Mené sur 61 patients atteints d'un cancer avec 1 à 3 métastases hépatiques non résécables et traités en 2010 ou 2011, cet essai de phase II évalue, du point de vue du contrôle local, de la toxicité et de la survie, l'intérêt d'une radiothérapie corporelle stéréotaxique

Is Stereotactic Body Radiation Therapy an Attractive Option for Unresectable Liver Metastases? A Preliminary Report From a Phase 2 Trial

Scorsetti, Marta ; Arcangeli, Stefano ; Tozzi, Angelo ; Comito, Tiziana ; Alongi, Filippo ; Navarria, Pierina ; Mancosu, Pietro ; Reggiori, Giacomo ; Fogliata, Antonella ; Torzilli, Guido ; Tomatis, Stefano ; Cozzi, Luca

To evaluate the feasibility of high-dose stereotactic body radiation therapy (SBRT) in the treatment of unresectable liver metastases. Patients with 1 to 3 liver metastases, with maximum individual tumor diameters less than 6 cm and a Karnofsky Performance Status of at least 70, were enrolled and treated by SBRT on a phase 2 clinical trial. Dose prescription was 75 Gy on 3 consecutive days. SBRT was delivered using the volumetric modulated arc therapy by RapidArc (Varian, Palo Alto, CA) [...]

Cet article fait le point sur les avancées biologiques et technologiques récentes en matière de radio-oncologie, identifie les problèmes rencontrés et propose des pistes d'amélioration

New Paradigms and Future Challenges in Radiation Oncology: An Update of Biological Targets and Technology

Liauw, Stanley L. ; Connell, Philip P. ; Weichselbaum, Ralph R.

Radiation oncology exploits the biological interaction of radiation within tissue to promote tumor death while minimizing damage to surrounding normal tissue. The clinical delivery of radiation relies on principles of radiation physics that define how radiation energy is deposited in the body, as well as technology that facilitates accurate tumor targeting. This review will summarize the current landscape of recent biological and technological advances in radiation oncology, describe the [...]

A partir de données médicales portant sur 613 patients atteints d'un cancer du poumon non à petites cellules de stade I-II, cette étude rétrospective compare, du point de vue du contrôle locorégional, de la récidive à distance et de la survie globale, l'efficacité d'une lobectomie par chirurgie thoracoscopique vidéo-assistée et d'une radiothérapie stéréotaxique ablative

Stage I–II non-small-cell lung cancer treated using either stereotactic ablative radiotherapy (SABR) or lobectomy by video-assisted thoracoscopic surgery (VATS) : outcomes of a propensity score-matched analysis

Verstegen, N. E. ; Oosterhuis, J. W. A. ; Palma, D. A. ; Rodrigues, G. ; Lagerwaard, F. J. ; van der Elst, A. ; Mollema, R. ; van Tets, W. F. ; Warner, A. ; Joosten, J. J. A. ; Amir, M. I. ; Haasbeek, C. J. A. ; Smit, E. F. ; Slotman, B. J. ; Senan, S.

Background Video-assisted thoracoscopic surgery (VATS) lobectomy and stereotactic ablative radiotherapy (SABR) are both used for early-stage non-small-cell lung cancer. We carried out a propensity score-matched analysis to compare locoregional control (LRC). Patients and methods VATS lobectomy data from six hospitals were retrospectively accessed; SABR data were obtained from a single institution database. Patients were matched using propensity scores based on cTNM stage, age, gender, Charlson [...]

Menée sur 361 patients atteints d'un cancer de la prostate de stade pT2 ou pT3a/pT3b et ayant subi une prostatectomie radicale, cette étude évalue l'impact d'une radiothérapie adjuvante sur la récupération de la continence urinaire

Impact of Adjuvant Radiation Therapy on Urinary Continence Recovery After Radical Prostatectomy

Nazareno, Suardi ; Andrea, Gallina ; Giuliana, Lista ; Giorgio, Gandaglia ; Firas, Abdollah ; Umberto, Capitanio ; Paolo, Dell'Oglio, ; Alessandro, Nini ; Andrea, Salonia ; Francesco, Montorsi ; Alberto, Briganti

Background : Little is known about the impact of adjuvant radiation therapy (aRT) after radical prostatectomy (RP) on urinary continence (UC). Objective : To evaluate the impact of aRT on UC recovery in patients with unfavourable pathologic characteristics. Design, setting, and participants : The study included 361 patients with either pT2 with positive surgical margin(s) or pT3a/pT3b node-negative disease treated with RP at a tertiary care referral centre. Intervention : Patients were [...]

A partir de données médicales portant sur 190 patients atteints d'une tumeur rénale traitée entre 2007 et 2012, cette étude rétrospective évalue, en fonction de la technique utilisée, le taux de complications d'une néphrectomie partielle laparo-endoscopique avec accès unique et identifie les facteurs prédictifs associés

Laparoendoscopic Single-site Partial Nephrectomy: A Multi-institutional Outcome Analysis

Francesco, Greco ; Riccardo, Autorino ; Koon, H. Rha ; Ithaar, Derweesh ; Luca, Cindolo ; Lee, Richstone ; Thomas, R. W. Herrmann ; Evangelos, Liatsikos ; Yinghao, Sun ; Caterina, Fanizza ; Udo, Nagele ; Jens-Uwe, Stolzenburg ; Soroush, Rais-Bahrami ; Michael, A. Liss ; Luigi, Schips ; Ahmad, Kassab ; Linhui, Wang ; Panagiotis, Kallidonis ; Zhenjie, Wu ; Shin Tae, Young ; Nasreldin, Mohammed ; Georges-Pascal, Haber ; Christopher, Springer ; Paolo, Fornara ; Jihad, H. Kaouk

Background : Laparoendoscopic single-site surgery (LESS) has been developed in an attempt to further reduce the surgical trauma associated with conventional laparoscopy. Partial nephrectomy (PN) represents a challenging indication for LESS. Objective : To report a large multi-institutional series of LESS-PN and to analyze the predictors of outcomes after LESS-PN. Design, setting, and participants : Consecutive cases of LESS-PN done between November 2007 and March 2012 at 11 participating [...]

Cet article analyse la validité des études démontrant l'intérêt de la résection chirurgicale de métastases pulmonaires asymptomatiques pour améliorer la survie et la qualité de vie des patients atteints d'un sarcome

Surgical removal of asymptomatic pulmonary metastases: time for better evidence

Tom Treasure ; Martin Utley

Surgical removal of blood borne deposits of disseminated cancer in the lung is widely believed to benefit patients. Tom Treasure and Martin Utley analyse the evidence for pulmonary metastasectomy in sarcoma and call for a randomised trial Patients with cancer are routinely screened to detect recurrence. The lungs are the commonest site of metastases, where they are readily detected by computed tomography, prompting consideration of their removal.1 Operative risk is minimised by selecting fitter [...]

Menée sur 29 patients pédiatriques atteints d'un astrocytome de la moelle épinière de grade 1 à 4 (durée médiane de suivi : 55 mois ou 17 mois selon le grade tumoral), cette étude évalue l'efficacité, du point de vue de la survie sans progression, et la toxicité d'une radiothérapie en fonction du grade de la maladie

Management of Pediatric Spinal Cord Astrocytomas: Outcomes With Adjuvant Radiation

Guss, Zachary D. ; Moningi, Shalini ; Jallo, George I. ; Cohen, Kenneth J. ; Wharam, Moody D. ; Terezakis, Stephanie A.

Pediatric intramedullary spinal cord tumors are exceedingly rare; in the United States, 100 to 200 cases are recognized annually, of these, most are astrocytomas. The purpose of this study is to report the outcomes in pediatric patients with spinal cord astrocytomas treated at a tertiary care center. An institutional review board-approved retrospective single-institution study was performed for pediatric patients with spinal cord astrocytomas treated at our hospital from 1990 to 2010. The [...]

Menée sur 40 patients adultes atteints d'un médulloblastome traité entre 2003 et 2011, cette étude rétrospective montre que la radiothérapie crânio-spinale par protons (durée médiane de suivi : 26 mois) réduit la toxicité aiguë par rapport à une radiothérapie crânio-spinale conventionnelle par photons (durée médiane de suivi : 57 mois)

Proton Beam Craniospinal Irradiation Reduces Acute Toxicity for Adults With Medulloblastoma

Brown, Aaron P. ; Barney, Christian L. ; Grosshans, David R. ; McAleer, Mary Frances ; de Groot, John F. ; Puduvalli, Vinay K. ; Tucker, Susan L. ; Crawford, Cody N. ; Khan, Meena ; Khatua, Soumen ; Gilbert, Mark R. ; Brown, Paul D. ; Mahajan, Anita

Efficacy and acute toxicity of proton craniospinal irradiation (p-CSI) were compared with conventional photon CSI (x-CSI) for adults with medulloblastoma. Forty adult medulloblastoma patients treated with x-CSI (n=21) or p-CSI (n=19) at the University of Texas MD Anderson Cancer Center from 2003 to 2011 were retrospectively reviewed. Median CSI and total doses were 30.6 and 54 Gy, respectively. The median follow-up was 57 months (range 4-103) for x-CSI patients and 26 months (range 11-63) for [...]

Cet article fait le point sur les avancées récentes en matière de prise en charge thérapeutique des cancers urothéliaux de la vessie avec ou sans invasion musculaire

Management of superficial and muscle-invasive urothelial cancers of the bladder

Resnick, Matthew J. ; Bassett, Jeffrey C. ; Clark, Peter E.

Purpose of review: To summarize recent developments and controversies in the management of both nonmuscle-invasive and muscle-invasive urothelial carcinoma of the bladder. Recent findings: Bladder cancer remains a commonly diagnosed disease both within the United States and worldwide. Despite improvements in diagnosis and management of nonmuscle-invasive bladder tumors, the risk of both recurrence and progression remains significant. Tobacco use remains the single most common modifiable [...]

Cet article passe en revue les perspectives offertes par le ciblage de mécanismes liés à l'autophagie pour le traitement d'un cancer du foie

The Role of Autophagy in Liver Cancer: Molecular Mechanisms and Potential Therapeutic Targets

Cui, Jianzhou ; Gong, Zhiyuan ; Shen, Han-Ming

Autophagy is an evolutionarily conserved pathway for degradation of cytoplasmic proteins and organelles via lysosome. Proteins coded by the autophagy-related genes (Atgs) are the core molecular machinery in control of autophagy. Among the various biological functions of autophagy identified so far, the link between autophagy and cancer is probably among the most extensively studied and is often viewed as controversial. Autophagy might exert a dual role in cancer development: autophagy can serve [...]

Menée à l'aide de modèles murins, cette étude évalue l'intérêt de nanoparticules présentant un peptide du « soi » pour échapper au système immunitaire et acheminer des agents thérapeutiques à l’intérieur des tumeurs

Minimal "Self" Peptides That Inhibit Phagocytic Clearance and Enhance Delivery of Nanoparticles

Rodriguez, Pia L. ; Harada, Takamasa ; Christian, David A. ; Pantano, Diego A. ; Tsai, Richard K. ; Discher, Dennis E.

Foreign particles and cells are cleared from the body by phagocytes that must also recognize and avoid clearance of "self" cells. The membrane protein CD47 is reportedly a "marker of self" in mice that impedes phagocytosis of self by signaling through the phagocyte receptor CD172a. Minimal "Self" peptides were computationally designed from human CD47 and then synthesized and attached to virus-size particles for intravenous injection into mice that express a CD172a variant compatible with hCD47. [...]

Menée à l'aide de modèles murins, cette étude met en évidence un mécanisme suggérant l'intérêt des inhibiteurs de bromodomaines BET pour le traitement de patients pédiatriques atteints d'un neuroblastome avec amplification du gène MYCN

Targeting MYCN in Neuroblastoma by BET Bromodomain Inhibition

Puissant, Alexandre ; Frumm, Stacey M. ; Alexe, Gabriela ; Bassil, Christopher F. ; Qi, Jun ; Chanthery, Yvan H. ; Nekritz, Erin A. ; Zeid, Rhamy ; Gustafson, William Clay ; Greninger, Patricia ; Garnett, Matthew J. ; McDermott, Ultan ; Benes, Cyril H. ; Kung, Andrew L. ; Weiss, William A. ; Bradner, James E. ; Stegmaier, Kimberly

Bromodomain inhibition comprises a promising therapeutic strategy in cancer, particularly for hematologic malignancies. To date, however, genomic biomarkers to direct clinical translation have been lacking. We conducted a cell-based screen of genetically defined cancer cell lines using a prototypical inhibitor of BET bromodomains. Integration of genetic features with chemosensitivity data revealed a robust correlation between MYCN amplification and sensitivity to bromodomain inhibition. We [...]

Menée in vitro et à l'aide de xénogreffes, cette étude évalue l'activité antitumorale d'un composé anticorps-médicament (milatuzumab-SN38) pour le traitement de tumeurs solides surexprimant CD74

Milatuzumab-SN-38 conjugates for the treatment of CD74+ cancers

Govindan, Serengulam V. ; Cardillo, Thomas M. ; Sharkey, Robert M ; Tat, Fatma ; Gold, David V. ; Goldenberg, David M.

CD74 is an attractive target for antibody-drug conjugates (ADC), because it internalizes and recycles after antibody binding. CD74 mostly is associated with hematological tumors, but is expressed also in solid cancers. Therefore, ADCs of the humanized anti-CD74 antibody, milatuzumab, were examined for the therapy CD74-expressing solid tumors. Milatuzumab-doxorubicin, and two milatuzumab-SN-38 conjugates with cleavable linkers, differing in their stability in serum and how they release SN-38 in [...]

Menée in vitro et à l'aide de modèles murins, cette étude suggère l'intérêt de cibler la protéine SERCA pour le traitement de leucémies présentant des mutations du gène NOTCH1

Complementary Genomic Screens Identify SERCA as a Therapeutic Target in NOTCH1 Mutated Cancer

Roti, Giovanni ; Carlton, Anne ; Ross, Kenneth N ; Markstein, Michele ; Pajcini, Kostandin ; Su, Angela H ; Perrimon, Norbert ; Pear, Warren S ; Kung, Andrew L ; Blacklow, Stephen C ; Aster, Jon C ; Stegmaier, Kimberly

Notch1 is a rational therapeutic target in several human cancers, but as a transcriptional regulator, it poses a drug discovery challenge. To identify Notch1 modulators, we performed two cell-based, high-throughput screens for small-molecule inhibitors and cDNA enhancers of a NOTCH1 allele bearing a leukemia-associated mutation. Sarco/endoplasmic reticulum calcium ATPase (SERCA) channels emerged at the intersection of these complementary screens. SERCA inhibition preferentially impairs the [...]

Menée in vitro et in vivo, cette étude suggère l'intérêt d'un ciblage combiné des voies de signalisation MEK/ERK et PI3K/mTOR pour le traitement d'un mélanome présentant une mutation du gène NRAS

Combined targeting of MEK and PI3K/mTOR effector pathways is necessary to effectively inhibit NRAS mutant melanoma in vitro and in vivo

Posch, Christian ; Moslehi, Homayoun ; Feeney, Luzviminda ; Green, Gary A. ; Ebaee, Anoosheh ; Feichtenschlager, Valentin ; Chong, Kim ; Peng, Lily ; Dimon, Michelle T. ; Phillips, Thomas ; Daud, Adil I. ; McCalmont, Timothy H. ; LeBoit, Philip E. ; Ortiz-Urda, Susana

Activating mutations in the neuroblastoma rat sarcoma viral oncogene homolog (NRAS) gene are common genetic events in malignant melanoma being found in 15–25% of cases. NRAS is thought to activate both mitogen activated protein kinase (MAPK) and PI3K signaling in melanoma cells. We studied the influence of different components on the MAP/extracellular signal-regulated (ERK) kinase (MEK) and PI3K/mammalian target of rapamycin (mTOR)-signaling cascade in NRAS mutant melanoma cells. In general, [...]

Cet article passe en revue les perpectives thérapeutiques offertes par les connaissances récentes sur la physiopathologie des ascites malignes, en particulier dans le contexte d'un cancer ovarien

Meeting the challenge of ascites in ovarian cancer: new avenues for therapy and research

Kipps, Emma ; Tan, David S. P. ; Kaye, Stan B.

Malignant ascites presents a considerable clinical challenge to the management of ovarian cancer, but also provides a wealth of opportunities for translational research. The accessibility of ascitic fluid and its cellular components make it an excellent source of tumour tissue for the investigation of prognostic and predictive biomarkers, pharmacodynamic markers and for molecular profiling analysis. In this Opinion article, we discuss recent advances in our understanding of its pathophysiology, [...]

Menée in vitro et in vivo, cette étude évalue l'activité antitumorale d'un anticorps monoclonal bloquant l'expression de la métalloprotéinase matricielle MMP-14 pour le traitement adjuvant d'un cancer ovarien de stade avancé

Selective blockade of matrix metalloprotease-14 with a monoclonal antibody abrogates invasion, angiogenesis and tumor growth in ovarian cancer

Kaimal, Rajani ; Aljumaily, Raid ; Tressel, Sarah L ; Pradhan, Rutika V ; Covic, Lidija ; Kuliopulos, Athan ; Zarwan, Corrine ; Kim, Young B ; Sharifi, Sheida ; Agarwal, Anika

Most ovarian cancer patients are diagnosed late in progression and often experience tumor recurrence and relapses due to drug resistance. Surface expression of matrix metalloprotease MMP-14 on ovarian cancer cells stimulates a tumor-stromal signaling pathway that promotes angiogenesis and tumor growth. In a cohort of 92 patients, we found that MMP-14 was increased in the serum of women with malignant ovarian tumors. Therefore, we investigated the preclinical efficacy of a MMP-14 monoclonal [...]

Menée sur des lignées cellulaires et à l'aide de xénogreffes de tumeurs du côlon, cette étude met en évidence un mécanisme par lequel le crizotinib induit une apoptose des cellules cancéreuses

Crizotinib induces PUMA-dependent apoptosis in colon cancer cells

Zheng, Xingnan ; He, Kan ; Zhang, Lin ; Yu, Jian

Oncogenic alterations in MET or ALK have been identified in a variety of human cancers. Crizotinib (PF02341066) is a dual MET and ALK inhibitor and approved for the treatment of a subset of non-small-cell lung carcinoma; and in clinical development for other malignancies. Crizotinib can induce apoptosis in cancer cells while the underlying mechanisms are not well understood. In this study, we found that crizotinib induces apoptosis in colon cancer cells through the BH3-only protein PUMA. In [...]

Menée sur des lignées cellulaires et à l'aide de xénogreffes de tumeurs du côlon, cette étude met en évidence un mécanisme d'action du tandutinib sur la signalisation Akt/mTOR

Tandutinib inhibits the Akt/mTOR signaling pathway to inhibit colon cancer growth

Ponnurangam, Sivapriya ; Standing, David ; Rangarajan, Parthasarathy ; Subramaniam, Dharmalingam

The c-Kit receptor can activate distinct signaling pathways including phosphatidylinositol-3-kinase (PI3K)/Akt and mammalian target of rapamycin (mTOR). Aberrant c-Kit activation protects cells from apoptosis and enhances invasion of colon carcinoma cells. Tandutinib is a novel quinazoline-based inhibitor of the type III receptor tyrosine kinases including c-Kit. We determined the effect of Tandutinib on colon cancer growth and identified a mechanism of action. Tandutinib inhibited [...]

Mené sur 69 patients atteints d'une tumeur solide de stade avancé, cet essai de phase I évalue un composé appelé BAY 86-9766, un inhibiteur de MAPK 1/2, du point de vue de paramètres pharmacocinétiques et pharmacodynamiques

Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Weekes, Colin D. ; Von Hoff, Daniel D. ; Adjei, Alex A. ; Leffingwell, Diane P. ; Eckhardt, S. Gail ; Gore, Lia ; Lewis, Karl D. ; Weiss, Glen J. ; Ramanathan, Ramesh K. ; Dy, Grace K. ; Ma, Wen W. ; Sheedy, Beth ; Iverson, Cory ; Miner, Jeffrey N. ; Shen, Zancong ; Yeh, Li-Tain ; Dubowy, Ronald L. ; Jeffers, Michael ; Rajagopalan, Prabhu ; Clendeninn, Neil J.

Purpose: To evaluate the safety, pharmacokinetics, and pharmacodynamics of BAY 86-9766, a selective, potent, orally available, small-molecule allosteric inhibitor of mitogen-activated protein kinase 1/2 in patients with advanced solid tumors. Experimental Design: BAY 86-9766 was administered orally daily in 28-day courses, with doses escalated to establish the maximum-tolerated dose (MTD). An expanded cohort was evaluated at the MTD. Pharmacokinetic and pharmacodynamic parameters were assessed, [...]

Menée à l'Institut Gustave-Roussy entre juin 2010 et septembre 2011 auprès de 73 patients atteints d'un mélanome métastatique traité par ipilimumab à titre compassionnel, cette étude évalue la faisabilité de la prise en charge des effets toxiques du traitement

Experience in daily practice with ipilimumab for the treatment of patients with metastatic melanoma: an early increase in lymphocyte and eosinophil counts is associated with improved survival

Delyon, J. ; Mateus, C. ; Lefeuvre, D. ; Lanoy, E. ; Zitvogel, L. ; Chaput, N. ; Roy, S. ; Eggermont, A. M. M. ; Routier, E. ; Robert, C.

Background Ipilimumab is a recently approved immunotherapy that has demonstrated an improvement in the overall survival (OS) of patients with metastatic melanoma. We report a single-institution experience in patients treated in a compassionate-use program. Patients and methods In this prospective study, patients were treated between June 2010 and September 2011. Inclusion criteria were a diagnosis of unresectable stage III or IV melanoma, at least one previous line of chemotherapy, and survival [...]

A partir de données d'un essai de phase III ayant inclus 750 patients atteints d'un carcinome métastatique à cellules rénales, cette étude montre que le sunitinib, qui était évalué par rapport à l'interféron alpha, n'accélère pas la croissance tumorale et ne réduit pas la survie

Sunitinib Does Not Accelerate Tumor Growth in Patients with Metastatic Renal Cell Carcinoma

Blagoev, Krastan B ; Wilkerson, Julia ; Stein, Wilfred D ; Motzer, Robert J ; Bates, Susan E ; Fojo, A.  Tito

Preclinical studies have suggested that sunitinib accelerates metastases in animals, ascribing this to inhibition of the vascular endothelial growth factor receptor or the tumor s adaptation. To address whether sunitinib accelerates tumors in humans, we analyzed data from the pivotal randomized phase III trial comparing sunitinib and interferon alfa in patients with metastatic renal cell carcinoma. The evidence clearly shows that sunitinib was not harmful, did not accelerate tumor growth, and [...]

Menée sur 724 patientes atteintes d'un cancer du sein ER+ incluses dans l'essai BOLERO-2, cette étude évalue les effets de l'everolimus en combinaison avec l'exémestane sur les niveaux de marqueurs du métabolisme osseux

Effect of Everolimus on Bone Marker Levels and Progressive Disease in Bone in BOLERO-2

Gnant, Michael ; Baselga, Jose ; Rugo, Hope S. ; Noguchi, Shinzaburo ; Burris, Howard A. ; Piccart, Martine ; Hortobagyi, Gabriel N. ; Eakle, Janice ; Mukai, Hirofumi ; Iwata, Hiroji ; Geberth, Matthias ; Hart, Lowell L. ; Hadji, Peyman ; El-Hashimy, Mona ; Rao, Shantha ; Taran, Tetiana ; Sahmoud, Tarek ; Lebwohl, David ; Campone, Mario ; Pritchard, Kathleen I.

Background Breast Cancer Trials of Oral Everolimus 2 (BOLERO-2), a phase III study in postmenopausal women with estrogen receptor–positive breast cancer progressing despite nonsteroidal aromatase inhibitor therapy, showed statistically significant benefits with adding everolimus to exemestane. Moreover, in preclinical studies, mammalian target of rapamycin inhibition was associated with decreased osteoclast survival and activity. Exploratory analyses in BOLERO-2 evaluated the effect of [...]

Cette revue systématique de la littérature (50 essais) analyse les résultats des essais cliniques de thérapies ciblées en traitement adjuvant d'un cancer du sein HER2+

HER2-targeted therapy in breast cancer: A systematic review of neoadjuvant trials

Dent, Susan ; Oyan, Basak ; Honig, Arnd ; Mano, Max ; Howell, Sacha

Targeting human epidermal growth factor receptor 2 (HER2) during or in sequence with chemotherapy improves overall survival in metastatic and early HER2-overexpressing breast cancer. In this paper we systematically review neoadjuvant clinical trial data in HER2-positive breast cancer and discuss key unanswered clinical questions. All trials of HER2-targeted neoadjuvant therapy were identified through non-date-limited searches of PubMED® and Biosis® and congress abstract book searches from [...]

Cette étude présente les résultats à long terme (durée médiane de suivi : 45,4 mois) d'un essai de phase III évaluant l'efficacité, du point de vue de la survie globale, de la vinflunine chez 370 patients atteints d'un carcinome urothélial à cellules transitionnelles avancé ou métastatique en échec d'une chimiothérapie contenant du platine

Long-term survival results of a randomized phase III trial of vinflunine plus best supportive care versus best supportive care alone in advanced urothelial carcinoma patients after failure of platinum-based chemotherapy

Bellmunt, J. ; Fougeray, R. ; Rosenberg, J.E. ; von der Maase, H. ; Schutz, F.A. ; Salhi, Y. ; Culine, S. ; Choueiri, T.K.

Background To compare long-term, updated overall survival (OS) of patients with advanced transitional cell carcinoma of the urothelium (TCCU) treated with vinflunine plus best supportive care (BSC) or BSC alone, after failure of platinum-based chemotherapy. Patients and methods Three hundred and seventy patients were randomly assigned in a phase III trial and allocated (2:1) to vinflunine (320 or 280 mg/m2) plus BSC or BSC alone. The first report (Bellmunt J, Theodore C, Demkov T et al. Phase [...]

Menée auprès de 365 patients atteints d'un cancer traité dans un centre hospitalier néerlandais, cette étude analyse les facteurs associés à leur éventuelle participation à un essai clinique de phase I

Evaluation of Patient Enrollment in Oncology Phase I Clinical Trials

van der Biessen, Diane A.J. ; Cranendonk, Merlijn A. ; Schiavon, Gaia ; van der Holt, Bronno ; Wiemer, Erik A.C. ; Eskens, Ferry A.L.M. ; Verweij, Jaap ; de Jonge, Maja J.A. ; Mathijssen, Ron H.J.

Introduction. For anticancer drug development, it is crucial that patients participate in early-phase clinical trials. The main aim of this study was to gain insight into the motivations and other variables influencing patients in their decision to participate in phase I oncology trials. Materials and Methods. Over a period of 25 months, all patients who were informed about (specific) phase I trials in our cancer center were retrospectively included in this study. Data on providing informed [...]

A partir de données portant sur la période 2006-2011, cette étude analyse et compare les procédures d'autorisation de mise sur le marché de médicaments anticancéreux dans l'Union européenne par rapport aux Etats-Unis et au Japon

Approval probabilities and regulatory review patterns for anticancer drugs in the European Union

Hartmann, Markus ; Mayer-Nicolai, Christine ; Pfaff, Otmar

Aim This article reviews outcomes of marketing authorization applications for anticancer drugs in the EU and outlines factors and hurdles of impact. Methods Procedures for initial approval of anticancer and non-cancer drugs were analyzed and compared to anticancer drug approvals in the USA and Japan for the same period. Results From 2006 to 2011, the regulatory review of 46 marketing authorization applications resulted in 29 new cancer drug approvals. The overall approval probability (63%) [...]