Role of trabectedin (T) in the management of advanced uterine leiomyosarcoma (U-LM)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 10530-10530
Author(s):  
F. Grosso ◽  
R. Sanfilippo ◽  
R. L. Jones ◽  
P. Collini ◽  
C. Morosi ◽  
...  
Keyword(s):  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Median Number ◽  
Local Relapse ◽  
Tumor Control ◽  
Uterine Leiomyosarcoma ◽  
Systemic Treatments ◽  
Genetic Features ◽  
Metastatic Sites ◽  
Clinical Records

10530 Background: To explore the clinical impact of T in U-LM. T has been approved in Europe for second line treatment of advanced soft tissue sarcomas (STS). Efficacy is well established in liposarcoma and leiomyosarcoma. U-LMs display peculiar clinical and genetic features compared to other STS. These differences may be responsible for the sensitivity of this subtype to therapy, thus justifying an evaluation of the activity of T in a relatively homogeneous series of U-LM patients. Methods: From April 2000, 56 patients (pts) with advanced disease, previously exposed to a median of 3 chemotherapy lines (range 1–5), received T within an expanded access programme at two European referral institutions for sarcoma. The clinical records were reviewed focusing on response and treatment outcome. Two pts were excluded from the analysis having received only 1 course of T. Median age was 56 yrs (range 29–73), median number of metastatic sites was 2 (range 1–4), the most frequent metastatic site was lung (88%), 24 patients had a local relapse. Results: A total of 252 courses were delivered (median 3, IQR2–6) and 36% of patients received more than 5 courses of T. Fifty-two patients were evaluable for response. A partial response was observed in 11 patients and stable disease in 15, for a PR rate of 21% and a tumor control rate of 50%. The median progression-free survival was 3.6 months (CI95% 2.6–6.7), with 41% of patients free from progression at 6 months. Conclusions: These results compare favourably with other systemic treatments in advanced U-LMS and support their sensitivity to T. This should prompt further studies to prospectively evaluate the efficacy of T in U-LMS and elucidate possible biological predictive factors (e.g. DNA repair protein expression). [Table: see text]

Imatinib for the treatment of aggressive fibromatosis/desmoid tumors (AF/DT) failing local treatment: updated outcome and predictive factors for progression free survival. A FNCLCC French Sarcoma Group-GETO study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 10062-10062
Author(s):  
J. Fayette ◽  
A. Dufresne ◽  
N. Penel ◽  
A. Le Cesne ◽  
B. Bui Nguyen ◽  
...  
Keyword(s):  
Predictive Factors ◽  
Local Treatment ◽  
Progression Free Survival ◽  
Aggressive Fibromatosis ◽  
Tissue Microarrays ◽  
Long Term Results ◽  
Tumor Control ◽  
Curative Surgery ◽  
Kit Mutation ◽  
Systemic Treatments

10062 Background: The optimal treatment of AF/DT failing local treatments is not defined. We report long term results and predictive factors for response to imatinib in AF/DT. Methods: Pts =18 years with advanced AF/DT from all sites in whom neither curative surgery nor radiotherapy (RT) was possible were eligible. Imatinib was given at the dose of 400mg/d (and increased to 800 mg/d if progression) during 1 year then stopped. Primary endpoint was the progression free at 3 months. A two stages Simon‘s optimal design was used with p0=10%, p1=30%, a=0.05 and 90% power (18 pts first stage, total of 35 evaluable pts). Predictive factors were investigated using tissue-microarrays (TMA) and KIT mutation analysis. Results: Between 09/2004 and 10/2005, 40 pts were included in 15 centers. Median age was 40 (range 20–72) with 30% males. Primary sites were extra abdominal, mesenteric, and abdominal wall in 69, 18, and 13% of pts respectively. 23% had received RT. Prior systemic treatments were: NSAID, hormonotherapy or chemotherapy (CT) in 33%, 45% and 20% of pts respectively. Median treatment duration of imatinib is 9 months (range 0.8–13.8). G4 and G3 toxicities were notified in 0 and 17 patients (42.5%) respectively: rash (4 pts), abdominal pain (3 pts), and vomiting (3 pts). 38 pts (95%) are evaluable at 3 months, with 1 (3%) CR, 3 (8%) RP, 31 (82%) SD and 3 (8%) PD. With a median follow-up of 13.8 months, 13 of the 40 pts had progressed. PFS at one year is 71% and 1 patient died (PD). 8 patients received an increased dose of imatinib upon progression under a 400mg/d dose: 3 reprogressed and 5 achieved tumor stabilization during 5+, 6+, 8+ months. PFS was correlated to weight or to previous CT, but not to gender, Gardner, age, PS, size, site. Using TMA, the expression of PDGFR β and a β catenin, E-cadherine, cyclinD1, M-CSFR, estrogen receptor β, ERK, phospho-Akt-Ser473, phospho-MEK1–2 were investigated. None of the CycD1+ tumors have progressed so far. 3 mutations of KIT exon 10 were detected in 10 patients tested. All achieved tumor control. Conclusions: Imatinib induces prolonged disease stabilization in the majority of evaluable patients with AF/DT. Prognostic factors were identified. [Table: see text]

Phase II dose escalation study of sorafenib in patients with metastatic renal cell carcinoma (mRCC) who have had prior treatment with VEGFR-TKI antiangiogenic treatment

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16027-e16027
Author(s):  
A. P. Mancuso ◽  
E. Donato De Paola ◽  
A. Catalano ◽  
F. Calabrò ◽  
C. Messina ◽  
...  
Keyword(s):  
Standard Dose ◽  
Progression Free Survival ◽  
Median Number ◽  
Dose Escalation Study ◽  
Multikinase Inhibitor ◽  
Prior Therapy ◽  
Hand Foot Syndrome ◽  
Tki Treatment ◽  
Number Of Cycles ◽  
Metastatic Sites

e16027 Background: Sorafenib is an orally active multikinase inhibitor (Raf kinase, VEGFR 1, 2, 3 and PDGFR inhibitor) for the treatment of advanced RCC. The purpose of this study was to assess the efficacy and toxicity of Sorafenib in mRCC patients (pts) previously treated with an anti-angiogenic VEGFR-TKI using escalating dose levels. Methods: Pts with mRCC, PS 0–2 and adequate organ function were eligible. Pts received Sorafenib 400 mg/BID/continuously in 4-wk cycles. Pts with no progressive disease (evaluated at 12 weeks) continued to receive Sorafenib at the standard dose, while progressive pts received an increasing dose (600 mg BID) with early disease restaging after 4 weeks. Pts who progressed at 600 mg BID were taken off study. Efficacy was assessed by RECIST criteria. Results: 18 pts were entered; baseline characteristics: PS 0–1: 94%; median age 62 years (41–82); nephrectomy: 100%; surgery for metastatic disease: 28%, clear-cell 78%, papillary-cell 16%, sarcomatoid 6%.≥ 2 metastatic sites: 84%. 10 pts were refractory to cytokine treatment and all progressed or experienced unacceptable toxicity after anti-angiogenic VEGFR-TKI treatment, Sunitinib (13 pts) or Pazopanib (5 pts). Median number of cycles was 7.5 (1–16). Overall, 72% of pts had disease control without significant correlations between response to prior therapy and hypertension. 14 pts had progression free survival (PFS) of 4.3 months (mos). 4 pts are still in treatment with a median PFS > 8 mos. Of 6 pts in which the dose was escalated, 3 benefitted with a PFS of > 3 mos. The most common toxicity (NCIC 3.0, all pts) was grade (g) ≥ 1 diarrhea in 10 pts, g2–3 hand-foot syndrome in 7 pts and g-3 mucositis in 1 pt. Other hematological and non-hematological toxicities were g1 with a frequency < 15%. Conclusions: Sorafenib at doses of 400–600 mg/BID/continuosly results in acceptable and well tolerated salvage treatment after VEGFR-TKI failure. In progressive patients, treatment with a higher dose could be a valid option. Final and mature data will be presented in combination with translational research evaluating biological characteristics on tissue and blood. No significant financial relationships to disclose.

Doxorubicin, cisplatin, and ifosfamide (API) as first-line therapy for relapsed or metastatic uterine leiomyosarcoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10098-10098
Author(s):  
Julien Hadoux ◽  
Annie Rey ◽  
Pierre Duvillard ◽  
Catherine Lhomme ◽  
Corinne Balleyguier ◽  
...  
Keyword(s):  
Metastatic Disease ◽  
Response Rate ◽  
Objective Response ◽  
Local Relapse ◽  
High Rate ◽  
Physiological Age ◽  
Uterine Leiomyosarcoma ◽  
First Line ◽  
First Line Therapy ◽  
Metastatic Sites

10098 Background: Uterine leiomyosarcomas (ULMS) are rare gynecologic malignancies characterized by a poor prognosis due to a high rate of local and metastatic recurrences. Chemotherapy (CT) with doxorubicin or ifosfamide or both is associated with a 10 to 30% objective response rate (ORR) and a cisplatin-based multiCT approach achieved a good response rate (DECAV therapy: API + dacarbazine + vindesine, 54% ORR in uterine sarcomas), though toxic. We aimed to determine efficacy and toxicity of doxorubicin, cisplatin and ifosfamide (API) combination as first line treatment of metastatic or relapsed ULMS (MRULMS). Methods: This monocentric study included MRULMS pts with a physiological age < 65 y. CT consisted in doxorubicin 50 mg/m² d1, ifosfamide 3 g/m²/d d1d2 + mesna, cisplatin 75 mg/m² d3, + G-CSF; q 3 weeks. Results: Results in 38 pts with MRULMS were analyzed; median age was 51 (40-64), median cycles of CT was 5; 8 (21%) pts were treated for local relapse, 21 (55.3%) for metastatic disease and 9 (23.7%) for both. Metastatic sites were: lungs in 16 pts (42.1%), pelvis in 7 pts (18.4%), liver in 7 pts (18.4%), peritoneum in 6 pts (15.8%) and bone in 5 pts (13.2%); 14 pts (36.8%) had a multisite metastatic disease. Main grade 3-4 toxicities in 38 pts were neutropenia (74%), thrombopenia (60%), anemia (55%), fatigue (18%) and vomiting (13%). Febrile neutropenia was observed in 35% of pts and 1 patient died of septic shock after cycle 1. Thirty four pts were evaluable for response (4 pts had complete surgery at relapse) and 16 pts responded (4 CR + 12 PR) (ORR: 47%); 23.5% and 29.4% of the pts had respectively stable and progressive disease. For all pts (38) and evaluable pts (34), median PFS were 9.8 and 9.5 months and OS 27 and 25.3 months respectively. Conclusions: Despite toxicity observed, API is an effective treatment which compares favorably with other first line therapies for MRULMS pts.

Neoadjuvant chemotherapy for locally advanced cervical cancer: Experience at the Instituto Oncologico Nacional SOLCA Guayaquil.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15571-e15571
Author(s):  
Guillermo Paulson ◽  
Katherine Garcia ◽  
Mayra Santacruz ◽  
Ruth Ginger Engracia ◽  
Jose Francisco Mendoza
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Invasive Cervical Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Number Of Cycles ◽  
Clinical Records ◽  
Cancer Experience

e15571 Background: Cervical cancer is the most common malignancy of women in Ecuador. The main problem of concomitant chemo-radiotherapy (CRT) is the delay in starting radiation therapy, economic and logistical problems for high demand in radiotherapy. It has been neoadjuvant chemotherapy (NACT) followed by CRT the main treatment at our center in order to find an alternative to long waits before the start of radiotherapy. The aim of this study was to determine the response to NACT followed by CRT in terms progression-free survival (PFS) and overall survival (OS). Methods: diagnosed with invasive cervical cancer locally advanced stage II-III were analyzed retrospectively reviewed clinical records of pre-existing data from 2008 to 2010. Results: after meeting the criteria of exclusion, leaving 116 cases. The median age: 49 years (range: 28-82 years). The histology was 73% (85) squamous cell carcinoma, 26% (30) adenocarcinoma and 0.9% (1) not specified. Patients with stage IIB: 81.9% (95), IIIA: 10.3% (12), IIIB: 7.8% (9). Of the 116 patients 69% (80) received NACT. The main NACT was paclitaxel 175mg/m2 + Cisplatin 75mg/m2 every 3 weeks 63.8% (74), the remaining group received another protocol, the median number of cycles of NACT was 5 (1 - 8 cycles), the start of radiotherapy since the conclusion of NACT was 53 days on average (1 to 285 days) and the main regimen of CRT concomitant was cisplatin 40mg/m2 weekly 47.5% (38). In the 49 patients who underwent NACT followed by CRT, a radiological study showed, complete response (CR) 38.8% (19), 18.4% partial response (PR) (9), disease progression (DP) 12.2% (6), stable disease (SD) 8.2% (4) and the end of treatment evaluation gynecological was performed and CR was obtained in 59.2% (29). Persistent or progressive disease after treatment was 22.4% (11), recurrence was 12.2% (6), local recurrence 2.0% (1), distant metastasis 10.2% (5). OS of NACT followed by CRT was 93.9% (46) and PFS was 65.3% (32), OS after CR was 96% (25 / 1) and then 91.7% PR (24 / 2) with p: 0.439. Conclusions: NACT followed by CRT is a valid option because it improves disease-related symptoms, but OS did not improve significantly even after CR.

mTOR inhibitor therapy for metastatic sarcomatoid clear cell renal cell carcinoma (ccRCC).

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 450-450 ◽  
Author(s):  
Diogo Assed Bastos ◽  
Martin Henner Voss ◽  
Christoph Karlo ◽  
Albulena Ajeti ◽  
Sujata Patil ◽  
...  
Keyword(s):  
Mtor Inhibitor ◽  
Progression Free Survival ◽  
Mtor Inhibitors ◽  
Risk Groups ◽  
Median Number ◽  
Tumor Burden ◽  
Inhibitor Therapy ◽  
Cancer Center ◽  
Cell Renal Cell Carcinoma ◽  
Metastatic Sites

450 Background: Sarcomatoid variant describes a histomorphologic pattern with presence of spindle-cell features that can be seen across all subtypes of RCC. It is associated with an aggressive phenotype and poor prognosis. Outcome to mTOR inhibitor therapy was accessed in patients (pts) with ccRCC with sarcomatoid features. Methods: Patients with metastatic sarcomatoid ccRCC treated with mTOR inhibitors at our center were retrospectively identified. Demographic characteristics and treatment outcome were assessed. Overall response rate (ORR) was determined by formal response criteria (RECIST 1.1). Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Results: 29 pts were treated with temsirolimus (18) or everolimus (11). Median age was 57 years (53 to 61) and there were 21 male pts (72%). Median number of metastatic sites was 3 (1 to 7) and 18 pts (62%) had ≥ 3 metastatic sites. Distribution between Memorial Sloan-Kettering Cancer Center risk groups was 14% favorable, 72% intermediate, and 14% poor-risk disease. Median number of prior therapies was 1 (0 to 5) and 79% of pts received mTOR inhibitor as ≥ 2nd-line of therapy. Three patients (10.3%) achieved a partial response (PR), 11 (38%) stable disease (SD), and 15 (51.7%) had progressive disease (PD). Tumor shrinkage was observed in 9 pts (31%) and the mean change in tumor burden was +24% (-45% to +100%). Median PFS and OS were 3.4 months (CI: 1.4-5.3) and 8.3 months (CI: 4.8- 17), respectively. Conclusions: OS was poor in this heterogeneous group of pts. Future studies to characterize this variant at a molecular level are warranted and might identify predictive markers for clinical outcome in patients treated with mTOR inhibitors. [Table: see text]

scholarly journals Trabectedin in Advanced Sarcomas—Experience at a Tertiary Care Center and Review of Literature

2021 ◽  
Vol 10 (02) ◽  
pp. 53-57
Author(s):  
Saurav Verma ◽  
Kaushal Kalra ◽  
Sameer Rastogi ◽  
Ekta Dhamija ◽  
Avinash Upadhyay ◽  
...  
Keyword(s):  
Group Performance ◽  
Care Center ◽  
Performance Status ◽  
Tertiary Care ◽  
Eastern Cooperative Oncology Group ◽  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Median Number ◽  
Poor Performance Status

Abstract Background There is sparse literature on trabectedin in advanced soft-tissue sarcomas from developing world. It would be interesting to know about use and outcomes of trabectedin in Indian patients. Method In a retrospective study, consecutive patients treated with trabectedin from 2016 to 2019 were analyzed. Patients with L-sarcomas were treated at a dose of 1.5 mg/m2, while those with translocation-related sarcomas were treated at a dose of 1.2 mg/m2 as a 24-hour infusion through peripherally inserted central catheter line. From July 2019, infusions were administered through an ambulatory elastomeric pump, while before that patients were admitted for 24 hours. We used SPSS version 23.0 for statistical calculation. Result A total of 20 patients received trabectedin with a total of 116 infusions. The median age was 46 years (range: 22–73 years). The male (n = 11, 55%) and female patients were almost equal (n = 9, 45%). Thirteen patients (65%) had Eastern Cooperative Oncology Group Performance Status 1. Majority of the patients had leiomyosarcoma (n = 8, 40%); remaining comprised of liposarcoma (3, 15%), translocation-related sarcomas excluding myxoid liposarcoma (n = 8, 40%) and others (n = 1,5%). Most common site was extremity (n = 11, 55%) followed by retroperitoneal (n = 3, 15%), visceral (n = 3, 15%), and others (n = 3,15%). Median number of previous lines received was 2 (range: 0–4). Median number of trabectedin cycles received was 4 (range: 1–17). Best response assessed was stable disease (n = 10, 50%), progressive disease (n = 6, 30%), partial response (n = 1, 5%), and not assessed in 3 patients. After a median follow-up of 19 months, median progression-free survival was 4 months. Conclusion In this heavily treated population (composed of L-sarcomas and translocation-related sarcomas) with many patients with poor performance status, the outcome with trabectedin is in synchrony with literature. However, the need of 24-hour admission might deter quality of life. Elastomeric pump seems to be a reasonable alternative to admission and can be a breakthrough in administering trabectedin, especially in developing countries.

A retrospective review of metastatic or recurrent uterine sarcomas treated with ifosfamide and doxorubicin (IMA)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15053-15053
Author(s):  
N. Guler ◽  
D. Hizli ◽  
S. Sarici ◽  
R. Ocalan ◽  
M. Kose ◽  
...  
Keyword(s):  
Survival Time ◽  
Endometrial Stromal Sarcoma ◽  
Progression Free Survival ◽  
Median Number ◽  
Uterine Sarcoma ◽  
Uterine Sarcomas ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Stromal Sarcoma ◽  
Metastatic Sites

15053 Background: The prognosis of metastatic uterine sarcoma is poor with median survival reported between 4 to 26 months. We evaluated the efficacy and toxicity of ifosfamide (I) mesna (M) and doxorubicin (A) (IMA) chemotherapy regimen retrospectively in patients (pts) with metastatic, or recurrent uterine sarcomas. Methods: Eligible patients had measurable recurrent or metastatic disease, ECOG PS < 2, had adequate renal, hepatic and hematologic functions. The IMA regimen was ifosfamide 2500 mg/m2 days 1–3, mesna 2500 mg/m2 days 1–3, doxorubicin 60 mg/m2 day 1, repeated every 21 days. Patients were evaluated for response for each two cycles. Results: Thirty-five pts (17 leiomyosarcoma [LMS], 6 malignant mixed mesodermal tumor [MMMT], 5 endometrial stromal sarcoma, 4 carcinosarcoma, and 3 adenosarcoma) were enrolled in this study. The median age was 49 yrs (range, 18–72). Two pts were lost to follow up after the first cycle; one patient had ifosfamide encephalopathy on the third day of the first cycle. Thirty-two pts were assessable for response, toxicity, and survival. Nine pts had prior chemotherapy and 4 pts had radiotherapy. Most frequent metastatic sites were peritoneum, lung and liver. Median period of time from the diagnosis to starting IMA regimen was 14.5 months. A total of 132 cycles of chemotherapy were introduced and for each patient median number of chemotherapy cycles were 4 (range, 1–6). We observed CR in 2 pts; PR in 15 pts. Objective RR was % 48.6 (95% CI, 32% to 67%). Of 17 pts with LMS, 1 CR and 6 PRs were observed. The median progression-free survival time of the responders was 12.0 months. The median progression-free survival time of all patients was 7.0 months. NCI-CTC grade 3 or 4 leucopenia, neutropenia, thrombocytopenia, and anemia occurred in 40%, 55%, 12%, and 13%, respectively. There was no significant nausea/vomiting, nephrotoxicity. Febrile neutropenia was encountered in 6 pts. Dose modifications were required in 4 pts due to myelotoxicity. CNS toxicity was observed in one pts. Conclusions: IMA regimen has moderate anti-tumor activity (48.6%) with acceptable toxicity in pts with recurrent or metastatic uterine sarcomas. No significant financial relationships to disclose.

A SARC multicenter phase III study of gemcitabine (G) vs. gemcitabine and docetaxel (G+D) in patients (pts) with metastatic soft tissue sarcomas (STS)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 9514-9514 ◽  
Author(s):  
R. G. Maki ◽  
M. L. Hensley ◽  
J. K. Wathen ◽  
S. R. Patel ◽  
D. A. Priebat ◽  
...  
Keyword(s):  
Soft Tissue Sarcomas ◽  
Progression Free Survival ◽  
Median Number ◽  
Phase Iii ◽  
Clinical Activity ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Adaptive Randomization ◽  
Exact Test ◽  
Phase Iii Study

9514 Background: We sought to compare the response of metastatic STS to G vs. G+D in a phase III study using a novel Bayesian adaptive randomization strategy. Methods: Entry criteria included non-GIST STS diagnosis, age > 10, measurable disease, ≤ 3 prior regimens, normal organ function, and Grade (Gr) ≤ 1 neuropathy. Pts were stratified by histology (leiomyosarcoma [LMS] vs. other), and history of prior pelvic radiation (PPR) or not, yielding 4 diagnostic subgroups. Therapy was G 1200 mg/m2 (over 120 min, d1+d8) or G 900 mg/m2 (over 90 min, d1+d8) and docetaxel (100 mg/m2 d8) q21d; all pts received (peg)-filgrastim starting d9. 25% dose reductions were employed for PPR or toxicity. The primary endpoint was tumor response (CR, PR, or 24+ weeks stable), using a double-blind Bayesian adaptive randomization procedure to incrementally assign more pts to the superior treatment arm, while accounting for possible treatment-subgroup interactions. Although this study is not based on a 1:1 randomized phase III design, enrolling ∼120 pts would show a difference between a response rate (RR) of 10% for G and 30% with G+D with a power of 0.8 and two-sided alpha of 0.05. Results: 122 pts were randomized; 119 pts had evaluable outcomes. Median number of prior regimens was 1; median number of cycles was 4 (range 1–26). 49 pts were adaptively randomized to G and 73 to G+D, indicating superiority of G+D. Of 119 evaluable pts, 27% (G) and 32% (G+D) showed response as defined. The odds of pts with LMS receiving G+D instead of G increased from 1:1 at the start of the study to ∼6:1 at its completion. RR was 10% (G) vs. 16% (G+D) (p=0.15, Fisher exact test). Consistent with the RR outcomes, progression free survival (PFS) was 6.2 m (G+D, K-M 95%CI 3.6–8.8) vs. 2.6 m (G, 95%CI 2.0–3.2). Overall survival (OS) was 18.0 m (G+D, K-M 95%CI 11.7–24.1) vs. 11.2 m (G, 95%CI 6.8–15.5). Pts receiving G+D had a higher rate of discontinuation due to toxicity than those receiving G (p<0.01, log rank). Conclusions: We observed substantial clinical activity in this pre-treated STS population. G+D yields superior PFS and OS to G, but at the price of increased toxicity. Adaptive randomization is an effective method that substantively reduces the number of pts receiving inferior therapy. [Table: see text]

Aromatase inhibitors (AI) are highly effective in uterine sarcomas (US) expressing estrogen receptors

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 9576-9576 ◽  
Author(s):  
J. Fayette ◽  
I. Ray-Coquard ◽  
E. Bompas ◽  
L. Zufferey ◽  
S. Tabone-Eglinger ◽  
...  
Keyword(s):  
Aromatase Inhibitors ◽  
Hormonal Treatment ◽  
Progression Free Survival ◽  
Complete Response ◽  
Uterine Sarcoma ◽  
Tumor Control ◽  
Uterine Leiomyosarcoma ◽  
Uterine Sarcomas ◽  
A Prospective Study

9576 Background: US frequently recur despite adequate locoregional treatments. Estrogen (ER) and progesterone (PR) receptors are expressed by 43–88% of US, mostly in endometrial stromal sarcomas (ESS) without correlation with survival. Whether hormonal treatment may be useful in estrogenreceptor (ER) expressing connective tumors of the uterus and pelvis is not known. Here, we report on the clinical antitumor effect of aromatase inhibitors (AI) in patients with US. Methods: Since september 2002, 8 menopaused women relapsing uterine leiomyosarcoma, ESS or intravascular leiomyomatosis, (all of grade 1 or 2 in WHO grading) were treated with AI (letrozole, n=5 or anastrozole, n=3). Median age was 62 (41–84), 7/8 expressed ER and 8/8 progesterone (PgR). Progression free, overall survival, and response to AI in evaluable patients were analyzed. Results: After a median follow-up of 16.5 months [1–38], 6 patients are currently non progressive under treatment by AI, without toxicity. All 8 (100%) evaluable patients experienced tumor control with 2 complete response -CR- (1 after lung surgery 25+, 38+), 2 PR (21 and 17+) and 4 stabilizations -SD- (15 months and at 1+, 3+ and 9+ months). Time to response was 3, 5 and 6 months respectively. Two patients progressed after 15 and 21 months; 3 patients are currently treated after 17+, 25+ and 38+ months. At 2 years. Median survival was not reached. 2 years DFS is 60% currently. Conclusions: AI enables prolonged progression free survival in uterine sarcoma expressing hormonal receptors. A prospective study for treatment of relapses and later in adjuvant setting is needed in these rare diseases. No significant financial relationships to disclose.

TS-1 in patients with capecitabine-resistant breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1103-1103
Author(s):  
D. Yamamoto ◽  
H. Yoshida ◽  
S. Iwase ◽  
H. Odagiri ◽  
K. Kitamura
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast ◽  
Gastrointestinal Disorder ◽  
Median Number ◽  
Molar Ratio ◽  
Biochemical Modulation ◽  
Tumor Control ◽  
Good Tolerability ◽  
Metastatic Sites ◽  
Dose Modifications

1103 Background: TS-1 is a novel oral anticancer drug, composed of tegafur, gimestat and otastat potassium in a molar ratio of 1:0.4:1, based on the biochemical modulation of 5-Fuorouracil. To evaluate the efficacy and safety of TS-1 in patients with capecitabine-resistant metastatic breast cancer (MBC). Methods: Forty patients with MBC who failed capecitabine-based chemotherapy, received TS-1 (100 mg/m2) at four centers. Resistance to capecitabine was defined as either progression of disease during treatment, failure to achieve regression of disease after at least four courses, or rapid recurrence after completion of therapy. Results: From January 2006 to May 2008, 40 pts were enrolled. Baseline characteristics of the pts were: median age 50 years (range 34–78), median ECOG PS 0 (range 0–2), and adequate bone marrow, renal, and hepatic functions. Median number of metastatic sites was 2 (range 1–5). The pts were evaluable for response and toxicity. Ten pts (25 %) achieved a partial response, 12 patients (30 %) patients had stable disease, and 18 (45 %) progressive disease. The median time to disease progression was 26.6 weeks. The most treatment-related adverse events were grade 1/2 in intensity. 7 pts experienced serious TS-1- related gastrointestinal disorder requiring dose modifications in 3 pts and treatment discontinuation in 4 pt. Further, interestingly, 6 of the 40 patients (15.0%) who received TS-1 did hand-foot syndrome (HFS), although 20 of the 40 patients (50.0%) who had received capecitabine, developed HFS. Conclusions: This study confirms that TS-1 achieves a high tumor control rate in pretreated MBC pts and is active in patients with capecitabine-resistant breast cancer. Response rates were comparable to or better than those seen with other therapies for patients with capecitabine-resistant MBC. TS-1 should be considered the reference treatment in this setting based on consistently high efficacy and good tolerability. No significant financial relationships to disclose.

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