Out-of-pocket payments for complementary medicine following cancer and the effect on financial outcomes in middle-income countries in southeast Asia: a prospective cohort study.

BACKGROUND: Complementary medicine, which refers to therapies that are not part of conventional medicine, comprising both evidence-based and non-evidence-based interventions, is increasingly used following a diagnosis of cancer. We aimed to investigate out-of-pocket spending patterns on complementary medicine and its association with adverse financial outcomes following cancer in middle-income countries in southeast Asia. METHODS: In this prospective cohort study, data on newly diagnosed patients with cancer were derived from the ASEAN Costs in Oncology (ACTION) cohort study, a prospective longitudinal study in 47 centres located in eight countries in southeast Asia. The ACTION study measured household expenditures on complementary medicine in the immediate year after cancer diagnosis. Participants were given cost diaries at baseline to record illness-related payments that were directly incurred and not reimbursed by insurance over the 12-month period after study recruitment. We assessed incidence of financial catastrophe (out-of-pocket cancer-related costs ≥30% of annual household income), medical impoverishment (reduction in annual household income to below poverty line following subtraction of out-of-pocket cancer-related costs), and economic hardship (inability to make necessary household payments) at 1 year. FINDINGS: Between March, 2012, and September, 2013, 9513 participants were recruited into the ACTION cohort study, of whom 4754 (50·0%) participants were included in this analysis. Out-of-pocket expenditures on complementary medicine were reported by 1233 households. These payments constituted 8·6% of the annual total out-of-pocket health costs in lower-middle-income countries and 42·9% in upper-middle-income countries. Expenditures on complementary medicine significantly increased risks of financial catastrophe (adjusted odds ratio 1·52 [95% CI 1·23-1·88]) and medical impoverishment (1·75 [1·36-2·24]) at 12 months in upper-middle-income countries only. However, the risks were significantly higher for economically disadvantaged households, irrespective of country income group. INTERPRETATION: Integration of evidence-supported complementary therapies into mainstream cancer care, along with interventions to address use of non-evidence-based complementary medicine, might help alleviate any associated adverse financial impacts. FUNDING: None.

Clinico-pathologic profile and clinical outcomes of patients with indolent lymphoma at the Cancer Institute of the Philippine General Hospital: A seven-year experience

INTRODUCTION: Indolent lymphoma (IL) is a slowly growing lymphoma, generally refractory to conventional chemotherapy. There are several types of IL, which includes follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and waldenstrom macroglobulinemia/ lymphoplasmacytic lymphoma (WM/LPL). Presently, there are no known data in the Philippines on IL. This study is done to determine the clinico-pathologic profile and outcomes of Filipino patients with IL. METHODS: This study is a retrospective chart review of outpatient department cases of IL seen at the Philippine General Hospital-Cancer Institute from January 2009 to January 2016. The following were documented: age; gender; primary location; presence or absence of B symptoms; type of IL; Ann-arbor stage; prognostic indices for FL and MCL; and staging with bone marrow aspiration and whole body CT scan. Treatment intervention and clinical outcomes were documented. RESULTS: This study showed that SLL was the most common IL. Most were elderly (>40 years old); male; lacked B symptoms; limited disease; and primary location at or near the orbital area. MCL were seen in all risk groups. Follicular lymphoma (FL) were mostly low risk and had grade one histology. Majority had disease control regardless of treatment intervention. Most patients with recurrence/progression after initial treatment had limited disease but were understaged. Most of the patients were not staged with bone marrow aspiration or whole body computed tomography. CONCLUSION: The results of this study are mostly consistent with known literature on IL. Absence of B symptoms and limited disease may indicate a low-grade histology. Observation was the most common option for asymptomatic patients.  

Bevacizumab in HER2neu negative locally recurrent and metastatic breast cancer: The BHerN review

INTRODUCTION: A promising strategy for HER2-negative metastatic breast cancer (mBC) is to target the veascular endothelial growth factor receptor using bevecizumab. Several randomized controlled trials (RCTs) have consistently demonstrated improvement in progression-free survival (PFS).METHODS: This meta-analysis was undertaken to determine the added benefit of bevacizumab (BV) to chemotherapy in HER2-negative locally recurrent and mBC. RCTs that compared the efficacy and safety of BV+chemotherapy to placebo+chemotherapy in the first- or second-line setting were selected. The primary outcome was PFS. The secondary outcome measures were overall survival (OS) and objective response rate (ORR). Analysis of safety was done by pooling grades 3-5 toxicities. Four RCTs were included in the meta-analysis: E2100, AVADO, RIBBON-1, and RIBBON-2.RESULTS: The use of BV+chemotherapy showed statistically significant improvement in PFS (HR 0.73 [0.65, 0.82] 95% Cl, pCONCLUSION: BV prolongs PFS and increases ORR in patients with HER2-negative locally-recurrent and mBC. OS was comparable in both arms. Toxicities significantly increased with the addition of BV to chemotherapy, but fatal reactions were rare in all four trials. The addition of BV to conventional first- or second-line chemotherapy is justified in TN mBC since there is still no standard treatment fot this. 

Satisfaction in HER2 testing among medical oncologists- Aiming for multidisciplinary HER2 testing in the Philippines

INTRODUCTION: A multidisciplinary approach is essential to optimize patient care. In the practice of oncology, surgeons, medical oncologists, and pathologists are essential for the histology-based diagnosis of cancer patients. In breast cancer, hormone receptor and HER2 positivity are both predictive and prognostic, and so testing for these has been strongly recommended for every newly diagnosed breast cancer patient. A unique but meaningful information that can be provided by medical oncologists, as customers, is their satisfaction to the services (e.g. HER2 testing) and product (e.g. reports) of the pathology laboratory. Any quality initiative effort to improve HER2 testing can also be extended to hormone receptor (ER/PR) testing. This study measures the general satisfaction of medical oncologists practicing in Metro Manila with local HER2 testing services and reports.METHODS: This cross-sectional study had survey questionnaires distributed to medical oncologists practicing in Metro Manila chosen on the basis of their considerable experience with requesting HER2tests and with the use of anti-HER2 therapy in their management of breast carcinoma patients. Demographics, practice information, rating of satisfaction per laboratory service category, and a checklist of elements of IHC/FISH reports were collected.RESULTS: 32 medical oncologists participated in the survey, most of whom were from tertiary hospitals. Breast carcinoma cases make up around 26-50% of cancer cases in their practice. More than half request HER2 testing for their breast cancer patients. Medical oncologists are generally satisfied with the services for IHC and FISH HER2 testing (composite scores >2) provided by the laboratories. Overall, medical oncologists were very satisfied with diagnostic accuracy and completeness of relevant information in the report. Laboratory services were mostly rated good, with the exception of pathologists' responsiveness to problems and notification of equivocal results. For both IHC and FISH, patient/physician identification, date of service, specimen identification/ site/ type, results, and interpretation were reported to be included in the reports. However, time to/duration of/ type of fixation, method and image analysis method, antibody clone/ vendor, and comment that an FDA-approved method was used, were reported missing by the many.CONCLUSION: For both IHC and FISH, overall satisfaction was found to be moderately directly correlated with diagnostic accuracy. In a country like the Philippines where quality initiatives of laboratories may still be far from ideal, medical oncologists can demand inclusion of their preferences into assessments processes by laboratories and correct assumptions of laboratory managers as to what element of the services and products they value most. Measurement of customer satisfaction can be integrated into the quality assurance programs of laboratories and corresponding hospitals.  

Correlation between demographic, socio-economic, and cancer-specific factors with quality of life scores among newly-diagnosed cancer patients of the Medical Oncology Clinics of the Philippine General Hospital Cancer Institute

INTRODUCTION: Over the last two decades, psychosocial research has explored the experience of cancer patients. This study evaluated if demographic, socio-economic and cancer-specific factors impact and correlate with quality of life (QoL) scores at the time of first consult of newly-diagnosed cancer patients seen at medical oncology clinics of the University of the Philippines¬Philippine General Hospital (UP-PGH) Cancer Institute from 2012-2013.METHODS: Review of charts and interview with a pre-approved and validated questionnaire were done after informed consent. Age, gender, marital status, number of close friends, household income band, employment status, cancer site and stage were recorded. Outcomes were cancer-specific QoL EORTC QLQ-C30 questionnaire and generic QoL EQ5D questionnaire. Scores were correlated with demographic, socio-economic, and cancer¬specific factors.RESULTS: 535 patients were included, 257 male and 278 female. Mean age was 52 years (SD 13.5 years; range20-92 years). Majority (28.7%) belonged to income bracket P4,293-P8,583/month. Majority were married (74.31%) and unemployed (58.4%). Top 5 cancers were colorectal (28.09%), breast (20.70%), head and neck (16.63%), lung (9.97%), lymphoma (7.94%). According to EORTC QLQ-C30, physical functioning (p=0.0037) and cognitive functioning (p=0.003) were significantly correlated with younger patients while role functioning (p=0.04) and emotional functioning (p=0.03) showed negative correlation with older patients. Fatigue was less in female patients (p=0.0005) while being the household head (p=0.0005) was significantly correlated with increased fatigue. According to EQ5D, single patients (p=0.016) had better mobility than the rest of patients. Having 5  family members significantly reported less pain (p=0.038). Breast cancer patients had best QOL while bladder cancer patients had the worst QOL. As cancer stage increased, QOL decreased.CONCLUSION: This is a first baseline study on self-reported QOL among newly-diagnosed Filipino cancer patients, an important relevant reference in the field of psychosocial issues among low-resourced cancer patients in the Philippines.

Immunohistochemical profile, pattern of recurrence, and time to progression of non-metastatic breast cancer patients of the Department of Health-Breast Cancer Medicines Access Program

BACKGROUND: Breast cancer remains to be the leading cause of malignancy among women and survival rates vary worldwide. Molecular and immunohistochemical (NC) profiling of breast cancer has emerged to improve treatment, which led to 6 different breast cancer subtypes luminal-A, luminal-B, Her-2 enriched, basal-like, daudin low, and normal breast. Essentially, this guides clinicians as to the choice of treatment and prognostication of disease. This study evaluates the characteristics of the different IHC subtypes of breast cancer among Filipinos as to pattern of recurrence and time to progression (TIP) within their 1st 2 years of follow-up.METHODS: This is a retrospective cohort study, approved by the University of the Philippines Manila Research Ethics Board (UPMREB). Study population included breast cancer patients enrolled in the DOH-BCMAP and managed at the medical oncology clinics of the Philippine General Hospital (PGH) and Jose R. Reyes Memorial Medical Center (JRRMMC) from 1 May 2011 to 31 December 2013. Patients' demographics, disease and treatment profile were gathered from the medical charts. Patients were grouped into 12 different IHC subtypes utilizing only IHC staining results of Her2neu, ER and PR. Disease progression/ relapse and time to progression (UP) were primary outcomes analyzed and compared between subtypes using SPSS.RESULTS: There were 368 eligible patients; 50% were >50 years old, 48% postmenopausal, 34% stage IIA, and 94% had invasive ductal carcinoma. About 88% completed their chemotherapy regimen, mostly AC-T. At 1 to 2 years follow-up, 18% had disease progression, mostly distant metastasis, with HER2neu(-)/ER(-)/PR(-), HER2(+), and HER2neu(-)/ER(+)/PR(+) subtypes having the most number of disease progression. The HER2neu(-)/ER(-)/PR(-) subtype had the shortest median TTP (11 months 9sd). HER2(+) subtype had median TTP of 14±8 sd, while HER2neu(-)/ER(+)/PR(+) had median TTP at 11.6±7.41 sd. The median TTPs among the different IHC subtypes were statistically comparable. CONCLUSION: Filipinas with non-metastatic breast cancer after surgery and mainly on adjuvant chemotherapy started to develop disease progression/ relapse within the first 2 years of follow-up; 82% had no relapse. At these early years of follow-up, the median TTPs among the different breast cancer IHC subtypes who went into relapse were comparable, although HER2neu(+) regardless of ER/PR subtype tended to have more disease progression, followed by HER2neu(-)/ ER(-)/ regardless of PR subtype, and then HER2neu(-)/ ER(+)/ regardless of PR subtype. IHC resultant HER2neu(+) regardless of ER/PR and HER2neu(-)/ER(-)/PR(-/+) subtypes can serve as early prognosticators of breast cancer relapse.  

Impact of histopathological profile on disease progression of breast cancer patients during the 1st 1-2 years follow-up: Evidence from the Philippine DOH-Breast Cancer Medicine Access Program

INTRODUCTION: Current international consensus confirms that certain histopathologic factors such as tumor morphology, histologic grade and presence of lymphovascular invasion are correlated with prognosis. This retrospective cohort study evaluated the correlation between histopathologic profile and time to disease progression (UP) within the first 1-2 years follow-up of Filipino Stage I-Ill early breast cancer patients.METHODS: This is a retrospective cohort study which included breast cancer patients enrolled in the Department of Health¬Breast Cancer Medicine Access Program (DOH-BCMAP) at the medical oncology clinics of two tertiary hospitals in Manila. Clinical and histopathologic factors were gathered from patient records, and the patients were grouped according to the modified St. Gallen definition of risk categories for patients with breast cancer. Kaplan-Meier survival analysis determined the average UP as well as progression-free survival (PFS). Multivariate logistic regression determined factors contributing to disease progression.RESULTS AND CONCLUSION: Of the 326 patients enrolled in this study, 18% showed progression, with a median HP of 14 months. UP was comparable among the low-, intermediate- and high-risk groups. PFS during the 1st 1-2 years follow-up was estimated to be at 78% for the high-risk group, 83% for the intermediate-risk group, and 86% for the low-risk group. During this 1st 1-2 years follow-up, no studied factors of interest were shown to be significantly correlated with outcome among this predominantly intermediate to high risk for recurrence breast cancer patients. Follow-up of this patients up to 5 or more years would define sustained gains from the DOH-BCMAP.

The effect of DOH-PCSI patient navigation access program for breast cancer on quality of care at the Medical Oncology Clinic at the Philippine General Hospital: The 1st 6 months

INTRODUCTION: Cost has become a limiting factor for indigent breast cancer patients at the Philippine General Hospital (PGH). The Department of Health-Philippine Cancer Society Inc (DOH¬PCSI) Access Program for Breast Cancer Medicine provided free chemotherapy through a patient navigation system in PGH starting January 2012 to improve breast cancer treatment quality. This study looked into the differences of quality care in the non-metastatic setting among enrolled patients in the first 6 months compared to patients outside of the program from 2011-2012.METHODS: This retrospective cohort used follow-up rates and 19 quality care indicators linked to improved outcomes to look into quality of care among patients who were enrolled (n=58) and those who were not (n=118 for 2011 and 2012). Subgroup analyses compared patients in the program and those who were not included in the same period (n=28). Another analysis compared 2011 patients (n= 90) with those in 2012 (n=86). Z¬test for the difference of proportions was done.RESULTS: Attrition rate decreased from 62% in 2011 to 18% in 2012 (pConclusion. The DOH-PCSI Access Program for Breast Cancer Medicine program improved care among breast cancer patients in PGH, noted as early as within its first six months.

Understanding current attitudes in HER2 testing for breast cancer at tertiary referral hospitals of Metro Manila, Philippines

INTRODUCTION: The difficulty of obtaining accurate and reproducible assessment of HER2 status in the Philippines, despite the predictive value of the test for HER2 positive breast cancer patients, may be sufficiently addressed if an effective multidisciplinary approach to HER2 testing is carried out. This may be accomplished by identifying disparities and similarities in HER2 testing for breast cancer.METHODS: This is a cross-sectional study which included medical oncologists who had used trastuzumab for HER2-positive patients. Surgeons, who belonged to the same tertiary hospital as the medical oncologists were also interviewed. The survey questionnaires were administered via face-to-face, mail, or fax. Responses were kept confidential. Questionnaire responses were analysed using summary statistics.RESULTS: There were 35 medical oncologists and 37 surgeons - 93% stated that all women diagnosed with breast cancer should be tested for HER2 at the point of diagnosis; 61% stated that the greatest barrier to initiating HER2 testing was inadequate patient funds. 57% medical oncologists and 65% surgeons believed that HER2 testing for all breast cancer patients at the point of clinical diagnosis was being observed at their hospital. 69% stated that medical oncologists or surgeons should request for HER2 test whoever saw the patients first; 59% stated that whoever saw the patient first provide the patient information about HER2 testing whereas 28% stated it is the medical oncologist who should provide information about HER2 testing. 47% medical oncologist and 63% surgeons stated that surgeons should arrange for breast tissue sample collection; 27% medical oncologists and 20% surgeons stated that pathologists should do this.CONCLUSION: Medical oncologists and surgeons were similar in the opinion that all women diagnosed with breast cancer should be tested for HER2 at the point of diagnosis, financial capability was the greatest barrier for initiating HER2 testing, and whoever saw the patient first should provide patient education. There was disparity on who should request and who should arrange for tissue collection.

Chromosomal aberrations among Filipino health workers at the chemotherapy oncology wards/clinics of a tertiary government hospital

INTRODUCTION: Chromosomal mutations are casual events in neoplasia development. Biomarker cytogenetic assays can determine exposure to mutagenic agents in occupational settings. This study assessed early biological marker chromosomal aberrations among health workers in the chemotheraphy oncology wards/ clinics, exploring its association to the subjects' occupational, environmental and baseline profile.METHODS: This was an IRB approved cross-sectional exploratory study among hospital personnel working in the chemotherapy oncology facility of a tertiary government hospital, who underwent structured interview and blood extraction for cytogenetic assay after informed consent. Study funds only permitted assay of 44 specimens of 144 planned sample size, hence, Stata 6.0 only analyzed data from 44 subjects.RESULTS: All 44 subjects had varying exposure to chemotherapy drug infusions. Of these, 79% had 1.0 breaks per cell (hypersensitive). Predominantly chromatid breaks (CTB), chromatid gaps (CTG), sister chromatid exhanges (SCE) were seen. No significant association was shown between mutagenic sensitivity and baseline characteristics, but with small sample size.CONCLUSION: 21% borderline to hypersensitive mutagenic sensitivity among oncology workers at the tertiary government hospital is relatively significant, despite small sample size, connoting a must preventive promotive practice of chemotherapy administration in the workplace.

Genetic polymorphisms in CYP1A1, GSTM1, GSTP1, GSTT1, NAT1 and NAT2 and oral cavity cancer risk among Filipinos

Polymorphisms in metabolic genes have been shown to modulate susceptibility to oral cavity cancer. Cases (n=176) and controls (n=317) from the Filipino population were genotyped for selected polymorphisms in CYP1A1, GSTM1, GSTP1, GSTT1, NAT1 and NAT2. Medical and diet histories, occupational exposure and demographic data were also collected for all subjects. The CYP1A1m1/m1 genotype is protective against oral cancer, while being homozygous for the GSTP1 c.313G genotype and heterozygous for the NAT1*10 homozygotes and non-homozygotes for the CYP1A1 m1 allele. The risk from heterozygosity for the NAT1*10 allele was limited to subjects who were not homozygous for the GSTP1 c.313G genotype remained a significant oral cancer risk modifier, together with environmental variables, the homozygous GSTP1 c.313G genotype remained a significant oral cancer risk modifier, together with environmental risk factors, such as smoking, passive smoking, inverted smoking and tobacco chewing, and environmental protective factors, i.e. moderate consumption of fish sauce (patis) and shrimp paste (bagoong). The GSTP1 c.313G polymorphism increases susceptibility for oral cavity cancer in the Filipino population.

Risk factors for breast cancer among Filipino women in Manila.

Age-adjusted incidence rates of breast cancer vary greatly worldwide with highest rates found in the typically 'westernised' countries of North America and Europe. Much lower rates are observed in Asian and African populations but an exception to this has been reported for the Manila Cancer Registry in the Philippines. The reason for this high rate is unknown but may be associated with the change in lifestyle that has occurred in urban Manila since the 1960s. In 1995, a randomised controlled trial was set up in Manila to evaluate the feasibility of a screening intervention by clinical breast examination as an alternative to mammography. The cohort of 151,168 women was followed-up to 2001 for cancer incidence and a nested case-control study carried out. This aimed to evaluate the increase in breast cancer risk associated with known risk factors. Increased risks were seen for a high level of education (OR = 1.9 95%CI 1.1-3.3 for education stopped at > or =13 versus <13 years), nulliparity (OR = 5.0 95% CI 2.5-10.0 for nulliparity versus five or more children), and late age at first birth (OR = 3.3 95% CI 1.3-8.3 for age > or =30 versus <20 years). We found no association with excess body weight, height, use of exogenous hormones or alcohol consumption. From this study, the recognised "classical" risk factors do not fully explain the high breast cancer incidence in Metro Manila, especially when compared to other urban Asian populations. We conclude that it is too simplistic to ascribe the high risk to 'westernisation'.

Epidemiological risk factors for cancers of the lung, breast, colon-rectum and oral cavity: A case-control study in the Philippines

INTRODUCTION: In the Philippines, lung, breast, colon-rectum, and oral cavity cancers are among the top 10 most common cancers. This study evaluates the risk factors for these cancers among Filipinos. METHODS: This age-matched case-control study included incident primary cancers (histologically-diagnosed) of the lung, breast (also matched for sex), colon-rectum and oral cavity. Controls (clinically free and no history of cancer) were obtained from the same tertiary hospitals as the cases. Target sample size was 283 cases and 283 controls per cancer type. Conditional logistic regression was done. RESULTS: Exposure to cigarette/tobacco was a significant risk factor for lung (OR of current smoker compared to non-smoker [95% Confidence Interval]: 3.6 [1.6-7.9]) and oral cavity cancers (2.0 [1.2-3.3]); family history (1st degree) for lung (4.3 [1.314.2]) and breast cancers (3.0 [1.2-7.5]); every year increase in age at first pregnancy for breast cancer (1.06 [1.02-1.11]). Other risk factors for oral cavity were passive smoking (2.8 [1.6-5.1]), chewing tobacco (5.2[1.4-19.5]) and inverted cigarette smoking (3.2[1.3-8.1]). Fish sauce (patis) was found to be a protective factor for breast cancer (0.34 [0.22-0.51]) and oral cavity (0.44 [0.25-0.78]) and use of shrimp paste (bagoong) (0.48 [0.27-0.84]) for oral cavity. CONCLUSION AND RECOMMENDATIONS: Except for family history of cancer, the identified risk factors for lung, colon-rectum, and oral cavity cancers are preventable. Proper diet and lifestyle, avoidance of cigarettes and tobacco, and environmental safety in the workplace are key cancer prevention measures. Public awareness campaign and continuing healthcare provider education must always be part of a cancer prevention program.

Epidemiology and prevention of cervical cancer in Indonesia, Malaysia, the Philippines, Thailand and Vietnam.

Cervical cancer remains one of the leading causes of cancers in women from Indonesia, Malaysia, the Philippines, Thailand and Vietnam. High-risk human papillomavirus (HPV) types, particularly HPV-16 and 18, are consistently identified in cervical cancer cases regardless of geographical region. Factors that have been identified to increase the likelihood of HPV exposure or subsequent development of cervical cancer include young age at first intercourse, high parity and multiple sexual partners. Cervical cancer screening programs in these countries include Pap smears, single visit approach utilizing visual inspection with acetic acid followed by cryotherapy, as well as screening with colposcopy. Uptake of screening remains low in all regions and is further compounded by the lack of basic knowledge women have regarding screening as an opportunity for the prevention of cervical cancer. Prophylactic HPV vaccination with the quadrivalent vaccine has already been approved for use in Malaysia, the Philippines and Thailand, while the bivalent vaccine has also been approved in the Philippines. However, there has been no national or government vaccination policy implemented in any of these countries.

Gemcitabine and split-dose paclitaxel or docetaxel in metastatic breast cancer: a randomised phase II study.

PURPOSE: The purpose was to evaluate the activity and toxicity of split-dose paclitaxel or docetaxel in combination with gemcitabine in patients with metastatic breast cancer (MBC) who had previously received anthracyclines. PATIENTS AND METHODS: A total of 210 patients were randomly assigned to one of three treatment arms: gemcitabine 1,250 mg/m(2) Days 1 and 8 and paclitaxel 175 mg/m(2) as a 3-h infusion on Day 1 (GP1); gemcitabine 1,000 mg/m(2) Days 1 and 8 and paclitaxel 100 mg/m(2) as a 1-h infusion on Days 1 and 8 (GP2); gemcitabine 1,000 mg/m(2) Days 1 and 8 and docetaxel 40 mg/m(2) as a 1-h infusion on Days 1 and 8 (GD). Cycles were repeated every 3 weeks. RESULTS: For the 204 patients evaluable for response assessment, the response rates were 48.6% for GP1, 52.2% for GP2, and 52.3% for GD. Median response duration, time to treatment failure, and time to progression (TTP) were similar in each arm. Median TTP for GP1, GP2 and GD was 7.5, 7.0 and 7.4 months, respectively. For the 208 patients evaluable for safety, the most common grade 3/4 toxicity for each regimen was neutropaenia, with 64%, 57%, and 68% for GP1, GP2, and GD, respectively. Grade 4 neutropaenia, grade 3/4 anaemia, febrile neutropaenia, and diarrhoea were more common in the docetaxel arm, as was the use of intravenous antibiotics and blood transfusions. CONCLUSION: The study confirmed the high activity of gemcitabine-taxane combinations in MBC. Split-dose paclitaxel had similar activity and toxicity to the 3-weekly administration. The split-dose docetaxel regimen had similar activity to the paclitaxel combinations though associated with higher toxicity.

Outcome of screening by clinical examination of the breast in a trial in the Philippines.

The value of screening by Clinical Examination of the Breast (CBE) as a means of reducing mortality from breast cancer (BC) is not established. The issue is relevant, as CBE may be a suitable option for countries in economic transition, where incidence rates are on the increase but limited resources do not permit screening by mammography. Our aims were to assess whether mass screening by CBE carried out by trained para-medical personnel is feasible in an urban population of a low-income country, and its efficacy in reducing BC mortality. Our study was designed as a randomised controlled trial of the effect on BC mortality of 5 annual CBE carried out by trained nurses. The target population was women aged 35-64 years, resident in 12 municipalities of the National Capital Region of Manila, Philippines. The units of randomization were the 202 health centres (HC) within the selected municipalities. During 1995 nurses and midwives were recruited and trained in performing CBE. The first round of screening took place in 1996-1997. The intervention however showed a refractory attitude of the population with respect to clinical follow-up and was discontinued after the completion of the first screening round. Cases of breast cancer occurring in the study population during 1996-1999 were identified by the 2 local population-based registries. In the single screening round 151,168 women were interviewed and offered CBE, 92% accepted (138,392), 3,479 were detected positive for a lump and referred for diagnosis. Of these only 1220 women (35%) completed diagnostic follow-up, whereas 42.4% actively refused further investigation even with home visits, and 22.5% were not traced. Of 53 cases that occurred among screen-positive women in the 2 years after CBE only 34 were diagnosed through the intervention. Eighty cases occurred among screen-negative women. The test sensitivity for CBE repeated annually was 53.2%. The actual sensitivity of the programme was 25.6% and positive predictive value 1%. Screen-detected cases were non-significantly less advanced than the others. Previous studies have shown that most breast cancer cases in the Philippines present at advanced stages and have an unfavourable outcome. Although CBE undertaken by health workers seems to offer a cost-effective approach to reducing mortality, the sensitivity of the screening programme in the real context was low. Moreover, in this relatively well-educated population, cultural and logistic barriers to seeking diagnosis and treatment persist and need to be addressed before any screening programme is introduced.

Cancer and the Philippine Cancer Control Program.

Cancer is the third leading cause of morbidity and mortality in the Philippines. Leading cancer sites/types are lung, breast, cervix, liver, colon and rectum, prostate, stomach, oral cavity, ovary and leukemia. There is at present a low cancer prevention consciousness and most cancer patients seek consultation only at advanced stages. Cancer survival rates are relatively low. The Philippine Cancer Control Program, begun in 1988, is an integrated approach utilizing primary, secondary and tertiary prevention in different regions of the country at both hospital and community levels. Six lead cancers (lung, breast, liver, cervix, oral cavity, colon and rectum) are discussed. Features peculiar to the Philippines are described; and their causation and prevention are discussed. A recent assessment revealed shortcomings in the Cancer Control Program and urgent recommendations were made to reverse the anticipated 'cancer epidemic'. There is also today in place a Community-based Cancer Care Network which seeks to develop a network of self-sufficient communities sharing responsibility for cancer care and control in the country.

Male circumcision, penile human papillomavirus infection, and cervical cancer in female partners.

BACKGROUND: It is uncertain whether male circumcision reduces the risks of penile human papillomavirus (HPV) infection in the man and of cervical cancer in his female partner. METHODS: We pooled data on 1913 couples enrolled in one of seven case-control studies of cervical carcinoma in situ and cervical cancer in five countries. Circumcision status was self-reported, and the accuracy of the data was confirmed by physical examination at three study sites. The presence or absence of penile HPV DNA was assessed by a polymerase-chain-reaction assay in 1520 men and yielded a valid result in the case of 1139 men (74.9 percent). RESULTS: Penile HPV was detected in 166 of the 847 uncircumcised men (19.6 percent) and in 16 of the 292 circumcised men (5.5 percent). After adjustment for age at first intercourse, lifetime number of sexual partners, and other potential confounders, circumcised men were less likely than uncircumcised men to have HPV infection (odds ratio, 0.37; 95 percent confidence interval, 0.16 to 0.85). Monogamous women whose male partners had six or more sexual partners and were circumcised had a lower risk of cervical cancer than women whose partners were uncircumcised (adjusted odds ratio, 0.42; 95 percent confidence interval, 0.23 to 0.79). Results were similar in the subgroup of men in whom circumcision was confirmed by medical examination. CONCLUSIONS: Male circumcision is associated with a reduced risk of penile HPV infection and, in the case of men with a history of multiple sexual partners, a reduced risk of cervical cancer in their current female partners.

Evidence for Chlamydia trachomatis as a human papillomavirus cofactor in the etiology of invasive cervical cancer in Brazil and the Philippines.

Chlamydia trachomatis infection was examined as a cause of invasive cervical cancer (ICC) among women with human papillomavirus (HPV) infection. In total, 499 women with incident ICC (ICC patients) and 539 control patients from São Paulo, Brazil, and Manila, the Philippines, were included. C. trachomatis antibodies were detected by microimmunofluorescence assay. Presence of HPV DNA in cervical specimens was determined by a polymerase chain reaction-based assay. C. trachomatis seropositivity was associated with sexual behavior but not with HPV infection. C. trachomatis increased the risk of squamous cervical cancer among HPV-positive women (odds ratio, 2.1; 95% confidence interval, 1.1-4.0). Results were similar in both countries. There was a suggestion of increasing squamous cancer risk with increasing C. trachomatis antibody titers. This large study examined C. trachomatis and cervical cancer, taking into account the central role of HPV infection. C. trachomatis infection was found to be a possible cofactor of HPV in the etiology of squamous cervical cancer, and its effect may be mediated by chronic inflammation.