Pub Date : 2013-12-01DOI: 10.1016/j.cogc.2014.06.002
Ilya Pokataev, Alexey Tryakin, Alexandra Tjulandina, Mikhail Fedyanin, Sergei Tjulandin
Introduction
This study was aimed at evaluating the efficacy and tolerability of oxaliplatin/doxorubicin combination therapy in patients with platinum-sensitive and platinum-resistant ovarian cancer.
Materials and Methods
Patients with recurrent ovarian cancer after 1 regimen of platinum-based chemotherapy received doxorubicin (50 mg/m2 intravenously) and oxaliplatin (130 mg/m2 intravenously) on day 1 every 3 weeks. The platinum-free interval was set to be < 24 months.
Results
A total of 33 patients were enrolled (21 platinum-resistant and 12 platinum-sensitive relapses). The response rate in platinum-resistant ovarian cancer was lower than in platinum-sensitive disease (33.4% vs. 54.5%), although the difference was not statistically significant (P = .59). The median progression-free survival (PFS) and overall survival in the whole cohort were 7.4 and 24.3 months, respectively. PFS in platinum-sensitive cancer was longer than in platinum-resistant cancer (10.8 vs. 6.7 months); however, this difference did not reach statistical significance (P = .14).
Conclusion
The combination of oxaliplatin/doxorubicin is an active regimen for patients with platinum-sensitive and platinum-resistant recurrent ovarian cancer.
{"title":"A Phase II Nonrandomized Study of Oxaliplatin/Doxorubicin Combination Therapy in the Treatment of Recurrent Ovarian Cancer","authors":"Ilya Pokataev, Alexey Tryakin, Alexandra Tjulandina, Mikhail Fedyanin, Sergei Tjulandin","doi":"10.1016/j.cogc.2014.06.002","DOIUrl":"10.1016/j.cogc.2014.06.002","url":null,"abstract":"<div><h3>Introduction</h3><p>This study was aimed at evaluating the efficacy and tolerability of oxaliplatin/doxorubicin combination therapy in patients with platinum-sensitive and platinum-resistant ovarian cancer.</p></div><div><h3>Materials and Methods</h3><p>Patients with recurrent ovarian cancer after 1 regimen of platinum-based chemotherapy received doxorubicin (50 mg/m<sup>2</sup> intravenously) and oxaliplatin (130 mg/m<sup>2</sup> intravenously) on day 1 every 3 weeks. The platinum-free interval was set to be < 24 months.</p></div><div><h3>Results</h3><p>A total of 33 patients were enrolled (21 platinum-resistant and 12 platinum-sensitive relapses). The response rate in platinum-resistant ovarian cancer was lower than in platinum-sensitive disease (33.4% vs. 54.5%), although the difference was not statistically significant (<em>P</em> = .59). The median progression-free survival (PFS) and overall survival in the whole cohort were 7.4 and 24.3 months, respectively. PFS in platinum-sensitive cancer was longer than in platinum-resistant cancer (10.8 vs. 6.7 months); however, this difference did not reach statistical significance (<em>P</em> = .14).</p></div><div><h3>Conclusion</h3><p>The combination of oxaliplatin/doxorubicin is an active regimen for patients with platinum-sensitive and platinum-resistant recurrent ovarian cancer.</p></div>","PeriodicalId":100274,"journal":{"name":"Clinical Ovarian and Other Gynecologic Cancer","volume":"6 1","pages":"Pages 11-16"},"PeriodicalIF":0.0,"publicationDate":"2013-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cogc.2014.06.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84899936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2013-12-01DOI: 10.1016/j.cogc.2013.12.007
Valentin Luc Jr. , Michel Canis , Gérard Mage , Nicolas Bourdel
{"title":"Ovarian Dermoid Cyst Recurrence, 15 Years Later, in the Form of Intra-Abdominal Thyroid Tissue Mass","authors":"Valentin Luc Jr. , Michel Canis , Gérard Mage , Nicolas Bourdel","doi":"10.1016/j.cogc.2013.12.007","DOIUrl":"10.1016/j.cogc.2013.12.007","url":null,"abstract":"","PeriodicalId":100274,"journal":{"name":"Clinical Ovarian and Other Gynecologic Cancer","volume":"6 1","pages":"Pages 50-52"},"PeriodicalIF":0.0,"publicationDate":"2013-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cogc.2013.12.007","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73462113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2013-12-01DOI: 10.1016/j.cogc.2014.06.003
Caroline C. Billingsley , Jonathan R. Foote , Jeffrey E. Korte , Elizabeth A. Gagliardi , Matthew F. Kohler , William T. Creasman
This study aimed to determine the postoperative fever index in the gynecologic oncology patient associated with significant infectious morbidity. A retrospective analysis was performed of 355 patients who underwent abdominal surgery. Charts were reviewed to evaluate postoperative temperature and risk factors for infectious morbidity. Statistical analyses were performed as indicated by the data type, including the Student t test, Mann-Whitney U test, χ2 test, and 1-way analysis of variance. A value of P < .05 was considered significant. There were 210 patients with temperatures < 100.5°F (group 1), 69 with a temperature ≥ 100.5°F to < 101°F (group 2), and 76 with a temperature ≥ 101°F (group 3). Demographic data were similar among groups. There were 285 diagnostic tests performed, with 51 test results indicative of infectious morbidity. Patients in group 3 underwent more testing and had more positive test results compared with groups 1 and 2. The majority of diagnostic testing and positive test results (60%) were in patients from group 3. Groups 1 and 2 were statistically similar in the number of positive test results and antibiotic duration, demonstrating a lower risk of infectious morbidity compared with group 3. This study suggests that a postoperative temperature of ≥ 101°F appears to be a better predictor of significant infectious morbidity compared with the prior definition of a temperature ≥ 100.5°F. Furthermore, this illustrates the need for the development of a postoperative temperature evaluation protocol to avoid expensive evaluations and empiric treatment of benign causes of postoperative fever.
{"title":"Evaluation of Risk Factors for Infectious Morbidity in Postoperative Gynecologic Oncology Patients: A Time for a New Paradigm?","authors":"Caroline C. Billingsley , Jonathan R. Foote , Jeffrey E. Korte , Elizabeth A. Gagliardi , Matthew F. Kohler , William T. Creasman","doi":"10.1016/j.cogc.2014.06.003","DOIUrl":"10.1016/j.cogc.2014.06.003","url":null,"abstract":"<div><p>This study aimed to determine the postoperative fever index in the gynecologic oncology patient associated with significant infectious morbidity. A retrospective analysis was performed of 355 patients who underwent abdominal surgery. Charts were reviewed to evaluate postoperative temperature and risk factors for infectious morbidity. Statistical analyses were performed as indicated by the data type, including the Student <em>t</em> test, Mann-Whitney <em>U</em> test, χ<sup>2</sup> test, and 1-way analysis of variance. A value of <em>P</em> < .05 was considered significant. There were 210 patients with temperatures < 100.5°F (group 1), 69 with a temperature ≥ 100.5°F to < 101°F (group 2), and 76 with a temperature ≥ 101°F (group 3). Demographic data were similar among groups. There were 285 diagnostic tests performed, with 51 test results indicative of infectious morbidity. Patients in group 3 underwent more testing and had more positive test results compared with groups 1 and 2. The majority of diagnostic testing and positive test results (60%) were in patients from group 3. Groups 1 and 2 were statistically similar in the number of positive test results and antibiotic duration, demonstrating a lower risk of infectious morbidity compared with group 3. This study suggests that a postoperative temperature of ≥ 101°F appears to be a better predictor of significant infectious morbidity compared with the prior definition of a temperature ≥ 100.5°F. Furthermore, this illustrates the need for the development of a postoperative temperature evaluation protocol to avoid expensive evaluations and empiric treatment of benign causes of postoperative fever.</p></div>","PeriodicalId":100274,"journal":{"name":"Clinical Ovarian and Other Gynecologic Cancer","volume":"6 1","pages":"Pages 1-6"},"PeriodicalIF":0.0,"publicationDate":"2013-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cogc.2014.06.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79918916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The primary debulking surgery that is performed to achieve complete debulking is one of the most important prognostic factors in patients with advanced ovarian cancer. However, the relationship between lymph node metastases and the surgical outcome is still unclear. This study analyzed the effect of the N factor on the prognosis of patients with pT3C ovarian cancer who underwent optimal surgery (OpS).
Patients and Methods
The participants were 68 patients with pT3C serous adenocarcinoma. The overall survival (OS) and the median survival time (MST) were analyzed by the diameter of the residual tumor and by lymph node metastasis using the Kaplan-Meier method and the log-rank test. The patients received retroperitoneal lymph node dissection in the pelvic cavity up to the para-aortic lymph nodes. The patients in the OpS group were further divided into a complete-surgery group with no residual tumor and a group with residual tumor of less than 1 cm, and differences were analyzed.
Results
The OS rates in the OpS group and Sub-OpS group were 77.5% and 11.1%, respectively. According to the analyses made by different levels of lymph node metastasis in all patients, the OS rates in patients with N0 and N1 disease were 77.1% and 47.5%, respectively; the prognosis was significantly poorer in the N1 group. According to the analyses of the N factor in the OpS group, the prognosis was significantly poorer in the N1 group even with OpS compared with that in the N0 group (53.7% and 86.6%, respectively). Furthermore, in the N1 group with OpS, the prognosis was significantly better in the complete-surgery group than in the other group with residual tumor of less than 1 cm (77.8% and 16.7%, respectively).
Conclusion
The prognosis of pT3CpN1 ovarian cancer with OpS was as poor as with Sub-OpS. However, the results suggested that the prognosis could be improved if the tumor was completely resected in OpS.
{"title":"Effect of the N Factor on the Prognosis of pT3C Ovarian Cancer With Optimal Debulking Surgery","authors":"Fumitoshi Terauchi, Takahisa Ishikawa, Ryoko Omura, Tetsuya Moritake, Rina Kato, Yasukazu Sagawa, Hirotaka Nishi, Hiroe Ito, Keiichi Isaka","doi":"10.1016/j.cogc.2014.06.006","DOIUrl":"10.1016/j.cogc.2014.06.006","url":null,"abstract":"<div><h3>Introduction</h3><p>The primary debulking surgery that is performed to achieve complete debulking is one of the most important prognostic factors in patients with advanced ovarian cancer. However, the relationship between lymph node metastases and the surgical outcome is still unclear. This study analyzed the effect of the N factor on the prognosis of patients with pT3C ovarian cancer who underwent optimal surgery (OpS).</p></div><div><h3>Patients and Methods</h3><p>The participants were 68 patients with pT3C serous adenocarcinoma. The overall survival (OS) and the median survival time (MST) were analyzed by the diameter of the residual tumor and by lymph node metastasis using the Kaplan-Meier method and the log-rank test. The patients received retroperitoneal lymph node dissection in the pelvic cavity up to the para-aortic lymph nodes. The patients in the OpS group were further divided into a complete-surgery group with no residual tumor and a group with residual tumor of less than 1 cm, and differences were analyzed.</p></div><div><h3>Results</h3><p>The OS rates in the OpS group and Sub-OpS group were 77.5% and 11.1%, respectively. According to the analyses made by different levels of lymph node metastasis in all patients, the OS rates in patients with N0 and N1 disease were 77.1% and 47.5%, respectively; the prognosis was significantly poorer in the N1 group. According to the analyses of the N factor in the OpS group, the prognosis was significantly poorer in the N1 group even with OpS compared with that in the N0 group (53.7% and 86.6%, respectively). Furthermore, in the N1 group with OpS, the prognosis was significantly better in the complete-surgery group than in the other group with residual tumor of less than 1 cm (77.8% and 16.7%, respectively).</p></div><div><h3>Conclusion</h3><p>The prognosis of pT3CpN1 ovarian cancer with OpS was as poor as with Sub-OpS. However, the results suggested that the prognosis could be improved if the tumor was completely resected in OpS.</p></div>","PeriodicalId":100274,"journal":{"name":"Clinical Ovarian and Other Gynecologic Cancer","volume":"6 1","pages":"Pages 36-41"},"PeriodicalIF":0.0,"publicationDate":"2013-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cogc.2014.06.006","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80221713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2012-12-01DOI: 10.1016/j.cogc.2013.12.001
Monjri M. Shah, Jacob M. Estes, Ronald D. Alvarez
{"title":"No Residual Disease: The New Definition for Optimal Cytoreduction in Ovarian Cancer?","authors":"Monjri M. Shah, Jacob M. Estes, Ronald D. Alvarez","doi":"10.1016/j.cogc.2013.12.001","DOIUrl":"10.1016/j.cogc.2013.12.001","url":null,"abstract":"","PeriodicalId":100274,"journal":{"name":"Clinical Ovarian and Other Gynecologic Cancer","volume":"5 2","pages":"Pages 45-47"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cogc.2013.12.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79286082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The aim of this study was to find out the long-term survival of patients with primary International Federation of Gynecology and Obstetrics (FIGO) stage IIIC epithelial ovarian cancer (EOC IIIC) in a population-based patient cohort treated in Norway in 2002.
Patients and Methods
All 198 women with a diagnosis of EOC IIIC who underwent surgery were included. The data were derived from notifications to the Norwegian Cancer Registry and medical, surgical, and histopathologic records. The hospitals were grouped into teaching hospitals (THs) and nonteaching hospitals (NTHs). The follow-up period was from 0 to 106 months.
Results
The long-term survival at 8 years was 15% for women operated on at THs and 10% for women operated on at NTHs (P < .05). The median survival was 35.6 months at THs and 23.4 months at NTHs (P < .05). After simultaneous adjustment for 4 prognostic factors (age, histologic type, grade of differentiation, and residual disease), the risk of death within 8 years at NTHs was unchanged, with a hazard ratio of 1.38 (95% confidence interval [CI], 1.00-1.89), compared with THs.
Conclusion
Patients operated on for EOC IIIC at THs achieved better long-term survival than did patients operated on at NTHs. Centralization of EOC IIIC surgery should be introduced in all countries to improve outcomes for this patient group.
{"title":"Improved 8-Year Survival for Patients With Stage IIIC Ovarian Cancer Operated on at Teaching Hospitals: Population-Based Study in Norway 2002","authors":"Torbjørn Paulsen , Witold Szczesny , Janne Kærn , Ingvild Vistad , Claes Tropé","doi":"10.1016/j.cogc.2012.12.002","DOIUrl":"10.1016/j.cogc.2012.12.002","url":null,"abstract":"<div><h3>Background</h3><p>The aim of this study was to find out the long-term survival of patients with primary International Federation of Gynecology and Obstetrics (FIGO) stage IIIC epithelial ovarian cancer (EOC IIIC) in a population-based patient cohort treated in Norway in 2002.</p></div><div><h3>Patients and Methods</h3><p>All 198 women with a diagnosis of EOC IIIC who underwent surgery were included. The data were derived from notifications to the Norwegian Cancer Registry and medical, surgical, and histopathologic records. The hospitals were grouped into teaching hospitals (THs) and nonteaching hospitals (NTHs). The follow-up period was from 0 to 106 months.</p></div><div><h3>Results</h3><p>The long-term survival at 8 years was 15% for women operated on at THs and 10% for women operated on at NTHs (<em>P</em> < .05). The median survival was 35.6 months at THs and 23.4 months at NTHs (<em>P</em> < .05). After simultaneous adjustment for 4 prognostic factors (age, histologic type, grade of differentiation, and residual disease), the risk of death within 8 years at NTHs was unchanged, with a hazard ratio of 1.38 (95% confidence interval [CI], 1.00-1.89), compared with THs.</p></div><div><h3>Conclusion</h3><p>Patients operated on for EOC IIIC at THs achieved better long-term survival than did patients operated on at NTHs. Centralization of EOC IIIC surgery should be introduced in all countries to improve outcomes for this patient group.</p></div>","PeriodicalId":100274,"journal":{"name":"Clinical Ovarian and Other Gynecologic Cancer","volume":"5 2","pages":"Pages 60-66"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cogc.2012.12.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89181978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2012-12-01DOI: 10.1016/J.COGC.2013.06.001
B. Lawton, S. Rose, S. Pullon, J. Stanley, Sue Garrett, P. Sykes, D. Cormack, B. Robson, F. Langdana, Annette J. Cooper, S. Filoche
{"title":"The Impact of Outpatient Booking Systems on Waiting Times for Investigation of Suspected Cancer: The Case of Post-Menopausal Bleeding","authors":"B. Lawton, S. Rose, S. Pullon, J. Stanley, Sue Garrett, P. Sykes, D. Cormack, B. Robson, F. Langdana, Annette J. Cooper, S. Filoche","doi":"10.1016/J.COGC.2013.06.001","DOIUrl":"https://doi.org/10.1016/J.COGC.2013.06.001","url":null,"abstract":"","PeriodicalId":100274,"journal":{"name":"Clinical Ovarian and Other Gynecologic Cancer","volume":"47 1","pages":"87-93"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84654757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2012-12-01DOI: 10.1016/j.cogc.2013.06.001
Beverley A. Lawton , Sally B. Rose , Sue Pullon , James Stanley , Sue Garrett , Peter Sykes , Donna Cormack , Bridget Robson , Fali Langdana , Annette Cooper , Sara K. Filoche
Background
A 2-week waiting time from primary care referral to first specialist assessment is recommended for patients with symptoms of suspected cancer, such as post-menopausal bleeding (PMB). We compared 2 different booking systems in relation to the observed waiting time for patients with suspected uterine cancer.
Methods
Data were collected concurrently between July 2009 and August 2010, and captured the duration of waiting time from referral to specialist assessment for each woman with PMB. A comparison of 2 outpatient booking systems on waiting times was undertaken for 2 District Health Boards (DHBs) in New Zealand. DHB1 uses a centralized booking system, and DHB2 uses a clinic-based system.
Results
A total of 147 women were included in the timing analysis. At DHB1, 2 of 90 women (2%) were seen within 2 weeks and 61 of 90 women (68%) waited more than 42 days. At DHB2, 24 of 57 women (42%) were seen within 2 weeks and 19 of 57 women (33%) waited more than 42 days. Overall, only 18% of women in this study were seen within the 2-week time-frame and 80 of 147 women (54%) waited more than 42 days from referral to specialist assessment.
Conclusions
In this study, a clinic-based booking system was associated with shorter waiting times compared with a centralized booking system in 2 reasonably comparable DHB services. Waiting times were longer than the recommended guidelines, regardless of booking system. Further research is needed to clarify the effects of these different booking systems on waiting times.
{"title":"The Impact of Outpatient Booking Systems on Waiting Times for Investigation of Suspected Cancer: The Case of Post-Menopausal Bleeding","authors":"Beverley A. Lawton , Sally B. Rose , Sue Pullon , James Stanley , Sue Garrett , Peter Sykes , Donna Cormack , Bridget Robson , Fali Langdana , Annette Cooper , Sara K. Filoche","doi":"10.1016/j.cogc.2013.06.001","DOIUrl":"https://doi.org/10.1016/j.cogc.2013.06.001","url":null,"abstract":"<div><h3>Background</h3><p>A 2-week waiting time from primary care referral to first specialist assessment is recommended for patients with symptoms of suspected cancer, such as post-menopausal bleeding (PMB). We compared 2 different booking systems in relation to the observed waiting time for patients with suspected uterine cancer.</p></div><div><h3>Methods</h3><p>Data were collected concurrently between July 2009 and August 2010, and captured the duration of waiting time from referral to specialist assessment for each woman with PMB. A comparison of 2 outpatient booking systems on waiting times was undertaken for 2 District Health Boards (DHBs) in New Zealand. DHB1 uses a centralized booking system, and DHB2 uses a clinic-based system.</p></div><div><h3>Results</h3><p>A total of 147 women were included in the timing analysis. At DHB1, 2 of 90 women (2%) were seen within 2 weeks and 61 of 90 women (68%) waited more than 42 days. At DHB2, 24 of 57 women (42%) were seen within 2 weeks and 19 of 57 women (33%) waited more than 42 days. Overall, only 18% of women in this study were seen within the 2-week time-frame and 80 of 147 women (54%) waited more than 42 days from referral to specialist assessment.</p></div><div><h3>Conclusions</h3><p>In this study, a clinic-based booking system was associated with shorter waiting times compared with a centralized booking system in 2 reasonably comparable DHB services. Waiting times were longer than the recommended guidelines, regardless of booking system. Further research is needed to clarify the effects of these different booking systems on waiting times.</p></div>","PeriodicalId":100274,"journal":{"name":"Clinical Ovarian and Other Gynecologic Cancer","volume":"5 2","pages":"Pages 87-93"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cogc.2013.06.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91768449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2012-12-01DOI: 10.1016/j.cogc.2012.06.001
Willem M. Smit , Jozef Šufliarsky , Theresa L. Werner , Don S. Dizon , Maria Wagnerová , Holger W. Hirte , Nick M. Spirtos , Amit Oza , Luc Dirix , Mona El-Hashimy , Suddhasatta Acharyya , Eugene Y. Tan , Dirk Weber , Jan H.M. Schellens
Background
Patients with ovarian cancer whose disease relapses or progresses within 6 months after frontline platinum- and taxane-containing therapy have a poor prognosis and limited treatment options. In this phase II study, the activity and safety profiles of patupilone, a novel microtubule-targeting agent, were assessed in patients with platinum-resistant or -refractory ovarian, primary fallopian tube, or primary peritoneal cancer.
Patients and Methods
Patients whose disease relapsed while they were either receiving or within 6 months after completion of their most recent platinum-based therapy were given patupilone 10 mg/m2 by a 20-minute intravenous infusion once every 3 weeks (q3w). The primary study endpoint was the overall response rate (ORR), defined as the percentage of patients with a complete or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Results
Patients (N = 112) received a median of 4 cycles of patupilone. Median overall survival was 11.2 months. The ORR was 6.3%. Disease control according to RECIST was observed in 57 (50.9%) patients (7 [6.3%] PRs, 50 [44.6%] stable disease). Median duration of disease control was 5.4 months, whereas median progression-free survival was 2.8 months. Diarrhea, the most common adverse event (AE) regardless of relationship to study drug (55.4% grade 1/2, 25.0% grade 3/4), was predictable and generally manageable. Other AEs, including nausea, vomiting, fatigue, and peripheral neuropathy, were generally mild.
Conclusion
Patupilone was well tolerated and demonstrated an encouraging disease control rate in these patients with platinum-resistant or -refractory disease; this is a challenging population with a poor prognosis.
{"title":"A Phase II Study of Patupilone (EPO906) in Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer","authors":"Willem M. Smit , Jozef Šufliarsky , Theresa L. Werner , Don S. Dizon , Maria Wagnerová , Holger W. Hirte , Nick M. Spirtos , Amit Oza , Luc Dirix , Mona El-Hashimy , Suddhasatta Acharyya , Eugene Y. Tan , Dirk Weber , Jan H.M. Schellens","doi":"10.1016/j.cogc.2012.06.001","DOIUrl":"10.1016/j.cogc.2012.06.001","url":null,"abstract":"<div><h3>Background</h3><p>Patients with ovarian cancer whose disease relapses or progresses within 6 months after frontline platinum- and taxane-containing therapy have a poor prognosis and limited treatment options. In this phase II study, the activity and safety profiles of patupilone, a novel microtubule-targeting agent, were assessed in patients with platinum-resistant or -refractory ovarian, primary fallopian tube, or primary peritoneal cancer.</p></div><div><h3>Patients and Methods</h3><p>Patients whose disease relapsed while they were either receiving or within 6 months after completion of their most recent platinum-based therapy were given patupilone 10 mg/m<sup>2</sup> by a 20-minute intravenous infusion once every 3 weeks (q3w). The primary study endpoint was the overall response rate (ORR), defined as the percentage of patients with a complete or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).</p></div><div><h3>Results</h3><p>Patients (N = 112) received a median of 4 cycles of patupilone. Median overall survival was 11.2 months. The ORR was 6.3%. Disease control according to RECIST was observed in 57 (50.9%) patients (7 [6.3%] PRs, 50 [44.6%] stable disease). Median duration of disease control was 5.4 months, whereas median progression-free survival was 2.8 months. Diarrhea, the most common adverse event (AE) regardless of relationship to study drug (55.4% grade 1/2, 25.0% grade 3/4), was predictable and generally manageable. Other AEs, including nausea, vomiting, fatigue, and peripheral neuropathy, were generally mild.</p></div><div><h3>Conclusion</h3><p>Patupilone was well tolerated and demonstrated an encouraging disease control rate in these patients with platinum-resistant or -refractory disease; this is a challenging population with a poor prognosis.</p></div>","PeriodicalId":100274,"journal":{"name":"Clinical Ovarian and Other Gynecologic Cancer","volume":"5 2","pages":"Pages 53-59"},"PeriodicalIF":0.0,"publicationDate":"2012-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.cogc.2012.06.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83204552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2012-12-01DOI: 10.1016/J.COGC.2013.02.002
A. Dizon, Karen L Samples, K. Kimball, L. Kilgore
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