Tenon Medical

Morgan Hill, CA, United States

Tenon Medical

Morgan Hill, CA, United States
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Pautier P.,Institute Gustave Roussy | Floquet A.,Institute Bergonie | Chevreau C.,Institute Claudius Regaud | Penel N.,Center Oscar Lambret | And 17 more authors.
The Lancet Oncology | Year: 2015

Background: Metastatic leiomyosarcomas of uterine or soft-tissue origin have poor prognosis and moderate chemosensitivity. Trabectedin has shown activity in pretreated leiomyosarcoma. We did a single-group, multicentre, phase 2 trial (LMS-02) to assess the effect of first-line doxorubicin and trabectedin combination on disease control and survival. Methods: Adults (18 years to physiological age ≤70 years) with measurable metastatic or unresectable uterine leiomyosarcoma or soft-tissue leiomyosarcoma who had not received any previous chemotherapy were enrolled at 19 centres in France. Treatment consisted of 60 mg/m2 intravenous doxorubicin followed by 1·1 mg/m2 trabectedin in a 3 h intravenous infusion on day 1, both by the central venous route, and 6 mg subcutaneous pegfilgrastim on day 2, repeated every 3 weeks for up to six cycles. Surgery for residual disease was permitted. The primary endpoint was the proportion of patients achieving disease control, defined as complete or partial response or stable disease. Stratification was done by anatomical site and analyses were per protocol. This study is registered with ClinicalTrials.gov, number NCT02131480. Findings: Between July 28, 2010, and May 10, 2013, 109 patients were enrolled and treated, of whom 108 were assessable for response: 47 in the uterine leiomyosarcoma group and 61 in the soft-tissue leiomyosarcoma group. 32 (68%) patients in the uterine leiomyosarcoma group and 45 (74%) in the soft-tissue leiomyosarcoma group received all six cycles of treatment. Of 47 patients with uterine leiomyosarcoma, 28 (59·6%, 95% CI 44·3-73·6) achieved a partial response and 13 (27·7%, 15·6-42·6) stable disease; 41 (87·2%, 74·3-95·2) patients achieved disease control. Of 61 patients with soft-tissue leiomyosarcoma, two (3·3%, 95% CI 0·4-11·7) achieved a complete response, 22 (36·1%, 25·0-50·8) had a partial response, and 32 (52·5%, 40·8-67·3) had stable disease; 56 (91·8%, 81·9-97·3) of patients achieved disease control. The most common grade 3-4 treatment-associated adverse events were neutropenia (84 [78%] of 108 patients), increased alanine aminotransferase concentration (42 [39%]), thrombocytopenia (40 [37%]), anaemia (29 [27%]), febrile neutropenia (26 [24%]), and fatigue (21 [19%]). Interpretation: Despite expected but manageable toxic effects, these results support the activity of doxorubicin plus trabectedin as first-line treatment for uterine leiomyosarcoma and soft-tissue leiomyosarcoma. This combination should be developed further in a phase 3 trial against the present standard of care. Funding: Pharmamar and Amgen. © 2015 Elsevier Ltd.


Genin A.-S.,Tenon University Hospital | Lesieur B.,Tenon University Hospital | Gligorov J.,Tenon Medical | Antoine M.,Tenon University Hospital | And 2 more authors.
Breast | Year: 2012

The impact of pregnancy in the physiopathology of pregnancy-associated breast cancer (PABC) is still unclear.We compared the characteristics of PABCs and breast cancers not associated with pregnancy (non-PABCs) in terms of their loco-regional invasion and histological phenotype.We conducted a retrospective chart review on women less than 43 years of age treated for breast cancer from January 1, 2004 to December 31, 2010. We compared age at diagnosis, loco-regional invasion and histological data.We recorded 282 breast cancers in 276 patients. Forty-one tumors (14.5%) were PABCs. PABC patients were significantly younger than non-PABC patients. Compared with the non-PABCs, PABCs were twice more frequent advanced tumors (T3-4) and have twice more frequent HER2 over-expression and hormone negative status.The more aggressive histological profile observed in the PABCs, especially in post-partum tumors and women older than 35 years of age, seems to be a direct consequence of the association with pregnancy. © 2012 Elsevier Ltd.


Tsoutsou P.G.,Democritus University of Thrace | Belkacemi Y.,University Paris Est Creteil | Gligorov J.,Tenon Medical | Kuten A.,Rambam Medical Center | And 3 more authors.
Oncologist | Year: 2010

The adjuvant setting of early breast cancer treatment is an evolving field where different modalities must be combined to improve outcomes; moreover, quality of life of breast cancer survivors emerges as a new important parameter to consider, thus implying a better understanding of toxicities of these modalities. We have conducted a review focusing on the latest literature of the past 3 years, trying to evaluate the existing data on the maximum acceptable delay of radiotherapy when given as sole adjuvant treatment after surgery and the optimal sequence of all these modalities with respect to each other. It becomes evident radiotherapy should be given as soon as possible and within a time frame of 6-20 weeks. Chemotherapy is given before radiotherapy and hormone therapy. However, radiotherapy should be started within 7 months after surgery in these cases. Hormone therapy with tamoxifen might be given safely concomitantly or sequentially with radiotherapy although solid data are still lacking. The concurrent administration of letrozole and radiotherapy seems to be safe, whereas data on trastuzumab can imply only that it is safe to use concurrently with radiotherapy. Randomized comparisons of hormone therapy and trastuzumab administration with radiotherapy need to be performed. © AlphaMed Press.


Alexandre J.,University of Paris Descartes | Ray-Coquard I.,Center Leon Berard | Selle F.,Tenon Medical | Floquet A.,Institute Bergonie | And 5 more authors.
Annals of Oncology | Year: 2010

Background: Advanced mucinous epithelial ovarian carcinoma (mEOC) has been associated with a worse prognosis than the more common serous epithelial ovarian carcinomas (sEOC), but it remains unclear whether this observation reflects a more aggressive clinical presentation and/or chemoresistance. Patients and methods: Data from four randomized phase III and one phase II advanced epithelial ovarian carcinoma (EOC) first-line clinical trials were retrospectively collected, yielding 1118 patients with advanced EOC (International Federation of Gynecology and Obstetrics stages IIB-IV), 85% of whom were treated with paclitaxel (Taxol)-carboplatin-based chemotherapy. Results: Based on 786 patients with sEOC and 54 (5%) with mEOC, peritoneal carcinomatosis were more limited in mEOC, which was more frequently stages IIB-IIIB (32% versus 19%, P = 0.001) and had more frequently macroscopic complete resection after initial surgery (50% of stages II-III versus 30%, P = 0.02). In contrast, visceral metastases (stage IV) were more frequent in mEOC (30% versus 15%, P = 0.004). mEOC had a lower response rate to carboplatin-paclitaxel, and shorter progression-free and overall survival rates, for both stage IV and optimally debulked stages II-III patients. Conclusions: Advanced mEOC appears to be highly chemoresistant and complete resection of peritoneal metastases is unable to reverse its poor prognosis. New therapeutic options are needed. © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


Thomassin-Naggara I.,Tenon Medical | Darai E.,Hopitaux Universitaires Paris Est | Bazot M.,Tenon Medical
Diagnostic and Interventional Imaging | Year: 2012

The diagnosis of pelvic infection is most often made clinically, based on a combination of pelvic pain and fever, and possibly a foul discharge. The patient is referred to radiology in two very different circumstances: either in the acute phase where the challenge is to differentiate a pelvic infection from appendicitis, urinary tract infection, and complications of a hemorrhagic luteal cyst; or some time after the infectious episode, which may have gone unnoticed, and the patient presents with an undetermined pelvic mass that needs to be characterized, where the challenge in that situation is not to confuse it with ovarian cancer. The signs and symptoms on the pelvic ultrasound, CT scan, and MRI suggest the correct diagnosis. © 2012 Published by Elsevier Masson SAS on behalf of the Éditions françaises de radiologie.


Joensuu H.,University of Helsinki | Gligorov J.,Tenon Medical
Annals of Oncology | Year: 2012

Conventional chemotherapy is the mainstay of adjuvant systemic treatment for most patients with early triple-negative breast cancer (TNBC). At present, comparisons between adjuvant chemotherapy regimens are retrospective in nature, and so the optimal drugs or drug combinations have not been established for patients with early TNBC. In retrospective subgroup analyses, taxanes are more effective than 5-fluorouracil in combination with cyclophosphamide and doxorubicin. Classical CMF (cyclophosphamide, methotrexate and 5-fluorouracil) has shown efficacy, whereas few data on the role of anthracyclines are available. An unplanned subgroup analysis of one randomised study suggests that capecitabine adds efficacy to a taxane-anthracycline regimen, but this observation requires confirmation. High-dose adjuvant chemotherapy is considered experimental. Ongoing trials are comparing standard adjuvant regimens with regimens that integrate an anti-angiogenic agent, a platin or maintenance capecitabine. Inhibitors of DNA repair or specific tyrosine kinases have not yet been addressed in the adjuvant setting. In the absence of data from prospective trials that focus on adjuvant therapy of early TNBC, several regimens, such as a taxane and an anthracycline-containing regimen or classical CMF may be considered reasonable choices. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


Patent
Tenon Medical | Date: 2013-04-05

Configurations are described for conducting minimally invasive medical interventions utilizing elongate instruments and assemblies thereof to stabilize and/or fixate a sacro-iliac joint. In one embodiment, a tool assembly may be advanced from a posterior approach into the SI junction and configured to create a defect defined at least in part by portions of both the sacrum and the ilium, the defect having a three dimensional shape defined in part by at least one noncircular cross sectional shape in a plane substantially perpendicular to the longitudinal axis of the tool assembly. After a defect is created, the tool assembly may be retracted and a prosthesis deployed into the defect.


Patent
Tenon Medical | Date: 2013-04-05

Configurations are described for conducting minimally invasive medical interventions utilizing elongate instruments and assemblies thereof to stabilize and/or fixate a sacro-iliac joint. In one embodiment, a tool assembly may be advanced from a posterior approach into the SI junction and configured to create a defect defined at least in part by portions of both the sacrum and the ilium, the defect having a three dimensional shape defined in part by at least one noncircular cross sectional shape in a plane substantially perpendicular to the longitudinal axis of the tool assembly. After a defect is created, the tool assembly may be retracted and a prosthesis deployed into the defect.


PubMed | Tenon Medical
Type: | Journal: Anais da Academia Brasileira de Ciencias | Year: 2016

It has now been 15 years since the HER2-targeted monoclonal antibody trastuzumab was introduced in clinical and revolutionized the treatment of HER2-positive breast cancer patients. Despite this achievement, most patients with HER2-positive metastatic breast cancer still show progression of their disease, highlighting the need for new therapies. The continuous interest in novel targeted agents led to the development of pertuzumab, the first in a new class of agents, the HER dimerization inhibitors. Pertuzumab is a novel recombinant humanized antibody directed against extracellular domain II of HER2 protein that is required for the heterodimerization of HER2 with other HER receptors, leading to the activation of downstream signalling pathways. Pertuzumab combined with trastuzumab plus docetaxel was approved for the first-line treatment of patients with HER2-positive metastatic breast cancer and is currently used as a standard of care in this indication. In the neoadjuvant setting, the drug was granted FDA-accelerated approval in 2013. Pertuzumab is also being evaluated in the adjuvant setting. The potential of pertuzumab relies in the dual complete blockade of the HER2/3 axis when administered with trastuzumab. This paper synthetises preclinical and clinical data on pertuzumab and highlights the mechanisms underlying the synergistic activity of the combination pertuzumab-trastuzumab which are essentially due to their complementary mode of action.


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