PURPOSE: In premenopausal women with metastatic hormone receptor-positive breast cancer, hormonal therapy is the first-line therapy. Gonadotropin-releasing hormone analogue + tamoxifen therapies have been found to be more effective. The pattern of recurrence risk over time after primary surgery suggests that peri-operative factors impact recurrence. Secondary analyses of an adjuvant trial suggested that the luteal phase timing of surgical oophorectomy in the menstrual cycle simultaneous with primary breast surgery favourably influenced long-term outcomes.
METHODS: Two hundred forty-nine premenopausal women with incurable or metastatic hormone receptor-positive breast cancer entered a trial in which they were randomised to historical mid-luteal or mid-follicular phase surgical oophorectomy followed by oral tamoxifen treatment. Kaplan-Meier methods, the log-rank test, and multivariable Cox regression models were used to assess overall and progression-free survival (PFS) in the two randomised groups and by hormone-confirmed menstrual cycle phase.
RESULTS: Overall survival (OS) and PFS were not demonstrated to be different in the two randomised groups. In a secondary analysis, OS appeared worse in luteal phase surgery patients with progesterone levels <2 ng/ml (anovulatory patients; adjusted hazard ratio 1.46, 95% confidence interval [CI]: 0.89-2.41, p = 0.14) compared with those in luteal phase with progesterone level of 2 ng/ml or higher. Median OS was 2 years (95% CI: 1.7-2.3) and OS at 4 years was 26%.
CONCLUSIONS: The history-based timing of surgical oophorectomy in the menstrual cycle did not influence outcomes in this trial of metastatic patients. ClinicalTrials.gov number NCT00293540.
Study site: Bangladesh, The Philippines, China, Nigeria,
Indonesia, Malaysia, Taiwan, Morocco, and Vietnam
The incidence and mortality of breast cancer continues to rise rapidly in Asian countries. However, most of our current knowledge on breast cancer has been generated in Western populations. As the socio-economic profile, life style and culture of Asian and Western women are substantially different, and genetic backgrounds vary to some extent, we need to answer the question on whether to 'adopt' or 'adapt' Western knowledge before applying it in the Asian setting. It is generally accepted that breast cancer risk factors, which have mainly been studied in Western populations are similar worldwide. However, the presence of gene-environment or gene-gene interactions may alter their importance as causal factors across populations. Diagnostic and prognostic study findings, including breast cancer prediction rules, are increasingly shown to be 'setting specific' and must therefore be validated in Asian women before implementing them in clinical care in Asia. Interventional research findings from Caucasian patients may not be applicable in patients in Asia due to differences in tumour biology/profiles, metabolism of drugs and also health beliefs which can influence treatment acceptance and adherence. While breast cancer research in Asia is warranted in all domains of medical research, it is felt that for Asian breast cancer patients, needs are highest for diagnostic and prognostic studies. International clinical trials meanwhile need to include breast cancer patients from various Asian settings to provide an insight into the effectiveness of new treatment modalities in this part of the world.
Adjuvant! Online is a free web-based tool which predicts 10-year breast cancer outcomes and the efficacy of adjuvant therapy in patients with breast cancer. As its prognostic performance has only been validated in high income Caucasian populations, we validated the model in a middle income Asian setting.
Worldwide, prices for cancer drugs have been under downward pressure where several governments have mandated price cuts of branded products. A better alternative to government mandated price cuts would be to estimate a final price based on drug performance, cost effectiveness and a country's ability to pay. We developed a global pricing index for new cancer drugs in patients with metastatic colorectal cancer (mCRC) that encompasses all of these attributes.
BACKGROUND: Evidence to guide policymakers in developing affordable and equitable cancer control plans are scarce in low- and middle-income countries (LMIC).
METHODS: The 2012-2014 ASEAN Costs in Oncology Study prospectively followed-up 9513 newly diagnosed cancer patients from eight LMIC in Southeast Asia for 12 months. Overall and country-specific incidence of financial catastrophe (out-of-pocket health costs ≥ 30% of annual household income), economic hardship (inability to make necessary household payments), poverty (living below national poverty line), and all-cause mortality were determined. Stepwise multinomial regression was used to estimate the extent to which health insurance, cancer stage and treatment explained these outcomes.
RESULTS: The one-year incidence of mortality (12% in Malaysia to 45% in Myanmar) and financial catastrophe (24% in Thailand to 68% in Vietnam) were high. Economic hardship was reported by a third of families, including inability to pay for medicines (45%), mortgages (18%) and utilities (12%), with 28% taking personal loans, and 20% selling assets (not mutually exclusive). Out of households that initially reported incomes above the national poverty levels, 4·9% were pushed into poverty at one year. The adverse economic outcomes in this study were mainly attributed to medical costs for inpatient/outpatient care, and purchase of drugs and medical supplies. In all the countries, cancer stage largely explained the risk of adverse outcomes. Stage-stratified analysis however showed that low-income patients remained vulnerable to adverse outcomes even when diagnosed with earlier cancer stages.
CONCLUSION: The LMIC need to realign their focus on early detection of cancer and provision of affordable cancer care, while ensuring adequate financial risk protection, particularly for the poor.