Gemcitabine in heavily pretreated adult soft tissue sarcoma patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 20524-20524 ◽  
Author(s):  
D. Schoeler ◽  
A. Kunitz ◽  
P. Reichardt
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Performance Status ◽  
Single Agent ◽  
Poor Performance ◽  
Cytotoxic Agents ◽  
Poor Performance Status ◽  
Advanced Soft Tissue Sarcoma ◽  
Undifferentiated Sarcoma ◽  
Heavily Pretreated

20524 Background: The number of effective cytotoxic agents in treatment of advanced soft tissue sarcoma (STS) is limited when patients have failed anthracyclin and ifosfamide therapy. There are inconsistent data in phase I / II studies and retrospective analyses evaluating the efficiacy of gemcitabine (G, 900mg/m2, d1+8, q3w) or combination of gemcitabine and docetaxel (GD, G: 900mg/m2, d1+8, D: 100 mg/m2, d8, q3w). Methods: Between 2002 and 2006 we retrospectively analyzed 14 females and 6 males with heavily pretreated advanced soft tissue sarcoma (1–5 pretreatments) who were treated in our department (Charité Campus Virchow-Klinikum) with G (n=10) or GD (n=10) depending on their performance status. The following histology types were represented: leiomyosarcoma (10), liposarcoma (3), MPNST (3), synovial sarcoma (2), undifferentiated sarcoma (1), malignant large cell sarcoma (1). Results: A total of 99 cycles (range 1 to 15) were applied. Best response was partial remission (PR=20%, G: n=2, GD: n=2) and was achieved in four patients, among them three leiomyosarcoma and one MPNST. In six cases disease stabilization was achieved for up to 15 month (SD=30%, G: n=2, GD: n=4). Four patients had progressive disease after 2–3 cycles of gemcitabine based therapy (PD=20%, G: n=0, GD: n=4). In another six cases only day one of the first cycle (G alone) was administered because of serious problems due to pretreatment and poor performance status (e.g. prolonged thrombopenia and neutropenia Grade IV, gemcitabine-induced vasculitis, gastrointestinal bleeding due to tumor localization, pneumonia, rapid tumor progression). Conclusions: Gemcitabine-based therapy for heavily pretreated STS patients in our retrospective analysis has a significant overall response rate. In patients considered unfit for GD combination, single agent G treatment remains an option with moderate effiacy. No significant financial relationships to disclose.

Advanced soft-tissue sarcoma in patients over age 75: Patterns of care and survival.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 10057-10057
Author(s):  
Delphine Garbay Decoopman ◽  
Mary Louise Keohan ◽  
Angela Cioffi ◽  
Robert G. Maki ◽  
Binh Bui Nguyen ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Systemic Therapy ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Advanced Soft Tissue Sarcoma ◽  
Optimal Care ◽  
Entire Cohort

10057 Background: There are no data regarding the management and the outcome of elderly patients (pts) diagnosed with advanced soft-tissue sarcoma (STS). Methods: The charts of pts aged ≥ 75 years and diagnosed with metastatic and/or unresectable STS between 1990 and 2011 at Memorial Sloan Kettering (New York) and Institut Bergonié (Bordeaux, France) were reviewed. Results: 189pts were included.Median age was 79 years (range 75-93).160 pts (84.5%) had metastatic disease. The most frequent histological subtype was leiomyosarcoma (n=57, 30%). The median age-adjusted Charlson comorbidity score was 10 (range 5-17). 120 pts (63.5%) received systemic therapy whereas 69 pts (36.5%) were managed with best supportive care (BSC) only. Pts who received BSC only were more likely ≥ 80 years old (58% versus 38%, p=0.01) and with performance status (PS) ≥ 2 (35% versus 14%, p=0.01). Single agent and combination therapy were delivered in 87 (72.5%) and 33 (27.5%) cases respectively. 67 pts (56%) received a 1st-line anthracycline-containing regimen. The median progression-free survival of pts treated with systemic therapy was 4 months (95% CI: 2.5-5.5). 21 pts (17.5%) had to stop 1st line treatment because of toxicity. On multivariate analysis, age ≥ 80 years, PS ≥ 2, and single-agent therapy were significantly associated with poor PFS. 51 pts received one or more further lines of therapies. At the time of analysis, 170 pts (90%) had died. 96% of deaths were related to the disease. The median OS for the entire cohort of pts was 9.6 months (95% CI: 7.3-12). The 1-year and 2-year OS rates were 43% (95% CI: 36–50), and 22% (95% CI: 16–28), respectively. The median OS of pts managed with systemic therapy and BSC were 12.5 months (95% CI: 8.4-16.6) and 5.1 months (95% CI: 3.7-6.5), respectively (p=0.02). However, on multivariate analysis, PS ≥ 2 and age-adjusted Charlson score ≥ 10 were the sole independent factors significantly associated with OS. Conclusions: A high proportion of elderly pts with advanced STS were considered unfit for chemotherapy. The OS of STS pts ≥ 75 years who were managed with systemic therapy seems similar to that of younger pts. Further efforts are needed to better define the optimal care for fit and unfit elderly pts with advanced STS.

Efficacy of Sequential High-Dose Doxorubicin and Ifosfamide Compared With Standard-Dose Doxorubicin in Patients With Advanced Soft Tissue Sarcoma: An Open-Label Randomized Phase II Study of the Spanish Group for Research on Sarcomas

2009 ◽  
Vol 27 (11) ◽  
pp. 1893-1898 ◽  
Author(s):  
Joan Maurel ◽  
Antonio López-Pousa ◽  
Ramón de las Peñas ◽  
Joaquín Fra ◽  
Javier Martín ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Standard Dose ◽  
Performance Status ◽  
Single Agent ◽  
Eastern Cooperative Oncology Group ◽  
High Dose ◽  
Open Label ◽  
Advanced Soft Tissue Sarcoma ◽  
Ecog Performance Status

Purpose To assess the progression-free survival (PFS) and antitumor response to standard-dose doxorubicin compared with sequential dose-dense doxorubicin and ifosfamide in first-line treatment of advanced soft tissue sarcoma. Patients and Methods Patients with measurable advanced soft tissue sarcoma, Eastern Cooperative Oncology Group (ECOG) performance status (PS) < 2, between the ages 18 and 65 years, and with adequate bone marrow, liver, and renal function were entered in the study. The stratifications were: ECOG PS (0 v 1), location of metastases, and potentially resectable disease. Patients were randomly assigned to either doxorubicin 75 mg/m2 given as a bolus injection every 3 weeks for 6 cycles (arm A) or doxorubicin at 30 mg/m2 per day for 3 consecutive days once every 2 weeks for 3 cycles followed by ifosfamide at 12.5 g/m2 delivered by continuous infusion over 5 days once every 3 weeks for 3 cycles with filgastrim or pegfilgastrim support (arm B). Results Between December 2003 and September 2007, 132 patients were entered onto the study. Febrile neutropenia, asthenia, and mucositis were more frequent in the arm B. The interim preplanned analysis for futility allowed the premature closure. Objective responses were observed in 23.4% of assessable patients in arm A and 24.1% in arm B. PFS was 26 weeks in the arm A and 24 weeks in arm B (P = .88). Overall survival did not differ between the two therapeutic arms (P = .14). Conclusion Single-agent doxorubicin remains the standard treatment in fit patients with advanced soft tissue sarcoma.

scholarly journals Performance status is the most powerful risk factor for early death among patients with advanced soft tissue sarcoma

2011 ◽  
Vol 104 (10) ◽  
pp. 1544-1550 ◽  
Author(s):  
N Penel ◽  
M V Glabbeke ◽  
S Mathoulin-Pelissier ◽  
I Judson ◽  
S Sleijfer ◽  
...  
Keyword(s):  
Risk Factor ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Performance Status ◽  
Early Death ◽  
Advanced Soft Tissue Sarcoma

scholarly journals Role of Stereotactic Body Radiotherapy in the Treatment of Elderly and Poor Performance Status Patients With Pancreatic Cancer

2017 ◽  
Vol 13 (3) ◽  
pp. 157-166 ◽  
Author(s):  
Lauren M. Rosati ◽  
Joseph M. Herman
Keyword(s):  
Pancreatic Cancer ◽  
Stereotactic Body Radiotherapy ◽  
Group Performance ◽  
Performance Status ◽  
Single Agent ◽  
Locally Advanced ◽  
Poor Performance ◽  
Tumor Control ◽  
Poor Performance Status ◽  
Patient Reported

Literature on the management of nonmetastatic pancreatic ductal adenocarcinoma in patients who are elderly or have poor performance status is sparse. The median survival of this unique cohort of patients is < 6 months, and most patients are only offered single-agent gemcitabine or supportive care. Recently, adding nanoparticle albumin-bound paclitaxel to gemcitabine was shown to improve survival of patients with metastatic disease with Eastern Cooperative Group performance status of 2. Although standard chemoradiotherapy provides long-term locoregional control in locally advanced pancreatic cancer, it is difficult for this group of patients to tolerate 6 weeks of therapy. Stereotactic body radiotherapy (SBRT) can be delivered in only 3 to 5 days, does not require concurrent chemotherapy, and has limited toxicity, and tumor control rates appear to be equivalent to or better than those achieved with standard chemoradiotherapy. Additionally, SBRT has been shown to improve cancer-related pain and patient-reported quality of life. Given the favorable toxicity profile, SBRT seems like an obvious choice for patients who are elderly, have multiple comorbidities, or have poor performance status. Herein, we review the literature on SBRT in this unique patient population and discuss future directions.

scholarly journals A Review of Docetaxel: Its Use in the Treatment of Gastric Cancer

2010 ◽  
Vol 2 ◽  
pp. CMT.S5191
Author(s):  
Alessandro Inno ◽  
Michele Basso ◽  
Alessandra Cassano ◽  
Carlo Barone
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Phase Iii ◽  
Poor Performance Status ◽  
Phase Ii Studies ◽  
Combination Regimens

Docetaxel, a member of the taxane family, promotes cell death by binding β-tubulin and has demonstrated activity against several human malignancies, both as a single agent and in combination therapy. It has been approved in Europe and the US as front-line treatment for advanced gastric cancer in combination with cisplatin and fluorouracil (DCF regimen). This approval was based on the results of a pivotal study (V325) which demonstrated that the addition of docetaxel to the reference regimen of cisplatin and fluorouracil improves overall survival and progression-free survival with a better quality of life despite increased toxicity (mainly haematological). Modifications of DCF regimen have been successfully investigated as a means of making the treatment more tolerable and suitable also for elderly patients or patients with poor performance status. Emerging data from several phase II studies suggest that other docetaxel-based combination regimens with anthracyclines or irinotecan have interesting activity with acceptable toxicity profiles, but the true efficacy of these regimens needs to be assessed in large randomized phase III studies. Thus, the best docetaxel-containing regimen has yet to be identified. Docetaxel also represents a good candidate for combination with novel molecular target agents. In light of the high response rates observed in phase II-III studies, a docetaxel-based chemotherapy regimen might also be considered a treatment option as perioperative or adjuvant therapy in potentially curable gastric cancer and further studies with or without biological agents are eagerly awaited in this setting.

Multimodality Treatment for Esophageal Malignancy: The Roles of Surgery and Neoadjuvant Therapy

2009 ◽  
Vol 75 (6) ◽  
pp. 489-497 ◽  
Author(s):  
Edward Malin ◽  
Paul D. Kiernan ◽  
Michael J. Sheridan ◽  
Sandeep J. Khandhar ◽  
Cheryl Fraser ◽  
...  
Keyword(s):  
Hospital Mortality ◽  
Performance Status ◽  
Single Agent ◽  
Survival Rates ◽  
Poor Performance ◽  
Multimodality Treatment ◽  
Stage I ◽  
Poor Performance Status ◽  
Esophageal Malignancy

The best curative treatment for esophageal malignancy remains controversial. In 2003, we presented our institution's experience with 124 patients treated from 1990 to 2001. Here we update that experience with an additional 6 years’ data. A total of 221 patients underwent surgical resection from 1990 to 2007; 128 had up-front surgery, 88 underwent surgery after neoadjuvant radiation and chemotherapy (NARCS), and five underwent surgery after neoadjuvant, single-agent therapy Principle outcomes of interest were 30-day and in-hospital mortality as well 3- and 5-year survival rates. Overall 3- and 5-year survival rates were 38 and 33 per cent. NARCS achieved complete pathologic result in 32 per cent of patients with corresponding 3- and 5-year survival rates of 58 and 53 per cent. The 3- and 5-year survival rates for all patients undergoing NARCS were 36 and 31 per cent versus 24 and 18 per cent for patients with up-front surgery for anything over Stage I disease ( P = 0.01). The 3- and 5-year survival rates for patients with up-front resection of Stage I disease were 78 and 70 per cent. Overall, 30-day and in-hospital mortalities were 1.8 and 2.3 per cent. Since January 1, 2000, hospital mortality has been less than 0.8 per cent. We prefer NARCS for malignancy of the esophagus, except in those patients with high-grade dysplasia (carcinoma in situ), suspected Stage I disease, poor performance status, or urgent/emergent circumstances.

Regression of chemotherapy-refractory metastatic tumor from CD117-negative prostate sarcoma with imatinib mesylate plus thalidomide

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 9557-9557 ◽  
Author(s):  
V. C. Kok ◽  
K. Yeh ◽  
W. Chang
Keyword(s):  
Pleural Effusion ◽  
Soft Tissue ◽  
Soft Tissue Sarcoma ◽  
Imatinib Mesylate ◽  
Tumor Regression ◽  
Performance Status ◽  
Clinical Activity ◽  
Malignant Neoplasms ◽  
Dramatic Improvement ◽  
Undifferentiated Sarcoma

9557 Background: Chemoresistant relapsing prostate sarcoma has no standard treatment and the prognosis is extremely poor. Imatinib mesylate may target on tyrosine kinases of platelet-derived growth factor receptor (PDGFR) which has been shown to be important in tumor growth of certain types of soft tissue sarcoma. Thalidomide, itself a potent immunomodulatory agent has exhibited clinical activity in several malignant neoplasms which have been linked to abnormal angiogenesis and tumor vasculature. Case Report: A 38-year-old man who underwent radical cystoprostatectomy in June 2004 for a stage III high-grade soft tissue sarcoma of spindle and round cell type of prostate staged pT2b(8cm) pN0(0/26) M0, received adjuvant radiotherapy up to 6,660 cGy/37Fx postoperatively. Immunohistochemistry study showed vimentin+, CD34+, CD117−, desmin+, SMActind- and S-100−. Distant relapse in lungs was noted in April 2005. Shortly later massive pleural effusion developed. Three cycles of salvage chemotherapy with MAID were given. Tumor assessment disclosed Progressive Disease status and metastatic tumors were chemoresistant. Imatinib mesylate 400 mg once a day plus thalidomide with increment dose to 200 mg/day was chosen as biologic treatment for his devastating condition after an informed consent was obtained. PDGFR immunohistochemistry staining of the paraffin block and gene sequencing are planned. Results: Marked tumor regression reaching very good partial remission and resolution of pleural effusion without recurrence. Dramatic improvement in terms of performance status and cancer-associated symptoms are obvious. Except for skin changes and mild periorbital edema from imatinib, no other significant adverse reactions were noted. Postulated mechanism of action may suggest PDGFR tyrosine kinase inhibition as well as antiangiogenesis. Conclusions: We documented a case of undifferentiated sarcoma of prostate with pulmonary metastases which were refractory to MAID chemotherapy but subsequently regressed on a combination of double biologic agents, imatinib mesylate plus thalidomide. No significant financial relationships to disclose.

Frequency of cisplatin administration in patients presenting with advanced urothelial carcinoma in the community.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 285-285 ◽  
Author(s):  
Guru Sonpavde ◽  
Deidre Watson ◽  
Marcia Tourtellott ◽  
Erica Higgins ◽  
Charles Lance Cowey ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Performance Status ◽  
Single Agent ◽  
Unmet Need ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Cancer Centers ◽  
Ajcc Stage ◽  
Stage 4 ◽  
Advanced Urothelial Carcinoma

285 Background: Renal dysfunction, poor performance status, advanced age, and comorbidities may preclude standard frontline cisplatin-based chemotherapy in patients with advanced urothelial carcinoma (UC). We hypothesized that cisplatin-based regimens are not administered to the majority of patients in the community. A study was conducted to identify chemotherapy regimens administered by medical oncologists in community-based cancer centers. Methods: A retrospective study was conducted on patients with AJCC stage 4 UC presenting from 2001 to 2010 to Texas Oncology Cancer Centers. The frontline chemotherapy regimen was classified as cisplatin-based, carboplatin-based, non-platinum based and no chemotherapy administered. The association of age with administration of cisplatin was studied. Results: A total of 298 patients with stage 4 disease were eligible for this analysis out of 3574 patients with UC in this database. Of the 298 patients, 197 (66.1%) were male, the median age was 70 years (range 28-97), and the primary sites of disease were bladder (243, 81.5%), renal pelvis (41, 13.8%) and ureter (14, 4.7%). The regimens administered were cisplatin-based in 107 patients (35.9%), carboplatin-based in 81 (27.2%), non-platinum in 25 (8.4%), no chemotherapy was administered in 71 (23.8%) and data were not available in 14 patients (4.7%). Cisplatin administration appeared more common in patients aged ≤70 years (62 of 150, 41.3%) as opposed to >70 years (45 of 148, 30.4%), p=0.05. Non-cisplatin regimens or no chemotherapy were trending to be more commonly administered to patients >70 years (64.2 vs. 54.7%, p=0.10). Limitations of a retrospective database study apply and the reasons for not administering cisplatin are unclear. Conclusions: Cisplatin-based chemotherapy was administered to 35.9% of patients presenting with AJCC stage 4 UC to community cancer centers. Given that the majority of patients may not be cisplatin-eligible or candidates for chemotherapy, this population has a significant unmet need. Drug development focused on single agent therapy with tolerable, convenient and efficacious agents or combination regimens without a cisplatin backbone should be a priority.

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