Oc-88 First Clinical Results of the Gec-Estro Breast Wg Phase Iii Multicentric Apbi Trial.

Strnad, Vratislav; Ott, Oliver J.; Hildebrandt, Guido; Pötter, Richard; Fietkau, R.; Łyczek, Jarosław; Uter, Wolfgang; Major, Tibor; Lotter, Michael; Polgár, C.

doi:10.1016/s0167-8140(12)72055-8

Cited by 9 publications

(3 citation statements)

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“…Les résultats de toxicité à un an pour 1193 patientes ont été présentés au congrès de l'ESTRO de 2012 [54]. En termes de toxicité aiguë, il a été retrouvé une différence significative pour l'épidermite grade 1 à 3 en faveur de l'irradiation partielle et [57].…”

Section: Irradiation Postopératoire Externeunclassified

État de l’art et perspectives de l’irradiation partielle et accélérée du sein en 2014

Chand-Fouché

Hannoun‐Lévi

2014

Cancer/Radiothérapie

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Section: Irradiation Postopératoire Externeunclassified

État de l’art et perspectives de l’irradiation partielle et accélérée du sein en 2014

Chand-Fouché

Hannoun‐Lévi

2014

Cancer/Radiothérapie

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“…Even describing the study results can be confusing, given that Cuttino et al remark that the preliminary results indicated that "for all forms of APBI (including BB [breast brachytherapy]), toxicity was less than or equal to WBI," yet the cited abstract specifically excludes brachytherapy. 10,11 RCTs and observational studies alike should measure outcomes and follow-up periods that are relevant to patients. The cited data derived from the Groupe Europe ´en de Curiethe ´rapie-European Society for Radiotherapy and Oncology (GEC-ESTRO) trial (which also uses interstitial, rather than balloon, brachytherapy) only address toxicity at the end of therapy, omitting long-term complication and toxicity data.…”

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confidence: 99%

“…The cited data derived from the Groupe Europe ´en de Curiethe ´rapie-European Society for Radiotherapy and Oncology (GEC-ESTRO) trial (which also uses interstitial, rather than balloon, brachytherapy) only address toxicity at the end of therapy, omitting long-term complication and toxicity data. 12 Because this trial is still observing patients and the primary outcome data will not be mature for years, it is uncertain how to interpret interim findings that were captured immediately after the completion of therapy.…”

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confidence: 99%

Reply to L.W. Cuttino et al

Presley

Soulos

Herrin

et al. 2013

JCO

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Angeles, wrote an editorial accompanying the Yale study entitled, "When Hope Hinders Science and Patient-Centered Care." 11 The progression of BB during the last 20 years from institutional phase I/II studies, to multiinstitution phase II trials, to the creation of patient selection guidelines from several major organizations, and finally to the implementation of prospective randomized trials that have enrolled more than 10,000 women to date is the very definition of rigorous scientific evaluation. Malin recognizes "the important role CER can have in providing data on therapies for which outcomes from randomized clinical trials are lacking," 11(p4283) but fails entirely to acknowledge the existence of randomized data on BB.Prospective data should not be ignored in favor of retrospective analyses that are based on billing claims data. Just as with the publication of the MD Anderson BB analysis, the media is reporting on the Yale study with fervor. On October 22, 2012, Reuters published a story entitled, "New breast cancer therapy tied to more complications," 12 which has been picked up by most of the lay press. In this article, the senior author of the Yale study, Gross, is cited as saying that "there is no solid research showing brachytherapy is a safe and effective alternative to whole-breast radiation." This statement ignores the results of multiple large, prospective studies. Unfortunately, this media sensationalism is creating a false equivalence between patient-derived prospective data and retrospective analyses that are based on billing claims.The efficacy of APBI and BB in comparison with WBI is best answered by randomized phase III clinical trials. Ioannidis of Stanford University recently observed, "…observational evidence about commonly and easily measured exposures and outcomes resembles an opinion poll or self-fulfilling prophecy: researchers can selectively mold… data into studies that produce the desired result." 13(p576) This type of analysis should simply never trump the results of carefully conducted randomized trials. Moreover, these data may serve as distractions and fruitless scientific detours that steal precious time and resources from the next generation of rigorously designed and conducted clinical trials. Thus far, there is absolutely no evidence to suggest increased toxicity or local failure after APBI in the thousands of women who have been treated prospectively in modern phase III trials.

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Partial breast irradiation for early breast cancer

Hickey

Lehman

Francis

et al. 2016

Cochrane Database of Systematic Reviews

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It appeared that local recurrence and 'elsewhere primaries' (new primaries in the ipsilateral breast) are increased with PBI/APBI (the difference was small), but we found no evidence of detriment to other oncological outcomes. It appeared that cosmetic outcomes and some late effects were worse with PBI/APBI but its use was associated with less acute skin toxicity. The limitations of the data currently available mean that we cannot make definitive conclusions about the efficacy and safety or ways to deliver of PBI/APBI. We await completion of ongoing trials.

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Oc-88 First Clinical Results of the Gec-Estro Breast Wg Phase Iii Multicentric Apbi Trial.

Cited by 9 publications

References 0 publications

État de l’art et perspectives de l’irradiation partielle et accélérée du sein en 2014

État de l’art et perspectives de l’irradiation partielle et accélérée du sein en 2014

Reply to L.W. Cuttino et al

Partial breast irradiation for early breast cancer

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