scholarly journals Intravitreal and Subconjunctival Melphalan for Retinoblastoma in Transgenic Mice

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Nisha V. Shah ◽  
D. G. Pham ◽  
T. G. Murray ◽  
C. Decatur ◽  
E. Hernandez ◽  
...  
Keyword(s):  
Transgenic Mice ◽  
Intravitreal Injection ◽  
Tumor Size ◽  
Tumor Hypoxia ◽  
Tumor Burden ◽  
Significant Decline ◽  
Maximum Dosage ◽  
Subconjunctival Injection

Purpose. To measure the chemotherapeutic effects of focal melphalan (intravitreal and subconjunctival) on tumor burden, hypoxia, and vasculature in LHBETATAG murine retinoblastoma model.Methods.LHBETATAG transgenic mice were treated with a single 1 mcg intravitreal injection of melphalan, 100 mcg subconjunctival injection, or semiweekly 10 mcg subconjunctival injections for 3 weeks. At 1 or 3 weeks, eyes were enucleated, serially sectioned, and processed with haematoxylin and eosin (H&E) for tumor burden measurements and probed with immunofluorescence to analyze tumor hypoxia and vasculature.Results. Focal melphalan significantly reduced retinal tumor size (P< 0.02) when given intravitreally or subconjunctivally. Eyes treated with a one-time intravitreal injection of 1 mcg melphalan had significantly smaller tumors at both 1 week (P= 0.017) and at 3 weeks after injection (P= 0.005). Intratumoral hypoxia showed a significant decline in hypoxia at 1 week following intravitreal injection and after maximum dosage of subconjunctival melphalan. Total vasculature was not significantly affected following intravitreal administration.Conclusion. Focal delivery of melphalan via intravitreal or subconjunctival injection has a significant effect on reducing tumor burden, hypoxia, and vasculature, in the treatment of murine retinoblastoma tumors.

scholarly journals Detection of Circulating Tumor DNA in Patients With Leiomyosarcoma With Progressive Disease

2019 ◽  
pp. 1-11 ◽  
Author(s):  
Matthew L. Hemming ◽  
Kelly Klega ◽  
Justin Rhoades ◽  
Gavin Ha ◽  
Kate E. Acker ◽  
...  
Keyword(s):  
Disease Progression ◽  
Tumor Size ◽  
Disease Burden ◽  
Progressive Disease ◽  
Circulating Tumor Dna ◽  
Tumor Burden ◽  
Blood Draw ◽  
Cell Free Dna ◽  
Free Dna ◽  
Tumor Dna

Purpose Leiomyosarcoma (LMS) is a soft-tissue sarcoma characterized by multiple copy number alterations (CNAs) and without common recurrent single-nucleotide variants. We evaluated the feasibility of detecting circulating tumor DNA (ctDNA) with next-generation sequencing in a cohort of patients with LMS whose tumor burden ranged from no evidence of disease to metastatic progressive disease. Patients and Methods We evaluated cell-free DNA in plasma samples and paired genomic DNA from resected tumors from patients with LMS by ultra-low passage whole-genome sequencing. Sequencing reads were aligned to the human genome and CNAs that were identified in cell-free DNA and tumor DNA by ichorCNA software to determine the presence of ctDNA. Clinical data were reviewed to assess disease burden and clinicopathologic features. Results We identified LMS ctDNA in 11 (69%) of 16 patients with disease progression and total tumor burden greater than 5 cm. Sixteen patients with stable disease or low disease burden at the time of blood draw were found to have no detectable ctDNA. Higher ctDNA fraction of total cell-free DNA was associated with increasing tumor size and disease progression. Conserved CNAs were found between primary tumors and ctDNA in each case, and recurrent CNAs were found across LMS samples. ctDNA levels declined after resection of progressive disease in one case and became detectable upon disease relapse in another individual patient. Conclusion These results suggest that ctDNA, assayed by a widely available sequencing approach, may be useful as a biomarker for a subset of patients with uterine and extrauterine LMS. Higher levels of ctDNA correlate with tumor size and disease progression. Liquid biopsies may assist in guiding treatment decisions, monitoring response to systemic therapy, surveying for disease recurrence, and differentiating benign and malignant smooth muscle tumors.

scholarly journals Current Management of Pheochromocytoma/Paraganglioma: A Guide for the Practicing Clinician in the Era of Precision Medicine

Cancers ◽  
2019 ◽  
Vol 11 (10) ◽  
pp. 1505 ◽  
Author(s):  
Nölting ◽  
Ullrich ◽  
Pietzsch ◽  
Ziegler ◽  
Eisenhofer ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Tumor Size ◽  
Gene Mutations ◽  
Tumor Burden ◽  
Current Management ◽  
Therapy Options ◽  
Cluster 2 ◽  
Other Neoplasms ◽  
First Diagnosis

Pheochromocytomas and paragangliomas (PCC/PGLs) are rare, mostly catecholamine-producing neuroendocrine tumors of the adrenal gland (PCCs) or the extra-adrenal paraganglia (PGL). They can be separated into three different molecular clusters depending on their underlying gene mutations in any of the at least 20 known susceptibility genes: The pseudohypoxia-associated cluster 1, the kinase signaling-associated cluster 2, and the Wnt signaling-associated cluster 3. In addition to tumor size, location (adrenal vs. extra-adrenal), multiplicity, age of first diagnosis, and presence of metastatic disease (including tumor burden), other decisive factors for best clinical management of PCC/PGL include the underlying germline mutation. The above factors can impact the choice of different biomarkers and imaging modalities for PCC/PGL diagnosis, as well as screening for other neoplasms, staging, follow-up, and therapy options. This review provides a guide for practicing clinicians summarizing current management of PCC/PGL according to tumor size, location, age of first diagnosis, presence of metastases, and especially underlying mutations in the era of precision medicine.

CDDO and CDDO-Im Reduce Tumor Burden in a Transgenic Mouse Model of CLL.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3477-3477
Author(s):  
Juan M. Zapata ◽  
Christina L. Kress ◽  
Marina Konopleva ◽  
Maryla Krajewska ◽  
Mark Hyer ◽  
...  
Keyword(s):  
B Cells ◽  
Transgenic Mice ◽  
B Cell ◽  
B Cell Lymphoma ◽  
Chemotherapeutic Agents ◽  
Tumor Burden ◽  
Leukemic Cells ◽  
Medium Size ◽  
Control Group

Abstract Transgenic mice over-expressing in B lymphocytes both Bcl-2 and a TRAF2 mutant lacking the N-terminal RING and zinc finger domains (TRAF2DN), which mimics TRAF1, develop small B cell lymphoma and leukemia that have remarkably similar characteristics to human chronic lymphocytic leukemia (CLL). TRAF2DN/Bcl-2 mice develop over time leukemia, severe splenomegaly, and lymphadenopathy, which are associated with monoclonal and oligoclonal B cell neoplasms. The lifespan of TRAF2DN/Bcl-2 mice is markedly reduced compared to Bcl-2 and TRAF2DN single transgenics or wild-type littermates. The expanded B cell population in the blood of leukemic TRAF2DN/Bcl-2 double transgenic mice is primarily comprised of small-medium size, non-cycling B220M/IgMH/IgDL/CD21L/CD23−/CD11b+/CD5+ cells that were Bcl-6 negative, consistent with a B-1 phenotype, closely resembling their human CLL counterparts. Indeed, these B cells showed comparable proliferation rates to normal B-cells, but exhibited markedly increased survival and were resistant to apoptosis induced by chemotherapeutic agents and glucocorticoids. We studied the effects of synthetic triterpenoid 2-Cyano-3,12-Dioxooleana-1,9-Dien-28-Oic Acid (CDDO) and its imidazolide derivative (CDDO-Im) on cultured B-cells from the TRAF2DN/Bcl-2 transgenic mice. Both CDDO and CDDO-Im efficiently induced apoptosis of these cells in vitro, although CDDO-Im was approximately 10-times more potent than CDDO (LD50: 0.35μM CDDO-Im vs 3.8 μM CDDO). To study the effect of CDDO and CDDO-Im in vivo, groups of TRAF2DN/Bcl-2 mice that had developed leukemia were injected i.v. with liposomes alone or liposomes containing either CDDO or CDDO-Im, at a dose of 20 mg/kg/day. Each mouse received a total of nine injections administered over a period of 22 days. The concentration of B cells in the blood of these mice was monitored daily after each injection, using a mini-FACS (Guava Technologies, Inc.). CDDO-treated mice showed a steady reduction in the number of leukemic cells in blood during the treatment and this tendency was maintained 10 days after the last treatment. In contrast, CDDO-Im treated mice showed a striking increase in the concentration of B cells in blood (B220+ events) immediately after the first inoculation. One mouse of this group died after the first injection, and 2 more mice died after 5 injections. Only 2 mice treated with CDDO-Im survived the full treatment, showing a striking reduction of leukemic cells in blood by the end of the treatment. Administration of empty liposomes had no inhibitory effect on the leukemia, and mice in this control group had massive splenomegaly (1431±323 mg; n=3) and severe disseminated lymphadenopathy. In contrast, CDDO-treated mice had less severe splenomegaly (938±234; n=4) but still had severe lymphadenopathy. CDDO-Im treated mice showed a dramatic reduction in the spleen size that was evident also in those mice that died after 5 injections (474±185 mg; n=4) and had no signs of lymphadenopathy. Although preliminary, these results indicate that in vivo administration of CDDO and CDDO-Im reduced the tumor burden in a transgenic model of CLL, and illustrate the potential of triterpenoids as single agents for the treatment of CLL.

Prospective phase II study of chemoembolization with drug-eluting beads for hepatic neuroendocrine metastases: Interim analysis.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 331-331
Author(s):  
D. K. Reyes ◽  
I. R. Kamel ◽  
C. Georgiades ◽  
K. Hong ◽  
N. Bhagat ◽  
...  
Keyword(s):  
Mr Imaging ◽  
Stable Disease ◽  
Tumor Size ◽  
Interim Analysis ◽  
Tumor Response ◽  
Phase Ii Study ◽  
Tumor Burden ◽  
Diffuse Disease ◽  
Prospective Phase

331 Background: To evaluate safety and efficacy of transarterial chemoembolization with doxorubicin eluting beads (DEB-TACE) in 30 patients with hepatic neuroendocrine metastases (NET) in a prospective phase II study. We report the interim analysis on 10 patients. Methods: Patients who met inclusion criteria (NET liver-dominant metastases, ECOG 0-1, treatment naïve) underwent up to 4 DEB-TACE sessions (100-300 micron beads loaded with up to 100mg of doxorubicin) within a 6-month period. Statistical plan included interim analysis of initial 10 patients to assess therapeutic efficacy (defined as objective response≥50%). Tumor response was assessed by MR imaging 1 month after treatment using contrast-enhancement (EASL) and tumor size (RECIST). Safety was assessed by NCI Common Terminology Criteria. Results: DEB-TACE was successfully performed in 10 patients (22 targeted lesions). Patient characteristics included mean age 65 yrs; ECOG 0/1 (6/4); carcinoid syndrome (n=2); tumor burden range (4-75%), and mean targeted tumor size 4.8 cm (range 1.2-10.2). At one month follow-up (n=9), Grade 3 toxicities consisted of hyperglycemia (n=3), abdominal pain (n=3), fatigue (n=1), biloma (n=1) and elevated ALT (n=1). Note that four patients had Grade 2 bilomas, which occurred in the setting of small lesions (<2cm), diffuse disease with very low tumor burden (near military pattern), and single lesion ≥ 5cm. Tumor response using MR imaging at 1 month-follow-up revealed a mean treated tumor decrease in size of 7% (p=0.03), and a mean decrease in contrast-enhancement of 59% (p<0.0001). Using RECIST, partial response was achieved in 1 patient (11%), whereas 8 patients (89%) had stable disease. Using EASL criteria, 7 patients (78%) had objective tumor response and 2 (12%) had stable disease. Conclusions: Interim analysis shows therapeutic efficacy of DEB-TACE in liver-dominant NET metastases. Early recommendation suggests DEB-TACE may be best suited for NET patients with multifocal disease or diffuse disease with large tumor burden. [Table: see text] No significant financial relationships to disclose.

Overall survival modeling and association with serum biomarkers in durvalumab-treated patients with head and neck cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6549-6549
Author(s):  
Vadryn Pierre ◽  
Xiang Guo ◽  
Ignacio Gonzalez-Garcia ◽  
Nassim Morsli ◽  
Alejandro Javier Yovine ◽  
...  
Keyword(s):  
Overall Survival ◽  
Head And Neck ◽  
Tumor Size ◽  
Tumor Burden ◽  
P Value ◽  
Plasminogen Activator Inhibitor 1 ◽  
Term Survival ◽  
Baseline Serum ◽  
Neutrophil Lymphocyte Ratio ◽  
Pai 1

6549 Background: Optimal patient selection for immunotherapy remains a challenge as most patients fail to respond. We aim to assess baseline factors for association with long-term survival from durvalumab treatment in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)1,2. Methods: Pooled longitudinal tumor size, survival, and dropout data from four trials (1108: NCT01693562, CONDOR: NCT02319044 , HAWK: NCT02207530, and EAGLE: NCT02369874) involving 467 HNSCC patients were used to develop tumor size-driven hazard models. A panel of 66 serum protein biomarkers at baseline and 4 relevant clinical markers from 346 out of 413 patients treated with durvalumab (all studies except 1108) were initially screened to select a pool of 21 candidate covariates. The criteria for dimensionality reduction comprised correlation strength between biomarkers and pharmacological hypotheses pertaining to a prior analysis3 (inflammation, immunomodulation, tumor burden and angiogenesis). Results: The final tumor model highlighted that high tumor burden, elevated LDH and neutrophil-lymphocyte ratio were associated with faster tumor growth while patients with lower baseline tumor burden had an increase in net tumor shrinkage. For overall survival, the model suggested that high levels of immunomodulators (IL23, Osteocalcin), low inflammation (IL6, NLR), low tumor burden, and low angiogenesis factors (von Willebrand factor (vWF), plasminogen activator inhibitor-1 (PAI-1)) were associated with survival benefits for patients treated with durvalumab. Specifically, these patients had baseline serum IL23 > 2.1 pg/mL and Osteocalcin > 32 pg/mL or serum PAI-1 < 229 pg/mL and serum IL6 < 5.4 pg/mL which corresponded to a hazard ratio estimate (HR and 95%CI) of 0.36 (0.27- 0.47), logrank p-value: 2.3x10−14. The median (n, 95%CI) overall survival time for the patients with favorable biomarker profile was 14.6 months (n = 129, 11.2-21.4) vs. 4.4 months (n = 217, 3.6-5.3). Conclusions: Our results corroborate the prior hypothesis highlighting the prognostic value of inflammation, disease burden, tumor angiogenesis, and immunomodulatory factors on the clinical outcomes of HNSCC patients treated with durvalumab3. Collectively, we identified a serum biomarker profile of HNSCC patients with median survival times exceeding 1 year which may potentially be used for patient enrichment following further validation in prospective studies. References: 1Yanan CPT 2017, 2Baverel, 2018 ENA, 3Guo, X, 2019 Asco P6048 Clinical trial information: NCT01693562, NCT02319044, NCT02207530, NCT02369874 .

Tumor size and pretreatment speech and swallowing in patients with resectable tumors

2000 ◽  
Vol 122 (5) ◽  
pp. 653-661 ◽  
Author(s):  
Laura A. Colangelo ◽  
Jeri A. Logemann ◽  
Alfred W. Rademaker
Keyword(s):  
Soft Palate ◽  
Tumor Size ◽  
Tumor Volume ◽  
Tumor Burden ◽  
Oral Tongue ◽  
Swallowing Function ◽  
Functional Deficits ◽  
Floor Of Mouth ◽  
Regression Techniques ◽  
Relationship Of

The pretreatment relationship of tumor burden to speech and swallowing function in 230 patients with oral or oropharyngeal cancer before surgery was assessed. Reduced articulation, reduced conversational understandability, or self-reported dysphagia were present in at least 34% of patients before treatment. Videofluoroscopy showed at least 9% of patients had reduced swallowing efficiency on liquid, paste, or cookie boluses. By use of regression techniques, the percentages of the oral tongue and of the anterior floor of mouth affected by neoplasm were found to be significantly related to reduced articulation; T stage and the percentage of the oral tongue affected with tumor were mildly related to reduced understandability; tumor volume and having soft palate affected by neoplasm were significantly related to self-reported dysphagia; and percentages of affected oral tongue and of affected tongue base were significantly related to reduced swallowing efficiency. Tumor burden may contribute to functional deficits at diagnosis in patients who have resectable tumors.

scholarly journals Imaging Predictors for Nonsentinel Lymph Node Metastases in Breast Cancer Patients

Breast Care ◽  
2019 ◽  
Vol 15 (4) ◽  
pp. 372-379
Author(s):  
Yizi Cong ◽  
Suxia Wang ◽  
Haidong Zou ◽  
Shiguang Zhu ◽  
Xingmiao Wang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Tumor Size ◽  
Tumor Burden ◽  
Axillary Lymph ◽  
Imaging Features ◽  
Breast Cancer Patients ◽  
Size Number ◽  
Positive Slns ◽  
Nonsentinel Lymph Node

Background: The relationship between imaging features and nonsentinel lymph node (NSLN) metastasis is not clear. Objectives: To determine whether imaging features could predict NSLN metastasis in sentinel lymph node (SLN)-positive breast cancer patients and to provide new clues for avoiding unnecessary axillary lymph node dissection. Method: 171 patients with clinically negative axillary lymph nodes and a pathologically positive SLN were recruited between January 2007 and January 2014. According to the Breast Imaging Reporting and Data System (BI-RADS), the effects of clinicopathological factors, especially imaging features, on NSLN metastases were assessed by univariate and multivariate statistical analyses. Results: The average number of dissected SLNs was 2.11 (range, 1–6); 56 of the 171 (32.75%) patients exhibited NSLN metastases. In univariate analysis, tumor size, number of positive SLNs, ratio of positive SLNs, mammographic mass margins, ultrasonographic mass margins, and ultrasonographic vascularity were significantly correlated with NSLN involvement. Furthermore, through multivariate analysis, tumor size, number of positive SLNs, mammographic mass margins, and ultrasonographic vascularity were still independent predictors of NSLN involvement. Additionally, in SLN-positive patients, number of positive SLNs and ultrasonographic vascularity could also predict the tumor burden in NSLN. Conclusions: In addition to tumor size and the number of positive SLNs, mammographic mass margins and ultrasonographic vascularity were also independent predictors of NSLN metastases in SLN-positive patients of breast cancer. The number of positive SLNs and ultrasonographic vascularity could also predict the tumor burden in NSLN.

scholarly journals 2313 Characterization of the host pericyte role in glioblastoma angiogenesis

2018 ◽  
Vol 2 (S1) ◽  
pp. 1-1
Author(s):  
Frank Attenello ◽  
Frank Attenello ◽  
Yingxi Wu ◽  
Kathleen Tsung ◽  
William Mack ◽  
...  
Keyword(s):  
Transgenic Mice ◽  
Tumor Growth ◽  
Effect Size ◽  
Tumor Size ◽  
Lung Tumor ◽  
Cell Activity ◽  
Feasibility Studies ◽  
Wild Type ◽  
Cerebral Vessel

OBJECTIVES/SPECIFIC AIMS: Glioblastoma (GBM) carries a prognosis of 14.6 months mean survival despite maximal surgical, chemotherapeutic, and radiation therapy. The pericyte is a recently characterized cell shown to be a critical component of cerebral vessel physiology and pathology. Importantly, alterations in pericyte densities have shown resulting changes in breast and lung tumor growth. We leverage transgenic pericyte-deficient mouse models to evaluate resulting behavior of implanted patient-derived GBM. METHODS/STUDY POPULATION: Patient-derived, green fluorescent protein labeled, GBM will be implanted in right frontal bregma of both 6-month old pericyte-deficient (PDGFR+/−) mice and age-matched wild-type littermate controls (IACUC 20755, IRB 16-00929), which are immunosuppressed via daily intraperitoneal cyclosporine injection. In total, 30 mice of both genders are included in tumor and control cohorts. Fixed cortical sections following 3-week period will be stained for pericytes (NG2), endothelium (CD31), hypoxia (piminidazole), and tumor size. One-way ANOVA with will used to compare groups using SAS software (Cary, NC). RESULTS/ANTICIPATED RESULTS: Feasibility studies show robust in vitro growth of patient-derived GBM cells, showing continued growth over 10 cellular division passages. Lentivirally transduced GFP reveals reliable tumor tracking both in vitro and in vivo. Transgenic mice at 6 months display reproducibly decreased pericyte and microvascular density in triplicate. Wild-type mice tolerate tumor injection up to three weeks with visible tumor growth, peritumoral hypervascularity, and no evidence of mouse neural dysfunction. With current cohorts recently implanted with tumor, we anticipate a significant decrease in tumor size with Cohen’s d effect size of 0.5 in GBM implanted in pericyte-deficient mice when compared to control. Effect sizes are based moderate to large (effect size 0.5–0.8) reductions of in vitro GBM growth in vascular gene (TGF-β knockdown studies). In addition, tagged tumor-derived pericytes should comprise a greater proportion of new vasculature in pericyte-knockdown mice to overcome host pericyte depletion. Finally, tumors in transgenic mice should show increased hypoxia from limitations in angiogenesis. DISCUSSION/SIGNIFICANCE OF IMPACT: Feasibility studies show successful tracking of fluorescently tagged-patient derived GBM samples in transgenic mice with decreased vasculature. GBM grafts show no evidence of immunogenic response with cyclosporine protocol. Successful limitation of tumor size with reduced pericyte density will provide support to increasing study of blood-brain barrier, stem cell activity and inflammatory activity of pericyte microenvironments altering GBM behavior. Furthermore, implementation of known pericyte targeted therapies, such as imantinib, can be evaluated for GBM patient treatment efficacy. Studies with assembled clinical translational research scholar mentorship team will allow the principal investigator to develop an independent career with laboratory focused on contributing to improved patient outcomes, translating successful pericyte-targeted results to patient trials.

Sunitinib in patients (pts) with unresectable primary renal cell carcinoma (RCC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5096-5096 ◽  
Author(s):  
L. Wood ◽  
J. A. Garcia ◽  
P. Elson ◽  
R. N. Salas ◽  
B. R. Lane ◽  
...  
Keyword(s):  
Tumor Size ◽  
Primary Tumor ◽  
Alternative Hypothesis ◽  
Tumor Resection ◽  
Tumor Burden ◽  
Surgical Morbidity ◽  
Large Tumor ◽  
Primary Tumors ◽  
Ivc Thrombosis ◽  
Prospective Investigation

5096 Background: Sunitinib inhibits VEGF and related receptors, with high tumor shrinkage rates in metastatic (met) RCC. Shrinkage of primary tumors has been observed, although prospective investigation is lacking. The ability of sunitinib to convert primary RCC tumors from unresectable to resectable is of high clinical interest. Methods: Pts with histologically-confirmed RCC with an unresectable primary tumor with or without met disease were enrolled on a single-arm phase II trial. Primary tumors were unresectable due to ≥ 1 of the following: large tumor size, bulky lymphadenopathy, encasement of renal vessels, IVC thrombosis or proximity to vital structures. Pts received 50 mg sunitinib continuous dosing in repeated 6-week cycles. Staging by CT scans or MRI was done at baseline and every 2 cycles. A Simon 2-stage design was employed to test the alternative hypothesis of a conversion to resectability rate of 20% versus the null hypothesis of 5%; β = 0.8, α = 0.05 (n = 31). Results: 18 pts have been enrolled; 1 excluded due to a non-RCC diagnosis. Pts were unresectable due to bulky lymphadenopathy (6), IVC thrombosis (4), proximity to vital structures (4) or tumor size (3), although most pts had multiple factors. Median age among 14 evaluable pts was 61 years (range, 37–80), 59% male, 76% ECOG PS 0; 79% had distant met disease. The 14 evaluable pts have received a median of 3 cycles of therapy (range, 1–10+). Three pts (21%) have undergone primary tumor resection; viable RCC was identified in all specimens with no unexpected surgical morbidity. Nine pts (53%) had primary tumor reduction (median 19%; range, -64% to -1%). Overall, median best % change in tumor burden was 4.9% reduction for primary tumors (range, -43.1% to +8.5%) and 10.7% reduction for met sites (range, -89.5% to +28.6%). Median PFS is 4.9 months. Eleven pts (79%) discontinued therapy; 8 for PD, 1 for adverse events and 2 following surgery which removed all visible disease. Eight pts (57%) experienced grade 3 toxicity including thrombocytopenia, fatigue, hypertension, anemia, hemoptysis, and hand-foot syndrome; 1 pt had grade 4 neutropenia. Conclusions: Sunitinib has activity in unresectable primary RCC tumors, permitting resection in some pts. Continued prospective investigation is required to optimize patient selection and timing of surgery. [Table: see text]

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