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Nick M Spirtos - One of the best experts on this subject based on the ideXlab platform.
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surgical outcomes among elderly women with endometrial Cancer treated by laparoscopic hysterectomy a nrg gynecologic oncology group study
American Journal of Obstetrics and Gynecology, 2018Co-Authors: E Bishop, Nick M Spirtos, Michael L Pearl, Kathleen N. Moore, J Java, Oliver Zivanovic, David M Kushner, Floor J Backes, Chad A Hamilton, Melissa A GellerAbstract:Objective Tolerance of and complications caused by minimally invasive hysterectomy and staging in the older endometrial Cancer population is largely unknown despite the fact that this is the most rapidly growing age group in the United States. The objective of this retrospective review was to compare operative morbidity by age in patients on the Gynecologic Oncology Group Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus (LAP2) trial. Study design This is a retrospective analysis of patients from Gynecologic Oncology Group LAP2, a trial that included clinically early-stage Uterine Cancer patients randomized to laparotomy vs laparoscopy for surgical staging. Differences in the rates and types of intraoperative and perioperative complications were compared by age. Specifically complications between patients Results LAP2 included 1477 patients ≥60 years old. As expected, with increasing age there was worsening performance status and disease characteristics including higher rates of serous histology, high-stage disease, and lymphovascular space invasion. There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups. Toxicity analysis showed a sharp increase in toxicity seen in patients ≥60 years old in the laparotomy group. Further analysis showed that when comparing laparotomy with laparoscopy in patients 2 days (odds ratio, 17.48; 95% confidence interval, 11.71-27.00, P 2 days (odds ratio, 12.77; 95% confidence interval, 8.74-19.32, P Conclusion Laparoscopic staging for Uterine Cancer is associated with decreased morbidity in the immediate postoperative period in patients ≥60 years old. These results allow for more accurate preoperative counseling. A minimally invasive approach to Uterine Cancer staging may decrease morbidity that could affect long-term survival.
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impact of histology and surgical approach on survival among women with early stage high grade Uterine Cancer an nrg oncology gynecologic oncology group ancillary analysis
Gynecologic Oncology, 2016Co-Authors: Amanda N. Fader, Nick M Spirtos, Michael L Pearl, Camille C Gunderson, J Java, Meaghan Tenney, Stephanie Ricci, Sarah M Temkin, Christina L Kushnir, Oliver ZivanovicAbstract:Objectives We sought to analyze the clinicopathologic features, recurrence patterns and survival outcomes of women with high-grade Uterine Cancer (UC) enrolled on The Gynecologic Oncology Group (GOG) LAP2 trial.
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recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group lap2 study
Journal of Clinical Oncology, 2012Co-Authors: Joan L Walker, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Richard R. Barakat, Sudarshan K. SharmaAbstract:Purpose The primary objective was to establish noninferiority of laparoscopy compared with laparotomy for recurrence after surgical staging of Uterine Cancer. Patients and Methods Patients with clinical stages I to IIA disease were randomly allocated (two to one) to laparoscopy (n = 1,696) versus laparotomy (n = 920) for hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The primary study end point was noninferiority of recurrence-free interval defined as no more than a 40% increase in the risk of recurrence with laparoscopy compared with laparotomy. Results With a median follow-up time of 59 months for 2,181 patients still alive, there were 309 recurrences (210 laparoscopy; 99 laparotomy) and 350 deaths (229 laparoscopy; 121 laparotomy). The estimated hazard ratio for laparoscopy relative to laparotomy was 1.14 (90% lower bound, 0.92; 95% upper bound, 1.46), falling short of the protocol-specified definition of noninferiority. However, the actual recurrence ...
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laparoscopy compared with laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group study lap2
Obstetrical & Gynecological Survey, 2010Co-Authors: Joan L Walker, Gregory Spiegel, Richard Barakat, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Sudarshan K. SharmaAbstract:The conventional method for comprehensive surgical staging in endometrial Cancer is open laparotomy. Since the 1990s, minimally invasive laparoscopy has been investigated for comprehensive surgical staging in endometrial Cancer in small efficacy and safety studies. This prospective randomized trial was designed to compare use of laparotomy and laparoscopy for complete comprehensive surgical staging of Uterine Cancer. Between 1996 and 2005, a total of 2616 patients with clinical stage I to IIA Uterine Cancer were randomly assigned —920 to open laparotomy and 1696 to laparoscopy. The procedures undertaken with both methods included hysterectomy, salpingo-oophorectomy, pelvic and paraaortic lymphadenectomy, and peritoneal cytology. The primary study end points were short-term (6 weeks) surgical outcomes, including recurrence-free survival, intraoperative complications, laparoscopy conversion to laparotomy, length of hospital stay, operative time, patient-reported quality of life, and sites of recurrence. The data was adjusted for patient age, race/ethnicity, body mass index, and performance status. Laparoscopy was completed without conversion to open laparotomy in 1248 patients (74.2%). Conversion to laparotomy was required in 434 participants (25.8%). Reasons for conversion included poor exposure in 246 patients (14.6%), metastatic Cancer in 69 patients (4.1%), excessive bleeding in 49 patients (2.9%), and other causes in 70 patients (4.2%). Fewer moderate-to-severe postoperative adverse events occurred with laparoscopy compared to laparotomy (14% versus 21%; P < 0.001). Although the median operative time was shorter for open laparotomy than laparoscopy (130 versus 204 minutes; P < 0.001), there was no statistical difference between the 2 treatment groups in rates of intraoperative complications (laparotomy: 8% versus laparoscopy: 10%; P = 0.106). The percentage of patients requiring more than 2 days of hospitalization after surgery was significantly lower in patients receiving laparoscopy compared with laparotomy (52% versus 94%; P < 0.001). Both pelvic and paraaortic nodes were not removed in 4% of laparotomy patients and 8% of laparoscopy patients (P < 0.0001). The proportion of laparotomy and laparoscopy patients found to have advanced surgical stage (FIGO stage IIIA, IIIC, or IV) was not significantly different (17% for each method; P = 0.851). The investigators conclude from these findings that laparoscopic comprehensive surgical staging for Uterine Cancer is feasible. Compared to laparotomy, short-term outcomes of laparoscopy show fewer postoperative complications, and shorter hospital stay without increased intraoperative injuries.
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laparoscopy compared with laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group study lap2
Journal of Clinical Oncology, 2009Co-Authors: Joan L Walker, Gregory Spiegel, Richard Barakat, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Sudarshan K. SharmaAbstract:Purpose The objective was to compare laparoscopy versus laparotomy for comprehensive surgical staging of Uterine Cancer. Patients and Methods Patients with clinical stage I to IIA Uterine Cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920), including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The main study end points were 6-week morbidity and mortality, hospital length of stay, conversion from laparoscopy to laparotomy, recurrence-free survival, site of recurrence, and patient-reported quality-of-life outcomes. Results Laparoscopy was initiated in 1,682 patients and completed without conversion in 1,248 patients (74.2%). Conversion from laparoscopy to laparotomy was secondary to poor visibility in 246 patients (14.6%), metastatic Cancer in 69 patients (4.1%), bleeding in 49 patients (2.9%), and other cause in 70 patients (4.2%). Laparoscopy had fewer moderate to severe postoperative adverse events than laparotomy (14...
Michael L Pearl - One of the best experts on this subject based on the ideXlab platform.
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surgical outcomes among elderly women with endometrial Cancer treated by laparoscopic hysterectomy a nrg gynecologic oncology group study
American Journal of Obstetrics and Gynecology, 2018Co-Authors: E Bishop, Nick M Spirtos, Michael L Pearl, Kathleen N. Moore, J Java, Oliver Zivanovic, David M Kushner, Floor J Backes, Chad A Hamilton, Melissa A GellerAbstract:Objective Tolerance of and complications caused by minimally invasive hysterectomy and staging in the older endometrial Cancer population is largely unknown despite the fact that this is the most rapidly growing age group in the United States. The objective of this retrospective review was to compare operative morbidity by age in patients on the Gynecologic Oncology Group Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus (LAP2) trial. Study design This is a retrospective analysis of patients from Gynecologic Oncology Group LAP2, a trial that included clinically early-stage Uterine Cancer patients randomized to laparotomy vs laparoscopy for surgical staging. Differences in the rates and types of intraoperative and perioperative complications were compared by age. Specifically complications between patients Results LAP2 included 1477 patients ≥60 years old. As expected, with increasing age there was worsening performance status and disease characteristics including higher rates of serous histology, high-stage disease, and lymphovascular space invasion. There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups. Toxicity analysis showed a sharp increase in toxicity seen in patients ≥60 years old in the laparotomy group. Further analysis showed that when comparing laparotomy with laparoscopy in patients 2 days (odds ratio, 17.48; 95% confidence interval, 11.71-27.00, P 2 days (odds ratio, 12.77; 95% confidence interval, 8.74-19.32, P Conclusion Laparoscopic staging for Uterine Cancer is associated with decreased morbidity in the immediate postoperative period in patients ≥60 years old. These results allow for more accurate preoperative counseling. A minimally invasive approach to Uterine Cancer staging may decrease morbidity that could affect long-term survival.
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impact of histology and surgical approach on survival among women with early stage high grade Uterine Cancer an nrg oncology gynecologic oncology group ancillary analysis
Gynecologic Oncology, 2016Co-Authors: Amanda N. Fader, Nick M Spirtos, Michael L Pearl, Camille C Gunderson, J Java, Meaghan Tenney, Stephanie Ricci, Sarah M Temkin, Christina L Kushnir, Oliver ZivanovicAbstract:Objectives We sought to analyze the clinicopathologic features, recurrence patterns and survival outcomes of women with high-grade Uterine Cancer (UC) enrolled on The Gynecologic Oncology Group (GOG) LAP2 trial.
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recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group lap2 study
Journal of Clinical Oncology, 2012Co-Authors: Joan L Walker, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Richard R. Barakat, Sudarshan K. SharmaAbstract:Purpose The primary objective was to establish noninferiority of laparoscopy compared with laparotomy for recurrence after surgical staging of Uterine Cancer. Patients and Methods Patients with clinical stages I to IIA disease were randomly allocated (two to one) to laparoscopy (n = 1,696) versus laparotomy (n = 920) for hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The primary study end point was noninferiority of recurrence-free interval defined as no more than a 40% increase in the risk of recurrence with laparoscopy compared with laparotomy. Results With a median follow-up time of 59 months for 2,181 patients still alive, there were 309 recurrences (210 laparoscopy; 99 laparotomy) and 350 deaths (229 laparoscopy; 121 laparotomy). The estimated hazard ratio for laparoscopy relative to laparotomy was 1.14 (90% lower bound, 0.92; 95% upper bound, 1.46), falling short of the protocol-specified definition of noninferiority. However, the actual recurrence ...
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laparoscopy compared with laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group study lap2
Obstetrical & Gynecological Survey, 2010Co-Authors: Joan L Walker, Gregory Spiegel, Richard Barakat, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Sudarshan K. SharmaAbstract:The conventional method for comprehensive surgical staging in endometrial Cancer is open laparotomy. Since the 1990s, minimally invasive laparoscopy has been investigated for comprehensive surgical staging in endometrial Cancer in small efficacy and safety studies. This prospective randomized trial was designed to compare use of laparotomy and laparoscopy for complete comprehensive surgical staging of Uterine Cancer. Between 1996 and 2005, a total of 2616 patients with clinical stage I to IIA Uterine Cancer were randomly assigned —920 to open laparotomy and 1696 to laparoscopy. The procedures undertaken with both methods included hysterectomy, salpingo-oophorectomy, pelvic and paraaortic lymphadenectomy, and peritoneal cytology. The primary study end points were short-term (6 weeks) surgical outcomes, including recurrence-free survival, intraoperative complications, laparoscopy conversion to laparotomy, length of hospital stay, operative time, patient-reported quality of life, and sites of recurrence. The data was adjusted for patient age, race/ethnicity, body mass index, and performance status. Laparoscopy was completed without conversion to open laparotomy in 1248 patients (74.2%). Conversion to laparotomy was required in 434 participants (25.8%). Reasons for conversion included poor exposure in 246 patients (14.6%), metastatic Cancer in 69 patients (4.1%), excessive bleeding in 49 patients (2.9%), and other causes in 70 patients (4.2%). Fewer moderate-to-severe postoperative adverse events occurred with laparoscopy compared to laparotomy (14% versus 21%; P < 0.001). Although the median operative time was shorter for open laparotomy than laparoscopy (130 versus 204 minutes; P < 0.001), there was no statistical difference between the 2 treatment groups in rates of intraoperative complications (laparotomy: 8% versus laparoscopy: 10%; P = 0.106). The percentage of patients requiring more than 2 days of hospitalization after surgery was significantly lower in patients receiving laparoscopy compared with laparotomy (52% versus 94%; P < 0.001). Both pelvic and paraaortic nodes were not removed in 4% of laparotomy patients and 8% of laparoscopy patients (P < 0.0001). The proportion of laparotomy and laparoscopy patients found to have advanced surgical stage (FIGO stage IIIA, IIIC, or IV) was not significantly different (17% for each method; P = 0.851). The investigators conclude from these findings that laparoscopic comprehensive surgical staging for Uterine Cancer is feasible. Compared to laparotomy, short-term outcomes of laparoscopy show fewer postoperative complications, and shorter hospital stay without increased intraoperative injuries.
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laparoscopy compared with laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group study lap2
Journal of Clinical Oncology, 2009Co-Authors: Joan L Walker, Gregory Spiegel, Richard Barakat, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Sudarshan K. SharmaAbstract:Purpose The objective was to compare laparoscopy versus laparotomy for comprehensive surgical staging of Uterine Cancer. Patients and Methods Patients with clinical stage I to IIA Uterine Cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920), including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The main study end points were 6-week morbidity and mortality, hospital length of stay, conversion from laparoscopy to laparotomy, recurrence-free survival, site of recurrence, and patient-reported quality-of-life outcomes. Results Laparoscopy was initiated in 1,682 patients and completed without conversion in 1,248 patients (74.2%). Conversion from laparoscopy to laparotomy was secondary to poor visibility in 246 patients (14.6%), metastatic Cancer in 69 patients (4.1%), bleeding in 49 patients (2.9%), and other cause in 70 patients (4.2%). Laparoscopy had fewer moderate to severe postoperative adverse events than laparotomy (14...
Joan L Walker - One of the best experts on this subject based on the ideXlab platform.
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the impact of obesity on surgical staging complications and survival with Uterine Cancer a gynecologic oncology group lap2 ancillary data study
Gynecologic Oncology, 2014Co-Authors: Camille C Gunderson, Kathleen N. Moore, J Java, Joan L WalkerAbstract:Abstract Objective To determine the association of body mass index (BMI) on complications, recurrence, and survival in GOG LAP2, a randomized comparison of laparoscopic versus open staging in clinically early stage Uterine Cancer (EC). Methods An ancillary data analysis of GOG LAP2 was performed. Categorical variables were compared using Pearson chi-square test and continuous variables using the Wilcoxon–Mann–Whitney and Kruskal–Wallis tests by BMI group. Survival was estimated using the Kaplan–Meier method. Cox proportional hazards model was used to evaluate independent prognostic factors on survival. Statistical tests were two-tailed with α =0.05, except where noted. Statistical analyses utilized R programming language. Results 2596 women were included. BMI (kg/m 2 ) groups were p =0.021), grade ( p p =0.005) differed by BMI. Obese women were less likely to have high risk (HR) disease (+lymph nodes/ovaries/cytology) or tumor features that met GOG99 high intermediate risk (HIR) criteria ( p p =0.151) and recurrence ( p =0.46) did not vary by BMI. Hospitalization >2days, antibiotic use, wound infection, and venous thrombophlebitis were higher with BMI ≥40. BMI ( p =0.016), age ( p p =0.033), and risk group ( p p =0.79), but age ( p =0.032) and risk group ( p Conclusion Obese women have greater surgical risk and lower risk of metastatic disease. BMI is associated with all-cause but not disease-specific mortality, emphasizing the detrimental effect of obesity (independent of EC), which deserves particular attention.
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recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group lap2 study
Journal of Clinical Oncology, 2012Co-Authors: Joan L Walker, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Richard R. Barakat, Sudarshan K. SharmaAbstract:Purpose The primary objective was to establish noninferiority of laparoscopy compared with laparotomy for recurrence after surgical staging of Uterine Cancer. Patients and Methods Patients with clinical stages I to IIA disease were randomly allocated (two to one) to laparoscopy (n = 1,696) versus laparotomy (n = 920) for hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The primary study end point was noninferiority of recurrence-free interval defined as no more than a 40% increase in the risk of recurrence with laparoscopy compared with laparotomy. Results With a median follow-up time of 59 months for 2,181 patients still alive, there were 309 recurrences (210 laparoscopy; 99 laparotomy) and 350 deaths (229 laparoscopy; 121 laparotomy). The estimated hazard ratio for laparoscopy relative to laparotomy was 1.14 (90% lower bound, 0.92; 95% upper bound, 1.46), falling short of the protocol-specified definition of noninferiority. However, the actual recurrence ...
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laparoscopy compared with laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group study lap2
Obstetrical & Gynecological Survey, 2010Co-Authors: Joan L Walker, Gregory Spiegel, Richard Barakat, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Sudarshan K. SharmaAbstract:The conventional method for comprehensive surgical staging in endometrial Cancer is open laparotomy. Since the 1990s, minimally invasive laparoscopy has been investigated for comprehensive surgical staging in endometrial Cancer in small efficacy and safety studies. This prospective randomized trial was designed to compare use of laparotomy and laparoscopy for complete comprehensive surgical staging of Uterine Cancer. Between 1996 and 2005, a total of 2616 patients with clinical stage I to IIA Uterine Cancer were randomly assigned —920 to open laparotomy and 1696 to laparoscopy. The procedures undertaken with both methods included hysterectomy, salpingo-oophorectomy, pelvic and paraaortic lymphadenectomy, and peritoneal cytology. The primary study end points were short-term (6 weeks) surgical outcomes, including recurrence-free survival, intraoperative complications, laparoscopy conversion to laparotomy, length of hospital stay, operative time, patient-reported quality of life, and sites of recurrence. The data was adjusted for patient age, race/ethnicity, body mass index, and performance status. Laparoscopy was completed without conversion to open laparotomy in 1248 patients (74.2%). Conversion to laparotomy was required in 434 participants (25.8%). Reasons for conversion included poor exposure in 246 patients (14.6%), metastatic Cancer in 69 patients (4.1%), excessive bleeding in 49 patients (2.9%), and other causes in 70 patients (4.2%). Fewer moderate-to-severe postoperative adverse events occurred with laparoscopy compared to laparotomy (14% versus 21%; P < 0.001). Although the median operative time was shorter for open laparotomy than laparoscopy (130 versus 204 minutes; P < 0.001), there was no statistical difference between the 2 treatment groups in rates of intraoperative complications (laparotomy: 8% versus laparoscopy: 10%; P = 0.106). The percentage of patients requiring more than 2 days of hospitalization after surgery was significantly lower in patients receiving laparoscopy compared with laparotomy (52% versus 94%; P < 0.001). Both pelvic and paraaortic nodes were not removed in 4% of laparotomy patients and 8% of laparoscopy patients (P < 0.0001). The proportion of laparotomy and laparoscopy patients found to have advanced surgical stage (FIGO stage IIIA, IIIC, or IV) was not significantly different (17% for each method; P = 0.851). The investigators conclude from these findings that laparoscopic comprehensive surgical staging for Uterine Cancer is feasible. Compared to laparotomy, short-term outcomes of laparoscopy show fewer postoperative complications, and shorter hospital stay without increased intraoperative injuries.
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laparoscopy compared with laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group study lap2
Journal of Clinical Oncology, 2009Co-Authors: Joan L Walker, Gregory Spiegel, Richard Barakat, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Sudarshan K. SharmaAbstract:Purpose The objective was to compare laparoscopy versus laparotomy for comprehensive surgical staging of Uterine Cancer. Patients and Methods Patients with clinical stage I to IIA Uterine Cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920), including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The main study end points were 6-week morbidity and mortality, hospital length of stay, conversion from laparoscopy to laparotomy, recurrence-free survival, site of recurrence, and patient-reported quality-of-life outcomes. Results Laparoscopy was initiated in 1,682 patients and completed without conversion in 1,248 patients (74.2%). Conversion from laparoscopy to laparotomy was secondary to poor visibility in 246 patients (14.6%), metastatic Cancer in 69 patients (4.1%), bleeding in 49 patients (2.9%), and other cause in 70 patients (4.2%). Laparoscopy had fewer moderate to severe postoperative adverse events than laparotomy (14...
Sudarshan K. Sharma - One of the best experts on this subject based on the ideXlab platform.
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recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group lap2 study
Journal of Clinical Oncology, 2012Co-Authors: Joan L Walker, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Richard R. Barakat, Sudarshan K. SharmaAbstract:Purpose The primary objective was to establish noninferiority of laparoscopy compared with laparotomy for recurrence after surgical staging of Uterine Cancer. Patients and Methods Patients with clinical stages I to IIA disease were randomly allocated (two to one) to laparoscopy (n = 1,696) versus laparotomy (n = 920) for hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The primary study end point was noninferiority of recurrence-free interval defined as no more than a 40% increase in the risk of recurrence with laparoscopy compared with laparotomy. Results With a median follow-up time of 59 months for 2,181 patients still alive, there were 309 recurrences (210 laparoscopy; 99 laparotomy) and 350 deaths (229 laparoscopy; 121 laparotomy). The estimated hazard ratio for laparoscopy relative to laparotomy was 1.14 (90% lower bound, 0.92; 95% upper bound, 1.46), falling short of the protocol-specified definition of noninferiority. However, the actual recurrence ...
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laparoscopy compared with laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group study lap2
Obstetrical & Gynecological Survey, 2010Co-Authors: Joan L Walker, Gregory Spiegel, Richard Barakat, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Sudarshan K. SharmaAbstract:The conventional method for comprehensive surgical staging in endometrial Cancer is open laparotomy. Since the 1990s, minimally invasive laparoscopy has been investigated for comprehensive surgical staging in endometrial Cancer in small efficacy and safety studies. This prospective randomized trial was designed to compare use of laparotomy and laparoscopy for complete comprehensive surgical staging of Uterine Cancer. Between 1996 and 2005, a total of 2616 patients with clinical stage I to IIA Uterine Cancer were randomly assigned —920 to open laparotomy and 1696 to laparoscopy. The procedures undertaken with both methods included hysterectomy, salpingo-oophorectomy, pelvic and paraaortic lymphadenectomy, and peritoneal cytology. The primary study end points were short-term (6 weeks) surgical outcomes, including recurrence-free survival, intraoperative complications, laparoscopy conversion to laparotomy, length of hospital stay, operative time, patient-reported quality of life, and sites of recurrence. The data was adjusted for patient age, race/ethnicity, body mass index, and performance status. Laparoscopy was completed without conversion to open laparotomy in 1248 patients (74.2%). Conversion to laparotomy was required in 434 participants (25.8%). Reasons for conversion included poor exposure in 246 patients (14.6%), metastatic Cancer in 69 patients (4.1%), excessive bleeding in 49 patients (2.9%), and other causes in 70 patients (4.2%). Fewer moderate-to-severe postoperative adverse events occurred with laparoscopy compared to laparotomy (14% versus 21%; P < 0.001). Although the median operative time was shorter for open laparotomy than laparoscopy (130 versus 204 minutes; P < 0.001), there was no statistical difference between the 2 treatment groups in rates of intraoperative complications (laparotomy: 8% versus laparoscopy: 10%; P = 0.106). The percentage of patients requiring more than 2 days of hospitalization after surgery was significantly lower in patients receiving laparoscopy compared with laparotomy (52% versus 94%; P < 0.001). Both pelvic and paraaortic nodes were not removed in 4% of laparotomy patients and 8% of laparoscopy patients (P < 0.0001). The proportion of laparotomy and laparoscopy patients found to have advanced surgical stage (FIGO stage IIIA, IIIC, or IV) was not significantly different (17% for each method; P = 0.851). The investigators conclude from these findings that laparoscopic comprehensive surgical staging for Uterine Cancer is feasible. Compared to laparotomy, short-term outcomes of laparoscopy show fewer postoperative complications, and shorter hospital stay without increased intraoperative injuries.
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laparoscopy compared with laparotomy for comprehensive surgical staging of Uterine Cancer gynecologic oncology group study lap2
Journal of Clinical Oncology, 2009Co-Authors: Joan L Walker, Gregory Spiegel, Richard Barakat, Marion R Piedmonte, Scott M. Eisenkop, Nick M Spirtos, John B. Schlaerth, Robert S Mannel, Michael L Pearl, Sudarshan K. SharmaAbstract:Purpose The objective was to compare laparoscopy versus laparotomy for comprehensive surgical staging of Uterine Cancer. Patients and Methods Patients with clinical stage I to IIA Uterine Cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920), including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The main study end points were 6-week morbidity and mortality, hospital length of stay, conversion from laparoscopy to laparotomy, recurrence-free survival, site of recurrence, and patient-reported quality-of-life outcomes. Results Laparoscopy was initiated in 1,682 patients and completed without conversion in 1,248 patients (74.2%). Conversion from laparoscopy to laparotomy was secondary to poor visibility in 246 patients (14.6%), metastatic Cancer in 69 patients (4.1%), bleeding in 49 patients (2.9%), and other cause in 70 patients (4.2%). Laparoscopy had fewer moderate to severe postoperative adverse events than laparotomy (14...
J Java - One of the best experts on this subject based on the ideXlab platform.
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surgical outcomes among elderly women with endometrial Cancer treated by laparoscopic hysterectomy a nrg gynecologic oncology group study
American Journal of Obstetrics and Gynecology, 2018Co-Authors: E Bishop, Nick M Spirtos, Michael L Pearl, Kathleen N. Moore, J Java, Oliver Zivanovic, David M Kushner, Floor J Backes, Chad A Hamilton, Melissa A GellerAbstract:Objective Tolerance of and complications caused by minimally invasive hysterectomy and staging in the older endometrial Cancer population is largely unknown despite the fact that this is the most rapidly growing age group in the United States. The objective of this retrospective review was to compare operative morbidity by age in patients on the Gynecologic Oncology Group Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus (LAP2) trial. Study design This is a retrospective analysis of patients from Gynecologic Oncology Group LAP2, a trial that included clinically early-stage Uterine Cancer patients randomized to laparotomy vs laparoscopy for surgical staging. Differences in the rates and types of intraoperative and perioperative complications were compared by age. Specifically complications between patients Results LAP2 included 1477 patients ≥60 years old. As expected, with increasing age there was worsening performance status and disease characteristics including higher rates of serous histology, high-stage disease, and lymphovascular space invasion. There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups. Toxicity analysis showed a sharp increase in toxicity seen in patients ≥60 years old in the laparotomy group. Further analysis showed that when comparing laparotomy with laparoscopy in patients 2 days (odds ratio, 17.48; 95% confidence interval, 11.71-27.00, P 2 days (odds ratio, 12.77; 95% confidence interval, 8.74-19.32, P Conclusion Laparoscopic staging for Uterine Cancer is associated with decreased morbidity in the immediate postoperative period in patients ≥60 years old. These results allow for more accurate preoperative counseling. A minimally invasive approach to Uterine Cancer staging may decrease morbidity that could affect long-term survival.
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impact of histology and surgical approach on survival among women with early stage high grade Uterine Cancer an nrg oncology gynecologic oncology group ancillary analysis
Gynecologic Oncology, 2016Co-Authors: Amanda N. Fader, Nick M Spirtos, Michael L Pearl, Camille C Gunderson, J Java, Meaghan Tenney, Stephanie Ricci, Sarah M Temkin, Christina L Kushnir, Oliver ZivanovicAbstract:Objectives We sought to analyze the clinicopathologic features, recurrence patterns and survival outcomes of women with high-grade Uterine Cancer (UC) enrolled on The Gynecologic Oncology Group (GOG) LAP2 trial.
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the impact of obesity on surgical staging complications and survival with Uterine Cancer a gynecologic oncology group lap2 ancillary data study
Gynecologic Oncology, 2014Co-Authors: Camille C Gunderson, Kathleen N. Moore, J Java, Joan L WalkerAbstract:Abstract Objective To determine the association of body mass index (BMI) on complications, recurrence, and survival in GOG LAP2, a randomized comparison of laparoscopic versus open staging in clinically early stage Uterine Cancer (EC). Methods An ancillary data analysis of GOG LAP2 was performed. Categorical variables were compared using Pearson chi-square test and continuous variables using the Wilcoxon–Mann–Whitney and Kruskal–Wallis tests by BMI group. Survival was estimated using the Kaplan–Meier method. Cox proportional hazards model was used to evaluate independent prognostic factors on survival. Statistical tests were two-tailed with α =0.05, except where noted. Statistical analyses utilized R programming language. Results 2596 women were included. BMI (kg/m 2 ) groups were p =0.021), grade ( p p =0.005) differed by BMI. Obese women were less likely to have high risk (HR) disease (+lymph nodes/ovaries/cytology) or tumor features that met GOG99 high intermediate risk (HIR) criteria ( p p =0.151) and recurrence ( p =0.46) did not vary by BMI. Hospitalization >2days, antibiotic use, wound infection, and venous thrombophlebitis were higher with BMI ≥40. BMI ( p =0.016), age ( p p =0.033), and risk group ( p p =0.79), but age ( p =0.032) and risk group ( p Conclusion Obese women have greater surgical risk and lower risk of metastatic disease. BMI is associated with all-cause but not disease-specific mortality, emphasizing the detrimental effect of obesity (independent of EC), which deserves particular attention.
