplatin [area under the curve 5]) or the same chemotherapy regimen plus bevacizumab (15 mg/kg of bodyweight) every 3 weeks and continued as maintenance every 3 weeks until disease progression or unacceptable toxicity. Individuals who participated in both the bevacizumab objective and surgical objective (which is ongoing) were randomly assigned (1:1:1:1) to receive either of these two chemotherapy regimens with or without prior secondary cytoreductive surgery. Randomisation for the bevacizumab objective was stratified by treatment-free interval and participation in the surgical objective. The primary endpoint was overall survival, analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00565851.FindingsBetween Dec 10, 2007, and Aug 26, 2011, 674 women were enrolled and randomly assigned to standard chemotherapy (n=337) or chemotherapy plus bevacizumab (n=377). Median follow-up at the end of the trial on Nov 5, 2014, was 49·6 months in each treatment group (IQR 41·5-62·2 for chemotherapy plus bevacizumab; IQR 40·8-59·3 for chemotherapy), at which point 415 patients had died (214 in the chemotherapy group and 201 in the chemotherapy plus bevacizumab group). Based on pretreatment stratification data, median overall survival in the chemotherapy plus bevacizumab group was 42·2 months (95% CI 37·7-46·2) versus 37·3 months (32·6-39·7) in the chemotherapy group (hazard ratio [HR] 0·829; 95% CI 0·683-1·005; p=0·056). We identified incorrect treatment-free interval stratification data for 45 (7%) patients (equally balanced between treatment groups); a sensitivity analysis of overall survival based on the audited treatment-free interval stratification data gave an adjusted HR of 0·823 (95% CI 0·680-0·996; p=0·0447). In the safety population (all patients who initiated treatment), 317 (96%) of 325 patients in the chemotherapy plus bevacizumab group had at least one grade 3 or worse adverse event compared with 282 (86%) of 332 in the chemotherapy group; the most frequently reported of these in the chemotherapy plus bevacizumab group compared with the chemotherapy group were hypertension (39 [12%] vs two [1%]), fatigue (27 [8%] vs eight [2%]), and proteinuria (27 [8%] vs none). Two (1%) treatment-related deaths occurred in the chemotherapy group (infection [n=1] and myelodysplastic syndrome [n=1]) compared with nine (3%) in the chemotherapy plus bevacizumab group (infection [n=1], febrile neutropenia [n=1], myelodysplastic syndrome [n=1], secondary malignancy [n=1]; deaths not classified with CTCAE terms: disease progression [n=3], sudden death [n=1], and not specified [n=1]).InterpretationThe addition of bevacizumab to standard chemotherapy, followed by maintenance therapy until progression, improved the median overall survival in patients with platinum-sensitive recurrent ovarian cancer. Although the intention-to-treat analysis for overall survival was not significant, our sensitivity analysis based on corrected treatment-free interval stratification indicates that this strategy might be an important addition to the therapeutic armamentarium in these patients.FundingNational Cancer Institute and Genentech.
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- 2017
24. A phase I pharmacokinetic study of intraperitoneal bortezomib and carboplatin in patients with persistent or recurrent ovarian cancer: An NRG Oncology/Gynecologic Oncology Group study
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Jandial, Danielle A, Brady, William E, Howell, Stephen B, Lankes, Heather A, Schilder, Russell J, Beumer, Jan H, Christner, Susan M, Strychor, Sandra, Powell, Matthew A, Hagemann, Andrea R, Moore, Kathleen N, Walker, Joan L, DiSilvestro, Paul A, Duska, Linda R, Fracasso, Paula M, and Dizon, Don S
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Biomedical and Clinical Sciences ,Clinical Sciences ,Oncology and Carcinogenesis ,Rare Diseases ,Cancer ,Orphan Drug ,Digestive Diseases ,Clinical Trials and Supportive Activities ,Clinical Research ,Ovarian Cancer ,Pain Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adult ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Bortezomib ,Carboplatin ,Carcinoma ,Ovarian Epithelial ,Dose-Response Relationship ,Drug ,Female ,Humans ,Infusions ,Parenteral ,Middle Aged ,Neoplasm Recurrence ,Local ,Neoplasms ,Glandular and Epithelial ,Ovarian Neoplasms ,Young Adult ,Intraperitoneal ,Ovarian cancer ,Proteasome inhibition ,Platinum ,Paediatrics and Reproductive Medicine ,Oncology & Carcinogenesis ,Clinical sciences ,Oncology and carcinogenesis ,Reproductive medicine - Abstract
PurposeIntraperitoneal (IP) therapy improves survival compared to intravenous (IV) treatment for women with newly diagnosed, optimally cytoreduced, ovarian cancer. However, the role of IP therapy in recurrent disease is unknown. Preclinical data demonstrated IP administration of the proteasome inhibitor, bortezomib prior to IP carboplatin increased tumor platinum accumulation resulting in synergistic cytotoxicity. We conducted this phase I trial of IP bortezomib and carboplatin in women with recurrent disease.MethodsWomen with recurrent ovarian cancer were treated with escalating doses of IP bortezomib - in combination with IP carboplatin (AUC 4 or 5) every 21days for 6cycles. Pharmacokinetics of both agents were evaluated in cycle 1.ResultsThirty-three women participated; 32 were evaluable for safety. Two patients experienced dose-limiting toxicity (DLT) at the first dose level (carboplatin AUC 5, bortezomib 0.5mg/m2), prompting carboplatin reduction to AUC 4 for subsequent dose levels. With carboplatin dose fixed at AUC 4, bortezomib was escalated from 0.5 to 2.5mg/m2 without DLT. Grade 3/4 related toxicities included abdominal pain, nausea, vomiting, and diarrhea which were infrequent. The overall response rate in patients with measurable disease (n=21) was 19% (1 complete, 3 partial). Cmax and AUC in peritoneal fluid and plasma increased linearly with dose, with a favorable exposure ratio of the peritoneal cavity relative to peripheral blood plasma.ConclusionIP administration of this novel combination was feasible and showed promising activity in this phase I trial of heavily pre-treated women with ovarian cancer. Further evaluation of this IP combination should be conducted.
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- 2017
25. Is age a prognostic biomarker for survival among women with locally advanced cervical cancer treated with chemoradiation? An NRG Oncology/Gynecologic Oncology Group ancillary data analysis
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Moore, Kathleen N, Java, James J, Slaughter, Katrina N, Rose, Peter G, Lanciano, Rachelle, DiSilvestro, Paul A, Thigpen, J Tate, Lee, Yi-Chun, Tewari, Krishnansu S, Chino, Junzo, Seward, Shelly M, Miller, David S, Salani, Ritu, Moore, David H, and Stehman, Frederick B
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Clinical Trials and Supportive Activities ,Cervical Cancer ,Clinical Research ,Cancer ,Good Health and Well Being ,Age Factors ,Aged ,Aged ,80 and over ,Biomarkers ,Brachytherapy ,Chemoradiotherapy ,Female ,Humans ,Middle Aged ,Prognosis ,Uterine Cervical Neoplasms ,Cervical cancer ,Chemoradiation ,Oncology and Carcinogenesis ,Paediatrics and Reproductive Medicine ,Oncology & Carcinogenesis - Abstract
ObjectiveTo determine the effect of age on completion of and toxicities following treatment of local regionally advanced cervical cancer (LACC) on Gynecologic Oncology Group (GOG) Phase I-III trials.MethodsAn ancillary data analysis of GOG protocols 113, 120, 165, 219 data was performed. Wilcoxon, Pearson, and Kruskal-Wallis tests were used for univariate and multivariate analysis. Log rank tests were used to compare survival lengths.ResultsOne-thousand-three-hundred-nineteen women were included; 60.7% were Caucasian, 15% were age 60-70years and an additional 5% were >70; 87% had squamous histology, 55% had stage IIB disease and 34% had IIIB disease. Performance status declined with age (p=0.006). Histology and tumor stage did not significantly differ. Number of cycles of chemotherapy received, radiation treatment time, nor dose modifications varied with age. Notably, radiation protocol deviations and failure to complete brachytherapy (BT) did increase with age (p=0.022 and p50 for all-cause mortality (HR 1.02; 95% CI, 1.01-1.04) was found, but no association between age and disease specific mortality was found.ConclusionThis represents a large analysis of patients treated for LACC with chemo/radiation, approximately 20% of whom were >60years of age. Older patients, had higher rates of incomplete brachytherapy which is not explained by collected toxicity data. Age did not adversely impact completion of chemotherapy and radiation or toxicities.
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- 2016
26. SO018/#362 Molecular classification of endometrial cancers (EC) and association with relapse-free survival (RFS) outcomes: ancillary analysis of GOG-0258
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Clements, Aine, primary, Enserro, Danielle, additional, Strickland, Kyle, additional, Previs, Rebecca, additional, Disilvestro, Paul, additional, Spirtos, Nick, additional, Cosgrove, Casey, additional, Sfakianos, Greg, additional, Liu, J, additional, Vargas, Roberto, additional, Shahin, Mark, additional, Corr, Bradley, additional, Le, Linda Van, additional, Ueland, Frederick, additional, Warshal, David, additional, Gillen, Jessica, additional, and Secord, Angeles Alvarez, additional
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- 2023
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27. Consensus in controversy: The modified Delphi method applied to Gynecologic Oncology practice
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Cohn, David E, Havrilesky, Laura J, Osann, Kathryn, Lipscomb, Joseph, Hsieh, Susie, Walker, Joan L, Wright, Alexi A, Alvarez, Ronald D, Karlan, Beth Y, Bristow, Robert E, DiSilvestro, Paul A, Wakabayashi, Mark T, Morgan, Robert, Mukamel, Dana B, and Wenzel, Lari
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Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Cancer ,Rare Diseases ,Clinical Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Consensus ,Delphi Technique ,Female ,Humans ,Ovarian Neoplasms ,Ovarian cancer ,Intraperitoneal ,Delphi technique ,Opinion ,Paediatrics and Reproductive Medicine ,Oncology & Carcinogenesis ,Clinical sciences ,Oncology and carcinogenesis ,Reproductive medicine - Abstract
ObjectivesTo determine the degree of consensus regarding the probabilities of outcomes associated with IP/IV and IV chemotherapy.MethodsA survey was administered to an expert panel using the Delphi method. Ten ovarian cancer experts were asked to estimate outcomes for patients receiving IP/IV or IV chemotherapy. The clinical estimates were: 1) probability of completing six cycles of chemotherapy, 2) probability of surviving five years, 3) median survival, and 4) probability of ER/hospital visits during treatment. Estimates for two patients, one with a low comorbidity index (patient 1) and the other with a moderate index (patient 2), were included. The survey was administered in three rounds, and panelists could revise their subsequent responses based on review of the anonymous opinions of their peers.ResultsThe ranges were smaller for IV compared with IP/IV therapy. Ranges decreased with each round. Consensus converged around outcomes related to IP/IV chemotherapy for: 1) completion of 6 cycles of therapy (type 1 patient, 62%, type 2 patient, 43%); 2) percentage of patients surviving 5 years (type 1 patient, 66%, type 2 patient, 47%); and 3) median survival (type 1 patient, 83 months, type 2 patient, 58 months). The group required three rounds to achieve consensus on the probabilities of ER/hospital visits (type 1 patient, 24%, type 2 patient, 35%).ConclusionsInitial estimates of survival and adverse events associated with IP/IV chemotherapy differ among experts. The Delphi process works to build consensus and may be a pragmatic tool to inform patients of their expected outcomes.
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- 2015
28. Multiple biomarker algorithms to predict epithelial ovarian cancer in women with a pelvic mass: Can additional makers improve performance?
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Moore, Richard G., Blackman, Alexandra, Miller, M. Craig, Robison, Katina, DiSilvestro, Paul A., Eklund, Elizabeth E., Strongin, Robert, and Messerlian, Geralyn
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- 2019
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29. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial
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Vergote, Ignace, Scambia, Giovanni, Park, Sang Yoon, Song, Yong Sang, Makarova, Yulia, Trinidad, Joshua, Ngan, Hextan Yuen Sheung, Bamias, Aristotelis, Aravantinos, Gerasimos, Nam, Joo-Hyun, Gorbunova, Vera, Krikunova, Ludmila, Bae, Duk-Soo, Arija, Jose Angel Arranz, Mirza, Mansoor Raza, Zamagni, Claudio, Papandreou, Christos, Raspagliesi, Francesco, Lisyanskaya, Alla, Benzaquen, Ana Oaknin, Tognon, Germana, Ortega, Eugenia, Herraez, Antonio Casado, Buscema, Joseph, Green, Andrew, Burger, Robert, Sakaeva, Dina, Sanchez, Andres Redondo, Ghamande, Sharad, King, Laurel, Petru, Edgar, Peen, Ulla, Takeuchi, Satoshi, Ushijima, Kimio, Martin, Antonio Gonzalez, Kamelle, Scott, Carney, Michael, Marth, Christian, Forget, Frédéric, Bentley, James, Sehouli, Jalid, Colombo, Nicoletta, Zola, Paolo, Kato, Hidenori, Fadeeva, Natalya, Gotovkin, Evgeny, Vladimirov, Vladimir, Marin, Margarita Romeo, Alia, Eva Guerra, Shahin, Mark, Bhoola, Snehalkumar, Tewari, Krishnansu, Anderson, Daniel, Honhon, Brigitte, Pelgrims, Joseph (Gino), Oza, Amit, Jimenez, Jesus Garcia-Donas, Hansen, Vincent, O'Malley, David, Benjamin, Ivor, Renard, Vincent, Van den Bulck, Heidi, Meier, Werner, Haenle, Claudia, Koumakis, Georgios, Yokota, Harushige, Popov, Vadim, Bradley, William, Wenham, Robert, Reid, Robert, McNamara, Donna, Friedman, Richard, Barlin, Joyce, Spirtos, Nicola, Chapman, Julia, Sevelda, Paul, Huizing, Manon, Lamot, Caroline, Goffin, Frédéric, Hondt, Lionel D, Covens, Allan, Spadafora, Silvana, Rautenberg, Beate, Reimer, Toralf, Möbus, Volker, Hilpert, Felix, Gropp-Meier, Martina, Savarese, Antonella, Pignata, Sandro, Verderame, Francesco, Mizuno, Mika, Takano, Hirokuni, Ottevanger, Petronella, Velasco, Andres Poveda, Palacio-Vazquez, Isabel, Law, Amy, McIntyre, Kristi, Teneriello, Michael, Fields, Abbie, Lentz, Samuel, Street, Daron, Schwartz, Benjamin, Mannel, Robert, Lim, Peter, Pulaski, Heather, Janni, Wolfgang, Zorr, Andreas, Karck, Ulrich, Cheng, Ashley Chi Kin, Sorio, Roberto, Gridelli, Cesare, Aoki, Daisuke, Oishi, Tetsuro, Hirashima, Yasuyuki, Boere, Ingrid, Ferrer, Esther Falco, Braly, Patricia, Wilks, Sharon, Lee, Christine, Schilder, Jeanne, Veljovich, Dan, Secord, Angeles, Davis, Kevin, Rojas-Espaillat, Luis, Lele, Shashikant, DePasquale, Stephen, Squatrito, Robert, Schauer, Christian, Dirix, Luc, Vuylsteke, Peter, Joosens, Eric, Provencher, Diane, Lueck, Hans-Joachim, Hein, Alexander, Burges, Alexander, Canzler, Ulrich, Park-Simon, Tjoung-Won, Griesinger, Frank, Gadducci, Angiolo, Alabiso, Oscar, Okamoto, Aikou, Sawasaki, Takashi, Saito, Toshiaki, Ibañez, Ana Herrero, Calomeni, Coralia, Spillman, Monique, Choksi, Janak, Taylor, Nicholas, Muller, Carolyn, Moore, David, DiSilvestro, Paul, Cunningham, Mary, Rose, Peter, Oppelt, Peter, Verhoeven, Didier, Graas, Marie-Pascale, Ghatage, Prafull, Tonkin, Katia, Kurzeder, Christian, Schnappauf, Benjamin, Müller, Volkmar, Schmalzrie, Hannah, Kalofonos, Haralambos, Bruzzone, Milena, Kroep, Judith, Diaz, Cristina Caballero, Garcia, Jeronimo Martinez, Polo, Susana Hernando, Garrison, Mitchell, Rocconi, Rodney, Andrews, Stephen, Bristow, Robert, McHale, Michael, Basil, Jack, Houck III, William, Bell, Maria, Cosin, Jonathan, Modesitt, Susan, Kendrick, James, Wade III, James, Wong, Cheung, Evans, Anthony, Buekers, Thomas, Vanderkwaak, Timothy, Ferriss, James, Darus, Christopher, DAndre, Stacy, Higgins, Robert, Monk, Bradley, Bakkum-Gamez, Jamie, DeMars, Leslie, Van Le, Linda, Puls, Larry, Trehan, Shruti, LaPolla, James, Michelson, Elizabeth Dickson, Merchant, Joseph, Peterson, Christopher, Reid, Gary, Seago, Donald, Zweizig, Susan, Gajewski, Walter, Panwalkar, Amit, Leikermoser, Rudolf, Bogner, Gerhard, Debruyne, Philip, D'hondt, Randal, Berteloot, Patrick, Kerger, Joseph, Biagi, James, Castonguay, Vincent, Welch, Stephen, Muhic, Aida, Heubner, Martin, Grischke, Eva-Maria, Rack, Brigitte, Fleisch, Markus, Lordick, Florian, Pectasides, Dimitrios, Ho, Wing Ming, Selvaggi, Luigi, Vasquez, Flavia Morales, Villanueva, William Orlando Brito, Alavez, Alejandro Molina, Kessels, Lonneke, Bertran, Ana Santaballa, Fernandez, Cesar Mendiola, Fabregat, Miguel Beltran, Del Prete, Salvatore, Elkas, John, Cecchi, Gary, Kumar, Pallavi, Huh, Warner, Messing, Mark, Karimi, Misagh, Kelley, Ann, Edraki, Babak, Mutch, David, Leiserowitz, Gary, Anderson, Jeanne, Lentz, Scott, Chambers, Setsuko, Morris, Robert, Waggoner, Steven, Gordon, Alan, Method, Michael, Johnson, Peter, Lord, Raymond, Drake, Janet, Sivarajan, Kulumani, Midathada, Madhu, Rice, Kristen, Wadsworth, Troy, Pavelka, James, Edwards, Robert, Miller, David Scott, Ford, Patricia Locantore, Hurteau, Jean, Bender, David, Schimp, Veronica, Creasman, William, Lerner, Rachel, Chamberlain, Donald, Kueck, Angela, McDonald, John, Malad, Salman, Robinson-Bennett, Bernice, Davidson, Susan, Krivak, Thomas, Lestingi, Timothy, Arango, Hector, Berard, Paul, Finkelstein, Karen, Gaur, Rakesh, Krasner, Carolyn, Ueland, Frederick, Talmage, Lance, Yamada, Seiko, Sutton, Gregory, Potkul, Ronald, Prasad-Hayes, Monica, Osborne, Janet, Celano, Paul, Thigpen, James, Sharma, Sudarshan, Schilder, Russell, Tammela, Jonathan, Kemeny, Mary, Brown, Amy, Eisenhauer, Eric, Williams, James, Rowland, Kendrith, Nahum, Kenneth, Burke, James, Dar, Zahid, Fleming, Nicole, Gibb, Randall, Guirguis, Alfred, Herzog, Thomas, John, Veena, Kumar, Santhosh, Kamat, Aparna, Kassar, Mohamad, Leitao, Mario, Levine, Lyuba, Mendez, Luis, Patel, Dhimant, Berry, Emily, Warshal, David, Wolf, Judith, Zarwan, Corrine, Collins, Yvonne, Spitzer, Gary, Miller, Brigitte, Einstein, Mark, O'Malley, David M, Van Calster, Ben, Park, Sang-Yoon, del Campo, Josep M, Wenham, Robert M, Covens, Al, Raza Mirza, Mansoor, Kroep, Judith R, Ma, Haijun, Pickett, Cheryl A, and Monk, Bradley J
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- 2019
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30. Shaping the standard of care in ovarian cancer management: A review of Gynecologic Oncology Group (GOG)/NRG oncology clinical trials of the past twenty years
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DiSilvestro, Paul A.
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- 2019
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31. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial
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Moore, Kathleen N, Secord, Angeles Alvarez, Geller, Melissa A, Miller, David Scott, Cloven, Noelle, Fleming, Gini F, Wahner Hendrickson, Andrea E, Azodi, Masoud, DiSilvestro, Paul, Oza, Amit M, Cristea, Mihaela, Berek, Jonathan S, Chan, John K, Rimel, Bobbie J, Matei, Daniela E, Li, Yong, Sun, Kaiming, Luptakova, Katarina, Matulonis, Ursula A, and Monk, Bradley J
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- 2019
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32. Pathologic findings at risk-reducing salpingo-oophorectomy: primary results from Gynecologic Oncology Group Trial GOG-0199.
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Sherman, Mark, Piedmonte, Marion, Mai, Phuong, Ioffe, Olga, Ronnett, Brigitte, Van Le, Linda, Ivanov, Iouri, Bell, Maria, Blank, Stephanie, DiSilvestro, Paul, Hamilton, Chad, Wakeley, Katie, Kauff, Noah, Yamada, S, Rodriguez, Gustavo, Skates, Steven, Alberts, David, Walker, Joan, Minasian, Lori, Lu, Karen, Greene, Mark, and Tewari, Krishnansu
- Subjects
Adult ,Biomarkers ,Tumor ,Breast Neoplasms ,CA-125 Antigen ,Fallopian Tube Neoplasms ,Female ,Genes ,BRCA1 ,Genes ,BRCA2 ,Genetic Predisposition to Disease ,Humans ,Middle Aged ,Mutation ,Neoplasm Invasiveness ,Neoplasms ,Unknown Primary ,Ovarian Neoplasms ,Ovariectomy ,Risk Factors - Abstract
PURPOSE: Risk-reducing salpingo-oophorectomy (RRSO) lowers mortality from ovarian/tubal and breast cancers among BRCA1/2 mutation carriers. Uncertainties persist regarding potential benefits of RRSO among high-risk noncarriers, optimal surgical age, and anatomic origin of clinically occult cancers detected at surgery. To address these topics, we analyzed surgical treatment arm results from Gynecologic Oncology Group Protocol-0199 (GOG-0199), the National Ovarian Cancer Prevention and Early Detection Study. PARTICIPANTS AND METHODS: This analysis included asymptomatic high-risk women age ≥ 30 years who elected RRSO at enrollment. Women provided risk factor data and underwent preoperative cancer antigen 125 (CA-125) serum testing and transvaginal ultrasound (TVU). RRSO specimens were processed according to a standardized tissue processing protocol and underwent central pathology panel review. Research-based BRCA1/2 mutation testing was performed when a participants mutation status was unknown at enrollment. Relationships between participant characteristics and diagnostic findings were assessed using univariable statistics and multivariable logistic regression. RESULTS: Invasive or intraepithelial ovarian/tubal/peritoneal neoplasms were detected in 25 (2.6%) of 966 RRSOs (BRCA1 mutation carriers, 4.6%; BRCA2 carriers, 3.5%; and noncarriers, 0.5%; P < .001). In multivariable models, positive BRCA1/2 mutation status (P = .0056), postmenopausal status (P = .0023), and abnormal CA-125 levels and/or TVU examinations (P < .001) were associated with detection of clinically occult neoplasms at RRSO. For 387 women with negative BRCA1/2 mutation testing and normal CA-125 levels, findings at RRSO were benign. CONCLUSION: Clinically occult cancer was detected among 2.6% of high-risk women undergoing RRSO. BRCA1/2 mutation, postmenopausal status, and abnormal preoperative CA-125 and/or TVU were associated with cancer detection at RRSO. These data can inform management decisions among women at high risk of ovarian/tubal cancer.
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- 2014
33. Phase III randomized trial of weekly cisplatin and irradiation versus cisplatin and tirapazamine and irradiation in stages IB2, IIA, IIB, IIIB, and IVA cervical carcinoma limited to the pelvis: a Gynecologic Oncology Group study.
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DiSilvestro, Paul, Ali, Shamshad, Craighead, Peter, Lucci, Joseph, Lee, Yi-Chun, Cohn, David, Spirtos, Nicola, Muller, Carolyn, Gajewski, Walter, Steinhoff, Margaret, Monk, Bradley, and Tewari, Krishnansu
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Adenocarcinoma ,Adult ,Aged ,Antineoplastic Combined Chemotherapy Protocols ,Canada ,Carcinoma ,Adenosquamous ,Carcinoma ,Squamous Cell ,Chemoradiotherapy ,Chi-Square Distribution ,Cisplatin ,Disease Progression ,Disease-Free Survival ,Female ,Humans ,Kaplan-Meier Estimate ,Middle Aged ,Neoplasm Staging ,Proportional Hazards Models ,Prospective Studies ,Time Factors ,Tirapazamine ,Treatment Outcome ,Triazines ,United States ,Uterine Cervical Neoplasms - Abstract
PURPOSE: This prospective, randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine (TPZ) to standard cisplatin (CIS) chemoradiotherapy in locally advanced cervix cancer. PATIENTS AND METHODS: Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy. Primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS) and tolerability. RESULTS: PFS was evaluable in 387 of 402 patients randomly assigned over 36 months, with enrollment ending in September 2009. Because of the lack of TPZ supply, the study did not reach its original target accrual goal. At median follow-up of 28.3 months, PFS and OS were similar in both arms. Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0% and 64.4%, respectively (log-rank P = .7869). Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5% and 70.6%, respectively (log-rank P = .8333). A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm, with resulting tolerance in both treatment arms. CONCLUSION: TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS, although definitive commentary was limited by an inadequate number of events (progression or death). TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose.
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- 2014
34. An NRG Oncology/GOG study of molecular classification for risk prediction in endometrioid endometrial cancer
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Cosgrove, Casey M., Tritchler, David L., Cohn, David E., Mutch, David G., Rush, Craig M., Lankes, Heather A., Creasman, William T., Miller, David S., Ramirez, Nilsa C., Geller, Melissa A., Powell, Matthew A., Backes, Floor J., Landrum, Lisa M., Timmers, Cynthia, Suarez, Adrian A., Zaino, Richard J., Pearl, Michael L., DiSilvestro, Paul A., Lele, Shashikant B., and Goodfellow, Paul J.
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- 2018
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35. Incorporation of triapine (T) with cisplatin chemoradiation (CRT) for locally advanced cervical and vaginal cancer: Results from NRG-GY006, a phase III randomized trial.
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Leath, Charles A., primary, Deng, Wei, additional, Mell, Loren K., additional, Richardson, Debra L., additional, Walker, Joan L., additional, Holman, Laura L., additional, Lea, Jayanthi Sivasothy, additional, Amarnath, Sudha R., additional, Santos-Reyes, Luis Javier, additional, Arend, Rebecca Christian, additional, Mayadev, Jyoti, additional, Jegadeesh, Naresh, additional, Disilvestro, Paul, additional, Chon, Hye Sook, additional, Ghamande, Sharad A., additional, Quick, Allison M, additional, Chino, Junzo P., additional, Mackay, Helen, additional, Aghajanian, Carol, additional, and Monk, Bradley J., additional
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- 2023
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36. Surgical-pathological findings in type 1 and 2 endometrial cancer: An NRG Oncology/Gynecologic Oncology Group study on GOG-210 protocol
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Creasman, William T., Ali, Shamshad, Mutch, David G., Zaino, Richard J., Powell, Matthew A., Mannel, Robert S., Backes, Floor J., DiSilvestro, Paul A., Argenta, Peter A., Pearl, Michael L., Lele, Shashikant B., Guntupalli, Saketh R., Waggoner, Steven, Spirtos, Nick, Boggess, John F., Edwards, Robert P., Filiaci, Virginia L., and Miller, David S.
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- 2017
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37. FGFR2 mutations are associated with poor outcomes in endometrioid endometrial cancer: An NRG Oncology/Gynecologic Oncology Group study
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Jeske, Yvette W., Ali, Shamshad, Byron, Sara A, Gao, Feng, Mannel, Robert S, Ghebre, Rahel G, DiSilvestro, Paul A, Lele, Shashikant B, Pearl, Michael L, Schmidt, Amy P, Lankes, Heather A, Ramirez, Nilsa C, Rasty, Golnar, Powell, Matthew, Goodfellow, Paul J, and Pollock, Pamela M
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- 2017
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38. The biomarker HE4 (WFDC2) promotes a pro-angiogenic and immunosuppressive tumor microenvironment via regulation of STAT3 target genes
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James, Nicole E., Emerson, Jenna B., Borgstadt, Ashley D., Beffa, Lindsey, Oliver, Matthew T., Hovanesian, Virginia, Urh, Anze, Singh, Rakesh K., Rowswell-Turner, Rachael, DiSilvestro, Paul A., Ou, Joyce, Moore, Richard G., and Ribeiro, Jennifer R.
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- 2020
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39. Secondary Surgical Cytoreduction for Recurrent Ovarian Cancer
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Coleman, Robert L., Spirtos, Nick M., Enserro, Danielle, Herzog, Thomas J., Sabbatini, Paul, Armstrong, Deborah K., Kim, Jae-Weon, Park, Sang-Yoon, Kim, Byoung-Gie, Nam, Joo-Hyun, Fujiwara, Keiichi, Walker, Joan L., Casey, Ann C., Alvarez Secord, Angeles, Rubin, Steve, Chan, John K., DiSilvestro, Paul, Davidson, Susan A., Cohn, David E., Tewari, Krishnansu S., Basen-Engquist, Karen, Huang, Helen Q., Brady, Mark F., and Mannel, Robert S.
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- 2020
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40. Supplementary Data from Circulating Tumor Cells In Advanced Cervical Cancer: NRG Oncology—Gynecologic Oncology Group Study 240 (NCT 00803062)
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Tewari, Krishnansu S., primary, Sill, Michael W., primary, Monk, Bradley J., primary, Penson, Richard T., primary, Moore, David H., primary, Lankes, Heather A., primary, Ramondetta, Lois M., primary, Landrum, Lisa M., primary, Randall, Leslie M., primary, Oaknin, Ana, primary, Leitao, Mario M., primary, Eisenhauer, Eric L., primary, DiSilvestro, Paul, primary, Van Le, Linda, primary, Pearl, Michael L., primary, Burke, James J., primary, Salani, Ritu, primary, Richardson, Debra L., primary, Michael, Helen E., primary, Kindelberger, David W., primary, and Birrer, Michael J., primary
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- 2023
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41. Supplementary Figure Legends from CT Perfusion as an Early Biomarker of Treatment Efficacy in Advanced Ovarian Cancer: An ACRIN and GOG Study
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Ng, Chaan S., primary, Zhang, Zheng, primary, Lee, Susanna I., primary, Marques, Helga S., primary, Burgers, Kyle, primary, Su, Feng, primary, Bauza, Joseph, primary, Mannel, Robert S., primary, Walker, Joan L., primary, Huh, Warner King, primary, Rubin, Stephen C., primary, DiSilvestro, Paul, primary, Martin, Lainie P., primary, Chan, John K., primary, Bookman, Michael A., primary, Coleman, Robert L., primary, and Lee, Ting-Yim, primary
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- 2023
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42. Supplementary Figure 1-2 from CT Perfusion as an Early Biomarker of Treatment Efficacy in Advanced Ovarian Cancer: An ACRIN and GOG Study
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Ng, Chaan S., primary, Zhang, Zheng, primary, Lee, Susanna I., primary, Marques, Helga S., primary, Burgers, Kyle, primary, Su, Feng, primary, Bauza, Joseph, primary, Mannel, Robert S., primary, Walker, Joan L., primary, Huh, Warner King, primary, Rubin, Stephen C., primary, DiSilvestro, Paul, primary, Martin, Lainie P., primary, Chan, John K., primary, Bookman, Michael A., primary, Coleman, Robert L., primary, and Lee, Ting-Yim, primary
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- 2023
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43. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial
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Disilvestro, P, Banerjee, S, Colombo, N, Scambia, G, Kim, B, Oaknin, A, Friedlander, M, Lisyanskaya, A, Floquet, A, Leary, A, Sonke, G, Gourley, C, Oza, A, González-Martín, A, Aghajanian, C, Bradley, W, Mathews, C, Liu, J, Mcnamara, J, Lowe, E, Ah-See, M, Moore, K, DiSilvestro, Paul, Banerjee, Susana, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Friedlander, Michael, Lisyanskaya, Alla, Floquet, Anne, Leary, Alexandra, Sonke, Gabe S, Gourley, Charlie, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William, Mathews, Cara, Liu, Joyce, McNamara, John, Lowe, Elizabeth S, Ah-See, Mei-Lin, Moore, Kathleen N, Disilvestro, P, Banerjee, S, Colombo, N, Scambia, G, Kim, B, Oaknin, A, Friedlander, M, Lisyanskaya, A, Floquet, A, Leary, A, Sonke, G, Gourley, C, Oza, A, González-Martín, A, Aghajanian, C, Bradley, W, Mathews, C, Liu, J, Mcnamara, J, Lowe, E, Ah-See, M, Moore, K, DiSilvestro, Paul, Banerjee, Susana, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Friedlander, Michael, Lisyanskaya, Alla, Floquet, Anne, Leary, Alexandra, Sonke, Gabe S, Gourley, Charlie, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William, Mathews, Cara, Liu, Joyce, McNamara, John, Lowe, Elizabeth S, Ah-See, Mei-Lin, and Moore, Kathleen N
- Abstract
PURPOSEIn SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986), maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation. We report overall survival (OS) after a 7-year follow-up, a clinically relevant time point and the longest follow-up for any poly(ADP-ribose) polymerase inhibitor in the first-line setting.METHODSThis double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib (n = 260) or placebo (n = 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end point, was conducted after a 7-year follow-up.RESULTSThe median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to 0.76; P =.0004 [P <.0001 required to declare statistical significance]). At 7 years, 67.0% of olaparib patients versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not received a first subsequent treatment (Kaplan-Meier estimates). The incidence of myelodysplastic syndrome and acute myeloid leukemia remained low, and new primary malignancies remained balanced between treatment groups.CONCLUSIONResults indicate a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term follow-up.
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- 2023
44. Utility of PET-CT to evaluate retroperitoneal lymph node metastasis in advanced cervical cancer: Results of ACRIN6671/GOG0233 trial
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Atri, Mostafa, Zhang, Zheng, Dehdashti, Farrokh, Lee, Susanna I., Ali, Shamshad, Marques, Helga, Koh, Wui-Jin, Moore, Kathleen, Landrum, Lisa, Kim, Jae Weon, DiSilvestro, Paul, Eisenhauer, Eric, Schnell, Frederick, and Gold, Michael
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- 2016
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45. Evaluation of anal cytology and dysplasia in women with a history of lower genital tract dysplasia and malignancy
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Cronin, Beth, Bregar, Amy, Luis, Christine, Schechter, Steven, Disilvestro, Paul, Pisharodi, Latha, Sung, C. James, Raker, Christina, Clark, Melissa, and Robison, Katina
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- 2016
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46. A phase I trial of pegylated liposomal doxorubicin (PLD), carboplatin, bevacizumab and veliparib in recurrent, platinum-sensitive ovarian, primary peritoneal, and fallopian tube cancer: An NRG Oncology/Gynecologic Oncology Group study
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Landrum, Lisa M., Brady, William E., Armstrong, Deborah K., Moore, Kathleen N., DiSilvestro, Paul A., O'Malley, David M., Tenney, Meaghan E., Rose, Peter G., and Fracasso, Paula M.
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- 2016
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47. Assessing the risk of ovarian malignancy algorithm for the conservative management of women with a pelvic mass
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Lokich, Elizabeth, Palisoul, Marguerite, Romano, Nicole, Craig Miller, M., Robison, Katina, Stuckey, Ashley, DiSilvestro, Paul, Mathews, Cara, Granai, C.O., Lambert-Messerlian, Geralyn, and Moore, Richard G.
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- 2015
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48. Randomized Clinical Trial of Intravenous Versus Intraperitoneal Chemotherapy Plus Bevacizumab in Advanced Ovarian Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study
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Walker, Joan L., Brady, Mark F., Wenzel, Lari, Fleming, Gini F., Huang, Helen Q., DiSilvestro, Paul A., Fujiwara, Keiichi, Alberts, David S., Zheng, Wenxin, Tewari, Krishnansu S., Cohn, David E., Powell, Matthew A., Van Le, Linda, Davidson, Susan A., Gray, Heidi J., Rose, Peter G., Aghajanian, Carol, Myers, Tashanna, Secord, Angeles Alvarez, Rubin, Stephen C., and Mannel, Robert S.
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- 2019
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49. Maintenance Olaparib in Patients With Newly Diagnosed Advanced Ovarian Cancer
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Moore, Kathleen, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Friedlander, Michael, Lisyanskaya, Alla, Floquet, Anne, Leary, Alexandra, Sonke, Gabe S., Gourley, Charlie, Banerjee, Susana, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William, Mathews, Cara, Liu, Joyce, Lowe, Elizabeth S., Bloomfield, Ralph, and DiSilvestro, Paul
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- 2019
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50. O014/#415 Phase II trial of pembrolizumab and epacadostat in recurrent clear cell carcinoma of the ovary: an NRG oncology study
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Gien, Lilian, primary, Enserro, Danielle, additional, Block, Matthew, additional, Waggoner, Steven, additional, Duska, Linda, additional, Hendrickson, Andrea Wahner, additional, Thaker, Premal, additional, Backes, Floor, additional, Bottsford-Miller, Justin, additional, Muller, Carolyn, additional, Disilvestro, Paul, additional, Covens, Allan, additional, Gershenson, David, additional, Moore, Kathleen, additional, Aghajanian, Carol, additional, and Coleman, Robert L, additional
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- 2022
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