Radiotherapy after breast removal: 20-year results of 22 trials

Overview

EBCTCG; McGale P et al.. Lancet 2014 · PMID 24656685 · DOI 10.1016/S0140-6736(14)60488-8

In women with cancer in the lymph nodes, radiotherapy prevented about 1 in 10 recurrences and about 1 in 12 breast-cancer deaths; in low-risk women with old techniques it did more harm than good.

Does the study support the specific claim? No · Methodological quality: high

Original publication

Plain-language summary

Scientific in-depth review

1. Full reference

Authors

EBCTCG; McGale P et al.

Journal

Lancet

Year

2014

Identifier

PMID 24656685 DOI 10.1016/S0140-6736(14)60488-8

Verification

verified – PubMed efetch 2026-10-26 (PublicationType and CommentsCorrections checked); Crossref 2026-10-26

Retracted

no

Corrections

ErratumIn Lancet 2014;384(9957):1848 (PubMed); Crossref erratum 10.1016/s0140-6736(14)62245-5; no retraction

Extent checked

full text

Conflicts of interest and funding

Cancer Research UK, British Heart Foundation, UK Medical Research Council; authors declare no competing interests.

2. Research question

Does radiotherapy after mastectomy and axillary dissection reduce recurrence and breast cancer mortality, by nodal status?

3. Study design and population

Study design

Meta-analysis – Individual-patient-data meta-analysis of 22 randomised trials (1964-86) of postmastectomy radiotherapy vs none

Population

Women after mastectomy and axillary surgery in randomised trials

Country

International

Period

Randomisation 1964-86; mortality follow-up to 1 Jan 2009 (up to 20 years)

Sample size

8135 women (3786 with axillary dissection and known nodal status in the main analyses)

Inclusion and exclusion criteria

Trials beginning before 2000 comparing radiotherapy to chest wall and regional nodes vs no radiotherapy with the same surgery

4. Methods and endpoints

Exposure / intervention

Radiotherapy to chest wall, supraclavicular/axillary fossa and (in 20/22 trials) internal mammary chain

Comparator

Same surgery, no radiotherapy

Endpoints

10-year locoregional and overall recurrence; 20-year breast cancer mortality; overall mortality

Statistical methods

Stratified log-rank rate ratios; deaths of unknown cause before recurrence counted as non-breast-cancer deaths

5. Actual results

Results

pN1-3 (n=1314): overall recurrence RR 0.68 (0.57-0.82), breast cancer mortality RR 0.80 (0.67-0.95); with systemic therapy (n=1133) RR 0.67 and 0.78. pN4+ (n=1772): recurrence RR 0.79 (0.69-0.90), breast cancer mortality RR 0.87 (0.77-0.99). All pN+ after axillary dissection (n=3131): 10-year recurrence 62.5% vs 51.9%, 20-year breast cancer mortality 66.4% vs 58.3%, overall mortality RR 0.89 (0.81-0.97). pN0 after axillary dissection (n=700): no effect on recurrence (RR 1.06, 0.76-1.48) or breast cancer mortality (RR 1.18, 0.89-1.55), but overall mortality increased (RR 1.23, 1.02-1.49).

Absolute risks

pN+: recurrence -10.6 and breast-cancer death -8.1 percentage points; pN1-3: recurrence 45.7% -> 34.2% (-11.5), 20-year breast-cancer death -7.9 points

Authors' conclusion

Radiotherapy after mastectomy and axillary dissection reduced recurrence and breast cancer mortality in women with one to three positive nodes, even with systemic therapy. Absolute gains today may be smaller because baseline risks are lower; proportional gains may be larger and risks lower with modern techniques.

6. Strengths

• Individual patient data, long follow-up (20 years)
• Randomised comparisons by nodal status
• Reports harm signal in low-risk women

7. Weaknesses

• Old trials (1964-86) with outdated radiotherapy techniques and higher heart doses
• Systemic therapy mostly CMF
• Nodal staging less accurate than today
• Subgroup analyses by nodal status

8. Risk of bias

Orienting tool

AMSTAR 2

Type of assessment

simplified assessment (abstract only)

Full formal assessment

no

Overall risk of bias

low

Rationale

IPD meta-analysis; main concern is applicability (old techniques), not internal bias.

9. Assessment of the statistical interpretation

Absolute benefits recomputed: NNT about 9 to prevent one recurrence and about 12 to prevent one breast cancer death at 20 years in node-positive women (stats/C-CHM-09_benefit_harm.py). The pN0 overall-mortality excess shows that old-technique radiotherapy caused net harm in low-risk women.

10. Relevance to the specific claim

Shows both the survival benefit of radiotherapy in node-positive disease and net harm in low-risk node-negative women (old techniques), which is why guidelines restrict radiotherapy to women with meaningful recurrence risk.

11. Independent contrary findings

Modern lower-dose techniques reduce harms (I-CHM-06); current baseline risks lower (authors).

12. Transferability to Germany and Europe

Applicable with caution: modern European/Egyptian radiotherapy uses lower heart doses; proportional effects transferable.

13. Overall methodological judgement

Strong randomised evidence of benefit when risk is substantial, and of harm when risk is low: benefit depends on indication.

14. Open questions

Size of absolute benefit with modern systemic therapy and radiotherapy techniques.

15. Linked fact checks

• The archive's 19 chemo/radiation studies are presented on the homepage as 'scientific studies confirming what Dr. Diaa proposed'; the harm-only study selection implies that the harms of chemotherapy and radiotherapy outweigh their benefits. – Studies contradicting or limiting the claim
• Chemotherapy and tumour-removal surgery do not address root causes; the body will reactivate its 'defensive plan' elsewhere, so these treatments should be avoided. – Studies contradicting or limiting the claim
• Cancer patients should not take chemotherapy, radiotherapy or biological therapy (or should stop them) and follow the Tayebat system instead; 'we are against the word medicine'. – Studies contradicting or limiting the claim