Present-day management of uterine leiomyosarcoma: Evaluation of treatment sequencing and other prognostic factors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18035-e18035
Author(s):  
Emily Hinchcliff ◽  
Jennifer Rumpf ◽  
Ravin Ratan ◽  
Nicole D. Fleming ◽  
Amir A. Jazaeri ◽  
...  

e18035 Background: Uterine leiomyosarcoma (ULMS) is a rare tumor with limited therapeutic options and no clearly established best treatment sequence strategy. Methods: Women with ULMS between 2013-2018 were identified. Clinical data was collected; descriptive statistics were performed and predictors of overall survival (OS) and progression free survival (PFS) were analyzed. Results: 189 patients were included. Median age was 53 (20-84), 91% had grade 3 tumors and 51.3% had stage IB disease. 50% underwent surgery followed by chemotherapy (n = 94, 49.7%) and 37% had surgery only (n = 70). 49 patients retained their ovaries; there was no difference in OS by oophorectomy status (p = 0.71). Estrogen and progesterone receptor (ER/PR) status, positive in 41% and 33% respectively, was not independently associated with OS (p = 0.23, p = 0.12) nor did it impact OS among those with oophorectomy and without (p = 0.70). The most common adjuvant therapy regimens were gemcitabine/docetaxel (gem/doce, 64%) or ifosphamide/doxorubicin (ifos/doxo, 19%). There were no differences in the regimens prescribed by physician specialty (gynecologic oncology vs other, p = 0.21). 147 patients (78%) experienced a recurrence or progression. For the 73 patients who received gem/doce as adjuvant therapy, 58.9% recurred and were most commonly treated with doxo containing regimens (67%). Of the 22 patients treated with ifos/doxo, only 3 recurred and each received a different second line regimen. For those not treated with adjuvant therapy (70 patients), 58.2% recurred and were treated with gem/doce (62%) and ifos/doxo (24%). In early stage patients, the majority received surgery only (45%) or surgery followed by chemotherapy (44%). There was no difference in OS in those who received adjuvant therapy and those who did not (p = 0.39). 46 (24%) had molecular testing and 37 had identified mutations. The most common mutation found was P53 (n = 25, 54%) followed by RB1 (8, 17%), PTEN (7, 15%), and BRCA (2, 4%). Conclusions: Recurrence occurred in 78% of patient despite many women undergoing adjuvant therapy after surgery. Oophorectomy did not influence OS, even though 41% of tumors were ER positive. The sequence of treatment was not associated with OS, however, the risk for recurrence in patient treated with adjuvant Ifos/Doxo was 14% compared to 59% in gem/doce. This finding warrants additional evaluation to determine the optimal adjuvant therapy for these women.

2017 ◽  
Vol 27 (4) ◽  
pp. 730-737 ◽  
Author(s):  
Erin A. Bishop ◽  
James J. Java ◽  
Kathleen N. Moore ◽  
Joan L. Walker

ObjectivesElderly endometrial cancer patients have worse disease-specific survival than their younger counterparts, but the cause for this discrepancy is unknown. The goal of this analysis is to compare outcomes by age in a fully staged elderly endometrial cancer population.Methods/MaterialsThis is an analysis of patients on Gynecologic Oncology Group Study (GOG) LAP2, which included clinically early stage endometrial cancer patients randomized to laparotomy versus laparoscopy for surgical staging. Patients were divided into risk groups based on criteria defined by GOG protocol 99. Differences in outcomes and adjuvant therapy were assessed within these risk groups.ResultsLAP2 included 715 patients 70 years or older. With increasing age, worse tumor characteristics were seen. Older patients received similar rates of adjuvant therapy when stratified by stage. Patients 70 years or older had significantly worse progression-free survival and overall survival, and on multivariate analysis, older age and high-risk uterine factors were predictors of progression-free survival and overall survival, whereas stage and lymph node metastases were not. When patients were divided into GOG protocol 99 risk categories, most of those who met the high-intermediate risk criteria did so based on age above 70 years and grade 2 to 3 disease. These patients had low risk of recurrence (3.3%) compared with those who met the criteria by age above 70 years and all 3 uterine factors (20.9%).ConclusionsIn early stage endometrial cancer, patients 70 years or older who undergo similar surgical management and adjuvant therapy, age and tumor characteristics independently predict recurrence. Most patients older than 70 years meet the high-intermediate risk criteria for recurrence based on age and 1 other uterine risk factor, and our results suggest that these patients are at low risk for recurrence.


2009 ◽  
Vol 27 (16) ◽  
pp. 2686-2691 ◽  
Author(s):  
David S. Miller ◽  
John A. Blessing ◽  
Carolyn N. Krasner ◽  
Robert S. Mannel ◽  
Parviz Hanjani ◽  
...  

Purpose To estimate the antitumor activity of pemetrexed in patients with persistent or recurrent platinum-resistant epithelial ovarian or primary peritoneal cancer and to determine the nature and degree of toxicities. Patients and Methods A phase II trial was conducted by the Gynecologic Oncology Group. Patients must have had cancer that had progressed on platinum-based primary chemotherapy or recurred within 6 months. Pemetrexed at a dose of 900 mg/m2 was to be administered as an intravenous infusion over 10 minutes every 21 days. Dose delay and adjustment was permitted for toxicity. Treatment was continued until disease progression or unacceptable adverse effects. Results From July 6, 2004, to August 23, 2006, 51 patients were entered. A total of 259 cycles (median, four; range one to 19 cycles) of pemetrexed were administered, with 40% of patients receiving six or more cycles. Overall, the treatment was well tolerated. More serious toxicities (grade 3 and 4) included neutropenia in 42%, leukopenia in 25%, anemia in 15%, and constitutional in 15% of patients. No treatment-related deaths were reported. One patient (2%) had a complete and nine patients (19%) had partial responses, with a median duration response of 8.4 months. Seventeen patients (35%) had stable disease for a median of 4.1 months. Eighteen patients (38%) had increasing disease. Three patients (6%) were not assessable. Median progression-free survival was 2.9 months, and overall survival was 11.4 months. Conclusion Pemetrexed has sufficient activity in the treatment of recurrent platinum-resistant ovarian cancer at the dose and schedule tested to warrant further investigation.


2018 ◽  
Vol 11 (1) ◽  
pp. 81-89 ◽  
Author(s):  
Viktoria-Anna Nteli ◽  
Wolfgang Knauf ◽  
Anja Janton-Klein ◽  
Samer El-Safadi

Background: Uterine leiomyosarcoma (uLMS) is a rare tumor that accounts for 1% of all uterine malignancies. In spite of adequate surgical resection of uLMS, even in the early stage, patients remain at high risk for local and distant recurrence. Therefore, the treatment of advanced uLMS represents a considerable challenge. Methods: We report the case of a 47-year-old woman who presented with uLMS with abnormal vaginal bleeding. Results: The patient underwent a total hysterectomy and bilateral adnexectomy, which was followed by 1 year progression-free survival without adjuvant therapy. Thereafter, new lung metastases and local progression at the vaginal stump were observed. Chemotherapy with ifosfamide and doxorubicin was administered. However, after 4 cycles, a CT scan revealed disease progression in the lung metastases. Subsequently, the patient was treated with trabectedin at a dose of 1.5 mg/m2 for 6 cycles resulting in complete remission of the lung metastases as well as partial remission of the mass in the vaginal stump after 9 cycles of trabectedin. The patient is currently on maintenance therapy with trabectedin and has no recurrence. Conclusion: Trabectedin seems to be an efficient option for patients with uLMS as demonstrated by a long-lasting response in a pretreated patient with an acceptable safety profile with no signs of cumulative toxicity.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11035-11035 ◽  
Author(s):  
H. Joensuu ◽  
A. Hemminki ◽  
R. Huovinen ◽  
M. Tanner ◽  
R. Kokko ◽  
...  

11035 Background: Adding X to T extends survival in pts with metastatic BC. The primary objective of the FinXX trial is to compare recurrence-free survival with XT→CEX vs T→CEF as adjuvant therapy in pts with early stage BC. Secondary objectives were comparison of safety and overall survival. Methods: Between Jan 2004 and May 2005, 600 of a planned 1,500 pts were randomized to receive T x 3 → CEF x 3 (T 80 mg/m2 d1 → C 600 mg/m2 d1, E 75 mg/m2 d1, F 600 mg/m2 d1) or TX x 3 → CEX x 3 (T 60 mg/m2 d1 + X 900 mg/m2 bid d1–15 → C 600 mg/m2 d1, E 75 mg/m2 d1, X 900 mg/m2 bid d1–15) q3 wks. Results: Grade 3/4 toxicities (CTCAE, v3) in >5% of pts are shown below. 62 pts required G-CSF. Nos. of cycles with G-CSF were: T 34; XT 15; CEF 17; CEX 15. Adverse events (AEs) led to interruption of T in 7 pts (2%) and XT in 50 pts (16%). Median dose intensities at cycle 3 were T: 95%; XT: 84/97%; CEF: 98/97/98%; CEX: 98/98/84%. T dose reductions of =20% in cycle 3 were needed in 18% and 8% of pts receiving T and XT, respectively. 4 pts died during treatment: pulmonary embolism (n=1) with T and suicide, sudden death and colitis/sepsis (each n=1) with XT. Conclusions: XT→CEX is generally well tolerated. Treatment interruptions were more common with XT→CEX, but were effective in reducing development of grade 3/4 AEs. Neutropenic infections were less frequent with XT vs T and infrequent with XT, CEF and CEX. Rates of grade 3/4 diarrhea and HFS were acceptable with XT and minimal with CEX. Accrual is nearly complete; efficacy data are expected in 2009. [Table: see text] [Table: see text]


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 11056-11056
Author(s):  
Hiroko Matsuura ◽  
Sayaka Ikeda ◽  
Kazuya Kudoh ◽  
Naoki Sasaki ◽  
Masashi Takano ◽  
...  

11056 Background: Uterine leiomyosarcomas (ULMs) tend to recur regardless of their stage, and there is no satisfactory report for relapsed ULMs. Temozolomide (T) is derivatives of dacarbazin and these agents have been used for treatment of ULMs. ULMs has a plenty of vessels compared to uterine myoma so that bevacizumab (B) was used in ULMs. In the present study, we evaluated the effect of TB in heavily pretreated relapsed ULMs. Methods: From 2009 to 2016, total 19 patients (pts) with heavily pretreated ULMs were enrolled. Patients were treated with T (80mg/body/day) and B (2mg/kg; days 1, 8 and 15, q4 weeks). Treatment was continued until disease progression and/or unmanageable toxicities. Response was evaluated with the response evaluation criteria in solid tumors (RECIST) v1.1, and adverse effect (AE) was assessed by common terminology criteria for adverse events (CTCAE) v4.0. Results: Seventeen of 19 pts were subjected to response evaluation. Median age of pts was 56.3 years (range: 31-69). Three pts (18%) had complete response (CR), 2 (12%) had partial response, and 7 (41%) had stable disease (SD). The response rate (RR: CR+PR) and clinical benefit rate (CBR: CR+PR+SD) were 29% and 71%. The median progression-free survival was 14.2 months (range: 0-89). Median administration cycle was 9.5 (range: 2-48). AE with grade 3 and more over were observed in 6 pts. There was one dead case from perforation, but toxicity was almost manageable. Conclusions: We experienced 3 cases of CR, and two of them had CR for more than two years. Intriguingly, TB could be substantially effective even in relapsed patients with heavily pretreated ULMs. These results warrant further prospective and randomized studies.


2011 ◽  
Vol 21 (9) ◽  
pp. 1585-1591 ◽  
Author(s):  
Seisuke Kumagai ◽  
Toru Sugiyama ◽  
Tadahiro Shoji ◽  
Hirofumi Michimae ◽  
Noriyuki Katsumata ◽  
...  

IntroductionTo evaluate the incidence of anemia in patients with epithelial ovarian cancer receiving paclitaxel-carboplatin combination therapy (TC) using data from the Japanese Gynecologic Oncology Group (JGOG) 3016 trial, and to examine the effect of severe anemia on survival during dose-dense TC.MethodsRetrospective analysis was conducted in patients enrolled in the JGOG 3016 trial who underwent at least one cycle of the protocol therapy (n = 622). Hemoglobin values at enrollment and during each cycle of TC were collected. One-to-one matching was performed between patients with and patients without grade 3/4 anemia during TC (anemia and nonanemia groups) to adjust the baseline characteristics of the patients. The cumulative survival curve and median progression-free survival were estimated using the Kaplan-Meier method.ResultsGrades 2 to 4 anemia was observed in 19.8% of patients before first-line TC. The incidence of grade 3/4 anemia rapidly increased to 56.1% after the fourth cycle of dose-dense TC. After matching, the median progression-free survival in the anemia (hemoglobin <8.0 g/dL) and nonanemia (hemoglobin >8.0 g/dL) groups was 777 and 1100 days, respectively (P = 0.3493) for patients receiving dose-dense TC. The median progression-free survival in patients receiving conventional TC was similar between the 2 groups.ConclusionsThe difference in progression-free survival between patients with epithelial ovarian cancer with and those without severe anemia during TC was not statistically significant, but for patients receiving dose-dense TC, severe anemia seems to have prognostic relevance. Prospective trials are needed to investigate whether the optimal management of chemotherapy-induced anemia, including appropriate use of erythropoiesis-stimulating agents, would further improve the survival of patients with ovarian cancer receiving dose-dense TC.


2006 ◽  
Vol 24 (12) ◽  
pp. 1892-1897 ◽  
Author(s):  
Jeffrey A. Meyerhardt ◽  
Andrew X. Zhu ◽  
Peter C. Enzinger ◽  
David P. Ryan ◽  
Jeffrey W. Clark ◽  
...  

Purpose To investigate the combination of erlotinib, capecitabine, and oxaliplatin in patients who were previously treated for metastatic colorectal cancer. Patients and Methods Patients were eligible if they had metastatic colorectal cancer that progressed, were intolerant to first-line chemotherapy, or had disease recurrence within 1 year of adjuvant therapy for early-stage disease. Each 21-day cycle consisted of daily oral erlotinib at 150 mg, oral capecitabine at 1,000 mg/m2 (reduced to 750 mg/m2 after the first 13 patients) twice a day on days 1 to 14, and intravenous oxaliplatin at 130 mg/m2 on day 1. Results Thirty-two patients were enrolled onto this phase II study. By intention-to-treat analyses, eight patients (25%) experienced a partial response and 14 patients (44%) had stable disease for at least 12 weeks. The median progression-free survival was 5.4 months and the median overall survival was 14.7 months. These results were essentially unchanged when limited to the cohort of patients (78%) who received prior irinotecan for metastatic colorectal cancer. Most common grade 3 to 4 toxicities included diarrhea (38%), nausea/emesis (19%), fatigue (16%), dehydration (16%), and dermatitis (13%); grade 3 or 4 toxicities were reduced with a lower starting dose of capecitabine. Conclusion The combination of capecitabine, oxaliplatin, and erlotinib seems to have promising activity against metastatic colorectal cancer in patients who received prior chemotherapy, with a relatively higher response rate and progression-free survival compared with previous reports of either infusional FU, leucovorin, and oxaliplatin or capecitabine and oxaliplatin in similar patient populations.


2020 ◽  
Vol 20 (11) ◽  
pp. 887-895 ◽  
Author(s):  
Martina Catalano ◽  
Giandomenico Roviello ◽  
Raffaele Conca ◽  
Alberto D’Angelo ◽  
Valeria Emma Palmieri ◽  
...  

Background: The phase III MPACT trial demonstrated the superiority of gemcitabine (Gem) combined with Nab-paclitaxel (Nab-P) versus gemcitabine alone in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The purpose of this study was to evaluate the effect of Gem/Nab-P in routine clinical practice. Methods: From January 2015 to December 2018, patients with metastatic PDAC receiving firstline treatment with a combination of gemcitabine and Nab-paclitaxel were included in a multicentre retrospective observational study. Exploratory analyses of efficacy, and prognostic and predictive markers, were performed. Results: The cohort comprised 115 patients (median age 65 [range 50-84] years) with good performance status (ECOG PS 0-1). The median overall survival (OS) was 11 months (95% CI; 9-13) and the median progression-free survival (PFS) was 6 months (95% CI 5-7). Partial response and stable disease were achieved in 44 and 30 patients, respectively, yielding an overall disease control rate (DCR) of 64.3%. Grade 3-4 hematological toxicity frequency was 22.61% for neutropenia, 5.22% for anemia, and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 non-hematological events were reported. Dose reduction was necessary in 51.3% of the patients. Conclusions: Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine and Nab-paclitaxel in metastatic PDAC in a real-life population.


Cancers ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 2489
Author(s):  
Sazan Rasul ◽  
Tim Wollenweber ◽  
Lucia Zisser ◽  
Elisabeth Kretschmer-Chott ◽  
Bernhard Grubmüller ◽  
...  

Background: We investigated the response rate and degree of toxicity of a second course of three cycles of [177Lu]Lu-PSMA radioligand therapy (PSMA-RLT) every 4 weeks in mCRPC patients. Methods: Forty-three men (71.5 ± 6.6 years, median PSA 40.8 (0.87–1358 µg/L)) were studied. The response was based on the PSA level 4 weeks after the third cycle. The laboratory parameters before and one month after the last cycle were compared. Kaplan–Meier methods were used to estimate the progression-free survival (PFS) and overall survival (OS), and the Cox regression model was performed to find predictors of survival. Results: Twenty-six patients (60.5%) exhibited a PSA reduction (median PSA declined from 40.8 to 20.2, range 0.6–1926 µg/L, p = 0.002); 18 (42%) and 8 (19%) patients showed a PSA decline of ≥50% and ≥80%, respectively. The median OS and PFS were 136 and 31 weeks, respectively. The patients with only lymph node metastases survived longer (p = 0.02), whereas the patients with bone metastases had a shorter survival (p = 0.03). In the multivariate analysis, only the levels of PSA prior to the therapy remained significant for OS (p < 0.05, hazard ratio 2.43, 95% CI 1.01–5.87). The levels of hemoglobin (11.5 ± 1.7 g/dL vs. 11 ± 1.6 g/dL, p = 0.006) and platelets (208 ± 63 g/L vs. 185 ± 63 g/L, p = 0.002) significantly decreased one month after cycle three, though only two grade 3 anemia and one grade 3 thrombocytopenia were recorded. Conclusion: A further intensive PSMA-RLT course is well tolerated in mCRPC patients and associated with promising response rates and OS.


2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Qingduo Kong ◽  
Hongyi Wei ◽  
Jing Zhang ◽  
Yilin Li ◽  
Yongjun Wang

Abstract Background Laparoscopy has been widely used for patients with early-stage epithelial ovarian cancer (eEOC). However, there is limited evidence regarding whether survival outcomes of laparoscopy are equivalent to those of laparotomy among patients with eEOC. The result of survival outcomes of laparoscopy is still controversial. The aim of this meta-analysis is to analyze the survival outcomes of laparoscopy versus laparotomy in the treatment of eEOC. Methods According to the keywords, Pubmed, Embase, Cochrane Library and Clinicaltrials.gov were searched for studies from January 1994 to January 2021. Studies comparing the efficacy and safety of laparoscopy versus laparotomy for patients with eEOC were assessed for eligibility. Only studies including outcomes of overall survival (OS) were enrolled. The meta-analysis was performed using Stata software (Version 12.0) and Review Manager (Version 5.2). Results A total of 6 retrospective non-random studies were included in this meta-analysis. The pooled results indicated that there was no difference between two approaches for patients with eEOC in OS (HR = 0.6, P = 0.446), progression-free survival (PFS) (HR = 0.6, P = 0.137) and upstaging rate (OR = 1.18, P = 0.54). But the recurrence rate of laparoscopic surgery was lower than that of laparotomic surgery (OR = 0.48, P = 0.008). Conclusions Laparoscopy and laparotomy appear to provide comparable overall survival and progression-free survival outcomes for patients with eEOC. Further high-quality studies are needed to enhance this statement.


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