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Effect of screening by clinical breast examination on breast cancer incidence and mortality after 20 years: prospective, cluster randomised controlled trial in Mumbai

BMJ (Online), 2021-02, Vol.372, p.n256-n256 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ. ;Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ. ;2021 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ. BMJ This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ. 2021 BMJ ;ISSN: 1756-1833 ;ISSN: 0959-8138 ;EISSN: 1756-1833 ;DOI: 10.1136/bmj.n256 ;PMID: 33627312

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  • Title:
    Effect of screening by clinical breast examination on breast cancer incidence and mortality after 20 years: prospective, cluster randomised controlled trial in Mumbai
  • Author: Mittra, Indraneel ; Mishra, Gauravi A ; Dikshit, Rajesh P ; Gupta, Subhadra ; Kulkarni, Vasundhara Y ; Shaikh, Heena Kauser A ; Shastri, Surendra S ; Hawaldar, Rohini ; Gupta, Sudeep ; Pramesh, C S ; Badwe, Rajendra A
  • Subjects: Adult ; Age ; Age Factors ; Breast cancer ; Breast Neoplasms - diagnosis ; Breast Neoplasms - mortality ; Cancer screening ; Cervical cancer ; Clinical trials ; Cluster Analysis ; Diagnosis ; Early Detection of Cancer ; Female ; Follow-Up Studies ; Health insurance ; Humans ; Incidence ; India ; Low income groups ; Mammography ; Medical personnel ; Middle Aged ; Mortality ; Neoplasm Staging ; Outcome Assessment, Health Care ; Population studies ; Prospective Studies ; Roads & highways ; Social workers ; Software ; Statistical analysis ; Surveillance ; Survival Rate ; Time Factors ; Womens health
  • Is Part Of: BMJ (Online), 2021-02, Vol.372, p.n256-n256
  • Description: AbstractObjectiveTo test the efficacy of screening by clinical breast examination in downstaging breast cancer at diagnosis and in reducing mortality from the disease, when compared with no screening.DesignProspective, cluster randomised controlled trial.Setting20 geographically distinct clusters located in Mumbai, India, randomly allocated to 10 screening and 10 control clusters; total trial duration was 20 years (recruitment began in May 1998; database locked in March 2019 for analysis).Participants151 538 women aged 35-64 with no history of breast cancer.InterventionsWomen in the screening arm (n=75 360) received four 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. Women in the control arm (n=76 178) received one round of cancer awareness followed by eight rounds of active surveillance every two years.Main outcome measuresDownstaging of breast cancer at diagnosis and reduction in mortality from breast cancer.ResultsBreast cancer was detected at an earlier age in the screening group than in the control group (age 55.18 (standard deviation 9.10) v 56.50 (9.10); P=0.01), with a significant reduction in the proportion of women with stage III or IV disease (37% (n=220) v 47% (n=271), P=0.001). A non-significant 15% reduction in breast cancer mortality was observed in the screening arm versus control arm in the overall study population (age 35-64; 20.82 deaths per 100 000 person years (95% confidence interval 18.25 to 23.97) v 24.62 (21.71 to 28.04); rate ratio 0.85 (95% confidence interval 0.71 to 1.01); P=0.07). However, a post hoc subset analysis showed nearly 30% relative reduction in breast cancer mortality in women aged 50 and older (24.62 (20.62 to 29.76) v 34.68 (27.54 to 44.37); 0.71 (0.54 to 0.94); P=0.02), but no significant reduction in women younger than 50 (19.53 (17.24 to 22.29) v 21.03 (18.97 to 23.44); 0.93 (0.79 to 1.09); P=0.37). A 5% reduction in all cause mortality was seen in the screening arm versus the control arm, but it was not statistically significant (rate ratio 0.95 (95% confidence interval 0.81 to 1.10); P=0.49).ConclusionsThese results indicate that clinical breast examination conducted every two years by primary health workers significantly downstaged breast cancer at diagnosis and led to a non-significant 15% reduction in breast cancer mortality overall (but a significant reduction of nearly 30%in mortality in women aged ≥50). No significant reduction in mortality was seen in women younger than 50 years. Clinical breast examination should be considered for breast cancer screening in low and middle income countries.Trial registrationClinical Trials Registry of India CTRI/2010/091/001205; ClinicalTrials.gov NCT00632047.
  • Publisher: England: BMJ Publishing Group LTD
  • Language: English
  • Identifier: ISSN: 1756-1833
    ISSN: 0959-8138
    EISSN: 1756-1833
    DOI: 10.1136/bmj.n256
    PMID: 33627312
  • Source: BMJ Open Access Journals
    MEDLINE
    ProQuest Central
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