Final results from the phase 3 TH3RESA study
At the San Antonio Breast Cancer Symposium held in December 2015, final results from the TH3RESA trial were presented. The trial showed that women with metastatic HER2-positive (HER2+) breast cancer who were treated with Kadcyla (T-DM1) compared with a treatment chosen by their doctor experienced improved overall survival (median overall survival of 22.7 months compared to 15.6 months). This confirms positive interim study findings.
TH3RESA was an international study, which involved 602 women affected by HER2-positive (HER2+) breast cancer who were recruited to participate between September 2011 and November 2012.
If you are interested in learning more about Kadcyla, you may like to speak to your medical oncologist.
- For more information about the TH3RESA trial, please see the Journal of Cancer Research.
In July 2015, BCNA welcomed the listing of Kadcyla on the Pharmaceutical benefits Scheme. For more information, please see BCNA’s News item, ‘New drugs on PBS from today’.
Source: Wildiers, H. et al. (2016). ‘Abstract S5-05: Trastuzumab emtansine improves overall survival versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer: Final overall survival results from the phase 3 TH3RESA study’, The Journal of Cancer Research, doi: 10.1158/1538-7445.SABCS15-S5-05.
BCNA’s Survey Report - The support and information needs of women with secondary breast cancer
One of BCNA’s strategic priorities for 2014 to 2016 is to focus on supporting the complex and specific needs of women with secondary breast cancer.
In August 2014, BCNA undertook research with Australians living with secondary breast cancer to better understand the needs and challenges faced by women with secondary breast cancer. As part of this project, we developed an online survey to identify the unmet financial, practical, information and supportive care needs of women living with secondary breast cancer in Australia.
In total, 579 women and 3 men diagnosed with secondary breast cancer responded to the survey. Those who responded lived in all states and territories. Fifty-nine per cent of participants (328) lived in a metropolitan area and forty-one per cent (228) lived in a regional, rural or remote area.
Key findings of the research were:
- 27% (370) experienced secondary breast cancer as their first diagnosis of breast cancer
- 60% (351) indicated they had experienced financial difficulty in the previous week due to their secondary breast cancer
- 31% (182) reported a change for the worse in their working role
- 34% (260) had not seen a breast care nurse since being diagnosed with secondary breast cancer
- 29% (169) reported not receiving enough emotional support from their treatment team
- When discussing strategies they used to cope with their diagnosis and keep themselves well, many women talked about exercise, socialising with family and friends, participating in hobbies, sleeping and eating well and reducing overall stress
- Participants indicated that their highest unmet needs related to:
- fears about the cancer spreading further
- lack of energy / tiredness
- uncertainty about the future.
Based on the research findings, BCNA has developed a number of key recommendations and research priorities to help support women diagnosed with secondary breast cancer and their families. It is hoped that the findings and recommendations will contribute to greater awareness of the experiences and unmet needs of women living with secondary breast cancer and be translated into improvements in treatment, care and support for women and their families.
- For more information, please download BCNA’s report, The support and information needs of women with secondary breast cancer.
Source: D Spence, L Morstyn, & K Wells, The support and information needs of women with secondary breast cancer, Breast Cancer Network Australia, 2015.
New drug palbociclib (Ibrance) receives accelerated approval in U.S. for treatment of women with secondary breast cancer
Results from the international phase II randomised control trial PALOMA-1/TRIO-18 have shown that postmenopausal women with oestrogen-receptor-positive, HER2-negative secondary breast cancer who were treated with palbociclib in combination with letrozole (Femara) had a median progression-free survival of 20.2 months, compared with a median progression-free survival of 10.2 months for women receiving letrozole only.
PALOMA-1/TRIO-18 was an international team study which involved 50 treatment centres in 12 countries. A total of 165 women were randomly assigned to receive palbociclib plus letrozole (84 women) or letrozole alone (81 women).
The most common side effects for women receiving palbociclib plus letrozole were neutropenia (reduction in white blood cells), leucopenia (a reduction in red blood cells) and fatigue.
Based on the results of this phase II clinical trial, the U.S. Food and Drug Administration granted accelerated approval for palbociclib to treat women with secondary breast cancer in February 2015.
The phase III clinical trial, ‘A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole for 1st Line Treatment of Postmenopausal Women with ER+/HER2- Advanced Breast Cancer’ (PALOMA-2), is currently underway in Australia, but it is fully recruited and not taking new participants. There are a number of Australian treatment centres running the trial.
If would like more information about your individual situation, please speak to your medical oncologist.
- For more information on this study, please visit The Lance Oncology website.
- To read the U.S. Food and Drug Administration (FDA) media release about the approval of Ibrance, please visit the FDA’s website.
Pertuzumab (Perjeta) found to have potential for some women living with HER2-positive secondary breast cancer
At the European Society for Medical Oncology’s 2014 meeting, final results from the CLEOPATRA trial were presented. The results show that women with secondary HER2-positive (HER2+) breast cancer who were treated with Perjeta in combination with Herceptin and the chemotherapy drug docetaxel had a median improved overall survival increase of 15.7 months, when compared with women who received a placebo, Herceptin and docetaxel.
CLEOPATRA was an international study which involved 204 treatment centres in 25 countries. In July 2012, those in the trial who were still receiving the placebo were given the option of receiving Perjeta instead.
- For more information on this study, please visit the European Society for Medical Oncology website.
In Australia, Perjeta is not currently listed on the Pharmaceutical Benefits Scheme (PBS), but is being considered by the Pharmaceutical Benefits Advisory Committee (PBAC). A patient access program is being offered by the pharmaceutical company that manufactures it.
BCNA has and will continue to advocate for the addition of Perjeta to the PBS.
Perjeta will not be suitable for all women with secondary breast cancer. If would like more information, please speak to your medical oncologist about your individual situation.
Effects of medical qigong on the physical wellbeing and quality of life of women living with secondary breast cancer
Researchers have conducted a small study investigating the impact of medical qigong on Australian women living with secondary breast cancer. Medical qigong involves gentle exercise, as well as meditation and breathing relaxation techniques.
Twenty-seven women with secondary breast cancer from three Sydney hospitals took part in the study. The participants were randomly assigned to a group receiving standard medical treatment as well as a 10 week medical qigong program, or a group receiving standard medical treatment and a 10 week meditation program run by the hospitals.
The researchers asked participants to complete questionnaires at the beginning of the study, in week five and at the end of week 10. They measured women’s quality of life, stress levels, fatigue and sexual wellbeing.
The researchers did not find significant differences in the overall quality of life, fatigue, stress levels or sexual wellbeing of the women in the two groups. However, they did find that the women receiving medical qigong had fewer neuropathy symptoms than the women who did not receive medical qigong. Neuropathy refers to pain, numbness, tingling or weakness due to damage to the nerves of the peripheral nervous system, and can be related to chemotherapy.
The researchers concluded that medical qigong may have the potential to reduce cancer-related neuropathy and they suggest that a larger study of medical qigong be conducted with women living with secondary breast cancer. They also note that the women participating in the medical qigong program did not report any adverse effects, indicating that a clinical trial exploring the impact of medical qigong on women with secondary breast cancer would be safe.
- For more information, please visit the International Journal of Physical Medicine & Rehabilitation website to view the study's abstract.
Providing palliative care services to women living with secondary breast cancer and their carers can improve carers’ sense of wellbeing
Researchers in the U.S. conducted a study of 207 people living with advanced cancer and 122 of their caregivers. The researchers explored whether a telephone-based palliative care program for people diagnosed with advanced cancers and their carers may have a positive impact on caregivers’ quality of life. The palliative care program aimed to help people with advanced cancers manage their symptoms, as well as improve mood and quality of life for those with cancer and their caregivers.
Participants and their caregivers were randomly allocated to a group receiving the phone-based program immediately or a group receiving the program 12 weeks after the initial group received the program.
The study found that caregivers who were part of the group immediately receiving the palliative care program had lower rates of depression and a better quality of life. The researchers conclude that providing palliative care as early as possible for people living with advanced cancers and their caregivers can have benefits for caregiver’s wellbeing and quality of life.
While the research was not specific to women living with secondary breast cancer, it may have relevance for women diagnosed with secondary breast cancer and their loved ones.
- For more information on this study, please visit the Abstracts Library for the 2014 ASCO Annual Meeting.
Less frequent treatment with Zometa just as effective as treatment every month
Results from a clinical trial presented at the recent American Society of Clinical Oncology (ASCO) meeting suggest that women with secondary breast cancer in the bone can have fewer Zometa (zoledronic acid) treatments.
Zometa is a bone-strengthening medication used to treat women with secondary breast cancer in the bone to reduce the risk for complications such as bone fracture and spinal cord compression.
The OPTIMIZE-2 clinical trial compared treatment with Zometa every month with treatment every three months.
The researchers recruited 403 women, all of whom were diagnosed with secondary breast cancer in the bone. The women were randomly selected to receive Zometa either
- every 4 weeks for 1 year or
- every 12 weeks for 1 year.
After an average follow-up period of 11.9 months the researchers found that both treatment groups had a similar rate of bone-related complications:
- 22 per cent of women who received treatment every 4 weeks
- 23.2 per cent of women who received treatment every 12 weeks.
The researchers conclude that less frequent treatment with Zometa is just as effective as treatment every month.
To read the study abstract, visit the ASCO website.
Afinitor prolongs progression-free survival in HER2-positive secondary breast cancer
An international phase 3 clinical trial has investigated the effectiveness of Afinitor (everolimus) in women with HER2-positive secondary breast cancer.
Afinitor is a drug for women with hormone positive secondary breast cancer, where the cancer no longer responds to hormone therapy.
In this study, the researchers wanted to determine whether Afinitor would also benefit women with HER2-positive secondary breast cancer, where the cancer no longer responds to Herceptin (trastuzumab).
For the study, 569 women were recruited between 2009 and 2012. Each woman had been diagnosed with HER2-positive, Herceptin-resistant secondary breast cancer, and had previously received taxane chemotherapy.
Women in the study were randomly assigned to receive one of two drug combinations:
- Afinitor, Herceptin and Navelbine (a chemotherapy) or
- Placebo, Herceptin and Navelbine
The researchers then assessed progression-free survival in each woman after an average follow-up period of 20.2 months. The average progression-free survival period was found to be 7 months in women treated with Afinitor and 5.78 months in women treated with the placebo.
The most common side effects included:
- neutropenia (73 per cent of women on Afinitor vs 62 per cent in the placebo group)
- leucopenia, or the reduction in leukocyte white blood cells (38 per cent vs 29 per cent)
- anaemia, or a reduction in red blood cells (19 per cent vs 6 per cent)
- febrile neutropenia (16 per cent vs 4 per cent)
- stomatitis, or mouth sores (13 per cent vs 1 per cent)
- fatigue (12 per cent vs 4 per cent).
The researchers conclude that the addition of Afinitor to existing Herceptin treatment significantly prolongs progression-free survival in women with Herceptin-resistant HER2-positive secondary breast cancer who have been previously treated with a taxane chemotherapy. Overall survival follow-up in this study is still in progress.
- More information about this research can be found on the Lancet Oncology website.
More than one third of women with secondary breast cancer experience pain
More than one third of women living with secondary breast cancer report experiencing high levels of pain, according to a recent UK-based study.
Researchers recruited 235 women diagnosed with secondary breast cancer, and asked them to complete a questionnaire. Women ranged from 25 – 84 years, with an average age of 58.
The study results highlighted that side effect burden was a significant problem, with 81 women (34.5 per cent) reporting high levels of pain. Those women with only bone metastases were more likely to report significant pain (33 of 75, 44 per cent) than women with other metastases sites (48 of 158, 30.4 per cent).
Other findings relating to physical quality of life:
- Significant lack of energy reported by 89 women (37.9 per cent)
- Nausea reported by 62 women (26.4 per cent)
- Shortness of breath reported by 63 women (26.8 per cent)
- No relationship was found between time since diagnosis of secondary breast cancer and side effect burden.
The researchers note that uncontrolled side effects may be a problem for women, and that they do not necessarily worsen with disease progression.
More information about this study can be found on the Journal of Pain and Symptom Management website.
Combination chemotherapy no better than sequential chemotherapy
Combination chemotherapy (more than one chemotherapy drug at once) does not provide an overall survival benefit to women with secondary breast cancer compared with sequential chemotherapy (one chemotherapy drug at a time), according to an Australian Cochrane review.
A ‘Cochrane Review’ involves an analysis of the latest research on a particular topic to help people make evidence-based decisions about health care.
The aim of the review was to understand whether there was a difference in overall survival for women diagnosed with breast cancer based on whether they received combination chemotherapy or sequential chemotherapy.
Twelve clinical trials including more than 2,300 women with secondary breast cancer were included in the review.
After reviewing the evidence, researchers found that:
- overall survival was the same in women regardless of whether they received combination or sequential chemotherapy
- the risk of febrile neutropenia was 32 per cent higher with combination therapy
- there was no difference in rates of nausea or vomiting between the two groups.
One of the study authors, Associate Professor Nicholas Wilcken, Director of Medical Oncology at Westmead Hospital, said there had been a trend towards sequential chemotherapy, and this review was the first to show that it was both safe and effective.
The results of the review were presented at the recent Advanced Breast Cancer Consensus Guidelines Conference in Lisbon, Portugal.
To read the plain language summary of the review, visit the Cochrane Library website.
Information needs of women with secondary breast cancer
A small American study has investigated the information needs of women diagnosed with secondary breast cancer, and whether their medical oncologists are meeting this need.
Fifty-nine women diagnosed with secondary breast cancer were included in the study. Women were asked to pre-prepare questions to ask their medical oncologist during their next medical consultation.
Researchers analysed the types of questions women wanted to ask their medical oncologists, and the responses that the oncologists gave.
The women in the study most often asked about:
- clinical trials (43 women; 72 per cent)
- prognosis (38 women; 64 per cent)
- quality of life (38 women; 64 per cent)
- side effect management (31 women; 52 per cent)
Medical oncologists answered questions about:
- side effect management (81 per cent of the time)
- clinical trials (79 per cent of the time)
- quality of life (66 percent of the time)
- prognosis (37 per cent of the time).
The researchers note that while women frequently asked questions about prognosis, medical oncologists infrequently discussed it. The researchers conclude that oncologists may benefit from training in communicating prognosis and end of life information to women diagnosed with secondary breast cancer.
For more information, visit the PubMed website.