Centchroman in Fibroadenois of breast

 Attention Dr Hema Trivedi

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Abstract

Fibroadenoma is a common cause of breast lump in young girls. Nearly 10–15 % of lesions regress spontaneously over the period of 6 to 60 months. The aim of study was to investigate the role of Centchroman in regression of fibroadenoma in comparison to natural observation and to study the association of hormonal receptors with degree of regression. The study was carried out at the outpatient clinic of Department of Surgery, All India Institute of Medical Sciences, New Delhi, from November 2004 to November 2007. Patients aged ≤30 years with fibroadenoma were included. Patients with fibroadenoma equal to or larger than 5 cm and with polycystic ovarian disease were excluded. Patients were randomized in two groups. Patients in active therapy arm were prescribed Centchroman 30 mg daily for 12 weeks, and another group was observed without any intervention (control group). Patients were followed at weeks 4, 8, 12, and 24 to assess response to therapy. Twenty-two (31.88 %) fibroadenomas in Centchroman arm disappeared completely as compared to four (7.69 %) in control arm over a period of 6 months. There was a decrease in the volume of fibroadenoma in ten (19.23 %) patients in control arm and 36 (52.17 %) patients in Centchroman arm. Centchroman therapy allowed 31 % fibroadenoma to regress completely with scanty menses or amenorrhea as the only side effect.

Keywords: Fibroadenoma, Centchroman, Polycystic ovarian disease, Saheli, Hormone receptor, Antiestrogen

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Introduction

Fibroadenoma is a common cause of discrete, firm, and mobile lump in the breast in young girls between ages 15 and 25 years. It is considered an “aberration in development and involution” of ductolobular tissue in the breast and not a true neoplasm (Ref: Dupont WD, Pad FF, Hartmann WH, et al. Breast cancer risk associated with proliferative breast disease and atypical hyperplasia. Cancer. 1993;71:1258–65. doi: 10.1002/1097-)

Fibroadenoma begins as hyperplasia of the lobules from “terminal ductal lobular units” which progressively increases in size from 1 to 3. Most of them remain static, but some increase in size to more than 5 cm when they are named “giant fibroadenoma”. Multiple fibroadenomatas can occur in the same breast or bilaterally. Nearly 10–15 % of lesions regress spontaneously over the period of 6 to 60 months (Ref: Santen RJ, Mansel R. Current concepts: benign breast disorders. N Engl J Med. 2005;353:275–85. doi: 10.1056/NEJMra035692. [PubMed]

Simple fibroadenoma is usually managed by natural observation, as they are benign and asymptomatic without any risk of future cancer Complex fibroadenoma is associated with moderate risk of cancer and those associated with atypia (relative risk of >2) or family history of breast cancer should be excised

(Ref: Barton SA, Pathak DR, Black WC. Prevalence of benign, atypical and malignant breast lesion in populations at different risk of breast cancer. Cancer. 1987;60:2751–60. doi: 10.1002/1097-

Some patients prefer to have the lump excised because of pain, discomfort, psychological reasons, or fear of cancer. Hormonal manipulation has been attempted to suppress the growth of fibroadenoma with antiestrogenic drug tamoxifen as fibroadenoma is considered to arise from hyperresponsiveness of lobular tissue to estrogen . Ref: Greenblatt RB, Dmowske WP, Mhesh VB, et al. Clinical studies with an antigonadotrophin-Danazol. Fertil Steril. 1971;22:102–112. [PubMed]

Presence of estrogen receptors on tissue obtained from fibroadenoma has been described]. Hence, most of us use an antiestrogen,

Centchroman, in order to suppress the proliferation of ductolobular tissue of fibroadenoma. Centchroman (ormeloxifene) is a nonsteroidal antiestrogen drug developed by the Central Drug Research Institute, Lucknow, India, 1967 . It is a selective estrogen receptor modulator with weak agonist (on endometrium) and strong antagonist (on breast ductolobular epithelium) action. Triple assessment (clinical evaluation, ultrasound scan, and a large-core-needle biopsy under local anesthesia) were included. Large-core (Trucut) biopsy was performed to assess the histological features and to perform estrogen receptor and progesterone receptor (ER and PR) estimation.

Centchroman 30 mg daily for 12 weeks, while the control arm women were observed without any intervention. Patients purchased tablet Centchroman 30 mg (trade name Saheli; Hindustan Latex Company, Ltd., a Government of India Undertaking) from the market for Rs 2 per tablet and knew about the medicine. There was a gradual decline in volume with Centchroman till the end of treatment period, but the control group showed a progressive increase in the median volume. The volume measured by ultrasound at the end of treatment period also showed significant difference. Centchroman, an antiestrogen drug, at a dosage of 30 mg daily for 3 months allowed complete regression of 31 % fibroadenoma, whereas only 7 % of lesions regressed completely with simple observation. The drug is inexpensive (Rs 2 a day) and is well tolerated with scanty periods or delayed menses as the only side effect. Long-term results beyond 6 months need further study. Acknow: Regression of Fibroadenomas with Centchroman: a Randomized Controlled Trial

Prakash Laxmichand Tejwani, Hrishikesh Nerkar, Anita Dhar, Kamal Kataria, Smriti Hari, Sanjay Thulkar, Sunil Chumber, Sunesh Kumar, and Anurag Srivastava