Editorial

. 2015 Jul 1;92(3):491-7.

doi: 10.1016/j.ijrobp.2015.03.022. Epub 2015 Apr 8.

Pride, Prejudice, or Science: Attitudes Towards the Results of the TARGIT-A Trial of Targeted Intraoperative Radiation Therapy for Breast Cancer

Affiliations

¹ Clinical Trials Group, Division of Surgery and Interventional Science, University College London, London, UK; Department of Surgery, Royal Free Hospital, London, UK; Department of Surgery, Whittington Health, London, UK. Electronic address: jayant.vaidya@ucl.ac.uk.
² Department of Biostatistics, University of Notre Dame, Fremantle, WA, Australia.
³ Department of Radiation Oncology, University Medical Centre Mannheim, University of Heidelberg, Heidelberg, Germany.
⁴ Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.
⁵ Department of Surgery, Sir Charles Gairdner Hospital, Perth, WA, Australia; School of Surgery, University of Western Australia, Perth, WA, Australia.
⁶ Department of Surgery, Centro di Riferimento Oncologia, Aviano, Italy.
⁷ Department of Breast Surgery, University of Copenhagen, Copenhagen, Denmark.
⁸ Department of Gynecology and Obstetrics, Red Cross Hospital, Munich, Germany.
⁹ Department of Surgery, University of California, San Francisco, California.
¹⁰ Department of Pathology, University College London Hospitals, London, UK.
¹¹ Clinical Trials Group, Division of Surgery and Interventional Science, University College London, London, UK.
¹² Department of Clinical Oncology, University College London Hospitals, London, UK.

PMID: 26068479
PMCID: PMC4464618
DOI: 10.1016/j.ijrobp.2015.03.022

Editorial

Pride, Prejudice, or Science: Attitudes Towards the Results of the TARGIT-A Trial of Targeted Intraoperative Radiation Therapy for Breast Cancer

Jayant S Vaidya et al. Int J Radiat Oncol Biol Phys. 2015.

. 2015 Jul 1;92(3):491-7.

doi: 10.1016/j.ijrobp.2015.03.022. Epub 2015 Apr 8.

Authors

Affiliations

¹ Clinical Trials Group, Division of Surgery and Interventional Science, University College London, London, UK; Department of Surgery, Royal Free Hospital, London, UK; Department of Surgery, Whittington Health, London, UK. Electronic address: jayant.vaidya@ucl.ac.uk.
² Department of Biostatistics, University of Notre Dame, Fremantle, WA, Australia.
³ Department of Radiation Oncology, University Medical Centre Mannheim, University of Heidelberg, Heidelberg, Germany.
⁴ Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.
⁵ Department of Surgery, Sir Charles Gairdner Hospital, Perth, WA, Australia; School of Surgery, University of Western Australia, Perth, WA, Australia.
⁶ Department of Surgery, Centro di Riferimento Oncologia, Aviano, Italy.
⁷ Department of Breast Surgery, University of Copenhagen, Copenhagen, Denmark.
⁸ Department of Gynecology and Obstetrics, Red Cross Hospital, Munich, Germany.
⁹ Department of Surgery, University of California, San Francisco, California.
¹⁰ Department of Pathology, University College London Hospitals, London, UK.
¹¹ Clinical Trials Group, Division of Surgery and Interventional Science, University College London, London, UK.
¹² Department of Clinical Oncology, University College London Hospitals, London, UK.

PMID: 26068479
PMCID: PMC4464618
DOI: 10.1016/j.ijrobp.2015.03.022

No abstract available

PubMed Disclaimer

Figures

**Fig. 1**
The meaning of non-inferiority: 10 examples of different scenarios that might occur in a randomized trial testing noninferiority between 2 treatments. The dots represent the absolute difference; the lines represent the confidence intervals. The green circle includes 2 of the trial results: on the left is the targeted intraoperative radiation therapy (TARGIT) prepathology stratum (difference 0.37%), and on the right is the earliest cohort of the whole trial (n=1222), which has the median follow-up time of 5 years (difference 1.14%) (see Table 3 of the main report) .

**Fig. 2**
Survival without local recurrence. This Kaplan-Meier plot is the true representation of how patients with breast cancer would fare in the first 5 years of their life after treatment with targeted intraoperative radiation therapy (TARGIT) during lumpectomy or external beam radiation therapy (EBRT) with respect to local control. Censoring is done at the point of last follow-up or withdrawal. For any patient, her chance of being alive without local recurrence can be read from this plot. The 5-year survival without local recurrence: TARGIT: 93.9% (95% CI 90.9-95.9); EBRT: 92.5% (95% CI 89.7-94.6), P=.35.

**Fig. 3**
Demonstration of how the reduction in local recurrence by radiation therapy occurs only in the first 5 years, most of the effect being already seen in the first 2 to 3 years. The top 2 figures are Kaplan-Meier plots from the landmark National Surgical Adjuvant Breast and Bowel Project (NSABP) B06 (left) and the Swedish trial (right) of radiation therapy (XRT) versus no radiation therapy after lumpectomy . The bottom half shows the data from the Swedish trial expressed as hazard of local recurrence of radiation therapy versus no radiation therapy from the same Swedish trial. On the left are the smoothened hazard plots and on the right the absolute values of hazard ratios taken from Wickberg et al , again showing that almost all the reduction in recurrence by radiation therapy is in the first 5 years.

**Fig. 4**
Pictogram to help patients and doctors make a shared, well-informed decision. EBRT = external beam radiation therapy; TARGIT = targeted intraoperative radiation therapy.

See this image and copyright information in PMC

Comment in

In Regard to Vaidya et al.
Wazer DE, Hepel JT, Riker AI, Harness JK, Chung C, Khan AJ, Offersen BV, Poortmans P, Taghian A. Wazer DE, et al. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):952-953. doi: 10.1016/j.ijrobp.2015.05.032. Epub 2015 Jul 14. Int J Radiat Oncol Biol Phys. 2015. PMID: 26194662 No abstract available.
In Regard to Vaidya et al.
Haviland JS, Bliss JM, Bentzen SM, Cuzick J. Haviland JS, et al. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):954-955. doi: 10.1016/j.ijrobp.2015.05.026. Epub 2015 Jul 14. Int J Radiat Oncol Biol Phys. 2015. PMID: 26194664 No abstract available.
In Regard to Vaidya et al.
Kirby A, Hanna G, Wilcox M, MacKenzie M. Kirby A, et al. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):957-958. doi: 10.1016/j.ijrobp.2015.05.027. Epub 2015 Jul 14. Int J Radiat Oncol Biol Phys. 2015. PMID: 26194666 No abstract available.
In Regard to Vaidya et al.
Yarnold J, Bentzen SM. Yarnold J, et al. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):958-959. doi: 10.1016/j.ijrobp.2015.05.033. Epub 2015 Jul 14. Int J Radiat Oncol Biol Phys. 2015. PMID: 26194668 No abstract available.
In Regard to Vaidya et al.
Kaidar-Person O, Wygoda M, Symon Z, Corn BW, Kuten A. Kaidar-Person O, et al. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):959-960. doi: 10.1016/j.ijrobp.2015.05.028. Epub 2015 Jul 14. Int J Radiat Oncol Biol Phys. 2015. PMID: 26194669 No abstract available.
In Regard to Vaidya et al.
Meattini I, Boersma L, Livi L, Kirkove C, Gabryś D, Somaiah N, Remouchamps V, Elkhuizen PHM, Kirova Y, Rivera S. Meattini I, et al. Int J Radiat Oncol Biol Phys. 2015 Aug 1;92(5):960-961. doi: 10.1016/j.ijrobp.2015.05.030. Epub 2015 Jul 14. Int J Radiat Oncol Biol Phys. 2015. PMID: 26194670 No abstract available.

Comment on

A flawed study should not define a new standard of care.
Hepel J, Wazer DE. Hepel J, et al. Int J Radiat Oncol Biol Phys. 2015 Feb 1;91(2):255-7. doi: 10.1016/j.ijrobp.2014.09.019. Int J Radiat Oncol Biol Phys. 2015. PMID: 25636752 No abstract available.

References

1. Vaidya J.S., Wenz F., Bulsara M. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet. 2014;383:603–613. - PubMed
1. Vaidya J.S., Wenz F., Bulsara M. Radiotherapy for breast cancer, the TARGIT-A trial - Authors' reply. Lancet. 2014;383:1719–1720. - PubMed
1. Hepel J., Wazer D.E. A flawed study should not define a new standard of care. Int J Radiat Oncol Biol Phys. 2015;91:255–257. - PubMed
1. Lamont E.B., Herndon J.E., 2nd, Weeks J.C. Measuring disease-free survival and cancer relapse using Medicare claims from CALGB breast cancer trial participants (companion to 9344) J Natl Cancer Inst. 2006;98:1335–1338. - PMC - PubMed
1. United States Department of Health and Human Services FDA. Guidance for industry: Clinical trial endpoints for the approval of cancer drugs and biologics. May 2007.

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Pride, Prejudice, or Science: Attitudes Towards the Results of the TARGIT-A Trial of Targeted Intraoperative Radiation Therapy for Breast Cancer

Affiliations

Pride, Prejudice, or Science: Attitudes Towards the Results of the TARGIT-A Trial of Targeted Intraoperative Radiation Therapy for Breast Cancer

Authors

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References

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Full Text Sources

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