Frequency of Certain Established Risk Factors in Soft Tissue Sarcomas in Adults: A Prospective Descriptive Study of 658 Cases

Soft tissue sarcomas are rare tumours with infrequent identified aetiological factors. Several genetic syndromes as well as previous radiation therapy and/or chronic lymphoedema have been suspected to predispose to some soft tissue sarcomas. Between January 1997 and September 2005, we carried out a prospective descriptive study to estimate the frequency of some particular etiological factors among 658 patients with soft tissue sarcomas. Sarcomas associated with a clinically identified genetic disease represent 2.8% out of all cases (95%CI: 1.5–3.8%). Most of these cases (14/19) are related to Recklinghausen neurofibromatosis. Radiation-induced sarcomas represent 3.3% out of all cases (95%CI: 1.7–5.1%). Most of these cases (9/22) are related to prior breast cancer treatment. We had observed only 1 case of Stewart-Treves syndrome. Liposarcoma, the most frequent histological subtype observed, is not associated with any particular aetiological entity. Finally, most of the adult soft tissue sarcomas are not related to any classical clinically identified genetic disease or previous radiation therapy and/or chronic lymphoedema risk factors. Frequency of underlying genetic syndrome which may predispose to soft tissue sarcomas could be higher than previously reported

Preoperative chemoradiation with paclitaxel-carboplatin or with fluorouracil-oxaliplatin-folinic acid (FOLFOX) for resectable esophageal and junctional cancer: the PROTECT-1402, randomized phase 2 trial.

BACKGROUND: Often curative treatment for locally advanced resectable esophageal or gastro-esophageal junctional cancer consists of concurrent neoadjuvant radiotherapy and chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy regimens in this setting is a combination of a fluoropyrimidin and of a platinum analogue. Due to the promising results of the recent CROSS trial, another regimen combining paclitaxel and carboplatin is also widely used by European and American centers. No clinical study has shown the superiority of one treatment over the other. The objective of this Phase II study is to clarify clinical practice by comparing these two chemotherapy treatments. Our aim is to evaluate, in operable esophageal and gastro-esophageal junctional cancer, the complete resection rate and severe postoperative morbidity rate associated with these two neoadjuvant chemotherapeutic regimens (carboplatin-paclitaxel or fluorouracil-oxaliplatin-folinic acid) when each is combined with the radiation regime utilized in the CROSS trial. METHODS/DESIGN: PROTECT is a prospective, randomized, multicenter, open arms, phase II trial. Eligible patients will have a histologically confirmed adenocarcinoma or squamous cell carcinoma and be treated with neoadjuvant radiochemotherapy followed by surgery for stage IIB or stage III resectable esophageal cancer. A total of 106 patients will be randomized to receive either 3 cycles of FOLFOX combined to concurrent radiotherapy (41.4 Grays) or carboplatin and paclitaxel with the same radiation regimen, using a 1:1 allocation ratio. DISCUSSION: This ongoing trial offers the unique opportunity to compare two standards of chemotherapy delivered with a common regimen of preoperative radiation, in the setting of operable locally advanced esophageal or gastro-esophageal junctional tumors. TRIAL REGISTRATION: NCT02359968 (ClinicalTrials.gov) (registration date: 9 FEB 2015), EudraCT: 2014-000649-62 (registration date: 10 FEB 2014)

Predictive value of clinical judgment of tumour progression in phase II trials.

BACKGROUND: The diagnosis of tumour progression or progressive disease (PD) is a key element for designing and interpreting contemporary phase II trials. In some cases, PD is stated by the physician and is not formally confirmed by imaging. PURPOSE: In this study, we intend to analyze the value of the PD based on clinical judgment and the risk of overestimating the occurrence of PD by clinical judgment. METHODS: We have conducted a single-centre retrospective study to analyse the diagnostic accuracy of this clinical judgment compared to planned imaging including all patients enrolled in our institution in phase II trials investigating systemic treatments for advanced solid tumours between January 2008 and November 2010. RESULTS: The positive predictive value (PPV) and the specificity of clinical judgment of PD was very high (>90%). CONCLUSIONS: According to this study, the clinical judgment of PD is highly predictive of radiological PD as assessed, for example, by RECIST. Physicians do not overestimate PD occurence. Clinical judgment of PD could be taken into account in the definition of PD

Index de compréhension des essais cliniques randomisés en oncologie

International audienceL’objectif principal de cette étude est d’élaborer un outil de mesure (ICEC-R) validé en français de la compréhension objective des modalités etfinalités de la participation à une étude clinique randomisée (phase II ou III). Il s’agit également de comparer les scores obtenus à l’ICEC-R par différents groupes de participants selon leur niveau d’expertise dans le domaine (médecins vs patients inclus dans un essai clinique vs patients recevant un traitement standard vs profanes), et de vérifier si l’état d’anxiété et la satisfaction générale par rapport aux soins des patients ont un impact sur le score global de compréhension objective.L’échantillon comprend 474 participants : 73 « patients cibles » atteints d’une pathologie cancéreuse et inclus dans un essai clinique randomisé, 97 « patients standard » atteints d’une pathologie cancéreuse mais non inclus dans un essai clinique, 25 « médecins » procédant aux inclusions de patients dans des essais cliniques, 18 « soignants » ne procédant pas aux inclusions dans les essais cliniques, 261 « profanes » (étudiants en psychologie). Les patients « cibles » ou « standard » ont reçu un questionnaire composé d’un inventaire de compréhension des essais cliniques randomisés (ICEC-R), d’une mesure de l’anxiété état et trait STAI-Y, et d’une échelle de satisfaction par rapport aux soins prodigués (SAT). Outre des informations générales, les médecins, les soignants et les profanes ne complétaient que l’ICEC-R. Les analyses ont permis de retenir un inventaire unidimensionnel de compréhension composé de dix items suffisamment discriminants auprès des patients et dont les réponses sont consensuelles au sein d’une population de médecins experts. En outre, les réponses des participants à cet inventaire ne semblent être affectées ni par l’anxiété, ni par la satisfaction à l’égard des soins prodigués. Mieux appréhender les connaissances des patients inclus dans un essai clinique randomisé nous semble un atout indéniable pour l’amélioration de leur prise en charge globale

Performance of clinical judgment of tumour progression.

<p>Performance of clinical judgment of tumour progression.</p

Baseline characteristics.

<p>Baseline characteristics.</p