Why is the 25 Gy (Gray) in 5 fractions regimen not widely used for breast cancer radiotherapy despite showing promising results?

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Why 25 Gy/5 Fractions Is Not Widely Used Despite Promising Results

The 25 Gy in 5 fractions regimen is not used because it was never tested—the actual regimen studied and proven effective was 26 Gy in 5 fractions, which IS now recommended by current guidelines and is being adopted into clinical practice. 1

The Evidence Base: What Was Actually Studied

The confusion stems from misidentifying the dose. The FAST-Forward trial, which provided the breakthrough evidence for ultra-hypofractionation, tested 26 Gy in 5 fractions (not 25 Gy) and demonstrated non-inferiority to the standard 40 Gy in 15 fractions regimen. 2, 3

Key Trial Results

  • FAST-Forward trial (2020,5-year results): With 71.5 months median follow-up, 26 Gy/5 fractions showed a 5-year ipsilateral breast tumor relapse rate of 1.4% compared to 2.1% for 40 Gy/15 fractions, with a hazard ratio of 0.67 (95% CI 0.38-1.16), meeting non-inferiority criteria (p=0.00019). 2

  • Normal tissue effects were comparable: 5-year prevalence of moderate/marked clinician-assessed breast effects was 11.9% for 26 Gy versus 9.9% for 40 Gy, with an odds ratio of 1.12 (95% CI 0.94-1.34, p=0.20)—not statistically significant. 2, 3

  • The trial also tested 27 Gy/5 fractions, which showed significantly worse cosmetic outcomes (OR 1.55, p<0.0001) and was therefore rejected. 2

Current Guideline Adoption

The 26 Gy/5 fractions regimen IS now endorsed by major guidelines:

  • ESMO 2024 guidelines explicitly state: "The FAST-Forward trial demonstrated that after 6 years' median follow-up, ultra-hypofractionation of 26 Gy in five fractions in 1 week results in the same oncological and safety outcomes for breast and chest wall irradiation." 1

  • The ESTRO Advisory Committee recommends shorter regimens whenever indicated. 1

Important Limitations on Use

The critical caveat is that this regimen is validated specifically for breast and chest wall irradiation, NOT for comprehensive locoregional radiotherapy:

  • Awaiting data: The ESMO guidelines explicitly note that "in terms of outcomes after ultra-hypofractionation for locoregional RT, data from a prospective sub-study are awaited." 1

  • Current restriction: The 26 Gy/5 fractions schedule should be used for whole breast or chest wall radiation only, not when treating regional lymph nodes comprehensively. 1

  • For patients requiring regional nodal irradiation (axillary levels, supraclavicular, internal mammary nodes), moderate hypofractionation (15-16 fractions) remains the standard until further evidence emerges. 1

Why Adoption Takes Time

Even with strong evidence, clinical practice changes gradually due to:

  • Infrastructure requirements: Implementing ultra-hypofractionation requires updated treatment planning systems, quality assurance protocols, and staff training. 3

  • Physician comfort: Many radiation oncologists are waiting for 10-year follow-up data before fully adopting the regimen, despite 5-year data showing non-inferiority. 2, 4

  • Regional variations: The FAST-Forward trial was conducted in predominantly Caucasian UK populations; validation in other populations (particularly node-positive disease requiring regional nodal radiation) is ongoing through trials like HYPORT-Adjuvant in India. 5

Clinical Algorithm for Implementation

For whole breast radiation after breast-conserving surgery (without regional nodal irradiation):

  • Use 26 Gy in 5 fractions over 1 week as a standard option, equivalent to 40 Gy in 15 fractions. 1, 2
  • Add boost doses as needed (typically 10-16 Gy) for high-risk features. 1

For post-mastectomy chest wall radiation (without regional nodes):

  • 26 Gy in 5 fractions is acceptable based on FAST-Forward data. 1, 2

For locoregional radiation including regional lymph nodes:

  • Continue using moderate hypofractionation (40 Gy in 15 fractions) until prospective sub-study data become available. 1
  • Conventional fractionation (45-50 Gy in 25-28 fractions) remains an alternative. 1

For frail patients with transportation difficulties:

  • An alternative ultra-hypofractionation regimen of 5.7-6.0 Gy once weekly over 5 weeks can be used. 1

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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