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Hormone maintenance therapy improves LGSC survival

Hormone maintenance therapy may significantly improve survival in women with low-grade serous carcinoma (LGSC).

For women with a rare sub-type of epithelial ovarian or peritoneum cancer, known as low-grade serous carcinoma (LGSC), hormone maintenance therapy (HMT) may significantly improve survival, according to a new study from researchers at the University of Texas MD Anderson Cancer Centre.

The research has been updated since it was first presented at the 2016 Annual Meeting of the American Society of Clinical Oncology.

According to the researchers, LGSC accounts for just 10% of serous carcinomas of the ovary/peritoneum. It is typically diagnosed in women, as early as in their 40s and 50s (however, teenagers and women in their 20s and 30s also may be diagnosed). Patients usually present with advanced disease.

MD Anderson has a long history of discovery in this field of rare ovarian cancer – publishing a study in 2004 that changed the way serous carcinomas were graded and thereby identifying LGSC. MD Anderson research also showed that LGSC is relatively chemo-resistant compared with high-grade serous carcinoma, said Dr David M Gershenson, professor, gynaecologic oncology and reproductive medicine.

Should this new retrospective data be validated in a randomized study, the findings could one day represent a significant improvement to frontline standard of care.
"There is a true unmet need for these patients – roughly 70% of women with this disease will experience a recurrence of the cancer at some point," said Gershenson, the study's corresponding author. "Our group published research demonstrating that hormonal therapy showed promise in the recurrent setting, with most patients responding or having stable disease. It was a natural progression over time that we began to study this up front, after women received their primary chemotherapy."

In this retrospective cohort study, researchers analysed data from 203 women with Stage II-IV LGSC treated at MD Anderson between 1981 and 2013 to evaluate the effect of HMT, compared with surveillance, after surgery and chemotherapy. Women who received HMT (70 patients) showed an average progression-free survival (PFS) of 64.9 months compared with 26.4 months for those in the surveillance group (133 patients). Overall survival (OS) was 115.7 months following HMT, versus 102.7 months for the surveillance group.

Further, among 149 women who showed no evidence of disease following completion of primary chemotherapy, HMT appears to have resulted in even greater survival: 81.1 vs 30 months PFS; and 191.3 vs 106.8 months OS.

"Hormonal therapy has shown promising results in reducing cancer recurrence, and there is increasing interest in integrating this approach into first-line therapy," said Gershenson. "If confirmatory research in a clinical trial setting shows hormonal maintenance therapy can prevent or delay recurrence of this cancer sub-type, it would be practice changing."

Though recruitment for this patient population is challenging given the rarity of the disease, Gershenson noted that a prospective international Phase III clinical trial has been designed. The study will compare: chemotherapy and observation; chemotherapy and HMT; and hormonal therapy alone, which also has shown early promise in other studies.

Purpose: The purpose of this study was to examine outcomes associated with hormonal maintenance therapy (HMT) compared with routine observation (OBS) after primary cytoreductive surgery and platinum-based chemotherapy in women with stage II to IV low-grade serous carcinoma of the ovary or peritoneum.
Patients and Methods
Eligibility criteria for patients from our database were: treatment with primary surgery followed by platinum-based chemotherapy, stage II to IV disease, at least 2 years of follow-up for patients who had not experienced recurrence, and adequate clinical information. The two groups were compared for progression-free survival (PFS) and overall survival, and a multivariable Cox regression analysis was performed. Subset analyses for patients who were disease free or had persistent disease were also performed.
Results: Between 1981 and 2013, 203 eligible patients—133 who underwent OBS and 70 who received HMT—were seen at our institution. Median PFS for patients who underwent OBS was 26.4 months, compared with 64.9 months for those who received HMT (P < .001). No statistically significant difference in overall survival was observed between the two groups (102.7 v 115.7 months, respectively). For subgroups of women who were disease free or had persistent disease, median PFS was superior for those who received HMT (81.1 v 30.0 months; P < .001 and 38.1 v 15.2 months; P < .001, respectively). Women who received HMT had a significantly lower risk of disease progression compared with those who underwent OBS (hazard ratio, 0.44; 95% CI, 0.31 to 0.64; P < .001).
Conclusion: Women with stage II to IV low-grade serous carcinoma who received HMT after primary treatment had significantly longer PFS compared with women who underwent OBS. These findings warrant further investigation using a prospective trial design.

David M Gershenson, Diane C Bodurka, Robert L Coleman, Karen H Lu, Anais Malpica, Charlotte C Sun

[link url=""]University of Texas MD Anderson Cancer Centre material[/link]
[link url=""]Journal of Clinical Oncology abstract[/link]

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