Grand Rounds

RCT Results; Does Clinical Breast Examination Lead to Earlier Breast Cancer Diagnoses in Low- and Middle-Income Countries?

BACKGROUND AND PURPOSE:

In low- and middle-income countries, breast cancer is often detected at advanced stages
Clinical breast examination (CBE) may be a good screening method in this setting
Mittra et al. (BMJ, 2021) examined the efficacy of screening by CBE in downstaging breast cancer at diagnosis and in reducing mortality

Prospective, cluster randomized controlled trial
Setting
- 20 geographically distinct clusters located in Mumbai, India over 20 years (May 1998 to March 2019)
  - 10 clusters were designated as screening clusters, and 10 as controls
Participants
- Women aged 35 to 64
- No history of breast cancer
Interventions
- Screening
  - 4 screening rounds of clinical breast examination (conducted by trained female primary health workers) and cancer awareness every two years
  - Followed by five rounds of active surveillance every two years
- Control
  - One round of cancer awareness
  - Followed by eight rounds of active surveillance every two years
Health workers who performed CBE
- Passed 10th grade education
- Training period of approximately 4 weeks
Primary outcomes
- Downstaging of breast cancer at diagnosis
- Reduction in mortality from breast cancer

Screening arm: 75,360 women | Control arm: 76,178 women
Breast cancer was detected at an earlier age in the screening group (P = 0.01)
- Screening: mean age 55.18 years
- Control: 56.50 years
There was a significant reduction in the proportion of women with stage III or IV disease in the screening group (P = 0.001)
- Screening: 37%
- Control: 47%
15% reduction in breast cancer mortality was observed in the screening arm but was non-significant (P = 0.07)
- Screening: 20.82 deaths/100,000 person years (95% CI, 18.25 to 23.97)
- Control: 24.62 (95% CI, 21.71 to 28.04)
- Rate ratio 0.85 (95% CI, 0.71 to 1.01)
There was a reduction in breast cancer mortality in women aged ≥50 on post-hoc analysis (P = 0.02)
- Screening: 24.62 deaths/100,000 person years (95% CI, 20.62 to 29.76)
- Control: 34.68 (95% CI, 27.54 to 44.37)
- Rate ratio 0.71 (95% CI, 0.54 to 0.94)
There was no significant reduction in women <50 (P = 0.37)
There was no difference in all cause mortality between groups (P = 0.49)
- Rate ratio 0.95 (95% CI, 0.81 to 1.10)
- Authors note that “because breast cancer deaths comprise less than 3% of all deaths in women in India, we did not expect a reduction in all cause mortality in our study”

Clinical breast examination led to a significant downstaging of breast cancer at diagnosis
While a 15% reduction in overall breast cancer mortality was not significant, there was a significant 30% reduction in women over 50 years of age
The authors conclude that clinical breast examination is a viable screening option for low- and middle-income countries

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