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Purpose This study aims to evaluate in vivo skin dose delivered by intraoperative radiotherapy (IORT) and determine the factors associated with an increased risk of radiation‐induced skin toxicity. Methodology A total of 21 breast cancer patients who underwent breast‐conserving surgery and IORT, either as IORT alone or IORT boost plus external beam radiotherapy (EBRT), were recruited in this prospective study. EBT3 film was calibrated in water and used to measure skin dose during IORT at concentric circles of 5 mm and 40 mm away from the applicator. For patients who also had EBRT, the maximum skin dose was estimated using the radiotherapy treatment planning system. Mid‐term skin toxicities were evaluated at 3 and 6 months post‐IORT. Results The average skin dose at 5 mm and 40 mm away from the applicator was 3.07 ± 0.82 Gy and 0.99 ± 0.28 Gy, respectively. Patients treated with IORT boost plus EBRT received an additional skin dose of 41.07 ± 1.57 Gy from the EBRT component. At 3 months post‐IORT, 86% of patients showed no evidence of skin toxicity. However, the number of patients suffering from skin toxicity increased from 15% to 38% at 6 months post‐IORT. We found no association between the IORT alone or with the IORT boost plus EBRT and skin toxicity. Older age was associated with increased risk of skin toxicities. A mathematical model was derived to predict skin dose. Conclusion EBT3 film is a suitable dosimeter for in vivo skin dosimetry in IORT, providing patient‐specific skin doses. Both IORT alone and IORT boost techniques resulted in similar skin toxicity rates.

Previous studies found that ethnicity influences oral cancer patients' survival; however, most studies were limited to certain ethnic groups particularly from the West, thus of limited relevance to Asians where the disease is most prevalent. We investigated the relationship between ethnicity and patient survival in multi-racial Malaysia. 5-year survival rate was 40.9%. No statistically significant difference was observed in survival between Malays, Chinese, Indians and Indigenous peoples (45.7%, 44.0%, 41.3%, 27.7% respectively). Increased tumor size, lymph node involvement and advanced tumor were predictive of poor survival. We conclude that ethnicity has no effect on survival or its prognostic indicators.

Aim: To evaluate the efficacy and safety of neratinib as extended adjuvant therapy in patients from Asia based on exploratory analyses of the Phase III ExteNET trial. Patients & methods: A total of 2840 women with early stage HER2-positive breast cancer were randomly assigned to neratinib 240 mg/day or placebo for 1 year after trastuzumab-based adjuvant therapy. Results: A total of 341 patients were from Asia (neratinib, n = 165; placebo, n = 176). 2-year invasive disease-free survival rates were 92.8 and 90.8% with neratinib and placebo, respectively (HR: 0.70; 95% CI: 0.31–1.55), and 5-year rates were 91.9 and 87.2%, respectively (HR: 0.57; 95% CI: 0.27–1.13). Diarrhea was the most common adverse event with neratinib. Conclusion: Extended adjuvant therapy with neratinib reduces disease recurrences in Asian women with HER2-positive breast cancer. Trial registration: Clinicaltrials.gov NCT00878709.

Although not a new concept in itself, competency-based education has set the trend for the globally accepted standard norm for education and training of medical professionals including postgraduate education in radiation oncology. Societal needs demand from radiation oncologists that they be not only competent in the knowledge and skills relevant to their specific discipline, but that they also display competencies such as professionalism, scholarship, health advocacy, management/leadership, collaboration and communication. The realities of developing countries, in particular low and middle income countries (LMICs) set different priorities than in high income countries. A large proportion of cancer patients do not have access to adequate radiotherapy services. Resource constraints determine limitations in equipment, accessories, and dosimetry. Lower than standard staffing levels and limited quality education and training also contribute to substandard care and clinical outcomes. In this environment, the addition and assessment of competency-based elements to training programmes can be challenging. On the other hand, it is precisely in these countries, where competencies such as the ones listed above are highly needed in the radiation oncology profession. Implementation of competency-based medical education in the education of radiation oncologists in LMICs is both a need and a challenge. The available frameworks and competencies, despite being very relevant to the realities faced by radiation oncologists in LMICs, will still need to be adapted in order to ensure effective implementation at the national/regional level. Radiation oncologists need to employ effective change-management strategies to ensure that the changes which are introduced can remain sustainable within the context of national healthcare, education and political systems.

BACKGROUND: Scalp cooling has been shown in several studies to be an effective method in preventing chemotherapy-induced alopecia (CIA). Data on the use of scalp cooling in Asian countries are limited, and evidence for its use and efficacy among our patients are not available. OBJECTIVE: The aim of this study was to assess the effectiveness and tolerability of scalp cooling among breast cancer patients in our study population. METHODS: Consecutive breast cancer patients receiving FE75C, FE100C, FE100C-D, docetaxel75 or docetaxel, and cyclophosphamide (TC) at our treatment center were recruited and allocated to the treatment (scalp cooling, DigniCapTM system) or control group in this prospective nonrandomized controlled study. The assessment of alopecia was carried out using the World Health Organization grading system and clinical photographs. RESULTS: Seventy patients were recruited, but only 25 completed the study and were evaluable for analysis. Five of 12 patients (42%) in the scalp cooling group managed to preserve hair. Two of three patients who received FE75C and TC regimens had minimal hair loss. All patients treated with FE100C had severe hair loss. Half of all patients who received scalp cooling throughout chemotherapy rated the treatment as reasonably well tolerated. The most common reason for discontinuing scalp cooling was intolerance to its side effects. CONCLUSION: Scalp cooling is potentially effective in reducing CIA caused by docetaxel, TC, and FE75C chemotherapy regimen. However, it was not well tolerated by our study population. The dropout rate was high, and this needs to be taken into consideration when pursuing further trials in a similar setting.

Purpose Pediatric medulloblastoma (MB) treatment has evolved over the past few decades; however, treating children in countries with limited resources remains challenging. Until now, the literature regarding childhood MB in Malaysia has been nonexistent. Our objectives were to review the demographics and outcome of pediatric MB treated at the University Malaya Medical Center between January 1994 and December 2013 and describe the challenges encountered. Methods Fifty-one patients with childhood MB were seen at University Malaya Medical Center. Data from 43 patients were analyzed; eight patients were excluded because their families refused treatment after surgery. Results Headache and vomiting were the most common presenting symptoms, and the mean interval between symptom onset and diagnosis was 4 weeks. Fourteen patients presented with metastatic disease. Five-year progression-free survival (± SE) for patients ≥ 3 years old was 41.7% ± 14.2% (95% CI, 21.3% to 81.4%) in the high-risk group and 68.6% ± 18.6% (95% CI, 40.3% to 100%) in the average-risk group, and 5-year overall survival (± SE) in these two groups was 41.7% ± 14.2% (95% CI, 21.3% to 81.4%) and 58.3% ± 18.6% (95% CI, 31.3% to 100%), respectively. Children younger than 3 years old had 5-year progression-free and overall survival rates (± SE) of 47.6% ± 12.1% (95% CI, 28.9% to 78.4%) and 45.6% ± 11.7% (95% CI, 27.6% to 75.5%), respectively. Time to relapse ranged from 4 to 132 months. Most patients who experienced relapse died within 1 year. Febrile neutropenia, hearing loss, and endocrinopathy were the most common treatment-related complications. Conclusion The survival rate of childhood MB in Malaysia is inferior to that usually reported in the literature. We postulate that the following factors contribute to this difference: lack of a multidisciplinary neuro-oncology team, limited health care facilities, inconsistent risk assessment, insufficient data in the National Cancer Registry and pathology reports, inadequate long-term follow-up, and cultural beliefs leading to treatment abandonment.

Percutaneous biopsy in breast cancer has been associated with an increased risk of malignant cell seeding. However, the importance of these observations remains obscure due to lack of corroborating evidence from clinical studies. We determined whether method of biopsy is associated with breast cancer survival. This hospital registry-based cohort study included 3416 non-metastatic breast cancer patients diagnosed from 1993 to 2011 in a tertiary setting. Factors associated with biopsy methods were assessed. Multivariable Cox regression analysis was used to determine the independent prognostic impact of method of biopsy. Overall, 990 patients were diagnosed by core needle biopsy (CNB), 1364 by fine needle aspiration cytology (FNAC), and 1062 by excision biopsy. Excision biopsy was significantly associated with more favorable tumor characteristics. Radiotherapy modified the prognostic impact of biopsy method (Pinteraction < .001). Following multivariable analysis, excision biopsy was consistently associated with lower risk of mortality compared to FNAC in women receiving adjuvant radiotherapy (adjusted hazard ratio: 0.81, 95%CI: 0.66-0.99), but not in those who did not receive adjuvant radiotherapy (adjusted hazard ratio: 0.87, 95%CI: 0.65-1.17). While the risk of mortality was not different between patients undergoing FNAC and CNB when radiotherapy is administered, in the absence of radiotherapy, CNB was associated with higher risk of mortality than FNAC (adjusted hazard ratio: 1.57, 95%CI: 1.16-2.12). Given that our results contradict with findings of previous clinical studies assessing the prognostic impact of method of biopsy in women with breast cancer, further studies are warranted.

Background: Oral capecitabine is increasingly replacing intravenous 5-fluorouracil in many chemotherapy regimens. However, data on the risk of febrile neutropaenia (FN) and treatment related death (TRD) with the drug remain sparse outside of clinical trial settings despite its widespread usage. This study aimed to determine these rates in a large cohort of patients treated in the University of Malaya Medical Centre (UMMC). Materials and Methods: We reviewed the clinical notes of all patients prescribed with oral capecitabine chemotherapy for any tumour sites in University Malaya Medical Centre (UMMC) from 1 st January 2009 till 31 st June 2010. Information collected included patient demographics, histopathological features, treatment received including the different chemotherapy regimens and intent of treatment whether the chemotherapy was given for neoadjuvant, concurrent with radiation, adjuvant or palliative intent. The aim of this study is to establish the pattern of usage, FN and TRD rates with capecitabine in clinical practice outside of clinical trial setting. FN is defined as an oral temperature >38.5°C or two consecutive readings of >38.0°C for 2 hours and an absolute neutrophil count

The relatively new treatment modality electronic intraoperative radiotherapy (IORT) is gaining popularity, irradiation being obtained within a surgically produced cavity being delivered via a low-energy x-ray source and spherical applicators, primarily for early stage breast cancer. Due to the spatially dramatic dose-rate fall off with radial distance from the source and effects related to changes in the beam quality of the low keV photon spectra, dosimetric account of the Intrabeam system is rather complex. Skin dose monitoring in IORT is important due to the high dose prescription per treatment fraction. In this study, modeling of the x-ray source and related applicators were performed using the Monte Carlo N-Particle transport code. The dosimetric characteristics of the model were validated against measured data obtained using an ionization chamber and EBT3 film as dosimeters. By using a simulated breast phantom, absorbed doses to the skin for different combinations of applicator size (1.5-5 cm) and treatment depth (0.5-3 cm) were calculated. Simulation results showed overdosing of the skin (>30% of prescribed dose) at a treatment depth of 0.5 cm using applicator sizes larger than 1.5 cm. Skin doses were significantly increased with applicator size, insofar as delivering 12 Gy (60% of the prescribed dose) to skin for the largest sized applicator (5 cm diameter) and treatment depth of 0.5 cm. It is concluded that the recommended 0.5-1 cm distance between the skin and applicator surface does not guarantee skin safety and skin dose is generally more significant in cases with the larger applicators. Highlights • Intrabeam x-ray source and spherical applicators were simulated and skin dose was calculated. • Skin dose for constant skin to applicator distance strongly depends on applicator size. • Use of larger applicators generally results in higher skin dose. • The recommended 0.5-1 cm skin to applicator distance does not guarantee skin safety.

BACKGROUND: ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings. METHODS: In this ongoing randomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (≥20 years in Japan) with stage 1-3c (modified to stage 2-3c in February, 2010) operable breast cancer, who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab with no evidence of disease recurrence or metastatic disease at study entry. Patients who were eligible patients were randomly assigned (1:1) via permuted blocks stratified according to hormone receptor status (hormone receptor-positive vs hormone receptor-negative), nodal status (0 vs 1-3 vs or ≥4 positive nodes), and trastuzumab adjuvant regimen (given sequentially vs concurrently with chemotherapy), then implemented centrally via an interactive voice and web-response system, to receive 1 year of oral neratinib 240 mg/day or matching placebo. Treatment was given continuously for 1 year, unless disease recurrence or new breast cancer, intolerable adverse events, or consent withdrawal occurred. Patients, investigators, and trial funder were masked to treatment allocation. The predefined endpoint of the 5-year analysis was invasive disease-free survival, analysed by intention to treat. ExteNET is registered with ClinicalTrials.gov, number NCT00878709, and is closed to new participants. FINDINGS: Between July 9, 2009, and Oct 24, 2011, 2840 eligible women with early HER2-positive breast cancer were recruited from community-based and academic institutions in 40 countries and randomly assigned to receive neratinib (n=1420) or placebo (n=1420). After a median follow-up of 5·2 years (IQR 2·1-5·3), patients in the neratinib group had significantly fewer invasive disease-free survival events than those in the placebo group (116 vs 163 events; stratified hazard ratio 0·73, 95% CI 0·57-0·92, p=0·0083). The 5-year invasive disease-free survival was 90·2% (95% CI 88·3-91·8) in the neratinib group and 87·7% (85·7-89·4) in the placebo group. Without diarrhoea prophylaxis, the most common grade 3-4 adverse events in the neratinib group, compared with the placebo group, were diarrhoea (561 [40%] grade 3 and one [BACKGROUND: ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings.METHODS: In this ongoing randomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (≥20 years in Japan) with stage 1-3c (modified to stage 2-3c in February, 2010) operable breast cancer, who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab with no evidence of disease recurrence or metastatic disease at study entry. Patients who were eligible patients were randomly assigned (1:1) via permuted blocks stratified according to hormone receptor status (hormone receptor-positive vs hormone receptor-negative), nodal status (0 vs 1-3 vs or ≥4 positive nodes), and trastuzumab adjuvant regimen (given sequentially vs concurrently with chemotherapy), then implemented centrally via an interactive voice and web-response system, to receive 1 year of oral neratinib 240 mg/day or matching placebo. Treatment was given continuously for 1 year, unless disease recurrence or new breast cancer, intolerable adverse events, or consent withdrawal occurred. Patients, investigators, and trial funder were masked to treatment allocation. The predefined endpoint of the 5-year analysis was invasive disease-free survival, analysed by intention to treat. ExteNET is registered with ClinicalTrials.gov, number NCT00878709, and is closed to new participants.FINDINGS: Between July 9, 2009, and Oct 24, 2011, 2840 eligible women with early HER2-positive breast cancer were recruited from community-based and academic institutions in 40 countries and randomly assigned to receive neratinib (n=1420) or placebo (n=1420). After a median follow-up of 5·2 years (IQR 2·1-5·3), patients in the neratinib group had significantly fewer invasive disease-free survival events than those in the placebo group (116 vs 163 events; stratified hazard ratio 0·73, 95% CI 0·57-0·92, p=0·0083). The 5-year invasive disease-free survival was 90·2% (95% CI 88·3-91·8) in the neratinib group and 87·7% (85·7-89·4) in the placebo group. Without diarrhoea prophylaxis, the most common grade 3-4 adverse events in the neratinib group, compared with the placebo group, were diarrhoea (561 [40%] grade 3 and one [INTERPRETATION: At the 5-year follow-up, 1 year of extended adjuvant therapy with neratinib, administered after chemotherapy and trastuzumab, significantly reduced the proportion of clinically relevant breast cancer relapses-ie, those that might lead to death, such as distant and locoregional relapses outside the preserved breast-without increasing the risk of long-term toxicity. An analysis of overall survival is planned after 248 events.FUNDING: Wyeth, Pfizer, and Puma Biotechnology.

OBJECTIVE: To evaluate the survival outcomes in patients diagnosed with intracranial germ cell tumours (iGCT). METHODS: Retrospective review of all patients with iGCT treated in a single center from July 1996 to Jun 2017. Three treatment regimens were used: MSKCC, SIOP CNS GCT 96 and SIOP CNS GCT II. RESULTS: Thirty patients were identified with a median follow-up of 4.04 years (range 0.17–19.10). The mean age was 10.23 years. Male: female ratio was 5:1. Visual impairment (50%), endocrinopathy (30%) and precocious puberty (20%) were the commonest presenting symptoms. Duration of symptoms prior to presentation ranged from 1 to 108 weeks. Pure germinomas (n=15) and non-germinomatous germ cell tumours (NGGCT) (n=15) were equally distributed. Tumour location was pineal in 15 (50.0%), suprasellar in 8 (26.7%), hypothalamic in 2 (6.7%) and other sites (basal ganglia, thalamus, frontal lobe) in 5 (16.7%) patients. Eight patients (26.7%) had metastatic disease at diagnosis. Four cases underwent surgical debulking, 14 were biopsied and 7 had complete resection. Fifteen patients received chemo-radiotherapy, 7 had chemotherapy only and 8 underwent radiotherapy only. Elevated levels of serum alpha-fetoprotein and beta-human chorionic gonadotropin normalised after 2 courses of chemotherapy in all NGGCT cases. The 5-year event-free survival (EFS) and overall survival (OS) were 61.3 ± 14.1% and 78.3 ± 11.1% for pure germinoma, respectively. For NGGCT, the 5-year EFS and OS were 36.0 ± 13.3% and 41.3 ± 13.7%. Eleven recurrences occurred within a median duration of 11 months following diagnosis and 8 of them died within 10 months. CONCLUSION: Compared to pure germinoma, NGGCTs have poor prognosis.

Background: Body image dissatisfaction among breast cancer survivors has been associated with psychological stress resultant from breast cancer and resultant surgery. This study aimed to examine the psychometric properties of the Malay Version of the Breast-Impact of Treatment Scale (MVBITS) and to investigate the associations of retained factors with the Hospital Anxiety and Depression Scale (HADS) and the Rosenberg Self-Esteem Scale (RSES). Materials and Methods: The MVBITS was ‘forward–backward’ translated from English to Malay and then administered to 70 female breast cancer patients who came to the Oncology Clinic of University Malaya Medical Centre, Kuala Lumpur, Malaysia to undergo chemotherapy. Principal component analysis (PCA) with varimax rotation was performed to explore the factor structure of the MVBITS. Associations of retained factors were estimated with reference to Spearman correlation coefficients. Results: The internal consistency reliability of MVBITS was good (Cronbach’s alpha 0.945) and showed temporal stability over a 3-week period. Principal component analysis suggested two factors termed as ‘Intrusion’ and ‘Avoidance’ domains. These factors explained 70.3% of the variance. Factor 1 comprised the effects of breast cancer treatment on the emotion and thought, while Factor 2 informed attempts to limit exposure of the body to self or others. The Factor 1 of MVBITS was positively correlated with total, depression and anxiety sub-scores of HADS. Factor 2 was positively correlated with total and anxiety sub-scores of HADS. MVBITS was also positively correlated with the RSES scores. Conclusions: The results showed that the Malay Version of Breast-Impact of Treatment Scale possesses satisfactory psychometric properties suggesting that this instrument is appropriate for assessment of body change stress among female breast cancer patients in Malaysia.

Identification of diagnostic markers for early detection and development of novel and therapeutic agents for effective patient management are the main motivation for cancer research. Biological specimens from large cohort and case-control studies which are crucial in providing successful research outcomes are often the limiting factor that hinders research efforts, especially in developing countries. Therefore, the Malaysian Oral Cancer Database and Tissue Bank System (MOCDTBS) were established to systematically collect large number of samples with comprehensive sociodemographic, clinicopathological, management strategies, quality of life and associated patient follow-up data to facilitate oral cancer research in Malaysia. The MOCDTBS also promotes sharing among researchers and the development of a multidisciplinary research team. The following article aims to describe the process of setting-up and managing the MOCDTBS.

To evaluate the toxicity and efficacy of concurrent chemoradiotherapy using weekly cisplatin for patients with locally advanced cervical cancer in East and Southeast Asia, a multi-institutional Phase II clinical study was conducted among eight Asian countries.Between April 2003 and March 2006, 120 patients (60 with bulky Stage IIB and 60 with Stage IIIB) with previously untreated squamous cell carcinoma of the cervix were enrolled in the present study. Radiotherapy consisted of pelvic external beam radiotherapy (total dose, 50 Gy) and either high-dose-rate or low-dose-rate intracavitary brachytherapy according to institutional practice. The planned Point A dose was 24-28 Gy in four fractions for high-dose-rate-intracavitary brachytherapy and 40-45 Gy in one to two fractions for low-dose-rate-intracavitary brachytherapy. Five cycles of weekly cisplatin (40 mg/m(2)) were administered during the radiotherapy course.All patients were eligible for the study. The median follow-up was 27.3 months. Of the 120 patients, 100 (83%) received four or five cycles of chemotherapy. Acute Grade 3 leukopenia was observed in 21% of the patients, and Grade 3 gastrointestinal toxicity was observed in 6%. No patient failed to complete the radiotherapy course because of toxicity. The 2-year local control and overall survival rate for all patients was 87.1% and 79.6%, respectively. The 2-year major late rectal and bladder complication rate was 2.5% and 0%, respectively.The results have suggested that concurrent chemoradiotherapy using weekly cisplatin is feasible and effective for patients with locally advanced cervical cancer in East and Southeast Asia.

The use of lectin affinity chromatography prior to 2-DE separation forms an alternative method to unmask the expression of targeted glycoproteins of lower abundance in serum samples. Reduced expression of alpha-2 macroglobulin (AMG) and complement factor B (CFB) was detected in sera of patients with nasopharyngeal carcinoma (NPC) when pooled serum samples of the patients and those of healthy individuals were subjected to affinity isolation using immobilized champedak mannose-binding lectin and analyzed by 2-DE and densitometry. The AMG and CFB spots were not detected in the 2-DE protein profiles when the same pooled serum samples were subjected to albumin and IgG depletion and neither were they detected when the depleted samples were analyzed by western blotting and lectin detection. Together with other acute-phase response proteins that were previously reported to be altered in expression in NPC patients, AMG and CFB may serve as useful complementary biomarkers for NPC.

A 35 kDa glycoprotein whose abundance was previously demonstrated to be enhanced in sera of patients with endometrial adenocarcinoma (n = 12), was isolated from pooled sera of three of the cancer patients using champedak galactose-binding lectin affinity chromatography in the present study. Subjecting it to 2-DE and MS/MS, the glycoprotein was identified as the O-glycosylated fragment of inter-alpha-trypsin inhibitor heavy chain H4 (ITIH4). When compared to control sera (n = 17), expression of the 35 kDa ITIH4 cleavage fragment was demonstrated to be significantly enhanced in sera of patients with breast carcinoma (n = 10), epithelial ovarian carcinoma (n = 10), and germ cell ovarian carcinoma (n = 10) but not in patients with nasopharyngeal carcinoma (n = 13) and osteosarcoma (n = 7). The lectin-based electrophoretic bioanalytical method adopted in the present study may be used to assess the physiological relevance of ITIH4 fragmentation and its correlation with different malignancies, their stages and progression.

Background: This study was performed to assess patient symptoms prevalence, frequency and severity, as well as distress and coping strategies used, and to identify the relationships between coping strategies and psychological and physical symptoms distress and demographic data of cancer patients. This cross-sectional descriptive study involved a total of 268 cancer patients with various types of cancer and chemotherapy identified in the oncology unit of an urban tertiary hospital. Materials and Methods: Data were collected using questionnaires (demographic questionnaire, Medical characteristics, Memorial Symptom Assessment Scale (MSAS) and Brief COPE scales and analyzed for demographic, and disease-related variable effects on symptom prevalence, severity, distress and coping strategies. Results: Symptom prevalence was relatively high and ranged from 14.9% for swelling of arms and legs to 88.1% for lack of energy. This latter was the highest rated symptom in the study. The level of distress was found to be low in three domains. Problem-focused coping strategies were found to be more commonly employed compared to emotion-focused strategies, demonstrating significant associations with sex, age group, educational levels and race. However, there was a positive correlation between emotion-focused strategies and physical and psychological distress, indicating that patients would choose emotion-focused strategies when symptom distress increased. Conclusions: These findings demonstrate that high symptom prevalence rates and coping strategies used render an improvement in current nursing management. Therefore development of symptoms management groups, encouraging the use of self-care diaries and enhancing the quality of psychooncology services provided are to be recommended.

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 1250 mg/m 2 Days 1 and 8 and paclitaxel 175 mg/m 2 as a 3-h infusion on Day 1 (GP1); gemcitabine 1000 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 1000 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.

Background: The risk of treatment-related death (TRD) and febrile neutropaenia (FN) with adjuvant taxanebased chemotherapy for early breast cancer is unknown in Malaysia despite its widespread usage in recent years. This study aims to determine these rates in patients treated in University Malaya Medical Centre (UMMC). Patients and Methods: Patients who were treated with adjuvant taxane-based chemotherapy for early breast cancer stages I, II or III from 2007-2011 in UMMC were identified from our UMMC Breast Cancer Registry. The TRD and FN rates were then determined retrospectively from medical records. TRD was defined as death occurring during or within 30 days of completing chemotherapy as a consequence of the chemotherapy treatment. FN was defined as an oral temperature >38.5°C or two consecutive readings of >38.0°C for 2 hours and an absolute neutrophil count

Locoregional recurrence after mastectomy for breast cancer may predict distant recurrence and mortality. This study examined the pattern and rates of post-mastectomy locoregional recurrence (PMLRR), survival outcome and prognostic factors for isolated PMLRR (ILR) in a breast cancer cohort in University of Malaya Medical Center (UMMC).We studied 522 patients who underwent mastectomy between 1998 and 2002 and followed them up until 2008. We defined PMLRR as recurrence to the axilla, supraclavicular nodes and or chest wall. ILR was defined as PMLRR occurring as an isolated event. Prognostic factors for locoregional recurrence were determined using the Cox proportional hazards regression model.The overall PMLRR rate was 16.4%. ILR developed in 42 of 522 patients (8.0%). Within this subgroup, 25 (59.5%) remained disease free after treatment while 17 (40.5%) suffered disease progression. Univariate analyses identified race, age, size, stage, margin involvement, lymph node involvement, grade, lymphovascular invasion and ER status as probable prognostic factors for ILR. Cox regression resulted in only stage III disease and margin involvement as independent prognostic factors. The hazard of ILR was 2.5 times higher when the margins were involved compared to when they were clear (aHRR 2.5; 95% CI 1.3 to 5.0). Similarly, compared with stage I those with Stage II (aHRR 2.1; 95%CI 0.6 to 6.8) and stage III (aHRR 4.6; 95%CI 1.4 to 15.9) had worse prognosis for ILR.Margin involvement and stage III disease were identified to be independent prognostic factors for ILR. Close follow-up of high risk patients and prompt treatment of locoregional recurrence were recommended.

Locally advanced breast cancer (LABC) is characterized by the presence of a large primary tumour (5 cm) associated with or without skin or chest-wall involvement (T4) or with fixed (matted) axillary lymph nodes in the absence of any evidence of distant metastases. These cancers are classified as stage IIIA and IIIB according to the AJCC Staging System. Treatment of choice involves combinations of surgery, chemotherapy, radiotherapy and/or hormonal therapy. Current guidelines recommend primary surgery or neoadjuvant therapy followed by surgery. The primary objective of this study was to compare the outcome of LABC patients subjected to neoadjuvant chemotherapy before surgery and those who underwent surgery as the primary treatment and to determine prognostic predictors. Secondary objectives were to evaluate the response after neoadjuvant therapy and to determine the treatment compliance rate.This retrospective study of Stage III breast cancer patients was conducted over a 5 year period from 1998 to 2002. The survival data were obtained from the National Registry of Births and Deaths with the end-point of the study in April 2006. The Kaplan Meier method was applied for survival analysis. Cox regression analysis by stepwise selection was performed to identify important prognostic factors.Out of a 155 evaluable patients, 74 (47.7%) had primary surgery, 62 (40%) had neoadjuvant chemotherapy, 10 patients (6.5%) were given Tamoxifen as the primary treatment, while 9 patients (5.8%) defaulted any form of treatment. After neoadjuvant chemotherapy, 9 patients defaulted further treatment, leaving 53 evaluable patients. Out of these 53 evaluable patients, 5 patients (9.4%) had complete pathological response, 5 (9.4%) a complete clinical response, and 26 (49.1%) had partial response after neoadjuvant chemotherapy. The 5-year survival in the primary surgery group was 56.7 % compared to 44.7% in the neoadjuvant chemotherapy group (p0.01). The important prognostic factors were race, size of tumour, nodal status, estrogen receptor status and response to neoadjuvant chemotherapy.Patients who had primary surgery had better survival than those who underwent neoadjuvant chemotherapy, which may be due to bias in the selection of patients for neoadjuvant chemotherapy. Out of a total of 155 patients, 25.1% defaulted part of the treatment, or did not receive optimal treatment, emphasizing the importance of psychosocial support and counselling for this group of patients.

The proteomics approach was adopted to study the simultaneous expression of serum proteins in patients with nasopharyngeal carcinoma (NPC). We have subjected unfractionated whole sera of ten newly diagnosed Malaysian Chinese patients with WHO type III NPC to two-dimensional gel electrophoresis (2-DE) and image analysis. The results obtained were then compared to that generated from sera of ten normal healthy controls of the same ethnic group and range of age. Our data demonstrated that the serum high abundance 2-DE protein profiles of NPC patients were generally similar to that of the controls, with exception of the ceruloplasmin (CPL) spots (identified by mass spectrometric analysis and MASCOT database search), which showed higher expression. The enhanced expression of CPL in the patients' sera was confirmed by competitive ELISA. Immunohistochemical analysis of nasopharyngeal lesions of NPC patients demonstrated moderate to strong positive CPL staining in the cytoplasm of cells at the regions of malignancy but only weak cytoplasmic staining at normal epithelial lining areas. When follow-up 2-DE and ELISA studies were performed on five of the NPC patients who responded positively to six months treatment, the difference in CPL expression was no longer significant.

Background: The risk of TRD with adjuvant chemotherapy for early breast cancer is unknown in Malaysia despite its widespread usage. This study aims to determine this rate in a large cohort of patients treated in UMMC. Patients & Methods: Patients who were treated with neoadjuvant or adjuvant chemotherapy for early breast cancer stages I, II or III from 2000-2007 in UMMC were identified from our UMMC Breast Cancer Registry. The TRD rate and 5 years overall survival (OS) were determined. TRD is defined as death occurring during or within 30 days of completing chemotherapy as a consequence of the chemotherapy treatment. OS was defined as death from any cause from the date of diagnosis to the date of death. OS was determined using the Kaplan-Meier method and differences between AJCC stages were compared by log-rank test. Results: A total of 1317 were identified for analysis. The median age at diagnosis was 49 years with a range of 24 to 74 years. The rate of TRD was 0.1%. The 5 years OS rate was 77.3% with a median follow up of 62 months. The 5 years OS according to AJCC stage were 90.7% for stage I, 83.9% for stage II and 62.2% for stage III disease. The commonest chemotherapy regimen used was the FEC (5-Fluorouracil, Epirubicin, Cyclophosphamide) regimen accounting for approximately 90% of the cases. Conclusion: Adjuvant chemotherapy for early breast cancer with the FEC regimen is safe with a TRD rate of 0.1% in our centre. Background The role of chemotherapy in cancer treatment is highly misunderstood not just in the public domain but also amongst medical practitioners. The fact that chemotherapy only plays a minor role as a definitive modality of cancer treatment is not well understood and it is mainly limited to haematological malignancies and germ cell tumours. Chemotherapy's role in the treatment of solid tumours is mainly confined to neoadjuvant, adjuvant and palliative settings. As such, it is of utmost importance to be cognizant to the rate of TRDs with chemotherapy other than being aware of its potential benefits when used in these settings. Informing patients that this risk is negligible or less than one percent which is the figure often quoted by clinicians may be inadequate as this gives the impression that it is extremely rare. Moreover less than 1% can mean anywhere between 1 in 1001, 1 in 10000, 1 in 100000, 1 in 1000000 and so forth. Patients deserve to fully understand the real risk of TRDs and equally important is the need for clinicians to realize that TRDs are much commoner than perceived. There are various definitions of TRD used in the literature. For the purpose of this study the TRD was defined as deaths that occurred less than or equal to 30 days after the last cycle of chemotherapy, death of which was due to the chemotherapy itself. This definition was chosen as it was commonly used in many reported phase 3 trials and it is the least ambiguous amongst all definitions encountered in the literature. One major drawback is the fact that it does not take into account deaths that may be related to the long term side effects of chemotherapy for example deaths due to cardiac events which is especially relevant for anthracycline drugs commonly used for breast cancer treatment. Having said that, it is very difficult to prove that these deaths are directly due to the effect of chemotherapy alone as there are frequently many other confounding factors. Breast cancer is the commonest cancer treated with adjuvant chemotherapy in Malaysia. A commonly used regimen is the FAC regime (5 Fluorouracil, Adriamycin, Cyclophosphamide). In a trial involving 1491 patients in node positive breast cancer patients post definitive surgery, 745 patients received adjuvant TAC (Docetaxel, Adriamycin, Cyclophosphamide) and 746 patients received FAC. The TRDs for the TAC group and FAC group was similar at 0.3%. (1). The commonest regime used in our center is the FEC regime (5 Fluorouracil, Epirubicin, Cyclophosphamide). A pivotal phase 3 study, PACS 01 trial compared the FEC regime for 6 cycles with the FEC-D regime (FEC3-Docetaxel3) involving 996 patients in the FEC arm and 1003 patients in the FEC-D arm. Although significant high rates of febrile neutropaenia at 8.4% and 11.2% were reported in the FEC and FEC-D arms respectively, there were no early TRDs. However, there was one delayed cardiac death in each

Aim: Feeling distressed is often a normal reaction to the diagnosis of cancer and cancer treatment. However, if excessive, distress may lead to more disabling conditions such as depression and anxiety. The aims of the study were to determine the prevalence and level of distress in patients with cancer who were undergoing chemotherapy and to examine the associated factors related to psychological distress in these patients. Methods: Adult patients with confirmed cancer who were undergoing out-patient chemotherapy at the Clinical Oncology Unit, Universiti Malaya Medical Centre were invited to participate in the study. They were assessed on their sociodemographic profiles, clinical history, distress level as measured using the ‘Distress Thermometer’, and problems checklist on practical, family, emotional and physical symptoms. The Hospital Anxiety Depression Scale (HADS) was used by patients to report anxiety and depression. Results: One hundred and sixty-eight patients with mean age of 50 years participated in the study. The prevalence of psychological distress determined by the ‘Distress Thermometer’ was 51%. HADS found the prevalence of depression/anxiety to be 32%. There was no significant association between distress and the primary site of cancer, the phase of chemotherapy and the sociodemographic profiles except for age (r = −0.21, P = 0.007). Distress was significantly associated with practical, family and emotional problems. Some of the physical problems such as appearance, breathing, changes in urination, constipation, eating, fatigue, getting around, memory/concentration, nausea, pain and sleep were also significantly associated with distress. Conclusion: Cancer patients undergoing chemotherapy experienced high level of distress. This finding should alert oncologists that some patients exhibiting these signs of distress may need referral to the mental health team.

Introduction: Uncoordinated data collection by different research groups prompted the initiation of Malaysian oral cancer Research Initiative (MOCRI) group. Objectives: To coordinate and standardize data and tissue collection and storage, develop a minimum dataset on risk factors, intervention techniques and quality of life of oral cancer patients. Materials and Methods: A computer software programme is currently being developed to accommodate multi-centre data collection and research activities in eight hospitals. The complete dataset includes parameters on sociodemographic, clinical, pathological, quality of life measures, details of treatment methods, vital status and dietary intake. Tissues are being collected, stored and catalogued as fresh and formalin-fixed tissues for future use in satellite researches. The networking in tissue and data collection includes the establishment of oral cancer cell-lines. These tissues are being planned for studies on genetic profile, genetic polymorphism, diagnostic and prognostic markers. Results: Tissues and data on 115 oral cancers, 9 leukoplakia and 13 lichen planus has been collected since 2003. Preliminary data from 2004 were analysed for 58 cancer patients. Majority of them are more than 60 years old (65.5%) with a mean age of 63.3. Twenty-four (41.4%) were males, 34 (58.6%) females with the majority of them being Indians (56.9%) followed by Chinese and Malays (15.5% each), Indigenous people of Sabah and Sarawak (12.1%). Eighteen (31%) respondents were smokers, 17 (29.3%) alcohol drinkers and 31 (53.4%) betel quid chewers. Five patients have had histories of family cancers where 3 included immediate family members with head and neck cancers. For the quality of life measure, only 30.2% felt that their daily activities were disrupted despite having advanced cancers. Satellite researches are in progress on genetic polymorphism and tumour markers. One oral cancer cell-line has been established. Conclusion: The establishment of oral cancer database and tissue bank in encouraging and supports on-going satellite researches.

710 Background: Two-drug combinations of GEM and paclitaxel (P) or docetaxel (D) have shown promising efficacy in MBC. This study evaluated efficacy and safety of GEM plus single or split dose taxanes. Methods: Major eligibility criteria: tissue diagnosis of breast carcinoma; stage IV; prior anthracycline therapy; KPS ≥70; age ≥18; adequate bone marrow, liver and kidney function; written informed consent. Patients (pts) were randomized to receive: GEM 1250 mg/m2 D1+8 and P 175 mg/m2 as 3-hr infusion D1 (GP1); GEM 1000 mg/m2 D1+8 and P 100 mg/m2 as 1-hr infusion D1+8 (GP2); GEM 1000 mg/m2 D1+8 and D 40 mg/m2 as 1-hr infusion D1+8 (GD) in a 3-week cycle (8 cycles max). Primary endpoint was response rate; secondary endpoints were time to progression (TTP), time to treatment failure (TTTF), response duration and toxicity. Results: 210 pts were enrolled, 208 qualified for safety and time-to-event efficacy analysis, 204 for response assessment. Baseline variables were balanced across arms. Dominant site of dise...