Ribociclib Active Across Premenopausal Breast Cancer Subgroups


“The progression-free survival (PFS) benefit for ribociclib (Kisqali) in pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer was sustained across patient subgroups, according to findings from the phase III MONALEESA-7 trial presented at the 2018 Miami Breast Cancer Conference.

“MONALEESA-7 randomized patients to either the CDK4/6 inhibitor ribociclib in combination with tamoxifen or a nonsteroidal aromatase inhibitor (NSAI; letrozole or anastrozole) plus goserelin (n = 335), or to endocrine treatment plus goserelin (n = 337). Across the overall study population, the median PFS was 23.8 months for the ribociclib arm compared with 13.0 months for the control arm (HR, 0.553; 95% CI, 0.441-0.694; P <.0001).”

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French Trial Shows Benefit of Adding Short-Term Hormone Therapy to Salvage Radiotherapy for Rising PSA After Prostatectomy


“In the phase III GETUG-AFU 16 trial reported in The Lancet Oncology, Carrie et al found that adding short-term androgen suppression therapy to salvage radiotherapy was associated with improved biochemical or clinical progression-free survival among patients with prostate cancer who exhibited rising prostate-specific antigen (PSA) levels after radical prostatectomy.

“In the open-label trial, 743 patients from 43 sites were randomized between October 2006 and March 2010 to receive radiotherapy alone (n = 374) or with goserelin (Zoladex; n = 369). Patients had received no previous androgen-deprivation therapy or pelvic radiotherapy and had a rising PSA level of 0.2 to < 2.0 μg/L after having a level < 0.1 μg/L for at least 6 months after surgery with no evidence of clinical disease.

“Treatment consisted of three-dimensional (3D) conformal radiotherapy or intensity-modulated radiotherapy at 66 Gy in 33 fractions 5 days per week for 7 weeks or radiotherapy plus 10.8 mg of goserelin by subcutaneous injection on the first day of radiotherapy and 3 months later. The primary endpoint was progression-free survival in the intention-to-treat population.”

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Adding ADT to RT Improved PFS After Radical Prostatectomy

“Assigning men in biological relapse after radical prostatectomy to combined salvage treatment with hormone therapy and radiation therapy significantly delayed disease progression compared with radiation therapy alone, according to the results of the GETUG-AFU 16 phase III trial (abstract 5006).

“ ‘Salvage radiotherapy combined with limited androgen deprivation therapy improves the 5-year progression-free survival rate compared to radiotherapy alone,’ said study presenter Christian Carrie, MD, of the department of radiation oncology at the University of Lyon-Centre Leon Berard. ‘There is no significant difference in overall survival, but the follow-up is still too short.’

“Between October 2006 and March 2010, 743 patients were enrolled in GETUG-AFU 16 and randomly assigned to radiation therapy alone (n = 374) or radiation plus hormone therapy with goserelin 10.8 mg for 6 months (n = 369). The primary endpoint of the trial was progression-free survival.”

For Breast Cancer Patients, Goserelin during Chemotherapy Prevents Early Menopause and Preserves Fertility

“Early menopause can be prevented and fertility may be preserved in young women with early stage breast cancer, according to a study published today in The New England Journal of Medicine.

“A major international clinical trial has found that the risk of sudden onset of menopause can be significantly reduced by adding a drug called to the regimen. Women who took goserelin and wanted to have children also were more likely to get pregnant and deliver a healthy baby.

” ‘Some of the most distressing side effects of chemotherapy in young with breast cancer are early and sudden onset of menopause and infertility,’ said Kathy Albain, MD, senior author, medical oncologist and Director of Loyola University Chicago Cardinal Bernardin Cancer Center’s Breast Cancer Clinical Research Program. ‘These findings provide hope for young women with breast cancer who would like to prevent early menopause or still have children.’

“The overall purpose of goserelin is to temporarily put the ovaries ‘at rest’ during chemotherapy. ‘We found that, in addition to reducing the risk of sudden, early menopause, and all of the symptoms that go along with menopause, goserelin was very safe and may even improve survival,’ Dr. Albain said. ‘These findings are changing how we manage with breast cancer.’ “

Mixed Results for Saving Ovaries in Breast Cancer

Editor’s note: This article is about a clinical trial—a research study with volunteer patients. The trial tested whether adding a drug called triptorelin to chemotherapy might help preserve fertility in breast cancer patients. The researchers found a slight increase in pregnancies for patients who took triptorelin, but it was statistically insignificant, meaning it could have been due to chance. However, an earlier trial found more promising results for a similar drug (goserelin). Researchers are still hopeful that drugs like triptorelin and goserelin might help some women preserve fertility after breast cancer treatment.

“Women who received a luteinizing hormone-releasing hormone (LHRH) analog during chemotherapy had a nonsignificant increase in pregnancies and resumption of menstruation, a randomized trial showed.

“The addition of triptorelin to breast cancer chemotherapy did not adversely affect disease control or survival compared with chemotherapy alone, reported Matteo Lambertini, MD, of Azienda Ospedaliera Universitaria San Martino in Genova, Italy, and colleagues.

“The results mean that a previously reported significant reduction in chemotherapy-induced premature menopause in triptorelin-treated women did not translate into a significantly increased likelihood of pregnancy, they said in a presentation at the Breast Cancer Symposium.

“The use of the LHRH analog triptorelin showed a trend towards an increased probability for becoming pregnant and a trend towards an increased probability for menstrual resumption at longer follow-up, although neither finding was significant,” Lambertini said, adding that the lack of difference in 5-year disease-free survival (DFS) between the two arms was “reassuring regarding the safety of the procedure.”

New Option for Preserving Fertility in Women Being Treated With Chemotherapy for Early-Stage Breast Cancer

“One of the most reported studies emanating from the 2014 ASCO Annual Meeting involves the use of the luteinizing hormone–releasing hormone (LHRH) agonist goserelin (Zoladex) to reduce the risk of ovarian failure among women being treated with chemotherapy for early-stage breast cancer, and to increase the likelihood of a successful pregnancy afterward (see page 22).1 Network and cable television, national and regional newspapers, and international news services covered the study and what it might mean to women concerned about preserving fertility after being treated for cancer.

“In an interview with The ASCO Post, the study’s lead author, Halle Moore, MD, said that she welcomed the media coverage because ‘the more the public is aware of fertility preservation options for patients receiving chemotherapy, the more likely it is that those patients will ask their doctors about [such measures].’ Dr. Moore is a Staff Physician and Chair of the Survivorship Program at the Cleveland Clinic. The study was funded by the National Institutes of Health, and Dr. Moore was hopeful that the extensive media coverage might also help the public see ‘where our dollars are going’ and understand the importance of federally funded research.”

How Much Hormonal Therapy Is Sufficient?

A recent trial suggests that the standard duration of hormonal therapy is longer than necessary for many patients. In the study, men with localized, but high-risk prostate cancer who were treated with hormonal therapy for 18 months lived just as long as those treated for 36 months. The phase III trial was conducted at multiple hospitals in Quebec, Canada. Dr. Abdenour Nabid of Sherbrooke University Hospital Center in Sherbrooke, Quebec, is lead author of the study. He presented these results last month at the American Society of Clinical Oncology Genitourinary (ASCO GU) Symposium in Orlando, Florida. Continue reading…

Prostate Cancer Study Suggests Shorter Hormone Treatment As Good as Longer Treatment

A study of 630 high-risk localized prostate cancer patients shows 18 months of hormonal therapy is likely as good as 36 months of therapy. The results were presented at the ASCO Genitourinary Cancers Symposium press conference. The patients, followed for a median of 6.5 years will be followed up for several more years.